Abon Pharmaceuticals announces its presence; Stada sells Russian plants
An interesting article from Espicom’s World Generic Markets business publication.
On 31st July 2012, Abon Pharmaceuticals announced that it had filed an ANDA with a Paragraph IV certification with the FDA for a proposed generic 1 mg / ml clofarabine injection product. The proposed generic is a version of Genzyme’s Clolar Injection, a prescription drug indicated for the treatment of paediatric patients between one and 21 years old with relapsed or refractory acute lymphoblastic leukaemia. The filing has led to Genzyme filing a lawsuit against Abon in the US District Court for the District of New Jersey, alleging infringement of patent number 5,661,136, the only patent listed in the FDA’s Orange Book protecting Clolar, and which expires on 14th January 2018, but additional paediatric exclusivity until 14th July 2018. To date, no versions of Clolar, which was introduced in the US in December 2004, have been tentatively or fully approved by the FDA.
Abon Pharmaceuticals is a new company, having been founded in 2009, and is based in Northvale, New Jersey. This patent challenge announcement appears to herald the firm’s first generic; Abon has commented that the filing is an important milestone for it. The firm describes itself as a specialty pharmaceutical company engaged in the development of generic and proprietary products that have challenging formulation barriers. The firm has filed a number of patent applications for drug delivery technologies. Abon was founded by two former employees of Barr Pharmaceuticals: Salah U Ahmed and Bruce Downey. In Barr, Dr Ahmed had been the Executive Vice President of Global Research and Development and Chief Scientific Officer, and had been responsible for the development of generic and proprietary pharmaceuticals as well as API and biotechnology products. Dr Ahmed worked with Barr for 16 years. Bruce Downey had been the Chairman and CEO of Barr, and had joined the firm in 1993. Unlike Dr Ahmed, Mr Downey had a law background prior to joining Barr.
Elsewhere, on 7th August 2012, Stada Arzneimittel announced that it expected the sale of two Russian production facilities to occur within the third quarter of 2012, further announcing on 15th August that the contract for the sale had been signed. The facilities are being sold through a partial management buyout; the assets of the facilities have been transferred through the sale of Stada’s indirectly-owned subsidiaries, OOO Makiz Pharma and OOO Skopin Pharmaceutical Plant, to LLC DMN Invest Moscow. Stada commented that the sale of the plants fit in with its Group-wide cost efficiency programme, which was announced in 2010. All products currently manufactured for Stada in the plants will be transferred to other existing Russian Stada facilities, in a move expected to be finalised in 2014.
Russia is Stada’s second-largest market, behind Germany. In 2011, the firm reported sales in Russia worth 279.6 million euros (US$389.4 million), compared to 479.9 million euros (US$668.4 million) in Germany. Sales in Russia in 2011 grew by some 26% in euro terms over 2010.
Article source: Ian Platts. Editor of Espicom’s business publication World Generic Markets
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