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Elan and J&JPRD submit NDA for novel Invega reformulation

Ireland-headquartered Elan and Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) have submitted an NDA to the FDA for a reformulation of the schizophrenia treatment, Invega (paliperidone).

Ireland-headquartered Elan and Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) have submitted an NDA to the FDA for a reformulation of the schizophrenia treatment, Invega (paliperidone).

The new formulation is an atypical antipsychotic, once monthly intramuscular injection. Paliperidone is a long-acting injectable ester of the active ingredient in Invega and uses Elan's proprietary NanoCrystal Technology as the delivery system.

Invega is a once-daily oral atypical antipsychotic for the treatment and maintenance of schizophrenia. The treatment has been seen to cause side-effects including tachycardia and hyperprolactinemia. The new formulation is J&J's way of reducing the side-effects and keeping the product ahead of rivals, such as Janssen Pharmaceutical's schizophrenia treatment, Risperdal Consta (risperidone).

Elan's NanoCrystal technology increases the rate of dissolution of paliperidone, which is poorly soluble in water and enables the formulation of an aqueous suspension for the once-monthly administration. The technology is covered by US and foreign patents and is part of a suite of technologies which Elan's Drug Technologies business offers to third party clients.

Four US marketed products currently use NanoCrystal Technology: lipid-lowering TriCor (fenofibrate), which is marketed by Abbott and Solvay; cachexia treatment Megace ES (megestrol), which is marketed by Par Pharmaceutical; immunosuppressant Rapamune (sirolimus), which is marketed by Wyeth: and the anti-emetic treatment Emend (aprepitant), which is marketed by Merck & Co.

Per the license agreement, Elan will receive payments when certain milestones are achieved. The company will also receive royalty payments based on sales of the formulation, if it is successfully commercialised.

Shane Cooke, CFO and head of Elan Drug Technologies, said: "This is the first long-acting injectable product developed and submitted to a Health Authority using Elan's NanoCrystal Technology and marks a significant milestone in the advancement of the technology."

In Q3 FY07, sales in J&J's antipsychotics portfolio, which includes Invega, were USD 2bn in the US, up from USD 1.8bn in Q3 FY06. Total global sales in Q3 FY07 for the segment were USD 3.5bn, up from USD 3.1bn in Q3 FY06.

30th September 2008

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