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NBIX, EDAP On High, ONCY Soars, FDA's Thumbs Up To CELG, Thumbs Down To NVO

NBIX, EDAP On High, ONCY Soars, FDA's Thumbs Up To CELG, Thumbs Down To NVO
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2/11/2013 3:43 AM ET

Biogen Idec (BIIB: Quote) on Friday said that new data from a phase III study confirmed the ability of its investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) to provide long-lasting protection from bleeding for patients with hemophilia A and B.

The company noted that rFVIIIFc and rFIXFc have the potential to reduce the treatment burden associated with hemophilia A and B as it requires less frequent injections compared to the current standard of care for hemophilia A and B.

Celgene Corp. (CELG: Quote) on Friday received FDA approval for POMALYST (pomalidomide) for the treatment of patients with relapsed and refractory multiple myeloma. The company noted that the approval is based on response rate and that clinical benefit, such as improvement in survival or symptoms, has not been verified.

The drug will only be available in the United States through POMALYST REMS, a restricted distribution program.

EDAP TMS SA (EDAP: Quote) set a new 52-week high of $3.65 on Friday before closing at $3.45 after the company announced new data demonstrating the safety and long-term efficacy of Ablatherm-HIFU, an ultrasound guided High Intensity Focused Ultrasound device for the treatment of localized prostate cancer.

The company submitted its Pre-Market Approval application for Ablatherm-HIFU to the FDA on January 31, 2013.

Gilead Sciences Inc. (GILD: Quote) has completed its acquisition of YM BioSciences Inc. As a result, YM Bio will no longer be listed for trading on the NYSE MKT LLC or the Toronto Stock Exchange, on or about February 12, 2013.

Shareholders of YM Bio of record date Feb 8, 2013 are entitled to receive U.S.$2.95 per common share in cash, and holders of warrants and stock options are entitled to receive a cash payment equal to the difference between U.S.$2.95 and the exercise price of such warrant or stock option.

Impax Laboratories Inc. (IPXL: Quote) and Shire plc (SHPG) have settled all pending litigation relating to supply of authorized generic Adderall XR. As part of the settlement, Shire has agreed to make a one-time cash payment to Impax of $48 million.

Impax commenced sales of authorized generic Adderall XR in October 2009. On November 1, 2010, Impax filed a suit against Shire for breach of contract and other related claims alleging that Shire failed to fill Impax's orders for the authorized generic Adderall XR. Shire filed a counterclaim against Impax relating to its ordering practices under the agreement.

Now that the companies have resolved the litigation, their claims and counterclaims will be dismissed.

The Medicines Co. (MDCO: Quote) on Friday said that the 2-year global alliance for surgical anti-clotting product Recothrom that was established with Bristol-Myers Squibb Co. (BMY) last December has become effective.

Recothrom is a recombinant thrombin approved by the FDA for use as a topical hemostat to control non-arterial bleeding during surgical procedures.

In an effort to build a global commercial pipeline, Innovus Pharmaceuticals Inc. (INNV: Quote) will be acquiring a portfolio of 9 US prescription products from Prospector Capital Partners II. The nine products are currently not being marketed. Innovus plans to set up the manufacturing capacities and reimbursement procedures needed to get the products on the market. The first product launch is projected to be in 2014.

Neurocrine Biosciences Inc. (NBIX: Quote) touched a new 52-week high of $10.99 on Friday before closing at $10.84 following better-than-expected Q4 results.

This year, the company expects to have two phase IIb readouts for its VMAT2 trials for tardive dyskinesia, and anticipates its partner AbbVie to progress Elagolix into phase IIb in uterine fibroids.

The FDA has declined to approve Danish pharmaceutical company Novo Nordisk A/S's (NVO: Quote) 'new generation' insulin products - Tresiba and Ryzodeg.

Tresiba, also known as insulin degludec, is a once-daily, ultra-long-acting basal insulin, for the treatment of type 1 and 2 diabetes. Ryzodeg, also known as insulin degludec/insulin aspart, is a soluble fixed combination of ultra long-acting basal insulin in combination with a boost of bolus insulin aspart, for the treatment of type 1 and 2 diabetes.

The company has been asked to provide additional cardiovascular data from a dedicated cardiovascular outcomes trial in order for the review to be complete.

Oncolytics Biotech Inc. (ONCY) (ONC.TO: Quote) rose as much as 38% on Friday after the company reported that 95% of patients with squamous cell carcinoma of the lung exhibited tumor shrinkage in a phase II Study of REOLYSIN in combination with carboplatin and paclitaxel.

POZEN Inc. (POZN: Quote) on Friday presented data from combined results of two phase III studies of PA32540, which showed that in subjects with a history of transient ischemic attack or stroke, long-term (6 months) treatment with PA32540 was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers compared to EC-ASA (enteric-coated Aspirin (acetylsalicylic acid).

There was a lower rate of discontinuation in the PA32540 arm, noted the company.

Sucampo Pharmaceuticals Inc. (SCMP: Quote) and Takeda Pharmaceutical Co. Ltd. have filed a patent infringement lawsuit against Anchen Pharmaceuticals Inc. and Par Pharmaceuticals Inc. related to an Abbreviated New Drug Application filed by Anchen to market generic Amitiza.

Amitiza was approved by the FDA in 2006 for the treatment of chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in women 18 years and over.

Sucampo noted that Amitiza patents are scheduled to expire between 2020 and 2027.

Tranzyme Inc. (TZYM: Quote) rose more than 8% in regular trading on Friday and gained another 3% in extended trading after the company announced that it has decided to explore and evaluate strategic alternatives, including the possibility of a merger, sale, or other transaction to maximize value to its stockholders.

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by RTT Staff Writer

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