I Bytes Healthcare industry

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I-Bytes
Healthcare
December Edition 2020
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Table of Contents
1. Financial, M & A Updates..................................................................................................................................1
2. Solution Updates...............................................................................................................................................23
3. Rewards and Recognition Updates.................................................................................................................82
4. Customer Success Updates..............................................................................................................................89
5. Partnership Ecosystem Updates.....................................................................................................................93
6. Environment & Social Updates......................................................................................................................122
7. Miscellaneous Updates....................................................................................................................................126

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Financial, M & A
Updates Healthcare Industry

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Financial, M&A Updates
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AstraZeneca (UK) to Acquire Alexion, Accelerating the Company's Strategic and
Financial Development
AstraZeneca and Alexion Pharmaceuticals, Inc. (Alexion) have entered into a definitive
agreement for AstraZeneca to acquire Alexion. Alexion shareholders will receive $60 in
cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) (each ADS
representing one-half of one (1/2) ordinary share of AstraZeneca, as evidenced by
American Depositary Receipts (ADRs)) for each Alexion share. Based on AstraZeneca's
reference average ADR price of $54.14, this implies total consideration to Alexion
shareholders of $39bn or $175 per share. The boards of directors of both companies have
unanimously approved the acquisition. Subject to receipt of regulatory clearances and
approval by shareholders of both companies, the acquisition is expected to close in Q3
2021, and upon completion, Alexion shareholders will own c.15% of the combined
company. Both companies share the same dedication to science and innovation to deliver
life-changing medicines. The capabilities of both organisations will create a company
with great strengths across a range of technology platforms, with the ability to bring
innovative medicines to millions of people worldwide. The combined company will also
have an enhanced global footprint and broad coverage across primary, speciality and
highly specialised care.
Executive Commentary
Chief Executive Officer, Alexion, said: “For nearly 30 years Alexion has worked to
develop and deliver transformative medicines to patients around the world with rare
and devastating diseases. I am incredibly proud of what our organisation has
accomplished and am grateful to our employees for their contributions. This
transaction marks the start of an exciting new chapter for Alexion. We bring to
AstraZeneca a strong portfolio, innovative rare disease pipeline, a talented global
workforce and strong manufacturing capabilities in biologics. We remain committed
to continuing to serve the patients who rely on our medicines and firmly believe the
combined organisation will be well positioned to accelerate innovation and deliver
enhanced value for our shareholders, patients and the rare disease communities.”
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Astellas (Japan) Transfers DIFICLIRTM in Europe, Middle East, Africa and selected
CIS to Tillotts Pharma
Astellas Pharma Inc. announced that the subsidiary Astellas Pharma Europe Ltd. and Tillotts Pharma AG (“Tillotts”) have entered into
an Asset Purchase Agreement, under which Astellas Europe will transfer its marketing authorizations for “DIFICLIRTM (generic name:
fidaxomicin) tablets” for Clostridium difficile (CD)1 infections in Europe, Middle East, Africa and selected Commonwealth of
Independent States (CIS)2 to Tillotts. After the closing of the agreement and according to transitional arrangements, Tillotts will take
over DIFICLIRTM from Astellas and manufacture and sell it in Europe, Middle East, Africa and selected CIS. Astellas will continue to
work with Tillotts Pharma to promptly transfer its marketing authorizations to ensure stable delivery of this product to patients.
DIFICLIRTM is a unique narrow-spectrum macrocyclic anti-bacterial agent3 available as film-coated tablets and granules licensed from
a subsidiary of Merck & Co., Inc. Kenilworth, N.J., U.S.A., known as MSD outside the U.S. and Canada. Astellas Europe has been
selling DIFICLIRTM in Europe since 2012 and expanded our sales area to the Middle East and Africa. Astellas will continue to sell
Dafclir® tablets in Japan, where it has the marketing authorization for the treatment of infectious enteritis (including
pseudomembranous colitis4) (susceptible strains: fidaxomicin susceptible CD).
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AstraZeneca (UK): Crestor to be divested to Grünenthal in Europe
AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines
in over 30 countries in Europe, except the UK and Spain, to Grünenthal GmbH (Grünenthal).
Crestor is a statin approved for the treatment of dyslipidaemia and hypercholesterolaemia.
AstraZeneca will continue to manufacture and supply Crestor to Grünenthal during a
transition period. AstraZeneca will also continue selling the medicine in other countries,
including those in North America, in Japan, China and other emerging markets. The
divestment is anticipated to close in the first quarter of 2021, subject to customary closing
conditions and regulatory clearances, upon which Grünenthal will make an upfront,
non-contingent payment to AstraZeneca of $320m and may also make future milestone
payments of up to $30m. Income arising from the upfront and future payments will be
reported in AstraZeneca’s financial statements within Other Operating Income & Expense.
The divestment will not impact the Company’s financial guidance for 2020. Pursuant to
London Stock Exchange listing rule 10.4.1R (notification of class 2 transactions), the gross
book value of assets subject to the divestment as of 31 December 2019 was nil. In 2019,
Crestor generated Product Sales of $136m and Profit before Tax of $98m in the countries
covered by the agreement. The consideration will be paid in cash and the proceeds used for
general corporate purposes.
Executive Vice President, BioPharmaceuticals Business Unit, said: “This agreement
supports the management of our mature medicines to enable reinvestment into the
pipeline and bringing new, innovative treatments to patients. Grünenthal previously
acquired the rights to several established AstraZeneca medicines and is well placed to
ensure continued access to Crestor for patients across Europe.”
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Baxter BioPharma Solutions (USA) Announces $50 Million Investment to
Expand Sterile Fill/Finish Manufacturing Site in Bloomington, Ind.
Baxter International Inc., a global leader in sterile medication production and
delivery, announced a $50 million expansion of its sterile fill/finish
manufacturing facilities located in Bloomington, Ind. These facilities are operated
by Baxter’s BioPharma Solutions business, a premier contract manufacturing
organization that specializes in parenteral (injectable) pharmaceuticals. The
expansion is being funded by a combination of Baxter and client investment.
Additional details of the agreement were not disclosed. The planned expansion of
existing facility infrastructure includes construction of a new 25,000 square foot
warehouse; a new filling line for flexible plastic containers; a high-speed
automated syringe fill line capable of filling up to 600 units per minute and a new
high-speed automated visual inspection line. Construction is currently underway
and is expected to be completed in 2021. Contract product manufacturing in the
expanded facilities is expected to begin in 2022. The new facilities will support
programs that are expected to add approximately 100 new jobs at the site, in
addition to jobs created due to construction.
“We pride ourselves on being a contract manufacturing partner with the
specialized expertise, proven experience, and facilities to help our clients
successfully achieve their sterile manufacturing objectives,” said vice
president, BioPharma Solutions. “Our Bloomington facility is already a
global leader in sterile contract manufacturing, and this expansion will add
capacity and state-of-the-art technology that will better enable us to meet the
diverse needs of our clients and the patients they serve.”
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Bio-Rad (USA) Reports Third-Quarter 2020 Financial Results
• Third-quarter 2020 net sales were $647.3 million, an increase of 15.5 percent compared to $560.6 million
reported for the third quarter of 2019.
• Life Science segment net sales for the third quarter were $324.0 million, an increase of 50.2 percent
compared to the same period in 2019.
• Clinical Diagnostics segment net sales for the third quarter were $322.2 million, a decrease of 5.7 percent
compared to the same period in 2019.
• Income from operations during the third quarter of 2020 was $109.6 million versus $57.5 million during the
same quarter last year.
• Net income for the third quarter of 2020 was $1,314.8 million, or $43.64 per share on a diluted basis versus
a net loss of ($258.8) million, or ($8.68) per share, on a diluted basis, during the same period in 2019.
• Non-GAAP net income for the third quarter of 2020 was $90.3 million, or $3.00 per share on a diluted basis,
compared to $48.6 million, or $1.61 per share on a diluted basis, during the same period in 2019.
• The non-GAAP effective tax rate for the third quarter of 2020 was 22.5 percent, compared to 25.5 percent
for the same period in 2019. The decrease in the rate was driven by a change in our geographic mix of earnings
and the taxation of our foreign earnings.
• On a reported basis, net sales for the first three quarters of 2020 increased 4.1 percent to $1,755.8 million
compared to $1,687.2 million for the same period in 2019. On a currency-neutral basis, net sales grew 5.0
percent.
• Year-to-date net income for 2020 was $2,967.2 million, or $98.46 per share on a fully diluted basis,
compared to $1,205.2 million, or $39.97 per share, respectively, during the same period in 2019.
"As we anticipated, sales during the third quarter continued to be impacted both positively and negatively
by the coronavirus pandemic," said Bio-Rad President and Chief Executive Officer. "However, we
experienced increased activity and lab utilization across our customers, globally. Although the COVID-19
situation is still unpredictable, we remain focused on our core strategies as well as our contributions in
response to the pandemic. We would like to recognize our employees around the world who continue to
make extraordinary efforts to serve our customers during this challenging time. Although 2020 was met with
many challenges, our team has been able to effectively respond. "As we head into the end of the year, we
continue to expect a gradual improvement in our end-markets. Through our team's discipline and tight cost
control in this unique year, we expect to generate significantly higher operating profit over 2019."
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Boston Scientific (USA) Signs Definitive Agreement to Divest BTG Specialty
Pharmaceuticals Business
Boston Scientific Corporation announced that it has entered into a
definitive agreement with Stark International Lux S.A.R.L., and
SERB SAS, affiliates of SERB, a European specialty pharmaceutical
group, to sell its BTG Specialty Pharmaceuticals business for $800
million in cash. SERB, backed by private equity firm Charterhouse
Capital Partners since 2017, owns a diversified portfolio of
prescription medicines focused on rare and life-threatening diseases.
The BTG Specialty Pharmaceuticals business develops, manufactures
and commercializes life-saving antidotes used in hospitals and
emergency care settings, including the clinically proven and leading
products CroFab®, DigiFab®, and Voraxaze®. The three franchises
are expected to generate approximately $210 million in revenue for
the full year 2020.
"After acquiring BTG in 2019 for approximately $3.7 billion net of
cash on hand, and following the close of this transaction, we will
have divested the two BTG non-medical device portions –
Pharmaceutical Licensing royalties in the fourth quarter of 2019
and Specialty Pharmaceuticals announced – for more than $1.0
billion in net proceeds," said executive vice president and
president, Peripheral Interventions, Boston Scientific. "We
continue to be very pleased with the performance of the core
Interventional Medicines business, the primary driver of the BTG
acquisition, which has delivered strong growth and is expected to
exceed our original goal of $175 million in synergies."
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Centene (USA) Completes Acquisition of Apixio
Centene Corporation announced that it has completed its
acquisition of Apixio, a healthcare analytics company
offering Artificial Intelligence (AI) technology solutions.
With this transaction, Centene will continue to digitize the
administration of healthcare and accelerate innovation and
modernization across the enterprise. As previously
announced, Apixio will remain an operationally
independent entity as part of Centene's Health Care
Enterprises group to continue bringing value to its clients
and the industry, while also realizing the benefits of
enhanced scale with Centene.
"We are pleased to have completed our acquisition of
Apixio, further solidifying our position as a technology
company focused on healthcare," said Chairman,
President and Chief Executive Officer for Centene. "I
would like to officially welcome the Apixio team to the
Centene family and look forward to working together to
leverage comprehensive data to help improve the lives of
our members."
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Centene (USA) Signs Definitive Agreement to Acquire PANTHERx Rare
Pharmacy (PANTHERx)
Centene Corporation announced it has signed a definitive agreement to acquire
PANTHERx, one of the largest and fastest-growing specialty pharmacies in the
United States specializing in orphan drugs and rare diseases. The transaction is
subject to regulatory approvals and is expected to close by the end of 2020.
PANTHERx is a leader in rare disease pharmacy, comprehensively serving
patients afflicted with rare and devastating conditions through delivery of
medicine breakthroughs, clinical excellence, and access solutions. PANTHERx
offers a suite of synchronized compliance, logistics, and analytics solutions to
help streamline the process of delivering orphan medications and care to people
living with complicated rare diseases. PANTHERx and its management team will
continue to operate independently as part of Centene's Envolve Pharmacy
Solutions, a total drug management program that includes integrated Pharmacy
Benefit Manager (PBM) services and specialty pharmacy solutions to millions of
members throughout the United States.
"Centene has a long-standing commitment to providing care to the most
underserved, complex populations," said Chairman, President and Chief
Executive Officer for Centene. "PANTHERx adds a unique capability to our
comprehensive pharmacy portfolio. We share a common goal of helping to
remove barriers and reduce the burden for our members living with complex
and rare diseases."
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Centene Corporation (USA) Announces 2021 Guidance
• Total revenues are expected to be $114.1 billion to $116.1 billion, and diluted earnings
per share are expected to be $3.82 to $4.06.
• Adjusted diluted earnings per share for 2021 are expected to be $5.00 to $5.30.
• Health benefits ratio of approximately 86.6% to 87.2%.
• Selling, general and administrative (SG&A) expense ratio of approximately 8.8% to
9.3%.
• Adjusted SG&A expense ratio of approximately 8.6% to 9.1%, which excludes $189
