|Orexigen reports obesity drug also treated depression. After the bell Javelin soars as Hospira announces intention to complete acquisition|
|By BioMedReports.com Staff|
|Monday, 28 June 2010 18:47|
Below is a list of the companies that made news in the healthcare sector on Monday, June 28, 2010.
Javelin Pharmaceuticals, Inc. (NYSE - Amex: JAV) soared after the bell today after Hospira, Inc. (NYSE:HSP) announced its intention to complete the tender offer by Discus Acquisition Corporation, a wholly owned Hospira subsidiary, for all outstanding shares of the common stock of Javelin. upon its currently scheduled expiration at 12:00 midnight, New York City time, on June 30, 2010.
Javelin has notified Hospira that it is prepared to deliver a closing certificate in accordance with the merger agreement among the parties confirming the accuracy of its representations and warranties and its performance of all of its obligations under the merger agreement as of the end of the current offer period. Based on Javelin's notification, Hospira expects that all of the conditions to the tender offer will be satisfied upon its currently scheduled expiration, and intends to accept for payment, purchase and promptly pay for all shares of Javelin common stock validly tendered and not withdrawn prior to the expiration of the offer.
Shares of Javelin shot up more than 57% after the bell, rising 79 cents to $2.17.
American Medical Systems® (AMS) (Nasdaq:AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, announced after the bell that the Food and Drug Administration has cleared the MiniArc® Precise Single-Incision Sling System, a product for the treatment of female stress urinary incontinence (SUI). MiniArc Precise is the next generation sling in the MiniArc family sling system, the number one selling single-incision sling in the United States.
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) after the market close announced the Food & Drug Administration has accepted for review its Premarket Approval (PMA) application for Augment™ Bone Graft for use in foot and ankle fusions in the U.S. The FDA has now filed the application and begun the comprehensive review of the clinical module.
DARA BioSciences, Inc. (Nasdaq:DARA), announced after the bell that SurgiVision, Inc., a privately held company of which DARA owns 1,613,258 shares and warrants to purchase an additional 405,000 shares, has received 510(k) clearance from the Food and Drug Administration to market their ClearPoint system in the United States for general neurological interventional procedures.
The ClearPoint system is designed to allow minimally invasive procedures in the brain to be performed in an existing MRI suite. The ClearPoint system is an integrated system of reusable components, disposable components and intuitive, menu-driven software, which is referred to as SurgiVision's marketed products. Utilization of the ClearPoint system allows a physician to see and select a neurological target, aim the targeting device and watch as the surgical instrument is advanced to the target, significantly reducing the time and complexity of the interventional procedure.
Depomed, Inc. (Nasdaq:DEPO) announced after the market closed that it has received a $10 million milestone payment from Abbott Products, Inc., its licensee of DM-1796, for the U.S. Food and Drug Administration's acceptance for filing of the New Drug Application (NDA) for DM-1796 for the management of postherpetic neuralgia (PHN), or pain after shingles.
DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects. The FDA has set the Prescription Drug User Fee (PDUFA) goal date in the first quarter of 2011 for action on the NDA.
"This $10 million milestone payment strengthens our balance sheet and allows us to further advance our other pipeline programs," said Carl Pelzel, president and chief executive officer of Depomed.
News from earlier in the day:
Orexigen Therapeutics, Inc. (Nasdaq:OREX) surged after the company announced over the weekend that results from a 24-week open-label study demonstrating that treatment with Contrave® resulted in significant improvements in depressive symptoms that was accompanied by weight loss and improved control of eating in overweight and obese patients with major depression.
Patients who completed the study lost an average of 9.2% of total body weight and reported substantial reductions in hunger, strength and frequency of food cravings and demonstrated improved control of eating.
"Recent reports in the literature show that the risk of depression is higher in obese people and, at the same time, depression has been associated with increased obesity. In addition, obese women are more than twice as likely to be depressed as non-obese women. In this context, clinicians are in need of new tools to treat obese patients suffering from this common co-morbidity," said Dr. Susan McElroy, M.D., Lindner Center of HOPE, Mason, Ohio. "This study is the first step in assessing the value of Contrave in this important patient population and these positive results should encourage additional investigation."
In this study, the most common adverse events were nausea, constipation, headache and insomnia, and, in general, were consistent with past experience in the COR program. There were no serious adverse events reported by the investigator as related or possibly related to Contrave in the trial.
Shares of Orexigen surged more than 18% or 75 cents in Monday trading, closing the session at $4.90.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob) President and CEO Jeffrey B. Davis will present at the One Med Forum: Emerging Company Finance Conference on Wednesday, June 30th at 9:20 AM ET. The conference is being held at the Roosevelt Hotel in New York City.
Davis will provide an overview of Access' clinical development programs and update investors on commercialization launch activities for its lead product, MuGard - a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Access Pharmaceuticals, Inc. is gearing up for the North American commercial launch set for late summer.
Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced a collaborative study with Almac's Diagnostics division for the Company's doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, aimed at determining LHRH receptor expression through the development of a companion diagnostic tool. Selection for treatment with AEZS-108 is determined on the basis of LHRH receptor expression, currently measured immunohistochemically. In humans, LHRH receptors are expressed in ovarian, endometrial, breast, bladder, prostate and pancreatic tumors. AEZS-108 is currently in Phase 2 trials for advanced LHRH receptor positive ovarian and endometrial cancer.
CEL-SCI Corporation (NYSE AMEX:CVM) and researchers at the Northeastern Ohio Universities Colleges of Medicine and Pharmacy (NEOUCOM) jointly announced today that a LEAPSTM–based vaccine (Ligand Epitope Antigen Presentation System) study has demonstrated the technology’s potential using dendritic cells to stimulate the immune system to fight viral illnesses and other diseases. Results of the study were selected for an oral presentation at the prestigious Federation of Clinical Immunology Societies (FOCIS) Annual Meeting in Boston, Mass., June 27, 2010, and are to be published in Vaccine, a peer-reviewed, pre-eminent journal for vaccines and vaccination.
Depomed, Inc. (NASDAQ:DEPO) and Santarus, Inc. (NASDAQ:SNTS) today announced new data suggesting that patients previously intolerant of metformin may be able to tolerate higher doses of metformin when treated with GLUMETZA. The findings will be presented at the 70th Scientific Sessions of the American Diabetes Association (ADA) in Orlando. GLUMETZA is a once-daily, extended release formulation of metformin, and is approved for use in adults with type 2 diabetes mellitus and is promoted in the U.S. by Santarus.
Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease and other disorders, today announced that Chairman and Chief Executive Officer, Daniel Chain, Ph.D., will present and meet one-on-one with potential investors at the OneMedForum 2010 Emerging Company Finance Conference in New York, NY on Wednesday, June 30, 2010.
Masimo (Nasdaq:MASI), the inventor of Masimo Rainbow Pulse CO-Oximetry™, Masimo Rainbow Acoustic Monitoring™, and Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry, today announced FDA 510(k) clearance for the Pronto-7™—a new handheld device designed for quick and easy noninvasive hemoglobin (SpHb®) spot-check testing, along with SpO2, pulse rate, and perfusion index, in virtually any environment.
Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today a modification of its strategic alliance with King Pharmaceuticals, Inc. (NYSE:KG) for REMOXY outside the U.S. The move signals a desire to target Europe's small and growing market for strong pain medications.
"With the NDA resubmission in sight, we feel now is the time to turn our attention to Europe," said Remi Barbier, President & Chief Executive Officer of Pain Therapeutics.
King and Pain Therapeutics believe the target market for strong pain medication in Europe is smaller than the U.S. market for similar drugs. To accommodate a cohesive commercial strategy for REMOXY outside the U.S., King Pharmaceuticals and Pain Therapeutics recently modified a royalty term of their strategic alliance. Pain Therapeutics will now receive a flat royalty rate of 10% on net sales of REMOXY outside the U.S. We also expect to receive from King Pharmaceuticals a one-time payment of $5,000,000.00 in July 2010.
Pain Therapeutics' royalty rate in the U.S. and its potential milestone payments are unchanged.
The company has also received approval for a government grant in the amount of $2.5 million from the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of Israel, as government participation in R&D expenses for the period March 2010 to February 2011. This is the fifth consecutive year that Pluristem has received this grant.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced it has received commitments from certain institutional investors to purchase an aggregate of $10 million of Rexahn’s securities in a registered direct offering. Rexahn expects to receive net proceeds of approximately $9.45 million after deducting placement agent fees and other offering expenses.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today U.S. Food and Drug Administration (FDA) approval and commercial launch of Anastrozole Tablets 1 mg, the Company’s generic version of AstraZeneca’s ARIMIDEX®. The product is indicated for treatment of certain forms of breast cancer in postmenopausal women.
The brand product had annual sales of approximately $916.8 million in the United States, based on IMS sales data.
3SBio Inc. (Nasdaq: SSRX) a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that on June 25, 2010, the Company has filed with the United States Securities and Exchange Commission its Annual Report on Form 20-F for the year ended December 31, 2009.
Abbott (NYSE:ABT) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation's most prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden.
Abviva, Inc. (OTC: ABVV), a biomedical company engaged in the development and commercialization of breast cancer related applications of Mammastatin, today announced they will be presenting at OneMedForum sponsored by Stifel Nicolaus.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has published a new paper in the journal Nature Chemical Biology with collaborators at the University of Texas Southwestern Medical Center (UT Southwestern).
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results of an analysis of pooled safety data from three completed randomized controlled trials that showed the investigational product BYDUREON™ (exenatide extended-release for injectable suspension), dosed once weekly, was generally well-tolerated with a low discontinuation rate due to serious adverse events similar to pooled comparators in patients with type 2 diabetes.
