I Bytes Healthcare industry

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I-Bytes
Healthcare
October Edition 2020
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Table of Contents
1. Financial, M & A Updates..................................................................................................................................1
2. Solution Updates................................................................................................................................................24
3. Rewards and Recognition Updates..................................................................................................................78
4. Customer Success Updates................................................................................................................................91
5. Partnership Ecosystem Updates.......................................................................................................................94
6. Environment & Social Updates......................................................................................................................126
7. Miscellaneous Updates....................................................................................................................................129

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Financial, M & A
Updates Healthcare Industry

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Financial, M&A Updates
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Allergan Aesthetics, an AbbVie Company (USA), Acquires Innovative Luminera
Dermal Filler Business
Allergan Aesthetics, an AbbVie company, announced that it has entered into an
agreement with Luminera, a privately held, aesthetics company based in Israel
with a portfolio and pipeline of dermal filler products. Under the terms of the
agreement, Allergan Aesthetics will acquire Luminera's full dermal filler portfolio
and R&D pipeline further enhancing Allergan Aesthetics' leading dermal filler
portfolio with its JUVÉDERM® collection of fillers.Luminera's key value driver
for the future is HArmonyCa, an innovative dermal filler intended for facial soft
tissue augmentation comprised of a combination of cross-linked hyaluronic acid
(HA) with embedded calcium hydroxyapatite (CaHA) microspheres. The
combination of HA and CaHA in a single product is highly differentiated in the
dermal filler category. HArmonyCa is currently commercially available in Israel
and Brazil. Allergan Aesthetics will continue to develop this product for its
International and US markets. The Luminera dermal filler portfolio also includes
a line of HA dermal fillers, as well CaHA based fillers commercialised across
several markets. Brands include Crystalys, Hydryalix and Hydryal.
Executive Commentary
"The addition of the Luminera assets adds innovative technology,
complementing our leading JUVÉDERM® filler franchise. We welcome the
Luminera team as we continue to build our global aesthetics company and a
world-class product offering for healthcare professionals and patients around
the world," said SVP, AbbVie, and President, Global Allergan Aesthetics.
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CVS Health (USA) invests $13.7 million to renovate low-income housing, fund
community programs in Columbus
CVS Health announced it will invest $13.7 million to help renovate
230 low-income housing units at the Rosewind apartments in
Columbus, Ohio. These funds will also be used to make significant
improvements to the local community center and support new
community programs in the area. The investment kicks-off the
company’s commitment of nearly $600 million over five years to
address racial inequality and social determinants of health in Black
communities. This commitment includes an emphasis on increasing
access to affordable housing, which is inextricably linked to
health.CVS Health will work with the Columbus Metropolitan
Housing Authority (CMHA) and the Ohio Capital Corporation for
Housing on the project. Through CVS Health’s investment, CMHA
will spend $50,000 per unit in much-needed rehab and repairs.
“When people have access to high-quality, affordable housing, it
puts them in a better position to improve their overall wellbeing,
including taking care of their health or managing a chronic
disease,” said Chief Diversity Officer, CVS Health. “One aspect of
our commitment to address racial inequality is addressing social
determinants of health – like housing – at the community level,
which is where we can make a meaningful impact.”
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AstraZeneca (UK) acquires oral PCSK9 inhibitor programme from Dogma
Therapeutics
AstraZeneca has entered into an agreement with Dogma Therapeutics to acquire its
preclinical oral PCSK9 inhibitor programme. The Company aims to take the programme
forward into clinical development for dyslipidaemia, or abnormal amount of lipids in the
blood, and familial hypercholesterolemia, a common genetic condition that causes high
cholesterol. PCSK9 is a protein that regulates the level of low-density lipoprotein (LDL), or
‘bad’ cholesterol in the blood. Increased activity of PCSK9 is associated with high LDL
cholesterol. The acquired PCSK9 inhibitors are small molecules that bind directly to a novel
part of PCSK9 and have shown to block its activity and lower LDL cholesterol in preclinical
models. There are currently no oral PCSK9 inhibitors available to patients or in clinical
development.Dyslipidaemia is defined as abnormal amount of lipids, such as LDL
cholesterol, in the blood. Raised LDL cholesterol is a key risk factor for cardiovascular
disease and is estimated to cause 2.6 million deaths worldwide every year.1,2 Causes may be
primary (genetic) or secondary (lifestyle and other factors). Familial hypercholesterolaemia,
a primary dyslipidaemia, is a genetic condition that results in the body being unable to
remove LDL cholesterol from the blood. Patients with familial hypercholesterolaemia are at
high risk of premature coronary heart disease.
Executive Vice President, BioPharmaceuticals R&D, said: “Raised LDL cholesterol is a
key risk factor for cardiovascular disease and is estimated to cause 2.6 million deaths
worldwide every year. Whilst PCSK9 is a well validated target for lowering LDL
cholesterol it has been a hugely challenging target to inhibit with small molecules. This
agreement with Dogma Therapeutics offers us the opportunity to develop the first small
molecule, orally bioavailable PCSK9 inhibitor, for patients at risk of cardiovascular
disease.”
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Boston Scientific (USA) Announces Expanded Investment and Exclusive
Acquisition Option Agreement with Farapulse, Inc.
Boston Scientific Corporation announced it has signed an investment agreement with
an exclusive option to acquire Farapulse, Inc., a privately held company developing
a pulsed field ablation (PFA) system for the treatment of atrial fibrillation (AF) and
other cardiac arrhythmias. This PFA system – comprising a sheath, generator and
catheters – is intended to ablate heart tissue via the creation of a therapeutic electric
field instead of using thermal energy sources such as radiofrequency ablation or
cryoablation. Patients with AF, a common heart rhythm disorder that affects more
than 33 million people globally, are often treated with anti-arrhythmic drugs as well
as cardiac ablation.i Ablation therapy is the process of delivering energy to areas of
the heart muscle responsible for creating an abnormal heart rhythm. The Farapulse
platform employs an ablation modality based on pulsed electric fields, also referred
to as irreversible electroporation, that generates zones of ablated cardiac tissue to
interrupt the irregular electrical signals that can cause AF. This technology is
designed for physicians to precisely ablate tissue and, in turn, spare nearby tissue
from unintentional ablation.
"The tissue-selective Farapulse PFA technology is a promising energy source for
cardiac ablation – including pulmonary vein isolation – with recent study results
demonstrating the effectiveness of the ultra-rapid approach," said President and
chief executive officer, Farapulse, Inc. "This next chapter in our collaborative
relationship with Boston Scientific will further accelerate our progress towards
regulatory approval so we can bring this pioneering system to market."
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Coloplast (Denmark) completes minority investment in Francis Medical
Minneapolis-based Francis Medical is a privately held company committed to
developing minimally invasive urological cancer treatments. The foundation of the
company is a tribute to and legacy of the inventor’s father, Francis Hoey, whose life
was ended by prostate cancer with treatments that had harsh implications on his
normal daily living. The platform technology utilises water vapour energy to ablate
targeted cancerous tissue while preserving surrounding structures, potentially
minimizing the side effects often experienced with other cancer treatments. The
investment fits with Coloplast’s strategy to pursue organic and inorganic growth
opportunities in the Interventional Urology business. Francis Medical in particular
and the prostate cancer segment in general align with the Interventional Urology’s
strategic direction, bringing innovative solutions to the urology market.Coloplast is
dedicated to making life easier for people with intimate healthcare needs and
advancing the treatment of prostate cancer supports that mission. The investment in
Francis Medical will help the company continue to develop their minimally invasive
solution and help Coloplast Interventional Urology continue to grow its presence in
the market with customers and patients.
“We are proud to be supporting life-changing technologies in growing urology
segments. As part of our long-term strategy we are exploring multiple areas for
investment and growth, and we are excited about providing solutions in Men’s
Health segments like prostate cancer,” said President of Interventional Urology.
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Community Health Systems (USA) Completes Divestiture of St. Petersburg,
Florida Hospital
Community Health Systems, Inc. announced that an affiliate of the Company has completed the sale of 480-bed Bayfront
Health St. Petersburg in St. Petersburg, Florida, and its associated assets to a subsidiary of Orlando Health which has
assumed responsibility for the long-term lease and operations of the hospital. The effective date of the transaction is October
1, 2020. With the divestiture completed, Community Health Systems affiliates continue to operate 11 hospitals in
Florida.Community Health Systems, Inc. is one of the largest publicly traded hospital companies in the United States and a
leading operator of general acute care hospitals in communities across the country. The Company, through its subsidiaries,
owns, leases or operates 92 affiliated hospitals in 16 states with an aggregate of approximately 15,000 licensed beds. The
Company’s headquarters are located in Franklin, Tennessee, a suburb south of Nashville. Shares in Community Health
Systems, Inc. are traded on the New York Stock Exchange under the symbol “CYH.”
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DSM (Netherlands) announces sale of Resins & Functional Materials businesses
Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living,
announces that it has reached an agreement to sell its Resins & Functional Materials and
associated businesses to Covestro AG for an Equity Value of €1.6 billion. The proposed
transaction is another step forward in DSM’s evolution as a purpose-led, science-based
company operating in the fields of Nutrition, Health, and Sustainable Living. It follows
DSM’s recent acquisitions of the Erber Group, Glycom, and CSK. The transaction will
include all of DSM’s Resins & Functional Materials businesses, including DSM Niaga®,
DSM Additive Manufacturing and the coatings activities of DSM Advanced Solar. These
businesses represented €1,012 million of DSM’s 2019 total annual net sales and €133 million
of DSM’s 2019 total EBITDA. DSM will provide re-stated figures for its Materials Cluster
ahead of its Q3 results. DSM anticipates a book profit on the transaction to be recognized
upon closing. DSM expects to receive approximately €1.4 billion net in cash following
closing, including repayment of RFM’s net debt, and after transaction costs and capital gains
tax. The combination of RFM and Covestro will create a business of enhanced scale and
technological capability that will benefit existing and potential customers as well as its
employees through a stronger platform for growth. Completion of the transaction, which is
subject to the customary conditions and approvals, is expected in H1, 2021.
Co-CEOs of Royal DSM commented: “This sale builds on our approach of actively
managing our businesses, as DSM continues to evolve as a purpose-led, science-based
company operating in the fields of Nutrition, Health and Sustainable Living. The deal
delivers strong value to DSM and is strategically attractive for all parties. In Covestro,
we recognize a company that shares similar views on culture and the value of
sustainability. We know that Covestro will be a good owner of these businesses for
customers, colleagues and other stakeholders.”
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DSM (Netherlands) completes acquisition of Erber Group
Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announces the completion of its acquisition
of Erber Group for an enterprise value of €980 million. The transaction - which excludes two smaller units in the Erber Group - is
expected to be earnings enhancing in the first year upon completion. The acquisition of Erber Group was first announced on 12 June
2020. DSM acquired Erber Group’s Biomin and Romer Labs. Erber Group’s specialty animal nutrition and health business Biomin
specializes primarily in mycotoxin risk management and gut health performance management, whereas the Romer Labs business
focuses on food and feed safety diagnostic solutions. Both expand DSM’s range of higher value-add specialty solutions. The acquisition
of Erber Group’s Biomin further strengthens DSM’s expertise and reputation as a leading provider of animal health and nutrition
solutions for farm productivity and sustainability, with an emphasis on emissions reduction, feed consumption efficiency, and better use
of water and land. It is therefore very much aligned with DSM’s focus to make animal farming more sustainable from both an ecological
and economical perspective. Romer Labs also complements DSM’s human nutrition and health offering to customers in the food &
beverages market segments.
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Eisai (Japan) Establishes Pharma Sales Subsidiary In Vietnam
Eisai Co., Ltd. announced that it has established a new pharmaceutical sales subsidiary in Ho Chi Minh City, Socialist Republic of Viet Nam
(“Vietnam”), which will be named Eisai Vietnam Co., Ltd. (“Eisai Vietnam”). Eisai Vietnam is a wholly owned subsidiary of Eisai. The
pharmaceutical market in Vietnam is surpassed in size only by those of Thailand and the Philippines within the Association of South East Asian
Nations (ASEAN), with the market size reaching 4,199 million USD in 20191. The compound annual growth rate of the Vietnamese
pharmaceutical market from 2014 to 2019 was +10.6%1, and it is expected that this market rate will continue to grow in the double digits. In
1992, Eisai (Thailand) Marketing Co., Ltd., a pharmaceutical sales subsidiary of Eisai, started business in Vietnam through a local agency. Eisai
