Re: Agreements
April 02 2003 - 1:02AM
UK Regulatory
RNS Number:5251J
Galen Holdings PLC
02 April 2003
GALEN HOLDINGS PLC
ENTERS INTO CO-PROMOTION AGREEMENT WITH
BRISTOL-MYERS SQUIBB FOR DOVONEX(R)
AND
LICENCES DOVOBET(R) FROM LEO PHARMA A/S
Craigavon, Northern Ireland UK / Rockaway, New Jersey, US, 2 April 2003: Galen
Holdings PLC (LSE: GAL, NASDAQ: GALN) today announced that it has entered into
a Co-promotion Agreement with Bristol-Myers Squibb Company (NYSE: BMY) for
Dovonex(R) in the United States. Dovonex(R) (calcipotriene), a treatment for
mild to moderate psoriasis is currently marketed in the United States by
Bristol-Myers Squibb under license from LEO Pharma A/S, the Danish
pharmaceutical company. Net sales of Dovonex(R) in the US in 2002 were $126
million.
Concurrent with the agreement with Bristol-Myers Squibb, Galen is entering into
a Development Agreement with LEO Pharma to develop Dovobet(R), LEO Pharma's
combination product containing calcipotriene and betamethasone dipropionate, for
the United States market.
Co-Promotion Agreement - Dovonex(R)
Under the Co-promotion Agreement, Galen will be compensated by Bristol-Myers
Squibb based on an agreed formula relating to the sales levels of Dovonex(R).
In addition, Galen has also entered into an Option Agreement with Bristol-Myers
Squibb whereby, between now and January 1, 2006, Galen can offer to purchase
Bristol-Myers Squibb's rights to the product. The term of the Co-promotion
Agreement is until December 31, 2007 or until the option is exercised, whichever
is earlier. The option may be exercised by Galen on any of three dates: August
1, 2003, August 1, 2004 and August 1, 2005; however, Bristol-Myers Squibb can
refuse to sell its rights to Dovonex(R) prior to August 1, 2005. If Galen
exercises its option on August 1, 2005, Bristol-Myers Squibb is obliged to
conclude the purchase transaction. Any purchase would be targeted for a closing
in January following the option exercise. The terms of any purchase have been
pre-negotiated by the parties, and vary depending on the option exercise date.
The parties have agreed to keep the terms of the option agreement confidential.
Development Agreement - Dovobet(R)
Concurrent with the agreement with Bristol-Myers Squibb, Galen is entering into
a Development Agreement with LEO Pharma to develop Dovobet(R), its combination
product containing calcipotriene and betamethasone dipropionate that is
currently approved for marketing by LEO Pharma in certain countries in Europe.
LEO Pharma intends to submit shortly an Investigational New Drug Application
(IND) for Dovobet(R) to the Food and Drug Administration (FDA) in the US. Both
Dovonex(R) and Dovobet(R) are indicated for the treatment of mild to moderate
psoriasis in Europe.
Under the terms of the agreements for Dovobet(R), Galen will pay LEO Pharma a
total of $47 million if Dovobet(R) progresses to full FDA approval. Of the $47
million, $40 million is payable upon approval. Once approved, the License and
Supply Agreement between Galen and LEO Pharma for Dovobet(R) which has been
executed will become effective.
Commenting on the transaction, Roger Boissonneault, CEO of Galen, said: "This is
an excellent opportunity for Galen to enhance our pipeline in dermatology. The
Co-promotion Agreement will allow us to participate in the Dovonex(R) franchise
in the United States while the option agreement allows us to acquire the product
in the future. We are also delighted to have the opportunity to develop and
in-license Dovobet(R), a product developed by Europe's leading research-based
dermatology company, LEO Pharma. We are pleased that the long relationships
that we have had with Bristol-Myers Squibb and LEO Pharma has facilitated us in
bringing these arrangements to fruition."
Ernst Lunding, CEO of LEO Pharma, added: "We look forward to developing this new
partnership with Galen for our calcipotriene franchise in the United States.
Galen has demonstrated that they are an effective sales and marketing force in
the United States as evidenced by their success with other products, and we look
forward to seeing them do the same with Dovonex(R)."
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ENQUIRIES:
Galen Holdings PLC
David G. Kelly Tel: + 44 283 833 4974 (after 8.30am)
Senior Vice President Finance & Planning
Financial Dynamics
Sophie Pender-Cudlip/Francetta Carr Tel: + 44 20 7831 3113
For further information on Galen, please visit www.galenplc.com
Forward looking statements in this report, including, without limitation,
statements relating to the Galen's plans, strategies, objectives, expectations,
intentions and adequacy of resources, are made pursuant to the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of 1995. These
forward looking statements involve known and unknown risks, uncertainties and
other factors that may cause the actual results, performance or achievements of
Galen to be materially different from any future results, performance or
achievements expressed or implied by such forward looking statements. These
factors include, among others, the following: Galen's ability to manage its
growth, government regulation affecting the development, manufacture, marketing
and sale of pharmaceutical products, customer acceptance of new products,
competitive factors in the industries in which Galen operates, the loss of key
senior management or scientific staff, exchange rate fluctuations, general
economic and business conditions, and other factors described in filings of the
Galen with the SEC. Galen undertakes no obligation to publicly update or revise
any forward looking statement, whether as a result of new information, future
events or otherwise.
This information is provided by RNS
The company news service from the London Stock Exchange
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