The FDA requested that the labelling for leukotriene modifiers be updated to include a precaution about the potential for neuropsychiatric events in patients taking the asthma drugs. The request follows the agency’s review of such events, which have been reported in some patients taking Merck & Co.’s Singulair (montelukast), AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’ Zyflo and Zyflo CR (zileuton).

[ad]

In its safety update, the FDA noted that the side effects associated with the asthma drugs include agitation, aggression, suicidal behaviour, depression, insomnia and irritability.

In response to the request, Merck stated that Singulair’s label already contains post-marketing information about the neuropsychiatric events addressed in the agency’s communication, and added that it “will continue to work with the FDA to revise the prescribing information for Singulair in the US to include a precaution related to those events.”

Source: FirstWord

Popularity: 4% [?]

The FDA granted tentative approval to Mylan’s generic version of one dosage of Merck & Co.’s Singulair (montelukast), the generic drugmaker reported.

[ad]

US sales of the branded product were $2.6 billion in the 12-month period that ended March 31, according to Mylan. The drug, a treatment for allergies and asthma, is expected to lose patent protection in 2012.

Source: FirstWord

Popularity: 3% [?]

In an updated safety review posted to the FDA website Tuesday, the agency said that it “has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioural adverse events associated with” Merck & Co.’s asthma drug Singulair (montelukast), as well as similar medications including AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’ Zyflo (zileuton). The agency anticipates that the ongoing assessments might take up to nine months to complete.

[ad]

The agency statement follows the announcement in March 2008 of a safety review investigating a possible link between Singulair and suicidal behaviour. The FDA indicated that Merck submitted data from 41 placebo-controlled clinical studies including 9929 patients who received Singulair and 7780 who took a placebo. Among the patients treated with the drug, one had suicidal thoughts and there were no completed suicides.

The FDA also noted that AstraZeneca submitted results from 45 placebo-controlled clinical trials conducted with 7540 patients treated with Accolate and 4659 who received a placebo, and no patients on the drug reported any suicidal behaviour. Regarding the data submitted by Cornerstone, the FDA said that the data did not show any suicidal behaviour in the Zyflo- treated patients. However, US regulators said that the clinical study data reviewed for suicide risk “were not designed specifically to examine” neuropsychiatric events, adding that “as a result, some events may not have been reported.”

In response to the review, Merck stated that the company “stands by the proven efficacy and safety of Singulair,” noting that “after a thorough review of the data from the controlled clinical trials of Singulair, and a careful assessment of post-marketing adverse events, Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.”

Source: FirstWord

Popularity: 3% [?]

Merck & Co. CEO Richard Clark stated on Wednesday that the company is “aggressively looking” at all types of acquisitions for the coming year. “I think we’re in a very good position to make whatever investments are needed,” he said.

[ad]

The chief executive indicated that the company seeks “strategic opportunities,” reiterating Merck’s interest in acquiring a biotechnology firm to boost revenue and its pipeline, but specified that such a deal would have “to be financially smart.” He predicted that other drugmakers would also seek to complete merger deals and acquisitions, saying that “there is no doubt many companies are looking at that deal that will transform their company…I do think it can’t be business as usual and certainly the consolidations aren’t over.”

Deutsche Bank’s Barbara Ryan has speculated that the drugmaker might takeover Biogen Idec or Gilead Sciences. The drugmaker had approximately $6.8 billion in cash and short-term investments as of September 30, 2008, but if a deal does not transpire, Clark said he may raise the dividend or repurchase shares. Clark also mentioned that other priorities for Merck in 2009 include changing the company’s business model, which would include a plan to expand pilot projects in its US sales force.

Looking back on 2008, the chief executive described the year as “disappointing… and in many ways it was an unacceptable year.” Merck experienced several setbacks during the year, including the FDA’s not approvable letter for its experimental cholesterol drug MK-0524A. In addition, the company recorded declining sales of Singulair (montelukast), Gardasil, and Vytorin (ezetimibe and simvastatin), which it co-markets with Schering-Plough.

Source: FirstWord

Popularity: 4% [?]