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Bankleitzahlen - online.de


Eurand Reports Recent Developments and Third Quarter and Year-to-Date 2008 Financial Results

Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




Highlights:

* Grew third quarter 2008 revenues to EUR 24.6 million ($32.0
million), a 30% increase in constant currency from the third
quarter of 2007;

* Grew year-to-date revenues in 2008 to EUR 72.8 million ($95.0
million), up 23% in constant currency from the same period in
2007;

* Received $25 million cash payment as part of the $35 million cash
settlement of litigation with UCB, Inc.;

* Submitted to FDA the response to the FDA approvable letter on
EUR-1008 (Zentase(r)); Eurand's raw material supplier for
EUR-1008 is currently in the process of replying to the FDA's
questions regarding the Drug Master File (DMF);

* Entered into three new co-development contracts with different
pharmaceutical companies, bringing the year-to-date total to six
new collaborations; and

* Met with FDA and defined clinical and regulatory development
plans for EUR-1025 (once-daily formulation of ondansetron).

AMSTERDAM, Netherlands, Nov. 7, 2008 (GLOBE 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 reported strong
growth in revenues for the third quarter and nine months ended
September 30, 2008.

"The third quarter was another great quarter for Eurand; our revenues
grew significantly, and we achieved many important milestones," said
Gearoid Faherty, Chairman and Chief Executive Officer. "In addition,
the proceeds from the UCB settlement have significantly strengthened
our cash position." Faherty noted that revenues grew in part due to
the strong growth in sales of AMRIX(r) (Cyclobenzaprine Hydrochloride
Extended-Release Capsules) by Eurand's partner, Cephalon. Cephalon's
sales of AMRIX increased by 20% sequentially, to $20.5 million in the
third quarter and were $47.4 million for the nine months in 2008. In
further support of AMRIX, Cephalon announced that they intend to
expand their sales force detailing this once-daily muscle relaxant by
nearly 50% in early 2009, from the current 570 to 840
representatives.

As recently reported, Eurand and Cephalon received two Paragraph IV
Certification Notice Letters regarding Abbreviated New Drug
Applications submitted to the FDA by Mylan Pharmaceuticals, Inc. and
Barr Laboratories, Inc. requesting approval to market and sell a
generic version of AMRIX.

On September 5, 2008, Eurand received $25 million in cash from UCB,
Inc. as part of the $35 million litigation settlement announced on
August 6, 2008. This brings Eurand's total cash and cash equivalents
to EUR 26.6 million ($34.7 million) at September 30, 2008. The
settlement also includes $5 million payments on each of the first two
anniversaries of the settlement date.

During the third quarter, Eurand submitted its response to the U.S.
Food and Drug Administration's (FDA) approvable letter issued in June
2008 for its development product EUR-1008 (Zentase(r)), an innovative
pancreatic enzyme product (PEP) intended for the treatment of
exocrine pancreatic insufficiency. Eurand's raw material supplier for
EUR-1008 is expected to complete its responses in the coming weeks to
the FDA's questions pertaining to the DMF. Based on this timeline and
subject to the FDA's remaining review, Eurand anticipates FDA
approval of EUR-1008 in the first quarter of 2009 and launch about 30
to 60 days post-approval.

Also during the third quarter, the Company met with the FDA to define
the clinical and regulatory development plans for EUR-1025, a
once-daily formulation of Zofran(r) (ondansetron), an anti-emetic
sold by GlaxoSmithKline. Eurand intends to file an Investigational
New Drug (IND) application in 2008 to allow for initiation of
additional pharmacokinetic studies.

"Submitting our responses to the questions raised in the FDA's
approvable letter for EUR-1008 was an important step toward
completing the review process, and we look forward to our raw
material supplier completing its responses to the DMF questions
soon," said Gearoid Faherty, Chief Executive Officer. As previously
announced, upon receipt of FDA approval, the Company anticipates
launching EUR-1008 with its own sales force. "Combined with the
expected FDA approval of two other products, EUR 1048 and EUR-1000,
the depth of our pipeline and the continued strength and diversity of
our base business, we believe Eurand is well positioned for further
growth in 2009 and beyond."

PIPELINE REVIEW:

EUR-1008 - Zentase (pancrealipase capsules)

* Eurand completed its response in late August 2008 to the
agency's questions raised in the FDA approvable letter received
in June 2008. The Company's raw material supplier for EUR-1008
is currently in the process of completing its responses to
questions raised by the FDA related to its DMF. Assuming FDA
approval, the Company intends to market EUR-1008 in the U.S.
with its own specialty sales force targeting all 120 cystic
fibrosis treatment centers as well as key gastroenterologists
and pulmonologists.

