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Orion mulls legal options over generic Alzheimerís disease drugs

Orion Pharma is considering legal action after an unnamed generic drug company filed an abbreviated new drug application with the FDA to produce and market a generic version of entacapone in the US

Finland-based Orion Pharma is considering legal action after an unnamed generic drug company filed an abbreviated new drug application (ANDA) with the FDA to produce and market a generic version of entacapone in the US.

Entacapone is the active ingredient in Orion's Parkinson's disease drug Comtan, which is marketed by Novartis in the US.

Orion says it is considering its legal options to protect its rights.

"Under the US system, if a patent owner brings a lawsuit against an ANDA applicant within a certain time limit, there will be a 30-month stay of final FDA approval. During that time, the FDA can give only a tentative approval to the ANDA applicant unless the applicant obtains a favourable decision on all challenged patents in the lawsuit," said Orion in a statement. 

According to Orion, the applicant has filed so-called Paragraph IV certifications challenging three of five Orion US patents covering Comtan and listed in the Orange Book, the FDA's official listing of approved drug products. The US patents receiving Paragraph IV certifications were Nos 5,135,950, 5,446,194 and 6,599,530.

Paragraph IV certification means that a generic product will not infringe existing patents or that those patents are unenforceable.

For the two US entacapone patents which did not win Paragraph IV certifications (US Patent Nos 4,963,590 and 5,112,861), the applicant has assured the FDA it will not seek approval to market generic entacapone before the expiry of those two patents on 12 May 2009.

It is unclear at this stage what Orion will do to extend the lifecycle of Comtan, but the company already has links with the drug delivery firms Cardinal Health and RP Scherer, so a reformulation could be on the cards.

H1 FY07 net sales from the deliveries of Comtan and Orion's other PD drug, Stalevo, to Novartis were EUR 61.3m (USD 58.1m), an increase of 5.4 per cent on H1 FY06 sales.

14th August 2007

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