Biogen Idec Inc. (NASDAQ:BIIB) today announced it will report second quarter 2010 financial results on Tuesday, July 20, 2010, before the financial markets open.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced it has been added to the broad-market Russell 3000 Index as part of Russell Investments' recent reconstitution of its comprehensive set of U.S. and global equity indexes which occurred after market close on June 25, 2010.
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results up to 76-weeks from a Phase 3 study of ONGLYZA™ (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement [as measured by glycosylated hemoglobin level (HbA1c)] in treatment-naïve adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.
CardioNet, Inc. (NASDAQ:BEAT), a leading wireless medical technology company with an initial focus on the diagnosis and monitoring of cardiac arrhythmias, announced today that the Centers for Medicare and Medicaid Services has proposed that the technical component of mobile cardiovascular telemetry (CPT Code 93229) remains carrier-priced for calendar year 2011.
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that Jack Talley, President and CEO, will be presenting at the OneMedForum New York 2010 on June 30, 2010 at 9:00 a.m. EDT at the Roosevelt Hotel in New York City.
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced top-line results from a Phase II placebo and positive comparator-controlled, parallel-arm, double-blind, dose-response clinical trial of the novel, investigational NR2B-selective NMDA (N-methyl D-aspartate) receptor antagonist, radiprodil (RGH-896), for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPNP).
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced Phase 2 results demonstrating that the subcutaneous coinjection of rHuPH20 (recombinant human hyaluronidase, PH20) with lispro significantly improves postprandial hyperglycemia, reduces hypoglycemia, and accelerates the absorption of mealtime insulin in patients with type 2 diabetes.
Inhibitex, Inc. (Nasdaq: INHX) announced today that the Company was added to the broad-market Russell 3000® Index, as well as its Microcap and Global Indexes, when Russell Investments reconstituted its comprehensive set of U.S. and global equity indexes on Friday June 25, 2010.
Merck (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS® (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.
NeoStem, Inc. (NYSE Amex: NBS), an international biopharmaceutical company with operations in the U.S. and China, announced that it has been added to the broad-market Russell 3000 Index with Russell Investments' reconstitution of its comprehensive set of U.S. and global equity indexes effective June 25.
Oramed Pharmaceuticals, Inc. (OTCBB: ORMP) announced today that its executive management is participating in the 2010 Scientific Sessions of the American Diabetes Association currently being held in Orlando, Florida.
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that on June 25, 2010 it was added to the Russell 3000® Index following the Russell Investment Group's annual reconstitution of its comprehensive set of U.S. and global equity indexes.
PPD, Inc. (Nasdaq: PPDI) announced today it will serve as title sponsor of the third annual Beach2Battleship Iron Distance Triathlon, an internationally recognized competition to be held in Wrightsville Beach and Wilmington, N.C., on November 13, 2010.
Prana Biotechnology Limited (NASDAQ: PRAN) (ASX: PBT) today announced that it had reached an agreement with leading clinical research provider Quintiles that will see Quintiles subscribe for up to US$2 million in new Prana shares.
Sanofi-aventis (EURONEXT: SAN and NYSE:SNY) announced today results of a study which demonstrated that patients using Lantus® (insulin glargine [rDNA origin] injection) once-daily and Apidra® (insulin glulisine [rDNA origin] injection) before meals reported improved patient reported outcomes and decreased glycemic variability versus premix analog insulin.
Senomyx, Inc. (NASDAQ:SNMX), a leading company focused on using proprietary taste receptor technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that it has been included in the Russell 3000® Index following Russell Investments' reconstitution of its comprehensive set of U.S. and global equity indexes on June 25, 2010. Senomyx was also added to the Russell 2000® Index, a subset of the Russell 3000 composed of small-cap stocks.
Skystar Bio-Pharmaceutical Company (NASDAQ:SKBI) a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, announced that it has filed a Form RW with the Securities and Exchange Commission pursuant to Rule 477 under the Securities Act of 1933, as amended, requesting the withdrawal of the Shelf Registration Statement initially filed on June 1, 2010.
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 that the company’s shares have been added to the broad-market Russell 3000® Index, the Russell 2000® Index, Russell Global Index and Russell Microcap® Index following Russell Investments’ reconstitution of its comprehensive set of U.S. and global equity indexes after market close on June 25, according to an updated list of additions posted June 25.
Synthetech, Inc. (OTC Bulletin Board: NZYM) today announced that it has engaged Brocair Partners, LLC to conduct a comprehensive review of strategic alternatives aimed at enhancing shareholder value. Strategic alternatives Synthetech may pursue could include, among others, execution of Synthetech's operating plan, the sale or acquisition of assets or businesses, partnering or other collaboration agreements or arrangements, a merger or sale of the company or other strategic transactions.
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