PHARMA TECH
Globenewswire | May 12, 2023
SERB Pharmaceuticals, a global specialty pharmaceutical company, and SFJ Pharmaceuticals, a global drug development company, announce that SERB has acquired exclusive US rights to the ticagrelor reversal agent bentracimab from SFJ.
Bentracimab is a novel, monoclonal antibody fragment designed to reverse the antiplatelet activity of ticagrelor. Ticagrelor, marketed by AstraZeneca as Brilinta®, is a reversible oral P2Y12 platelet inhibitor for patients who have suffered a heart attack or stroke, or who have acute coronary syndromes or coronary artery disease (CAD). Bentracimab, if approved by the FDA, could allow these patients to benefit from the antithrombotic effect of ticagrelor, preventing vascular events and reducing risk of death, while giving physicians a way to control bleeding in rare emergency situations such as surgery or a major bleeding event.
SFJ will remain responsible for the ongoing clinical trials of bentracimab and will work in collaboration with SERB to submit the Biologics License Application (BLA) to the US Food and Drug Administration (FDA), which they expect to file later this year.
Jeremie Urbain, Executive Chairman of SERB Pharmaceuticals, said: “The acquisition of bentracimab marks a significant step in our strategy to grow through investment in innovative, biologic products for critical care conditions and leverages our existing commercial and technical capabilities. We're excited to partner with SFJ, recognized leaders in late-stage drug development, to bring this life-saving medicine to healthcare professionals and the patients they treat.”
Robert DeBenedetto, Chief Executive Officer of SFJ, said: “We are pleased to partner with Jeremie and the entire SERB team on this important step to help advance bentracimab to patients. Bentracimab has recognized potential benefits and we have confidence that SFJ in collaboration with SERB will be able to expeditiously and efficiently see bentracimab through the approvals process by the US FDA.”
Bentracimab binds ticagrelor and its major active metabolite with high affinity and specificity. A prespecified interim analysis of the ongoing Phase 3 trial REVERSE-IT published in the New England Journal of Medicine Evidence demonstrated that bentracimab immediately and sustainably reversed the antiplatelet effects of ticagrelor, and was generally well tolerated, with only minor adverse events reported. In 2019 bentracimab received Breakthrough Therapy Designation from the FDA, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
The companies did not disclose specific financial terms. Leopoldo Zambeletti acted as advisor for SFJ, and Evercore acted as advisor for SERB.
About SERB Pharmaceuticals
SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB has the broadest antidote portfolio in the world, including medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. SERB operates in the US as BTG Pharmaceuticals.Learn more at https://SERB.com.
About SFJ Pharmaceuticals®
SFJ is a global drug development company, which provides a unique and highly customized clinical development partnering model for the world's top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ's mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve. www.sfj-pharma.com
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PHARMACY MARKET
businesswire | April 03, 2023
Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapeutic areas, today announced that it has entered into a platform research evaluation collaboration and option agreement with Regeneron Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will use its proprietary drug-formulation platform, XeriJect™, to develop ultra-highly concentrated, ready-to-use, small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron. Xeris will receive an upfront payment and potential milestone payments for preclinical achievements. Regeneron has an option to commercially license the Xeris technology for such molecules and nominate additional molecules for reformulation and potential commercialization. Specific financial terms of the agreement were not disclosed.
“We are excited to be working with Regeneron on a platform collaboration basis, which builds on our prior feasibility studies and reflects the significant progress and investment we have been making into the development of XeriJect™,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Through our novel drug-formulation platform, we aim to provide our biologic development collaborators with the competitive advantage of delivering a significantly improved patient and provider experience through stable, ready-to-use, ultra-highly concentrated, small-volume subcutaneous injection formulations. This agreement with Regeneron is another in a series of collaborations Xeris has recently undertaken with top pharmaceutical and biotechnology companies.”
About XeriJect™
Xeris’ drug-delivery system, XeriJect, provides 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 >450mg/mL, enable small volume subcutaneous injections, do not settle on storage and are ready-to-use. 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.
About Xeris
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and 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®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.
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PHARMA TECH
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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