Teva Pharmaceuticals turns from poacher to gamekeeper
Two events occurred in October 2010 which highlighted Teva Pharmaceutical Industries‘ other role as a developer of innovative products. On 5th October, Watson Laboratories confirmed that it had filed an ANDA with the FDA for a generic version of Teva’s rasagiline mesylate product, Azilect. The announcement came after Teva filed a patent infringement lawsuit in the US District Court for the District of New Jersey alleging infringement of patent number 5,453,446, which expires on 7th February 2017. A look at the FDA’s log of Paragraph IV certifications reveals that the FDA received an ANDA with a Paragraph IV certificate for rasagiline on 17th May 2010. The log does not reveal which companies file ANDAs, but as this is the only such filing, it certainly was made by Watson. Azilect, indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease, is Teva’s second proprietary product.
Teva reported sales of the drug in 2009 were worth US$243 million, a small part of the US$13.9 billion of net sales Teva brought in for the year, but significant for the firm.
For the first six months of 2010, Teva’s sales of Azilect were worth some US$147 million.
Teva’s first proprietary product is Copaxone (glatiramer acetate), which is indicated for the treatment of multiple sclerosis, and was the subject of the second event in October highlighting Teva’s proprietary developments. On 4th October, Peptimmune announced that it had filed a Citizen Petition with the FDA, requesting that the agency does not approve any generic versions of Copaxone unless and until such applications can demonstrate bioequivalency using particular detailed methods. Copaxone has been marketed across the world for longer than Azilect, which is reflected in its sales: Teva reported Copaxone sales for 2009 worth US$2,826 million, with sales in the US rising by 29% to reach US$1,917 million, or 68% of total Copaxone sales. For the first six months of 2010, Copaxone brought in US$1,569 million to Teva.
Unlike Azilect, Copaxone is already facing numerous threats of generic competition in the US, with ANDAs having been filed by Sandoz and its partner, Momenta Pharmaceuticals, and Mylan and Natco Pharma.
The product is protected by a number of US patents, which all expire on 24th May 2014, and so far Teva has been successful in preventing these ANDAs from progressing.
Peptimmune’s Citizen Petition is not the first regarding Copaxone; Teva has also filed Citizen Petitions in the past, although with mixed results. However, the Peptimmune Citizen Petition is interesting because it does not appear to have been filed on behalf of Teva, or with any reference to the firm.
Peptimmune was founded in 2002, when Genzyme established it as a wholly-owned subsidiary. Genzyme provided the initial capitalisation by purchasing US$5.5 million in shares of preferred stock, a move that was intended to accelerate the progress of Peptimmune’s research programmes. Genzyme itself had acquired the firm in 1999. What is significant for Teva, however, is that the firm has therapeutics in clinical development for the treatment of multiple sclerosis. Peptimmune adds that its flagship programme in MS features PI-2301, which Peptimmune believes has the opportunity to replace Copaxone.
Teva is facing the full gamut of tribulations that innovative companies face in protecting their proprietary products. The firm’s two proprietary products are now under assault from both generic companies and innovative companies, both of which are seeking in different ways to replace Teva’s branded products.
As a company with feet in both camps, the irony of the issues the firm is facing as it acts separately as poacher and gamekeeper in the pharmaceutical industry is probably not lost on Teva; on the one hand using Citizen Petitions and litigation to protect its proprietary products whilst on the other hand having to adapt and respond to these very same tactics to push its generics onto the marketplace. Neither of course are the attacks on its proprietary stock unexpected. It will be interesting to see if Teva can defend its branded products with the same determination which has made it the world’s largest generics company.