This document is a corporate presentation by Apricus Biosciences given at the 2011 Bio International Convention. It provides an overview of Apricus, including its drug delivery platform technology called NexACT, its product pipeline focusing on treatments for erectile dysfunction and female sexual arousal disorder, clinical trial results and regulatory strategies. Key highlights include positive phase 3 results for Vitaros in erectile dysfunction and plans to submit regulatory filings for approval in Europe and discussions with health authorities in other regions for MycoVa for onychomycosis. The presentation provides context on Apricus' financial position and partnerships as a specialty biopharmaceutical company advancing its mid-to-late stage pipeline.
Dr. Soumava Mandal discusses the treatment options for neovascular age-related macular degeneration (NVAMD) that have emerged over time, including photocoagulation (1979), photodynamic therapy (PDT) (2001), and anti-VEGF drugs (2004). Key studies evaluated the efficacy of photocoagulation, PDT, pegaptanib, ranibizumab, bevacizumab, aflibercept, and brolucizumab in treating NVAMD. These studies demonstrated the benefits of anti-VEGF drugs over previous options, with ranibizumab and aflibercept approved for monthly or bi-monthly dosing based on visual acuity and OCT monitoring
AndroGel 1.62% is an androgen indicated for replacement therapy in males
for conditions associated with a deficiency or absence of endogenous
testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired) http://www.androgel.com
Apricus Biosciences - Jefferies 2011 Global Healthcare Conference PresentationApricus Biosciences
Apricus Biosciences is a specialty biopharmaceutical company presenting at the 2011 Jefferies Global Healthcare Conference. It has a proprietary drug delivery platform called NexACT that can rapidly advance drug candidates through clinical development for transdermal and other applications. Its mid-to-late stage pipeline includes Vitaros for erectile dysfunction, Femprox for female sexual arousal disorder, MycoVa for onychomycosis, and PrevOnco for liver cancer, representing a total market opportunity of over $10 billion. Apricus is well positioned with its experienced management team and cash runway into the second half of 2012.
The document discusses prioritizing social media efforts to grow a business. It analyzes the top 5 social networks - Facebook, YouTube, LinkedIn, Twitter, and Instagram - in terms of their usefulness for business purposes. Facebook is recommended for brand messaging due to its large user base. YouTube is good for video marketing since many people consume online video. LinkedIn is dedicated to business connections. Twitter allows businesses to remain focused on clients' needs. Instagram demonstrates being up on technology to tech-savvy clients and has search optimization benefits. The document encourages networking on these top platforms.
The document appears to be a portfolio website for a designer named John Hernandez. It features thumbnail images and brief descriptions of various design projects across different media, including CD/DVD covers, packaging, logos, banners, brochures, and digital retouching work. The projects cover a wide range of clients and industries including entertainment, food/beverage, apparel, and public sector.
1. Vitaros is a topical cream containing alprostadil that is approved for the treatment of erectile dysfunction in multiple countries.
2. It is marketed as the first line treatment for erectile dysfunction, including for patients who cannot take oral PDE5 inhibitors due to health conditions or medications.
3. With over 7 million men in the Middle East potentially benefiting from Vitaros as it treats erectile dysfunction in patients who are non-responders to PDE5 inhibitors, it represents a significant market opportunity.
The document appears to be a portfolio website for a designer named John Hernandez. It features thumbnail images and brief descriptions of various design projects across different media, including CD/DVD covers, packaging, logos, banners, brochures, and digital retouching work. The projects cover a diverse range of clients and industries including entertainment, food/beverage, apparel, and public sector.
VIAGRA: Wonder Drug or Ethical Irresponsibility?tofugirl
Pfizer developed and marketed the drug Viagra to treat erectile dysfunction. However, some deaths were linked to Viagra due to heart attacks or strokes. While the FDA considered the drug safe, there is debate around Pfizer's ethical responsibilities in thoroughly researching risks and ensuring consumer safety. Recommendations include Pfizer conducting more rigorous clinical trials, improving warnings to doctors, and considering whether marketing a drug primarily for enhanced sexual performance is ethical if life-threatening side effects are possible.