million to $220 million of acquisition related expenses.
• Effective tax rate of approximately 24.7% to 26.7%.
• Diluted shares outstanding of approximately 590.1 million to 593.1 million.
• The Company affirms its 2020 total revenues guidance in the previously announced
range of $109.8 billion to $111.4 billion.
• The Company updates its diluted earnings per share to a range of approximately $3.08
to $3.18.
• The Company affirms its adjusted diluted earnings per share guidance in the previously
announced range of approximately $4.90 to $5.06.
"In what has been an extraordinary year, Centene delivered a strong performance.
Leveraging the scale, breadth and agility of our diversified healthcare enterprise, we
supported our members, providers and state partners – while generating significant top-
and bottom-line growth for our shareholders in 2020," said Chairman, President and
Chief Executive Officer of Centene. "While our Marketplace enrollment is not coming
in as expected, which we will discuss further at our investor conference, we are
confident in the strength of our underlying business looking into 2021 and remain
focused on our mission serving our growing member base."
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Edwards Lifesciences (USA) Reports Third Quarter Results
• Sales for the quarter ended September 30, 2020, were $1.1 billion, an increase of 4% over the prior year, on both a reported and underlying basis.
Diluted earnings per share for the quarter were $0.52, while adjusted earnings per share grew 9% to $0.51.
Surgical Structural Heart and Critical Care
• Surgical Structural Heart sales for the quarter were $203 million, similar to 2019 levels. During the third quarter, patients were more willing to seek
heart valve surgery and hospitals more able to manage surgical patient flow. Ongoing prioritization of heart surgery in many hospitals also contributed to
rebounding case volumes.
• Critical Care sales were $181 million for the quarter, in-line with the year-ago period. Demand for the company's products used in cardiac surgeries
was solid but was offset by the COVID-driven impact of delayed elective procedures. Sales of Edwards' TruWave disposable pressure monitoring devices
used in the ICU were lifted by a large one-time order in Europe associated with ICU capacity expansion.
Additional Financial Results
• For the quarter, the company's adjusted gross margin was 75.5%, down from 75.9% in the prior year quarter. This decrease was driven by a negative
impact from foreign currency fluctuations and incremental costs associated with responding to COVID, partially offset by improved manufacturing
efficiencies.
• Selling, general and administrative expenses in the third quarter were $307 million, or 26.9% of sales, compared to $306 million in the prior year.
This consistent level of spending included increased transcatheter structural heart field personnel related expenses, including expanding the TMTT field
organization in Europe, offset by reduced spending resulting from COVID.
• Research and development expenses in the third quarter were $196 million, or 17.1% of sales, compared to $195 million in the prior year. This
consistent level of spending included increased investments in transcatheter mitral valve replacement clinical trials, partially offset by lower TAVR clinical
trial expenses and reduced spending resulting from COVID.
• Free cash flow for the third quarter was $113 million, defined as cash flow from operating activities of $216 million, less capital spending of $103
million.
• Cash and investments totaled $1.9 billion at September 30, 2020. Total debt was $595 million.
Outlook
• For the fourth quarter of 2020, the company anticipates year-over-year underlying sales growth similar to the third quarter. The company is raising
the bottom end of full-year 2020 adjusted earnings per share guidance to $1.85 to $1.95, versus previous guidance of $1.75 to $1.95. Looking ahead to 2021,
while still early in the forecasting process, the company anticipates a return to double-digit TAVR growth and aspires to double 2020 TMTT sales.
"I am very proud of the way our passionate team is serving patients during this difficult period. Our supply chain has delivered and our field team
has continued to support the dedicated clinicians that count on Edwards," said chairman and CEO. "We are pleased to report better-than-expected
third quarter results despite the challenges of the ongoing COVID pandemic."
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Lilly (USA) Announces Agreement to Acquire Prevail Therapeutics
Eli Lilly and Company and Prevail Therapeutics Inc. announced a definitive agreement for Lilly
to acquire Prevail for $22.50 per share in cash (or an aggregate of approximately $880 million)
payable at closing plus one non-tradable contingent value right ("CVR") worth up to $4.00 per
share in cash (or an aggregate of approximately $160 million), for a total consideration of up to
$26.50 per share in cash (or an aggregate of approximately $1.040 billion). The CVR is payable
(subject to certain terms and conditions) upon the first regulatory approval of a product from
Prevail's pipeline as set forth in more detail below. Prevail is a biotechnology company
developing potentially disease-modifying AAV9-based gene therapies for patients with
neurodegenerative diseases. The acquisition will establish a new modality for drug discovery and
development at Lilly, extending Lilly's research efforts through the creation of a gene therapy
program that will be anchored by Prevail's portfolio of clinical-stage and preclinical neuroscience
assets. Prevail's lead gene therapies in clinical development are PR001 for patients with
Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD)
and PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN).
Prevail's preclinical pipeline includes PR004 for patients with specific synucleinopathies, as well
as potential gene therapies for Alzheimer's disease, Parkinson's disease, amyotrophic lateral
sclerosis (ALS), and other neurodegenerative disorders.
"Gene therapy is a promising approach with the potential to deliver transformative
treatments for patients with neurodegenerative diseases such as Parkinson's, Gaucher and
dementia," said M.D., vice president of pain and neurodegeneration research at Lilly. "The
acquisition of Prevail will bring critical technology and highly skilled teams to complement
our existing expertise at Lilly, as we build a new gene therapy program anchored by
well-researched assets. We look forward to completing the proposed acquisition and working
with Prevail to advance their groundbreaking work through clinical development."
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Lilly (USA) Announces 2021 Financial Guidance, Updates 2020
Guidance
• The company has updated certain elements of its 2020 financial guidance. On a reported basis, earnings per share for 2020
are now expected to be in the range of $6.28 to $6.48. On a non-GAAP basis, earnings per share for 2020 are now expected to
be in the range of $7.45 to $7.65.
• Revenue for 2020 is now expected to be in the range of $24.2 billion to $24.7 billion, reflecting expectations of increased
bamlanivimab sales due to an additional purchase agreement with the U.S. government.
• Gross margin as a percent of revenue is still expected to be approximately 78 percent on a reported basis and is now
expected to be approximately 79 percent on a non-GAAP basis, reflecting expectations of increased bamlanivimab sales.
• Marketing, selling and administrative expenses are still expected to be in the range of $6.0 billion to $6.1 billion. Research
and development expenses are still expected to be in the range of $5.8 billion to $5.9 billion.
• Operating margin, defined as operating income as a percent of revenue, is still expected to be approximately 25 percent
on a reported basis, and is now expected to be approximately 30 percent on a non-GAAP basis.
• Other income (expense) is now expected to be income in the range of $600 million to $700 million, reflecting additional
projected gains on investments in equity securities. The market valuations for these securities could fluctuate significantly
throughout the remainder of the year, with current valuations placing other income (expense) above the revised 2020 guidance
range.
• The 2020 effective tax rate is still expected to be approximately 14 percent on both a reported basis and a non-GAAP
basis.
2021 Financial Guidance
• The company issued its 2021 financial guidance. Earnings per share for 2021 are expected to be in the range of $7.25 to
$7.90 on a reported basis and $7.75 to $8.40 on a non-GAAP basis. As noted, 2021 financial results will exclude gains and
losses on investments in equity securities from non-GAAP measures.
Lilly's chief financial officer, outlined the company's near-term growth prospects and provided 2021 financial guidance.
"We're pleased with our performance despite the unprecedented challenges facing the world in 2020. We expect 2021 to
be another exciting year for Lilly, characterized by robust volume-driven revenue growth for our key medicines, while we
continue to invest in and progress our pipeline, expand operating margins and deliver impressive EPS and cash flow
growth. Reflecting this growth, we have announced a 15 percent increase in our dividend for 2021. One year after we
outlined our high-level outlook through 2025, we are increasingly confident in our ability to deliver top-tier revenue
growth and operating margin percent expansion into the mid-to-high 30s during this timeframe."
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Fresenius (Germany) Helios acquires fertility services provider Eugin Group
Fresenius Helios acquires Luarmia S.L. and NMC Eugin US Corporation (together “Eugin Group”), one of
the leading international fertility groups, at a valuation of €430 million3 from NMC Health4. Eugin Group’s
network comprises 31 clinics and additional 34 sites across 9 countries on 3 continents. With about 1,300
employees, the company offers a wide spectrum of state-of-the-art services in the field of fertility
treatments. The transaction is expected to be highly accretive to Group net income2 already in 2021.
Fresenius Helios does not expect any meaningful integration expenses. Through healthy organic growth
coupled with a series of strategic acquisitions, Eugin Group has grown from a local player in Spain to a
global leader within five years. In 2019, Eugin Group acquired the leading U.S. fertility chain Boston IVF,
creating one of only two fertility groups with a global footprint. Demographic and health trends, as well as
changing lifestyle choices have proven to be strong and sustainable underlying growth drivers of the
fertility market in recent years. Notable scientific advances in this field have led to higher success rates and
less strain for patients. The global market for fertility services is highly fragmented, representing an
attractive opportunity for consolidation. Fresenius Helios has already for many years been a
well-established provider of fertility treatments in selected hospitals and outpatient centers in Germany,
Spain and Latin America. In 2019, Fresenius Helios performed more than 10,000 cycles5 for around 7,000
patients, most of them in Spain. In Germany, Fresenius Helios had around 800 referrals related to fertility
treatments being performed by external providers. With the acquisition of Eugin Group, Fresenius Helios
becomes a leading player in this dynamic growing market and establishes a strong basis for further
expansion.
CEO of Fresenius, said: “Eugin and Fresenius Helios are an excellent fit. Eugin is highly profitable and
holds excellent positions in attractive country markets. Its proven management team shares our focus
on patient well-being and dedication to medical excellence. With this acquisition, we are creating a
unique buy-and-build platform that offers substantial organic and non-organic growth opportunities.
By bundling existing in- and outpatient services from our network, the new platform will serve as an
accelerator for holistic and interdisciplinary patient care, while leveraging significant synergies.”
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Intuitive (USA) Launches $100 Million Venture Capital Fund
Intuitive, a global technology leader in minimally invasive care and the pioneer of
robotic-assisted surgery, announced the launch of Intuitive Ventures. The inaugural $100
million fund will invest in the future leaders of minimally invasive care. Intuitive
Ventures is focused on investment opportunities in digital tools, precision diagnostics,
focal therapeutics and platform technologies that share Intuitive’s commitment to
advancing positive outcomes in healthcare. The fund will support independent initiatives
in the direct and adjacent fields of minimally invasive care and marks the entrance into
the venture capital space for parent company Intuitive. Leveraging Intuitive’s
entrepreneurial spirit and expansive technological and clinical reach, Intuitive Ventures
invests in transformative opportunities advancing positive outcomes in healthcare. The
fund is focused on U.S. and international early stage start-ups and takes a long-term
outlook to support portfolio companies reach their major milestones. Through its
inaugural $100 million fund and with leadership combining decades of investing and
operational experience, the team cultivates strategic resources to drive financial returns
and accelerate the future of minimally invasive care. Intuitive Ventures has already
started deploying capital and is actively building its portfolio.
“The future of minimally invasive care spans the patient journey from early
diagnosis to treatment and beyond,” said President of Intuitive Ventures. ”Intuitive
Ventures is investing in cutting-edge innovation across the continuum of care to
bring the future forward.”
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Janssen (USA) Acquires Rights to Novel Gene Therapy, Pioneering Treatment
Solutions for Late-Stage Age-Related Macular Degeneration
Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson,
announced the acquisition of rights to Hemera Biosciences, LLC’s investigational gene therapy HMR59,
administered as a one-time, outpatient, intravitreal injection to help preserve vision in patients with
geographic atrophy, a late-stage and severe form of age-related macular degeneration (AMD). Financial
terms of the transaction with Hemera Biosciences, a privately-owned biotechnology company, are not being
disclosed. Patients with AMD often have low levels of CD59, a protein that protects the retina from damage
caused by an essential part of the body’s natural immune response called “complement.” In geographic
atrophy, an overactivity of complement destroys cells in the macula, the central part of the retina
responsible for central vision and seeing fine details, and results in a relentless progression to blindness.
HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent
further damage to the retina and preserve vision. Geographic atrophy affects five million[i] people globally,
and is a leading cause of blindness in people over 50 years of age. The prevalence of geographic atrophy
increases as the global population ages with roughly one in 29 people over age 75 affected, and nearly one
in four people over age 90. There are currently no available therapies other than vitamins and low vision
aids. Gene therapy is an important modality for both therapeutic delivery and protein replacement, and one
of the ways Janssen aims to significantly improve health outcomes for patients. Beginning with the eye,
Janssen is rapidly developing expertise in the manufacturing, development, and commercialization of gene
therapies across a range of mechanisms of action, building the case for future applications to other parts of
the body.
“Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday
tasks, such as reading, driving, cooking, or even seeing faces,” said Global Therapeutic Area Head,
Cardiovascular & Metabolism, Janssen Research & Development, LLC. “Our aim with this novel,
single-administration gene therapy is to use our development expertise and deep heritage in vision care
to help improve patient outcomes by intervening early, halting the progression to blindness, and
preserving more years of sight.”
Description
15

