Judge wipes out Biogen's Tecfidera patent protections in suit against Mylan

Fiercepharma | June 18, 2020

In the high-stakes patent fight between Biogen and Mylan over Tecfidera’s main remaining patent, Mylan has scored a major win in federal court. U.S. District Judge Irene Keeley said Mylan “demonstrated by clear and convincing evidence” that certain claims of Biogen’s '514 patent are invalid for “lack of written description.” The decision threatens Biogen’s bestselling medicine with early generics; Tecfidera, a multiple sclerosis drug, generated $3.3 billion in the U.S. last year. The company's '514 patent is set to expire in 2028, meaning the decision, if upheld, could wipe out years of monopoly sales. Biogen’s shares were down about 6% on Thursday morning on the news. A spokesman said the company is disappointed with the decision and will appeal.

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Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

Spotlight

Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

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PHARMA TECH

Ginkgo Bioworks and Centrient Pharmaceutical Announce Expansion of Partnership Following Success of initial Project to Bring Innovation to Generic API

PR Newswire | May 26, 2023

Centrient Pharmaceuticals ("Centrient"), the global business-to-business leader in sustainable antibiotics, next-generation statins and anti-fungals, and Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced they are expanding their existing partnership aimed at broadening Centrient's portfolio of environmentally friendly active pharmaceutical ingredients (APIs), following the success of previous work together. Ginkgo's ongoing partnership with Centrient focuses on improving the sustainability of fermentation and enzymatic syntheses of beta-lactam antibiotic APIs. In the first phase of this project, Ginkgo delivered an enzyme with significantly improved efficiency, reducing the environmental footprint of enzymatic production of amoxicillin and cephalexin APIs. These semi-synthetic beta-lactam antibiotics are widely prescribed to both children and adults and are on the World Health Organization's List of Essential Medicines. Centrient aims to build on these improvements through ongoing strain projects on Ginkgo's platform which focus on reducing carbon emissions and waste production compared to traditional chemical routes. "Our partnership with Ginkgo is fully aligned with our main purpose: to improve lives through innovative and sustainable manufacturing of medicines," said Jorge Gil-Martinez, Chief Scientific Officer at Centrient. "The initial success of this collaboration has led us to expand our joint efforts to design new ways of producing essential medicines, minimizing the environmental impact of antibiotic manufacturing. Moreover, as we design and execute our Open Innovation business model, this strategic collaboration creates synergies to accelerate the diversification of our portfolio, a strategic pillar for the future of our company. Access to external disruptive technologies, focusing on enzymes and fermentation, contributes to our vision to be a diversified and integrated partner of choice for generic medicines." "Our partnership with Centrient, which began in 2021, underscores Ginkgo's commitment to supporting biopharma companies in bringing much-needed innovation to the field," said Kevin Madden, SVP of Platform Commercialization at Ginkgo Bioworks. "We are inspired by the early success we've already seen in our partnership and look forward to expanding our joint efforts to ultimately support better patient outcomes." About Centrient Pharmaceuticals Centrient Pharmaceuticals is the global business-to-business leader in sustainable, enzymatic antibiotics, next-generation statins, and anti-fungals. We are a pharmaceutical company with a clear Purpose: to improve lives through innovative and sustainable manufacturing of medicines - saving the lives of millions of people around the world annually. Regarding our portfolio, we produce and sell intermediates and active pharmaceutical ingredients (APIs), as well as finished dosage forms (FDFs). Our world-leading proprietary enzymatic technology PureActives® ensures an unmatched eco-friendly production process for our high-quality products. Driven by our Purpose and Sustainability through our ESG vision, we aim to create value for Centrient and our stakeholders. Centrient is a Board Member of the AMR Industry Alliance and a long-time advocate for industry responsibility in manufacturing. Founded 150 years ago as the 'Nederlandsche Gist- en Spiritusfabriek', our company was known as Gist Brocades and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is owned by Bain Capital Private Equity, a leading global private investment firm. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats.

