|Mela rises after the recent FDA approval of MelaFind; Pfizer's Lipitor to Go Generic At The End of Month|
|By Staff and Wire Reports|
|Monday, 07 November 2011 20:10|
Mela Sciences (NASDAQ:MELA) rises after an article in Barron's over the weekend cites a Needham analyst who says the recent FDA approval of MelaFind could push the stock as high as $20 over the next year. After a nearly three-year Herculean struggle with government regulators, medical-device maker Mela Sciences (MELA) said Wednesday that it had won approval from the Food and Drug Administration for Melafind, a noninvasive tool used for early detection of melanoma, a deadly form of skin cancer that kills one American every hour.
The company, which says it plans to launch Melafind in the Northeastern U.S. and Germany in the first quarter, sees a potential $1 billion market in America alone. Says CEO Joe Gulfo: "I feel a little like [the mythological Greek King] Sisyphus, except this time, the rock didn't roll back."
However, there's still a lot of heavy lifting to do to overcome investors' skepticism. Mela +11.6% shares rose Wednesday on the news of the approval, but they later were trashed. On the week, they crashed 21%, to 4.66.
Dalton Chandler, an analyst with Needham, contends that the naysayers are wrong. Wednesday, he raised his 12-month target price to 20. Over the next year, the market will tell who's right.
On November 30, Pfizer's (NYSE: PFE) blockbuster drug Lipitor will face generic competition. Lipitor, a cholesterol drug, is the best selling drug of all time. An Indian company called Ranbaxy Laboratories will begin selling a generic version of the drug (atorvastatin) at the end of the month after a settlement with Pfizer. Originally, Ranbaxy wanted to sell the drug in 2010 when the basic patent expired.
A legal battle ensued, however, with Pfizer arguing that auxiliary patents would keep the drug secure until 2016. Eventually, a settlement was reached between the two companies and now Lipitor in generic form will be available within days. The loss of the drug is expected to cost Pfizer as much as $10 billion per year in revenue - a fact that is already priced into the stock.
Pfizer's multiple has been shrinking in recent years, and the stock is quite cheap on a valuation basis. PFE shares trade at a trailing P/E of 14 and a forward P/E of 8.67. Growth is expected to slow in coming years, in large part as a result of the loss of the Lipitor patent. Analysts estimate that PFE's earnings will grow at a rate of 3.43% over the next five years versus an industry average of 11.19%. This is a mature company, but investors should not despair, because PFE makes up for its slowing growth with a very attractive 4.10% dividend yield.
The expiration of Lipitor has been priced into this stock for years now, and there is not a Lipitor-specific catalyst for a trade in PFE. Long-term, income oriented investors, however, may be interested in this name due to its blue-chip status, modest valuation, and juicy dividend yield. The stock that investors looking to capitalize on generic Lipitor should be focusing on is Teva Pharmaceuticals (NASDAQ: TEVA).
According to a recent Reuters report, Teva may be readying to sell its version of Lipitor as soon as November 30. Teva, an Israeli company, is the largest generic drugmaker in the world. According to analysts, just one month of generic Lipitor sales this year could add $0.10 to the company's 2011 earnings per share. Teva first needs to obtain regulatory approval, so the timing of a launch is still up in the air.
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that the U.S. Food and Drug Administration has completed its review of ACADIA’s Investigational New Drug application to begin Phase I clinical studies with AM-831, an innovative small molecule for the treatment of schizophrenia.
Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI) today announced that it has entered into a series of agreements to strengthen its financial position, improve its balance sheet and support ongoing biotech development plans for its immunotherapy pipeline.
Advanced Cell Technology, Inc. (“ACT”;OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it will release 2011 third quarter results on Tuesday, November 8th after the market closes.
Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel therapeutics, announced the acceptance of four abstracts detailing recent work with Astex Pharmaceuticals compounds. Poster presentations will occur on November 13, 14 and 15, 2011 at the 2011 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, California.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that TTY Biopharm Co., Ltd. (TTY), BDSI's commercial partner for BEMA Fentanyl in Taiwan, has submitted a New Drug Application (NDA) for marketing authorization of BEMA Fentanyl to the Taiwan Food and Drug Administration.
Biostar Pharmaceuticals, Inc. (NASDAQ GM: BSPM), a developer, manufacturer and marketer of pharmaceutical and health supplement products for a variety of diseases and conditions, today announced that its Chairman and Chief Executive Officer, Mr. Ronghua Wang, will attend the Asia-Pacific Economic Cooperation (APEC) 2011 CEO Summit, which will take place from November 11 ‐ 12, 2011 in Honolulu, Hawaii.
Caliper Life Sciences, Inc. (NASDAQ: CALP), a leading provider of tools and services for life science companies, today announced that Kevin Hrusovsky, President and CEO of Caliper delivered a keynote address at the BioConference Live event, which was held on October 26, and participated in the Personalized Medicine Panel during the World Health Forum on October 27 held at Harvard Medical School.
Celsius Holdings, Inc. (PINKSHEETS: CELH), the creator and marketer of Celsius®, Your Ultimate Fitness Partner®, today reported their results of operations for the third quarter ended September 30, 2011.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the commencement of its tender offer for all outstanding shares of the common stock of Adolor Corporation (NASDAQ: ADLR) for $4.25 per share in cash, plus one nontransferable Contingent Payment Right (CPR) entitling the holder to receive additional cash payments of up to $4.50 for each share tendered if certain regulatory approvals and/or commercialization milestones for ADL5945 are achieved.
