12/14/23, 8:43 PM
`Serono Group - Media - Archives 2002
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`Latest Press Release | Archives 2003 | Archives 2002 |
`SERONO AND IVAX TO DEVELOP ORAL THERAPY
`FOR MULTIPLE SCLEROSIS
`[English][French][German]
`
`Latest Press Release
`Archived Press
`Releases 2003
`Archived Press
`Releases 2002
`
`GENEVA, Switzerland and MIAMI, USA, 30 October 2002 Serono S.A. (virt-x: SEO
`and NYSE: SRA) and IVAX Corporation (AMEX: IVX and LSE: IVX.L) today announced a
`worldwide agreement to develop and commercialize IVAX' product, cladribine, as
`potentially the first orally effective treatment of multiple sclerosis.
`
`Ernesto Bertarelli, Chief Executive Officer of Serono, commented: "This agreement is
`part of our long-term strategy for developing novel therapies in neurology. With
`cladribine we plan to offer patients an oral therapy which complements Rebif, our
`leading treatment for multiple sclerosis."
`
`"We are very pleased to enter into this agreement with Serono, a leading innovator in
`the development of drugs to treat multiple sclerosis," remarked Phillip Frost, M.D,
`Chairman and Chief Executive Officer of IVAX Corporation. "This agreement brings
`together our combined expertise in the development of CNS therapeutics, IVAX'
`capabilities for manufacturing proprietary oral pharmaceutical products and Serono's
`global experience in the marketing and sales of Rebif, an important treatment for
`multiple sclerosis."
`
`Based upon clinical and Magnetic Resonance Imaging (MRI) data from phase II trials
`suggesting that intravenous cladribine may be effective in certain MS patients, Serono
`and IVAX plan to establish the optimal oral formulation of cladribine and then initiate
`further clinical trials.
`
`Under terms of the agreement, IVAX will receive a series of undisclosed milestone
`payments and will also receive royalties on sales of the product, once marketed. The
`current worldwide market for multiple sclerosis treatments is more than $2.5 billion.
`
`About Cladribine
`Cladribine is a purine-analogue that disrupts the proliferation of certain white blood
`cells, including monocytes and lymphocytes, which are involved in the pathological
`process of multiple sclerosis.
`
`About Serono
`Serono is a global biotechnology leader. The Company has six recombinant products on
`the market, Gonal-F®, Luveris®, Ovidrel®/Ovitrelle®, Rebif®, Serostim® and
`Saizen® [somatropin]. (Luveris® is not approved in the USA). In addition to being the
`world leader in reproductive health, Serono has strong market positions in neurology,
`metabolism and growth. The Company's research programs are focused on growing
`these businesses and on establishing new therapeutic areas. Currently, there are
`seventeen new molecules in development.
`
`In 2001, Serono achieved worldwide revenues of U.S. $1.38 billion, and a net income of
`U.S. $317 million, making it the third largest biotech company in the world based on
`revenues. The Company operates in 45 countries, and its products are sold in over 100
`countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x
`(SEO) and its American Depository Shares are traded on the New York Stock Exchange
`(SRA).
`
`About IVAX
`IVAX Corporation, with operations in nearly 30 countries and its products sold in 70
`countries, had sales in 2001 of $1.2 billion. IVAX discovers, develops, manufactures,
`and markets branded and brand equivalent (generic) pharmaceuticals and veterinary
`products in the U.S. and internationally. The company has a number of proprietary
`drugs in various phases of clinical trials to treat respiratory, oncologic, urologic and
`central nervous system diseases. Among the new molecules being developed,
`immunotoxins to treat cancer, soft steroids to treat a variety of inflammatory diseases,
`and a brain targeted estrogen for postmenopausal hormone replacement therapy
`represent particularly novel advances.
`
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`12/14/23, 8:43 PM
`
`Serono Group - Media - Archives 2002
`Copies of this and other news releases may be obtained free of charge from IVAX' web
`site at www.ivax.com. Shareholders and prospective investors can register to
`automatically
`receive
`the
`company's
`press
`releases
`via
`email
`at
`www.ivax.com/ComNewsv2.htm.
`
`###
`
`Some of the statements in this press release are forward looking. Such statements are inherently subject
`to known and unknown risks, uncertainties and other factors that may cause actual results, performance or
`achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in
`the forward-looking statements. Forward-looking statements are based on Serono's current expectations
`and assumptions, which may be affected by a number of factors, including those discussed in this press
`release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and
`Exchange Commission on May 21 2002. These factors include any failure or delay in Serono's ability to
`develop new products, any failure to receive anticipated regulatory approvals, any problems in
`commercializing current products as a result of competition or other factors, our ability to obtain
`reimbursement coverage for our products, and government regulations limiting our ability to sell our
`products. Serono has no responsibility to update the forward-looking statements contained in this press
`release to reflect events or circumstances occurring after the date of this press release.
`
`This press release contains certain forward-looking statements regarding product development efforts and
`product performance and other non-historical facts which are being are made pursuant to the safe harbor
`provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and
`uncertainties that cannot be predicted or quantified and, consequentially, actual results may differ
`materially from those expressed or implied by such forward-looking statements. Such risks and
`uncertainties include, among others, that development efforts for Cladribine may fail, may not achieve the
`expected results or effectiveness and/or may not generate data that would support the approval or
`marketing of this product for the indications being studied or for other indications; that clinical milestones
`may not be achieved on a timely basis or at all and accordingly IVAX may not receive any of the
`anticipated milestone or royalty payments under the license agreement; and that others may develop
`product formulations that are superior to IVAX' formulation. In addition to the risk factors set forth above,
`IVAX' forward looking statements may also be adversely affected by general market factors, competitive
`product development, product availability, federal and state regulations and legislation, the regulatory
`process for new products and indications, manufacturing issues that may arise, trade buying patterns,
`patent positions and litigation, among other things. For further details and discussion of these and other
`risks and uncertainties, see IVAX' Annual Report on Form 10-K and other filings with the Securities and
`Exchange Commission.
`
`For more information, please contact:
`
`###
`
`Media Relations:
`Tel: +41 22-739 36 00
`Fax: +41 22-739 30 85
`www.serono.com
`
`Serono Inc., Rockland,
`MA Media Relations
`Tel: +1 781-681 2340
`Fax: +1 781-681 2935
`
`Investor Relations:
`Tel: +41 22-739 36 01
`Fax: +41 22-739 30 22
`Reuters: SE02.S/SRA.N
`Bloomberg: SEO SW/SRA US
`IVAX Corporation
`Howard A. Goldman
`Director/Investor Relations & Corporate Communications
`Tel: 305.575.6043
`www.ivax.com
`
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