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Medtronic (Ireland) Reports Second Quarter Fiscal 2021
Financial Results
• The company reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8 percent as reported and 1.5
percent on an organic basis, which adjusts for the $59 million benefit of foreign currency translation.
• As reported, second quarter GAAP net income and diluted earnings per share (EPS) were $489 million and $0.36,
respectively.
• Second quarter U.S. revenue of $4.054 billion represented 53 percent of company revenue and decreased 2 percent as
reported and organic.
• Cardiac Rhythm & Heart Failure second quarter revenue of $1.426 billion was flat as reported and decreased 1.3 percent
organic. Arrhythmia Management revenue, including implantable defibrillators (ICDs), Pacemakers, Implantable Diagnostics,
and Cardiac Ablation Solutions declined in the low-single digits.
• Coronary & Structural Heart second quarter revenue of $831 million decreased 13.0 percent as reported and 13.6 organic,
reflecting high-twenties declines in drug-eluting stents (DES). The company experienced a slowdown in DES sales in China
ahead of the national tender announcement in mid-October.
• Aortic, Peripheral & Venous second quarter revenue of $468 million decreased 1.3 percent as reported and 1.9 percent
organic. Aortic grew in the low-single digits, Peripheral declined in the low-single digits, and Venous declined in the
high-single digits.
• Surgical Innovations second quarter revenue of $1.393 billion decreased 4.2 percent as reported and 4.9 percent organic.
Advanced Surgical declined low-single digits, reflecting the decline of worldwide surgical procedures. General Surgery
products declined in the high-single digits.
• Respiratory, Gastrointestinal & Renal second quarter revenue of $893 million increased 29.8 percent as reported and 29.7
organic, reflecting the increased demand for Respiratory Interventions products. Respiratory & Patient Monitoring grew in the
low-forties, with sales of ventilators increasing nearly four-fold, as the company increased production of its PB980 high-acuity
ventilator to address global demand.
"We're seeing a faster-than-expected recovery and approaching year-over-year growth. Our revenue growth is improving,
our pipeline is advancing, and we're gaining share in an increasing number of businesses. At the same time, we're in the
process of implementing our new operating model and augmenting our culture with a focus on market share and being
bold," said Medtronic chief executive officer. "Despite the challenges posed by the pandemic, we're well positioned to
accelerate growth over the medium- and long-term as we continue investing in and progressing a number of
opportunities, creating value for society and our shareholders."
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Merck (USA) to Acquire OncoImmune
Merck known as MSD outside the United States and Canada, and OncoImmune, a
privately-held, clinical-stage biopharmaceutical company, announced that the companies
have entered into a definitive agreement pursuant to which Merck, through a subsidiary,
will acquire all outstanding shares of OncoImmune for an upfront payment of $425
million in cash. In addition, OncoImmune shareholders will be eligible to receive
sales-based payments and payments contingent on the successful achievement of certain
regulatory milestones. OncoImmune recently announced positive top-line findings from
an interim efficacy analysis of a Phase 3 study evaluating its lead therapeutic candidate
CD24Fc for the treatment of patients with severe and critical COVID-19. Interim
analysis of data from 203 participants (75% of the planned enrollment) reported by
OncoImmune indicated that patients with severe or critical COVID-19 treated with a
single dose of CD24Fc showed a 60% higher probability of improvement in clinical
status, as defined by the protocol, compared to placebo. The risk of death or respiratory
failure was reduced by more than 50%. Detailed results will be submitted for publication
in a peer-reviewed medical journal.
“Meaningful new therapeutic options are desperately needed for possibly millions of
people around the world who will develop severe or critical COVID-19 disease,”
said President Merck Research Laboratories. “Recent clinical investigations support
the view that CD24Fc may provide benefit beyond standard of care therapy for
COVID-19 patients requiring oxygen support, and hence will represent an important
addition to the Merck pipeline of investigational medicines and vaccines designed to
address the COVID-19 pandemic.”
Description
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Novozymes (Denmark) acquires Microbiome Labs and adds a strong position in
the North American probiotics market
Novozymes has announced the acquisition of Microbiome Labs. Based in Illinois, US.
Microbiome Labs offers a comprehensive portfolio of proprietary probiotic and microbiome
solutions and is a vital player in the consumer health industry. The company is delivering
double-digit sales growth in 2020, resulting in a revenue of DKK ~250 million (USD ~40
million) with a positive cash flow and an EBIT margin slightly lower than Novozymes’EBIT
margin. The acquisition gives Novozymes broader access to the DKK ~40 billion global
market for human probiotics supplements and a well-established entry point into the
important North American market: a market valued at DKK ~15 billion and expected to grow
with a high-single-digit rate over the next 3-5 years. Novozymes is acquiring 100% of the
equity in Microbiome Labs for a cash payment of DKK ~780 million (USD 125 million) on
a cash and debt-free basis. The share purchase agreement includes an earn-out model with a
potential maximum payout of ~100% of the up-front cash payment. The earn-out model is
contingent on very ambitious sales targets being achieved in 2022.The acquisition will have
a negative effect in 2021 of roughly 0.5 percentage point on both Novozymes’ EBIT margin
and ROIC including goodwill due to higher amortization and invested capital. The
transaction is expected to close in the first half of January 2021.
“Within a few years, Microbiome Labs has built a solid market position and become a
key opinion leader on the microbiome in the consumer health industry, and I am very
happy to welcome Microbiome Labs to the Novozymes family. With its solid product
portfolio and position with health practitioners, the company is a natural fit and matches
our strategy of winning through scientifically proven solutions with specific health
benefits,” says President and CEO of Novozymes.
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Takeda (Japan) Completes Sale of Select OTC and Non-Core Assets to
Celltrion in Asia Pacific
Takeda Pharmaceutical Company Limited announced the completion of its previously-announced sale of a portfolio of select products to Celltrion Inc. (“Celltrion”) for a total value
of $278 million USD inclusive of milestone payments. The portfolio includes 18 pharmaceutical products and over-the-counter (OTC) products sold in Asia Pacific, which is part
of Takeda’s Growth & Emerging Markets Business Unit. This divestment agreement was first announced in June 2020. The divested portfolio includes pharmaceutical products and
OTC products in the Cardiovascular, Diabetes and General Medicine therapeutic areas, sold in Australia, Hong Kong, Macau, Malaysia, Philippines, Singapore, South Korea,
Taiwan and Thailand. The products, while addressing key patient needs in these countries and territories, are outside of the business areas Takeda has chosen as core to its global
long-term growth. As part of the deal, Takeda will continue to manufacture the portfolio of divested products and supply them to Celltrion under a manufacturing and supply
agreement.
Takeda has exceeded its $10 billion non-core asset divestiture target and has announced 10 deals since January 2019 to date for a total aggregate value of up to ~$11.3 billion,
including agreements to divest:
• Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates for a total value of
approximately JPY 242.0 billion ($2.3 billion USD).
• Other non-core portfolio assets within the Growth & Emerging Markets Business Unit, totaling ~$1.7 billion* with three separate buyers.
• Select OTC and non-core assets in Europe to Orifarm for approximately $670 million.
• Non-core assets in Europe and Canada to Cheplapharm for approximately $562 million.
• The TachoSil Fibrin Sealant Patch to Corza Health, Inc. for approximately €350 million.
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Tenet (USA) to Acquire Portfolio of Surgery Centers from SurgCenter
Development
Tenet Healthcare Corporation announced that it will acquire a portfolio of up to 45
ambulatory surgery centers (ASCs) from SurgCenter Development (SCD). The Portfolio will
be operated by Tenet’s United Surgical Partners International (USPI) subsidiary as part of its
industry-leading ambulatory surgery platform. SCD, founded in 1993, is a leading developer
of physician-owned ASCs with a history of establishing high-quality centers in partnership
with physicians with demonstrated leadership in musculoskeletal surgeries. The 45 centers
are located in Arizona, Florida, Indiana, Louisiana, Maryland, Ohio, New Hampshire, Texas
and Wisconsin. Under the terms of the transaction, the Company will purchase majority
interests in up to 45 centers by fully acquiring SCD’s interests, and partially acquiring
interests from physician partners, for approximately $1.1 billion in cash and the assumption
of approximately $18 million of center-level debt. USPI’s ownership interest will be up to 60
percent in each center, with the remainder owned by physician partners. Tenet will
consolidate the financial results of the Portfolio within its Ambulatory Care segment with the
exception of two centers in which USPI will own a minority interest. Tenet has completed the
acquisition of a majority of the 45 centers and expects to complete the acquisition of the
remainder of the Portfolio by the end of 2020, pending the finalization of documentation and
the receipt of certain state approvals.
Tenet’s Executive Chairman and CEO, said, “This is a transformative transaction within
our stated strategy to expand our ambulatory platform. It will enhance our overall
business mix and further diversify our earnings profile by accelerating our shift toward
lower cost of care, consumer-friendly, faster-growing assets for Tenet, USPI and our
physician and health system partners. The transaction is a testament to the caliber and
quality of the SCD facilities, physicians and staff, USPI’s incredible performance, and
both organizations’ quick recovery relative to the pandemic.”
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Tenet (USA) to Sell Urgent Care Platform to FastMed
Tenet Healthcare and FastMed Urgent Care announced that they have entered into a
definitive agreement under which FastMed will purchase Tenet’s urgent care platform, which
is operated under the CareSpot and MedPost brands and managed by Tenet’s United Surgical
Partners International (USPI) subsidiary. FastMed is one of the nation’s largest independent
urgent care providers with 104 locations in North Carolina, Arizona and Texas. The
transaction will add 87 CareSpot and MedPost centers, increasing patient access to
FastMed’s healthcare services in Arizona and Texas, while enabling the company to expand
into Florida and California where most of the acquired centers are located. Tenet’s urgent
care centers are well-established with a reputation for high-quality medical care. They will
complement FastMed’s portfolio, which is distinguished by its commitment to superior
patient service and adherence to the highest clinical standards. FastMed is the only
independent urgent care operator in the three states that it currently operates in that has
earned The Joint Commission’s Gold Seal of Approval® for quality, safety and infection
control in ambulatory healthcare. The transaction is expected to be completed in the first
quarter of 2021, subject to regulatory approvals and customary closing conditions. Allen
Mooney Barnes Investment Banking Group ("AMB") served as FastMed’s financial advisor
for this transaction and DLA Piper LLP (US) provided legal counsel.
Executive Chairman and CEO of Tenet Healthcare, said, “We have tremendous respect
for FastMed and are pleased that our facilities will become part of this strong and
growing urgent care business, while also enabling Tenet and USPI to sharpen our focus
on the continued growth and expansion of ambulatory surgical services. We are
confident our urgent care centers will continue to thrive under FastMed’s leadership.”
Description
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Zimmer Biomet (USA) Completes Acquisition of A&E Medical Corporation
Zimmer Biomet Holdings, Inc. a global leader in musculoskeletal
healthcare, announced that the company has completed the acquisition of
A&E Medical Corporation, a Vance Street Capital Portfolio Company,
for $150 million in cash at closing and $100 million in cash payable in
2021. The deal is expected to have an immaterial impact to net earnings
in 2020. Zimmer Biomet has acquired A&E Medical and its complete
portfolio of sternal closure devices – including sternal sutures, cable
systems, and rigid fixation – along with a range of single-use
complementary temporary pacing wire and surgical punch products. The
global sternal closure business is growing at a high single digit
percentage rate annually. Revenue from the new integrated business will
be recognized in Zimmer Biomet's Dental, Spine & Craniomaxillofacial
and Thoracic (CMFT) product category.
"A&E Medical's high-growth business and innovative products are
highly complementary to our current portfolio and will allow us to
offer a comprehensive suite of sternal closure products, including
rigid fixation, which has the potential to shift the standard of care and
address a variety of unmet patient and surgical needs," said President
and CEO of Zimmer Biomet. "This deal aligns with our active
portfolio management strategy and the ongoing transformation of our
business that will position Zimmer Biomet for long-term growth."
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Solutions Updates
Healthcare Industry