Dr. Soumava Mandal discusses the treatment options for neovascular age-related macular degeneration (NVAMD) that have emerged over time, including photocoagulation (1979), photodynamic therapy (PDT) (2001), and anti-VEGF drugs (2004). Key studies evaluated the efficacy of photocoagulation, PDT, pegaptanib, ranibizumab, bevacizumab, aflibercept, and brolucizumab in treating NVAMD. These studies demonstrated the benefits of anti-VEGF drugs over previous options, with ranibizumab and aflibercept approved for monthly or bi-monthly dosing based on visual acuity and OCT monitoring
AndroGel 1.62% is an androgen indicated for replacement therapy in males
for conditions associated with a deficiency or absence of endogenous
testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired) http://www.androgel.com
Apricus Biosciences - Jefferies 2011 Global Healthcare Conference PresentationApricus Biosciences
Apricus Biosciences is a specialty biopharmaceutical company presenting at the 2011 Jefferies Global Healthcare Conference. It has a proprietary drug delivery platform called NexACT that can rapidly advance drug candidates through clinical development for transdermal and other applications. Its mid-to-late stage pipeline includes Vitaros for erectile dysfunction, Femprox for female sexual arousal disorder, MycoVa for onychomycosis, and PrevOnco for liver cancer, representing a total market opportunity of over $10 billion. Apricus is well positioned with its experienced management team and cash runway into the second half of 2012.
The document discusses prioritizing social media efforts to grow a business. It analyzes the top 5 social networks - Facebook, YouTube, LinkedIn, Twitter, and Instagram - in terms of their usefulness for business purposes. Facebook is recommended for brand messaging due to its large user base. YouTube is good for video marketing since many people consume online video. LinkedIn is dedicated to business connections. Twitter allows businesses to remain focused on clients' needs. Instagram demonstrates being up on technology to tech-savvy clients and has search optimization benefits. The document encourages networking on these top platforms.
The document appears to be a portfolio website for a designer named John Hernandez. It features thumbnail images and brief descriptions of various design projects across different media, including CD/DVD covers, packaging, logos, banners, brochures, and digital retouching work. The projects cover a wide range of clients and industries including entertainment, food/beverage, apparel, and public sector.
1. Vitaros is a topical cream containing alprostadil that is approved for the treatment of erectile dysfunction in multiple countries.
2. It is marketed as the first line treatment for erectile dysfunction, including for patients who cannot take oral PDE5 inhibitors due to health conditions or medications.
3. With over 7 million men in the Middle East potentially benefiting from Vitaros as it treats erectile dysfunction in patients who are non-responders to PDE5 inhibitors, it represents a significant market opportunity.
The document appears to be a portfolio website for a designer named John Hernandez. It features thumbnail images and brief descriptions of various design projects across different media, including CD/DVD covers, packaging, logos, banners, brochures, and digital retouching work. The projects cover a diverse range of clients and industries including entertainment, food/beverage, apparel, and public sector.
VIAGRA: Wonder Drug or Ethical Irresponsibility?tofugirl
Pfizer developed and marketed the drug Viagra to treat erectile dysfunction. However, some deaths were linked to Viagra due to heart attacks or strokes. While the FDA considered the drug safe, there is debate around Pfizer's ethical responsibilities in thoroughly researching risks and ensuring consumer safety. Recommendations include Pfizer conducting more rigorous clinical trials, improving warnings to doctors, and considering whether marketing a drug primarily for enhanced sexual performance is ethical if life-threatening side effects are possible.
The document summarizes several new drug approvals and formulations by the FDA in October and November 2017. Key approvals included:
- Abilify Mycite (aripiprazole tablets with sensor), approved to track drug ingestion in real-time.
- Fasenra (benralizumab), approved for add-on maintenance treatment of severe asthma.
- Prevymis (letermovir), approved to prevent cytomegalovirus infection in transplant recipients.
- Vyzulta (latanoprostene bunod), approved to reduce eye pressure in glaucoma as an alternative to latanoprost.
- Juluca (dolutegra
The document summarizes recent FDA drug approvals and new formulations in June 2018. Key approvals included Moxidectin for onchocerciasis, Epidiolex for seizures associated with Lennox-Gastaut or Dravet syndrome, Zemdri for complicated urinary tract infections, Mektovi in combination with Braftovi for melanoma with BRAF mutations, and Aristada Initio, a new extended-release injectable formulation for initiating Aristada treatment of schizophrenia. Each drug is briefly described including indications, dosing regimens, warnings and common adverse reactions.
- Lutathera® (lutetium Lu 177 dotatate) was approved for treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. It is administered as an injection every 8 weeks for 4 doses and requires pre-treatment. Common side effects include lymphopenia and nausea.
- Biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) was approved as a complete regimen for HIV treatment. It is taken as one daily tablet with or without food. It carries a black box warning about hepatitis B exacerbation.
