TSRL Inc. is not a new company by any stretch of the imagination. It has been a going concern since 1986, when it was founded as a spinout from the University of Michigan.
Cytos Biotechnology Ltd. is taking drastic measures to keep the company afloat ahead of the looming maturity of its convertible bond in February 2012. Although its product, CYT003-QbG10, has shown positive results in three Phase II trials for allergic asthma and allergic rhinitis, the company has been unable to fund its earlier stage programs, and may face a financing gap of more than $21.5 million even after it slashes its staff and programs.
NPS Pharmaceuticals Inc. will receive a $145 million advance on royalties from Sensipar/Mimpara (cinacalcet HCL) sales from partner Amgen Inc. and will retire its 15.5 percent secured class B notes when they become redeemable Sept. 20. The move will save NPS about $13 million in interest expenses over the next two years.
Jennerex Inc. completed a private placement of $8.6 million in gross proceeds to support development of its lead cancer candidate, JX-594. The product, an oncolytic virus, has shown antitumor activity in Phase I and Phase II trials, with demonstrated overall survival benefit in advanced liver cancer.
Amarin Corp. plc and the FDA have reached an agreement on a special protocol assessment (SPA) for the design of a cardiovascular outcomes study (REDUCE-IT) of AMR101. The drug, a prescription-grade fish oil, has already turned in impressive results for dyslipidemia in two previous Phase III trials.
New Phase IIb results showed that Biogen Idec Inc.'s multiple sclerosis (MS) candidate, daclizumab high-yield process (DAC HYP), reduced the annualized relapse rate significantly compared to placebo and reduced disability progression by as much as 57 percent. Those results make DAC HYP potentially competitive with Tysabri (natalizumab), Lemtrada (alemtuzumab) and Gilenya (fingolimod). However, safety signals from the trial, including two deaths, may limit market potential for the drug.
Forest Laboratories Inc. said that it was "gratified" by a decision by the Health and Human Services Office of the Inspector General (HHS-OIG) not to pursue a federal health care exclusion against Forest CEO Howard Solomon following the company's $313 million settlement with the Department of Justice over illegal marketing and distribution of some of its products.
Shares in Seattle's Dendreon Corp. plummeted 67.4 percent Thursday after it broke the news that sales of Provenge (sipuleucel-T) were lower than expected. Dendreon reported just $49.6 million in revenues for the prostate cancer vaccine, coming in $8 million lower than consensus estimates of $57.7 million. Dendreon attributed the miss to a lack of understanding among physicians about how to get reimbursed for Provenge, and expressed confidence that the recent positive National Coverage Determination (NCD) and assignment of a Q-code would enable increased adoption of the therapy over time.
Celgene Corp. will pay $25 million up front to Acceleron Pharma Inc. plus up to $217 million more in potential milestones, under a new collaboration agreement between the two companies for the development of an anemia therapeutic.
A $45 million public offering by BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., will help float the company through Phase III Libigel trials. Libigel is a transdermal testosterone gel that BioSante is developing for female sexual dysfunction.
