N.C. pharma Pozen files court challenge to block generic competitor
Looming patent expiration on the migraine drug Treximet has led pharmaceutical company Pozen to take further legal action to fend off generic competition.
Chapel Hill, North Carolina-based Pozen (NASDAQ:POZN) said Tuesday it has filed a preliminary injunction to prevent Par Pharmaceuticals from launching a Treximet generic. Pozen made the filing in the U.S. District Court for the Eastern District of Texas, where Pozen’s ongoing patent litigation against Par and several other generic companies is pending. The company holds three patents on the drug; two that expire in 2017 and one that expires in 2025. Treximet’s regulatory exclusivity on Treximet expires much sooner — April 15. In the absence of a court decision stating otherwise, Par would be able to market its generic Treximet after that date.
The U.S. Food and Drug Administration approved Treximet in 2008 for the treatment of migraines. Treximet generated $15.4 million in 2010 royalty revenue for Pozen. The drug was developed and marketed in partnership with British pharmaceutical company GlaxoSmithKline (NYSE:GSK), which has its U.S. headquarters in Research Triangle Park, North Carolina.
Pozen has tried to get the FDA to extend the regulatory exclusivity of Treximet. But the company last month disclosed that the FDA did not accept clinical study data regarding pediatric use of Treximet. The company was seeking an additional six months of pediatric exclusivity.
Including Par, four generics makers have filed applications with the FDA seeking approval to market generic versions of Treximet. A settlement with Teva Pharmaceuticals was reached last year. Litigation with Par, Alphapharm and Dr. Reddy’s Laboratories has been consolidated into one suit, which is still pending.
Treximet is not the only Pozen product facing a generic challenge. The company disclosed in a regulatory filing earlier this month that Dr. Reddy’s, a generics company based in India, sent a letter notifying the company it had filed an application with the FDA seeking approval to market a generic version of Vimovo.
Bayer hit with discrimination suit by six current, ex-employees
Six current and former employees of Bayer Corp.’s HealthCare Pharmaceuticals unit filed a class-action lawsuit against the company yesterday alleging they suffered systematic gender discrimination at the Bayer business in Wayne, N.J.
The women claim they and “hundreds” of other female workers at Bayer were denied adequate pay and promotions, especially if they became pregnant, despite having a history of achievement at Bayer.
“High-ranking company officials within the predominantly male management team foster an environment hostile to the success and advancement of female employees,” the lawsuit stated.
Bayer spokesman Bryan Iams said the Robinson-based corporation denies the allegations of gender discrimination and will vigorously defend itself.
“(Bayer) is committed strongly to a policy of non-discrimination and equal treatment for all employees,” said Iams.
The 12-count complaint, filed in U.S. District Court in New Jersey, seeks unspecified money damages of well over a million dollars for alleged violations of the Equal Pay Act, the Family and Medical Leave Act and Title VII of the Civil Rights Act of 1964.
The lawsuit also seeks back pay and other remuneration, and demands Bayer take steps to follow equal employment practices.
For example, one of the six plaintiffs, who became interim director of a division, became so distraught under “undue levels of criticism and hostility” that she experienced a miscarriage in March 2009, the complaint stated.
Another plaintiff, a consumer marketing manager, was publicly “humiliated” by a male vice president when she started to make a company presentation while pregnant, the lawsuit stated. The vice president said she need not use the podium “because her belly was so large.”
The lawsuit asks the court to certify the lawsuit as a class-action on behalf of “hundreds” of female employees in lower to mid-level management positions at Bayer HealthCare Pharmaceutical who have worked there since Nov. 21, 2009.
Biostar Pharmaceuticals, Inc. to Host Fiscal 2010 Fourth Quarter and Year End Earnings Conference Call on Friday, March 25, 2011 at 10:00 a.m. ET
Biostar Pharmaceuticals, Inc. (Nasdaq: BSPM) (“Biostar” or “the Company”), Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, XinAoxingOleanolic Acid Capsules (“XinAoxing Capsules”), today announced that its 2010 fourth quarter and year-end financial results will be released before the market open on Friday, March 25, 2011. A conference call to discuss the results is scheduled at 10:00 a.m. ET, Friday, March 25, 2011.
About Biostar Pharmaceuticals, Inc.
Biostar Pharmaceuticals, Inc., through its wholly-owned subsidiary and controlled affiliate in China, develops, manufactures and markets pharmaceutical and health supplement products for a variety of diseases and conditions. The Company’s most popular product is its XinAo Xing Oleanolic Acid Capsule, an over-the-counter (“OTC”) medicine for chronic hepatitis B, a disease affecting approximately 10% of the Chinese population. In addition to its hepatitis product, Biostar currently manufactures two broad-based OTC products, two prescription-based pharmaceuticals, one medical device and five health supplements.
Cautions about Forward Looking Statements
This press release contains forward-looking statements, including forecasts of Biostar’s future expected financial results; its prospects for the business in fiscal 2010, which fall within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or words of similar meaning. They may also use words such as, “would,” “should,” “could” or “may.” Factors that may cause our actual results to differ materially from those described in forward-looking statements which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of sales and profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to continue our expansion in the rural areas, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2009, our most Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and other recent filings. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Biostar disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.