Recently, the European Union (EU) approved the proposed $41.1 billion merger between Schering-Plough (SGP) and Merck & Co. (MRK). The deal is awaiting approval from the U.S. Federal Trade Commission. The transaction is expected to close in the fourth quarter of this year. While approving the merger, the EU clarified that the tie-up will not hinder effective competition significantly in Europe, even though both participants in the merger operate in the field of prescription pharmaceuticals. While checking for overlaps in Europe, particularly in the fields of asthma and allergic rhinitis, the European body did not find the products to be close competitors. Consequently, the merger would not be considered to hog the market and choke other companies. As a reminder, Merck filed for EU approval last month after the completion of the sale of its 50% interest in animal health company Merial Limited (Merial) to ...

Last week, Cornerstone Therapeutics Inc. (CRTX) announced the receipt of approval from the United States Bankruptcy Court for Massachusetts district regarding the acquisition of Factive's (gemifloxacin mesylate) commercial rights  in North America and some European countries from Oscient Pharmaceuticals Corp., which filed for Chapter 11 bankruptcy protection in July. The transaction is worth $5 million in cash. Additionally, it includes an amount for purchased inventory, quarterly royalty payments based on adjusted net sales for a period of five years, and the assumption of certain liabilities. Factive, which belongs to the fluoroquinolone class of antibiotics, is indicated for the treatment of community-acquired pneumonia (CAP) of mild to moderate severity and acute bacterial exacerbations of chronic bronchitis (ABECB).  It was launched in the U.S. in September 2004 and is the only fluoroquinolone approved in the U.S. for the five-day treatment of both ABECB and CAP. Factive has generated ...

Last week, Cornerstone Therapeutics Inc. (CRTX) reported second quarter earnings of 13 cents per share, which was well below the Zacks Consensus Estimate of 33 cents. Net revenues for the quarter came in at $25 million, which reflected a 78% increase over the prior-year quarter. The company reported earnings of 31 cents per share in the previous year quarter. Operating expenses increased significantly in the quarter primarily due to increases in the workforce -- an increase in legal and accounting costs, costs associated with the Chiesi transaction, FDA regulatory-related fees, product liability, insurance-related costs, new product launches and royalties on increased product sales. As a reminder, Cornerstone Therapeutics Inc. was established through the merger of Critical Therapeutics with Cornerstone Biopharma Holdings Inc. in the fourth quarter of 2008. The financial statements for periods prior to the merger reflect the historical results of Cornerstone BioPharma, not ...

On July 15, 2009, North Carolina-based specialty pharma company Cornerstone Therapeutics Inc. (CRTX) announced the submission of a regulatory filing with the  US Food and Drug Administration (FDA) for an extended-release antitussive (cough suppressant) product, CRTX 067. On approval, it will compete directly in the narcotic antitussive market, which includes big players like Covidien (COV) and UCB. The company expects the product to hit the US market by 2011.

According to Wolters Kluwer Health, in 2008, there were over 30 million prescriptions generated for oral antitussive and antitussive combinations. Nearly 10 million of these prescriptions were for products that only contained a narcotic antitussive and an antihistamine.

The drug has a huge market opportunity since cough can adversely affect the quality of life, leading patients to seek medical attention. Most antitussive and antitussive combination products currently in the market must be dosed every four to six hours, which can be

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