- Symdeko® (tezacaftor/iv
Dr. Patrick Gorden - Animal Medicinal Drug Use Clarification Act (AMDUCA)John Blue
Animal Medicinal Drug Use Clarification Act (AMDUCA) - Dr. Patrick Gorden, College of Veterinary Medicine, Iowa State University, from the 2017 NIAA Annual Conference, U.S. Animal Agriculture's Future Role In World Food Production - Obstacles & Opportunities, April 4 - 6, Columbus, OH, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2017_niaa_us_animal_ag_future_role_world_food_production
Voriconazole for Injection Taj Pharma PILTajPharmaQC
Voriconazole for Injection 200mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Voriconazole Dosage & Rx Info | Voriconazole Uses, Side Effects Voriconazole: Indications, Side Effects, Warnings, Voriconazole -Drug Information –Taj Pharma, Voriconazole dose Taj pharmaceuticals Voriconazole interactions, Taj Pharmaceutical Voriconazole contraindications, Voriconazole price, Voriconazole Taj Pharma Voriconazole SmPC-Taj Pharma Stay connected to all updated on Voriconazole Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
The company founder effectively life-hacked a $billion dollar OTC product and was awarded 6 patents for it. The funds raised were to prove efficacy and will probably be the only funding required before licensing.
We took a highly technical breifing and created a story that is both understandable and informative. We developed the brands, strategy, copy, graphics, and put together the deck and arranged key meetings with investors.
www.wildoutwest.com
The document provides safety guidelines for the drug isotretinoin (Accutane). It discusses the drug's indications, pharmacokinetics, risks, and regulations. Key information includes:
1) Isotretinoin is used to treat severe cystic acne but can cause birth defects, so female patients must not get pregnant while taking it or for 1 month after.
2) The iPLEDGE program requires registration of patients, prescribers, and pharmacies and monthly pregnancy tests for female patients to help prevent fetal exposure.
3) Risks include depression, psychosis, birth defects, pancreatitis, and increased triglycerides. Strict contraception and testing protocols aim to eliminate risk of
General Investor and partnership presentation for the launch of a new pharmaceutical product. Specifically funds the initial clinical trial and market tests.
Ovidac Infusion is utilized for Enlistment of ovulation, Either of the testicles neglect to drop from the midsection into the scrotum, Gonadotropin-delivering chemical lack and different circumstances.
A benign tumor of muscular and fibrous tissues, typically developing in the wall of the uterus.
Prevalence varies among studies and countries (4.5-68.6%)
Nearly 20-30% Indian women in reproductive age group have fibroid uterus
At any given time, nearly 15-25 million Indian women have fibroid uterus
Understand fibroids in a better way
Dr. James McKean - FDA Antimicrobial UpdateJohn Blue
FDA Antimicrobial Update - James McKean, DVM, PhD, Extension Veterinarian, Iowa State University, from the 2014 NIAA Annual Conference titled 'The Precautionary Principle: How Agriculture Will Thrive', March 31 - April 2, 2014, Omaha, NE, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2014_niaa_how_animal_agriculture_will_thrive
This document discusses issues that may arise with generic drugs compared to innovator drugs. Bioequivalence studies only show equivalence at a single point in time and do not guarantee equivalence over the lifetime of the drug. Manufacturing the drug involves many variables like people, equipment, materials that could result in potency and dissolution differences compared to the innovator. The document provides data that showed increased hospitalization rates for certain generics compared to the innovator drug. It emphasizes the need for consistent quality manufacturing to ensure patient safety.
Vilitra (Generic Vardenafil Hydrochloride Tablets) is used for the treatment of erectile dysfunction in adult men, a medical condition which implies the inability to attain or maintain a penile erection long enough to satisfactorily complete sexual activity.
After the penis is stroked, Vardenafil maintains an erection by increasing blood flow. Without physical activity, such as that occurring during sexual intercourse, Vardenafil will not cause an erection.
This partnership between Biocon and Pfizer will enable Biocon's insulin portfolio to have a global presence. Pfizer will have exclusive commercialization rights for Biocon's biosimilar versions of insulin and insulin analogs globally. Biocon will be responsible for clinical development, manufacturing, supply, and regulatory approvals. The agreement is expected to provide upfront and milestone payments totaling $350 million to Biocon. This partnership will help expand access to affordable treatment options for diabetes patients worldwide.
Myrbetriq is a beta3 agonist approved for treatment of overactive bladder. It is indicated for patients unable to tolerate anticholinergic agents or whose quality of life is significantly impaired by overactive bladder symptoms. The Scorpio trial found Myrbetriq 50mg and 100mg significantly reduced daily urinary frequency and incontinence episodes compared to placebo. Common side effects include hypertension, urinary tract infections, and nasopharyngitis. Dosage adjustments may be needed in patients with hepatic or renal impairment.
