ISIS PDUFA date set. LGND/GSK file Promacta sNDA. EXEL files NDA + initiates second Phase 3 mCRPC + CLSN ALNY INSM ACRX news
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (ISIS), announced yesterday that the FDA has set a PDUFA date of of January 29, 2013 for KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme.
Exelixis, Inc. (NASDAQ:EXEL) announced it has initiated its Phase 3 pivotal trial, called COMET-1, of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint is overall survival (OS) in mCRPC patients who have had disease progression after treatment with docetaxel and abiraterone acetate and/or MDV3100. Data are due 1H 2014.
The company also noted that it has completed the filing of its rolling New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). It has requested a 6-month priority review.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner GlaxoSmithKline plc announced today that it has submitted regulatory applications in the United States (supplemental New Drug Application -sNDA) and European Union related to eltrombopag (Promacta/Revolade) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia).
Bionovo, Inc. (BNVI) said in a SEC filing that it has notified all clinical sites participating in its Phase 3 clinical trial for its drug Menerba (Study MF101-004) to terminate all patients enrolled on the trial and discontinue the study. Given its financial condition, all MF101-004 study related conduct and operations will cease effective June 30, 2012.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced today that it has obtained commitments from investors to purchase approximately $10.0 million of its common stock in a private placement ,where it will sell 2,922,337 shares of its common stock and warrants to purchase up to 2,630,103 additional shares of common stock. Each unit, consisting of one share of common stock and one warrant, to purchase 0.9 shares of common stock, will be sold for a purchase price of $3.40 to non-affiliated investors and approximately $3.51 to affiliated investors.
Insmed Incorporated (Nasdaq CM: INSM) gave a pipeline update noting that it expects top-line data from its European and Canadian Phase 3 trial of ARIKACE in patients with Cystic Fibrosis, in mid-2013. The company said it will defer plans to initiate a Phase 3 study of ARIKACE in the U.S. until it reviews the European/Canadian Phase 3 data. Patient enrollment in its Phase 2 trial of ARIKACE in patients with Non-TB Mycobacteria, is currently expected to begin in mid-2012, with top-line results projected in 4Q 2013. A dog toxicity study of ARIKACE is expected to generate top-line results in 2Q 2013.
Celsion Corporation (NASDAQ: CLSN) today announced that it has reached its enrollment objective of 700 patients in its pivotal, Phase 3 HEAT Study of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. The primary endpoint for the study is progression-free survival (PFS), and a total of 380 events of progression are required to reach the planned final analysis of the study. Celsion notes that 380 PFS events are projected to occur in late 2012.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), announced today top-line results from a Phase 2b trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients showed that it failed to meet its primary endpoint, the incidence of new or progressive bronchiolitis obliterans syndrome (BOS) at 180 days after RSV infection. The study missed the primary endpoint of reduced BOS in an “intent-to-treat” (ITTc) analysis of confirmed RSV infected patients (p=0.058).