Ammonett Pharma Granted Orphan Drug Designation From the U.S. FDA for Ibutamoren Mesylate (MK-0677) for Treatment of Growth Hormone Deficiency

MIDLOTHIAN, Va., June 19, 2017 -- Ammonett Pharma LLC (the Company or Ammonett), a privately-held biotechnology company developing a novel, daily, orally-administered mini-pill Growth Hormone (GH) secretagogue, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the Company’s MK-0677 (Oratrope™), for the treatment of Growth Hormone Deficiency (GHD).

The Orphan Drug status in the pediatric indication which Ammonett is pursuing will provide 7½ years of market exclusivity as well as eligibility for certain development incentives. The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that effect fewer than 200,000 people in the U.S.

Pediatric Growth Hormone Deficiency (PGHD) in children and GHD in adults are conditions caused by insufficient amounts of GH in the body. Children with GHD have abnormally short stature with normal body proportions. GHD can be present at birth (congenital) or develop later (acquired). Current standard treatment of PGHD and GHD is through daily injections of recombinant growth hormone (rhGH).

Oratrope is Ammonett’s novel drug, ibutamoren mesylate, a small molecule, which mimics the effects of Growth Hormone release inducing hormone (Ghrelin), a natural hormone found in the stomach, which controls the release of GH from the pituitary gland. Oratrope is planned to be administered orally as a daily mini-pill, allowing the body to produce its own natural GH in a physiologically pulsatile manner over 24 hours, unlike the single daily bolus of exogenous GH delivered at present by daily injection.

“This is another important regulatory milestone for Ammonett as we advance our clinical development of Oratrope,” said Michael Thorner, MB, BS, DSc, FRCP, MACP, Ammonett’s Founder and Chief Scientific Officer. “The U.S. Orphan Designation Grant along with our recently announced positive opinion from the European Medicines Agency (EMA) designating Oratrope as an orphan medical product in Europe for the treatment of GHD further validates our development program as we continue with plans for our intended Phase 2b trial in the PGHD indication.”

About Ammonett Pharma LLC
Ammonett Pharma LLC, is a privately held biopharmaceutical company focused on the development of novel therapies restoring normal growth and metabolism. Oratrope is Ammonett’s lead product, targeting children with PGHD who have an intact hypothalamic pituitary GH axis.

Kevin P Tully CPA, CGA
Chief Executive Officer
[email protected]

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Andrew Amiel
VP Business Development
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