opened a representative office in Ho Chi Minh City in 1995, and mainly markets the proton-pump inhibitor Pariet®, muscle relaxant Myonal®,
peripheral neuropathy treatment Methycobal®, and others.In addition, regarding its global products in Vietnam, Eisai recently launched its
antiepileptic drug Fycompa® in October 2019, and obtained marketing approval for the anti-cancer agent Lenvima® in June 2020. Eisai has also
filed for regulatory approval for the in-house developed anti-cancer agent Halaven®.With the establishment of Eisai Vietnam, Eisai aims to
enhance its own drug sales system in Vietnam, deliver innovative new drugs to more patients in Vietnam, and contribute to improving the benefits
of patients and their families.
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Lilly (USA) Announces Agreement to Acquire Disarm Therapeutics
Eli Lilly and Companyannounced a definitive agreement to acquire Disarm Therapeutics, a
privately-held biotechnology company creating a new class of disease-modifying
therapeutics for patients with axonal degeneration. Disarm has discovered novel, potent
SARM1 inhibitors and is advancing them in preclinical development, with the goal of
delivering breakthrough treatments to patients with peripheral neuropathy and other
neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple
sclerosis.Axonal degeneration is a common, yet unaddressed, pathology in a broad range of
neurological diseases and is known to cause severe sensory, motor, and cognitive symptoms.
Disarm's scientific founders, Dr. Jeffrey Milbrandt and Dr. Aaron DiAntonio of Washington
University School of Medicine in St Louis, discovered that the SARM1 protein is a central
driver of axonal degeneration. Disarm's SARM1 inhibitors are designed to directly prevent
the loss of axons.Under the terms of the agreement, Lilly will acquire Disarm for an upfront
payment of $135.0 million. Disarm equityholders may be eligible for up to $1.225 billion in
additional future payments for potential development, regulatory and commercial milestones
should Lilly successfully develop and commercialize new medicines resulting from the
acquisition.
"Lilly continues to seek medicines to treat the debilitating pain and loss of function
associated with nerve damage," said M.D., vice president of pain and neurodegeneration
research at Lilly. "The scientific team at Disarm discovered an important and highly
promising approach to combat axonal degeneration. We will move quickly to develop
their SARM1 inhibitors into potential medicines for peripheral neuropathy and
neurological diseases, such as ALS and multiple sclerosis."
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Gilead Sciences (USA) to Acquire Immunomedics
Gilead Sciences, Inc. and Immunomedics announced that the companies have entered into a
definitive agreement pursuant to which Gilead will acquire Immunomedics for $88.00 per share
in cash. The transaction, which values Immunomedics at approximately $21 billion, was
unanimously approved by both the Gilead and Immunomedics Boards of Directors and is
anticipated to close during the fourth quarter of 2020.The agreement will provide Gilead with
TrodelvyTM (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug
conjugate (ADC) that was granted accelerated approval by the U.S. Food and Drug
Administration (FDA) in April for the treatment of adult patients with metastatic triple-negative
breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support
full approval of Trodelvy in the United States in the fourth quarter of 2020. Immunomedics is also
on track to file for regulatory approval in Europe in the first half of 2021.In the Phase 3 ASCENT
study, which was halted early due to efficacy based on the unanimous recommendation of the
independent Data Safety Monitoring Committee, Trodelvy significantly improved
progression-free survival (PFS) and overall survival (OS) in previously treated patients with
advanced mTNBC. Detailed results from this study are expected to be presented at the upcoming
European Society for Medical Oncology (ESMO) Virtual Congress 2020.
“This acquisition represents significant progress in Gilead’s work to build a strong and
diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of
cancer that is particularly challenging to treat. We will now continue to explore its potential
to treat many other types of cancer, both as a monotherapy and in combination with other
treatments,” said Chairman and Chief Executive Officer, Gilead Sciences. “We look forward
to welcoming the talented Immunomedics team to Gilead so we can continue to advance this
important new medicine for the benefit of patients with cancer worldwide.”
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Grifols (Spain) closes the acquisition of Green Cross fractionation plant in Canada
and 11 plasma centers in the U.S.
Grifols, a global healthcare company and one of world’s leading producers
of plasma-derived medicines, announced the closing of its transaction with
the South Korean firm, GC Pharma (Group) to acquire a plasma
fractionation plant, an immunoglobulin and an albumin purification plants
in Montreal (Canada) for US$370 million, and, in a separate transaction, 11
plasma collection centers in the United States property of Green Cross for
US$90 million.This acquisition aligns with Grifols’ international
sustainable growth strategy, whose core objectives include increasing the
company’s supply of plasma and reinforcing its global expansion.This
strategic acquisition will strengthen Grifols’ presence in Canada, building
on a legacy of partnership in Canada’s blood system. For more than three
decades, Grifols has been a fractionator of Canadian plasma under contract
manufacturing services, providing trusted plasma-derived medicines for
Canadian patients and their healthcare providers.
According to CO-CEO of Grifols, “The addition of 11 U.S.-based
plasma centers will reinforce our leadership and competitive advantages
provided by our plasma-center network. By increasing our plasma
collection and fractionation capacity, we are able to continue ensuring
that patients worldwide have safe and secure access to these life-saving
plasma-derived medicines.”
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Illumina (USA) to Acquire GRAIL to Launch New Era of Cancer Detection
Illumina, Inc. and GRAIL, a healthcare company whose mission is focused on
multi-cancer early detection, announced they have entered into a definitive agreement
under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion
upon closing of the transaction. In addition, GRAIL stockholders will receive future
payments representing a tiered single digit percentage of certain GRAIL-related
revenues. The agreement has been approved by the Boards of Directors of Illumina and
GRAIL.GRAIL was founded by Illumina in 2016 and was spun out as a standalone
company, powered by Illumina’s NGS technology, to develop state-of-the-art data
science and machine learning and create the atlas of cancer signals in the blood, enabling
multi-cancer early detection tests. GRAIL raised approximately $2 billion to support its
innovative technology platform and develop Galleri. An earlier version of Galleri was
able to detect more than 50 cancer types, over 45 of which have no recommended
screening in the United States. Galleri is expected to launch commercially in 2021 as a
multi-cancer, laboratory developed test for early cancer detection from blood. GRAIL
plans to follow Galleri with future blood-based tests for cancer diagnosis, detection and
post-treatment monitoring of cancer patients.
“Over the last four years, GRAIL’s talented team has made exceptional progress in
developing the technology and clinical data required to launch the GalleriTM
multi-cancer screening test. Galleri is among the most promising new tools in the
fight against cancer, and we are thrilled to welcome GRAIL back to Illumina to help
transform cancer care using genomics and our NGS platform,” said Illumina’s
President and Chief Executive Officer. “Together, we have an important opportunity
to introduce routine and broadly available blood-based screening that enables early
cancer detection when treatment can be more effective and less costly. Multi-cancer
early detection is better for patients, their physicians, and payors. As we accelerate
our path to clinical leadership and the path to multi-cancer early detection, we will
continue to drive significant value creation for our stockholders.”
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Intuitive (USA) Announces Third Quarter Earnings
Q3 Highlights
• Worldwide da Vinci procedures increased approximately 7% compared with the third quarter of
2019, reflecting a partial recovery from the significant disruption caused by the COVID-19 pandemic.
• The Company shipped 195 da Vinci Surgical Systems, a decrease of 29% compared with 275 in
the third quarter of 2019.
• The Company grew its da Vinci Surgical System installed base to 5,865 systems as of September
30, 2020, an increase of 8% compared with 5,406 as of the end of the third quarter of 2019.
• Third quarter 2020 revenue of $1,078 million decreased 4% compared with $1,128 million in the
third quarter of 2019. Third quarter 2020 revenue included a $23 million decrease in service revenue
relating to our previously announced Customer Relief Program.
• Third quarter 2020 GAAP net income was $314 million, or $2.60 per diluted share, compared
with $397 million, or $3.33 per diluted share, in the third quarter of 2019. Third quarter 2020 GAAP
net income included $62 million, or $0.51 per diluted share, of other income related to unrealized
gains on strategic investments.
• Third quarter 2020 non-GAAP* net income was $334 million, or $2.77 per diluted share,
compared with $409 million, or $3.43 per diluted share, in the third quarter of 2019.
• The Company launched Intuitive Ventures, an inaugural $100 million fund focused on
investment opportunities in companies that share Intuitive's commitment to advancing positive
outcomes in healthcare.
“We are pleased with procedure results in the third quarter and the concerted efforts of our team
across our business," said Intuitive CEO. “We remain focused on supporting our customers and
on product and process innovation now and in the long term.”
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Johnson & Johnson (USA) Completes Acquisition of Momenta Pharmaceuticals,
Inc.
Johnson & Johnson announced it has successfully completed its acquisition of
Momenta Pharmaceuticals, Inc. (“Momenta”), a company that discovers and
develops novel therapies for immune-mediated diseases, in an all cash transaction
for approximately $6.5 billion.Johnson & Johnson’s tender offer for all
outstanding shares of Momenta for $52.50 per share expired at 12:00 a.m.
(midnight), New York City time, at the end of the day on September 30, 2020.
American Stock Transfer & Trust Company, LLC, the depositary and paying
agent for the tender offer, has advised Johnson & Johnson that approximately
100,595,118 shares of Momenta’s common stock were validly tendered and not
validly withdrawn in the tender offer, representing approximately 79.4% of the
outstanding shares of Momenta’s common stock on a fully diluted basis. All of
the conditions to the tender offer have been satisfied, and on October 1, 2020,
Vigor Sub, Inc. (“Vigor”), a wholly-owned subsidiary of Johnson & Johnson,
accepted for payment, and will as promptly as practicable pay for, all shares
validly tendered and not properly withdrawn in the tender offer.
“We’re delighted to welcome Momenta’s talented team to the Janssen
Pharmaceutical Companies of Johnson & Johnson and to begin our work
together to further advance patient care in autoantibody-driven diseases,” said
Executive Vice President, Worldwide Chairman, Pharmaceuticals, Johnson &
Johnson. “We anticipate multiple launches, many of which would be
first-in-class indications in rare diseases and areas of significant unmet need.”
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Johnson & Johnson (USA) Reports 2020 Third-Quarter Results
• Sales of $21.1 billion reflecting an overall and operational increase of
1.7%*, and adjusted operational increase of 2.0%* despite the estimated
negative impact of the COVID-19 pandemic
• EPS of $1.33 increased 101.5%; adjusted EPS of $2.20 increased 3.8%*
• Company increasing guidance for Full Year Reported Sales by $1.0 billion
and Adjusted EPS by $0.15 driven by the strength of the recovery and strong
underlying business fundamentals
“Our third-quarter results reflect solid performance and positive trends
across Johnson & Johnson, powered by better-than-expected procedure
recovery in Medical Devices, growth in Consumer Health, and continued
strength in Pharmaceuticals,” said Chairman and Chief Executive Officer.
“I am proud of the relentless passion and Credo-led commitment to
patients and customers that our colleagues around the world continue to
demonstrate as we boldly fight the COVID-19 pandemic. Our world-class
R&D team is working tirelessly to advance the Phase 3 trials of our
COVID-19 vaccine and to uphold the highest standards of transparency,
safety and efficacy; while other dedicated teams provide ongoing support
to hospitals and patients as they return to sites of care, and ensure patients
and consumers have the medicines and products they need. This resilient
mindset, combined with our strategic capabilities and execution
excellence, increase our optimism for continued recovery in 2020 and
strong momentum entering into 2021.”
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Rite Aid Corporation (USA) Reports Fiscal 2021 Second Quarter Results
• Revenues from continuing operations for the quarter were $5.98 billion compared to revenues from
continuing operations of $5.37 billion in the prior year's quarter. The increase in revenues was driven by growth
at both the Retail Pharmacy and Pharmacy Services segments.
• Net loss from continuing operations was $13.2 million, or $0.25 per share compared to last year's second
quarter net loss from continuing operations of $78.7 million, or $1.48 per share.
• Adjusted EBITDA from continuing operations was $151.6 million or 2.5% of revenues, compared to last
year's second quarter Adjusted EBITDA of $134.2 million or 2.5% of revenues.
• Retail Pharmacy Segment revenues from continuing operations increased 4.4 percent over the prior year
quarter. Same store sales from continuing operations for the second quarter increased 3.5 percent over the prior
year period, consisting of a 4.6 percent increase in front-end sales and a 2.3 percent increase in pharmacy sales.
• Retail Pharmacy Segment Adjusted EBITDA from continuing operations was $122.3 million or 3.0 percent
of revenues for the second quarter compared to last year's second quarter Adjusted EBITDA from continuing
operations of $92.7 million or 2.4 percent of revenues.
• Pharmacy Services Segment revenues were $2.0 billion, an increase of 29.1 percent compared to the prior
year period. The increase in Pharmacy Services Segment revenues was due primarily to a membership increase
of 259,000 in Medicare Part D.
• Pharmacy Services Segment Adjusted EBITDAfrom continuing operations was $29.3 million or 1.4 percent
of revenues for the second quarter compared to last year's second quarter Adjusted EBITDA from continuing
operations of $41.5 million or 2.6 percent of revenues.
"We are pleased with our second quarter performance as we delivered another quarter of strong results while
making solid progress on our bold, new RxEvolution strategy," said President and chief executive officer,
Rite Aid. "Our retail pharmacists and associates have always been deeply committed to our communities,
