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

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.



View drug information on Lamictal.