Below is a list of the companies that made news in the healthcare sector on Monday, June 28, 2010.
Javelin Pharmaceuticals, Inc. (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to accept for payment, purchase and promptly pay for all shares of Javelin common stock validly tendered and not withdrawn prior to the expiration of the offer.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 (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.
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.