and they are doing a great job protecting our customers during a global pandemic. Thanks to them, Rite Aid
continues to gain retail market share and increase both same store prescription count and front-end sales."
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Rite Aid (USA) to Acquire Bartell Drugs
Rite Aid and Bartell Drugs announced they have entered into a definitive agreement
under which Rite Aid will acquire Bartell Drugs. Founded in 1890, family-owned Bartell
Drugs generates over $550 million in revenue and fills approximately 5.5 million
prescriptions annually across its 67 stores in Seattle and throughout King, Snohomish
and Pierce counties in Washington state. Bartell Drugs' stores join Rite Aid's existing 69
Seattle area stores and will continue to operate under the Bartell Drugs name. The
purchase price is $95 million.Within each community it serves, Rite Aid aspires to be the
neighborhood pharmacy that best supports the overall health and well-being of its
residents. The greater Seattle area is made up of a large and growing number of people
who share Rite Aid's holistic health mindset. These same customers value the expanded
role pharmacists play in choices impacting the well-being of their families. Rite Aid
supports these families as a whole health destination with pharmacists that embrace their
role as the everyday extension of the broader healthcare ecosystem. By deepening the
organization's commitment to families in the Seattle area, Rite Aid is better positioned to
support the health and well-being of its customers, as well as the many notable regional
health plans and health systems in the region which serve them.
"For more than a century, Bartell's has been an integral part of the fabric of Seattle
and neighboring communities serving families with pharmacy services while
promoting the health and well-being of local communities," said President and chief
executive officer, Rite Aid. "The acquisition of Bartell's fits perfectly into and
accelerates our RxEvolution strategy, as our companies share a commitment to total
health and wellness, the importance of the pharmacist as a trusted health advisor and
the critical role the neighborhood pharmacy plays. Expansion within the growing
Seattle area will allow Rite Aid to better serve customers, health plans and healthcare
providers."
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Takeda (Japan) to Divest TachoSil® to Corza Health for €350 Million
Takeda Pharmaceutical Company Limited announced that it has entered into an agreement to divest its
TachoSil® Fibrin Sealant Patch to Corza Health, Inc. Corza Health was formed in 2019 as a partnership
between private equity firm GTCR and healthcare industry veteran Gregory T. Lucier to build a
market-leading healthcare business with a particular focus on the broader medical technology and life
sciences sector. Takeda will receive €350 million in cash upon closing of the transaction, which is subject
to customary legal and regulatory closing conditions.TachoSil® is a surgical patch trusted by medical
professionals globally to deliver safe, fast and reliable bleeding control. Takeda recorded full year net sales
for TachoSil® of approximately $160 million USD in the fiscal year ended March 31, 2020.Takeda has
sustained the momentum of its divestiture program in 2020. Most recently, Takeda announced the sale of
non-core assets in Europe and Canada to Cheplapharm for approximately $562 million USD. In August,
Takeda announced an agreement to divest Takeda Consumer Healthcare Company Limited to Blackstone
for approximately $2.3 billion USD. In June, Takeda agreed to divest a portfolio of non-core assets sold
exclusively in the Asia Pacific region to Celltrion for up to $278 million USD; in April, Takeda announced
the sale of non-core products in Europe to Orifarm Group for up to approximately $670 million USD,
including the sale of two manufacturing sites in Denmark and Poland; and in March, Takeda announced the
sale of non-core products in Latin America to Hypera Pharma for $825 million USD, as well as completed
the previously announced sales of non-core assets spanning the Russia-CIS region to STADA and in
countries spanning the Near East, Middle East and Africa region to Acino.
Chief Financial Officer, Takeda, said, “This announcement continues Takeda’s strong momentum
toward optimizing our portfolio for growth by delivering highly-innovative medicines and
transformative care in our chosen business areas, as well as meeting our leverage targets. As we
continue to streamline and simplify our portfolio, Takeda is confident that we have found the right
partner in Corza Health as the next home for TachoSil®. Corza Health’s expertise in healthcare,
commitment to patients, customers and employees, and resources in partnership with GTCR make it
well-positioned to ensure continued patient access to TachoSil® and to invest in the product over the
long term for their benefit.”
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Smith+Nephew (UK) expands in higher-growth extremities segment through
planned acquisition of Integra LifeSciences’ Extremity Orthopaedics business
Smith+Nephew, the global medical technology business, announces that it has agreed to
acquire the Extremity Orthopaedics business of Integra LifeSciences Holdings
Corporation for $240 million. The acquisition supports Smith+Nephew’s strategy to
invest in higher-growth segments. This acquisition will significantly strengthen
Smith+Nephew’s extremities business by adding a combination of a focused sales
channel, complementary shoulder replacement and upper and lower extremities
portfolio, and an exciting new product pipeline. The focused extremities commercial
channel includes a specialised sales force and distributors, predominantly in the US as
well as Canada and Europe. The portfolio is highly complementary to Smith+Nephew’s
existing orthopaedics offering, in particular providing entry into the shoulder
replacement and foot and ankle segments. The full portfolio includes devices, implants,
and instruments which provide for shoulder replacement as well as reconstruction of
bone in the hand, wrist and elbow (Upper Extremity) and foot and ankle (Lower
Extremity). The US extremities segment has been growing at around 6-7% per annum.
The Extremity Orthopaedics R&D pipeline includes a next-generation shoulder
replacement system, which is expected to be ready for full commercial launch in 2022.
President, Global Orthopaedics at Smith+Nephew, said:“Integra’s Extremity
Orthopaedics business is an established global player in the rapidly growing
extremities segment, including total shoulder replacement, and has a well-regarded
specialised sales channel and a strong pipeline of new products. This strategic
acquisition represents a significant opportunity to strengthen Smith+Nephew’s
position in a high-value area and allows us to offer a leading extremities portfolio to
customers.”
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UCB (Belgium) Further Invests In UK Operations With Agreement To Acquire A
New Leading-Edge Campus
UCB has signed an agreement to acquire a new campus for its UK operations supporting cutting-edge research
and development, early manufacturing and commercialisation of medicines aiming to transform the lives of
people living with severe immunological and neurological conditions. The acquisition of the world-class site in
Windlesham, Surrey is anticipated to be completed in November 2020 and reflects UCB’s commitment to retain
the UK as one of its three global hubs for research and development, alongside Belgium and the US. UCB’s
projected investment in the UK, including this site, will be more than £1 billion over five years and the transition
to this new facility will support more than 650 high-value jobs in scientific research, translational medicine,
clinical development, early manufacturing and commercial roles. The 47-acre (19 hectare) campus will be
acquired from Eli Lilly and Company Limited and was formerly its second largest research site worldwide.
Following completion of the acquisition, the site will undergo state-of-the-art refurbishment prior to UCB
relocating from its current UK headquarters in Slough, Berkshire. This refurbishment will enable successful
execution of UCB’s research plan to develop innovative treatments for patients including gene therapies and
translational medicine, as well as development of UCB’s world-class antibody discovery platforms. This new
campus in Windlesham reinforces UCB’s conviction in UK life sciences and its drive in developing innovative
treatments for patients with neurological and immunological conditions. UCB reinvests between 23-28% of its
revenue into R&D per annum globally, making the company one of the most research-intensive companies in
Europe. With an extensive network of collaborations with UK universities, charities and other companies, UCB
endeavours to further advance scientific research in the UK and deliver the solutions that patients need globally.
Chief Executive Officer at UCB said: “We have a strong track record of discovering medicines in the UK
which go on to make a difference to the lives of patients worldwide. I am delighted to have signed an
agreement to secure this new campus for our UK hub, from which our scientists will be able to continue to
develop their extensive collaborations with some of the most innovative universities, bio-techs and medical
research charities, bringing even greater benefit for patients.This new UK site will not only support our
ambitions for future drug discovery but will be well-placed to enable us to achieve our 2030 global
sustainability goals and provides an environment which supports the physical and mental wellbeing of our
people – essential to helping us thrive.”
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Bausch Health (USA) To Acquire Option To Purchase All Ophthalmology Assets Of
Allegro Ophthalmics
Bausch Health Companies Inc. and Bausch + Lomb, its leading global eye health
business, and Allegro Ophthalmics, LLC (Allegro), a privately held
biopharmaceutical company focused on the development of novel therapies that
regulate integrin functions for the treatment of ocular diseases, announced that
Bausch Health (through its affiliate) has entered into an agreement to acquire an
option to purchase all ophthalmology assets of Allegro (the "Option"), including
global rights for risuteganib (Luminate®)1, Allegro's lead investigational
compound in retina, which is believed to simultaneously act on the angiogenic,
inflammatory and mitochondrial metabolic pathways implicated in diseases such
as intermediate dry Age-related Macular Degeneration (AMD). It is estimated
that as many as 16 million people in the United States have AMD2, and globally,
the prevalence of AMD is expected to reach 196 million people worldwide this
year and to increase to 288 million by 2040.3 Approximately 90 percent of people
diagnosed with AMD have dry AMD, for which there are currently no treatments.
"As part of the ongoing transformation of Bausch Health, we continue to seek
strategic opportunities to build-up our pipeline in core businesses, including
Bausch + Lomb, our global eye health business. The addition of the
ophthalmic assets of Allegro would significantly enhance our comprehensive
portfolio of products for AMD," said, chairman and CEO of Bausch Health.
"If approved, risuteganib may be the first treatment indicated to help reverse
vision loss due to dry AMD and would address a significant unmet medical
need affecting millions of people globally."
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Walgreens Boots Alliance (USA) Reports Fiscal Year 2020 Results
Fourth quarter Walgreens Boots Alliance highlights, year-over-year
• Sales increased 2.3 percent to $34.7 billion, up 2.3 percent on a constant currency basis
• Operating income decreased 26.0 percent to $650 million; Adjusted operating income decreased 27.7
percent to $1.1 billion, down 27.4 percent on a constant currency basis
• EPS decreased 42.8 percent to $0.43; Adjusted EPS decreased 28.2 percent to $1.02, down 27.9
percent on a constant currency basis; reflecting an estimated adverse COVID-19 impact of approximately
$0.46
Fiscal 2020 highlights, year-over-year
• Sales increased 2.0 percent to $139.5 billion, up 2.5 percent on a constant currency basis
• Operating income decreased 73.7 percent to $1.3 billion; Adjusted operating income decreased 24.9
percent to $5.2 billion, down 24.8 percent on a constant currency basis
• EPS decreased 88.0 percent to $0.52; Adjusted EPS decreased 20.8 percent to $4.74, down 20.6
percent on a constant currency basis; reflecting an estimated adverse COVID-19 impact of approximately
$1.06
• Net cash provided by operating activities was $5.5 billion, a decrease of $109 million compared with
fiscal 2019; Free cash flow increased 5.6 percent to $4.1 billion
Fiscal 2021 guidance
• Company introduced fiscal 2021 guidance of low single-digit growth in adjusted EPS at constant
currency rates
Executive Vice Chairman and CEO said, “I am pleased to report results that came in at the high end of
our expectations as we continue to adapt and transform our business model to changing customer
needs. Despite uncertainty amid the global COVID-19 pandemic, we are seeing gradual improvement
in key U.S. and UK markets and continued strong performance in our wholesale business. I'm also
encouraged by the accelerating growth in our e-commerce platforms. Now, more than ever, our
pharmacy-centered business is at the heart of community healthcare and we are expanding on that role
for the future. I continue to be inspired by the tireless efforts of our teams as they support and care for
our customers, patients and communities, while accelerating progress on our clear set of strategic
priorities. Looking ahead, we are projecting adjusted EPS growth in fiscal 2021, as reflected in our
new guidance."
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AbbVie (USA) Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for
Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
24
Solution Description
AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab
(ABT-555), an investigational treatment for patients following spinal cord injury. Elezanumab is a monoclonal antibody of the human immunoglobulin
(Ig)G1 isotype that binds selectively to repulsive guidance molecule A (RGMa). RGMa is an inhibitor of axonal outgrowth and recognized as an
important factor in inhibiting neuronal regeneration and functional recovery following central nervous system (CNS) damage. Elezanumab is being
investigated to treat spinal cord injuries, multiple sclerosis and acute ischemic stroke. It is currently in a phase 2 study (NCT04295538) for the treatment
of spinal cord injury.Currently AbbVie is partnering with the Shirley Ryan AbilityLab, a global leader in physical medicine and rehabilitation, and
MC10, a health digital solutions company, in a pilot study involving 20 spinal cord injury patients. The pilot study will inform the ongoing Phase 2 study
of elezanumab by testing optimal biosensor placement to capture surface electromyography (sEMG), among other assessments. The pilot study will be
completed in approximately two months.AbbVie is also partnering with United Spinal Association and the North American Spinal Cord Injury
Consortium to support spinal cord injury awareness and incorporate spinal cord injury community perspectives into our clinical research and
outreach.Orphan Drug Designation is given to a drug or biologic for the treatment, diagnosis or prevention of a rare disease or condition.The FDA uses
a fast track process to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

