Map Pharmaceuticals Inc. (MAPP) plans to meet with the Food and
Drug Administration during the current quarter to discuss
manufacturing issues that are preventing approval of its migraine
medication Levadex.
The FDA in March sent a complete response letter to the
biopharmaceutical company that required Map Pharmaceuticals to
address manufacturing issues, chemistry and controls issues found
in an inspection of the drug maker's third-party manufacturer.
Investors have been awaiting the agency's decision on the
usability of Map's inhalable drug, which delivers a common migraine
treatment in an aerosol format.
President and Chief Executive Timothy S. Nelson said the company
continues to work closely with partner Allergan Inc. (AGN), as it
seeks to resolve the issues as quickly as possible. Allergan has a
deal with Map Pharmaceuticals to jointly promote Levadex.
The company also announced that it recently was issued a third
patent related to Levadex.
Map shares closed Thursday at $13.14, down 1.2%, and were
inactive in after-hours trading. The stock is off nearly 27% from a
2-year high last month before the company received the FDA's
complete response letter.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com