Copycats wanted: Pfizer, AZ and more under threat as China solicits generics

fiercepharma | June 20, 2019

The U.S. FDA compiles a list of off-patent drugs without an approved generic to encourage the development of copycats. Now, the Chinese authorities are rolling out a similar initiative, only with some extra incentives. On Thursday, China’s National Health Commission published (Chinese) its first proposed list of 34 drugs (full list below) that the agency says are already off patent or nearing patent expiration but have no generic drug application in the country or lack competition. The plan is to invite drugmakers to make copies—and here comes the key—under drug regulator’s priority review pathway, which was until now only given to innovative drugs. The list covers originators from many foreign pharmas, including Pfizer, AstraZeneca, Merck & Co., Johnson & Johnson, Roche, Bristol-Myers Squibb, Takeda, Eli Lilly, and more. And the drugs span a wide range of therapeutic areas, including HIV, anti-infectives, ophthalmology, cancer, blood and immune disorders, etc. Some prominent names can be found on the list. Teva’s multiple sclerosis blockbuster Copaxone, which just saw its first U.S. copycat from Mylan less than two years ago, is probably the best-selling drug on the list by global sales. Johnson & Johnson subsidiary Actelion’s pulmonary artery hypertension drug Tracleer and United Therapeutics' rival med Remodulin are both included. Roche’s CMV retinitis treatment Valcyte and chemotherapies Faslodex and Ixempra from AZ and BMS, respectively, are also among those listed. China made certain of its intention to make that list in January. At that time, it said the government would update the list at the end of each year starting from 2020. And key small molecules and biologics on the list will also be incorporated into state-backed R&D plans. The initiative is seen as another push by the Chinese government to bring in competition to rein in drug costs. In a recent decree, physicians are strictly not allowed to write brand names on prescriptions, and even if they do, pharmacists could fill them with generics.

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The global Diabetes Attitudes, Wishes and Needs (DAWN2™) study represents the voices of more than 15,000 patients, family members, and health care professionals across 17 countries and 4 continents. DAWN2™ found that the emotional burden of diabetes affects not only patients, but also their families; people living with diabetes are strongly impacted by the negative perceptions of the disease, while family members feel that they do not know how to help their loved ones.

Spotlight

The global Diabetes Attitudes, Wishes and Needs (DAWN2™) study represents the voices of more than 15,000 patients, family members, and health care professionals across 17 countries and 4 continents. DAWN2™ found that the emotional burden of diabetes affects not only patients, but also their families; people living with diabetes are strongly impacted by the negative perceptions of the disease, while family members feel that they do not know how to help their loved ones.

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PHARMA TECH

KiOmed Pharma and Hansoh Pharma Announce License Agreement for KiOmedinevsOne in China’s Mainland, Macau and Taiwan

