VALENCIA, Calif. ( TheStreet) -- Mannkind ( MNKD) shares plunged Tuesday morning after the company said it was delaying efforts to sign a partner for its inhaled insulin Afresa. The disclosure is raising fears that the Food and Drug Administration may delay Afresa's approval. Mannkind disclosed that it would not meet its previously stated goal of signing a partnership for Afrea before the end of the year, according to an 8-K filing with the Securities and Exchange Commission. "We made substantial progress toward a definitive agreement with a lead potential partner; however, as the discussions progressed, we came to believe that it would be more productive to complete a partnership after we have received a response from the United States Food and Drug Administration, or FDA, regarding our new drug application for Afresa," said Mannkind in its SEC filing. Speaking at the JMP Securities conference in New York this morning, Mannkind executives were also cautious when asked if they thought FDA would grant full approval to Afresa on or before the agency's approval decision deadline, or PDUFA date, of Jan. 16, 2010. The risk of the company getting a complete response letter from the FDA is now significantly increased," said JMP analyst Jason Butler, speaking by phone from his firm's conference. "The company said a partner is not willing to sign on before the FDA's PDUFA date." Mannkind has also not indicated whether it will be asked to bring Afresa in front of an FDA advisory panel prior to the agency's approval decision date. Mannkind shares are down 23% to $7.01 in recent trading.
No Lupus Confab Invite for Immunomedics(At 7:42 AM EDT) Lupus will be a big focus of the upcoming annual meeting of the American College of Rheumatology (ACR) next week, but Immunomedics ( IMMU) has been shut out of the discussion. Immunomedics and its partner UCB submitted a late-breaker abstract seeking to present phase II data on its lupus drug epratuzumab, but ACR didn't accept the submission. "UCB did file their late-breaking abstract in time. Unfortunately, ACR only accepted 6 late breakers and ours was not chosen," confirmed Immunomedics' investor relations spokesman Chau Cheng, in an email response. Top-line data from a phase II study of epratuzumab in lupus patients were announced on August 27, sending shares of Immunomedics soaring 61% to $6.84. Since then, the stock has given back some of those gains, closing Monday at $4.99. Immunomedics owns the rights to epratuzumab but licensed development of the drug in lupus to the Belgian drug firm UCB in 2006. Human Genome Sciences ( HGSI) will be presenting detailed data from its successful phase III study of Benlysta in lupus patients at the ACR meeting on Oct. 20. The full ACR meeting runs Oct. 16-21. "As management had signaled, the abstract reveals that Benlysta did significantly benefit lupus patients on clinically important flare endpoints, and that the drug's safety profile is indistinguishable from placebo. This data should increase confidence in the quality of the Benlysta dataset and in the likelihood of a positive result in the second phase III study, BLISS-76, to be reported in November," writes Monness Crespi Hardt analyst Avik Roy in a research note published Monday.
ACR's decision to turn back the abstract submission from UCB and Immunomedics, by contrast, "implies that they did not find the epratuzumab data compelling," added Roy. He has a buy rating on Human Genome Sciences with a $24 price target. Immunomedics' Cheng says the epratuzumab data from the phase II lupus study will be submitted for presentation at a future medical meeting.
Feds Apply More Heat to SequenomMore trouble afoot for the already-troubled genetic test maker Sequenom ( SQNM): The U.S. Attorney for the Southern District of California and the FBI have been in contact with the company following its Sept. 28 announcement about its internal investigation of the data fabrication of its prenatal Down's syndrome test. The scandal forced the company to fire top executives, including CEO Harry Stylli and research head Elizabeth Dragon. Sequenom disclosed the new outside probes in a filing with the Securities and Exchange Commission Monday. The company said it has met with representatives of the U.S. Attorney and FBI, as well as with the enforcement staff of the SEC.
Acadia, Biovail Keep Parkinson's Drug AliveAcadia Pharmaceuticals ( ACAD) and Biovail ( BVF) are sticking with their Parkinson's disease drug pimavanserin despite a failed phase III study. The companies announced a new plan Tuesday to design and conduct a third phase III study using a higher dose of pimavanserin. Acadia and Biovail announced the negative results of the phase III study of pimavanserin in patients with Parkinson's psychosis first on Sept. 1. A second phase III study is underway, but the companies said patient enrollment will be cut short so that the data can be analyzed more quickly.
Data from these two studies will be used to help design the new, third phase III study. Under the collaboration agreement between the two companies, Biovail is responsible for paying for the new study, which is expected to start in the first half of 2010. In related news, Acadia says it will implement cost-cutting measures in October to reduce operating expenses and extend its cash burn. The company did not specifically say if employees were being laid off. -- Reported by Adam Feuerstein in Boston