Pozen soars over 40% on migraine drug royalty sale; Amarin rises on application acceptance from FDA Print E-mail
By Staff and Wire Reports   
Friday, 25 November 2011 19:33
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 25, 2011.

Pozen Inc  (NASDAQ:POZN) sold its right to receive American royalties from its migraine drug to Canada's national pension fund, sending the pharmaceutical company's shares up as much as 32 percent in extended trade.  The company received $75 million for the deal and would get a fifth of any royalties received by the fund, CPPIB Credit Investments, from April 1, 2018, Pozen said in a filing.

GlaxoSmithKline (NYSE:GSK)
holds the license to develop and market Trexmet in the United States, and Pozen has the right to develop and market a lower dose of the drug outside the country.  Under its agreement with GSK, Pozen currently receives 18 percent of the net sales of Treximet, which makes for over 80 percent of the company's total revenue.

In October, Pozen forecast full-year revenue slightly below estimates after a U.S. district court upheld the drugmaker's litigation involving several pharmaceutical companies which had filed for marketing approvals for generic versions of Treximet.

The drug, which has been receiving generic threats from companies like Par Pharmaceutical and Dr. Reddy's Laboratories, was approved in April 2008 for the acute treatment of migraine attacks in adults.

It shrinks the swollen blood vessels in the head and inhibits the enzyme responsible for pain and inflammation.

Shares of Chapel Hill, North Carolina-based Pozen, which have lost 62 percent of their value in one year, were up at $3.30 in after-market trading. They had closed at $2.50 on Wednesday on Nasdaq.


Amarin Corporation plc (NASDAQ:AMRN), a late-stage biopharmaceutical company focused on cardiovascular disease, today announced that its New Drug Application (NDA) for AMR101 has been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review.

"We are very pleased with the FDA's acceptance for filing of our AMR101 NDA submission as it is a significant achievement in the development of what we believe is a next generation Omega-3 based triglyceride lowering therapy," said Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin.

Amarin's NDA, submitted to FDA on September 26, 2011, seeks approval to market and sell AMR101 in the United States for the indication studied in the MARINE trialthe treatment of patients with very high triglycerides (e500mg/dL). The NDA for AMR101 is supported by data from both Phase 3 AMR101 clinical trials, MARINE and ANCHOR, in which trials AMR101 achieved all of the primary endpoints and was well tolerated with a safety profile comparable to placebo.

The application will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012. The PDUFA date is the goal date for the FDA to complete its review of the NDA.

Also Friday:

Cannabis Science, Inc. (OTCBB; CBIS), a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce the successful release of the second Cannabis Science brand formulation.

Celgene Corporation (NASDAQ: CELG) today announced its presentation at the Piper Jaffray Health Care Conference 2011 on Tuesday, November 29, 2011 at 11 a.m. EST will be webcast live and will be available in the investor relations section of the Company’s Web site at www.celgene.com. Celgene management will provide an overview of the Company.

Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today confirmed that Takeda Pharmaceutical Company Limited has submitted to the U.S. Food and Drug Administration a new drug application (NDA) for marketing approval of the fixed-dose combination alogliptin/metformin for type 2 diabetes.

Imaging Diagnostic Systems, Inc., (OTCBB:IMDS),a pioneer in laser optical breast imaging announced today that it has sold the first system of five ordered to be installed in Mexico.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that Patrick F. Williams, Vice President of Strategy and Investor Relations, is scheduled to present at the Piper Jaffray Health Care Conference at The New York Palace Hotel at 455 Madison Avenue, New York, NY, on Tuesday, November 29, 2011, at 9:00 a.m. ET.

Tikcro Technologies Ltd. (OTCBB:TIKRF) today announced that its Annual General Meeting of Shareholders will be held on December 29, 2011 at 3:00 p.m. Israel time, at the Company's offices, 126 Yigal Allon Street, Tel Aviv, Israel.

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