KiOmed Pharma and Hansoh Pharma | September 27, 2022

KiOmed Pharma, a Belgian biotechnology company with a focus on the development, manufacture and distribution of safe and effective medical devices based on a medical-grade highly pure natural chitosan-derivative, and Hansoh Pharmaceutical Group Company Limited a leading biopharmaceutical company in Asia, today announced a license agreement for the development and commercialization of KiOmedinevsOne, a carboxymethyl chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis, in China’s mainland, Macau and Taiwan. Under the terms of the agreement, KiOmed will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestones of up to € 66 million, as well as tiered royalties on future product sales. Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory. KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets. Osteoarthritis is a progressive and disabling disease affecting about 250 million people worldwide. According to a recent epidemiology report, the prevalence of knee osteoarthritis in China is 8.1%. As the population in China is aging rapidly, disease burden caused by knee osteoarthritis continues to rise while safe and effective treatment options are still lacking. “We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China. We believe that with Hansoh’s impactful presence in China, their support will be essential to bring this long-acting treatment to the large population of patients suffering from osteoarthritis in China. We launched KiOmedinevsOne last year in several regions of Europe, and the feedback we continue to receive from osteoarthritis patients and physicians is great. With just one single injection to the knee, it can provide symptoms relief including pain, stiffness, and function improvement for more than 6-month. It is the world-first next generation non-animal sourced chitosan injection with a potential safety advantage over animal-sourced chitosan,” added Dr. Houtaï Choumane, CEO and Managing Director of KiOmed. Mr. François Blondel, Founder and Executive Chairman of the Board of KiOmed Pharma “KiOmed is a leader and an expert in developing natural chitosan products to fulfill unmet medical needs in different spaces. Osteoarthritis negatively impacts an individual’s quality of life and creates a large burden for the patients and their families. We are very glad to see KiOmed’s product (KiOmedinevsOne) will help to solve this problem,” said Eliza Sun, Executive Director of the Board of Hansoh Pharma. “We are also very excited to partner with them and bring this unique product to much needed patients in China.” About KiOmedinevsOne KiOmedinevsOne is a new generation single injection for the treatment of knee osteoarthritis based on world-first exclusive animal free KiOmedine® CM-Chitosan. KiOmedine® CM-Chitosan is a highly purified polysaccharide derived from Agaricus Bisporus (button mushroom) and a patented technology made in Belgium, resulting from years of research and innovation. Different from hyaluronic acid, KiOmedinevsOne has dual mechanism of action to tackle osteoarthritis discomfort and other symptoms by reducing oxidative stress and enhancing joint lubrication. Clinical studies have shown that after a single injection of KiOmedinevsOne, significant pain reduction was observed within 2 weeks and the WOMAC pain score was reduced by 66%, with a long-lasting osteoarthritis symptom reduction for at least 6 months. KiOmedinevsOne is a regulated health product which bears the CE mark under this regulation. It has been launched in Europe in 2021. About KiOmed Pharma Based in Belgium, KiOmed Pharma has a history of innovation and expertise in exclusive natural chitosan chemistry. The company develops a unique pipeline of medical devices that address unmet medical needs in high impact pathologies and major social burdens such as osteoarthritis, skin aging and ophthalmology. KiOmed Pharma's innovative pipeline is based on a solid building block exclusive technology: KiOmedine®, a medical-grade highly pure natural chitosan-derivative. About Hansoh Pharmaceutical Group Hansoh Pharma one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders.

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PHARMA TECH

Eyenovia Announces $15 Million Credit Facility with Avenue Venture Debt Fund

Eyenovia, Inc. | November 30, 2022

Eyenovia, Inc. a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the company has entered into a $15 million credit facility with the Avenue Venture Opportunities Fund, L.P. The financing is intended to support manufacturing in anticipation of a MydCombi launch and clinical supply for ongoing programs. Per the terms of the agreement, Eyenovia received $10 million of gross proceeds at closing. The additional $5 million will be available, at the company’s option, should MydCombi™ be approved for marketing in the U.S. by the Food and Drug Administration by August 2023. The Avenue facility replaces the company’s Silicon Valley Bank facility, which was recently paid off. “We are pleased to have the support of Avenue through this credit facility at terms which create minimal dilution as compared to a traditional equity capital raise. Together with our existing cash on-hand, we expect the additional capital provided by this facility to fund our operations through at least late 2023 or early 2024, or through value creating milestones, including the potential approval of MydCombi™ and preparations for the possible submission of a New Drug Application for our novel presbyopia treatment, MicroLine™.” Michael Rowe, chief executive officer of Eyenovia “We are pleased to provide this financing to Eyenovia as we believe its Optejet dispensing technology truly differentiates the company from its peers and offers great potential across a broad range of high value ophthalmic indications,” stated Chad Norman, Senior Portfolio Manager of the Avenue Venture Debt Fund. Eyenovia’s current pro-forma unrestricted cash balance, including approximately $9.5 million of net proceeds from this facility, is approximately $25.5 million. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. About Avenue Venture Opportunities The Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets estimated to be approximately $12.3 billion as of October 31, 2022.

