|Vitamin maker NYBT acquired for $3.8 billion. After the bell: VIVUS shares tumble as FDA review panel rejects weight loss drug, AVI BioPharma soars on DOD contract award|
|By BioMedReports.com Staff|
|Thursday, 15 July 2010 18:34|
Below is a list of the companies that made news in the healthcare sector on Thursday, July 15, 2010.
VIVUS (NASDAQ:VVUS) saw its shares hammered after the bell Thursday. Trading in the stock had been halted earlier in the day as an FDA advisory panel reviewed the companies experimental weight loss drug QNEXA. The shares began trading again in the after hours session, dropping as much as 66%. Investors had run the stock up to nearly $13.00 this week in anticipation of a positive review.
QNEXA had shown efficacy promise in trials, reporting most patients had experienced more than 10% weight loss. But, despite those benefits, the drug also showed concerning safety issues including lapses in memory, suicidal thoughts, heart palpitations and birth defects. The panel concluded that some these side effects were serious enough to vote 10-6 against the drug.
VIVUS stated that although they were disappointed in the panels conclusion, they would continue to work with the FDA on the saftey concerns. Leland Wilson, chief executive officer, VIVUS said in a statement: "While the final vote was close, and we are encouraged that the Committee recognized the efficacy demonstrated in the QNEXA clinical trials, we will work closely with the FDA leading up to our October 28, 2010 PDUFA date to address the labeling and safety questions raised during today's proceedings"
Meanwhile, the other two competitors with potential blockbuster weight loss drugs, Arena Pharmaceuticals (NASDAQ:ARNA) and Orexigen Therapeutics (NASDAQ:OREX) were also hit hard today in sympothy to the panels negative vote. Arena, however, rallied after the bell as a study, that was reported in the New England Journal of medicine, showed the companies' experimental drug, lorcaserin, caused more than 5% weight loss in most patients. Lorcaserin is considered by many to have less serious side effects than its competitors.
Shares of VIVUS were halted today at $12.11. In the after hours market shares fell as low as $4.00 and settled around $5.25, down more than 56% from Thursday's close.
Shares of Arena were up more than 16% or 65 cents in the extra session after dropping more than 8% in Thursday trading.
Shares of Orexigen were down another 31 cents or 6.20% after the bell after dropping more than 55 cents or 10% in Thursday trading.
AVI BioPharma Inc (NASDAQ: AVII) soared in the after hours market after the company said that it had been awared a contract from the U.S. Department of Defense for the treatments of Ebola and Marburg viruses. AVI BioPharma will receive up to $80 million immediately and as much as $291 million in further payments.
Shares of AVI shot up sending shares of the company to $2.25, up more than 38 percent or 62 cents in after-hours trading. The stock closed Thursday's regular session at $1.63.
News from earlier in the day:
NBTY, Inc. (NYSE: NTY), a leading global manufacturer and marketer of nutritional supplements, today announced the execution of a definitive merger agreement under which The Carlyle Group will acquire NBTY in a transaction valued at $3.8 billion. Under the terms of the merger agreement, Carlyle will acquire all of the outstanding common shares of NBTY for $55.00 per share in cash, representing a premium of approximately 57% over NBTY's average closing share price during the 30 trading days ended July 14, 2010.
NBTY makes nutritional supplements and vitamins under brands such as Nature's Bounty and Vitamin World.
Market research firm Mintel estimates U.S. vitamin and minerals sales in 2009 were $11.2 billion, a 6.2 percent increase from 2008. Growth is expected to continue in coming years as the U.S. population ages and older Americans put more focus on their health. Other vitamin and nutritional makers rallied on the news. Schiff Nutrition (NYSE: WNI) was up 9%, and Herbalife (NYSE: HLF) moved up 2%.
Shares of NBYT closed up $16.27 or 43.42 % to $53.74.
Access Pharmaceuticals, Inc. (OTC Bulletin Board:ACCP.ob), announced today that it has entered into a pre-licensing feasibility agreement with a leading biotechnology company to develop an oral formulation of its currently-marketed, proprietary injectable drugs. Access will utilize its proprietary Cobalamin Oral Drug Delivery Technology to develop oral formulations of the drug for pre-clinical testing. Although the terms of the agreement have not been disclosed, Access indicated that any successful formulation developed will be subject to a subsequent full-licensing agreement.
Access recently reported that its novel Cobalamin-coated insulin containing nanoparticle formulations delivered orally provided a pharmacological response (lowering of blood glucose levels in animal models) equivalent to greater than 80% of that achieved by insulin delivered subcutaneously. The Company believes the substantial oral bioavailability found underscores the formulation's potential for clinical development and ultimate commercialization.
Inverness Medical Innovations, Inc. (NYSE:IMA), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced today that it has changed its name to Alere Inc., after shareholders approved the name change at its Annual Meeting of Stockholders held on July 14, 2010. The Company also announced that it expects its NYSE stock symbol to change from "IMA" to "ALR" effective Monday, July 19, 2010.
Intellect Neurosciences, Inc. (OTCBB:ILNS), today announced that it is pleased with the data presented on Bapineuzumab and Ponezumab (PF-04360365) at the Alzheimer's Association International Conference (ICAD), taking place in Honolulu, HI from July 10-15.