Novel Formulation of Prostaglandins for Induction of Labour Dinoprostone V...Lifecare Centre
The document discusses a novel formulation of prostaglandins called dinoprostone vaginal pessary for induction of labour. It provides several key advantages over existing prostaglandin formulations like misoprostol and dinoprostone gel. The sustained release pessary allows for precise control of cervical ripening over 24 hours with one application and is easy to administer and remove. Clinical studies show the pessary increases rates of vaginal delivery within 24 hours and reduces need for oxytocin or C-section compared to other induction methods.
Dr. Jim McKean - Talking Animal Health - The Future of AntimicrobialsJohn Blue
Talking Animal Health - The Future of Antimicrobials - Dr. Jim McKean, Iowa State University, from the 2013 Iowa Pork Congress, January 23-24, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2013-iowa-pork-congress
This document summarizes and promotes the anti-aging supplement Vivix, developed by Shaklee Corporation. It claims Vivix is the most complex anti-aging product ever created through years of research isolating potent polyphenols from a rare super grape. Laboratory studies show Vivix ingredients impact the four key mechanisms of cellular aging by protecting DNA, positively influencing genetic regulators, promoting mitochondrial biogenesis, and slowing advanced glycation end products. A 30-day supply contains the equivalent amount of resveratrol found in 3,000 glasses of wine, and Vivix ingredients are said to be 10 times more powerful than resveratrol alone in slowing one aging mechanism. The document promotes Vivix as a revolutionary breakthrough and exclusive product
For pediatric and elderly patients, conditions related to impaired swallowing, and for when compliance may be difficult effective fast dissolve dose forms deliver solutions.
The document summarizes several new drug approvals and formulations by the FDA in October and November 2017. Key approvals included:
- Abilify Mycite (aripiprazole tablets with sensor), approved to track drug ingestion in real-time.
- Fasenra (benralizumab), approved for add-on maintenance treatment of severe asthma.
- Prevymis (letermovir), approved to prevent cytomegalovirus infection in transplant recipients.
- Vyzulta (latanoprostene bunod), approved to reduce eye pressure in glaucoma as an alternative to latanoprost.
- Juluca (dolutegra
The document summarizes recent FDA drug approvals and new formulations in June 2018. Key approvals included Moxidectin for onchocerciasis, Epidiolex for seizures associated with Lennox-Gastaut or Dravet syndrome, Zemdri for complicated urinary tract infections, Mektovi in combination with Braftovi for melanoma with BRAF mutations, and Aristada Initio, a new extended-release injectable formulation for initiating Aristada treatment of schizophrenia. Each drug is briefly described including indications, dosing regimens, warnings and common adverse reactions.
- Lutathera® (lutetium Lu 177 dotatate) was approved for treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. It is administered as an injection every 8 weeks for 4 doses and requires pre-treatment. Common side effects include lymphopenia and nausea.
- Biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) was approved as a complete regimen for HIV treatment. It is taken as one daily tablet with or without food. It carries a black box warning about hepatitis B exacerbation.
- Symdeko® (tezacaftor/iv
Dr. Patrick Gorden - Animal Medicinal Drug Use Clarification Act (AMDUCA)John Blue
Animal Medicinal Drug Use Clarification Act (AMDUCA) - Dr. Patrick Gorden, College of Veterinary Medicine, Iowa State University, from the 2017 NIAA Annual Conference, U.S. Animal Agriculture's Future Role In World Food Production - Obstacles & Opportunities, April 4 - 6, Columbus, OH, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2017_niaa_us_animal_ag_future_role_world_food_production
Voriconazole for Injection Taj Pharma PILTajPharmaQC
Voriconazole for Injection 200mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Voriconazole Dosage & Rx Info | Voriconazole Uses, Side Effects Voriconazole: Indications, Side Effects, Warnings, Voriconazole -Drug Information –Taj Pharma, Voriconazole dose Taj pharmaceuticals Voriconazole interactions, Taj Pharmaceutical Voriconazole contraindications, Voriconazole price, Voriconazole Taj Pharma Voriconazole SmPC-Taj Pharma Stay connected to all updated on Voriconazole Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
The company founder effectively life-hacked a $billion dollar OTC product and was awarded 6 patents for it. The funds raised were to prove efficacy and will probably be the only funding required before licensing.
