Pharmacyclics, Inc. (Nasdaq: PCYC) announced after hours yesterday that it had entered into a worldwide collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ), to develop and commercialize PCI-32765, a novel, oral, first-in-class Bruton’s tyrosine kinase (Btk) inhibitor being developed for the treatment of Non Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma, all of which are considered hematological malignancies. PCI-32765 was developed by Pharmacyclics and is currently in Phase 2 clinical trials. It will receive an upfront payment of $150m. In addition, it will receive up to an additional $825m in development and regulatory milestone payments, based upon continued development, regulatory progress and approval of the product, for total potential upfront and milestone payments of $975m. Pharmacyclics and Janssen will collaborate on the development of PCI-32765 for oncology and other indications, excluding inflammation and immune mediated conditions. Each company will lead development for specific indications as stipulated in a global development plan, with development costs shared on a 40/60 basis (Pharmacyclics 40% and Janssen 60%). Profits and losses from the commercialization activities will be equally split on a worldwide basis.
Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) announced that top-line results from its Phase 2 trial of PPD-10558 in patients with statin-associated myalgia, or SAM, did not meet its primary efficacy endpoint in this randomized, double-blind, proof-of-concept study and will cease further development.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the independent Data and Safety Monitoring Board (DSMB) for the VALOR Phase 3 trial of vosaroxin in patients with first relapsed or refractory acute myeloid leukemia (AML), has completed a planned periodic safety review and recommended that the trial continue as planned without changes to study conduct. A single interim analysis by the DSMB is expected in mid-2012, to examine pre-specified efficacy and safety data sets and decide whether to stop the study early for efficacy or futility, continue the study as planned or implement a one-time sample size adjustment of 225 additional evaluable patients. Without a sample size adjustment, the unblinding of the trial is currently expected in 2013.
Hemispherx Biopharma, Inc. (NYSE Amex: HEB) finally got shareholder approval to increase the number of authorized shares of Common Stock from 200,000,000 to 350,000,000.
Cell Therapeutics, Inc. (Nasdaq:CTIC) today announced that it has entered into an agreement to sell $20 million of shares of its Series 14 Preferred Stock and warrants to purchase shares of its common stock in a registered offering to two institutional investors. Each share of Series 14 Preferred Stock is convertible at the option of the holder, at any time during its existence, into approximately 870 shares of common stock at a conversion price of $1.15 per share of common stock, for a total of approximately 17,391,304 shares of common stock.