Antares Pharma (NASDAQ: ATRS ) on Monday received the news it hoped to get. The Food and Drug Administration gave a thumbs-up to Otrexup, the company's subcutaneous methotrexate administered via self-injection. Antares' shares jumped nearly 14% on the announcement before settling down to a roughly 4% gain. Could this FDA decision also be good news for patients?
To market they go
Otrexup gained approval for treatment of three different groups of patients: adults with rheumatoid arthritis, children with polyarticular juvenile idiopathic arthritis, and adults with severe psoriasis. The rheumatoid arthritis indication is for use of Otrexup as a second-line treatment after patients either didn't respond to or were intolerant of initial therapy such as nonsteroidal antiinflammatory agents, or NSAIDS. Likewise, the psoriasis indication is for treating patients for whom other therapies didn't prove effective.
There's no question that the market potential is large. About 6 million prescriptions for methotrexate, or MTX, were given in 2012 for the three approved indications. Approximately 70% of rheumatoid arthritis patients take MTX. Most of these prescriptions are for the oral form of the drug, but many patients experience side effects in this treatment. Dosage increases of the drug can actually result in lower absorption of MTX.
Patients who suffer side effects or who don't don't respond well to oral MTX can move up to biologics. AbbVie's (NYSE: ABBV ) Humira is the most-prescribed biologic for rheumatoid arthritis and similar diseases. Humira is effective, but the big downside is cost.
Antares hopes to position Otrexup as an attractive alternative to biologics, although the company really won't compete directly against AbbVie or other major players in the market. What it wants to do is make MTX injection a more convenient and viable option for patients using the Vibex Medi-Jet technology, which allows easy self-administration.
The company's standard business model has been to ally with big partners. For example, sales to Teva Pharmaceuticals (NYSE: TEVA ) accounted for more than two-thirds of total revenue last quarter. The Israeli company markets Tev-Tropin, a human growth hormone, using Antares' self-injection technology.Teva won't participate in the launch of Otrexup, though. Antares plans to commercialize the now-approved product largely on its own -- except in Canada, where Uman Pharma has marketing rights.
Probably the biggest key to Antares' success will be in convincing payers to pony up for Otrexup. To help with this effort, the company brought in Quintiles (NYSE: Q ) . Quintiles has helped launch many of the top-selling drugs on the market and has been in contact with major insurers and other payers to clear the way for reimbursement of Otrexup.
My hunch is that if the payers are on board, persuading physicians and patients to try Otrexup won't be too difficult. Antares already announced clinical results that show greater bioavailability of Otrexup compared to oral MTX. Given the ease of use of the Vibex Medi-Jet, and the fact that the drug is administered subcutaneously rather than through the intramuscular injection approach of current products, patients should see Otrexup as an attractive option.
While I don't expect Antares to soar when it first launches Otrexup in the coming months, investors should watch the stock closely in 2014. Good early sales results could lift this stock to new heights. That would obviously mean good news for Antares, but it would also be great for arthritis and psoriasis patients who could benefit from another convenient form of treatment.
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