Istanbul, Turkey, December 25, 2017 – TRPharm and Kastle Therapeutics, LLC today announced that the companies have entered into an agreement granting TRPharm exclusive rights in Turkey and Middle East to commercialize KYNAMRO® (mipomersen sodium) injection.
Under the agreement, TRPharm will be responsible for marketing authorizations, market access, commercialization, and distribution throughout Turkey, Lebanon, Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman. KYNAMRO was approved by the FDA in January 2013.
“We are pleased to enter into this collaboration with Kastle Therapeutics, where we have the chance to bring our unique strengths together to improve the health of HoFH patients across the region. This partnership also supports our long-term commitment to rare diseases. Despite the recent advances in the field of LDL-cholesterol lowering, there are still a significant number of patients with this unique mutation that have an unmet medical need,” said Mehmet C. Göker, Chief Executive Officer of TRPharm. “We look forward to rapidly establishing the regional footprint of KYNAMRO and bringing value to patients through a strong dialogue with physicians and authorities while investing into science and awareness around this critical condition.”
About KYNAMRO® (mipomersen sodium) injection
KYNAMRO is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis. KYNAMRO is indicated as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH). KYNAMRO reduces LDL-C by preventing the formation of atherogenic lipoproteins, the particles that carry cholesterol through the bloodstream. KYNAMRO acts by blocking the production of apo B, the protein that provides the structural core for these atherogenic particles, including LDL.
About Homozygous Familial Hypercholesterolemia (HoFH)
HoFH is a rare genetic disease characterized by extreme cholesterol levels. People with HoFH have inherited mutations that limit the body’s ability to clear cholesterol. HoFH is extremely rare. The true prevalence of HoFH may be underestimated because of inadequate data and under-diagnosis. Medical literature includes different criteria for making an HoFH diagnosis. HoFH may be diagnosed by clinical or genetic parameters, and may be considered in cases of unusually high LDL-C. Because HoFH is genetic, it is important that all family members of people with HoFH know their cholesterol levels, regardless of their age.
TRPharm is a biopharmaceutical company focused on innovation through investments in R&D and a cutting edge biotechnological manufacturing facility, with the aim of becoming a regional commercial player based out of Turkey. TRPharm focuses on the launch of new and innovative medicines, from registration and successful completion of clinical programs through to commercialization, as well as building a biotech manufacturing facility in Turkey for the supply of monoclonal antibodies to CIS and MENA region. TRPharm has a broad product portfolio, led by oncology, neurology, inflammatory and rare diseases.
ABOUT KASTLE THERAPEUTICS
Kastle Therapeutics is a biopharmaceutical company focused on developing and commercializing pharmaceuticals for diseases with high unmet medical needs. Kastle Therapeutics is headquartered in Chicago. For more information, please visit www.kastletherapeutics.com.
Kastle Therapeutics’ Contact:
J. Christopher LiPuma
Head of Business Development
Ozan Efe Ertem Business
Development and Strategy Sr Manager