Allergan (AGN +0.4%) asks the U.S. District Court for the Central District of California for an expedited schedule for discovery and a preliminary injunction against Valeant Pharmaceuticals (VRX +1.4%) and Pershing Square Capital Management for violating insider trading laws. If successful, the pursuers will be blocked from counting their AGN shares in the total used to call the special meeting and they will fall short of the minimum 25% required to do so.
Allergan has established October 27, 2014 as the date of record for stockholders entitled to vote at the December 18, 2014 meeting. Its request to the Court would require the expedited discovery to be completed in October 2014 and would set a hearing on on the preliminary injunction motion before the special meeting.
The FDA approves a label expansion for GlaxoSmithKline's (GSK +0.3%) Promacta (eltrombopag) for once-daily use in patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Promacta is currently cleared as a treatment for chronic immune (idiopathic) thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.
In a filing response to the Delaware Chancery Court, Allergan (AGN +0.3%) discloses that it has set December 18, 2014 for the special shareholders meeting requested by Valeant Pharmaceuticals (VRX +1.3%) and Pershing Square.
The 10-week 30-site trial will enroll ~200 patients who have had an inadequate response to commonly prescribed antidepressants. In an effort to reduce placebo response rates, the trial will utilize a sequential parallel comparison design.
Conmed's (CNMD +0.5%) BOD does not respond to Voce Capital's offer to withdraw it proxy solicitation if the BOD appoints two of Voce's independent nominees to the board. Voce believes its proposal is fair and reasonable considering its original slate of nominees was five. It reduced it to two in consideration of the recent changes in the BOD membership.
In its disclosure, Voce addresses what it believes as inaccurate statements from Conmed (Valeant and Allergan come to mind).
Nano cap MediciNova (MNOV +8.3%) secures FDA approval to begin a single center clinical trail evaluating MN-166 (ibudilast) as a treatment for patients with amyotrophic lateral sclerosis (ALS) who are on stable dose of riluzole for at least one month. The trial, which is slated to begin in the fall, will be conducted at the Carolinas HealthCare System Neurosciences Institute in Charlotte, NC.
The 60-patient trial's treatment period is six months followed by a six-month open label extension. The primary endpoint is the safety and tolerability of MN-166 (60 mg/day) compared to placebo when administered for six months with riluzole in patients with ALS.
Cellectar Biosciences (CLRB) closed its public offering of 3,333,333 shares of common stock at $3.75 per share. The offering also included warrants to purchase up to the same number of shares for $0.01 per warrant. An additional 1.11M shares and warrants were issued to cancel a $4M convertible note plus accrued interest. The exercise price of the warrants is $4.68 per share. They are immediately exercisable and have a five-year term.
The underwriter exercised part of its over-allotment by purchasing 250K shares of common stock and 500K warrants.
Genetic Tech filed the suit in 2011. On June 27, 2014 GSK moved to have Genetic Tech's complaint dismissed, arguing that the patent covers natural phenomena (laws of nature) that are not entitled to patent protection. The court issued its denial order on August 22.
The Northern California District Court denied a similar motion by Agilent (A -0.1%) on March 12, 2014.
According to Reuters, the FDA may clear Merck's (NYSE:MRK) anti-PD-1 Ab pembrolizumab for the treatment of patients with melanoma who are not responding to Yervoy (ipilimumab) (NYSE:BMY) in the next several weeks, significantly earlier that its October 28 PDUFA date. If approved, it will be the first PD-1 inhibitor cleared for sale in the U.S.
The first PD-1 inhibitor cleared anywhere in the world was BMY's nivolumab which was approved in Japan last month. Ono Pharmaceutical owns the commercial rights to the product in that country and will market the product under brand name Opdivo.
Analysts forecast the size of the worldwide PD-1 inhibitor market to be more than $30B by 2025.
Shares of Chinese health care services firm iKang Healthcare Group (NASDAQ:KANG) are off 16% premarket on light volume. The firm reported fiscal Q1 results after yesterday's close. Revenues were up 43% but net income was down 69%.
Pfizer (NYSE:PFE) and Merck (NYSE:MRK) collaborate in a Phase 1b study evaluating the safety and tolerability of a combination therapy in patients with anaplastic lymphoma kinase-positive (ALK-positive) advanced or metastatic non-small cell lung cancer. The combination consists of Pfizer's Xalkori (crizotinib) and Merck's investigational anti-PD-1 Ab pembrolizumab.
Crizotinib inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer and pembrolizumab harnesses the body's immune system to fight cancer cells.
Alkermes plc (NASDAQ:ALKS) initiates a Phase 1 study in 80 healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 as a treatment for pain. Results are expected in 1H 2015.
ALKS 7106 represents a new class of analgesics that have a low potential for abuse and overdose due to its intrinsic mechanism of action in the brain (opioid modulator platform) instead of relying on abuse-deterrent technologies or formulations. In preclinical studies, it demonstrated similar efficacy to morphine at a 30-fold lower dose and a ceiling effect on neurotransmitter release over a broad concentration range. This limits the potential euphoric effects and reduces the potential for abuse and overdose.