Eurand Announces FDA Approval
of EUR-1048 (Lamictal ODT),
Co-Developed With
GlaxoSmithKline
Drug Delivery Technology June 2009 Vol 9 No 6
Eurand N.V., a specialty pharmaceutical company that
develops enhanced pharmaceutical and biopharmaceutical
products based on its proprietary pharmaceutical technologies,
recently announced that the US FDA has approved EUR-1048,
to be marketed as GlaxoSmithKline's Lamictal ODT
(lamotrigine) Orally Disintegrating Tablets. Co-developed by
Eurand and GSK, Lamictal ODT uses Eurand's Adva Tab 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-, 50-, 100-, 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
Adva Tab and Microcaps 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 of Eurand. "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 US marketplace.
Net sales of Lamictal, one of the world's top 60
pharmaceutical products based on annual sales, were $1.3
billion in the US 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
US.
Lamictal ODT uses a combination of two of Eurand's
novel drug delivery technologies. Adva Tab 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. Adva Tab
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.
