Serono and Newron Announce Global Development and Commercialization Agreement for Safinamide
October 16 2006 - 1:00AM
PR Newswire (US)
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. DATASOURCE: Serono
International S A CONTACT: For more information, please contact:
Serono Corporate Media Relations: Tel: +41-22-739-36-00,
Fax:+41-22-739-30-85, http://www.serono.com/. Media Relations, USA,
Tel: +1-781-681-2340, Fax: +1-781-681-2935,
http://www.seronousa.com/. Corporate Investor Relations:
Tel:+41-22-739-36-01, Fax:+41-22-739-30-22, Reuters: SEO.VX / SRA,
Bloomberg: SEO VX / SRA US. Investor Relations,
USA:Tel:+1-781-681-2552, Fax:+1-781-681-2912, Newron
Pharmaceuticals, Luca Benatti, CEO+ 39-02-6103461, Julia Phillips,
Financial Dynamics, +44-20-7269-7187
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