Alvogen, today announced new exclusive commercialization agreements with PharmBio in South Korea, Kamada in Israel and Jamp in Canada for Teriparatide (PF708) Forteo®, the therapeutic equivalent for the treatment of osteoporosis.
Subject to applicable regulatory approvals, Teriparatide PF708 will be commercialized in South Korea by PharmBio, a leading specialty pharmaceutical company, in Israel by Kamada Ltd., an international biopharmaceutical company with a strong marketing presence in Israel, and in Canada by one of the leading Canadian pharmaceutical companies, Jamp, who are driven by the desire to provide better access to health.
Alvogen has also submitted the marketing authorization application for Teriparatide (PF708) to the Kingdom of Saudi Arabia's Saudi Food and Drug Authority, demonstrating Alvogen’s continued efforts towards patient access to biosimilars around the world.
Faysal Kalmoua, Executive Vice President of Alvogen, commented:
“We are very proud to announce strategic alliances with PharmBio, Kamada and Jamp, leading pharmaceutical companies. Through these partnerships, Alvogen gains access to strong commercial networks in South Korea, Israel and Canada, as well as deep marketing experience within their respective territories, which will ultimately benefit patients, giving them better access to high-quality biosimilars.” “We are also very pleased with the latest submission for Teriparatide PF708 in Saudi Arabia with our partner Saja, which creates further momentum around our commercialization program through the global Alvogen network and prestige business partners.“
About PF708 PF708 is being developed by Pfenex as a therapeutic equivalent candidate to Forteo®, which is approved and marketed by Eli Lilly for the treatment of osteoporosis in certain patients with a high risk of fracture. Forteo®/ Forsteo® achieved $1.6 billion in global product sales in 2018. PF708 is being developed pursuant to the 505(b)(2) regulatory pathway in the U.S. and received FDA approval in October and references Forteo® as the Reference Listed Drug. PF708 has been filed with the EMA using the biosimilar pathway and references Forsteo® as the Reference Drug.
About Jamp JAMP Pharma is a privately owned Canadian company with its head office in the Montreal area. Experiencing a sustained phenomenal growth for more than 10 years, JAMP Pharma has a portfolio with more than 240 molecules and is the leader in product launches in the generic pharmaceutical industry in Canada. JAMP Pharma is also growing through a diversified portfolio of brands: vitamins, supplements and natural health products from Wampole and Laboratoire Suisse and branded prescription products from Orimed Pharma.Number of new Notice of Compliance, Health Canada, September 1st 2018 to 31st August 2019*
About PharmBio Pharmbio Korea Inc. is biopharmaceutical company focusing on providing innovative healthcare solutions for patients who suffer from osteoporosis, pain, cancer, urinary and gastrointestinal diseases. The company started business in 1999 in South Korea. The company has licensed and marketed several products in close collaboration with pharmaceutical companies in the U.S., EU, Japan, and Canada and has exported its patent products to SE Asian countries including Myanmar, Philippines, Vietnam, and Pakistan to fulfill unmet worldwide medical needs. The company has also licensed out the world’s first ready to drink colonoscopy solution to Ferring pharmaceutical in the U.S. in 2016. Further information is available at www.pharmbio.co.kr
About Kamada Ltd. Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived Immune globulins. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets GLASSIA® in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other counties through local distributors. Kamada’s second leading product is KamRAB, a rabies immune globulin (Human) for Post-Exposure Prophylaxis against rabies infection. KamRAB is FDA approved and is being marketed in the U.S. under the brand name of KEDRAB and through a strategic partnership with Kedrion S.p.A. In addition to GLASSIA and KEDRAB, Kamada has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency, and in addition, its intravenous AAT is in development for other indications, such as GvHD, prevention of lung transplant rejection and type-1 diabetes. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties.