MediGene and Bradley Pharmaceuticals Enter Marketing and Development Partnership for Polyphenon(R) E Ointment
31 Enero 2006 - 8:53AM
PR Newswire (US)
* Bradley acquires US commercialization rights for genital warts
and other dermatological diseases. MediGene retains full rest of
world commercialization rights. MARTINSRIED, Germany and MUNICH,
Germany and SAN DIEGO, Jan. 31 /PRNewswire-FirstCall/ -- The
German-American biotechnology company MediGene AG (Frankfurt,
TecDAX) has entered into a partnership agreement with Bradley
Pharmaceuticals to commercialize Polyphenon(R) E Ointment in the
US. Bradley Pharmaceuticals, a US specialty pharmaceutical company
that markets to niche physician specialties, will take on US
promotion and commercialization of the drug for the treatment of
genital warts. MediGene and Bradley also agreed upon a development
partnership to examine the application of Polyphenon(R) E Ointment
for the treatment of other skin diseases. Under the terms of the
agreement, MediGene could receive successive milestone payments up
to $69 MM, including a payment of $5 MM due upon signing of the
contract. In addition, MediGene will receive royalties on sales of
Polyphenon(R) E Ointment in the US. Milestone payments are
dependent upon specific achievements in development, approval, and
commercialization of the Polyphenon(R) E Ointment in the genital
warts and actinic keratosis indications, and are linked to specific
sales targets reached in any indication. Bradley Pharmaceuticals
will take over the majority of the development costs for
Polyphenon(R) E Ointment if it is developed in dermatological
indications other than genital warts. MediGene holds the right to
commercialize all of these developments outside the US, whereas
Bradley holds the right to market Polyphenon(R) E Ointment in all
dermatological indications within the US. In November 2005, the US
regulatory authority Food and Drug Administration (FDA) accepted
the New Drug Application (NDA) for Polyphenon(R) E Ointment for the
treatment of genital warts for filing. Provided that the approval
procedure is successful and marketing authorization is granted, US
market launch of the Polyphenon(R) E Ointment is scheduled for
2007. "We believe that Bradley is ideally qualified to tap the full
potential of Polyphenon E in the US market," commented Dr. Peter
Heinrich, MediGene's Chief Executive Officer. It was our objective
to win a partner with a powerful sales force active in the
appropriate channels. Furthermore, our product should possess high
significance for this partner's strategic company development. In
the past months we screened multiple potential partners and are
excited to have signed a partnership with Bradley Pharmaceuticals,
one of the premier specialty pharmaceutical companies in the US.
Bradley is known for its strong marketing and will promote
Polyphenon(R) E in the US market with more than 100
representatives." Bradley President and CEO, Daniel Glassman,
stated: "Polyphenon(R) E Ointment fits perfectly into our
dermatology portfolio and represents an important expansion for us
into new specialty healthcare markets. We will position it as one
of our core products and will utilize our full resources and
expertise to capture a significant market share." Conference Call
Detais: Management will present and discuss today's press release:
Tuesday, January 31, 2006 at: 10.00 a.m. (ET) Dial In #
866.314.9013 International Dial In # 617.213.8053 Participant
Passcode Medigene Replay Available From 01/31/2006 6:00 PM CET
Available To 02/07/2006 11:59 PM CET Dial In # 888-286-8010
International Dial In # 617-801-6888 Passcode 62373089 Company
profile of Bradley Pharmaceuticals: Bradley Pharmaceuticals, Inc.
(NYSE:BDY) was founded in 1985 as a specialty pharmaceuticals
company serving niche physician specialties in the USA and in 38
countries worldwide. The Company has 300 employees, and Net Sales
of approximately 97 Million US dollars for 2004. Bradley estimates
net sales for the year ended December 31, 2005 will exceed reported
2004 net sales, as 2005 net sales will include a full year's
operations of the assets acquired from Bioglan and the introduction
during 2005 of several new products. Bradley's success is based on
the company's product life cycle management strategy. This means
that Bradley acquires brands and further develops them by means of
line extensions and improved formulations. Bradley Pharmaceuticals
is comprised of Doak Dermatologics, specializing in topical
therapies in dermatology, and Kenwood Therapeutics, providing drugs
for respiratory diseases, as well as for indications in
gastroenterology and internal medicine. Polyphenon(R) E Ointment:
The active substance in Polyphenon(R) E Ointment is a green tea
extract of defined catechin composition, produced by means of a
patented purification process. MediGene has developed this drug for
the treatment of various skin tumor diseases. The New Drug
Application recently filed was based on the positive results of two
phase III trials in more than 1,000 patients. In the indication
genital warts alone, MediGene expects an annual sales potential of
more than 100 million EUR in the USA. In parallel with the ongoing
approval process in the USA, MediGene is preparing a market
authorization application for European countries. Genital warts:
Genital warts are one of the most common and fastest spreading
venereal diseases worldwide. Genital warts are benign, but
disfiguring and contagious skin tumors in the genital and anal
areas, which are usually difficult to treat. Approximately 14
million people in North America and 15 million people in Europe are
infected by human papilloma viruses (HPV type 6 or 11), which cause
genital warts. This press release contains forward-looking
statements that involve risks and uncertainties. The
forward-looking statements contained herein represent the judgement
of MediGene as of the date of this release. These forward-looking
statements are no guarantees for future performance, and the
forward-looking events discussed in this press release may not
occur. MediGene disclaims any intent or obligation to update any of
these forward-looking statements. MediGene(TM) is a trademark of
MediGene AG, Polyphenon(R) E is a trademark of Mitsui Norin.
MediGene AG is a publicly quoted (Frankfurt: TecDAX),
German-American biotechnology company located in Martinsried,
Germany and San Diego, USA. MediGene is the first German biotech
company with a drug on the market. The NDA for a second drug,
Polyphenon(R) E Ointment, has been submitted. In addition, MediGene
has several oncological drug candidates undergoing clinical
development, and possesses innovative platform technologies for
drug development. MediGene's core competence lies in research into
and development of novel approaches for the treatment of various
cancer and tumor diseases. DATASOURCE: MediGene AG CONTACT: Dr.
Georg Donges, Public Relations, +49-89-8565-3317, or Dr. Michael
Nettersheim, Investor Relations, +49-89-8565-2946; or Fax -
+49-89-8565-2920, , all of MediGene AG
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