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PHARMACY MARKET, PHARMA TECH

PANTHERx® Rare Launches Drug for APDS

prnewswire | March 31, 2023

PANTHERx® Rare, one of the largest and fastest growing rare pharmacies in the United States, is pleased to announce the launch of Joenja® (leniolisib), an oral selective small-molecule PI3K delta inhibitor indicated for the treatment of APDS in adult and pediatric patients ages 12 or older. "Our patients living with rare and devastating diseases deserve the best that medicine can offer. Through innovation and technology, we continue to make a positive impact on the quality of life of those living with rare diseases. We are pleased to add Joenja® to the list of medications in PANTHERx® portfolio," said Rob Snyder, president of PANTHERx® Rare. Activated Phosphoinositide 3-Kinase-Delta Syndrome, or APDS, is a rare primary immunodeficiency affecting approximately one to two people per million with disease onset occurring as early as infancy. This condition results from a variant in the genes PIK3CD or PIK3R1 with both genes playing a role in the regulation of white blood cell maturation. The presence of a mutation in these genes lead to hyperactivity of the PI3Kδ pathway resulting in a failure for the immune cells (B and T cells) to mature and properly function. Imbalance in the PI3Kδ pathway results in immunodeficiency and dysregulation. Those with APDS may develop recurrent respiratory tract infections, bronchiectasis, lymphoproliferation as well as neurodevelopment delay and failure to thrive. Clinical presentation is highly variable ranging from asymptomatic adults to those suffering from lymphoproliferation or development of profound immunodeficiency. Snyder explained Joenja® exerts its effects by blocking the active binding sites of PI3Kδ inhibiting the signaling pathway hyperactivity that leads to dysfunction and dysregulation of B and T cells. In clinical trials, Joenja® achieved both co-primary efficacy measures of reduction in lymph node size and correction of immunodeficiency in the target population. The most common adverse reactions (>10%) were headache, sinusitis, and atrophic dermatitis. About PANTHERx Rare PANTHERx Rare is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to people living with rare and devastating conditions. Although the overall incidence of rare diseases is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an FDA-approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community. PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care. PANTHERx is now a five-time winner of the prestigious MMIT Patient Choice Award, including the 2022 honor. PANTHERx is headquartered in Pittsburgh, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.

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PHARMACY MARKET, PHARMA TECH

Shields Health Solutions and Elliot Health System Establish New Specialty Pharmacy Services

Businesswire | April 12, 2023

Shields Health Solutions the premier specialty pharmacy accelerator in the country, announces that it is partnering with Elliot Health System, the largest provider of comprehensive healthcare services in Southern New Hampshire, to launch a new pharmacy program to meet the unique needs of patients with complex, chronic conditions. The program will increase access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health. The program with Elliot Health System and Shields will initially serve a variety of disease states and clinics including rheumatology, gastroenterology, neurology, pulmonology, oncology, endocrinology and family medicine. Specialty pharmacy liaisons will guide patients and caregivers who fill prescriptions with Elliot Health System and will work with patients on-site. These liaisons can assist patients and families with navigating barriers to care, such as health insurance prior authorizations or securing financial assistance, regardless of the location where they fill their prescription. “Through our partnership with Shields, we can provide Elliot patients, and patients from other health care systems in our community, with expanded access to critical medications to achieve even greater positive health outcomes, particularly for the patients who require the highest degree of expertise to meet their needs,” said Molly Mortimer, Elliot Health System Director of Pharmacy Services. “We are pleased to join the Shields network to ensure we are doing all that we can to best care for our community.” Expanded patient support services, combined with access to recently approved and newly available specialty medications, give patients greater availability for onsite treatment options. Shields currently partners with more than 75 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery — often within two days — and improved medication adherence greater than 90 percent on average. “Through a commitment to outstanding complex patient care and its position as a health care leader in the region, Elliot Health System, and SolutionHealth as a regional system, align well with Shields’ core mission and will make it a highly valued addition to our membership,” said John Lucey, Chief Executive Officer at Shields. “By securing access to 90 percent of the limited distribution drugs that complex patients need and opening the door to restricted payer networks, our partnership will elevate access to affordable care, while improving therapy management and care coordination for Elliot Health System’s patients.” About Shields Health Solutions Shields Health Solutions is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.

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