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AbbVie (USA): IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows High Rates of
Disease-Free Survival One Year Post-Treatment in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)
23
Solution Description
AbbVie announced new data from the Phase 2 CAPTIVATE (PCYC-1142) clinical trial evaluating IMBRUVICA® (ibrutinib) in combination with
VENCLEXTA®/VENCLYXTO® (venetoclax) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) during an
oral presentation session at the virtual 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The one-year disease-free survival (DFS) rate in patients
randomized to placebo or ibrutinib after completing the combination regimen provides data to support a fixed-duration treatment that can offer CLL/SLL patients remission and
time off treatment. These findings build on the previously reported results showing that this first-line combination regimen for CLL resulted in high rates of undetectable
minimal residual disease (uMRD) in both peripheral blood (PB) (75% of patients) and in bone marrow (BM) (72% of patients). Undetectable MRD is defined as little to no
cancer cells found after treatment. In the Confirmed uMRD group, one-year DFS rate was not significantly different for patients randomized to placebo (95.3%; 95% CI
82.7-98.8) versus ibrutinib (100%; 95% CI 100-100) (P=0.1475). During the overall study period across all-treated patients (with median treatment duration of 29 months),
most common grade 3/4 adverse events (≥5% of patients) were neutropenia (36%), hypertension (10%), thrombocytopenia (5%), and diarrhea (5%). The safety profile of the
combination was consistent with known adverse events for ibrutinib and venetoclax individually and no new safety signals emerged. CLL is one of the two most common forms
of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes). While these
cancer cells start in the bone marrow, they then later spread into the blood. The prevalence of CLL is approximately 115,000 patients in the U.S. with approximately 20,000
newly diagnosed patients every year.2,3 CLL is predominately a disease of the elderly, with a median age at diagnosis ranging from 65-70 years.

