PHARMACY

Biopharm maker Vivus submits NDA for new obesity drug

BY Rob Eder

MOUNTAIN VIEW, Calif. Vivus, a biopharmaceutical company focused on unmet needs in obesity, diabetes and sexual health, announced Tuesday that it has filed a New Drug Application to the Food and Drug Administration for approval of Qnexa, a new, investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with such co-morbidities as hypertension, Type 2 diabetes, dyslipidemia or central adiposity.

The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two, year-long phase 3 studies, EQUIP and CONQUER. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management, the company stated. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors, according to the study.

“The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities,” noted Leland Wilson, CEO, Vivus. “The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries.”

According to Vivus, other highlights from the two 56-week EQUIP and CONQUER studies — which comprised more than 3,750 patients — included:

  • Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;
  • FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program;
  • Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; and
  • Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.

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Elusys scores HHS contract for anthrax drug

BY Rob Eder

PINE BROOK, N.J. Elusys Therapeutics Inc. has received a $143 million federal contract to develop a drug to treat inhaled anthrax poisoning. Elusys will use the money to scale up manufacturing and chemical and human studies of its drug Anthim, a protein-based treatment for inhaled anthrax.

Elusys has competition in the form of Human Genome Sciences Inc., which also has a drug — raxibacumab, formerly called ABThrax — to treat inhaled anthrax, currently under development.

But, last month Human Genome Sciences hit a bit of a roadblock when the Food and Drug Administration balked on approving raxibacumab; earlier this year, the company had logged its first sale in the form of its $300 million Health and Human Services contract for raxibacumab, amounting to several thousand doses of the drug for the national stockpile. Human Genome Science is working to address the FDA’s questions, which centered around raxibacumab’s efficacy relative to other treatments already on the market.

Elusys’ Anthim also has yet to receive FDA approval.

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FDA gives Merck a Christmas present: Rules increased cancer risk unlikely for Vytorin

BY Rob Eder

WASHINGTON After taking a hammering in 2008, it appears that Merck’s blockbuster cholesterol drug Vytorin finally received some vindication as the calendar wound down on 2009. The Food and Drug Administration announced last week that it “believes it is unlikely that Vytorin or Zetia — the drug used in combination with Zocor to make Vytorin — increase the risk of cancer or cancer-related death.”

While FDA officials stopped short of ruling out any cancer risk altogether, the news was a positive for a drug that had shown so much promise out of the gate before a series of relatively small patient trials in 2008 cast a pall on Vytorin, which had been marketed to treat the two sources of high cholesterol: food and family.

First, in January 2008, the ENHANCE study questioned whether Vytorin’s effect was any better than placebo. Then, in July 2008, results from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) trial showed a heightened rate of cancer in patients taking Vytorin — 11.1% versus 7.5% of those patients on placebo.

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