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Martin Pharmaceuticals’ LIVANTRA™ Receives FDA Orphan Drug Designation In Second Indication8/14/2018 PRESS RELEASE
MARTIN PHARMACEUTICALS’ LIVANTRA™ RECEIVES FDA ORPHAN DRUG DESIGNATION IN SECOND INDICATION NEW YORK, August 14, 2018 — Martin Pharmaceuticals, a clinical stage pharmaceutical company focused on repurposing already-approved drugs to offer life-changing advances to patients afflicted with rare (orphan) diseases or challenging medical conditions, announced today that it has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for LIVANTRA™ in the treatment of Pulmonary Arterial Hypertension. Earlier this year LIVANTRA received orphan drug designation for the treatment of Acute-on-Chronic Liver Failure (ACLF). The FDA's Orphan Drug Designation program is intended to encourage the development of drugs and biologics that may provide benefit to patients suffering from rare diseases or conditions, specifically those affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs. ABOUT PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension (PAH) is a progressive, life-threatening disorder. It occurs when the very small arteries throughout the lungs narrow, thereby increasing the resistance to blood flow through the lungs. In an effort to compensate, blood pressure intensifies in the pulmonary artery. Ultimately, the increased blood pressure can damage the right ventricle of the heart, making it difficult for the heart to pump blood through the lungs to be oxygenated. It’s estimated that somewhere between 35,000 to 60,000 people in the U.S. are living with PAH. Current therapies aim to reduce symptoms and improve quality of life. Despite improvements in patient management, mortality rates for PAH remain high. The National Institutes of Health Registry has reported a 3-year mortality rate of approximately 50%. ABOUT MARTIN PHARMACEUTICALS Martin Pharmaceuticals, Inc. is a privately held pharmaceutical company headquartered in the historic Woolworth building in New York City. We concentrate on uncovering already-approved drugs and repurposing them to benefit patients facing a different need than originally intended for those medications. We also focus our discovery efforts on “orphan” indications. For more information on the company and LIVANTRA, please visit our website: martinpharma.com Contact: Martin Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@martinpharma.com
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PRESS RELEASE
MARTIN PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR LIVANTRA™ NEW YORK, March 29, 2018 — Martin Pharmaceuticals, a clinical stage pharmaceutical company focused on repurposing already-approved drugs to offer life-changing advances to patients afflicted with rare (orphan) diseases or challenging medical conditions, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for LIVANTRA™ in the treatment of Acute on Chronic Liver Failure. Orphan drug designation is granted to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs. ABOUT ACUTE ON CHRONIC LIVER FAILURE AND LIVANTRA Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute decompensation of chronic liver disease associated with organ failures and high short- term mortality. The greater the number of organ systems involved, the higher the mortality rate. Despite current aggressive medical management, mortality at 30 and 90 days in ACLF remains high, ranging from about 50% in milder cases to nearly 80% in patients with 3 or more organ system failures. Each year in the U.S. approximately 41,000 people are rushed to hospital with ACLF. Costs of ACLF patient care can range from $116,000 to $180,000 per episode. Medical management is often viewed as a bridge to transplantation, but many patients don’t qualify for transplantation (age, co-morbidities, etc.) and demand greatly exceeds the supply (50% die before getting a transplant and only 25% of patients are successfully transplanted). LIVANTRA is a potential game changer as it may help patients to survive ACLF without transplantation, or allow patients to live long enough to receive a new liver. ABOUT MARTIN PHARMACEUTICALS Martin Pharmaceuticals, Inc. is a privately held pharmaceutical company headquartered in the historic Woolworth building in New York City. We concentrate on uncovering already-approved drugs and repurposing them to benefit patients facing a different need than originally intended for those medications. We also focus our discovery efforts on “orphan” indications. On March 15, 2018, the Company announced it had completed a seed round of financing. Contact: Martin Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@martinpharma.com PRESS RELEASE
Healthcare Veterans Launch Martin Pharmaceuticals To Repurpose Drugs for Orphan Indications; Seed Round Oversubscribed NEW YORK, New York, March 15, 2018 — Two accomplished healthcare executives, David Martin Geliebter and Sven Martin Jacobson, founders of Remedy Pharmaceuticals, announced the launch of Martin Pharmaceuticals, with the mission of repurposing already-approved drugs in order to offer life-changing advances to patients afflicted with rare (orphan) diseases or challenging medical conditions. Martin is the sixth healthcare company the pair has started since 2001. In May 2017, Remedy Pharmaceuticals sold its repurposed, orphan-designated CNS drug program, CIRARA® to Biogen (NASDAQ:BIIB) for a $120 million upfront payment plus future potential milestones and royalties. Martin also revealed that it completed a seed round of financing from a group of outside investors to advance a clinical-stage, repurposed drug program. The offering was oversubscribed. No other details were provided other than the Company is planning to start recruiting patients into a phase 1/2 trial for an unspecified life-threatening acute condition. ABOUT MARTIN PHARMACEUTICALS Martin Pharmaceuticals, Inc. is a privately held pharmaceutical company headquartered in the historic Woolworth building in New York City. We concentrate on uncovering already-approved drugs and repurposing them to benefit patients facing a different need than originally intended for those medications. We also focus our discovery efforts on “orphan” indications. In the U.S. the Orphan Drug Designation program provides orphan status to drugs and biologics which affect fewer than 200,000 people. Orphan Drug Designation provides companies with, among other benefits, tax incentives and the exclusive right to commercialize the cure for a specific condition for a period of seven years without interference from potential competitors. Europe, Japan, and Australia have similar programs. Contact: Martin Pharmaceuticals Sven Jacobson 212-586- 2226 x 225 sven@martinpharma.com |
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