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AbbVie (USA) Presents Extended Follow-Up Data for Fixed Duration Treatment
VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL)
24
AbbVie announced new, updated results from the Phase 3 MURANO and CLL14 clinical trials evaluating VENCLEXTA®/VENCLYXTO® (venetoclax) fixed duration treatment
combinations at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition (abstracts 125, 127, and 1310, respectively). These findings add to the growing body
of data supporting the use of VENCLEXTA/VENCLYXTO in first-line or previously treated chronic lymphocytic leukemia (CLL) patients. Data from the MURANO and CLL14 trials
presented at ASH reinforce that CLL patients who have relapsed or have not started treatment and receive a VENCLEXTA/VENCLYXTO regimen can experience long-lasting responses, even
after stopping treatment, compared to standard of care treatment options. The results of the final, descriptive analysis of the MURANO trial (median follow-up of 59.2 months with all patients
off VENCLEXTA/VENCLYXTO in combination with rituximab [VenR] treatment for at least three years; Abstract 125) demonstrated the following:
• Investigator (INV)-assessed progression-free survival (PFS): Patients with relapsed or refractory (R/R) CLL on fixed duration VenR had a median PFS of 53.6 months (95% CI: 48.4-57.0)
compared to 17.0 months (95% CI: 15.5-21.7) with bendamustine plus rituximab (BR; HR 0.19, 95% CI: 0.15-0.26).
• Overall survival (OS): The OS estimate was 82.1% (95% CI: 76.4-87.8) with VenR compared to 62.2% (95% CI: 54.8-69.6) for BR (HR 0.40, 95% CI: 0.26-0.62), median not reached in
either arm.
• Minimal residual disease (MRD) status at completion of VenR treatment: Patients who achieved MRD-negativity without disease progression at the end of their treatment course had
improved PFS and OS compared to patients with MRD. MRD refers to the small number of cancer cells that remain in the body after treatment. The number of remaining cells may be so small
that they do not cause any physical signs or symptoms and often cannot even be detected through traditional methods.4
• Consistent safety profile: The safety profile of the VenR combination is consistent with the known safety profile of each individual therapy alone. No new, serious safety issues were
observed in the five-year MURANO updated analysis.

