TUCSON, Ariz., February 18, 2024 — Critical Path Institute’s® (C-Path)Critical Path for Alpha-1 (CPA-1) consortium today announced the addition of biopharmaceutical companies, Kamada and Sanofi, as its newest members. Joining alongside CSL Behring, and Takeda, as well as a coalition of academic clinician researchers, patient advocacy groups, and regulatory colleagues, these additional industry stakeholders bring unparalleled expertise and experience in Alpha-1 antitrypsin deficiency (AATD) therapeutic development and diagnostics.
“Sanofi has long been committed to bringing novel therapies to people living with a rare disease,” said Karin Knobe, M.D., Ph.D., Global Head of Development, Rare Diseases at Sanofi. “We also have deep experience in the study and treatment of respiratory conditions. Alpha-1 antitrypsin deficiency is a rare condition that can severely affect both the lungs and liver. We are hopeful that through rigorous research and development, and thoughtful partnerships with organizations such as CPA-1, we can bring much needed awareness and support to this very deserving community. We firmly believe in the power of public-private partnerships to advance clinical innovation for rare diseases.”
AATD is a rare genetic disease often undetected until adulthood, leading to debilitating conditions such as pulmonary emphysema and hepatic fibrosis, sometimes necessitating life-saving lung or liver transplants. The formation of this new public-private partnership marks a dedicated effort towards advancing regulatory-grade drug development solutions addressing both pulmonary and hepatic manifestations of AATD.
Amir London, Chief Executive Officer of Kamada, said, “As a global biopharmaceutical company focused on diseases of limited treatment alternatives we are dedicated to continued research, development and commercialization of treatments for AATD and are excited to join C-Path Alpha-1 consortium. We are committed to C-Path’s vision, aimed at accelerating the development of novel therapeutics for the Alpha-1 community, through our late-stage clinical trial of an investigational Inhaled AAT treatment which has the potential to be a transformational next-generation augmentation therapy for AATD. We look forward to working with C-Path leadership, the FDA team, and other members of the consortium to advance innovation, diagnostics, and treatment for the Alpha-1 patients.”
“The CPA-1 Consortium is excited to welcome Kamada and Sanofi as its newest members. Their participation strengthens our commitment to advancing regulatory science in AATD, and we look forward to their contributions to deepen collaboration and enhance learning within the global AATD community,” expressed Collin Hovinga, Pharm. D., Vice President of Rare and Orphan Disease Programs, C-Path.
For more information about CPA-1 consortium, please visit https://c-path.org/program/critical-path-for-alpha-1-antitrypsin-deficiency/.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path in Europe is headquartered in Amsterdam, Netherlands with additional staff in multiple other locations. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 55% funded by the FDA/HHS, totaling $17,612,250, and 45% funded by non-government source(s), totaling $14,203,111. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
About Kamada
Kamada Ltd. (the “Company”) is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company’s strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company’s commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, the Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D), KARAB and KEDRAB. In addition to the Company’s commercial operation, it invests in research and development of new product candidates. The Company’s leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media Contacts:
Roxan Triolo Olivas
C-Path
520.954.1634
rolivas@c-path.org
Kissy Black
C-Path
615.310.1894
kblack@c-path.org