Bipolar Disorder - Eurand Announces FDA Approval Of EUR-1048 (Lamictal(R) ODT(TM)), Co-Developed With GlaxoSmithKline

Main Category: Bipolar
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 May 2009 - 0:00 PDT

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Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline's (NYSE: GSK) Lamictal(R) ODT(TM) (lamotrigine) Orally Disintegrating Tablets. Co-developed by Eurand and GSK, Lamictal ODT uses Eurand's AdvaTab(R) orally disintegrating tablet (ODT) and Microcaps(R) taste-masking technologies to provide Lamictal in a pleasant-tasting tablet that disintegrates on the tongue and that may be taken with or without liquid.

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older who have been treated for mood episodes with other medicine. It is not known if Lamictal ODT is safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression. Lamictal ODT is also used together with other medicines to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people 2 years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. It is not known if Lamictal ODT is safe or effective when used alone as the first treatment of seizures in adults. Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and 200 mg strengths and is expected to be available in pharmacies in early July 2009.

"We were delighted to have the opportunity to use our AdvaTab(R) and Microcaps(R) proprietary technologies to co-develop Lamictal ODT with GSK, and we look forward to a successful launch," said Gearoid Faherty, Chairman and Chief Executive Officer. "We see Lamictal ODT, Eurand's fifth FDA-approved drug since 2001, as another clear demonstration of the breadth of our drug formulation expertise and the depth of our pipeline."

Eurand will receive an undisclosed milestone payment upon launch, revenue for manufacturing Lamictal ODT tablets for GSK, royalties on net sales of the product and milestone payments in connection with Lamictal ODT achieving predetermined sales levels in the U.S. marketplace.

Net sales of Lamictal(R), one of the world's top 60 pharmaceutical products based on annual sales, were $1.3 billion in the U.S. in 2008. Eurand retains exclusive worldwide manufacturing rights to Lamictal ODT and, subject to certain conditions, either Eurand or GSK may have certain rights to commercialize the product in a particular country outside the U.S.

Lamictal ODT uses a combination of two of Eurand's novel drug delivery technologies. AdvaTab(R) orally disintegrating tablet technology uses Eurand's proprietary granulation and tabletting processes that allow the tablet to disintegrate rapidly in the mouth without chewing or the need for liquid. AdvaTab is distinct from conventional ODT technologies because it can be combined with Microcaps(R) taste-masking technology. Microcaps(R) taste-masking technology provides a coating that encapsulates drug particles, forming a barrier between the medication and the taste buds while still allowing the drug to dissolve in the stomach.

Source
Eurand N.V.