Serono Submits New Formulation of Rebif(R) for Approval in the United States and in Europe
April 04 2006 - 2:02AM
PR Newswire (US)
Trial Data Show New Formulation of Rebif(R) Offers Substantial
Improvement in Overall Tolerability and Reduction in Antibody
Formation GENEVA, Switzerland, and ROCKLAND, Massachusetts, April 4
/PRNewswire-FirstCall/ -- Serono (virt-x:SEO and NYSE: SRA)
announced today the submission of a supplemental Biologics Licence
Application (sBLA) to the US Food and Drug Administration (FDA) and
of a variation to the current Marketing Authorization to the
European Medicines Agency (EMEA) for a new formulation of Rebif(R)
(interferon beta-1a) as a treatment of multiple sclerosis (MS).
Data from a Phase III clinical trial in patients with relapsing
forms of MS show that the new formulation of Rebif(R) results in a
substantial improvement in overall tolerability, as measured by
pre-specified parameters including injection site reactions, which
are an important factor for patients when choosing an MS therapy.
The trial data also show that the incidence of antibody formation
with the new formulation of Rebif(R) is reduced. Serono expects
data on the new formulation of Rebif(R) to be presented at a major
medical conference in the second half of 2006. "These results are
promising news for patients with multiple sclerosis," said Prof Per
Soelberg S0rensen, from the Danish MS Research Center, Copenhagen
University Hospital, Rigshospitalet and an investigator of the
trial. "While Rebif(R) is well established in the treatment of
relapsing forms of multiple sclerosis, results from this clinical
trial show that the new formulation offers promising improvements
which could translate into additional benefits to the patient."
"Serono is focused upon providing multiple sclerosis patients with
enhanced therapeutic solutions," said Franck Latrille, Senior
Executive Vice President Global Product Development. "This is
supported by innovative development and manufacturing technology
platforms that we have implemented to deliver world-leading biotech
therapies." The new formulation of Rebif(R) is the latest of many
product developments from Serono to continually enhance the
convenience and tolerability of Rebif(R). Other enhancements have
included the new Rebiject II auto-injector to facilitate
injections; a 29 gauge-needle pre-filled syringe, the thinnest
needle in a ready-to-use pre-filled syringe for the treatment of
MS; a titration pack designed to make starting on Rebif(R) therapy
easier and more convenient. About Rebif(R) Rebif(R) (interferon
beta-1a) is a disease-modifying drug used to treat relapsing forms
of multiple sclerosis and is similar to the interferon beta protein
produced by the human body. Interferon helps modulate the body's
immune system, fight disease and reduce inflammation. Rebif(R),
which was approved in Europe in 1998 and in the US in 2002, is
registered in more than 80 countries worldwide. In the United
States, Rebif(R) is co-marketed by Serono, Inc. and Pfizer Inc.
Rebif(R) has been proven to delay the progression of disability,
reduce the frequency of relapses and reduce MRI lesion activity and
area[1]. Rebif(R) is available in a 22 mcg and 44 mcg ready-to-use
pre-filled syringe and a titration pack, and can be stored at room
temperature for up to 30 days if a refrigerator is not available.
Most commonly reported side effects are injection site disorders,
flu-like symptoms, elevation of liver enzymes and blood cell
abnormalities. Patients, especially those with depression, seizure
disorders, or liver problems, should discuss treatment with
Rebif(R) with their doctors. About Serono Neurology In addition to
Rebif(R), Serono also offers a second therapy within its US
portfolio of multiple sclerosis (MS) therapies: Novantrone(R)
(mitoxantrone for injection concentrate) for worsening forms of MS.
Full prescribing information for these products can be obtained by
contacting Serono or visiting the Serono website. Additional
therapy options are currently under development at Serono,
including cladribine tablets, currently in Phase III studies and
potentially the first oral therapy for treatment of MS, as well as
osteopontin, an MMP-12 inhibitor, a JNK inhibitor and interferon
beta:Fc, in early-stage development for MS. Serono also is taking a
leading role in developing an understanding of the role of genetics
in MS, with a whole genome scan currently underway. To-date, 80
genes associated with MS have been identified, based on a 40% scan.
The project is due to be completed in 2006 and will improve
understanding of the causes of MS and the appropriate therapeutic
targets for the disease. About multiple sclerosis Multiple
sclerosis (MS) is a chronic, inflammatory condition of the nervous
system and is the most common, non-traumatic, neurological disease
in young adults. MS may affect approximately two million people
worldwide. While symptoms can vary, the most common symptoms of MS
include blurred vision, numbness or tingling in the limbs and
problems with strength and coordination. The relapsing forms of MS
are the most common. 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 government
investigations and litigation 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. 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. Currently, there are more than 25 on-going
development projects. 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). Reuters: SEO.VX / SRA.N Bloomberg: SEO VX / SRA US
[1] The exact relationship between MRI findings and the clinical
status of patients is unknown. DATASOURCE: Serono International
S.A. CONTACT: For more information, please contact: 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. Investor
Relations, USA: Tel: +1-781-681-2552, Fax: +1-781-681-2912
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