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AbbVie (USA): Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previ-
ously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients
25
AbbVie announced results from a long-term integrated analysis of two Phase 3 clinical studies and additional pooled analysis evaluating the effect of IMBRUVICA (ibrutinib)
based therapies for the first-line treatment of high-risk patients with chronic lymphocytic leukemia (CLL). The totality of data featured at the virtual 2020 American Society of
Hematology (ASH) Annual Meeting continues to establish the treatment benefit of IMBRUVICA for CLL patients with or without high-risk disease. Results from an integrated
analysis of two Phase 3 clinical trials (RESONATE-2 and iLLUMINATE) with up to 6.5 years of long-term follow-up investigating the use of IMBRUVICA-based therapies
in patients with CLL/small lymphocytic lymphoma (SLL) with first-line treatment showed similar progression-free survival (PFS) and overall response rates (ORR) in patients
with or without high-risk genomic features (Abstract #2220). Additionally, a pooled analysis across four clinical trials with up to 8 years of follow-up, including three Phase 3
studies (RESONATE-2, iLLUMINATE, E1912), and the Phase 2 PCYC-1122e study - sponsored by the National Heart, Lung, and Blood Institute (NHLBI) - showed that
first-line treatment with IMBRUVICA-based therapies resulted in sustained, long-term efficacy with high 4-year PFS rates in high-risk CLL patients, defined as del(17p) or
TP53 gene mutations (Abstract 2219). The informCLL™ real-world prospective observational registry assessing treatment patterns will be featured in an oral presentation. Data
from this real-world evidence study showed low testing rates for prognostic and biomarker features among patients with CLL.3 Further, when biomarker testing was performed,
the selection of chemo-immunotherapy (CIT) continued for a considerable proportion of patients with del(17p)/TP53 mutational status, which is inconsistent with current
guidelines (Abstract 547). As well, a retrospective, chart review study of real world patients featured as an oral presentation examined treatment patterns and time to next
treatment (TTNT) in patients with CLL. Results showed high-risk patients with CLL treated with IMBRUVICA monotherapy had longer TTNT than those treated with CIT,
and that IMBRUVICA therapy showed similar results in high risk and non-high-risk patients (Abstract 372).

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AbbVie (USA): Upadacitinib (RINVOQ™) Meets Primary and All Ranked
Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis
26
AbbVie announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met
the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints, in adult
patients with moderate to severe ulcerative colitis. In the study, 26 percent of patients receiving upadacitinib achieved clinical remission
compared to 5 percent of patients receiving placebo (p<0.001).1 U-ACHIEVE is the first of two Phase 3 induction studies to evaluate the
safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis. Significantly more upadacitinib-treated patients
achieved endoscopic improvement at week 8 compared to patients receiving placebo (36 percent versus 7 percent; p<0.001).1
Furthermore, 30 percent of patients treated with upadacitinib achieved histologic-endoscopic mucosal improvement at week 8, versus 7
percent of those receiving placebo (p<0.001).1 A greater proportion of patients treated with upadacitinib achieved clinical response (per
Adapted Mayo Score) at week 8 compared to placebo (73 percent versus 27 percent; p<0.001), and 60 percent of upadacitinib-treated
patients experienced clinical response (per partial Adapted Mayo Score) at week 2, versus 27 percent on placebo (p<0.001).

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AbbVie (USA): RINVOQ™ (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) For
Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis
27
AbbVie announced top-line results from the Phase 3b Heads Up study showing that upadacitinib (30 mg, once daily) achieved superiority to
dupilumab (300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema
Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis. Of patients treated with upadacitinib, 71 percent
achieved EASI 75 at week 16 compared to 61 percent of dupilumab-treated patients (p=0.006).1 Upadacitinib also showed superiority compared
to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction. The Heads Up study
evaluated the efficacy and safety of upadacitinib versus dupilumab in adults with moderate to severe atopic dermatitis who are candidates for
systemic therapy.1 Patients were randomized to receive upadacitinib or dupilumab, both as monotherapy treatments, for 24 weeks. Results of
ranked secondary endpoints showed higher efficacy in early improvements of itch and skin clearance in patients treated with upadacitinib
compared to patients treated with dupilumab.1 After one week of treatment, the upadacitinib treatment group had a 31 percent reduction in itch (as
measured by Worst Pruritus Numerical Rating Scale [NRS]) compared to 9 percent in the dupilumab group (p<0.001).1 Itch improvements were
maintained through week 16.1 Additionally, after two weeks of treatment, 44 percent of upadacitinib-treated patients achieved EASI 75 response
versus 18 percent of dupilumab-treated patients (p<0.001).

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AbbVie (USA): CHMP Recommends the Approvals of RINVOQ™ (Upadacitinib) for
the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis
28
AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval
of RINVOQ™ (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor, for the expanded use in two additional rheumatic indications:
the treatment of adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis.5 The CHMP positive opinions are based
on results from three pivotal clinical studies in which RINVOQ demonstrated efficacy across multiple measures of disease activity. In both the Phase 3
SELECT-PsA 1 and SELECT-PsA 2 clinical trials, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with
active psoriatic arthritis who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs,
respectively. RINVOQ also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus
placebo in SELECT-AXIS 1, a Phase 2/3 study in patients who were naïve to biologic DMARDs and had an inadequate response or intolerance to
nonsteroidal anti-inflammatory drugs (NSAIDs). Safety results from SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 have been previously reported
and were consistent with those observed in rheumatoid arthritis, with no new significant safety risks identified. The CHMP positive opinion is a scientific
recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing
Authorization would be valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway.

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Abiomed (USA): Two Milestones Achieved Toward Small Bore Access
with Impella
29
Abiomed announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP
heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted
510(k) clearance to the Impella XR sheath. The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access
and closure with the Impella 2.5 heart pump. It inserts at 10 French (Fr) and the flexible, nitinol braids momentarily expand during Impella delivery
then recoil, simplifying access for complex interventions. The Impella XR sheath is intended to produce less trauma at the arterial access site
compared to large bore sheaths. The Impella XR sheath has been studied in patients outside of the United States on multiple occasions. The first
patient in the U.S. is expected during Q4 of fiscal year 2021. Additionally, Abiomed has successfully completed the first stage of the EFS of
Impella ECP by enrolling and treating five patients. Impella ECP is the world’s smallest heart pump. It measures 9 Fr in diameter upon insertion
and removal from the body. Once in the body, it expands to support the heart’s pumping function, providing peak flows greater than 3.5 L/min.
The prospective, multi-center, non-randomized EFS is designed to allow Abiomed, study investigators, and the FDA to make qualitative
assessments about the safety and feasibility of Impella ECP use in high-risk percutaneous coronary intervention (PCI) patients. Abiomed will now
submit data to the FDA and request to move to a second stage of the study with expanded enrollment.

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Alexion (USA) Receives Marketing Authorization from European Commission for New
Formulation of ULTOMIRIS® (ravulizumab) with Significantly Reduced Infusion Time
30
Alexion Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the new 100 mg/mL intravenous (IV) formulation of ULTOMIRIS® (ravulizumab)
for the treatment of two ultra-rare diseases – paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). ULTOMIRIS is the first and only
long-acting C5 inhibitor administered to patients every eight weeks or every four weeks for pediatric patients less than 20 kg. ULTOMIRIS 100 mg/mL is an advancement in
the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL, while
delivering comparable safety and efficacy. With ULTOMIRIS 100 mg/mL, most patients will spend six hours or less a year receiving treatment. PNH is a blood disorder
characterized by complement-mediated destruction of the red blood cells that can cause a wide range of debilitating symptoms and complications, including thrombosis, which
can occur throughout the body, and result in organ damage and premature death.1 Atypical HUS can cause progressive injury to vital organs, primarily the kidneys, via damage
to the walls of blood vessels and blood clots.2 Affecting both adults and children, aHUS patients can present in critical condition, often requiring supportive care, including
dialysis, in an intensive care unit. The prognosis of both aHUS and PNH can be poor in many cases, so a timely and accurate diagnosis—in addition to appropriate treatment—is
critical to improving patient outcomes. The European Commission approval is based on a comprehensive chemistry, manufacturing and control submission and a supplementary
clinical data set showing that the safety, pharmacokinetics and immunogenicity following administration of ULTOMIRIS 10 mg/mL and ULTOMIRIS 100 mg/mL were
comparable. Similarly, the data set showed no relevant changes in the efficacy measure of mean lactate dehydrogenase (LDH) levels across the two formulations. The new
proposed formulation requires an infusion time of 0.4 to 1.3 hours (25 to 75 minutes) depending on body weight, reducing the infusion time by approximately 60 percent
compared with the currently available 10 mg/mL IV formulation, which ranges from 1.3 to 3.3 hours (77 to 194 minutes) depending on body weight.