* As previously reported, the Company's Marketing Authorization
Application (MAA) for EUR-1008 is eligible for review under the
centralized procedure in the European Union, allowing market
access to 27 EU member states and 10 years of regulatory market
exclusivity. Recently the European Medicines Evaluation Agency
(EMEA) issued draft guidance for PEPs; based on the draft
guidance, Eurand concluded that it would be prudent to conduct
an additional clinical study prior to filing its MAA. The Company
now expects to file the MAA with the EMEA in the second half of
2010. Eurand intends to out-license marketing rights to EUR-1008
outside the U.S. and is currently in late-stage negotiations
with potential partners in Europe. The Company is also seeking
potential partners in Asia.

* Eurand also noted that a Phase III trial evaluating the safety
and efficacy of EUR-1008 in chronic pancreatitis is nearing
completion of patient enrollment. The results of this trial are
expected to be available in the first half of 2009.

EUR-1025 - Once-Daily Formulation of Ondansetron

* In early 2008, Eurand announced positive results of a pilot
pharmacokinetic study demonstrating bioequivalence to Zofran(r)
when normalized for dose. During the third quarter, Eurand met
with the FDA to define the clinical and regulatory pathway for
EUR-1025. Based on the outcome of this meeting, the Company
intends to file an Investigational New Drug Application (IND)
to allow for initiation of additional pharmacokinetic studies
in 2008, which it anticipates completing in 2009 as part of a
future 505(b)(2) filing for this product.

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. Marketed in Europe under
the Clipper(tm) 5 mg tablets brand, EUR-1073 is intended for use
in the treatment of ulcerative colitis, one of the two most
prevalent forms of inflammatory bowel disease. EUR-1073 was
developed using a drug delivery system that targets the lower
gastrointestinal tract, providing a sustained release of drug
upon delivery that is intended to preserve the efficacy of
classical corticosteroids while reducing the risk of the known
side effects commonly associated with their use. Chiesi is nearing
completion of patient enrollment in a Phase IIIb clinical study
in Europe comparing Clipper to the current standard of care in
ulcerative colitis. The results of this trial, expected in the
second quarter of 2009, will influence the course of Eurand's
future discussions with the FDA regarding a clinical development
and regulatory pathway for this product in the U.S.

Eurand has more than 10 other product candidates in various earlier
stages of development, both on a proprietary basis and for
co-development partners.

Eurand has entered into six co-development agreements to date in 2008
and is in discussions with a number of leading pharmaceutical and
biotechnology companies for agreements to develop additional products
using its drug formulation technologies.

THIRD QUARTER 2008 FINANCIAL RESULTS

For the three months ended September 30, 2008, total revenues were
EUR 24.6 million ($32.0 million). This represents an approximately
30% increase at constant currency from the third quarter of 2007. The
growth can be attributed primarily to product sales and royalties
from Axcan's Ultrase(r) and Cephalon's Amrix, as well as revenues
from Source CF, which Eurand acquired in December 2007. Product sales
rose 34% at constant currency to EUR 20.1 million ($26.3 million) in
the 2008 third quarter compared with the same period of 2007.

Royalties were EUR 2.0 million ($2.6 million), representing an
increase of 103% at constant currency compared with the third quarter
of 2007. Development fees were EUR 2.4 million ($3.1 million), down
16% at constant currency from the prior year period. Revenue from
development fees can fluctuate from quarter to quarter because a
significant portion of fees are recognized upon achievement of
development milestones.

Cost of goods sold were EUR14.1 million ($18.4 million) for the three
months ended September 30, 2008 resulting in a margin on product
sales of approximately 30% for the quarter. Research and development
(R&D) expenses were EUR 4.7 million ($6.2 million) for the three
months ended September 30, 2008, up 14% at constant currency rates
compared with the same period in 2007. Selling, general and
administrative (SG&A) expenses of EUR 7.4 million ($9.7 million),
increased by 37% at constant currency compared with the third quarter
of 2007. This increase was primarily due to the costs associated with
the Company's sales and marketing infrastructure, built partly
through the acquisition of Source CF, in preparation for the launch
of EUR-1008, as well as other expenses related to the costs of public
company compliance and other legal costs.

The settlement of litigation with UCB for $35 million translated at
the then exchange rate of approximately EUR 1=$1.43 into a gain of
EUR 24.4 million ($31.8 million at the convenience rate; see the note
on currency presentation below) which was recorded as income from
litigation settlement, a component of our operating income for the
quarter.

