SOURCE: Celtic Pharma

September 06, 2007 07:52 ET

Celtic Pharma announces - Licensing Agreement

Hamilton, Bermuda--(Marketwire - September 6, 2007) -

                                  ALPHARMA INC

 Alpharma acquires US rights to Diractin(R), IDEA's lead pain treatment product

LONDON, NEW YORK and HAMILTON, BERMUDA: September 6, 2007 - Celtic
Pharmaceutical Holdings L.P. ("Celtic Pharma"), the global private equity firm
focused on the biotechnology and pharmaceutical industries, announces that its
German portfolio company, IDEA AG has licensed the US rights to its lead
product, Diractin(R) for the treatment of deep pain, to an affiliate of Alpharma
Inc. a specialty pharmaceutical company, whose shares are listed on the New York
Stock Exchange.  Diractin(R) is a transdermal formulation of ketoprofen which
utilizes IDEA's innovative Transfersome(R) targeted drug delivery platform.
Alpharma's press release is appended to this announcement.

Under the terms of the licence agreement, Alpharma is paying IDEA $60m upfront
and three additional near-term payments totaling $77m upon the achievement of
certain regulatory and patent-related milestones.  Upon US regulatory approval
of Diractin(R), Alpharma will make a final milestone payment of either $45m or
$65m, depending on the results of one of the clinical trials for the product.
Alpharma will also pay IDEA royalties based on the annual level of sales
achieved in the US market.  As part of the licence transaction, IDEA will also
receive warrants to purchase $100m of Alpharma's common stock upon regulatory
approval of Diractin(R) in the United States, giving IDEA and, indirectly,
Celtic Pharma a stake in Alpharma's overall success in building its pain
franchise, supported by the launch of Diractin(R).

"As IDEA's lead institutional investor it has been our privilege to support the
company in its negotiations.  We are delighted at the completion of this
excellent licensing agreement between IDEA and Alpharma, which is an ideal
commercial partner for the launch and marketing of a novel treatment for pain
relief.  Diractin(R) is the first of many targeted products with reduced
side-effects that we see coming from the exploitation of the powerful
Transfersome(R) technology platform," commented John Mayo, Joint Managing
General Partner of Celtic Pharma.

Joint Managing General Partner Stephen Evans-Freke added: "We congratulate the
Board and management teams of both IDEA and Alpharma on their deal.  This
represents an excellent first exit transaction for Celtic Pharma with its
growing portfolio of novel therapeutic products in late-stage development, and
we look forward to further exit transactions with large or specialty
pharmaceutical and biotechnology companies who are well positioned to execute
aggressive commercial launches in our products' targeted markets."

About Celtic Pharmaceutical Holdings L.P.

Celtic Pharmaceutical Holdings L.P. is a global private equity investment firm
focused on the biotechnology and pharmaceutical industries.  Celtic Pharma was
founded by Stephen Evans-Freke and John Mayo, CBE and is based in Bermuda, with
offices in New York and London. Celtic Pharma acquires and invests in late stage
pharmaceutical programmes and drives these programmes through the final stages
of regulatory approval.  Celtic Pharma's aim is to bridge the gap between the
established pharmaceutical companies' new product pipeline crisis and the
biotech industry's capital drought.  For further information, please visit
Celtic Pharma's website at


Celtic Pharma

John Mayo
Tel: +44 (0)20 7291-5450

Kathy Armstrong
Tel: +1 (212) 616-4042

Financial Dynamics
David Yates
Tel: +44 (0)20 7831-3113

Jonathan Birt
Tel:  +1 (212) 850-5634

Forward-Looking Statements

Except for the historical information contained herein, the matters discussed in
this press release are forward-looking statements that involve risks and
uncertainties, including: our dependence on third parties for the development,
regulatory approval and successful commercialization of our products, the
inherent risk of failure in developing product candidates based on new
technologies, risks associated with the costs of clinical development efforts,
as well as other risks.  Actual results may differ materially from those
projected.  These forward-looking statements represent our judgment as of the
date of the release.  Celtic Pharma disclaims any intent or obligation to update
these forward-looking statements.

(Alpharma press release announced today)

September 6, 2007


Bridgewater, New Jersey,  September 6, 2007...Alpharma Inc. ("Alpharma" NYSE:
ALO) today announced its affiliate has reached agreement with IDEA AG ("IDEA"),
a privately held biopharmaceutical company with headquarters in Munich, Germany,
to license  the exclusive United States rights to ketoprofen in Transfersome(R)
gel, a prescription topical NSAID (non-steroidal anti-inflammatory drug) in
Phase III clinical development.  This license includes access to IDEA's
innovative Transfersome(R) technology platform that delivers drugs locally to
targeted areas.

