DJ HUGIN NEWS/Eurand Reports Recent Developments and Second Quarter 2008 Financial Results

DJ HUGIN NEWS/Eurand Reports Recent Developments and Second Quarter 2008 Financial Results

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Highlights: 

  * Received approvable letter for New Drug Application (NDA) for
    EUR-1008 (Zentase(r)) 

  * Achieved successful FDA pre-approval inspection of Milan
    manufacturing facility and successful FDA pre-approval
    inspection of raw material supplier facility for EUR-1008 

  * Awarded patent from USPTO for Amrix(r), granting protection into
    2025 

  * Eurand to receive $35 million in settlement of litigation with
    UCB, Inc. 

  * Grew second quarter 2008 revenues 16% year-over-year at constant
    currency to EUR 23.4 million ($36.9 million U.S.) 

  * Grew first half 2008 revenues 20% year-over-year at constant
    currency to EUR 48.3 million ($76.0 million U.S.) 

AMSTERDAM, Netherlands, Aug. 7, 2008 (PRIME NEWSWIRE) -- Eurand N.V.
(Nasdaq:EURX), a specialty pharmaceutical company that develops
enhanced pharmaceutical and biopharmaceutical products based on its
proprietary drug formulation technologies, today announced recent key
achievements and financial results for the second quarter and first
half of 2008. 

The leading development of the quarter was the approvable letter from
the U.S. Food and Drug Administration (FDA) for Eurand's New Drug
Application (NDA) for EUR-1008 (pancrealipase capsules) for the
treatment of Exocrine Pancreatic Insufficiency (EPI). Eurand also
reported successful FDA pre-approval inspections of its Milan
manufacturing facility and the EUR-1008 raw material supplier's
facility. In another noteworthy development, the Company was granted
a patent for Amrix(r) (cyclobenzaprine HCl), the first and only
once-daily skeletal muscle relaxant which Eurand developed and that
is currently marketed in the U.S. by Cephalon, Inc. The patent
provides coverage on Amrix(r) until 2025. 

"The second quarter was another extremely active and productive
period for Eurand, highlighted by two important regulatory milestones
in our efforts to commercialize EUR-1008: the approvable letter and
successful plant inspections for EUR-1008," said Gearoid Faherty,
Chief Executive Officer. "In the coming weeks, we expect to submit
our responses to all of the FDA's questions in the approvable letter,
which pertain to the chemistry, manufacturing and controls section of
the NDA. We have been advised that our raw material supplier for
EUR-1008 also expects to respond to the FDA in the coming weeks on
the questions that they received regarding their Drug Master File
(DMF). Concurrently, our U.S. commercial team continues to prepare
for the anticipated launch of this product, which we believe will be
late fourth quarter 2008." He added that a fourth quarter 2008 launch
is dependent on the timing of final FDA approval of the NDA. 

"In all, three new products could potentially be granted FDA approval
in the fourth quarter of this year, including EUR-1008, the first
product that we intend to bring to market on our own. In addition, we
will maintain our focus on advancing our pipeline, growing our base
business and securing additional co-development and licensing
agreements," said Faherty. He noted that Eurand has signed three such
agreements year to date and is on track to meet its previously stated
goal of five signed agreements in 2008. 

LITIGATION SETTLEMENT 

As announced on August 6, 2008, Eurand and UCB, Inc. agreed to settle
litigation concerning a 1999 development, license and supply
agreement between the two companies for a sustained-release
formulation of methylphenidate hydrochloride (MPH). MPH is an active
ingredient used to treat Attention Deficit Hyperactivity Disorder.
The settlement will close by September 5, 2008. Under the terms of
the settlement, UCB will pay Eurand $35 million, as follows: 

    * $25 million at closing
    * $5 million, plus interest, at the first anniversary of
      the closing
    * $5 million, plus interest, at the second anniversary of
      the closing 

 PRODUCT DEVELOPMENT PIPELINE UPDATES: 

 EUR-1008 -- Zentase(r) 

    * On June 18, 2008, Eurand announced that it had received an
      approvable letter from the U.S. Food and Drug Administration
      (FDA) for its New Drug Application (NDA) for EUR-1008
      (pancrealipase capsules) for the treatment of exocrine
      pancreatic insufficiency (EPI).  The letter marks notable
      progress towards gaining approval and does not require Eurand to
      conduct additional clinical trials prior to approving EUR-1008.
      In addition, the FDA recently completed a successful pre-
      approval inspection (PAI) of the Company's manufacturing
      facilities and those of its raw material supplier for EUR-1008.
      Pending FDA approval, Eurand intends to market the product in
      the U.S. with a specialty sales force targeting all 120 Cystic
      Fibrosis Treatment Centers as well as key gastroenterologists
      and pulmonologists. 