We took a highly technical breifing and created a story that is both understandable and informative. We developed the brands, strategy, copy, graphics, and put together the deck and arranged key meetings with investors.
www.wildoutwest.com
The document provides safety guidelines for the drug isotretinoin (Accutane). It discusses the drug's indications, pharmacokinetics, risks, and regulations. Key information includes:
1) Isotretinoin is used to treat severe cystic acne but can cause birth defects, so female patients must not get pregnant while taking it or for 1 month after.
2) The iPLEDGE program requires registration of patients, prescribers, and pharmacies and monthly pregnancy tests for female patients to help prevent fetal exposure.
3) Risks include depression, psychosis, birth defects, pancreatitis, and increased triglycerides. Strict contraception and testing protocols aim to eliminate risk of
General Investor and partnership presentation for the launch of a new pharmaceutical product. Specifically funds the initial clinical trial and market tests.
Ovidac Infusion is utilized for Enlistment of ovulation, Either of the testicles neglect to drop from the midsection into the scrotum, Gonadotropin-delivering chemical lack and different circumstances.
A benign tumor of muscular and fibrous tissues, typically developing in the wall of the uterus.
Prevalence varies among studies and countries (4.5-68.6%)
Nearly 20-30% Indian women in reproductive age group have fibroid uterus
At any given time, nearly 15-25 million Indian women have fibroid uterus
Understand fibroids in a better way
Dr. James McKean - FDA Antimicrobial UpdateJohn Blue
FDA Antimicrobial Update - James McKean, DVM, PhD, Extension Veterinarian, Iowa State University, from the 2014 NIAA Annual Conference titled 'The Precautionary Principle: How Agriculture Will Thrive', March 31 - April 2, 2014, Omaha, NE, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2014_niaa_how_animal_agriculture_will_thrive
This document discusses issues that may arise with generic drugs compared to innovator drugs. Bioequivalence studies only show equivalence at a single point in time and do not guarantee equivalence over the lifetime of the drug. Manufacturing the drug involves many variables like people, equipment, materials that could result in potency and dissolution differences compared to the innovator. The document provides data that showed increased hospitalization rates for certain generics compared to the innovator drug. It emphasizes the need for consistent quality manufacturing to ensure patient safety.
Vilitra (Generic Vardenafil Hydrochloride Tablets) is used for the treatment of erectile dysfunction in adult men, a medical condition which implies the inability to attain or maintain a penile erection long enough to satisfactorily complete sexual activity.
After the penis is stroked, Vardenafil maintains an erection by increasing blood flow. Without physical activity, such as that occurring during sexual intercourse, Vardenafil will not cause an erection.
This partnership between Biocon and Pfizer will enable Biocon's insulin portfolio to have a global presence. Pfizer will have exclusive commercialization rights for Biocon's biosimilar versions of insulin and insulin analogs globally. Biocon will be responsible for clinical development, manufacturing, supply, and regulatory approvals. The agreement is expected to provide upfront and milestone payments totaling $350 million to Biocon. This partnership will help expand access to affordable treatment options for diabetes patients worldwide.
Myrbetriq is a beta3 agonist approved for treatment of overactive bladder. It is indicated for patients unable to tolerate anticholinergic agents or whose quality of life is significantly impaired by overactive bladder symptoms. The Scorpio trial found Myrbetriq 50mg and 100mg significantly reduced daily urinary frequency and incontinence episodes compared to placebo. Common side effects include hypertension, urinary tract infections, and nasopharyngitis. Dosage adjustments may be needed in patients with hepatic or renal impairment.
Novel Formulation of Prostaglandins for Induction of Labour Dinoprostone V...Lifecare Centre
The document discusses a novel formulation of prostaglandins called dinoprostone vaginal pessary for induction of labour. It provides several key advantages over existing prostaglandin formulations like misoprostol and dinoprostone gel. The sustained release pessary allows for precise control of cervical ripening over 24 hours with one application and is easy to administer and remove. Clinical studies show the pessary increases rates of vaginal delivery within 24 hours and reduces need for oxytocin or C-section compared to other induction methods.
Dr. Jim McKean - Talking Animal Health - The Future of AntimicrobialsJohn Blue
Talking Animal Health - The Future of Antimicrobials - Dr. Jim McKean, Iowa State University, from the 2013 Iowa Pork Congress, January 23-24, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2013-iowa-pork-congress
This document summarizes and promotes the anti-aging supplement Vivix, developed by Shaklee Corporation. It claims Vivix is the most complex anti-aging product ever created through years of research isolating potent polyphenols from a rare super grape. Laboratory studies show Vivix ingredients impact the four key mechanisms of cellular aging by protecting DNA, positively influencing genetic regulators, promoting mitochondrial biogenesis, and slowing advanced glycation end products. A 30-day supply contains the equivalent amount of resveratrol found in 3,000 glasses of wine, and Vivix ingredients are said to be 10 times more powerful than resveratrol alone in slowing one aging mechanism. The document promotes Vivix as a revolutionary breakthrough and exclusive product
For pediatric and elderly patients, conditions related to impaired swallowing, and for when compliance may be difficult effective fast dissolve dose forms deliver solutions.
