Could OTREXUP turn out to be a future earnings driver for Antares Pharma?
Mumbai, India -- (SBWIRE) -- 10/16/2013 -- Ewing, New Jersey-based Antares Pharma, Inc. (ATRS) reached a significant milestone with OTREXUP receiving U.S. FDA approval on October 14, 2013. Yesterday’s decision came after a 10-month review cycle by the FDA. The news saw its price shoot up from $4.53 at close on Friday, October 11th to $5.06 on Monday the 14th when it opened.
The OTREXUP injection has been developed for the subcutaneous delivery of methotrexate or MTX through self-administration to enhance treatment of rheumatoid arthritis, poly-articular-course juvenile RA and psoriasis. Antares Pharma had submitted their New Drug Application or NDA for OTREXUP to the FDA in December 2012. The NDA was subsequently accepted by the FDA a little over two months later in February 2013 with a PDUFA date of October 14, 2013 being assigned.
The opportunity for OTREXUP in the RA space is huge. Antares’ CEO Paul Wotton had pointed out at the Jefferies Healthcare Conference in June that the drug can be sold to a ‘very highly focused audience’. The RA market is worth somewhere around $17 billion and the psoriasis market around $5 billion. Importantly, injectable methotrexate would have utility in both these markets. The U.S. currently has around 3000 rheumatologists and Antares Pharma would need 25 representatives to hit all the high prescribers in this area. He also noted that OTREXUP has a sales potential in the $200 million range and wouldn’t be too heavy on Antares’ budget with sales and marketing expenses planned in the $12 million and $15 million range annually.
Another feature which makes OTREXUP unique is the fact that it is the first and only subcutaneous methotrexate product designed for self-administration in the U.S. Antares is counting heavily on its ease of administration with it being designed for use by rheumatoid arthritis patients who face hand function impairment.
Along with its ease of use, he also noted that it would be safe and comfortable to use as patients wouldn’t be seeing a needle; they would just need to press down on the skin for three second to administer the dose. The needle shield on the device ensures patients wouldn’t receive any accidental needle sticks while using it. At the conference, Paul Wotton also stated that he himself had tried out the device, saying it was pain-free. The injection takes about half a second to go through the skin. Antares Pharma received a patent for OTREXUP in June, providing them nearly 17 years of IP protection.
Speaking at the Deutsche Bank Health Care Conference in May, Paul Wotton called their getting ready to launch OTREXUP their ‘biggest goal’ over the next six to nine months. Antares has significant experience partnering with companies such as Teva, Pfizer, Actavis, Ferring in Europe, Meda Pharma, Daewoong Pharmaceuticals and others.
On the Pfizer front, they have been working with them on an undisclosed OTC product, which Paul Wotton had called a ‘very interesting product’ for them. Currently, work with Teva appears to be their largest partnership with CFO Bob Apple stating at their Q2 call that they were pleased with the progress they had made with Teva. In fact, the $4.5 million in product sales achieved in the second quarter of this year were mainly due to sales to Teva of pre-launch quantities of Antares’ VIBEX auto injector for Teva's generic epinephrine auto injector product.
Meanwhile, in terms of launch preparations for OTREXUP, a major indication could be their announcement of completing the recruitment of an experienced in-house sales and marketing team with Big Pharma product launch experience in the rheumatology market segment. Antares Pharma plans to commercially launch OTREXUP in early 2014. With yesterday’s approval from the FDA, they look all set to take on the market opportunity which lies ahead of them.
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