Regulatory News:
Ipsen (Paris:IPN) and Medicis (NYSE:MRX) today announced the
submission of the Biologics License Application ("BLA") for
Reloxin(R)(1) to the U.S. Food and Drug Administration ("FDA"). Upon
FDA´s acceptance of the Reloxin(R) filing, Medicis will pay Ipsen
approximately $25 million in accordance with the agreement between the
parties. In March 2006, Ipsen granted Medicis the rights to develop,
distribute and commercialize Ipsen´s botulinum toxin product in the
United States, Canada and Japan for aesthetic use by physicians.
Medicis anticipates a response from FDA in approximately 10 months
following FDA´s receipt of the Reloxin(R) submission.
According to the American Society for Aesthetic Plastic Surgery,
injections of botulinum toxin type A were the number one non-surgical
procedure in 2006, with over 3 million total procedures. Current
growth estimates in botulinum toxin type A in dollars are estimated to
be in excess of 20 percent over the prior year.(2) This translates
into a retail U.S. aesthetic market of approximately $300 million-$400
million.
"We are extremely pleased to announce the submission of the BLA
for Reloxin(R) with FDA," said Jonah Shacknai, Chairman and Chief
Executive Officer of Medicis. "Congratulations to the Medicis team and
our talented consultants who worked tirelessly to achieve our filing.
Our team has dedicated many hours compiling what we believe to be a
strong filing for an important product. Our shareholders owe these
persons a tremendous debt of gratitude for their extraordinary
efforts. We appreciate the support given to us by our colleagues at
Ipsen, and look forward to a continued excellent relationship with
them as we prepare for the potential of commercializing Reloxin(R) in
the growing, multi-million dollar aesthetic botulinum toxin market in
the U.S."
Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen,
stated: "The submission of the Reloxin(R) dossier to the FDA by our
partner Medicis is an important milestone for Ipsen´s future growth,
and we are very pleased that such an important project was carried out
in a rigorous and timely manner. Both Ipsen and Medicis are dedicated
to bring this product to market, so that Reloxin(R) may be a success
in the U.S.."
About Ipsen´s botulinum toxin type A
As of October 2007, Ipsen´s botulinum toxin type A, developed in
the field of aesthetic medicine in the U.S., Canada and Japan under
the trademark Reloxin(R), is approved for aesthetic indications in 21
countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador,
Egypt, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New
Zealand, Philippines, Slovak Republic, Ukraine, Uruguay, Venezuela,
Vietnam, and Russia (in Russia, it is the first botulinum toxin type A
approved in this field). Ipsen is also pursuing regulatory approval
for medical indications for the product in certain additional key
international markets.
Dysport(R) is a neuromuscular blocking agent which acts as a
neuromuscular blocking toxin, which was initially developed for the
treatment of motor disorders and various forms of muscular spasticity,
including cervical dystonia (a chronic condition in which the neck is
twisted or deviated), spasticity of the lower limbs in children with
cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial
spasm. It was later developed for the treatment of a wide variety of
neuromuscular disorders Dysport(R) was originally launched in the
United Kingdom in 1991 and has marketing authorisations in over 70
countries (at 31 December 2006). Ipsen has just recently submitted a
BLA for Dysport(R) in cervical dystonia to the FDA.
About Medicis
Medicis is the leading independent specialty pharmaceutical
company in the United States focusing primarily on the treatment of
dermatological and aesthetic conditions. The Company is dedicated to
helping patients attain a healthy and youthful appearance and
self-image. Medicis has leading branded prescription products in a
number of therapeutic and aesthetic categories. The Company´s products
have earned wide acceptance by both physicians and patients due to
their clinical effectiveness, high quality and cosmetic elegance.
The Company´s products include the prescription brands
RESTYLANE(R) (hyaluronic acid), PERLANE(R) (hyaluronic acid),
DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), PLEXION(R)
(sodium sulfacetamide/sulfur), SOLODYN(R) (minocycline HCl, USP)
Extended Release Tablets, TRIAZ(R) (benzoyl peroxide), LIDEX(R)
(fluocinonide) Cream, 0.05%, VANOS(R) (fluocinonide) Cream, 0.1%,
SYNALAR(R) (fluocinolone acetonide), and ZIANA(R) (clindamycin
phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL(R) (sodium
phenylbutyrate) and AMMONUL(R) (sodium phenylacetate/sodium benzoate),
prescription products indicated in the treatment of Urea Cycle
Disorder, and the over-the-counter brand ESOTERICA(R). For more
information about Medicis, please visit the Company´s website at
www.medicis.com.