SUSTAINABLE INVESTING UNVEILED: THE ROLE OF BOND RATINGS IN GUIDING GREEN BON...indexPub
The increasing urgency to address climate change has propelled sustainable investing into the spotlight, with green bonds emerging as a pivotal instrument for mobilizing the capital required for environmental projects. This study delves into the critical role that bond ratings play in guiding investments in green bonds, shedding light on how these ratings influence investor confidence and the allocation of funds towards sustainable initiatives. By employing a mixed-methods approach, combining quantitative analysis of green bond performance with qualitative interviews from industry experts, this research offers a comprehensive overview of the interplay between bond ratings and green bond investments. The findings suggest that higher bond ratings, often indicative of lower risk and better sustainability credentials, significantly impact the attractiveness of green bonds to investors. Additionally, the study examines the evolution of rating criteria to encompass environmental, social, and governance (ESG) factors, highlighting the shift towards more holistic assessments of investment risk and potential. This research contributes to the broader discourse on sustainable finance by providing insights into the mechanisms through which bond ratings can facilitate more informed and impactful green bond investments.
Bienestar Financiero al servicio de su jubilación anticipada
Pago de su 🏡
Estudio de sus hijos
Directamente a tu cuenta bancaria
Con Tesorería Auditoria Jurídica comercial
Administración de carteras
Apalancamiento Financiero
Desarrollo de tu marca personal
Acceso a Desarrollo de varias industrias
Cuentas bancarias
Estructuras Físicas en USA y en América Central
Avalado por Bolcomer
Puesto de Bolsa Comercial
Turismo
Y mucho más
Link de registro
https://business.myinfinity.global/maurod8/
https://therusnetwork.com/
Contacto:
https://goo.su/pzm1fja
UnityNet World Environment Day Abraham Project 2024 Press ReleaseLHelferty
June 12, 2024 UnityNet International (#UNI) World Environment Day Abraham Project 2024 Press Release from Markham / Mississauga, Ontario in the, Greater Tkaronto Bioregion, Canada in the North American Great Lakes Watersheds of North America (Turtle Island).
2. Safe‐Harbor Statement
Statements under the Private Securities Litigation Reform Act, as amended: With
the exception of the historical information contained in this presentation, the
matters described herein contain forward‐looking statements that involve risks
and uncertainties that may individually, mutually, or materially impact the
matters herein described, including, but not limited to, the Company’s ability to
execute its business plan, obtain regulatory approval for products under
development, enter into partnering agreements, realize revenue and pursue
growth opportunities, some of which are outside the control of the Company.
Attendees are cautioned not to place undue reliance on these forward‐looking
statements as actual results could differ materially from the forward‐looking
statements contained herein. Attendees are urged to read the risk factors set
forth in the Company’s most recent annual report on Form 10‐K, subsequent
quarterly reports filed on Form 10‐Q and its most recent SEC filings. Company
disclaims any intention to update this presentation.
2
3. Financial Snapshot
• NASDAQ: APRI
• Shares Outstanding 19.6M*
• Shares Fully‐diluted 22M*
• Shares in the float 16M*
• Cash‐position $10.2M*
• Share‐price $5.26**
• Marketcap ~$105M**
• Average Daily volume ~320k**
• Revenues 2010 ~$5M
*As of March 31, 2011
**As of June 24, 2011
3
4. Company Highlights
• Specialty Biopharmaceuticals company with proprietary drug delivery platform
technology (NexACT®) to rapidly advance drug candidates through clinical
development
• Mid‐to‐late staged pipeline with multiple, significant near‐term value drivers
• Multiple Partnerships in place with additional significant partnerships expected
near term
• Experienced management team, proven to deliver on milestones and objectives
• Solid financial position: Current cash position through H2 2012 with goal to be cash
flow positive exiting 2011
4
5. NexACT®: Multi‐Route Drug Delivery Technology
• Patented: NCE patents based on proprietary permeation enhancers that are
biodegradable, biocompatible, non‐toxic ingredients that mimic the composition of
human skin and tissues.
• Effective: enables rapid absorption of high concentrations of drug directly to target
site or systemically into blood stream.