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Restore EF Study Demonstrates Impella-Supported High-Risk PCI
Improves Left Ventricular Ejection Fraction
25
The Restore EF Study demonstrates the use of contemporary best practices, including attempting a more complete revascularization with Impella-supported
high-risk PCI, is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at
follow up. The interim analysis was presented by Mitul Patel, MD, an interventional cardiologist at UC San Diego Health, at TCT Connect, the 32nd annual
scientific symposium of the Cardiovascular Research Foundation.The ongoing, multi-center, prospective, single-arm study enrolled 193 consecutive
qualified patients who underwent a Protected PCI procedure with Impella between September 2019 and September 2020 at 19 hospitals in the United States,
representing a variety of hospital settings including rural, urban, community and academic centers. The interim analysis showed:
• Significant median LVEF improvement from baseline to 90-day follow up (31% to 45% p<0.0001). LVEF improvement at 90 days is the study’s primary
endpoint. (see figure 1)
• Significant reduction of heart failure symptoms with 80% reduction in New York Heart Association (NYHA) classification III/IV at follow up (54% to
11% p<0.001). (see figure 2)
• Significant reduction of anginal symptoms with 99% reduction in Canadian Cardiovascular Society (CCS) classification III/IV at follow up (70% to 1%
p<0.0001).

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CVS Health (USA) introduces special access to Apple Fitness+
26
CVS Health announced it is offering special access for its clients, customers and employees to Apple Fitness+, the first fitness experience built
for Apple Watch, arriving later this year. CVS Health is developing a one-year subscription offer for Aetna commercial and CVS Caremark
members and will share details soon. Additionally, a free two-month subscription for Fitness+ will be offered to CVS Pharmacy ExtraCare
members and all current CVS Health employees when the service is launched. Fitness+ intelligently incorporates metrics from Apple Watch
for users to visualize right on their iPhone, iPad, or Apple TV, offering a first-of-its-kind personalized workout experience. With Fitness+,
everyone from beginners to fitness enthusiasts can access studio-style workouts delivered by inspiring world-class trainers underscored by
motivating music from renowned artists, making it easier and more rewarding for users to exercise, whenever and wherever they like.The
announcement is a continuation of the relationship between Aetna, a CVS Health company, and Apple that originated in 2016 when 90 percent
of participants in their employee wellness subsidy program reported a health benefit from their use of Apple Watch. In 2019, Aetna launched
Attain, a unique health experience designed by Aetna in collaboration with Apple. Attain is a comprehensive integrated wellness program via
direct-to-member app that blends activity-driven incentives and rewards with personalized health recommendations.