      Eurand intends to out-license marketing rights to EUR-1008
      outside of the U.S. and is currently in negotiations with
      potential partners in Europe. In April 2008, Eurand received
      confirmation from the European Medicines Evaluation Agency (EMEA)
      that a marketing application for EUR-1008 is eligible for
      Community (Centralized) Marketing Authorization submission in
      the European Union (EU). Approval under this process would allow
      market access to 27 EU member states and provide 10 years of
      market exclusivity.  Eurand plans to file a marketing
      authorization application (MAA) for EUR-1008 by mid-2009 to meet
      the EMEA's 18-month timeline for filing once centralized review
      has been granted.  During the second quarter, the Company
      submitted a pediatric investigational plan for EUR-1008 as
      required under the EU's new pediatric medicines legislation. 

 EUR-1002 -- Amrix(r) (cyclobenzaprine HCl) 

    * On June 17, 2008, the United States Patent and Trademark Office
      (USPTO) granted the Company U.S. patent No. 7,387,793, entitled
      "Modified Release Dosage Forms of Skeletal Muscle Relaxants."
      The Company was also awarded a Patent Term Adjustment of an
      additional 470 days, providing Eurand with coverage until at
      least February 26, 2025.  Eurand's patent, which was listed in
      the FDA's Orange book on June 17, 2008, includes claims covering
      Amrix(r) (cyclobenzaprine hydrochloride), a product currently
      marketed in the U.S. by Cephalon under license from Eurand.
      Amrix(r) is the only approved once-daily formulation of the
      skeletal muscle relaxant cyclobenzaprine hydrochloride, for the
      relief of muscle spasm associated with acute, painful
      musculoskeletal conditions. 

      The extended-release formulation, developed by Eurand using its
      proprietary Diffucaps(r) technology, was launched by Eurand's
      partner, Cephalon, in the U.S. in November 2007. Currently
      marketed skeletal muscle relaxant products are typically dosed
      multiple times a day and cause varying degrees of somnolence.
      Amrix(r) not only provides the benefit of once-daily dosing, but
      Cephalon has reported that it also has a lower incidence of
      somnolence compared to immediate release cyclobenzaprine. Eurand,
      as the developer, licensor and exclusive manufacturer of the
      product, is working with Cephalon to support the
      commercialization of the product in the U.S. Eurand receives
      royalty payments and manufacturing revenue from Cephalon on
      Amrix(r) sales, which Cephalon reported as $26.9 million for the
      six months ended June 30, 2008. 

 EUR-1025 -- Once-Daily Formulation of Ondansetron 

    * In February 2008, Eurand announced positive results of a pilot
      pharmacokinetic study demonstrating bioequivalence, when
      normalized for dose, of this formulation to an 8 mg dose of the
      anti-emetic drug Zofran(r) (ondansetron) administered in two
      doses.  A meeting is planned with the FDA in the third quarter
      of 2008 to discuss the clinical and regulatory pathway for this
      proprietary product.  EUR-1025 uses Eurand's Diffucaps(r)
      extended-release technology. Pending the outcome of its
      discussions with the FDA, the Company expects commencing
      clinical trials by the end of 2008. 

 EUR-1073 -- Clipper(tm) (beclomethasone diproprionate) 

    * In April 2008, Eurand was granted an exclusive license by Chiesi
      Farmaceutici SpA to its gastro-resistant, controlled-release
      tablet formulation of the corticosteroid, beclomethasone
      diproprionate, in the U.S. and Canada. The product is currently
      approved and marketed in the United Kingdom, Italy, Spain, and
      Belgium. Eurand will make an up-front payment and commercial
      milestone payments to Chiesi contingent upon filing an
      Investigational New Drug (IND) application for the product,
      which Eurand refers to as EUR-1073. Eurand will also pay
      royalties on net sales of EUR-1073. 

      Marketed in Europe under the Clipper(tm) 5 mg tablets brand,
      Eurand's newly in-licensed product candidate EUR-1073 is an
      enteric-coated, controlled-release formulation of beclomethasone
      diproprionate, a corticosteroid intended for use in the
      treatment of Ulcerative Colitis, one of the two most prevalent
      forms of inflammatory bowel disease. EUR-1073 was developed by
      Chiesi using a drug delivery system that targets the lower
      gastrointestinal tract, providing a sustained release of drug
      upon delivery which is intended to preserve the efficacy of
      classical corticosteroids while reducing the side effects
      commonly associated with their use. Eurand plans to work with
      the FDA to establish a clinical development and regulatory

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