GENEVA, Switzerland and MILAN, Italy, October 16 /PRNewswire-FirstCall/
-- Serono (virt-X: SEO and NYSE: SRA) and Newron Pharmaceuticals SpA,
announced today an agreement under which Newron has granted Serono
exclusive worldwide rights to develop, manufacture and commercialise
safinamide in Parkinson's disease (PD), Alzheimer's disease, and other
cognitive disorders. Newron has recently reported positive results with
safinamide from an early Phase III study in Parkinson's disease.
    Under the terms of the agreement, Serono will be responsible for all
future development, manufacture and commercialisation costs. Serono will
make an upfront payment and additional milestone payments to Newron of up
to $200 million based on defined development and commercialization
achievements in all major markets. Serono will also pay Newron undisclosed
royalties on worldwide net sales. In addition, Newron will have the right
to opt for co-promotion with Serono in Italy and Spain. Other details of
the financial terms of the agreement were not disclosed.
    Luca Benatti, CEO of Newron, said, "Serono has a major presence in the
area of CNS and is the right partner to take safinamide on at this
late-stage in its development. The significant financial contribution from
Serono, together with the co-promotion opportunity, will enable us to
further develop Newron as a broader based fully integrated
bio-pharmaceutical company."
    Franck Latrille, Senior Executive Vice President Global Product
Development, Serono, commented, "This partnership enables us to expand our
Neurology portfolio by investing in innovative products to meet significant
unmet medical needs, such as Parkinson's and Alzheimer's disease."
    Safinamide will be the subject of an extensive clinical development
plan undertaken by both companies, with Serono assuming overall leadership
of the programme. This will involve Newron completing on-going Phase III
studies with safinamide as an add-on therapy to dopamine agonists in early
stage PD patients, and with safinamide as an adjunct treatment to Levodopa
in mid to late stage PD patients. Serono plans to expand the programme with
a series of innovative additional studies aimed at addressing unmet medical
needs in the treatment of Parkinson's disease, such as control of non motor
symptoms, mainly cognitive impairment and depression, the delay and
severity of motor complications and the possibility to delay disease
progression.
    Newron's early Phase 3 Clinical Trial in Parkinson's Disease
    The double blind placebo controlled trial, conducted in Europe, South
America and Asia with 270 early stage Parkinson's disease patients being
treated with safinamide as an adjunctive treatment to a stable dose of a
single dopamine agonist, proved over 24 weeks of treatment to be well
tolerated and associated with a clinically relevant and statistically
significant improvement in UPDRS part III motor score* (primary efficacy
measure) as well as several secondary endpoints such as responder rates and
Activities of Daily Living (ADL) compared to dopamine agonist monotherapy,
at a dose of 50 to 100 mg/day. In addition, safinamide showed promising
effects on cognition. Compared to patients on dopamine agonist monotherapy,
the addition of safinamide indicated a potential improvement in cognitive
function.
    - Unified Parkinson's Disease Rating Scale (UPDRS) - III motor scale,
which provides a semiquantitative evaluation of motor impairment as a means
of rating patients severity."
    About safinamide
    Safinamide is an alpha-aminoamide derivative which is orally
administered. Studies have shown that safinamide combines the inhibition of
dopamine re-uptake and MAO-B, two key mechanisms involved in the control of
dopamine concentration in the brain, and inhibition of glutamate release.
Based on the results of prior clinical trials, Newron believes that
safinamide, as an adjunctive treatment to dopamine agonists and levodopa,
has a competitive advantage over current therapies for Parkinson's disease.
    About Serono
    Serono is a global biotechnology leader. The Company has eight
biotechnology products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R
)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In
addition to being the world leader in reproductive health, Serono has
strong market positions in neurology, metabolism and growth and has
recently entered the psoriasis area. The Company's research programs are
focused on growing these businesses and on establishing new therapeutic
areas, including oncology and autoimmune diseases.
    In 2005, Serono, whose products are sold in over 90 countries, achieved
worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was
US$106.1 million, reflecting a charge of US$725 million taken relating to
the settlement of the US Attorney's Office investigation of Serostim.
Excluding this charge as well as other non-recurring items, adjusted net
income grew 28.4% to US$565.3 million in 2005. Bearer shares of Serono
S.A., the holding company, are traded on the virt-x (SEO) and its American
Depositary Shares are traded on the New York Stock Exchange (SRA).
    About Newron Pharmaceuticals
    Newron Pharmaceuticals S.p.A (http://www.newron.com) is a research and
development company focused on novel therapies for diseases of the Central
Nervous System (CNS), particularly pain and Parkinson's disease. Newron is
undertaking phase III trials with safinamide, a unique molecule with
multiple mechanisms of action, for the treatment of Parkinson's disease.
Preliminary results of a six-month phase III trial have demonstrated
benefit in motor symptoms and activities of daily living quality, as well
as improvement in cognitive function and good tolerability. Phase II trials
with safinamide in Restless Leg Syndrome (RLS) have shown promising
results. Newron continues to conduct phase II trials with ralfinamide for
the treatment of neuropathic pain. Newron's clinical pipeline is supported
by a broad portfolio of early stage proprietary compounds generated by its
ion channel drug discovery platform. Newron is headquartered in Bresso,
near Milan, Italy.
    Serono's forward-looking statement
    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 February 28, 2006. 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, the outcome of any government
investigations and litigation. Serono is providing this information as of
the date of this press release, and 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.
    On September 21, 2006 Merck KGaA entered into an agreement with the
Bertarelli Family, which owns the majority stake of Serono SA, to purchase
their Serono shares. Subject to antitrust review and closing of the
purchase, Merck will hold 64.5% of the capital of Serono and 75.5% of the
voting rights, for which Merck agreed to pay CHF 1,100 per share in cash.
Merck will make a public tender offer under Swiss law for the same price of
CHF 1,100 per share. The offer price represents a 20% premium to the share
price as of September 20, 2006, and a total equity value of CHF 16.6
billion (approximately EUR 10.6 billion) on a fully diluted basis.

Link to this page: