Amira Pharmaceuticals Receives Orphan Drug Status for a Novel LPA1 Antagonist, AM152, for the Treatment of Idiopathic Pulmonary FibrosisBy Amira Pharmaceuticals Inc., PRNE
Monday, April 18, 2011
SAN DIEGO, April 19, 2011 - Amira Pharmaceuticals, Inc. announced today that AM152, the company's
lead LPA1 antagonist, has been granted an orphan drug designation by the U.S.
Food and Drug Administration for the treatment of idiopathic pulmonary
fibrosis. Commonly referred to as IPF, this fibrotic disease affects the
lungs of patients and their ability to breathe.
"This is an important development for Amira, and potentially patients
suffering from IPF, as we continue to move this promising therapeutic
candidate forward in development," said Bob Baltera, Chief Executive Officer.
"We are currently completing our Phase 1 studies with AM152 and expect to
begin a Phase 2 study by the end of 2011 or in early 2012. Currently there
are no FDA-approved therapies for IPF, and we look forward to better
understanding the potential therapeutic benefit of an LPA1 antagonist in this
AM152 is a lysophosphatidic acid (LPA) receptor 1 antagonist. Activation
of the LPA1 receptor by LPA has been implicated in a number of disease
processes, including tissue fibrosis. LPA1 receptor antagonists have
displayed efficacy in a wide range of preclinical fibrosis models, including
lung, skin, eye, liver and kidney.
About Orphan Drug Designation
The United States Orphan Drug Act of 1983 was created to promote and
support the development of new drug therapies for diseases that affect fewer
than 200,000 people in the United States. Orphan Drug Designation provides a
sponsor seven years of market exclusivity for the designated therapeutic
indication in the United States, from the point at which the therapy is
granted marketing approval. Orphan Drug Designation also provides access to
regulatory support from the FDA, potential FDA fee reductions and tax credits
related to development expenses.
Founded in 2005 and headquartered in San Diego, Amira Pharmaceuticals is
a small molecule pharmaceutical company focused on the discovery and early
development of new drugs to treat inflammatory and fibrotic diseases. Amira
combines the rigor of a big pharmaceutical company with the ingenuity and
energy of a small company, creating an environment for efficient development
of novel compounds and effective pre-clinical and clinical program decisions.
Our team is building on unparalleled insights into bioactive lipid pathways
and complex signaling processes controlling many conditions including asthma,
chronic obstructive pulmonary disease, cardiovascular and various fibrotic
diseases. Amira has a partnership with GlaxoSmithKline for the development of
FLAP (5-lipoxygenase activating protein) inhibitors in respiratory and
cardiovascular disease. For more information, visit
Ian Stone of Russo Partners, +1-619-528-2220, ian.stone at russopartnersllc.com, for Amira Pharmaceuticals
Tags: Amira Pharmaceuticals Inc., April 19, california, San diego