PHILADELPHIA, PA -- (Marketwire) -- 05/11/09 -- Eurand N.V. (NASDAQ: EURX), a specialty
pharmaceutical company that develops enhanced pharmaceutical and
biopharmaceutical products based on its proprietary pharmaceutical
technologies, today announced that the U.S. Food and Drug Administration
(FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline's (NYSE: GSK) Lamictal® ODT(TM) (lamotrigine) Orally Disintegrating Tablets.
Co-developed by Eurand and GSK, Lamictal ODT uses Eurand's AdvaTab®
orally disintegrating tablet (ODT) and Microcaps® 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® and
Microcaps® proprietary technologies to co-develop Lamictal ODT with GSK,
and we look forward to a successful launch," said Gearóid 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®, 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® 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® taste-masking technology. Microcaps®
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.
Safety Information
Prescription Lamictal ODT Tablets are not for everyone. Lamictal ODT is
another form of Lamictal. Lamictal may cause a serious skin rash that may
cause the patient to be hospitalized or to stop Lamictal; it may rarely
cause death. There is no way to tell if a mild rash will develop into a
more serious reaction. These serious skin reactions are more likely to
happen when the patient begins taking Lamictal, within the first 2 to 8
weeks of treatment. But it can happen in people who have taken Lamictal for
any period of time.