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Alexion (USA) and Caelum Biosciences Announce Start of Phase 3
Studies of CAEL-101 in ALAmyloidosis
27
Alexion Pharmaceuticals, Inc. and Caelum Biosciences announced the initiation of the Cardiac Amyloid Reaching for Extended
Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination
with standard-of-care (SoC) therapy in AL amyloidosis. The CARES clinical program includes two parallel Phase 3 studies – one in
patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease – and will collectively enroll approximately
370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall
survival.The CARES clinical program consists of two parallel double-blind, randomized, event-driven global Phase 3 studies, which
are evaluating the efficacy and safety of CAEL-101 in AL amyloidosis patients who are newly diagnosed and naïve to standard of
care (SoC) treatment (cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy). One study is enrolling
approximately 260 patients with Mayo stage IIIa disease and one study is enrolling approximately 110 patients with Mayo stage IIIb
disease. The studies will be conducted at approximately 70 sites across North America, the United Kingdom, Europe, Israel, Japan,
and Australia.

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Alexion (USA) Receives CHMP Positive Opinion for New Advanced Formulation
of ULTOMIRIS® (ravulizumab) with Significantly Reduced Infusion Time
28
Alexion Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion,
recommending marketing authorization in the European Union for a new 100 mg/mL intravenous (IV) advanced formulation of ULTOMIRIS®
(ravulizumab). ULTOMIRIS is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare
diseases—paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). ULTOMIRIS 100 mg/mL would
constitute 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. Atypical HUS can cause progressive injury to vital organs, primarily the kidneys, via
damage to the walls of blood vessels and blood clots. 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.