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AmerisourceBergen: CenterX Implements Real-Time Prescription Benefit Solution
within Kettering Health Network's Epic Electronic Health Record via new App
31
CenterX, a part of AmerisourceBergen, announced that it implemented its new real-time prescription benefit (RTPB) solution within KetteringHealth Network’s
Epic electronic health record (EHR). The solution—which is built into the e-prescribing workflow—provides physicians access to patient-specific benefits and
cost information at the point of care, allowing them to view the out-of-pocket price for a medication before they order the prescription. Between 20 to 30 percent
of prescriptions are never filled, according to recent studies. With the updated RTPB solution, physicians will now have access to complete benefits data for all
patients, including those whose insurance status is unknown in Epic. After physicians select a medication, the solution will display the price and coverage
information, as well as pricing at other pharmacies and medications in a similar treatment class which the physician could consider as potential alternatives.
Kettering Health Network—a network of nine hospitals, 13 emergency departments and more than 200 outpatient facilities serving western Ohio—is among the
first health systems to use the CenterX app, which enables health systems to select additional RTPB and electronic prior authorization (ePA) features based on their
specific needs. The solution is available in the Epic App Orchard for all health systems that have an Epic EHR. CenterX has implemented its ePA or RTPB
solutions, or both, at nearly 30 health systems nationwide that support 100,000 prescribers. Many health systems and health care facilities add RTPB solutions to
their EHR so physicians can determine if a patient’s benefits cover the medication before they order the prescription. RTPB involves a number of components,
including patient eligibility and access to pharmacy benefit managers (PBMs). If there are gaps in benefits information or PBM coverage, physicians may not
receive a response, or may receive an incomplete or non-patient specific response.

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Amgen Inc. (USA): World's Leading Life Science Companies Now Enrolling
COMMUNITY, A Global, Platform Trial For Hospitalized Patients With COVID-19
32
Three members of the COVID R&D Alliance - Amgen Inc., Takeda Pharmaceutical Co. Ltd. and UCB - announced the first patient enrolled in the COMMUNITY Trial
(COVID-19 Multiple Agents and Modulators Unified Industry Members). COMMUNITY is a randomized, double-blind, placebo-controlled, adaptive platform trial that
enables an array of therapeutic candidates to be studied in hospitalized COVID-19 patients. With worldwide COVID-19 deaths exceeding one million and a resurgence of cases
globally, life science companies are working urgently to identify treatments that can potentially reduce clinical severity of COVID-19 in hospitalized patients. COMMUNITY
is the first platform trial designed and launched by members of the COVID R&D Alliance, a group of more than 20 leading pharmaceutical and biotech companies who are
devoting significant time, insights and company resources to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its
related symptoms. COMMUNITY uses an adaptive design which allows for the addition, removal and simultaneous study of multiple therapeutic candidates during the course
of the trial. Multiple candidates will be tested against a shared placebo-controlled arm. The design allows for a streamlined approach which may accelerate execution of the
study and save time as we search for therapeutics in the fight against the pandemic. Immunomodulating therapies will be the first candidates to enter COMMUNITY. Other
therapies may join in the future, such as antivirals. The trial's design and global footprint were selected to address potential barriers in the study of COVID-19 therapeutics. This
includes anticipating and activating trial sites to align with the rise and fall of COVID cases across geographic regions as well as streamlining an influx in trial-related inquiries
faced by some hospitals and health systems. COMMUNITY will onboard global sites in the United States, Brazil, Mexico, Russia, South Africa and other countries. This
geographic diversity will allow the trial sites to be active when cases spike locally. COMMUNITY aims to simplify the study of investigational therapies that may result in
potential treatment options and address the needs of hospitals in treating patients.

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Amgen (USA) To Present First Clinical Data For BCMA-Targeted Half-Life
Extended BiTE® Therapy AMG 701 At ASH 2020
33
Amgen announced the first presentation of clinical safety and efficacy data from the Phase 1 study of AMG 701 in heavily pre-treated patients
with relapsed/refractory multiple myeloma (R/R MM). AMG 701 is an investigational half-life extended (HLE) bispecific T cell engager
(BiTE®) immuno-oncology therapy targeting B-cell maturation antigen (BCMA). The data will be presented during a live oral presentation
on Dec. 5 at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition. This interim analysis of the Phase 1 dose
escalation study evaluated AMG 701 in 85 R/R MM patients who had received at least three prior lines of therapy, and a median of six lines.
The response rate was 36% at doses of 3-18 mg with responses lasting up to 26 months in one patient. Six of seven patients, who were tested
for minimal residual disease (MRD), were MRD-negative. In the most recent evaluable cohort, there was an 83% ORR, with 4/5 responders
being triple refractory. The most common hematological adverse events (AEs) were anemia (42%), neutropenia (25%) and thrombocytopenia
(21%). The most common non-hematological AEs were cytokine release syndrome (CRS, 65%), diarrhea (31%) and hypophosphatemia
(31%). CRS was mostly grade 1 (27%) or 2 (28%) based on Lee Blood 2014 criteria. All Grade 3 CRS events (9%) were reversible with
mitigation procedures outlined in the study protocol, with a median duration of two days.

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Amgen's (USA) Sotorasib Granted Breakthrough Therapy Designation For Advanced
Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation
34
Amgen announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, for
the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test,
following at least one prior systemic therapy. KRAS G12C is the most common KRAS mutation in NSCLC.1,2 In the U.S., about 13% of patients with NSCLC adenocarcinoma
harbor the KRAS G12C mutation3 and each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated NSCLC.4 Unmet need remains high
and options are limited for NSCLC patients with the KRAS G12C mutation that have failed first-line treatment. The outcomes with current therapies are suboptimal with
response rates of approximately 9-18% and a median progression-free survival of approximately 4 months for second-line NSCLC.5,6,7 Amgen has taken on one of the
toughest challenges of the last 40 years in cancer research8 by developing sotorasib. Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the
broadest clinical program exploring 10 combinations with global sites spanning across 4 continents. In just over two years, the sotorasib clinical program has also established
the deepest clinical data set with more than 600 patients studied across 13 tumor types. A Breakthrough Therapy designation is designed to expedite the development and
regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.9 The Real-Time Oncology Review
(RTOR) pilot program aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. The
designation and RTOR are supported by positive Phase 2 results in patients with advanced NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite
prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.

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Amgen (USA) Submits Sotorasib New Drug Application To U.S. FDA For Advanced
Or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation
35
Amgen announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an
investigational KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung
cancer (NSCLC), as determined by an FDA-approved test, following at least one prior systemic therapy. The NDA is being reviewed by the FDA
under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and
effective treatments are made available to patients as early as possible. The submission is supported by positive Phase 2 results in patients with
locally advanced or metastatic NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with
chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk
profile.2 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung
Cancer (WCLC) Presidential Symposium in January 2021. Amgen has taken on one of the toughest challenges of the last 40 years in cancer
research by developing sotorasib, an investigational KRASG12C inhibitor.3 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is
being studied in the broadest clinical program exploring 10 combinations with global sites spanning across four continents. In just over two years,
the sotorasib clinical program has established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

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FDAApproves Amgen's (USA) RIABNI™ (rituximab-arrx), A Biosimilar
To Rituxan® (rituximab)
36
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment
of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis),
and Microscopic Polyangiitis (MPA). RIABNI will be made available in the U.S. in January 2021. RIABNI, a CD20-directed cytolytic antibody, was proven to be highly
similar to Rituxan based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety
or effectiveness. The data package was composed of, in part, results from a pharmacokinetic (PK) similarity study and a comparative clinical study. The randomized,
double-blind, comparative clinical study evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability and immunogenicity of RIABNI
compared to Rituxan in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. There were 256 patients enrolled and randomized (1:1) to receive
375 mg/m2 intravenous infusion of either RIABNI or Rituxan, once weekly for 4 weeks followed by dosing at weeks 12 and 20. The primary endpoint, an assessment
of overall response rate (ORR) by week 28, was within the prespecified margin for RIABNI compared to Rituxan, showing clinical equivalence. PK, PD, safety and
immunogenicity of RIABNI were similar to Rituxan. The Wholesale Acquisition Cost (WAC or "list price") of RIABNI in the U.S. will be 23.7% lower than the
reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, 23.7% less than the WAC for
Rituxan, 15.2% less than the WAC for Truxima® (biosimilar to Rituxan) and matching the WAC for Ruxience® (biosimilar to Rituxan). At launch, RIABNI will be
priced 16.7% below the current Rituxan Average Selling Price (ASP). RIABNI will be available from both wholesalers and specialty distributors.

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Astellas (Japan) Receives Approval of EVRENZO® (roxadustat) in Japan for the
Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis
37
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. announced that Japan’s Ministry of Health,
Labour and Welfare (MHLW) approved EVRENZO® (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on
dialysis. This marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and
launched for use in adult patients with anemia of CKD on dialysis last year. This approval is based on results obtained from three clinical studies in more
than 500 Japanese patients with anemia of CKD not on dialysis. The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa,
met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.1 Roxadustat was
generally well tolerated, and the safety profile was comparable with that of darbepoetin alfa. The other two studies (one Phase 3 and one Phase 2) support
the safety and efficacy of roxadustat in erythropoiesis-stimulating agent (ESA)-untreated patients. The approval of the supplementary New Drug Application
(sNDA) for roxadustat in Japan for the treatment of anemia of CKD in adult patients not on dialysis triggers a milestone payment of $15 million by Astellas
to FibroGen. As a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), roxadustat increases Hb levels
through a mechanism of action that is different from that of traditional ESAs. As a HIF-PH inhibitor, roxadustat activates the body's natural protective
response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia.

