- “We plan to introduce additional products into the U.S. marketplace, and recently filed our first BLA for one such product, Neutroval TM, but currently an abbreviated regulatory pathway, such as the Hatch-Waxman Act, does not exist for these products. In 2009, the legislative environment in the U.S. improved, as a Senate Committee considered legislation to create a regulatory pathway for biogeneric products, but no final legislation was enacted. We took an active role in the development and introduction of the proposed legislation, and believe a regulatory pathway will be created in the U.S. in the next several years.”
What does TEVA say? “Into the U.S. marketplace… Neutroval.” That is what is says. TEVA intends to move Neutroval into the U.S. marketplace. And where Antares fits in is with its own injector line of products that are specially designed for biosimilar medicaments. It is already known that Antares is a preferred U.S. supplier of injectors for TEVA according the company's pipeline.
It was recently reported that "Teva Pharmaceutical Industries Ltd. ... expects the fledgling market for so-called biosimilar drugs to be big, but the cost and complexity of developing them will limit competition, company executives said." The reality is, what injectable biosimilars TEVA carves out, Antares fits in with its broad injectable IP line of products.
But now for new investors in Antares a little background. Amgen (AMGN) developed G-CSF (granulocyte colony-stimulating factor) or from that platform: Filgrastim (Key US patents: 5580755 and 5582823). In the U.S., the parenteral (injectable) version is called Neupogen. Neupogen stimulates white blood cells against a disease called Neutropenia which is abnormal or low white blood cell count. Since chemotherapy destroys white blood cells so you can see Neupogen's value to oncology. From Filgrastim, Amgen also developed Neulasta. Both patents, '755' expires 3 Dec 2013, '823' expires 10 Dec 2013. Neupogen and Neulasta: both expire the end of 2013.
Meanwhile, TEVA developed Tevagrastim (renamed Neutroval) and has been selling it in Europe since 2008, since the Amgen-Europe patents expired in 2006. TEVA desired to enter the U.S. market, but the courts in the U.S. district of Pennsylvania (summer 2011) ordered that they must wait to market Neutroval until 10 November 2013. TEVA has agreed not to market Neugranin until the same date unless the courts decide the Amgen patents are not infringed. Meaning, TEVA lost the right to enter the U.S. market early, but must wait until 20 November 2013. In the scope of things, that is not a very long wait. And this where Antares could be in play--Antares offers the injector (VIBEX QS) that TEVA may choose.
Neutroval and Neugranin are injectables. Neutroval is available in a pre-filled syringe delivered subcutaneously. It can be given at home. It is a growth-factor injection reminding us of Antares's HGH TEV-Tropin. A normal course of Neutroval is 10-14 daily injections following chemotherapy treatment. Meanwhile the FDA is swallowing hard to know how to deal with biosimilars. TEVA filed a standard BLA: 42 USC 262(a). Neutroval may be in the Antares pipeline (listed as "undisclosed"), or I might add, if not, should be very soon. Like Tev-Tropin the medicaments both sit at the top of TEVA's biosimilar food pyramid revealed in June 2011 and in many TEVA presentations. Furthermore, Antares's CEO Wotton has repeatedly stated that their injectable platform is poised for this biosimilar invasion.
Investors must keep a careful watch on the TEVA-Antares partnership. Right now, three TEVA partnerships remain "undisclosed" and Pfizer (PFE) just came on board in December and is also "undisclosed". The market has not priced these partnerships into the share price. If/when that happens, a drug like Neutroval and Neugranin would have a very positive impact on Antares's share price.
Disclosure: I am LONG AIS. Investors buy or sell at their own risk. According to SA policy, I am free to buy or sell any stock mentioned in this article after 72 hours.