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ULTOMIRIS® (ravulizumab) Receives Approval in Japan for Atypical
Hemolytic Uremic Syndrome (aHUS) in Adults and Children
29
Alexion Pharmaceuticals, Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved ULTOMIRIS® (ravulizumab) for adults and children living with atypical
hemolytic uremic syndrome (aHUS). ULTOMIRIS is the first and only long-acting C5 inhibitor for aHUS and is administered every other month for adults and children (20 kg or more) and
monthly for children (<20 kg). Atypical HUS is an ultra-rare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood
clots.Atypical HUS affects both adults and children and many patients present in critical condition in the hospital setting, often requiring supportive care, including dialysis, in an intensive
care unit. The prognosis of aHUS can be poor in many cases, with 56 percent of adults and 29 percent of children developing end-stage renal disease or dying within a year of diagnosis with
supportive care alone, so a timely and accurate diagnosis in addition to treatment, is critical to improving patient outcomes.The approval is based on data from two ongoing, global, single-arm
open-label studies of ULTOMIRIS – one in adults and one in children, referred to as pediatrics in the study. A total of 18 out of 21 complement inhibitor treatment-naïve children and 56 out
of 58 complement inhibitor treatment-naïve adults were enrolled and included in the interim analysis. Efficacy evaluation of Complete TMA Response was defined by normalization of
hematologic parameters (platelet count and LDH) and improved kidney function (as measured by ≥25 percent improvement in serum creatinine from baseline). In the initial 26-week treatment
periods, 54 percent of adults and 77.8 percent (interim data) of children demonstrated Complete TMA Response. Treatment with ULTOMIRIS resulted in normalization of platelet count in 84
percent of adults and 94 percent of children, normalization of LDH (marker of hemolysis) in 77 percent of adults and 90 percent of children, and improved kidney function in 59 percent of
adults and 83 percent (interim data) of children (for patients on dialysis at enrollment, baseline was established after they had come off dialysis). In the 52-week follow-up period, 4 additional
adult patients and 3 pediatric patients had a Complete TMA Response that was confirmed after the 26-week Initial Evaluation Period resulting in an overall Complete TMA Response of 61
percent in adults and 94 percent in children (interim data). A second cohort of 10 pediatric patients who were SOLIRIS-experienced were included in the pediatric study, demonstrating that
switching to ULTOMIRIS maintained disease control as evidenced by stable hematologic and renal parameters, with no apparent impact on safety.

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Alexion (USA) Receives FDAApproval for New Advanced Formulation of
ULTOMIRIS® (ravulizumab-cwvz) with Significantly Reduced Infusion Time
30
Alexion Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved ULTOMIRIS® (ravulizumab-cwvz) 100
mg/mL formulation for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome
(aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric (one month of age and older) patients. ULTOMIRIS
100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces 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. Atypical HUS can cause progressive injury to vital organs, primarily the kidneys, via
damage to the walls of blood vessels and blood clots. Affecting both adults and children, atypical HUS 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.

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Steraligner Aligner Cleaning System Now Available On Invisalign Doctor
Store And Invisalign Accessories Site
31
Align Technology, Inc. announced the addition of the Steraligner aligner cleaning system to the Invisalign Doctor Site web
store and InvisalignAccessories.com. The Steraligner cleaning solution was created by Dr. Sam Daher, a Vancouver-based
orthodontist and a top Invisalign provider in North America, to meet the daily cleaning needs of clear aligner patients. The
Steraligner cleaning solution is designed for twice-daily use to remove plaque, staining and 99.9% of bacteria found in the
mouth for better oral health and for fresh, clean aligners.Align Technology designs and manufactures the Invisalign® system,
the most advanced clear aligner system in the world, iTero® intraoral scanners and services, and CAD/CAM software. Align
has helped treat over 8 million patients with the Invisalign system and is driving the evolution in digital dentistry with the
iTero intraoral scanner and exocad® CAD/CAM software − modernizing today’s practices by enabling enhanced digital
orthodontic and restorative workflows to improve patient outcomes and practice efficiencies.

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Astellas (Japan) and Seattle Genetics Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved
Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer
32
Astellas Pharma Inc. and Seattle Genetics, Inc. announced that a phase 3 trial of PADCEV®met its primary endpoint of overall survival compared to chemotherapy. The
results were reviewed by an independent Data Monitoring Committee following a planned interim analysis. The global EV-301 clinical trial compared PADCEV to
chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1
inhibitor. In the trial, PADCEV significantly improved overall survival (OS), with a 30 percent reduction in risk of death (Hazard Ratio [HR]=0.70; [95% Confidence
Interval (CI): 0.56, 0.89]; p=0.001). PADCEV also significantly improved progression-free survival (PFS), a secondary endpoint, with a 39 percent reduction in risk of
disease progression or death (HR=0.61 [95% CI: 0.50, 0.75]; p<0.00001). For patients in the PADCEV arm of the trial, adverse events were consistent with those listed
in the U.S. Prescribing Information, with rash, hyperglycemia, decreased neutrophil count, fatigue, anemia and decreased appetite as the most frequent Grade 3 or greater
adverse event(s) occurring in more than 5 percent of patients. Data from EV-301 will be submitted for presentation at an upcoming scientific congress. Patients in the
chemotherapy arm of the trial will be offered the opportunity to receive PADCEV. The results will be submitted to the U.S. Food and Drug Administration (FDA) as the
confirmatory trial following the drug’s accelerated approval in 2019. EV-301 is also intended to support global registrations.Globally, approximately 580,000 people will
be diagnosed with bladder cancer in 2020.1 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis (where urine collects
inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.2 Approximately 80 percent of people do not respond to PD-1 or PD-L1 inhibitors
after a platinum-containing therapy has failed as an initial treatment for advanced disease.

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Lynparza recommended for approval in EU by CHMP as 1st-line maintenance
treatment with bevacizumab for HRD-positive advanced ovarian cancer
33
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance
treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. The Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a biomarker subgroup analysis of the PAOLA-1 Phase III trial,
which was published in The New England Journal of Medicine. The trial showed that Lynparza in combination with bevacizumab maintenance treatment reduced
the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). The addition of Lynparza improved
progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.
For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve
long-term remission. Ovarian cancer is the fifth most common cause of cancer death in Europe and the five-year survival rate is approximately 45%, due in part
because women are often diagnosed with advanced disease (Stage III or IV).The CHMP recommendation is for Lynparza in combination with bevacizumab for
the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who
are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is
associated with HRD positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.

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Lynparza recommended for approval in the EU by CHMP for BRCA-mutated
metastatic castration-resistant prostate cancer
34
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with
metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of
homologous recombination repair (HRR) gene mutations. The Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase III trial. The
primary results from the trial were published in The New England Journal of Medicine in May 2020. Prostate cancer is the second-most common
type of cancer in men, with an estimated 1.3 million new patients diagnosed worldwide in 2018.1 Approximately 12% of men with mCRPC have
a BRCA mutation.The CHMP recommendation for Lynparza is for the treatment of adult patients with mCRPC and BRCA1/2 mutations who have
progressed following prior therapy that included a new hormonal agent.Lynparza was approved in the US for men with HRR gene-mutated
mCRPC in May 2020 based on the PROfound Phase III trial. Regulatory reviews are ongoing in other countries around the world.AstraZeneca and
MSD are exploring additional trials in metastatic prostate cancer including the ongoing PROpel Phase III trial testing Lynparza as a 1st-line
treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021.

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Farxiga granted Breakthrough Therapy Designation in US for chronic
kidney disease
35
AstraZeneca’s Farxiga (dapagliflozin) has been granted Breakthrough Therapy Designation (BTD) in the US for patients with chronic kidney disease (CKD),
with and without type-2 diabetes (T2D). CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an
increased risk of heart disease or stroke.1,2,3 In the US, 37 million people are estimated to have CKD. The Food and Drug Administration (FDA)'s BTD is
designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a
significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a
clinically significant endpoint over available medicines. The FDA granted BTD based on clinical evidence from the DAPA-CKD trial. The detailed results
presented in August demonstrated that Farxiga on top of standard of care reduced the composite measure of worsening of renal function or risk of
cardiovascular (CV) or renal death by 39% compared to placebo (absolute risk reduction [ARR] = 5.3%, p<0.0001) in patients with CKD while also
significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo. In the US, Farxiga is indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with T2D and to reduce the risk of hospitalisation for heart failure (hHF) in patients with T2D and established
CV disease or multiple CV risk factors. In May, Farxiga was approved in the US to reduce the risk of CV death and hHF in adults with heart failure (HF)
(NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D.

