Count Antares Pharma (NASDAQ:ATRS) in the upper echelon of stocks over the past year. Strong demand for the company's self-injection devices and topical gels drove shares up 94% during the last 52 weeks. I reviewed Antares' current product lineup recently, but can its pipeline produce even better days ahead? Let's delve into what's on the way for Antares.
With a little help from its friends
The alliance between Antares and Teva Pharmaceuticals (NYSE:TEVA) runs strong. Teva ranks as Antares' largest customer, accounting for half of all sales in 2011.
Teva currently markets 5 mg TevTropin, a human growth hormone that uses the Tjet needle-free injector licensed from Antares. The company submitted a supplement New Drug Application, or sNDA, in the third quarter of 2012 for a 10 mg dosage of TevTropin. Antares expects Teva to launch the new product in 2013 pending approval.
That's not all for Teva. It also filed Abbreviated New Drug Applications, or ANDAs, for two products using Antares' Vibex disposable pressure-assisted auto-injector technology. One of these Vibex products administers epinephrine for allergic reactions, while the other delivers sumatriptan for treating migraine headaches. Teva plans to submit ANDAs for two disposable pen injectors licensed from Antares as well.
Then there is the "undisclosed product" that Pfizer (NYSE:PFE) is working on using Antares' technology. Antares received $750,000 in milestone payments related to the deal during the first nine months of 2012 plus undisclosed upfront payments in late 2011.
Antares also partnered with the Population Council in the development of Nestragel, a birth control gel. The last real news on Nestragel stemmed from positive results from a phase 2 study back in 2010. Antares and the Population Council state that they intend to find another partner to complete development for the product.
Last (and perhaps least) among possible new products involving partners is LibiGel. Biosante (NASDAQ:ANIP) licensed technology from Antares for the transdermal testosterone gel. However, Antares doesn't list LibiGel in its pipeline. Biosante reported disappointing phase 3 results in December 2011, but the company has stated publicly that it intends to press on with other studies.
Antares gets a lot of help from its friends, but the greater possibilities just might be obtained by flying solo. The primary pipeline candidate that Antares plans to commercialize largely on its own is Otrexup. While Uman Pharma has the rights to market Otrexup in Canada, Antares will sell the drug in the U.S. and elsewhere.
Otrexup, formerly known as Vibex MTX, allows patients to self-administer methotrexate for treatment of rheumatoid arthritis and other autoimmune diseases. In September 2012, Antares announced results from a study that showed 98% of patients using the product found it easy to use. The company followed up in November with results from a clinical study that found Otrexup was consistent in terms of system availability of methotrexate with oral forms of the drug.
Methotrexate is used by around 70% of rheumatoid arthritis patients. However, there are a couple of problems that can occur when taking the drug orally. First, many patients experience gastrointestinal side effects. Second, absorption of the drug tends to decrease as dosage levels increase. Taking the drug parenterally as done using Otrexup improves absorption and can lessen side effects, according to some studies.
Antares' other solo pipeline product is Vibex QST. This product will enable men to self-administer testosterone replacement therapy. In October, Antares raised $50 million in a secondary offering intended primarily for funding development and commercialization of Vibex QST and Otrexup.
Making the grade
I think that Otrexup has an excellent opportunity. The Arthritis Foundation states that an estimated 1.3 million Americans suffer from rheumatoid arthritis. With many of these patients taking methotrexate, the potential market for Otrexup looks promising.
Additional products sold by Teva should also generate nice new revenue for Antares. The upcoming Vibex EPI, in particular, seems to have the possibility for solid sales.
The wild cards in Antares' pipeline are the secret Pfizer product and Nestragel. Either could be big winners at some point down the road. They also could both be total duds.
With all this in mind, I give Antares' pipeline a grade of "B." There aren't enough sure-fire winners to warrant an "A" in my view, but the company has new products on the way that should continue to drive growth. I'm not sure that we'll see shares jump another 94% over the next year, but you never know.