|Javelin spurns Myriad bid, goes with Hospira. Radient continues higher. Molecular Insight soars after the bell|
|By BioMedReports.com Staff|
|Monday, 12 April 2010 18:27|
Below is a list of the companies that made news in the healthcare sector on Monday, April 12, 2010.
Javelin Pharmaceuticals, Inc. (Amex: JAV) announced today that it had received a binding offer from Hospira, Inc. (NYSE: HSP) and its wholly-owned subsidiary, Discus Acquisition Corporation, to enter into a merger agreement, a loan and security agreement and intellectual property security agreements whereby Discus will, subject to certain conditions, commence an all cash tender offer to acquire all of the outstanding shares of Javelin at a per share price of $2.20.
The offer tops a competing bid previously made by Myriad Pharmaceuticals "MPI" (NASDAQ: MYRX) in December of 2009.
In addition, Hospira will allow Javelin to borrow up to $4.5 million to fund Javelin’s operating activities prior to closing the merger, $8.3 million for Javelin’s repayment of the principal and accrued interest incurred under a similar financing arrangement entered into in connection with the planned merger with Myriad and $4.4 million for Javelin’s payment of the termination fee and certain stipulated expenses that the company may be required to pay Myriad following termination of its merger agreement with Myriad.
"Our Board of Directors, after consultation with our advisors, and in accordance with our merger agreement with MPI, has determined that Hospira’s proposal is a company superior proposal," said Martin Driscoll, Javelin’s Chief Executive Officer. "Accordingly, on the evening of Friday, April 9th, we sent MPI a notice of intent to terminate our merger agreement with them. Pursuant to the terms of our merger agreement with MPI, we are now required to negotiate in good faith with them for a period of five business days. If MPI does not favorably adjust the terms of its offer, then our Board expects to enter into the proposed merger and loan agreements negotiated with Hospira."
Javelin shares rose 81 cents, nearly 61 percent, to $2.15. Hosperia was down 14 cents on the news, closing the day at $56.11. Meanwhile shares of Myriad shot up more than 10% or 47 cents, closing at $5.00.
Radient Pharmaceuticals Corporation (AMEX:RPC) continued its march higher as the company today announced that it anticipates prospective purchasers or financiers will complete due diligence for RPC's China-based subsidiary Jade Pharmaceutical, Inc. aka JPI by the end of May 2010.
RPC expects JPI will be contractually positioned to move forward with the completion of a sale or financing by the end of the third quarter 2010. RPC currently owns approximately 98% of JPI, which as part of RPC's deconsolidation process, is noted as a special asset on RPC's balance sheet and valued at approximately US$20 million as of September 30, 2009.
According to Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals Corporation, "We are extremely pleased to move down an orderly path to maximize the monetization of our China-based asset. This is in accordance with our original deconsolidation plan and is in the best interest of the company, our subsidiary and RPC shareholders."
Shares of Radient closed up another 48% or 72 cents, closing the day at $2.19. Shares hit an intra-day of $2.59 before pulling back.
Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI) soared after the market closed today as the company announced that results from a completed Phase 2 clinical trial of Onalta™ (Yttrium-90 edotreotide) have been published in the Journal of Clinical Oncology (JCO). Results from the Phase 2 clinical trial of 90 patients show that treatment with Onalta improved symptoms associated with metastatic carcinoid tumors.
Patients enrolled in the Phase 2 clinical study suffered from malignant metastatic carcinoid tumors (neuroendocrine tumors of the GI tract and bronchus) and were refractory to conventional treatment with the somatostatin analogue, octreotide. Y-90-edotreotide therapy resulted in objective tumor response or stable disease in 67 (74.4%) of 90 patients with metastatic carcinoid refractory to octreotide therapy. Median progression-free survival and overall survival were 16.3 and 26.9 months, respectively.
"The patients in this study had incurable, progressive disease refractory to octreotide with severe symptoms which could themselves be life-threatening. In addition to nearly 75% of the patients showing disease stabilization, most tumor associated symptoms showed improvement with that improvement being of a sustained duration," said Norman LaFrance, M.D., Senior Vice President, Chief Medical Officer of Molecular Insight and an author on the JCO paper. "These findings further support Onalta's potential to improve outcomes among a refractory, metastatic patient population lacking treatment options."