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COVID-19 Long-Acting AntiBody (LAAB) combination AZD7442 rapidly
advances into Phase III clinical trials
36
AstraZeneca’s long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at
sites in and outside the US that are due to begin in the next weeks. The LAABs have been engineered with AstraZeneca’s proprietary half-life extension
technology to increase the durability of the therapy for six to 12 months following a single administration. The combination of two LAABs is also
designed to reduce the risk of resistance developed by the SARS-CoV-2 virus. The Company has received support of around $486m from the US
Government for the development and supply of AZD7442 under an agreement with the Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the
Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. One trial will evaluate the safety
and efficacy of AZD7442 to prevent infection for up to 12 months, in approximately 5,000 participants. The second trial will evaluate post-exposure
prophylaxis and pre-emptive treatment in approximately 1,100 participants. AstraZeneca is planning additional trials to evaluate AZD7442 in
approximately 4,000 patients for the treatment of COVID-19. AstraZeneca plans to supply up to 100,000 doses starting towards the end of 2020 and the
US Government can acquire up to an additional one million doses in 2021 under a separate agreement.

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Baxter (USA) Announces U.S. FDAApproval of Clinimix and Clinimix E
with Higher Protein for Patients Requiring Parenteral Nutrition
37
A global leader in clinical nutrition, announced the U.S. Food and Drug Administration (FDA) approval of new formulations of Clinimix (amino acids in dextrose)
Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections. These new Clinimix formulations contain up to 80 g/L of amino acids,
the highest protein in any multi-chamber bag available in the U.S., making it easier to reach patient protein targets while delivering less fluid and dextrose than
provided by existing formulations. Parenteral nutrition (PN) is an intravenous administration of nutrition that plays an important role in helping reduce malnutrition
and may include proteins (amino acids), carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements. Guidelines from the Society of Critical Care
Medicine (SCCM) and the American Society for Parenteral and Enteral Nutrition (ASPEN) recommend between and 2.0 grams of protein per kilogram of body
weight per day for a critically ill adult patient, and note that many patients may benefit from protein supplementation5. These patients may also have other
nutritional considerations, like controlling blood glucose levels4 and, in many cases, restricting fluid intake.In addition to these new higher protein formulations
intended for patients with moderate to high protein needs, Baxter will continue to provide existing formulations of Clinimix and Clinimix E for patients with lower
protein needs. The approval of Clinimix and Clinimix E with Higher Protein follows the U.S. introduction of Clinolipid (20% Lipid Injectable Emulsion), the
company's proprietary olive oil-based lipid emulsion. Clinolipid, with less soybean oil and more omega-9 fatty acid than other commercially available mixed lipid
emulsions, provides an additional therapy option for use in PN for adults.

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BioMarin (USA) Announces The Lancet Publishes Detailed Vosoritide Phase 3 Data Demonstrating Statistically
Significant Increase in Annualized Growth Velocity (AGV) Over 52 Weeks in Children with Achondroplasia
38
BioMarin Pharmaceutical Inc. announced that The Lancet has published online results from a randomized, double-blind, phase 3, placebo-controlled, multicenter
trial for vosoritide, an investigational analog of C-type Natriuretic Peptide (CNP), in children aged 5 to 18 years with achondroplasia. Achondroplasia is the most
common form of disproportionate short stature in humans. The data demonstrated that daily subcutaneous administration of vosoritide to children with
achondroplasia resulted in significantly increased growth velocity and height Z scores over baseline after one year of treatment as compared to those who received
placebo with similar adverse effect profiles.The primary endpoint was change from baseline in AGV at 52 weeks in participants administered daily subcutaneous
injections of vosoritide, at a dose of 15.0 µg/kg/day, compared with placebo. The findings demonstrated that the adjusted mean difference in AGV between children
in the vosoritide group and placebo group was 1.57cm per year in favor of vosoritide (95% CI: 1.22 - 1.93, p value <0•0001), a substantial proportion of the
approximately 2 cm/yr AGV deficit relative to average-stature children. The results of subgroup analyses for change from baseline in AGV were consistent with
the overall mean difference between treatment groups in favor of vosoritide, with all 95% CIs overlapping. Baseline AGV was calculated from the increase in
standing height measured over the last six months of the run-in study. Post-baseline AGV was calculated from standing height at baseline and 52-weeks, and then
summarized by treatment arm. As of October 30th, 2019, the 52-week placebo-controlled study was completed, and 119 participants had enrolled in the extension
study, where all children are receiving vosoritide.

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BioMarin (USA), Pioneer in Phenylketonuria (PKU) and Gene Therapy, Doses First
Participant in Global PHEARLESS Phase 1/2 Study of BMN 307 Gene Therapy
39
BioMarin Pharmaceutical Inc.announced that it has dosed the first participant in the global PHEARLESS Phase 1/2 study with BMN 307, an
investigational gene therapy for the treatment of individuals with PKU. BMN 307 is an AAV5-phenylalanine hydroxylase (PAH) gene therapy
designed to normalize blood phenylalanine (Phe) concentration levels in patients with PKU by inserting a correct copy of the PAH gene into liver
cells. BMN 307 will be evaluated to determine safety and whether a single dose of treatment can restore natural Phe metabolism, normalize plasma
Phe levels, and enable a normal diet in patients with PKU. BioMarin will conduct this study with material manufactured with a commercial-ready
process to facilitate rapid clinical development and potentially support approval. BMN 307 represents a potential third PKU treatment option in
BioMarin's PKU franchise and a second gene therapy development program. PKU is a rare genetic disease that manifests at birth and is marked
by an inability to break down Phe, an amino acid that is commonly found in many foods. Left untreated, high levels of Phe become toxic to the
brain and may lead to serious neurological and neuropsychological issues, affecting the way a person thinks, feels, and acts. Due to the seriousness
of these symptoms, in many countries, infants are screened at birth to ensure early diagnosis and treatment to avoid intellectual disability and other
complications. According to treatment guidelines, PKU patients should maintain lifelong control of their Phe levels.

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Boston Scientific (USA) Launches ACURATE neo2™ Aortic Valve System
in Europe
40
Boston Scientific Corporation announced it has initiated a controlled launch of the ACURATE neo2™ Aortic Valve System in Europe. This
next-generation transcatheter aortic valve implantation (TAVI) technology is a new platform designed with a number of features to improve upon the
clinical performance of the original ACURATE neo platform. Compared to the previous generation device, the ACURATE neo2 valve system also has
an expanded indication for patients with aortic stenosis – with no specified age or risk level – who are considered appropriate candidates for the therapy
by their heart team, including a cardiac surgeon.Indicated to restore function and normal blood flow through a severely narrowed aortic valve, the
ACURATE neo2 Valve System features a new annular sealing technology designed to conform to irregular, calcified anatomies and further minimize
paravalvular regurgitation or leaking (PVL). In addition, the delivery system simplifies access to smaller and complex vessels at the entry site and
allows for highly accurate valve positioning while the top-down deployment mechanism further supports stable placement and release to ensure the best
patient outcomes.Data from the ACURATE neo2 CE-Mark Study demonstrated PVL rates for the ACURATE neo2 Valve System to be lower than
previously reported with the current generation ACURATE neo valve. At 30 days and 1 year after implantation, respectively, 97% and 97.5% of patients
experienced ≤ no/trace or mild PVL, 3.0% and 2.5% of patients experienced moderate PVL and 0% of patients experienced severe PVL.

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Boston Scientific (USA) Launches WaveWriter Alpha™ Spinal Cord
Stimulator Systems In Europe
41
Boston Scientific announced the European launch of the WaveWriter Alpha™ portfolio of Spinal Cord Stimulator (SCS) Systems. The portfolio, consisting of four MRI
conditionali, 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 12
weeks, impacts approximately 100 million people across Europe.ii,iii SCS therapies provide pain relief by delivering pulses of mild electric current to the spinal cord to
interrupt pain signals traveling to the brain. The WaveWriter Alpha SCS Systems received CE Mark and are indicated as an aid in the management of chronic intractable
pain. It is also indicated for peripheral nerve stimulation of the trunk for pain management.The systems feature combination therapy, the only SCS portfolio that has the
ability to layer paraesthesia and paraesthesia-free options simultaneously, and support up to 32 contacts that target specific nerves along the spinal cord to meet the
personal pain relief coverage needs of the individual patient. The Bluetooth platform enables faster programming that can be done while maintaining a typical physical
distance of 10 feet (3meters) between the programmer and the patient.The COMBO randomized control trial, which compared the effectiveness of SCS with multiple
modalities to conventional SCS in patients with chronic pain, found 88% of patients were responders with multiple modalities, which is defined as patients achieving
50% or greater pain relief compared to baseline. Patients also realized a significant 26-point improvement in functional disabilityiv where many patients who were
"severely" or "moderately disabled" were able to return to many of their daily activities.v Multiple Level 1 RCTs and real-world studies support the design of Boston
Scientific's SCS therapy.

