Top Marketeer to Promote Taranabant, Competitor to Acomplia

Merck’s development of taranabant, a diet drug which has been described as a competitor for Acomplia (rimonabant), must be going pretty well because the pharmaceutical giant has brought back top marketeer Len Tacconi to serve as the drug’s global brand leader.

While taranabant, a cannabinoid-1 (CB-1) receptor inverse agonist that has a mechanism of action similar to that of Sanofi-Aventis’ rimonabant, is still in Phase III trials, it now appears that the Merck drug may well beat Acomplia to the U.S. market.

Merck continues to say little about taranabant, but Sanofi-Aventis withdrew its application to market Acomplia in the U.S. in June after an FDA advisory panel recommended against approving it due to concerns over psychiatric side effects.

Merck has said it intends to file for FDA approval of taranabant in 2008, and Sanofi — which continues to market rimonabant in Europe and some other countries — now is not expected to refile for the U.S.before the Merck filing.

Tacconi, who left Merck less than a year ago to become president of Discovery Health, spent a decade with Merck orchestrating high-spending consumer marketing campaigns for drugs that included Singulair, Zocor and Vioxx.

Before joining Merck, Tacconi had led North American marketing for Weight Watchers.

Pfizer is working on what has been called a cannabinoid receptor antagonist, called CP-945598, which also is in Phase III trials, but has not indicated when it hopes to file for FDA approval.

What has never been made totally clear is whether the Pfizer drug is a receptor antagonist, which would operate differently than the Sanofi and Merck drugs. Some researchers have expressed the belief that a true CB-1 antagonist could possible help in suppressing appetite while minimizing undesirable side-effects

While diet drug Acomplia (rimonabant) doubles the risk of depression, its benefits “continue to outweigh its risks” for overweight and obese individuals who are not taking antidepressants, European drug regulators concluded on July 19th.

But in deciding to let Acomplia remain on the market in Europe, the regulators expressed concern that “too many patients are taking Acomplia at the same time as antidepressants,” and issued a tougher warning to doctors to stop prescribing it to patients on antidepressants or suffering major depression.

The European Medicines Agency (EMEA) handed down their decision after reviewing safety data that led a U.S. FDA advisory panel last month to unanimously recommend against allowing rimonabant (also known as Zimulti) to be prescribed in the United States.

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) said it asked Sanofi-Aventis following the FDA advisory panel meeting in June 2007 to “submit all available information on the psychiatric side effects of Acomplia.”

In assessing the data at its just concluded July meeting, the CHMP said it concluded “that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants.”

But it added that the risk of depression is approximately doubled in all overweight and obese patients taking rimonabant, and the risk may be further increased in patients with a past history of depression.

“This increased risk is of concern, since Acomplia is now being used in patients with a history of psychiatric events,” the CHMP said. “In a small minority of cases, this could lead to suicidal ideation or even suicide attempts.”

The EMEA said that while doctors were warned when rimonabant was approved a year ago that they ” should not prescribe Acomplia in patients with uncontrolled serious psychiatric conditions such as major depression,” the warning will now be upgraded.

The CHMP said it is now recommending ” contraindicating Acomplia (rimonabant) from Sanofi-aventis, in patients with ongoing major depression or who are being treated with antidepressants, because of the risk of psychiatric side effects.