AMSTERDAM, THE NETHERLANDS -- (Marketwire) -- 08/06/09 -- Eurand N.V. (NASDAQ: EURX)
Recent Developments:
-- Second quarter 2009 revenues grew 31%, or 19% at constant currency
rates, to EUR 30.6 million ($42.8 million U.S.) compared with the same
period in 2008
-- U.S. Food and Drug Administration (FDA) approved EUR-1048, LAMICTAL®
ODT(TM) (lamotrigine) Orally Disintegrating Tablets; Eurand's partner
GlaxoSmithKline commenced product launch in late June
-- Strong growth of PANCRELIPASE, Eurand's unbranded pancreatic enzyme
product (PEP), which continues to gain market share and held 19% of all
prescriptions for coated PEPs for the week ended July 24, 2009, according
to IMS Health Incorporated
-- Successful completion of the registration procedure for Paracetamol
ODT 250 and 500 mg in The Netherlands, United Kingdom, Germany, France,
Italy and Spain
-- Positive results from two pivotal pharmacokinetic studies of EUR-1025
(ondansetron)
-- Signed a commercialization and supply agreement for its branded PEP,
ZENPEP(TM), in South Korea with Samil Pharmaceutical Co., Ltd.
-- Received notice of allowance from the U.S. Patent and Trademark Office
for an additional patent covering AMRIX® that is expected to strengthen
the intellectual property protection around this product
Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that
develops enhanced pharmaceutical and biopharmaceutical products based on
its proprietary pharmaceutical technologies, today announced recent
developments and financial results for the second quarter and first half of
2009.
"Eurand had another excellent quarter," said Gearóid Faherty, Chairman and
Chief Executive Officer. "In addition to our strong revenue growth, our
partner GlaxoSmithKline received FDA approval for LAMICTAL ODT. This is
the fifth Eurand-developed product to receive FDA approval in the last
eight years, an especially impressive achievement."
He noted that revenue growth was driven by strong sales of Eurand's
unbranded pancreatic enzyme product, PANCRELIPASE, combined with continued
growth in sales of partnered products, notably AMRIX® by Cephalon.
With a 19% share of total prescriptions dispensed in the coated PEP market
for the week ended July 24, 2009, PANCRELIPASE has strengthened the
position it has held since late April 2009 as the second most-prescribed
coated PEP, according to IMS Health.
"As the second half of the year unfolds, we look forward to a very exciting
time for Eurand with the ongoing launch of LAMICTAL ODT by GSK and the
expected approval and launch of our lead proprietary product candidate,
ZENPEP," Faherty added. "We are encouraged by our recent discussions with
the FDA regarding the ZENPEP label and packaging, and we believe that
approval remains on course for the third quarter of 2009."
PRODUCT DEVELOPMENT PIPELINE UPDATE:
EUR-1048 - Lamictal® ODT(TM) (lamotrigine) Orally Disintegrating Tablets
-- As announced on May 11, 2009, the FDA approved EUR-1048, LAMICTAL ODT
(lamotrigine) Orally Disintegrating Tablets for the treatment of Bipolar I
disorder and seizures. Co-developed by Eurand and GlaxoSmithKline,
LAMICTAL ODT uses Eurand's AdvaTab® orally disintegrating tablet and
Microcaps® taste-masking technologies. LAMICTAL ODT was launched by GSK
in late June. In addition to receiving an undisclosed milestone payment
upon launch, Eurand will earn 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.
PARACETAMOL ODT Orodispersible Tablets
-- On July 20, 2009, Eurand announced that the Dutch Medicines Evaluation
Board (MEB) informed the Company that the Decentralized Procedure (DCP) for
registration of Paracetamol 250 and 500 mg Orodispersible Tablets in six EU
countries has been successfully completed. In addition to The Netherlands,
which acted as the reference member state, the DCP involved the United
Kingdom, Germany, France, Italy and Spain. The product has since been
approved in the U.K., and formal approval is now expected in each of the
other countries by the end of 2009. Eurand is actively talking to potential
marketing partners in these countries. Like Lamictal ODT, Paracetamol ODT
uses Eurand's AdvaTab orally disintegrating tablet and Microcaps taste-
masking technologies.
EUR-1008 - ZENPEP(TM) (pancreatic enzyme product)
-- On June 22, 2009, Eurand announced that the FDA had extended the
review date to late third quarter 2009 for its New Drug Application (NDA)
for ZENPEP for the treatment of exocrine pancreatic insufficiency (EPI).
The FDA required no new information but requested additional time to review
the NDA.
-- Eurand has signed a commercialization and supply agreement with Samil
Pharmaceutical Co., Ltd. under which Samil will have exclusive marketing
and distribution rights to ZENPEP in South Korea.
EUR-1025 - Once-Daily Formulation of Ondansetron
-- Eurand has disclosed positive results of two pivotal pharmacokinetic
studies demonstrating bioequivalence of EUR-1025, a proprietary once-a-day
oral modified-release formulation of ondansetron to an 8 mg dose of the
anti-emetic drug Zofran® (ondansetron). Data from these studies showed
that single and repeated oral administrations of 24 mg of EUR-1025 once a
day resulted in similar rate and extent of exposure as 8 mg of Zofran dosed
three times a day. Based on these results, the Company expects that EUR-
1025 has a similar efficacy and safety profile as 8 mg Zofran dosed three
times a day. Eurand has scheduled a meeting with the FDA in the fourth
quarter of 2009 to discuss the data and its plans for clinically
differentiating EUR-1025 from the 8 mg Zofran.
EUR-1000 - Generic Formulation of Inderal® LA (propranolol)
-- Based upon recent communications between GSK and the FDA regarding EUR-
1000, Eurand now expects that approval could be delayed until 2010. A GSK-
partnered product, EUR-1000 is a bioequivalent formulation of INDERAL®
LA, which is indicated for treatment of hypertension and migraine.
SECOND QUARTER 2009 FINANCIAL RESULTS
Total revenues were EUR 30.6 million ($42.8 million U.S.) in the second
quarter of 2009, an increase of approximately 31%, or 19% at constant
currency rates, compared with the second quarter of 2008.