In May 2007, IDEA AG submitted a marketing authorization application in Europe
for ketoprofen in Transfersome(R) gel for the treatment of osteoarthritis. A
prior regulatory submission with Swiss regulators was approved by SwissMedic in
June 2007.  Two pivotal European trials, including a 12 week duration study in
osteoarthritis, demonstrated that ketoprofen in Transfersome(R) gel delivered a
statistically significant improvement in pain, function and patient global
response.  In addition, IDEA will conduct two clinical studies to support an NDA
submission to the U.S. Food and Drug Administration for this product candidate,
which the company is targeting for late 2009.  Alpharma anticipates a U.S.
product launch in early 2011 assuming the NDA is approved.

 "Ketoprofen in Transfersome(R) gel is an ideal addition to our product
pipeline," commented Dean Mitchell, President and Chief Executive Officer of
Alpharma.  "IDEA's unique, proprietary topical ketoprofen gel formulation, which
has reported strong clinical results in Europe, complements our recent
acquisition of the Flector(R) Patch, offering therapeutic solutions to different
segments of the market.  The Flector(R) Patch addresses acute pain in a patch
delivery system, while ketoprofen in Transfersome(R) gel is a novel topical
formulation that is being developed to target chronic pain associated with
osteoarthritis.  Both of these NSAIDs are formulated to treat pain with minimal
systemic exposure, a feature that may help address certain safety concerns in
the market and provide physicians with expanded options to treat pain.  These
latest additions to our pharmaceutical product pipeline, combined with our abuse
deterrent products currently under development, are expected to result in new
product launches in each of 2008, 2009, 2010, and 2011.  These product launches
could substantially increase top line growth and profitability, drive synergies
across the product lines, and establish Alpharma as a leading provider of
innovative pain products."

The terms of the license agreement between Alpharma's affiliate, Alpharma
Ireland Limited, and IDEA include a $60 million payment at closing.  In addition
to the initial payment, the company expects approximately $5 million ($0.10
earnings per share) in transaction related expenses during the third and fourth
quarters of 2007. The agreement also includes three clinical and regulatory
progress milestone payments totaling $77 million that are expected to be made
later this year or in 2008 based upon IDEA's achievement of contractually
specified conditions.  An additional milestone payment of either $45 or $65
million, depending upon the results of one of the clinical trials for the
product, is conditioned on U.S. product approval.  IDEA has agreed to pay the
costs of specified studies being undertaken to obtain FDA approval, and Alpharma
expects to incur minimal research and development expense prior to approval.

The agreement also includes commitments for commercialization expenditures
during the first four years following the product launch, the payment of
royalties based on product sales and the issuance of a contractually determined
number of warrants for the purchase of shares of the company's common stock that
are exercisable at contractually determined prices, only upon FDA approval of
the product in the United States.

"We are exceptionally pleased to have Alpharma as our commercialization partner,
" commented Gregor Cevc, PhD., founder and CEO of IDEA.  "We believe that
Alpharma has the focus and commitment to make ketoprofen in Transfersome(R) gel
a success in the U.S. marketplace."  Dr. Stefan Aigner, EVP Corporate and
Business Development of Alpharma, commented, "Our recent transactions with IDEA,
IBSA and TRIS demonstrate Alpharma's ability and willingness to craft mutually
beneficial partnerships with companies both in and outside the U.S. to build our
portfolio to address unmet medical needs."

The company expects to close this transaction in the fourth quarter of 2007,
following the completion of review under the Hart-Scott Rodino Antitrust
Improvements Act of 1976.

The company's affiliate, Alpharma Pharmaceuticals LLC has closed its previously
announced licensing and distribution agreement with IBSA ("Institut Biochimique
SA"), a privately-owned, global pharmaceutical company headquartered in Lugano,
Switzerland, for the FLECTOR(R) Patch, the first prescription topical NSAID
patch approved by the FDA in the United States. In addition, under the terms of
its agreements with IBSA, Alpharma Pharmaceuticals has also received exclusive
U.S. license and distribution rights to TIROSINT(R) (synthetic levothyroxine
sodium) gel capsules for thyroid hormone replacement therapy, recently approved
by the FDA.  Alpharma Pharmaceuticals has paid IBSA $100 million in accordance
with the terms of those agreements.


Kathleen Makrakis - VP, Investor Relations

About Ketoprofen in Transfersome(R) Gel

The licensed product combines ketoprofen and IDEA'S novel proprietary
Transfersome(R) technology.  In August 2006, IDEA reported the positive outcome
of a Phase III efficacy and safety trial of osteoarthritis of the knee. In May
2007, IDEA submitted a regulatory filing to the European Agency for the
Evaluation of Medicinal Products (EMEA) for approval of the product for the
short and long-term treatment of osteoarthritis, including data from four Phase
II and Phase III clinical studies in over 2000 patients.

