|Pfizer’s Lyrica Gains U.S. Approval for Spinal Pain; Onyx Soars after FDA Advisory Panel Vote|
|By Staff and Wire Reports|
|Thursday, 21 June 2012 18:21|
Pfizer Inc. (NYSE:PFE)’s second-best selling drug, Lyrica, was approved by U.S. regulators for use against pain caused by spinal cord injuries.
The FDA cleared the expanded use of Lyrica, already backed to treat nerve pain from fibromyalgia, diabetic nerve pain and pain after shingles, New York-based Pfizer, said today in a statement. Pfizer estimates a potential patient population size of about 100,000 people.
“Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling,” said Steven J. Romano, senior vice president and head of Pfizer’s medicines development group, Global Primary Care business unit, in the statement.
Lyrica is Pfizer’s best-selling drug after cholesterol pill Lipitor, which lost patent protection in November. It had $3.39 billion in revenue last year. The treatment has patent protection until 2018, and Pfizer is working to expand its use.
Pfizer declined less than 1 percent to $22.60 at the close in New York.
Shares of Onyx Pharmaceuticals (NASDAQ: ONXX) closed near $63.78, up around 43.1% for the session. Preceding this share price rise, an FDA advisory panel unanimously backed the company's drug for treating multiple myeloma in people who have tried at least two other medicines. The vote was 11-0 with one abstention. The positive FDA panel decision makes it likely that the drug will be approved by the FDA on July 27 at the company's Prescription Drug User Fee Act (PDUFA) date for completion of FDA accelerated review.
Including Thursday's move, Onyx Pharmaceuticals gained more than 45% year to date and nearly 78% over the last 52-weeks. The company's multiple myeloma drug, known as carfilzomib, will be marketed under the brand name Kyprolis. The FDA panel decision has triggered a number of ratings changes across Wall Street. Analysts at Brean Murray Carret & Co. upgraded the stock from Hold to Buy with a $60.00 price target. In a note, these analysts said, in their view, FDA approval is "clearly coming."
According to the equity research firm, "the overwhelming viewpoint is that the benefit of Kyprolis outweighs the potential risks, especially given the lack of alternatives for refractory MM patients" The FDA panel had to assess Kyprolis' potential for cardiovascular toxicity, among other potential safety concerns.
Brean Murray Carret & Co. also said Onyx has been preparing to launch the drug for some time and only needs to hire a sales force. The pharmaceutical company could begin this hiring prior to the PDUFA date.
Deutsche Bank analysts launched coverage on Onyx in the wake of the positive FDA panel decision and declared that Kyprolis is likely going to be a blockbuster drug in the treatment of multiple myeloma. The bank estimates that the drug's peak sales could be $1.5 billion to $2 billion. In addition, the bank attached a $58.00 price target on the healthcare stock. In a note, Deutsche Bank analysts said, "we view Onyx as an attractive M&A asset." Deutsche Bank said it thinks that Onyx could now command between $68.00 and $76.00 in a deal. Also, the bank notes that "large biotech or pharma with global oncology sales force could extract launch synergies." The bank's analysts added that they "see several potential acquirers."
Analysts at Goldman Sachs, who already had a Buy rating on the stock, raised their price target and estimates in the wake of the positive news for Onyx. The bank's price target for Onyx's stock was raised from $52.00 to $63.00. In a note, Goldman said that it now sees a potential M&A deal for Onyx as high as $91.00. Goldman now projects a 95% chance that Kyprolis will be approved, versus a previous estimate of 80%. Driven by sales of the new drug, Goldman is projecting that ONXX will become profitable in 2015 with non-GAAP EPS of $1.42.
Other brokers that raised price targets on Onyx include JP Morgan, Bank of America, Merrill Lynch, and Jefferies & Co. The analysts at JP Morgan noted "blockbuster sales potential" for the drug and raised their price target from $48.00 to $66.00. In light of the overwhelmingly positive panel vote, Wall Street analysts are now modeling a Kyprolis launch for late 2012 versus previous expectations of a 2014 launch. Bank of America reiterated its Buy rating and raised its price target from $57.00 to $62.00 while Jefferies stayed at Hold but bumped its price target from $45.00 to $55.00.
Thursday, Onyx was already trading above many Wall Street analysts' revised price targets. This is likely because of a potential M&A premium that investors are pricing into the stock. The decision from the FDA panel and the fast approaching PDUFA date on July 27 means that Onyx is now in play and could potentially be acquired.
Going forward, major catalysts for Onyx's stock price are likely to be the key PDUFA decision, buyout rumors, and updates on the potential launch of Kyprolis. The market has likely already priced in definite approval of Kyprolis on July 27. Considering these high expectations, Onyx's share price might decline sharply if the drug is approved later than anticipated or not approved at all.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that Phase 1 trial results for its oral PI3K/Akt inhibitor, perifosine, showed the drug's activity against chemo-resistant and radio-resistant neuroblastoma, while allowing good quality of life and sparing vital organs.
Amarantus BioSciences, Inc. (OTCBB: AMBS), a biotechnology company developing new treatments for brain-related disorders including Parkinson's disease and Traumatic Brain Injuries (TBI) centered on its proprietary anti-apoptotic therapeutic protein known as MANF, today announced that the Company was featured in BioWorld Today, Brewer Sports' 2nd Annual Sports Law and CLE Symposium and Opportunist Magazine.
Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical stage biopharmaceutical company, with repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction announced today the outcome of its pre-IND meeting with the CDER Urology and Reproductive group (DRUP) division of the FDA that took place on June 20, 2012.
A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced the appointment of Barry D. Quart, Pharm.D., and Stephen R. Davis, to its board of directors.
Codexis, Inc. (NASDAQ:CDXS), a developer of industrial enzymes to enable the cost-advantaged production of biofuels, bio-based chemicals and pharmaceutical intermediates, today announced that Joe Sarret has resigned as Senior Vice President and Chief Business Officer, effective August 3, 2012.
Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced the launch of its Nellcor™ SpO2 single parameter module for use with the Philips IntelliVue patient monitoring platform.
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced results from preclinical studies evaluating the mechanism of action of IMO-8400, a selective inhibitor of Toll-like Receptors (TLRs) 7, 8, and 9.
Oncothyreon Inc. (Nasdaq: ONTY) today announced the promotion of Scott Peterson, Ph.D., to Chief Scientific Officer.
Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY) today announced that it has entered into an agreement whereby the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct a randomized Phase II study of REOLYSIN® in patients with advanced or metastatic breast cancer.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved the use of Lyrica® (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury. Lyrica received a priority review designation for this new indication from the FDA.
Rite Aid Corporation (NYSE: RAD) today reported improved financial results for the first quarter ended June 2, 2012.
RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) today announced that Robert Bitterman and Keith Brownlie have been appointed to the Company’s Board of Directors.
Synageva BioPharma Corp. (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today announced acceptance of data for oral presentation at the upcoming Society for the Study of Inborn Errors of Metabolism (SSIEM) meeting being held in Birmingham, England, September 4-7, 2012.
TherapeuticsMD™, Inc. (OTCQB:TXMD), parent company of vitaMedMD®, LLC ("vitaMedMD"), a specialty pharmaceutical company ("TherapeuticsMD" or the "Company"), announced today that the Company has filed additional patent applications concerning its proprietary formulation technologies for its products TX12001HR, TX12002HR and TX12003HR.