In first, cancer drugs simultaneously approved in US, Canada, Australia

BioPharma Dive | September 18, 2019

Drug approvals often occur in succession, with pharmaceutical companies typically focusing first on top markets like the U.S. and Europe. Each country has different review procedures as well, at times resulting in delays for a drug cleared in, say, the U.S. to arrive elsewhere. Project Orbis, piloted by the FDA's Oncology Center of Excellence, is designed to help coordinate cancer drug reviews, allowing for simultaneous approval and, in theory, earlier patient access to new treatments. Merck and Eisai's combination of Keytruda (pembrolizumab) and Lenvima (lenvatininb) is the first recipient of a Project Orbis review. In this case, the FDA worked alongside its counterparts in Canada and Australia but future reviews could involve other international agencies like the European Medicines Agency. "As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative," said acting FDA Commissioner Ned Sharpless in a statement.  Approval of Keytruda and Lenvima in endometrial cancer is an expansion of each drug's label, rather than an initial OK for either drug. In a question-and-answer document posted online, the FDA said future collaborations could involve a New Drug Application or a Biologics License Application but cautioned that those reviews "may be more complex due to proprietary information involved."

Spotlight

Every day, 1,000 young women and girls get HIV, 4,000 lives are lost to TB and millions who could be helped suffer from serious mental illnesses. Johnson & Johnson's efforts in tackling these health threats, alongside many others, is why the company has continued to rank among the top three working to expand global access to medicines in low- and middle-income countries according to the Access to Medicine Index (ATMI).

Spotlight

Every day, 1,000 young women and girls get HIV, 4,000 lives are lost to TB and millions who could be helped suffer from serious mental illnesses. Johnson & Johnson's efforts in tackling these health threats, alongside many others, is why the company has continued to rank among the top three working to expand global access to medicines in low- and middle-income countries according to the Access to Medicine Index (ATMI).

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RESEARCH

Orsini Specialty Pharmacy Expands Collaborates with Alnylam® Pharmaceuticals as a Limited Distribution Partner for Oxlumo™

Orsini | December 04, 2020

Orsini Specialty Pharmacy, an innovator in uncommon illnesses and quality treatments, reported today that it has been chosen by Alnylam® Pharmaceuticals as a restricted appropriation accomplice for OXLUMO™ (lumasiran). OXLUMO is the solitary treatment affirmed for essential hyperoxaluria type 1 (PH1) to bring down urinary oxalate levels in pediatric and grown-up patients. PH1 is a super uncommon hereditary sickness described by the overproduction of oxalate, a side-effect that normally is dispensed with by the kidneys and discharged in the pee. The overabundance creation of oxalate brings about the affidavit of calcium oxalate gems in the kidneys and urinary plot and can prompt the development of agonizing and repetitive kidney stones, nephrocalcinosis, movement to kidney disappointment, and foundational organ brokenness. It is assessed that PH1 influences one to three people for each million in the United States and Europe. "We are satisfied to grow our organization with Alnylam Pharmaceuticals and add OXLUMO to the treatments we accommodate the treatment of super uncommon hereditary conditions," said Mike Fieri, Orsini Chief Executive Officer. "Our devoted OXLUMO Care Team is focused on offering caring help and individualized administrations to help individuals with PH1 and their families all through their excursion and assist them with exploring through the complexities of our medical services framework."

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PHARMACY MARKET

Cardurion Pharmaceuticals Announces Investment of up to $300 Million From Bain Capital