In June 2007, IDEA received an approval for ketoprofen in Transfersome(R) gel
from Swiss regulators for the treatment of inflammation and pain related to
osteoarthritis.  This approval was based on the first pivotal European trial,
which demonstrated that both ketoprofen in Transfersome(R) gel and Celebrex(R)
(celecoxib), improved patient's conditions comparably and progressively over the
six-week study period and are both statistically superior to placebo.  The much
broader EMEA submission package also included a long-term open-label, safety and
efficacy trial with patients treated with ketoprofen in Transfersome(R) gel for
up to 18 months.

Alpharma believes that IDEA's EMEA filing package, including the positive Phase
III trial in Europe will be helpful for its U.S. NDA filing strategy.  IDEA
plans, and will fund and conduct, two additional late stage clinical studies: a
second pivotal, placebo-controlled, Phase III US study in osteoarthritis
patients, and a multi-arm, placebo-controlled, Phase III European study, which
will also compare Ketoprofen in Transfersome(R) gel to Celebrex(R) in a
sub-study.  The latter is anticipated to help evaluate ketoprofen in
Transfersome(R) gel as a viable alternative to oral NSAIDs, including COX-2

About Transfersome Technology

Transfersome(R) vesicles are designed to penetrate the skin barrier, bypass the
blood capillaries and reach the targeted underlying tissue where the drug exerts
the prolonged localized effect.

About the Flector(R) Patch

The Flector(R) Patch is a 10x14 cm adhesive patch containing 180 mg of
diclofenac epolamine applied on a non-woven felt backing and covered with a
polypropylene release liner.  Flector(R) Patch contains 1.3% epolamine salt of
diclofenac, and has been approved by the FDA for the treatment of acute pain due
to minor strains, sprains and contusions.  Since its initial approval by Swiss
regulatory authorities in 1993, Flector(R) Patch has been approved for sale in
39 countries throughout the world.  IBSA's patented diclofenac epolamine was
specifically developed to achieve a significant release of active from the patch
and promote subsequent absorption through the skin.  Application to the injured
area twice a day results in a local analgesic and anti-inflammatory effect with
only minor systemic exposure to diclofenac.  Flector(R) Patch is contraindicated
for the treatment of peri-operative pain in the setting of coronary artery
bypass graft surgery.

Safety Aspects of NSAIDs

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal.  This risk may increase
with duration of use.  Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk.  NSAIDs cause an increased risk
of serious gastrointestinal adverse events including bleeding, ulceration, and
perforation of the stomach or intestines, which can be fatal.  These events can
occur at any time during use and without warning symptoms.  Elderly patients are
at greater risk for serious gastrointestinal events. Topically applied NSAIDS,
such as Flector(R) Patch and ketoprofen in Transfersome(R) gel, are designed to
minimize systemic exposure and may provide physicians with expanded options to
treat pain.

About Alpharma

Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical company with
leadership positions in products for humans and animals.  Alpharma is presently
active in more than 60 countries.  Alpharma has a growing branded pharmaceutical
franchise in the pain market with its morphine-based extended release KADIAN(R)
product. In addition, Alpharma is among the world's leading producers of several
specialty pharmaceutical-grade bulk antibiotics and is internationally
recognized as a leading provider of pharmaceutical products for poultry and

About IDEA

IDEA is a privately held biopharmaceutical company with headquarters in Munich,
Germany. IDEA develops and commercializes non-invasive, targeted therapeutics,
applied through the skin.  The basis of the technology platform are proprietary
carriers that are typically applied on skin and can be engineered to achieve
high drug concentration at or near the site of application, diminish local or
systemic adverse side effects, and often increase drug potency. In total, over
70 patents from 9 patent families are protecting the core technology.

Forward Looking Statements

Statements made in this release include forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.  These
statements, including those relating to future financial expectations, involve
certain risks and uncertainties that could cause actual results to differ
materially from those in the forward-looking statements.  Information on
important potential risks and uncertainties affecting those forward looking
statements may be found in the Company's filings with the Securities and
Exchange Commission, including its Form 10-K for the year ended December 31,

Alpharma press releases are also available at our website:  http://

Alpharma management will conduct a conference call / webcast on September 6,
2007 beginning at 8:30 AM Eastern Daylight Time to discuss this announcement.
The call will be open to all interested parties and may be accessed by using the
following information:

                             CONFERENCE CALL ACCESS

                     Domestic Dial In:       (800) 374-0147
                     International Dial In:  (706) 634-5431
                     Conference Call ID:           15718423

Investors can access the call in a "listen only" mode via the Internet at http:/
/ A presentation to accompany the call will be available on
the company's website,, in the Investor Support section.

In addition, for those unable to participate at the time of the call, a
rebroadcast will be available following the call from September 6, 2007 at 12:00
PM Eastern Daylight Time until September 20, 2007 at midnight.  The rebroadcast
may be accessed on the Internet at or by telephone
using the following information:

                               REBROADCAST ACCESS

                   Domestic Dial In:           (800) 642-1687
                   International Dial In:      (706) 645-9291
                   Participant Code:                 15718423

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