Shares shot up in the after hours session, surging more than 165% or $2.48.
In other news after the bell:
Cytomedix, Inc. (NYSE Amex:GTF) announced today that its audited financial statements for the fiscal year ended December 31, 2009, included in its Annual Report on Form 10-K filed on March 29, 2010, contained a going concern qualification from its independent registered accounting firm.
This announcement is required by NYSE Amex Company Guide Section 610(b), which requires separate disclosure of receipt of an audit opinion containing a going concern qualification. This announcement does not represent any change or amendment to the company's financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
Tongjitang Chinese Medicines Company (NYSE:TCM), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that it has established a special committee to evaluate the proposal presented on April 8, 2010 by Hanmax Investment Ltd. and Fosun Industrial Co., Ltd. If the proposal is accepted, Hanmax Investment Ltd. and Fosun Industrial Co., Ltd. will acquire all of the outstanding ordinary shares of the Company (including ordinary shares outstanding in the form of American Depositary Shares) in a merger transaction under Cayman Islands law that would result in the Company becoming a privately-held company.
News from earlier in the day Monday:
Accuray Incorporated (Nasdaq:ARAY), a global leader in the field of radiosurgery, announced today that Louis J. Lavigne, Jr. has been appointed Chairperson of the Company's Board of Directors, effective April 8, 2010.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced that it is offering to sell 8,000,000 primary shares of its common stock and a selling shareholder, HealthpointCapital Partners, L.P., is offering 8,000,000 shares of Alphatec common stock in an underwritten public offering. Shares traded lower on the news.
Amgen (Nasdaq:AMGN) today announced that results from several preclinical studies investigating potential new cancer agents and a comprehensive biomarker analysis will be presented at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C. from April 17 - 21, 2010. Amgen currently has 16 molecules in development for oncology in preclinical through Phase 3 clinical trials.
"The data presented at AACR highlight the important scientific advances that are being made in cancer research," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "We hope and expect that these important preclinical studies will permit us to develop dramatically improved therapies for patients suffering from malignant disease."
Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced the appointment of Stephen R. Davis as Executive Vice President and Chief Operating Officer. Prior to joining Ardea, Mr. Davis served as President and Chief Executive Officer of Neurogen Corporation, which was acquired by Ligand Pharmaceuticals in December 2009.
Celera Corporation (NASDAQ:CRA) and its collaborators at The University of Washington, WA, and Indiana University, IN, today announced the presentation of data from a research study that investigated the expression of KIF6 in a mouse Celera Corporation model. A key finding was that KIF6 was specifically expressed in macrophages and chondrocytes in mouse atherosclerotic lesions, but not in normal arteries. These data suggest a potential role for KIF6 in inflammatory processes of atherosclerotic lesions, processes that can result in the development of vulnerable plaques that may rupture, leading to coronary events.
Celsion Corporation (Nasdaq:CLSN) jumped on the news today that Dr. Ronnie T.P. Poon from the University of Hong Kong and lead principal investigator for the Asia Pacific region of the Phase I ThermoDox® dose escalation trial will hold a press conference on Thursday, April 15, 2010 at 10:30 AM HKT (Wednesday, April 14, 2010 10:30 PM ET) to discuss the long-term follow-up of patients treated from April 2006 to December 2006. The majority of the cancer patients Dr. Poon enrolled were diagnosed with hepatocellular carcinoma (HCC), the same indication currently being evaluated in the global Phase III HEAT Study of ThermoDox® with RFA, for which Dr. Poon also serves as the lead investigator for the Asia Pacific region.
"We first began studying ThermoDox in combination with RFA for liver cancer in a multi-center 24-patient Phase I safety study, with seven patients treated at our institution here in Hong Kong," said Dr. Ronnie T.P. Poon. "Not only did we witness safety and a dose response relationship, but more importantly, at least one of these patients who received the higher dose of ThermoDox continues to be tumor-free three years after treatment, which is remarkable for HCC patients. This initial experience has led me to remain committed to overseeing the Phase III global HCC study, and we expect to complete enrollment this year."