Operating income in the third quarter of 2008 was EUR 22.5 million
($29.3 million). Excluding the impact of the gain from the above
settlement of EUR 24.4 million ($31.8 million at the convenience
rate), operating income would have been a loss of approximately EUR
1.9 million ($2.5 million) versus an operating loss of EUR 1.0
million ($1.3 million) in the same period of 2007.

Income from financial items was EUR 115,000 ($150,000) for the three
months ended September 30, 2008 versus EUR 109,000 ($142,000) for the
same period of 2007.

Tax expense for the third quarter was EUR 1.0 million ($1.3 million).
The valuation allowance against our net operating losses (NOLs) was
reduced because certain of our subsidiaries incurred taxable income
in the period, which enabled them to utilize NOLs. In particular, the
operating results of our U.S. subsidiary benefited from the
litigation settlement. We estimate that utilization of NOLs incurred
in the past limited the tax expense attributable to the gain on the
settlement of the litigation with UCB to approximately EUR 758,000
($988,000) due to Alternative Minimum Tax (AMT) and certain local
taxes.

Net income for the third quarter of 2008 was EUR 21.6 million ($28.2
million), or EUR 0.46 per fully diluted share ($0.60 per share).
Excluding the impact of the gain attributable to the settlement of
approximately EUR 24.4 million ($31.8 million at the convenience
rate) and the above estimate of attributable tax expense of
approximately EUR 758,000 ($988,000), net income would have been a
loss of approximately EUR 2.0 million ($2.7 million), or EUR (0.05)
per share ($(0.06) per share), for the third quarter of 2008. This
compares with a net loss of EUR 1.1 million ($1.5 million), or EUR
(0.03) per share ($(0.03) per share), for the third quarter of 2007.

At September 30, 2008, cash and cash equivalents were EUR 26.6
million ($34.7 million), and debt was EUR 1.0 million ($1.3 million).

YEAR-TO-DATE 2008 FINANCIAL RESULTS

Total revenues were EUR 72.8 million ($95.0 million) for the nine
months ended September 30, 2008, an increase of approximately 23% at
constant currency rates compared with the first nine months of 2007.
The growth can be attributed primarily to product sales and royalties
from Axcan's Ultrase and Cephalon's Amrix, as well as revenues from
Source CF, which Eurand acquired in December 2007. In particular,
product sales grew 22% at constant currency to EUR 60.7 million
($79.1 million) year to date in 2008 compared with the same period of
2007. Royalties were EUR 5.4 million ($7.0 million), representing an
increase of 108% at constant currency compared with the first nine
months of 2007. Development fees were EUR 6.8 million ($8.9 million),
up 2% at constant currency from the prior year period.

Cost of goods sold were EUR 39.6 million ($51.7 million) for the nine
months ended September 30, 2008, resulting in a margin on product
sales of approximately 35% for the period. R&D expenses were EUR 13.2
million ($17.2 million) for the nine months ended September 30, 2008,
up 16% at constant currency rates compared with the same period in
2007. SG&A expenses of EUR 23.3 million ($30.3 million) were higher
by 68% at constant currency compared with the first nine months of
2007. This increase was primarily due to the costs associated with
building the Company's sales and marketing infrastructure, partly
through the acquisition of Source CF, in preparation for the launch
of EUR-1008, as well as other expenses related to the costs of public
company compliance and other legal expenses including litigation
costs.

The settlement of litigation with UCB for $35 million translated at
the then exchange rate of approximately EUR1=$1.43 into a gain of EUR
24.4 million ($31.8 million at the convenience rate) which was
recorded as income from litigation settlement, a component of our
operating income for the nine months to September 30, 2008.

For the nine months in 2008, operating income was EUR 20.1 million
($26.2 million). Excluding the impact of the gain from the above
settlement of EUR 24.4 million ($31.8 million), operating income
would have been a loss of EUR 4.3 million ($5.6 million) versus
operating income of EUR 844,000 ($1.1 million) for the same period of
2007. Income generated from financial items was EUR 365,000
($476,000) for the nine months ended September 30, 2008 versus an
expense of EUR 1.5 million ($1.9 million) for the same period in
2007. The year-over-year comparison reflects the impact of the debt
repayment combined with the increase in cash deposits from the
proceeds of Eurand's May 2007 IPO.

