|
Vanda Pharmaceuticals announced today the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia
ROCKVILLE, MD, USA | July 28, 2008 | Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.
The FDA stated that Vanda had demonstrated the effectiveness of iloperidone at 24 mg/day in the 3101 study for which the company reported results in December, 2006, and that the efficacy was similar to the active comparator, ziprasidone (Geodon(R), Pfizer Inc.). In addition, the FDA also stated that iloperidone was superior to placebo in patients with schizophrenia at doses of 12-16 mg/day and 20-24 mg/day in a prior study. However, the FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal(R), Johnson & Johnson), used in prior studies. The FDA indicated that it would require an additional trial comparing iloperidone to placebo and including an active comparator such as olanzapine (Zyprexa(R), Eli Lilly & Company) or risperidone in patients with schizophrenia to demonstrate the compound's efficacy further. The FDA also stated that it would require Vanda to obtain additional safety data for patients at a dose range of 20 to 24 mg/day.
"We are disappointed by this response, but will meet with the FDA to discuss this decision further," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.
Vanda has put on hold all iloperidone-related activities pending further review.
As of June 30, 2008, Vanda's cash, cash equivalents, and marketable securities totaled approximately $65.6 million. Additional financial details will be provided on the August 5, 2008 earning conference call.
Conference Call
The company has scheduled a conference call for today, Monday, July 28, 2008, at 10:30 AM ET to discuss the FDA's response. Investors can call 1-866-202-3109 (domestic) and 1-617-213-8844 (international) prior to the 10:30 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos. A replay of the call will be available Monday, July 28, 2008, at 12:30 PM ET and will be accessible until Monday, August 4, 2008, at 5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers. The access number is 48122809.
The conference call will be broadcast simultaneously on the company's Web site, http://www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the Web site at least 15 minutes early to register, download, and install any necessary software. The call will also be archived on the Vanda Web site for a period of 30 days, through August 27, 2008.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company with a focus on the development and commercialization of clinical-stage product candidates for central nervous system disorders. In addition to iloperidone, Vanda is developing tasimelteon (VEC- 162), a compound for the treatment of sleep and mood disorders which is currently in Phase III development for sleep disorders. Vanda's third product candidate in clinical development, VSF-173, is currently in Phase II development for the treatment of excessive sleepiness. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
SOURCE: Vanda Pharmaceuticals Inc. |
