Bristol-Myers Squibb Company (Nasdaq: BMY) announced on Saturday that it intends to acquire Inhibitex, Inc. (Nasdaq: INHX) for $26.00 per share or approximately $2.5 billion. The acquisition has been approved by the boards of directors of both companies. INHX have been developing treatments for hepatitis C virus (HCV).
VIVUS, Inc. (NASDAQ: VVUS) today announced that it has been asked by the FDA to remove the Qnexa contraindication for women of childbearing potential contained in the proposed label. Qnexa would remain contraindicated for women who are pregnant. A proposed Risk Evaluation and Mitigation Strategy, or REMS would be included. The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Qnexa NDA on February 22, 2012. The PDUFA date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.
GlaxoSmithKline (Nasdaq: GSK) and Theravance Inc. (Nasdaq: THRX) said today that they expect to submit both MAA and NDA filings for Relovair in patients with chronic obstructive pulmonary disease (COPD) during mid-2012. They also intend to file a MAA in patients with asthma in mid-2012 and will continue discussions with the FDA on regulatory requirements needed to file their NDA. Phase 3 data out today disappointed with one of the COPD trials showing non-significant data as well as reports of fatal pneumonia. Similar disappointing data was also evident in patients in the asthma trial.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) gave a pipeline update over the weekend noting that it intends to initiate a Phase 2 multi-dose study of ALN-TTR02 in transthyretin-mediated amyloidosis (ATTR) patients in 2H 2012 and, assuming positive results, expects to start a pivotal trial for ALN-TTR02 in 2013. It also maintained previous guidance that it intends to report results from its Phase 2b trial of ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection during mid 2012.
Sequenom, Inc. (NASDAQ: SQNM) announced highlights of its performance last year, noting that it had billed about 21,000 prenatal and retinal diagnostic tests and aims to bill at least a further 25,000 during 2012.
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today said that it expects to launch EXPAREL in April 2012. Approved in October 2011, the company had previously guided a launch date this month (January). However, it cited commercial manufacturing challenges for the delay.
Ventrus BioSciences, Inc (Nasdaq: VTUS) noted in a company presentation released in a filing today that it intends to release Phase 3 data of VEN 309 (iferanserin) for hemorrhoids in June this year. In addition, it maintained previous guidance of a Phase 3 initial topline data this May of Diltiazem (VEN 307) in patients with anal fissures.
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) reported 12-week results of its Phase 2 trial of ACH-1625 for the treatment of genotype 1 treatment-naive hepatitis C virus (HCV). Data on the first 35 of 60 patients enrolled were released. The data showed a complete early virologic response (cEVR) and viral load reduction at week 12 in all patients. Complete data will be released in April 2012.
Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) announced interim data from a 12-week Phase 2b clinical trial of IDX184 for the treatment of HCV. Rapid virologic response (RVR) findings demonstrated that 73% of patients in the 100 mg IDX184 arm (n=15) and 63% in the 50 mg arm (n=16) had undetectable virus (LLOQ < 25 IU/ml) at 28 days. Currently 87% of patients in the 100 mg arm and 94% in the 50 mg arm had undetectable virus at a median of 8 weeks of treatment.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) noted in a company presentation filed today that it intends to submit its NDA for Tivozanib during 3Q 2012.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today the initiation of two new Phase 2 clinical studies (SB-728-1101 and SB-728-902, Cohort 5) in its program to develop a “functional cure” for HIV/AIDS.
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today said it hopes to expand the DIFICID label currently approved for Clostridium difficile associated-diarrhea (CDAD). Optimer intends to evaluate prophylactic use of DIFICID in patients undergoing bone marrow transplantation, who are generally at risk for CDAD and where CDAD has a significant impact on the patient and the disease associated cost burden.