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AstraZeneca (UK): Imfinzi approved in the US for less-frequent,
fixed-dose use
38
AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the
approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated
advanced bladder cancer. This new option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and
will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks. The
approval by the Food and Drug Administration (FDA) was based on data from several Imfinzi clinical trials, including the PACIFIC Phase III trial
which supported the two-week, weight-based dosing in unresectable Stage III NSCLC, and the CASPIAN Phase III trial which used four-week,
fixed-dosing during maintenance treatment in ES-SCLC. The decision follows the Priority Review granted by the FDA in August 2020. The
four-week 1,500mg fixed-dosing option for Imfinzi is also under regulatory review in several other countries, including in the EU where the new
dosing option was granted accelerated assessment. Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after CRT
in the US, in the EU, in Japan, in China and in many other countries, based on the PACIFIC Phase III trial. Imfinzi is also approved for previously
treated patients with advanced bladder cancer in the US and several other countries. Additionally, it is approved in the US, the EU, Japan and
several other countries around the world for the treatment of ES-SCLC based on the CASPIAN Phase III trial.

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AstraZeneca (UK): Forxiga approved in Japan for chronic heart failure
39
AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving standard of care. HF is a
life-threatening chronic disease that prevents the heart from pumping sufficient levels of blood around the body. It affects approximately 64 million people worldwide, at
least half of whom have a reduced ejection fraction.1-3 This occurs when the left ventricle muscle is not able to contract adequately and therefore expels less oxygen-rich
blood into the body.4-6 The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from the landmark DAPA-HF Phase III
trial published in The New England Journal of Medicine. Forxiga is the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to have shown a statistically significant re-
duction in the risk of the composite of cardiovascular (CV) death or worsening of HF events, including hospitalisation for HF (hHF). The DAPA-HF Phase III trial demon-
strated that Forxiga, in addition to standard of care, reduced the risk of the composite outcome versus placebo by 26% and both components of the primary composite end-
point contributed benefit to the overall effect. In the DAPA-HF Phase III trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medi-
cine. During the trial, one CV death or hHF or an urgent visit resulting in intravenous therapy associated with HF could be avoided for every 21 patients treated. Forxiga
(known as Farxiga in the US) is approved in the US, Europe, and several other countries around the world for the treatment of patients with HF with reduced ejection fraction
(HFrEF). Forxiga is advancing cardiorenal prevention as science continues to identify the underlying links between the heart, kidneys and pancreas. DAPA-HF is part of
DapaCare, a robust clinical trial programme to assess the potential CV and renal benefits of Forxiga. The programme has also explored the treatment of patients with chronic
kidney disease (CKD) in the ground-breaking DAPA-CKD Phase III trial. Additionally, Forxiga is currently being tested for HF patients with preserved ejection fraction
(HFpEF) in the DELIVER Phase III trial with data readout anticipated in the second half of 2021.

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Baxter (USA) Announces U.S. FDA 510(k) Clearance of Homechoice
Claria with Sharesource
40
Baxter International Inc. a global innovator in renal care, announced U.S. Food and Drug Administration (FDA) clearance of the Homechoice Claria automated peritoneal
dialysis (APD) system with Sharesource connectivity platform. Homechoice Claria combines a simple user interface with the benefits of Sharesource, the only two-way remote
patient management platform for patients on peritoneal dialysis in the U.S. Homechoice Claria is cleared for both adult and pediatric populations.1 The clearance follows the
recent finalization of the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) payment model, which aims to significantly increase the number of new patients with
kidney failure who receive home dialysis and/or organ transplants. With one in four APD patients globally benefitting from Baxter’s two-way remote patient management
technology, Sharesource offers patients and clinicians the ability to stay closely connected to proactively address key aspects of peritoneal dialysis (PD) therapy. Through the
platform’s accurate, daily treatment data and analytics, clinicians can manage patients remotely and make timely therapy decisions while keeping patients safely at home.
Clinicians using Homechoice Claria with Sharesource also have greater visibility to patient adherence patterns, which may allow for early intervention and an increased focus
on proactive care.2 To date, more than 6 million home dialysis treatments completed in the U.S. have been enabled by Sharesource, with over 20 million PD treatments managed
around the world. Homechoice Claria offers enhanced features that facilitate added convenience for patients and clinical teams, as well as best-in-class educational companions
to further simplify the PD experience. For patients, intuitive control buttons and an easy-to-read screen complement straightforward instructions in 38 languages. To extend
patients’ learning beyond the clinic, MyClaria – a web-based app included as part of the Homechoice Claria system – features step-by-step, voice activated and enabled
instructions to guide patients through therapy. For clinicians, MySharesource – also a web-based app – is a resource featuring step-by-step guidance and quick demo videos on
how to use the Sharesource platform.

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Boston Scientific (USA) Receives FDAApproval for WaveWriter Alpha™
Spinal Cord Stimulator Systems
41
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for the WaveWriter Alpha™ portfolio of Spinal Cord
Stimulator (SCS) Systems. The portfolio, consisting of four MRI conditional Bluetooth-enabled implantable pulse generators (IPGs),
offers expanded personalization based on patient needs, including rechargeable and non-rechargeable options, and access to waveforms
that can cover multiple areas of pain. Chronic pain, defined as continuous and long-term pain lasting more than six months, impacts more
than 50 million people in the U.S. and is the chief cause of disability in American adults.[ii] SCS therapies provide pain relief by
delivering pulses of mild electric current to the spinal cord to interrupt pain signals traveling to the brain. Boston Scientific announced
the European launch of the WaveWriter Alpha SCS Systems in September 2020. The company expects to commence the U.S. commercial
launch during the first half of 2021. “We are excited by this earlier-than-anticipated FDA approval for the WaveWriter Alpha SCS
Systems which will provide patients with multiple therapy options,” said senior vice president and president, Neuromodulation, Boston
Scientific. “We look forward to sharing additional details about how our portfolio of SCS devices will usher in a new era of
personalization in the treatment of chronic pain during the North American Neuromodulation Society annual meeting.”

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Bristol Myers Squibb (USA) Receives European Commission Approval for Opdivo (nivolumab) as Second-Line
Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
42
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous
cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy. The EC’s decision is based on results from the Phase 3 ATTRACTION-3 trial, a study sponsored by Ono
Pharmaceutical Co., Ltd. of Japan, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in patients who received Opdivo versus chemotherapy. The
safety profile for Opdivo was favorable compared with chemotherapy and consistent with previously reported studies of Opdivo in other solid tumors. In addition to this approval in the EU, Opdivo has been
approved in five countries, including the United States and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic ESCC. Bristol Myers Squibb thanks the patients
and investigators involved in the ATTRACTION-3 clinical trial for their important contributions.
In the Phase 3 ATTRACTION-3 trial, which had a primary endpoint of OS:
• Opdivo reduced risk of death by 23%, compared to chemotherapy alone [Hazard Ratio (HR) 0.77; 95% Confidence Interval (CI): 0.62 to 0.96; p=0.019].
• Median OS with Opdivo was 10.9 months (95% CI: 9.2 to 13.3) compared to 8.4 months (95% CI: 7.2 to 9.9) with chemotherapy alone, demonstrating a 2.5-month improvement.
• The Opdivo arm showed 12- and 18-month OS rates of 47% (95% CI: 40 to 54) and 31% (95% CI: 24 to 37), respectively, versus 34% (95% CI: 28 to 41) and 21% (95% CI: 15 to 27) among patients in
the chemotherapy arm. Survival benefit with Opdivowas observed regardless of tumor PD-L1 expression levels.
• Objective response rates (ORR) between the Opdivo and chemotherapy arms were comparable at 19% (95% CI: 14 to 26) and 22% (95% CI: 15 to 29), respectively.
• Median duration of response (DoR) for patients was substantially increased in the Opdivo arm at 6.9 months (95% CI: 5.4 to 11.1) versus 3.9 months (95% CI: 2.8 to 4.2) in the chemotherapy arm.
• An exploratory analysis of patient-reported outcomes showed significant overall improvement in quality of life with Opdivo versus chemotherapy. Fewer treatment-related adverse events (TRAEs) were
reported with Opdivo versus chemotherapy, with a rate of 66% for any grade TRAEs in patients receiving Opdivo compared to 95% for those patients receiving chemotherapy. Patients in the Opdivo arm also
experienced a lower incidence of Grade 3 or 4 TRAEs compared to those in the chemotherapy arm (18% versus 63%), and the percentage of patients experiencing TRAEs leading to discontinuation was the
same in both arms (9%).

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