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CONTACT:
Kara Stancell, Investor Relations & Corporate Communications, (602) 808-3854
MEDICIS LICENSES SUBQ(TM) FROM Q-MED
SCOTTSDALE, Arizona--July 15, 2004--Medicis (NYSE:MRX) today announced that it
has entered into an exclusive license agreement with Q-Med AB ("Q-Med") to
market, distribute, sell and commercialize in the United States and Canada
Q-Med's product currently known as SubQ(TM). Q-Med will have the exclusive right
to manufacture SubQ(TM) for Medicis. SubQ(TM) is not approved currently for use
in the United States and Canada.
Under terms of the agreement, Medicis Aesthetics Holdings Inc., a wholly owned
subsidiary of Medicis Pharmaceutical Corporation, will license SubQ(TM) for
approximately $80 million, due as follows: approximately $30 million upon
closing of the transaction to be recorded as a current quarter expense to
research and development; approximately $10 million upon completion of certain
clinical milestones; approximately $20 million upon the satisfaction of certain
defined regulatory milestones; and approximately $20 million upon U.S. launch of
SubQ(TM). Medicis also will make additional milestone payments to Q-Med upon the
achievement of certain commercial milestones. Closing is subject to Q-Med's
receipt of the initial $30 million payment.
Like RESTYLANE(R), PERLANE(R) and RESTYLANE FINE LINES(TM), SubQ(TM) is
comprised of the same NASHA(TM) (non-animal stabilized hyaluronic acid)
substance with a larger gel particle size and has patent protection until at
least 2015.
"We are pleased to announce another significant license agreement with our
strategic partner, Q-Med, and an exciting addition to our aesthetic products,"
said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "With the
worldwide safety and efficacy of other NASHA(TM) products such as RESTYLANE(R)
and the close working relationship with Q-Med, we believe that SubQ(TM) will be
a very successful product. In countries where it is approved, SubQ(TM) provides
the aesthetic community with NASHA(TM) in a large-sized molecule, which may be
injected deep into the subcutaneous areas of the face to contour cheeks, chins
and other areas where added volume is desired."
With its larger NASHA(TM) molecule, SubQ(TM) is intended for subcutaneous or
supraperiosteal injections where more volume is required. Medicis believes
non-invasive procedures with SubQ(TM) could replace today's fat injections and
other implant procedures for deep facial augmentation. Additionally, in
countries other than the U.S., SubQ(TM) is used to temporarily diminish the
effects of lipoatrophy. In the United States, the FDA regulates this product as
a medical device.
NASHA(TM) is developed using a unique stabilization process that results in its
long duration of effect versus non-stabilized hyaluronic acid, which may last
only weeks. In contrast with most other hyaluronic acid products, NASHA(TM) is
not derived from animal sources. It is produced using biotechnological methods
of natural
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fermentation in a sterile laboratory environment. This significantly diminishes
the risk of transmitting diseases between species or of eliciting allergic
reactions in patients who are sensitive to common foods such as beef, chicken
and eggs. NASHA(TM) has been extensively researched for over a decade and has
been safe and effective when used as directed.
On March 10, 2003, Medicis acquired all outstanding shares of HA North American
Sales AB from a subsidiary of Q-Med, a Swedish biotechnology/medical device
company. HA North American Sales AB holds a license for the exclusive U.S. and
Canadian rights to market, distribute and commercialize the dermal filler
product lines known as RESTYLANE(R), PERLANE(R) and RESTYLANE FINE LINES(TM).
RESTYLANE(R) has been approved by the FDA for use in the U.S. RESTYLANE(R),
PERLANE(R) and RESTYLANE FINE LINES(TM) have been approved for use in Canada.
Q-Med currently promotes these market-leading, patented NASHA(TM) brands in over
75 countries, where over 1.5 million procedures have been performed. NASHA(TM)
products are manufactured by Q-Med in Uppsala, Sweden.
