Market Overview

Martin Pharmaceuticals' LIVANTRA™ Receives FDA Orphan Drug Designation in Second Indication


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.


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%.


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:

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