Global Insight Perspective | |
Significance | Sanofi-Aventis has filed a lawsuit against Apotex after the Canadian firm filed for U.S. approval of BPH drug Uroxatral (alfuzosin hydrochloride). At the same time, new plans have been revealed for up to 30% of all Sanofi-Aventis drugs to be biotech-based by 2012. |
Implications | News of the biotech goal comes just days after Sanofi-Aventis expanded it stake in U.S. biotech Regeneron in a new R&D pact. However, the deal focuses on early-stage compounds, and only an acquisition would ensure that Sanofi-Aventis meets its ambitious new target. |
Outlook | A potential buyout of Regeneron is a significant possibility, particularly given the group's focus on antibody therapies within oncology, which Sanofi-Aventis is known to value highly. The firm's legal defence of Uroxatral's U.S. patent is expected to be intense, but increasing generic competition within the U.S. market will ensure that prices—and consequently, turnover—will keep diminishing. |
French pharmaceutical giant Sanofi-Aventis has filed a lawsuit against Canadian drug-maker Apotex for its seeking U.S. regulatory approval for a generic version of Uroxatral (alfuzosin hydrochloride), reports Bloomberg. Filing a complaint to a federal court in Wilmington, Delaware (U.S.), Sanofi-Aventis claimed that Apotex's application to the FDA infringes an existing patent on Uroxatral (the '491 patent, issued in 1987), and said that Apotex was aware of the existence of the patent prior to its filing. The '491 patent is one of two covering the drug's U.S. intellectual property rights and is the first to expire; according to the FDA, the '491 patent's life will end on 18 January 2011.
Uroxatral is approved as a treatment for benign prostatic hyperplasia (BPH), and is marketed under the brand name Xatral outside of the United States. The product is among Sanofi-Aventis's top-selling drugs, with turnover of 259 million euro (US$379.8 million) recorded during the first nine months of 2007. However, with an increasing number of competitor products available, sales have cooled, down by 5% year-on-year over January-September.
Apotex is not the only generics maker to challenge Sanofi-Aventis's patent exclusivity for Uroxatral: earlier this year, the French firm took out legal action against Barr Laboratories (U.S.) after it submitted an abbreviated new drug application (ANDA) containing a Paragraph IV certification for the 10-mg extended-release generic alfuzosin hydrochloride tablets (see France: 26 September 2007: Sanofi-Aventis Sues Barr over Generic Uroxatral).
More Biotech Drugs to Hit Market in Medium Term
In other corporate news, Sanofi-Aventis's R&D Director, Marc Cluzel, has said that the group is planning to significantly increase its number of approved biotech drugs sold as a proportion of its overall drugs portfolio. According to French newspaper La Tribune, Cluzel said that his ambition was to increase the proportion of marketed biotech drugs from the current 10% of the company's portfolio to between 20 and 30% by 2012. The statement comes shortly after Sanofi-Aventis increased its stake in U.S. biotech partner Regeneron in a new deal focusing on the development of fully humanised therapeutic antibodies in various oncology areas (see France: 29 November 2007: Sanofi-Aventis Boosts Stake in Regeneron as Part of New Co-Development Pact).
Outlook and Implications
In recent months, Sanofi-Aventis has revealed that it is actively looking to make strategic acquisitions within the biotech sector in order to boost its R&D pipeline and protect itself against the looming onset of generic competition (see France: 10 October 2007: Monoclonal Antibodies at Forefront of Sanofi-Aventis's Acquisition Plans). However, while the Regeneron deal significantly increases the likelihood of the French pharma giant making a takeover bid for the firm, the immediate research part only focuses on very early-stage compounds, none of which are likely to be ready for marketing approval prior to the patent expiry of such blockbusters as Lovenox (enoxaparin sodium) or Plavix (clopidogrel bisulfate). The biotech's most advanced compound is aflibercept (VEGF Trap), which recently entered Phase III trials as a treatment for two different forms of cancer.
Regarding Uroxatral, Sanofi-Aventis has shown its tenacity in the past in fighting generic companies in court, and has a particularly colourful history with regard to Apotex (see France: 20 June 2007: Early Relief for Sanofi-Aventis, BMS as U.S. Judge Rules in Favour of Plavix Patent). However, with Uroxatral's sales already in decline and its status as a revenue-earner being significantly smaller than the likes of Plavix, it remains to be seen how much value Sanofi-Aventis attaches to the drug's future brand-name sales. The U.S. market for BPH treatments has already become more fragmented following the approval of Mylan's (U.S.) generic Proscar (finasteride) last year (see United States: 20 December 2006: BPH Market Faces New Generic Proscar) and prices having come down as a result. With the U.S. patent on Astellas (Japan) and Boehringer Ingelheim's (Germany) Harnal (tamsulosin) set to expire in 2009, this trend looks set to continue.