About Ipsen
Ipsen is an innovation driven international specialty
pharmaceutical group with over 20 products on the market and a total
worldwide staff of nearly 4,000. The company´s development strategy is
based on a combination of products in targeted therapeutic areas
(oncology, endocrinology and neuromuscular disorders) which are growth
drivers, and primary care products which contribute significantly to
its research financing. This strategy is also supported by an active
policy of partnerships. The location of its four Research and
Development centres (Paris, Boston, Barcelona, London) gives the Group
a competitive edge in gaining access to leading university research
teams and highly qualified personnel. In 2006, R&D expenditure was EUR
178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR
861.7 million while total revenues amounted to EUR 945.3 million (in
IFRS). 700 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. Ipsen´s shares are
traded on Segment A of Eurolist by Euronext(TM) (stock code: IPN, ISIN
code: FR0010259150). Ipsen´s shares are eligible to the "Service de
Reglement Differe" ("SRD") and the Group is part of the SBF 250 index.
From 24 December 2007, the Group will be part of the SBF 120 index.
For more information on Ipsen, visit our website at www.ipsen.com.
Medicis Forward-Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act. All
statements included in this press release that address activities,
events or developments that Medicis expects, believes or anticipates
will or may occur in the future are forward-looking statements,
including FDA´s acceptance of the RELOXIN(R) filing, the timing
associated with FDA´s response to the filing and the potential
commercialization of RELOXIN(R). These statements are based on certain
assumptions made by Medicis based on its experience and perception of
historical trends, current conditions, expected future developments
and other factors it believes are appropriate in the circumstances. No
assurances can be given, however, that these activities, events or
developments will occur or that such results will be achieved. Such
statements are subject to a number of assumptions, risks and
uncertainties, many of which are beyond the control of Medicis.
Several of these risks are outlined in the Company´s most recent
annual report on Form 10-K for the year ended December 31, 2006 and
quarterly report on Form 10-Q for the quarter ended September 30,
2007, and other documents we file with the Securities and Exchange
Commission. Forward-looking statements represent the judgment of
Medicis´ management as of the date of this release, and Medicis
disclaims any intent or obligation to update any forward-looking
statements contained herein, which speak as of the date hereof.
NOTE: Full prescribing information for any Medicis prescription
product is available by contacting the Company. RESTYLANE(R) and
PERLANE(R) are trademarks of HA North American Sales AB, a subsidiary
of Medicis Pharmaceutical Corporation. All other marks are the
property of Medicis or its Affiliates.
Ipsen Forward-Looking Statements
The forward-looking statements and targets contained herein are
based on Ipsen´s management´s current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may
cause actual results, performance or events to differ materially from
those anticipated herein. Moreover, the Research and Development
process involves several stages at each of which there is a
substantial risk that the Group will fail to achieve its objectives
and be forced to abandon its efforts in respect of a product in which
it has invested significant sums. Thus, in order to develop a product
which is viable from a commercial point of view, the Group must
demonstrate, by means of pre-clinical and human clinical trials, that
the molecules are effective and not dangerous to human beings.
Therefore, the Group cannot be certain that favourable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will be
sufficient to demonstrate the safe and effective nature of the product
concerned, or that the regulatory authorities will be satisfied with
the data and the information provided by the Company. Ipsen expressly
disclaims any obligation or undertaking to update or revise any
forward looking statements, targets or estimates contained in this
press release to reflect any change in events, conditions, assumptions
or circumstances on which any such statements are based, unless so
required by applicable law. Ipsen´s business is subject to the risk
factors outlined in its information documents filed with the French
Autorite des marches financiers.
(1) The proposed name for the product in the U.S. aesthetic market
is Reloxin(R), and it is called Dysport(R) for medical and aesthetic
markets outside the U.S.
(2) American Society for Aesthetic Plastic Surgery, Cosmetic
Surgery National Data Bank Statistics, 2006 and Allergan company
reports