• Safe: excellent pre‐clinical and clinical safety dossiers through thousands of patient
exposures
• Versatile: effective with wide range of drugs classes and different routes
• Small molecules, peptides, proteins, SiRNA, anti‐sense, and antibodies
• Transdermal, Oral, Sub‐Q, Buccal, Rectal, Nasal, Ophthalmic
5
9. Vitaros®
Key Conclusion:
Vitaros® 300 mcgs/100 ml dose strength is comparable to Viagra® 50 mgs dose strength
Phase 3 Pivotal Clinical Studies
Integrated Efficacy Analysis – Intent to Treat Population
Global Assessment Question
When using the study medication, did you feel your erections improved?
Vitaros® Viagra®
p<0.001 50 mgs and 100 mgs
Vitaros®
p<0.001
Vitaros®
p<0.001
Placebo
(Vitaros®
study) Placebo
(Viagra®
study)
Vitaros® Studies
Vitaros Vitaros Vitaros Vitaros
N=394 N=408 N=392 N=398 Viagra® Studies
Source: Viagra PI; Patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of VIAGRA; all patients, however, were receiving 50 mg or 100 mg at
the end of the study. On a global improvement question, 57% of VIAGRA patients reported improved erections versus 10% on placebo.
9
11. Vitaros®
Discontinuation Due to Serious Adverse Events: Orals vs. Vitaros®
% of Patients
Discontinuation Rhinitis/Nasal
Drug Rate Headaches Flushing Congestions Back Pain Dyspepsia Abnormal Vision
Vitaros® 0 0 0 0 0 0 0
Viagra® 2 16 10 7 >2 7 11
Cialis® 3.1 15 3 3 6 10
Levitra® 3.4 15 11 3 2 5
Key Conclusions:
•Vitaros® presents an excellent safety and tolerability profile
• No serious side effects
• Most adverse events were localized to the site of application
but were mild and short in duration
Source: Vitaros PIII Clinical Trial; PDE5 Package Inserts
11
15. Femprox® Phase 3 Study
Safety and Tolerability
• The most frequently reported adverse events were
mild to moderate local irritations, and were 14%,
22%, 18% and 31% observed for the placebo,
500mcg, 700 mcg and 900 mcg groups, respectively.
• No serious adverse events were reported.
• Overall, 5 patients (1.2%) were withdrawn from the
study because of adverse events.
15
16. Femprox® Clinical/ Regulatory Strategy Next Steps
Tasks Schedule
1. Establishment of US and EU Clinical Advisory Board
• Help design of confirmatory Phase 3 trial
required by FDA Q2, 2011
2. Submission of briefing books
for health authority interactions aimed at:
• Approvability of successful single Phase 3 trial 2 H, 2011
in Europa, Canada and Switzerland
• Type A FDA meeting to agree on regulatory path forward
for NDA.
3. Efforts to engage a pharmaceutical partner to continue 2 H, 2011
clinical development
16
18. MycoVa™ ‐ Approval Path for Europe
EU Regulatory Strategy:
• Switch from superiority claim to non‐inferiority claim based on N2303 data
and reanalysis.
• Obtain scientific advice from European health authorities.
• Partnering attempts prior to market authorization.
Clinical Studies conducted in more than 2000 patients world‐wide:
• China Proof of Concept Study – High clinical and mycologucal cure rate
• US Phase 1 (Safety and PK) – Relevant concentrations in nail clippings
• US, Canada and EU Phase 3 (N2301 and N2302) – Primary Endpoint not met
• Phase 3 comparative trial (N2303) vs amorolfine (Loceryl) – no difference
• Total patients treated > 2,000
18
19. EU Trial‐Non‐Inferiority Analysis
Terbinafine is non‐inferior to amorolfine
Mycological Cure Rates at the End of Study (ITT Population, LOCF)
Mycological Cure Rate, Chi-square 95%
n (%) Confidence Interval
Difference
Terbinafine Amorolfine Continuity
(N=507) (N=522) Uncorrected Corrected
82 (16.17) 82 (15.71) 0.46 -4.01, 4.94 -4.20, 5.13
19
21. New Analyses: Combined Phase 3 studies N2301 and
N2302
Mycological cure in combined analysis Revised analysis on mycological cure rate
= negative KOH microscopy & dermatophytes negative excluding patients with concomitant tinea pedis
culture
Proportion Difference P< 0.0001
Treatment n p-value† P=0.0003
(%) (95% CI)*
Terbinafine
24w 33 12.74 P=0.0058 n=174
(N=259) 6.54
0.0141
Vehicle ( 1.52, 11.55)
24w 16 6.20 n=175
(N=258)
Terbinafine
48w 51 18.82
(N=271)
13.35
<0.0001
Vehicle ( 7.93, 18.77)
48w 14 5.47
(N=256)
[*] Difference is terbinafine minus vehicle. Two-sided 95% CI of
difference is based on the normal approximation to the binomial. Mycological Cure is significantly greater in patients
[†] p-value given by the normal inverse combination test.