EDAP TMS SA (Nasdaq:EDAP), jumped today after the global leader in therapeutic ultrasound, announced today the European approval of its new lithotripter, the Sonolith i-move. The EDAP sales team and distributors will begin marketing Sonolith i-move immediately and will officially introduce the product to distributors, partners and visiting urologists at the European Association Urology (EAU) congress, from April 17-19, 2010 in Barcelona, Spain. Sonolith i-move is a compact, stand alone lithotripter with a revolutionary infrared stereo-vision system for real-time, three-dimensional ultrasound localization of urinary stones.Hugo Embert, EDAP's ESWL Product Manager, commented, "With the addition of Sonolith i-move, EDAP is the only company in the extracorporeal shock wave lithotripsy market covering all market segments, offering the widest range of lithotripters, from standard compact devices to high-end, fully integrated lithotripters. We look forward to the official introduction of Sonolith i-move during next week's EAU congress. This is the optimal forum for our sales team and distribution partners to promote and market our latest lithotripter. We encourage members of the urology community to stop by our booth and experience Sonolith i-move first hand." Shares moved up more than 9% on the news, closing the day at $3.41, up 30 cents.
Edwards Lifesciences Corporation (NYSE:EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that its board of directors has approved a two-for-one split of the company's outstanding shares of common stock to be effected in the form of a 100 percent stock dividend.
"As we celebrate our 10-year anniversary as a publicly traded company, I'm proud that Edwards Lifesciences has achieved such an outstanding return for our shareholders," said Michael A. Mussallem, chairman and CEO. "Today's decision to split the stock will help improve its liquidity and trading volume, which better positions us for the bright future we see ahead."
GenVec, Inc. (Nasdaq:GNVC) tracked higher today after the company announced that encouraging clinical and preclinical malaria vaccine data were presented at the Keystone Symposium -- Malaria: New Approaches to Understanding Host-Parasite Interactions taking place April 11-16, 2010 in Copper Mountain, Colorado.
Safety, tolerability, immunogenicity, and efficacy data from the Phase 1/2a malaria trial using GenVec technology were presented. Data indicate malaria vaccines given to malaria-naive adults were found to be safe and well-tolerated with minimal local or systemic reactions and no serious vaccine-related adverse reactions. Sterile protection, a complete absence of parasites in the blood, was seen in 4 out of 15 volunteers that had been inoculated with the vaccine and subsequently challenged with the malaria parasite.
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that eight presentations reporting on the Company's progress in diverse cancer therapy product candidates will be given at the 101st Annual Meeting of the American Association for Cancer Research (AACR), April 17 -- 21, 2010, in Washington, DC. The spotlight of this year's presentations will be on pancreatic cancer, highlighted by a study correlating the results from a blood test for pancreatic cancer detection with responses to a radiolabeled antibody therapy. Additionally, the Company will introduce new antibody-drug conjugates (ADC) being studied in this cancer.
Inhibitex, Inc. (Nasdaq: INHX) today announced that the independent Data Safety Monitoring Board (DSMB) responsible for reviewing safety data from the Company’s ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with 30-day follow-up data on the first half of the patients that the Company plans to enroll in the trial. In addition, an independent statistician conducted a prospectively described interim analysis on the primary endpoint, which is the reduction in a composite of the severity and duration of shingles-associated pain over the first thirty (30) days of follow-up. Based upon the results of these reviews, the trial will continue, as originally designed, without modification. The Company, which remains blinded to the efficacy data, anticipates that top-line data from the completed trial will be available in the fourth quarter of 2010.
MedaSorb Technologies Corporation (OTC.BB:MSBT) and its wholly-owned subsidiary, CytoSorbents, Inc., announced its financial results for the fiscal year ended December 31, 2009. The Company's research and development costs were $1,961,960 and $1,983,483 for the years ended December 31, 2009 and 2008, respectively. The Company had net losses of $2,736,715 and $3,017,890 for the years ended December 31, 2009 and December 31, 2008, respectively. Historically, our losses have resulted principally from costs incurred in the research and development of our polymer technology, and general and administrative expenses, which together were $2,719,410 and $2,892,855 for the years ended December 31, 2009 and December 31, 2008 respectively.
Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets 100 mg/12.5 mg, the generic version of Merck and Co., Inc.'s antihypertensive Hyzaar®. Additionally, the company received tentative approval for the 50 mg/12.5 mg and 100 mg/25 mg strengths, which are eligible for final approval on or around Oct. 4, 2010, upon the expiration of the first-to-file 180-day exclusivity period. Separately, the company also announced the final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP, (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline's antidepressant Wellbutrin SR®.
Bupropion Hydrochloride Extended-Release Tablets had U.S. sales of approximately $363 million for the 12 months ending Dec. 31, 2009, according to IMS Health. Mylan has started shipping this product.
NxStage Medical, Inc. (Nasdaq:NXTM), a leading manufacturer of innovative dialysis products, today announced that its Medisystems division has expanded the scope of its existing long-term product supply agreement with Renal Advantage Inc. ("RAI"), the third largest for profit provider of dialysis services in the U.S. Pursuant to the terms of the amendment, the original agreement has been expanded to include 43 additional facilities acquired from National Renal Alliance. As a result, NxStage will supply the Streamline® airless blood tubing set, as well as MasterGuard® needles and other products, to these additional facilities in RAI's dialysis center network.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) moved higher Monday after the company announced over the weekend that the top-line results from its second fidaxomicin Phase 3 clinical study in patients with Clostridium difficile infection (CDI) were presented today at the 20th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria.
Orchid Cellmark Inc. (Nasdaq:ORCH), a leading international provider of identity DNA testing services, today praised the Federal Bureau of Investigation's (FBI) announcement that it will re-evaluate the requirements for outsourcing forensic DNA testing to private laboratories. Current FBI quality assurance policies call for public labs to review 100% of private lab forensic DNA work before the results are uploaded into the National DNA Index System (NDIS).
Oragenics, Inc., (OTCBB:ORNI) and RICCI PHARMA, a recognized health products company with offices in Rome and Slovakia, have entered into a distribution agreement that the parties anticipate will provide Oragenics’ proprietary oral care probiotic products, EvoraPlus® and EvoraKidsTM, to RICCI PHARMA. RICCI PHARMA will have exclusive distribution rights through Duc in Altum, a foundation whose humanitarian projects are inspired by the social teachings of the late Pope John Paul II.
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical-stage biopharmaceutical company developing first-in-class phosphatidylserine (PS)-targeting monoclonal antibodies for the treatment of cancer and viral infections, today announced the launch of an investigator-sponsored trial (IST) program for bavituximab and Cotara®. Bavituximab is a novel approach to treating cancer and viral infections and has demonstrated promising interim results in ongoing Phase II clinical trials in non-small cell lung cancer (NSCLC) and advanced breast cancer. Cotara is a brain cancer therapy currently in a Phase II clinical trial for recurrent glioblastoma multiforme (GBM), and has generated promising survival data in earlier studies.
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that the Israeli Office of the Chief Scientist ("OCS") has approved a 2010 continuation of its grant to PROLOR's Israeli-based R&D subsidiary for the company's development program for hGH-CTP, its proprietary longer-acting version of human growth hormone (hGH). Human growth hormone is indicated for the long-term treatment of children and adults with growth hormone deficiency due to inadequate secretion of endogenous growth hormone. Currently available forms of hGH must be injected daily. In contrast, clinical data to date suggests that hGH-CTP, PROLOR's biobetter form of growth hormone, has the potential to require only bi-monthly or weekly injections.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, announced today it will present multiple posters at the upcoming American Association of Cancer Research’s (AACR) 101st Annual Meeting to be held at the Walter E. Washington Convention Center in Washington, D.C. from April 17-21, 2010.
The posters will include data on Rosetta Genomics’ unique microRNA-based technologies and how they may be applied to develop objective and standardized diagnostic tests for cancer.