Bapineuzumab, in Phase 3 clinical trials, is being co-developed by Pfizer and Johnson & Johnson, and Ponezumab, in Phase 2 trials, is being developed by Pfizer. Both drug candidates are based on the use of antibodies that uniquely bind molecular signatures at the ends of beta amyloid formed when the A? toxin is generated. This is the fundamental principle of Intellect's ANTISENILIN(R) technology, which is intended to promote the clearance of amyloid protein away from sites of damage in the brain while minimizing the potential for adverse effects that may result from less specific binding.
The Phase 2 Bapineuzumab data presented by Dr. Kaj Blennow from Lund University in Sweden showed that immunotherapy with Bapineuzumab lowers CSF Tau protein, which is considered to be an indicator of neuronal damage in patients with Alzheimer's disease. The Phase 1 Ponezumab data presented by Dr. Qinying Zhao of Pfizer showed favorable pharmacokinetics and pharmacodynamics of Ponezumab following a single dose intravenous infusion in patients with mild to moderate Alzheimer's disease.
Intellect's Chairman and Chief Executive Officer, Dr. Daniel Chain, who was attending the conference, commented: "We are gratified to see the progress being made by the large pharmaceutical companies that are independently developing drugs based on the technology that is the fundamental principle of our ANTISENILIN(R) technology for the treatment of Alzheimer's disease. We are increasingly confident that these molecules will prove successful in clinical trials and herald a new generation of drugs that can slow down, arrest and ultimately prevent Alzheimer's disease. The Bapineuzumab data on reducing Tau levels is especially encouraging when taken together with the recent report of the medical journal Lancet Neurology (Vol. 9, Issue 4, Pages 363-372, April 2010) indicating that Alzheimer's patients receiving Bapineuzumab show a significant reduction in amyloid plaques."
Intellect has granted royalty-bearing licenses to its ANTISENILIN(R) patent estate to several top-tier global pharmaceutical companies that are currently developing monoclonal antibodies for Alzheimer's disease.
Adolor Corporation (NasdaqGM: ADLR) today announced a reduction in force of 30 employees, or nearly 30% of its workforce, as well as other cost saving initiatives.
Amgen (Nasdaq: AMGN) today announced the appointment effective Sept. 1 of Jonathan M. Peacock as chief financial officer (CFO). He will be responsible for Amgen's finance and investor relations operations.
BSD Medical Corporation (NASDAQ: BSDM) today reported presentation of a clinical study being conducted at Duke University on the use of hyperthermia, delivered using the BSD-2000 Hyperthermia System, combined with chemotherapy to treat bladder cancer patients who have failed standard therapy.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, today announced the availability of an interview with Paul Hardman in regards to the Company's Letter of Intent (LOI) to acquire all the assets of Lanzhou Sanhuan New Technology Development Ltd. of Ganzu, China, which includes a unique formulation of PVA film, equipment and patented manufacturing process rights.
BioScrip, Inc. (Nasdaq: BIOS) today announced that the Company will release its 2010 second quarter financial results before the market opens on Friday, July 30, 2010 and host a conference call shortly thereafter at 8:30 a.m. Eastern Time.
Charles River Laboratories International, Inc. (NYSE: CRL) will release second-quarter 2010 financial results on Monday, August 2nd, after the market closes.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced results for the second quarter ended June 30, 2010.
Elan Corporation, plc (NYSE: ELN) today announced that it has reached an agreement in principle with the United States Attorney’s Office for the District of Massachusetts with respect to the previously disclosed U.S. Department of Justice’s investigation of sales and marketing practices for Zonegran (zonisamide), an antiepileptic prescription medicine that Elan divested in 2004.
Endo Pharmaceuticals (Nasdaq: ENDP) announced today the completion of its acquisition of HealthTronics, Inc. (Nasdaq: HTRN), a leading U.S. provider of urological products and services, located in Austin, Texas.
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) has amended the exercise price of its Series A Warrants and Series B Warrant sold in June 2010 from $1.57 per share to $1.64 per share.
K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that Thomas S. McHugh has been appointed Chief Financial Officer, effective immediately.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the launch of its completely redesigned Web site: www.ligand.com.
Marijuana, Inc. (PINKSHEETS: PCIO) announces the pending application for a true cannabis derived remedy. Marijuana, Inc. intends to file a patent application as the owner of a cannabis-based capsule to be taken orally.
Medizone International, Inc. (OTCBB: MZEI) announced today that it has retained The Eversull Group for Financial Public Relations, Investor Relations and Shareholder Services Consulting.
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT) reports on its first half 2010 clinical and corporate accomplishments, as well as its clinical development plans, in a letter to shareholders from Craig Dees, Ph.D., CEO of Provectus.
Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today it has launched a new investor video channel on its corporate website (www.radient-pharma.com) to deliver regularly scheduled, dynamic video content to Wall Street and the investing community.
Simulations Plus, Inc. (NASDAQ:SLP), a leading provider of software and consulting services for pharmaceutical R&D and environmental toxicology, announced that it expects to file its Form 10-Q quarterly report for the third quarter of its 2010 fiscal year ended May 31, 2010, with the Securities and Exchange Commission on Thursday, July 15, 2010.
Verint® Systems Inc. (NASDAQ: VRNT) today announced that one of the largest North American prescription fulfillment providers is implementing its next-generation Impact 360® Workforce Optimization suite.
Charles River Laboratories International, Inc. (NYSE: CRL) today announced that PROXY Governance, Inc., a proxy voting advisory service, recommends that Charles River shareholders vote FOR the issuance of stock to effect Charles River’s proposed acquisition of WuXi PharmaTech (NYSE: WX).
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.