Despite the regulatory rejection of its weight-loss drug, Vivus Inc. (VVUS) is confident that it can meet requests from the Food and Drug Administration and get approval for its drug next year.
Late Thursday, the Mountain View, Calif., company said it received a so-called complete response letter for its drug Qnexa that requests additional information but states no need for more clinical trials at this time. The company believes that it has sufficient data to meet the agency's needs and will file a formal response in about six weeks.
The FDA request is "just a step in the process towards approval," Vivus Chief Executive Leland Wilson said on a conference call Friday. He said the FDA requests were "clear and specific" and the company will not meet with the agency before filing a response.
Vivus shares rallied on the news, trading up 26% to $7.72.
Vivus is in a three-way race with Orexigen Therapeutics Inc. (OREX) and Arena Pharmaceuticals Inc. (ARNA) to sell a new weight-loss pill. Arena has partnered with Japan's Eisai Co. (ESALY, 4523.TO), while Orexigen is working with Japan's Takeda Pharmaceutical Co. (TKPYY, 4502.TO). Vivus has said it plans to find a large pharmaceutical company to help sell Qnexa but not until the drug is approved.
The FDA rejected Arena's lorcaserin last week out of safety concerns as it highlighted the drug's moderate effectiveness. The company hasn't provided a timeline for its response but plans to meet with the FDA by the end of the year.
Orexigen's Contrave is facing an FDA panel in December. A similar panel had rejected Qnexa in July and lorcaserin in September.
For Vivus, the response from the FDA is being viewed positively as the regulatory timeline is relatively short. Within two weeks of filing its response, Vivus expects the FDA will say if it has accepted it. The agency will then classify the review as Class 1, occurring over two months, or as Class 2, which is a six-month review.
"Our interpretation of the letter is that it provides a manageable path to approval in 2011," J.P. Morgan analyst Cory Kasimov said in a note to clients.
While some analysts had a similar sentiment--calling the letter positive or relatively benign--others raised concerns of whether the information presented to the FDA would be enough to the get drug to the market.
The FDA has scrutinized diet drugs because they are likely be taken indefinitely by millions of people, many of whom don't have any current health problems.
The contents of Vivus's letter aren't public, but CEO Wilson stressed that trying to "spin" the FDA's response in a favorable way wouldn't be in the company's interest.
According to the company, the agency requested more information about the risk of birth defects, along with evidence that an elevation in heart rate doesn't increase the risk for cardiovascular problems.
Vivus said it will compile analyses integrating existing data to address the agency's concerns about side effects. The FDA also wants more information on the formal plan on how the drug's risks can be managed and the formal submission of positive two-year data disclosed last month.
The agency didn't raise any concerns about the drug's effectiveness and its effects on the mind, the company said.
Qnexa is a combination of stimulant phentermine and antiseizure drug topiramate, sold as Topamax by Johnson & Johnson (JNJ). The two drugs work together to reduce appetite and make the user feel more satisfied.
The current label for topiramate includes warnings about potential birth defects, but Vivus argues that no definitive link has been established. Regardless, it is proposing a strict risk-control plan to advise patients to use birth control while on Qnexa and to stop using the drug if they become pregnant.
"It is clear to us and the FDA that weight loss in pregnancy isn't acceptable," Wilson said.
In answering concerns about cardiovascular risk, Vivus will provide data and analysis conducted after the FDA panel raised concerns in July. On Friday, the company said the rise in heart rate is very small and its recent two-year data showed no increased risk.
Cardiovascular risk has been a concern at the agency. Abbott Laboratories (ABT) removed its weight-loss drug Meridia from the markets earlier this month and severe restrictions have been placed on GlaxoSmithKline PLC's (GSK GSK.LN) diabetes drug Avandia.
"We remain concerned that VVUS may not have the data necessary to address the FDA letter, particular the question on major cardiovascular events," Jefferies analyst Thomas Wei wrote.
Vivus did say that clinical studies may be required if its response doesn't alleviate the FDA's concerns.
Last week, the agency again declined to approve diabetes drug Bydureon, in development by Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly & Co. (LLY) and Alkermes Inc. (ALKS).
The FDA requested new clinical data, delaying the drug's potential approval by years, in order to address cardiovascular safety. The request came after the agency's initial denial in March asked for more information but no additional clinical studies.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; firstname.lastname@example.org