Studies included: [Study N2301] and [Study N2302]
without comorbid tinea pedis (TP) treated with MycoVa™
ITT population, LOCF, at the end of the study (week 52) over 48 weeks than those receiving placebo at later
Source: Table 3.2-4 – CSFO327SCE – Combined data
stages of the study extending through to week 52.
21
22. MycoVa™ mycological cure rates in perspective with
Penlac® data
In the ITT analyses of Phase 3 studies
terbinafine-DDAIP/HCl shows statistically significant *
mycological cure compared with placebo, slightly higher than in pivotal ciclopirox studies.
Combined analysis excluding patients with tinea pedis increases the efficacy margin vs. placebo.
Mycological Cure = negative KOH microscopy & dermatophytes negative culture
* *
*
n.s . *
* *
n=110 n=223 n=237 n=264 n=263
n=527
n=349
Source: FDA Medical Review of ciclopirox Source: Nexmed Clinical Study Reports for terbinafine-DDAIP/HCl
22 Apricus Bio (NexMed USA's NexACT Technology) 7/29/2011
23. Market Opportunity
• Multifunctional NexACT® Small Molecule Platform Targets Over $10 Billion in approved and
Late‐Stage Product Opportunities
• Vitaros® For erectile dysfunction. Approved in Canada. NDA filed in US and Europe.
Worldwide market over $4 Billion
• Femprox® For FSAD. One successful Phase III. Awaiting guidance for filing in Europe
and Canada. Preparing for US Phase III for NDA filing. Worldwide market
estimated to be up to $4 Billion
• MycoVa™ For Onychomycosis. Europe Comparator Phase III trial competed. Awaiting
guidance for filing in Europe and Canada. Worldwide market over $1 Billion
• PrevOnco™ For liver cancer (HCC). In Phase II and heading to Phase III. Worldwide
market over $1 Billion
(Partial Pipeline)
23
24. Milestones Achieved
Had first drug Vitaros® for erectile dysfunction approved by Health Canada
Strengthened financial foundation of the company
Cash into H2 2012
Completed first partnerships for Vitaros®
Bracco‐Vitaros® (Italy)
Elis‐Vitaros® (Middle East)
Neopharm‐Vitaros® (Israel)
Unqualified audit opinion (Going Concern removed for the 1st time in 9 years)
Filed for European Approval for Vitaros® in Q2 2011
Last Financing October 2010 ~$9M at $1.83
Returned on shareholder value
Up over 50% YTD
24
25. Near Term Upcoming Milestones
Announce additional ex‐US commercial partnerships for Vitaros®:
Canada
Europe
Africa
Latin America
Announce clinical development and regulatory milestones
Goal to be cash‐flow positive by the end of 2011
through upfront payments from partnership agreements
Commence sales of Vitaros® in Canada
25
26. Upcoming Milestones
Announce first NexACT® technology licensing deal
File for marketing approval in Canada and Europe depending on regulatory
guidance for
MycoVa™
Femprox®
Out‐license other late‐stage clinical products
Femprox®
MyCova™
PrevOnco™
26
28. Proven & Experienced Management Team
• President & CEO‐ Dr. Bassam Damaj
• Pfizer, Genentech (now Roche), Pharmacopeia (now Ligand), Tanabe Seiyaku (now
Mitsubishi‐Tanabe), Bio‐Quant, Celltek, R&D Healthcare
• Strong Finance, Operations, and Legal Team
• Steve Martin‐ Gen‐Probe, Stratagene (now Agilent)
• Edward Cox‐ Bio‐Quant, NexMed
• Randy Berholtz‐ Nanogen, ACON Labs
• Proven Senior Business Development Team
• Mark Wilson‐ Pfizer, Halozyme (Technology)
• Linda Smibert‐ BMS, AstraZeneca, Santarus (Products)
• Experienced Research & Development and Medical/Regulatory Affairs Team
• Daniel Frank ‐ Wyeth, Pfizer
• Dr. Mohamed Hachicha ‐ Forest Labs, Purdue Pharma
• Dr. Richard Martin ‐ Exelixis
• Dr. Joachim P.H. Schupp – Ciba‐Geigy, Novartis
28