QLT Inc. (Nasdaq:QLTI) (TSX:QLT) announced that Dipak Panigrahi, M.D., will join QLT as Senior Vice-President, Research and Development and Chief Medical Officer, reporting to Bob Butchofsky, President and Chief Executive Officer, effective in May 2010. Dr. Panigrahi will be responsible for the QLT Research and Development portfolio, including clinical, pharmaceutical, and formulation development, as well as regulatory affairs. He has extensive experience in ophthalmology practice and research in a number of settings. Most recently, he was Vice President, Glaucoma Development at Alcon Laboratories, Inc., where he was responsible for managing the development of the company's glaucoma franchise. Prior to Alcon, Dr. Panigrahi was the Director of Ophthalmology at Merck & Co., Inc., where he planned, developed and supervised all aspects of global ophthalmic drug and device development for the retinal and glaucoma therapeutic areas.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), and miRagen Therapeutics, Inc., a biopharmaceutical company focused on improving patients’ lives by developing innovative microRNA (miRNA)-based therapeutics for cardiovascular and muscle disease, announced today that they have entered into a research collaboration. Under this agreement, the parties will evaluate the potential utility of RXi’s proprietary rxRNA™ technology against specific miRNA targets of interest to miRagen in the cardiac and neuromuscular disease areas. Each party will contribute its technology and resources to the collaboration to generate novel miRNA compounds. Financial terms of the collaboration were not disclosed. Separately, the company announced today that it has entered into a research collaboration with Mirna Therapeutics (Austin, TX), to determine the utility of combining RXi’s proprietary rxRNA™ technology with Mirna’s microRNA mimics as potential therapeutics in oncology. The parties will each contribute technology and resources to the collaboration to generate and evaluate novel microRNA compounds. Financial terms of the collaboration were not disclosed.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced the appointment of Tran B. Nguyen as Vice President and Chief Financial Officer. The company also announced other executive management team updates.
STAAR Surgical Company (Nasdaq:STAA), pushed higher today after the developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported that revenue for the first quarter ended April 3, 2010 grew approximately 12% as compared to the first quarter of 2009. In addition, the Company announced several developments at the American Society of Cataract and Refractive Surgeons (ASCRS) annual conference which continues through Tuesday, April 13, in Boston.
Talecris Biotherapeutics, Inc., (Nasdaq: TLCR) today announced results of a new survey showing that Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) is the preferred immune globulin intravenous (IGIV) among neurologists who indicated a brand preference. In the survey, conducted online by Harris Interactive® on behalf of Talecris, neurologists selected Gamunex over four times more often than all other available liquid IGIV therapies, with a statistically significant margin (p<0.05).
Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board: AOLS) announced today that a second study of its lead drug, AEOL 10150, has been initiated by the National Institutes of Health’s (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Radiation/Nuclear Medical Countermeasures development program as a countermeasure for radiation exposure to the gastrointestinal (GI) tract.
Affymax, Inc. (Nasdaq: AFFY) today announced that John A. Orwin, an executive with over 20 years of experience in the biotechnology and pharmaceutical industries, has joined the company as president and chief operating officer.
Array BioPharma Inc. (NASDAQ: ARRY) today announced that eight abstracts have been selected for presentation at the American Association for Cancer Research (AACR) Annual Meeting, being held from April 17-21, 2010, in Washington, DC. Presentations will disclose new findings about its anti-cancer programs: ARRY-162, ARRY-543, AZD6244 (ARRY-886) and three emerging programs for RAF, Chk1 and mTor inhibition.
Bio-Bridge Science, Inc. (OTCBB:BGES), a biotechnology company engaged in the commercial development of vaccines and vaccine-related products announced today that the Japanese Patent Office has granted claims in a patent application, and issued a Patent Number 4472724, regarding the use of the papilloma pseudovirus.
BioClinica, Inc. (NASDAQ: BIOC), a leading provider of clinical trial management services will participate in, and present at, key industry conferences during April and May.
BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced the organization is in the process of working with market makers to move the trading of its common shares to the OTCBB quotation system.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has dosed the first patient in the Phase III clinical program evaluating its investigational fixed-dose, single-tablet “Quad” regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate.
PPD, Inc. (Nasdaq: PPDI) today announced several of its experts will speak at the 19th annual Partnerships in Clinical Trials 2010 Conference in Orlando, Fla., on April 12-14.
Teva Pharmaceutical Industries, Ltd. (NASDAQ: TEVA) announced today that Copaxone® (glatiramer acetate injection), has now achieved one million patient years of experience in the treatment of relapsing-remitting multiple sclerosis (RRMS). This analysis is based on internal data submitted annually to the U.S. Food and Drug Administration (FDA).
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