Dyax Corp. (NASDAQ: DYAX) announced today that two oral and two poster presentations featuring KALBITOR® (ecallantide) data in hereditary angioedema (HAE) were presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting held November 3-8, at the Hynes Convention Center in Boston, MA.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the U.S. Food and Drug Administration (FDA) conditionally approved the addition of a second treatment group to The PARTNER II Trial, which is studying the company's next-generation Edwards SAPIEN XT transcatheter heart valve.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Gregory S. Lea, Senior Vice President and Chief Financial Officer, is scheduled to present at Lazard Capital Markets 8th Annual Healthcare Conference in New York, NY on Tuesday, November 15, 2011 at 2:00 pm ET.
Gilead Sciences, Inc. (Nasdaq: GILD) and the Cardiovascular Research Foundation (CRF) today announced the initiation of RIVER-PCI (Ranolazine for Incomplete VEssel Revascularization post-PCI), a Phase 3 clinical trial evaluating the utility of ranolazine to prevent major adverse cardiovascular events (MACE) in patients with a history of chronic angina who have incomplete revascularization following percutaneous coronary intervention (PCI).
Hadasit Bio-Holdings, Ltd. - (OTCBB: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, and its subsidiary, BioMarCare Technologies Ltd. ("BioMarCare") announced that the Hospital's Ethics Committee has approved the use of up to 400 tissue biopsy samples in a retrospective clinical study.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has entered into a stock purchase agreement to raise approximately $10 million for the sale of common stock at a price of $2.09 per share in a private placement transaction with existing shareholders, Oracle Partners, L.P., and Mr. Jack W. Schuler.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the completion of its offering and sale of $494.5 million in aggregate principal amount of 3.00% Convertible Senior Notes due 2018 pursuant to a registration statement filed with the Securities and Exchange Commission.
iBio, Inc. (NYSE AMEX: IBIO) today announced that it has set November 3, 2011 as the Record Date for its 2011 Annual Stockholders Meeting to be held December 8, 2011 at iBio's facilities located at 9 Innovation Way, Newark, Delaware commencing at 11:00 AM ET.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the Piper Jaffray 23rd Annual Healthcare Conference on Tuesday, November 29, 2011 at 2:00 p.m. ET in New York City.
In an exclusive interview, Horst G. Zerbe, Ph.D., President and CEO of IntelGenX Corporation (OTCBB: IGXT) shares his thoughts on the firm's pending U.S. regulatory decision involving the drug candidate CPI-300.
Neogen Corporation (Nasdaq: NEOG) has developed an even quicker method to rapidly and accurately detect yeast and mold in food products.
Nexia Holdings, Inc. (PINKSHEETS: NXHD), the parent company of Green Endeavors, Inc. (PINKSHEETS: GRNE) (OTCQB: GRNE), announced significant revenue growth from its salon operations for the third quarter of 2011 over third quarter results from 2010.
PAREXEL International Corporation (NASDAQ: PRXL) announced today that it will be presenting at the Lazard Capital Markets Healthcare Conference in New York. Josef von Rickenbach, Chairman and Chief Executive Officer will be making a presentation on PAREXEL at 11:30 a.m. ET on Tuesday, November 15, 2011.
PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today announced that the Company has completed its acquisition of Caliper Life Sciences, Inc. (NASDAQ: CALP), a Hopkinton, Massachusetts-based leader in imaging and detection solutions for life sciences research, diagnostics and environmental markets.
Pharmacyclics, Inc. (Nasdaq: PCYC) today reported financial results and recent developments for its fiscal first quarter ended September 30, 2011.
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) will webcast its presentation at the 2011 Credit Suisse Annual Healthcare Conference on Wednesday, November 9, 2011.
ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it will release its unaudited financial results for the third quarter ended September 30, 2011 on November 21, 2011.
Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of vaccines in China, today announced that it will release its unaudited financial results for the third quarter ended September 30, 2011 before market open on Monday, November 14, 2011.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (Sucampo) today announced that it will present, with materials, at the 2011 Credit Suisse Annual Health Care Conference on Thursday, November 10, 2011, at 1:00 pm Mountain Time, or 4:00 pm Eastern.
Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, today announced it will host a conference call and live audio webcast on Monday, November 14, 2011 at 5:00 p.m. EST to provide a business update and discuss its third quarter 2011 financial results.
Transgenomic, Inc. (OTC/BB: TBIO) and A. Menarini Diagnostics today announced an exclusive distribution agreement for Transgenomic’s SURVEYOR® Scan and WAVE® MCE (Micro-Capillary Electrophoresis) Mutation Detection system to its network of over 2,000 pathologists throughout Europe.
Unigene Laboratories, Inc.(OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, announced today that management will report third quarter 2011 financial results before market open and host a conference call and live audio webcast on Wednesday, November 9, 2011 at 11 a.m., ET to discuss the results.
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), today announced it would report updated results from its Phase I/II myelofibrosis study of CYT387, a JAK1/JAK2 inhibitor, in a poster session to be held from 6:00pm - 8:00pm on Monday, December 12th at the 53rd Annual Meeting of the American Society of Hematology (ASH) being held in San Diego, California.