) -- Welcome back to Biotech Stock Mailbag.
Rahul A. writes:
What do you think about Antares Pharma (ATRS - Get Report)? It has a PDUFA date set for October 2013.
Antares Pharma develops new ways -- mainly self injections and rub-on skin gels -- to administer currently approved drugs. The company's lead product candidate is Otrexup -- an automatic self-injection device that comes pre-filled with methotrexate for use by patients with rheumatoid arthritis. Antares submitted Otrexup to the U.S. Food and Drug Administration last year, with an expected approval decision date of Oct. 14.
Methotrexate is a generic medicine, which, in pill form, is commonly prescribed to approximately 70% of the 1.5 million rheumatoid arthritis patients in the U.S. Injectable methotrexate is also available and delivers higher blood levels of the drug compared to pills. Despite its advantages, injectable methrotrexate is rarely prescribed, mainly because it requires a weekly visit to the doctor's office.
Antares believes the convenience of Otrexup -- patients can self inject at home -- will convince doctors to increase their use of injectable methotrexate for treating rheumatoid arthritis patients. If oral methotrexate is no longer effective, some patients might try Otrexup before moving on to biologic therapies like
Johnson & Johnson's
First, FDA needs to approve Otrexup. Antares is not particularly transparent when it comes to sharing details of its drug development activities with investors. Most of the Otrexup data disclosures are press releases. Very little data have been presented at medical meetings or published in medical journals.
Methotrexate is already approved for rheumatoid arthritis and Antares doesn't change the drug used to fill its Otrexup self-injector device. This should work in the company's favor when it comes to FDA approval, as long as the agency is 1) copacetic with the self-injector device and 2) the efficacy and safety of Otrexup is comparable to injectable methotrexate using a conventional needle.
In August 2011,
Antares issued a press release
announcing positive results from a study demonstrating comparable performance between Otrexup and conventionally injected methotrexate. No details were provided in the press release. Reached this week, Antares spokeswoman Elaine Andrecovish says the study was never presented or published and data are not available.