Net income was EUR 17.8 million ($23.2 million), or EUR 0.38 per
fully diluted share ($0.50 per share), for the first nine months of
2008. Excluding the impact of the gain attributable to the settlement
of EUR 24.4 million ($31.8 million at the convenience rate) and the
above estimate of attributable tax expenses of approximately EUR
758,000 ($988,000), net income would have been a loss of
approximately EUR 5.9 million ($7.6 million), or EUR (0.13) per share
($(0.17) per share). This compares with a loss of EUR 1.6 million
($2.1 million), or EUR (0.04) per pro forma share ($(0.05) per pro
forma share), for the same period in 2007.

Attached to this earnings press release are three tables:

1. Selected consolidated statements of operations for the three
months ended September 30, 2008 compared with the same period
in 2007

2. Selected consolidated statements of operations for the nine
months ended September 30, 2008 compared with the same period
in 2007

3. Selected balance sheet data

Note on currency presentation

This press release contains translations of euros into U.S. dollars
at a convenience rate of EUR 1=$1.304, the noon buying rate at the
Federal Reserve Bank of New York on November 5, 2008.

The $35 million gain on the litigation settlement quoted in this
press release was recognized in the income statement in September as
EUR 24.4 million at the rate of EUR 1=$1.434, the rate at the time of
the transaction as required by US GAAP. When the Euro income
statement amount is converted to U.S. dollars at the convenience rate
of EUR 1=$1.304 used in this press release, the dollar converts to
$31.8 million.

Percentage variances quoted in "Constant Currency" represent the
increase or decrease recomputed as if euro/dollar exchange rates had
been the same in the three months ended September 30, 2008 as they
were in the same period in 2007. As a guide, average exchange rates
were EUR 1=$1.521 in the nine months to September 30, 2008, EUR
1=$1.345 in the nine months to September 30, 2007, and EUR 1=$1.502
in the three months to September 30, 2008, and EUR 1=$1.376 in the
three months to September 30, 2007.

Conference Call Information

Eurand will host a conference call on Friday, November 7, 2008 at
8:30 a.m. Eastern Time, 2:30 p.m. Central Europe Time, covering the
third quarter and nine months 2008 financial results.

To participate in the conference call, U.S. participants dial
1-877-407-9039, international participants dial +1-201-689-8470. A
replay of the call will be available until December 7, 2008. To
participate in the replay of the call, U.S. participants dial
1-877-660-6853, international participants dial +1-201-612-7415. The
account number is: 3055; conference ID number: 299594.

A live web cast of the call also will be available from the investor
relations section of the company website at www.eurand.com. Following
the live webcast, the archived version of the call will be available
at the same URL until December 7, 2008.

About Eurand

Eurand is a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary drug formulation
technologies. Eurand has had four products approved by the FDA since
2001 and has a pipeline of product candidates in development for
itself and its collaboration partners. Eurand's technology platforms
include bioavailability enhancement of poorly soluble drugs,
customized release, taste-masking/fast-dissolving formulations and
drug conjugation.

Eurand is a global company with facilities in the U.S. and Europe.
For more information, visit Eurand's website at www.eurand.com.

Eurand Forward-Looking Statement

This release, and oral statements made with respect to information
contained in this release, constitutes forward-looking statements.
Such forward-looking statements include those which express plan,
anticipation, intent, contingency, goals, targets or future
development and/or otherwise are not statements of historical fact
including, but not limited to, the future and status of our NDA or
MAA filing and EUR-1008, enrollment and future plans for our clinical
trials, progress of and reports of results from clinical studies,
clinical development plans and product development activities. The
words "potentially," "anticipates," "could," "calls for" and similar
expressions also identify forward-looking statements. These
statements are based upon management's current expectations and are
subject to risks and uncertainties, known and unknown, which could
cause actual results and developments to differ materially from those
expressed or implied in such statements. Factors that could affect
actual results include risks associated with the possibility that the
FDA does not approve our NDA relating to EUR-1008 or additional
delays associated with regulatory approvals; the outcome of any
discussions with the FDA; and unexpected delays or additional
requirements in preparation of materials for submission to the FDA as
a part of our NDA filing, including those relating to Eurand's raw
material supplier. Forward-looking statements contained in this press
release are made as of this date, and we undertake no obligation to
publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise. Actual events could
differ materially from those anticipated in the forward-looking
statements.



--- End of Message ---

Eurand N.V.
845 Center Drive Vandalia, Ohio USA

WKN: A0MSPK; ISIN:
NL0000886448;
;
Copyright © Hugin AS 2008. All rights reserved.



 
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