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European Medicines Agency Validates Bristol Myers Squibb’s (USA) Type II Variation Application for Opdivo
(nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma
42
Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated a type II variation application for Opdivo®(nivolumab) plus
Yervoy®(ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). Validation of the application
confirms the submission is complete and begins the EMA’s centralized review process.The type II variation application is supported by data from the pivotal Phase
3 CheckMate -743 trial, which met the primary endpoint of superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin
or carboplatin) in all randomized patients. The safety profile was consistent with previous studies of Opdivo plus Yervoy. Results from CheckMate -743 were
presented at the 2020 World Conference on Lung Cancer Virtual Presidential Symposium, hosted by the International Association for the Study of Lung Cancer
on August 8, 2020.CheckMate -743 is an open-label, multi-center, randomized Phase 3 trial evaluating Opdivo plus Yervoy compared to chemotherapy
(pemetrexed and cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma (n=605). In the trial, 303 patients were randomized
to receive Opdivo at 3 mg/kg every two weeks and Yervoy at 1 mg/kg every six weeks for up to 24 months or until disease progression or unacceptable toxicity;
302 patients were randomized to receive cisplatin 75 mg/m2 or carboplatin AUC 5 plus pemetrexed 500 mg/m2 in 21-day cycles for six cycles or until disease
progression or unacceptable toxicity. The primary endpoint of the trial was OS in all randomized patients. Key secondary endpoints included objective response
rate (ORR), disease control rate (DCR) and progression-free survival (PFS). Exploratory endpoints included safety, pharmacokinetics, immunogenicity and patient
reported outcomes.

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Bristol Myers Squibb (USA) Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Yervoy
(ipilimumab) Combined with Two Cycles of Chemotherapy as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
43
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) with two cycles of platinum-based chemotherapy
for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have no sensitizing EGFR mutation or
ALK translocation. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now
review the CHMP recommendation.The CHMP adopted the positive opinion based on results from the Phase 3 CheckMate -9LA trial, which
met the primary endpoint of superior overall survival (OS). The safety profile of Opdivo plus Yervoy and two cycles of chemotherapy was
reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC. The full data from the
CheckMate -9LA trial were featured in an oral session at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific
Program.To date, the combination of Opdivo plus Yervoy with two cycles of chemotherapy has been approved in nine countries, including the
U.S., for the first-line treatment of patients with metastatic NSCLC. Approval by the EC would mark the third indication for Opdivo plus
Yervoy-based combinations in the EU, following previous approvals in metastatic melanoma and advanced renal cell carcinoma.

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Opdivo (nivolumab) Demonstrated Superior Disease-Free Survival in Patients with Resected Esophageal
or Gastroesophageal Junction Cancer Compared to Placebo in the Adjuvant Setting
44
Bristol Myers Squibb announced first results from the Phase 3 CheckMate -577 trial in which adjuvant treatment with Opdivo (nivolumab) showed a statistically
significant and clinically meaningful improvement in disease-free survival (DFS), the trial’s primary endpoint, compared to placebo in patients with esophageal or
gastroesophageal junction (GEJ) cancer following neoadjuvant chemoradiation therapy (CRT) and tumor resection. The current standard of care for patients with
esophageal or GEJ cancer following neoadjuvant CRT and tumor resection is surveillance. These results signify the first time an adjuvant therapeutic option has
significantly prolonged DFS for patients in this setting. Median DFS was doubled in patients receiving Opdivo [22.4 months; (95% Confidence Interval [CI]: 16.6
to 34.0)] compared to those receiving placebo after surgery. The median duration of treatment for patients in the Opdivo arm was just over 10 months [10.1 months
(<0.1 to 14.2)] versus nine months for patients in the placebo arm [9.0 months (<0.1 to 15)]. The safety profile of Opdivo in CheckMate -577 was consistent with
previously reported studies of Opdivo monotherapy.Opdivo was well tolerated with an acceptable safety profile relative to placebo. The majority of patients in the
Opdivo arm (89%) were able to receive a relative dose intensity of ≥ 90%. The incidence of any treatment-related adverse events (TRAEs), including any grade
and Grade 3-4, was 71% and 13% among patients treated with Opdivo compared to 46% and 6% among patients receiving placebo. Serious TRAEs of any grade
and Grade 3-4 occurred in less than 10% of patients treated with Opdivo (any grade in 8%, Grade 3-4 in 5%) compared to 3% and 1% of patients receiving placebo,
with a low rate of any grade treatment-related discontinuations in both arms (9% for Opdivo vs. 3% in placebo).

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Cigna (USA) Launches Evernorth To Accelerate Delivery Of Innovative And
Flexible Health Service Solutions
45
Cigna Corporation announces the launch of Evernorth, a new brand for its growing, high-performing health services portfolio. Evernorth will accelerate delivery of innovative and
flexible solutions to meet the diverse needs of health plans, employers, and government organizations.Evernorth's ability to deliver differentiated value sets it apart in the marketplace
and positions it as the industry's partner of choice – highly sought out for its capabilities and its focus on elevating the health care experience for millions of people around the world.
Evernorth provides a distinct and dedicated platform for the distribution of health solutions geared toward health plans, employers, and government organizations – inclusive of those
without Cigna medical insurance. This enables Evernorth to partner deeply with, and provide unmatched and focused support to these groups, all guided by its unwavering commitment
to make health care better. Evernorth has a number of important characteristics that distinguish it in the marketplace and enable it to deliver differentiated value:
• A deeply rooted customer-centric orientation and philosophy that delivers solutions designed to meet the specific needs of those it serves. Evernorth brings together differentiated
capabilities and specialized expertise – from inside and outside the company – to deliver custom and flexible solutions that meet the needs of its clients and customers in ways that
unlock greater value and better health.
• A relentless, data-driven approach to innovation. With a unique vantage point across all critical moments of care and advanced data and analytics capabilities, Evernorth couples
meaningful insights with deep clinical expertise to provide solutions that advance innovation in health care.
• A proven approach to sustainable partnerships. Evernorth has a deep commitment to partnering in unconventional ways. With its open business model and unbiased approach,
Evernorth is equipped to solve complex problems across a fragmented health care ecosystem. Every player across the system is viewed as a potential partner with whom it can build
solutions or who can benefit from its solutions.

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Eisai (Japan) Presents Latest Data Of Phase I Clinical Trial On Liposomal Formulation
Of Anti-Cancer Agent Halaven® (Eribulin) At Esmo Virtual Congress 2020
46
Eisai Co., Ltd. announced that the latest results from the cohort targeting patients with HER2-negative breast cancer in the phase I clinical trial for the new liposomal formulation (E7389-LF) of the
in-house discovered anti-cancer treatment Halaven® were presented (abstract number: 346P) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. E7389-LF is a new
formulation using liposomes made of a lipid bilayer to encapsulate the halichondrin-class microtubule dynamics inhibitor eribulin. In tumor tissue, gaps exist among vascular endothelial cells due to
incomplete vasculature, which is thought to allow for penetration by macromolecules. This condition, in addition to incomplete lymphatic function, is predicted to enable high-molecular-weight drugs
including liposomal formulations to be respectively delivered and retained in greater amounts in tumors as compared to in normal tissue, through Enhanced Permeability and Retention (EPR) effects.
Thus E7389-LF is expected to improve the concentration of eribulin in tumor tissues. This presentation reported efficacy and safety results of E7389-LF in a cohort enrolling 28 patients with recurrent
(HER2-negative) breast cancer (hormone receptor positive: 21, triple negative: 7) who had previously undergone treatment with anthracycline or taxane class treatments and had no prior treatment
with eribulin (data cutoff: January 24, 2020, progression free survival and overall survival cutoff: April 17, 2020), as part of the open-label, phase I clinical trial (Study 114) on patients with select solid
tumors who had previously undergone treatment. Patients were treated with E7389-LF 2.0 mg/m2 body surface area (as free eribulin) intravenously once every three weeks, and demonstrated an overall
response rate (ORR) of 35.7% (95% confidence interval (CI): 18.6-55.9) in the HER2-negative breast cancer cohort as a whole. Within the cohort, hormone receptor positive patients demonstrated an
ORR of 42.9% (95% CI: 21.8-66.6) and triple negative patients demonstrated an ORR of 14.3% (95% CI: 0.4-57.9). The disease control rate combining stable disease rate, partial response rate, and
complete response rate was 89.3% (95% CI: 71.8-97.7). Additionally, progression-free survival (PFS) was a median of 5.7 months (95% CI: 3.9-8.3), and the median overall survival (OS) was not
reached (95% CI: 10.3 – not reached). Adverse events of grade 3 or above (top 5) were neutropenia (67.9%), leukopenia (42.9%), thrombocytopenia (32.1%), febrile neutropenia (25.0%), and increased
alanine aminotransferase (21.4%), which were consistent with the safety profile of eribulin to date. Additionally, preventive treatment with the G-CSF (granulocyte colony stimulating factor)
pegfilgrastim demonstrated a decrease in the ratio of febrile neutropenia occurrence (with treatment: 10.0%, without treatment: 33.3%).

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