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; [email protected]