Bad News for Merck, J&J Weigh on Healthcare Sector

This article published with permission from The Burrill Report.

The halting a key study of a much-anticipated anticlotting drug developed by Merck & Co. Inc. (NYSE: MRK) and more embarrassing recall news for drug giant Johnson & Johnson (NYSE: JNJ) were among the missteps that sank healthcare stocks this week.

Merck said it was discontinuing a study of its experimental anticlotting drug vorapaxar in patients with acute coronary syndrome after a monitoring board reviewed safety and efficacy data and recommended the study be halted. A second study of the drug in patients who had previously experienced a heart attack or peripheral artery disease will be discontinued in about 25% of the participants who experienced a stroke prior to entry into the study. The news is a blow to Merck because vorapaxar had been seen as the most promising drug in the pipeline acquired through its 2009 merger with Schering-Plough. Bloomberg estimated the drug had the potential for annual sales of $5 billion. Merck's shares closed Friday at $34.20.

The U.S. Food and Drug Administration Gastrointestinal Drugs Advisory Committee voted to recommend the agency reject Eli Lilly & Co.'s (NYSE: LLY) liprotamase, a non-porcine pancreatic enzyme replacement therapy the company is seeking approval to market as a treatment for people unable to properly digest food because of a lack of a digestive enzyme. The committee had questions about the degree of efficacy of liprotamase and recommended that additional studies be conducted prior to considering approval for the condition known as exocrine pancreatic insufficiency. Lilly said it will continue to work with the FDA to address the questions raised in the meeting, as the agency moves toward a final decision on the application. The FDA is not required to follow the recommendation of its advisory committees, but it usually does.

Lilly CEO John Lechleiter said a patient participating in the company’s ongoing trials of the experimental Alzheimer’s drug solanezumab temporarily developed brain swelling, although it is not known whether the patient received the drug or placebo, Reuters reported. Lechleiter, who made the comments during a presentation at the JP Morgan Healthcare Conference, said a data-monitoring committee so far has not suggested changes to the trials. Reuters noted that potentially dangerous brain swelling has been seen with high doses of a rival experimental drug being developed by Pfizer Inc. (NYSE: PFE) and Johnson & Johnson, and said the news raised some doubts about whether the drug will eventually win approval. Lilly's shares closed at $34.91.

The state of Oregon has sued Johnson & Johnson and two of its subsidiaries alleging the health-products giant exposed consumers to risks by waiting more than a year to remove defective Motrin caplets from stores before conducting a public recall. Instead of an immediate public recall, Johnson & Johnson and its subsidiaries allegedly attempted to quietly remove Motrin containers from store shelves, according to the suit. The phantom recall, Oregon Attorney General John Kroeger says, failed to notify consumers who had already purchased the defective product and exposed additional consumers by delaying public disclosure for more than a year. The lawsuit alleges multiple violations of Oregon's Unlawful Trade Practices Act. Among other things, the act prohibits employing unconscionable tactics, making certain false or misleading representations, or failing to disclose certain information. Each violation of the act carries a maximum penalty of $25,000. Johnson & Johnson's shares were at $62.55.

Bristol-Myers Squibb Co. (NYSE: BMY) has recalled 64 million tablets of the blood pressure medicine Avalide in the U.S. and Puerto Rico due to the potential for reduced effectiveness, Reuters reported. The company said the recall was a precautionary measure. It was the second major recall in less than four months of the medicine co-marketed with French drugmaker Sanofi-Aventis SA (NYSE: SNY), Reuters noted. In September, Bristol-Myers recalled 62 lots, or 60 million tablets, of the drug manufactured in Puerto Rico. The new recall involved 65 lots of Avalide manufactured in plants in Humacal, Puerto Rico and Evansville, Indiana. Avalide is a combination pill comprised of the drugs irbesartan, which is sold under the brand name Avapro, and hydrochlorothiazide, a generic diuretic. Bristol-Myers did not publicly announce the recall, but communicated it in letters to wholesalers and healthcare professionals, the company said. Bristol-Myers shares were at $24.84.

Astellas Pharma Inc. said that it has engaged Citigroup Global Markets to conduct a review of the Japanese company's strategic alternatives with regard to its Prosidion subsidiary. Prosidion was acquired as part of Astellas' acquisition of OSI Pharmaceuticals in June 2010. Prosidion's assets include two drug candidates in development for diabetes and obesity, as well as a patent estate relating to the use of dipeptidyl peptidase IV (DPP-IV) inhibitors for the treatment of Type 2 diabetes. The range of alternatives that will be assessed could include minority investment or strategic alliance, a merger or sale of some or all of Prosidion's assets.

The FDA notified Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP) that it will not approve its experimental crush-resistant opioid for moderate and severe pain, Opana ER, without additional data. The agency did not require additional clinical studies be conducted for approval of the drug. The company said it has begun to address the issue raised by the agency and will work closely with it to finalize its response. Endo expects to respond to the FDA by mid-2011 and will expect a six-month review once its response is filed. Its shares closed Friday at $34.88.

Valeant Pharmaceuticals International Inc. (NYSE: VRX) has taken steps to lay off nearly half of the employees slated to lose their jobs as a result of the company’s merger with Biovail, The Canadian Press reported. The company said it has identified 500 people considered “redundant” following the merger. About 300 people will be gone by the end of the first quarter and another 100 will have left by the end of the second quarter. Valeant targeted 1,100 jobs, or 25 per cent of the combined workforce of the merged companies, when it announced the merger in the summer. Its shares were at $35.03.

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