Cardurion Pharmaceuticals | October 28, 2021

Cardurion Pharmaceuticals, Inc a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of heart failure and other cardiovascular diseases, today announced it has received a private investment of up to $300 million from Bain Capital Life Sciences and Bain Capital Private Equity. Bain Capital joins existing investors, Takeda Pharmaceuticals and Polaris Partners, in supporting the evolution of Cardurion into a leading cardiovascular biotechnology company. Based in Boston, Massachusetts and with facilities there and in Shonan, Japan, Cardurion’s mission is to transform the treatment of cardiovascular diseases by translating the science of cardiovascular signaling pathways into groundbreaking therapeutics. The Company’s innovative pipeline of cardiovascular drug candidates includes a PDE9 inhibitor and a CaMKII inhibitor program. The investment will support the thoughtful advancement of Cardurion’s pipeline, enable the Company to scale its team, and create an industry-leading platform. “We could not be more excited to welcome Bain Capital as investors in this transformational milestone for Cardurion We have a shared vision to continue to build a world-class cardiovascular company pursuing treatments for a broad range of debilitating diseases. This funding will allow us to advance our first-in-class PDE9 inhibitor into a major Phase 2 trial in heart failure and to support the initiation of first-in-human studies with our CaMKII inhibitor program in several cardiovascular indications. We look forward to leveraging the experience and resources of our investors to build and scale Cardurion as a leading cardiovascular biotechnology company.” Peter Lawrence, Chief Executive Officer of Cardurion “This is an impressive team laser-focused on deep science, innovation, and collaboration in a strategically important therapeutic area where there is high unmet need for patients,” said Adam Koppel, M.D., PhD, a Managing Director at Bain Capital Life Sciences. “We look forward to a lasting partnership with Mike and Peter and their team, supporting the efforts to identify and develop novel therapies while building out a scale platform that can serve as a champion for cardiovascular drug development.” “This investment will accelerate our progress as we work to create transformative new medicines that deliver value for patients and other key stakeholders,” said Michael E. Mendelsohn, M.D., Founder and Chairman of Cardurion. “Cardurion is dedicated to advancing novel mechanisms that yield new treatments for cardiovascular disease, which remains the greatest cause of morbidity and mortality in our society.” In conjunction with Bain Capital’s investment, Koppel and Nicholas Downing, MD, a Principal at Bain Capital Life Sciences, will join the Cardurion Board of Directors. About Cardurion Pharmaceuticals Cardurion Pharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of heart failure and other cardiovascular diseases. Founded by physician-scientist Michael E. Mendelsohn, M.D., and built by a team of physician-scientists and industry leaders with extensive experience in cardiovascular science, drug development and business development, Cardurion Pharmaceuticals is pursuing unique drug discovery and development programs to target major unmet needs in cardiovascular medicine. Cardurion Pharmaceuticals has facilities in Boston, Massachusetts and Shonan, Japan. About Bain Capital Founded in 1984, Bain Capital, LP is one of the world’s leading private multi-asset alternative investment firms with offices on four continents and deep experience in healthcare. Bain Capital manages approximately $150 billion across asset classes and leverages the firm’s shared platform to capture opportunities in strategic areas of focus. Bain Capital Private Equity has partnered closely with management teams to provide the strategic resources that build great companies and help them thrive. A team of more than 275 investment professionals creates value for portfolio companies through its global platform and depth of expertise in key vertical industries including healthcare. Bain Capital Life Sciences pursues investments in biopharmaceutical, specialty pharmaceutical, medical device, diagnostics and enabling life science technology companies globally. The team focuses on companies that both drive medical innovation across the value chain and enable that innovation to improve the lives of patients with unmet medical needs.

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RESEARCH

Regeneron, following in Lilly's footsteps, wins FDA emergency nod for COVID-19 antibody cocktail

Regeneron | November 24, 2020

Covid-19 Regeneron antibody cocktail, one of the drugs of President Donald Trump was given after he was infected with the SARS-COV-02 virus, had been cleaned for emergency use by the FDA. And, despite the towering vaccine slide, one analyst still sees therapy as a $ 1 billion-plus business. Authorization of Emergency Use (EUA) for Regn-COV2, a combination of monoclonal antibodies Kasarivimab and IMdevimab, marked the second for antibody therapy. The first to go to Bamlanivimab Eli Lilly, who was given EUA a few days ago. In addition to the difference between Regn-COV2 is a concoction of several drugs, while Lilly's maintenance contains only one drug, both EUU is almost identical; The two of them for Covid-19 patients were light to medium for a minimum of 12 years old who were not hospitalized but at high risk to advance to Covid-19. “The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. FDA fact sheet detail the criteria for determining "high-risk" patients. These include obese people with more than 35 body mass index, older patients in or more than 65 years, or people with fundamental conditions such as chronic kidney disease, diabetes, cardiovascular disease or breathing conditions, among others. Data from a phase 1/2 study in 799 patients showed the cocktail could reduce viral load significantly better than placebo did. More importantly, there were lower rates of hospital visits among REGN-COV2-treated patients within 28 days. “This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement Saturday. Through a $450 million agreement signed in July with the Trump administration’s Operation Warp Speed, Regeneron could provide up to 300,000 treatment doses of REGN-COV2 to the federal government for distribution. The company plans to have the single-dose therapy available to about 80,000 patients by this month and hit the 300,000 mark by the end of January. The U.S. government has a separate $375 million pact with Lilly for 300,000 doses of bamlanivimab. Antibody drugs are hard to produce, and 300,000 doses are dwarfed in comparison by the 2 million treatment courses Gilead Sciences has pledged to produce of its small-molecule therapy Veklury (remdesivir) by the end of this year. With that limited initial supply, Regeneron CEO Len Schleifer, M.D., Ph.D. warned that demand of REGN-COV2 may exceed supply during the early days.

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