Bank of America Merrill Lynch analyst Gregg Gilbert said in a report dated Monday that Teva’s flagship drug, the multiple-sclerosis medication Copaxone, could benefit from research showing that a blood test may be able to identify MS patients who are likely to respond poorly to interferon therapy (MarketWatch).
Copaxone, he said, has the potential to benefit most from the findings as it is a front-line MS therapy that potentially works via a mechanism different from interferon. Gilbert reiterated a buy rating with a $75 price target on Teva.
Citigroup analyst John Boris last week re-iterated his “buy” rating for shares of Teva with a new price target of $72 after an Indiana Southern District Court ruling that will allow Teva to set up a generic Gemzar launch (AmericanBankingNews). Gemzar-maker Eli Lilly & Co. (LLY) also stands to benefit from the ruling: Leerink Swann analyst Seamus Fernandez says that if Lilly wins its appeal, he’ll boost his 2011 revenue forecast by up to $500 million (FiercePharma). Meanwhile, Lilly said U.S. regulators are still reviewing its application for an additional use of the antidepressant Cymbalta for chronic pain (Bloomberg).
Shares of Canada’s Allon Therapeutics (NPC) jumped 15 percent on the news that davunetide, its therapy for a degenerative brain disease, has been given fast-track status with regulators at the FDA. (FiercePharma) Genta, meanwhile, announced that the FDA has granted its fast track designation for tesetaxel, a treatment of patients with advanced gastric cancer.
AMAG Pharmaceuticals (AMAG) and Japan-based Takeda Pharmaceutical Co. Ltd. entered into a license, development and commercialization deal related to AMAG’s Feraheme (ferumoxytol) injection for kidney disease. (Zacks) This led Needham & Company to reiterate its ‘Buy’ rating with a price target of $80 (StreetInsider).
Keryx Biopharmaceuticals (KERX) received Fast Track designation from the FDA for the development of perifosine in advanced colorectal cancer, leading Canaccord Adams to maintains ‘Speculative Buy’ rating on Keryx’s partner AEterna Zentaris (AEZS), with a price target $1.65 (StreetInsider).
Researchers have dealt another blow to the new Sanofi-Aventis (SNY) drug Multaq. Approved to treat atrial fibrillation, Multaq proved less effective and no safer than its chief rival, a Cedars-Sinai Heart Institute study finds, and its authors recommend against first-line treatment with the drug. But a commentary in the same journal disagrees, saying Multaq should be a first choice for low-risk patients because of the volume of data on its safety (FiercePharma).
The St Louis Business Journal documents layoffs and other continuing problems at KV Pharmaceutical (KV.A),which was tagged last year by the FDA for making and selling unadulterated and unapproved drugs (Pharmalot).
Cubist Pharmaceuticals (CBST) has stopped a mid-stage trial of one of its pipeline candidates, CB-500,929 (ecallantide). The drug was being studied for lowering blood loss in patients undergoing cardiac surgery using cardiopulmonary bypass (Zacks). Savient Pharmaceuticals (SVNT) said the FDA accepted the Biologics License Application (BLA) for its gout candidate, Krystexxa (pegloticase). The BLA was resubmitted by Savient on March 15, 2010. A response from the FDA should be out in the fourth quarter of 2010 (target date: Sept 14, 2010).Novartis (NVS) received approval both in the European Union (EU) and the US for Menveo, a quadrivalent conjugate vaccine for the prevention of meningococcal disease.
Abbott Labs (ABT) and partner AstraZeneca (AZN) faced a regulatory setback when the FDA issued a complete response letter for their experimental drug, Certriad. Certriad is a fixed-dose, single pill formulation of Abbott’s next-generation triglycerides lowering pill, TriLipix and AstraZeneca’s powerful statin drug, Crestor. This new combination fenofibrate-statin looks to offer the best HDL-raising, LDL/triglyceride-lowering efficacy available.
Attention will turn on Wednesday to the FDA’s concerns over suicides linked to Forest Laboratories chronic obstructive pulmonary disease (COPD) drug Daxas (roflumilast), developed by Swiss drugmaker Nycomed. Labeling changes by Forest may delay Daxas’ approval, but in the end, the move could increase the likelihood of the drug getting the FDA’s OK, predicted Lazard Capital Markets analyst William Tanner (BioWorld).