Merrimack Pharm Wins Orphan Drug Status for MM-111
Inc. (Nasdaq: MACK) today announced that the U.S. Food and Drug
Administration's Office of Orphan Products Development has granted two
separate orphan drug designations for its bispecific antibody, MM-111, for the
treatment of esophageal cancer and for the treatment of gastric as well as
gastroesophageal junction (GEJ) cancers.
"We are pleased that the FDA has granted orphan status designation for the
development of MM-111 in these two indications," said Victor Moyo, MBChB.,
Vice President of Clinical Investigations at Merrimack Pharmaceuticals.
"Patients with HER2-expressing gastric and esophageal cancers have limited
treatment options. We are excited to move forward with the development of
MM-111 and hope to positively impact the lives of these patients by addressing
an unmet medical need."
MM-111 is designed to inhibit ErbB3 (HER3) receptor signaling in cancers that
overexpress ErbB2 (HER2). Overexpression of the ErbB2 cell surface receptor
has been reported in 7-34 percent of gastric cancers according to various
scientific articles. Research has shown that ErbB3 expression is associated
with poor prognosis in gastric cancer and may contribute to resistance to some
current standard treatments. Currently, MM-111 is being tested in a Phase 2
study in advanced gastric, esophageal and gastroesophageal junction cancers.
These two orphan drug designations will potentially provide Merrimack
Pharmaceuticals with 7-year marketing exclusivity for MM-111 and other
benefits if the drug is approved by the FDA. The FDA's Office of Orphan
Products Development is dedicated to supporting the development of products
that are promising for treatment and diagnoses of diseases that affect less
than 200,000 Americans annually.
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