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PHARMACY MARKET

Walgreens Boots Alliance Completes Majority Share Acquisition of CareCentrix

Walgreens Boots Alliance and CareCentrix | September 01, 2022

Walgreens Boots Alliance, Inc. announced it has completed its previously announced majority share acquisition of CareCentrix, Inc.—the leading independent home-centered platform that coordinates care to the home for health plans, patients and providers. The majority investment in CareCentrix accelerates Walgreens Health’s capabilities in delivering quality healthcare across a spectrum of settings including primary care, specialty pharmacy care, post-acute care and home care. By bringing together Walgreens trusted health services and community presence with CareCentrix’s technology-enabled, care-at-home solutions, the partnership better addresses the needs of people with complex or chronic conditions as they transition out of the hospital. CareCentrix’s advanced data analytics capabilities enable highly personalized care plans to help people transition to the right site of care, prioritizing care in the home when appropriate. This approach supports both care quality and value by reducing hospital readmissions and improving patient satisfaction and outcomes. “We created Walgreens Health to reimagine local healthcare and wellbeing for all. This partnership advances our ability to address the needs of people across care settings immediately following hospital discharge. Our collaboration with CareCentrix is one of the many ways we are expanding on our pharmacy and patient expertise to surround individuals with care when and how they need it.” Roz Brewer, CEO, WBA Healthcare services delivered after discharge, including care delivered in the home, are one of the fastest growing segments in healthcare today. Caring for patients from the hospital to the home represents more than $75 billion in annual healthcare costs for payers, providers and patients. “The most challenging part of the healthcare journey is the last mile – extending healthcare delivery into people’s homes,” said John Driscoll, CEO, CareCentrix. “Together with Walgreens Health, CareCentrix is able to combine Walgreens trusted community presence with our powerful technology-enabled care to better address patients’ unique health needs in their homes.” In addition to home-based care, CareCentrix connects patients to appropriate providers and sites of care post-discharge, utilizing a predictive analytics platform, HomeFirst Analytics. This level of customization also includes pairing patients with care transition teams that support patient engagement for 90 days post-discharge to improve quality metrics. Walgreens Health will continue to advance capabilities that integrate CareCentrix data analytics and home care expertise with WBA’s portfolio of health solutions to identify and close care gaps, as well as coordinate patient care across conditions, settings and provider networks. These capabilities will enable Walgreens to support medication reconciliation for CareCentrix patients transitioning from hospital to home and provide primary care options to patients when needed, including Village Medical physicians and advanced practice providers. CareCentrix will also play a critical role in Walgreens Health integrated offerings to manage population level risk for benefits management and post-acute spend and outcomes. CareCentrix manages care for 19 million members through approximately 7,400 provider locations, and empowers more people to live, heal and age at home. By partnering with health plans and health systems, CareCentrix has reduced total cost of care for members by 20 percent, including a greater than 11 percent reduction in emergency department usage and a 23 percent reduction in skilled nursing costs. This investment gives WBA majority ownership of CareCentrix, investing approximately $330 million for 55 percent of the company at an $800 million valuation, net of debt, with the option to acquire the remaining equity interests in the future. In WBA’s fiscal year 2021, CareCentrix delivered pro forma sales of $1.5 billion. Following the completion of the investment, CareCentrix will continue to operate as an independent company under its current executive leadership. Sidley Austin LLP acted as lead legal advisor for WBA, along with Weil, Gotshal & Manges LLP. Citi acted as financial advisor for CareCentrix, Inc., and Cleary Gottlieb Steen & Hamilton LLP acted as lead legal advisor. About Walgreens Boots Alliance Walgreens Boots Alliance is an integrated healthcare, pharmacy and retail leader serving millions of customers and patients every day, with a 170-year heritage of caring for communities. A trusted, global innovator in retail pharmacy with approximately 13,000 locations across the U.S., Europe and Latin America, WBA plays a critical role in the healthcare ecosystem. The company is reimagining local healthcare and well-being for all as part of its purpose – to create more joyful lives through better health. Through dispensing medicines, improving access to a wide range of health services, providing high quality health and beauty products and offering anytime, anywhere convenience across its digital platforms, WBA is shaping the future of healthcare. WBA has more than 315,000 team members and a presence in nine countries through its portfolio of consumer brands: Walgreens, Boots, Duane Reade, the No7 Beauty Company, Benavides in Mexico and Ahumada in Chile. Additionally, WBA has a portfolio of healthcare-focused investments located in several countries, including China and the U.S. About CareCentrix CareCentrix offers value-based home solutions to payors and health systems to help more of their members access the home care they need, when they need it. Through a single platform, CareCentrix coordinates multiple, complex home care needs for over 19 million members through a national network of approximately 7,400 provider locations, resulting in a simplified patient and physician experience. For over 25 years, CareCentrix’s focus on the whole person has improved continuity of care, reduced unnecessary readmissions and unnecessary emergency department utilization, and has delivered positive financial results for health plans. With proprietary HomeFirst Analytics to stratify risk and optimize care delivery, CareCentrix takes on the complexities of care coordination and management of care in the home to provide our clients with essential insights into care at home. CareCentrix has been named one of Fierce Healthcare’s 2022 “Fierce 15” companies and FORTUNE’s Best Workplaces for Aging Services.

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