RESTYLANE(R) is marketed and sold in over 75 countries outside the United
States. Since 1996, dermatologists and plastic surgeons outside the U.S. have
used it to contour and restore volume to skin and temporarily eliminate wrinkles
and facial folds. Additionally, in certain countries other than the U.S.,
RESTYLANE(R) also is approved to enhance the appearance and fullness of lips.
Medicis Aesthetics Inc., the company that currently is marketing and selling
RESTYLANE(R) in the U.S., is a wholly owned subsidiary of Medicis Pharmaceutical
Corporation, a leading independent specialty pharmaceutical company in the
United States focusing primarily on the treatment of dermatological and
podiatric conditions and aesthetics medicine. Medicis Pharmaceutical Corporation
has leading branded prescription products in a number of therapeutic categories,
including acne, eczema, fungal infections, hyperpigmentation, photoaging,
psoriasis, rosacea, seborrheic dermatitis and skin and skin-structure
infections. 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), DYNACIN(R)
(minocycline HCl), LOPROX(R) (ciclopirox), LUSTRA(R) (hydroquinone),
LUSTRA-AF(R) (hydroquinone) with sunscreen, ALUSTRA(R) (hydroquinone) with
retinol, OMNICEF(R) (cefdinir), PLEXION(R) Cleanser (sodium
sulfacetamide/sulfur), PLEXION TS(R) (sodium sulfacetamide/sulfur), PLEXION
SCT(R) (sodium sulfacetamide/sulfur), TRIAZ(R) (benzoyl peroxide), LIDEX(R)
(fluocinonide), and SYNALAR(R) (fluocinolone acetonide), the over-the-counter
brand ESOTERICA(R), and BUPHENYL(R) (sodium phenylbutyrate), a prescription
product indicated in the treatment of Urea Cycle Disorder. For more information
about Medicis, please visit the Company's website at www.medicis.com.
Except for historical information, this press release includes "forward-looking
statements" within the meaning of the 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. This includes earnings estimates,
future financial performance and other matters. 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. Such statements are
subject to a number of assumptions, risks and uncertainties, many of which are
beyond the control of Medicis. Any such projections or statements include the
current views of Medicis with respect to future events and financial
performance. No assurances can be given, however, that these events will occur
or that such results will be achieved. Medicis cannot validate its assumptions
of the full impact on its business of the approval of competitive generic
versions of its core brands, including DYNACIN(R) Tablets and/or LOPROX(R), or
any future competitive product approvals that may affect its brands. Also, there
are a number of additional important factors that could cause actual results to
differ materially from those projected, including the anticipated size of the
markets, the availability of product supply, the receipt of required regulatory
approvals, the ability to realize anticipated synergies and benefits of the
Q-Med transaction, the risks and uncertainties normally incident to the
pharmaceutical industry,
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dependence on sales of key products, the uncertainty of future financial results
and fluctuations in operating results, dependence on Medicis' strategy including
the uncertainty of license payments and/or other payments due from third
parties, the timing and success of new product development by Medicis or third
parties, product introductions, the risks of pending or future litigation, and
other risks described from time to time in Medicis' SEC filings including its
Annual Report on Form 10-K for the year ended June 30, 2003. There can be no
assurance as to when or if any of the holders of the Notes will have the right
to convert or if the Notes will be converted, and what impact the increase in
the number of shares outstanding will have on its results of operations.
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.
NOTE: Full prescribing information for any Medicis prescription product is
available by contacting the Company. OMNICEF(R) is a registered trademark of
Abbott Laboratories, Inc. under a license from Fujisawa Pharmaceutical Co., Ltd.
SubQ(TM), RESTYLANE FINE LINES(TM), PERLANE(R) and RESTYLANE(R) are trademarks
of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical
Corporation. NASHA(TM) is a trademark of Q-Med used under license. All other
marks (or brands) and names are the property of Medicis or its Affiliates.
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