MedinCell | December 01, 2022
MedinCell has received an additional US$ 4 million payment from the Bill & Melinda Gates Foundation
This amount is intended to finance the next steps of MedinCell’s program mdc-WWM in readiness to initiate the first clinical trial end of 2023
It follows US$ 11,8 million already received as part of the two successive grants for a total of up to US$ 22,5 million from the Bill & Melinda Gates Foundation to finance the development of the program up to phase 1 completion
The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide
MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.
Accord BioPharma | September 21, 2022
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today a partnership with StoryMD. The StoryMD platform is a single, unified, personalized digital health information portfolio that curates the most relevant, visually rich content based on a patient's condition. Accord BioPharma has signed on as StoryMD's very first corporate partner, to support StoryMD's advanced prostate cancer content, allowing Accord BioPharma to provide a comprehensive, user-friendly tool to help patients and their caregivers navigate advanced prostate cancer, just in time for prostate cancer awareness month this September.
"At Accord BioPharma, we recognize the need to go beyond biology – and beyond our responsibility of drug development – to help change the clinician and patient experience at all touchpoints in the care continuum where we can," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "StoryMD exemplifies that mission by providing clinicians with clear, easy-to-understand visuals, videos, and health information that help their patients understand their disease journey. Partnering with StoryMD on their advanced prostate cancer content felt like a natural fit given our recent drug launch."
In March of this year, Accord BioPharma announced the U.S. launch of CAMCEVI® (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. CAMCEVI should not be used in patients with hypersensitivity to GnRN, GnRH agonist analogs as anaphylactic reactions to these drugs have been reported in the medical literature. Accord BioPharma is heading all commercial initiatives in the U.S. and Canada. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021.
Through a vast library of curated, clinically accurate disease-state information, graphics, and videos, StoryMD enables physicians to share an easy-to-understand disease journey with patients at the point of care, which can help increase patient retention of information and engagement, improve physician efficiency, and reduce the amount of misinformation patients may seek out on their own. "Accord BioPharma is making efforts to provide important patient and provider education in pursuit of our aim to offer latest treatment options to patients of advanced prostate cancer and we look forward to our collaboration with StoryMD to provide comprehensive and user-friendly tools for patients and care givers" said Binish Chudgar, Vice Chairman and Managing Director of Intas Pharmaceuticals Ltd, which is the parent company of Accord BioPharma.
"Every once in a while, you meet a person and a partner who has a vision. Chrys Kokino has that vision to go beyond drug development and sees the value in advancing technology rather than being afraid of it. And that's exactly what we want – partners who recognize the gap in communication between physicians and patients and who want to work together to close that gap and fill an unmet need."
Alexander Tsiaras, CEO and Founder at StoryMD
On the importance of prostate cancer awareness, Tsiaras said, "I have a family member who works in the medical field, and when he was diagnosed with prostate cancer, it was amazing how little he knew. Cancer is such a confusing and overwhelming disease – 'Do I wait and watch? Should I be aggressive in treatment?' So, even for the most educated among us, it is a scary moment. Accord BioPharma and StoryMD are working together to go beyond offering patients drug options to impart knowledge and serve as a trusted resource."
About Accord BioPharma
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient's experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patient's perspective and develop high-quality therapies that impact patient's lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies.
CAMCEVI® injection emulsion is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels (less than or equal to 50ng/dL) after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.
Xeris | November 24, 2022
Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that it has entered into a research collaboration and option agreement with Horizon Therapeutics plc. Under the terms of the agreement, Xeris will use its proprietary formulation technology platform, XeriJect™, to develop an ultra-concentrated, ready-to-use, subcutaneous injection of teprotumumab and Horizon will have an option to license the Xeris technology. Teprotumumab is the first and only medicine approved by the U.S. Food and Drug Administration for the treatment of Thyroid Eye Disease a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States. Xeris will receive an upfront payment, and may be entitled to receive development milestones, regulatory milestones, and salesbased milestones, as well as royalties based on future sales if the commercial license option is exercised. Specific financial terms of the agreement were not disclosed.
“We are excited to announce our collaboration with Horizon for the development of a subcutaneous formulation of teprotumumab using our XeriJect technology to potentially enhance the patient experience and delivery of the treatment for Thyroid Eye Disease. This partnership demonstrates the potential value of our technology to enable large molecule subcutaneous injections that provide a more patient friendly regimen that is effective, safe, and more convenient, with potential for improved adherence.”
Paul R. Edick, Chairman and CEO of Xeris
XeriJect formulations are innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >400mg/mL, enable small volume subcutaneous injections and do not settle on storage. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.