Synthon’s glatiramer acetate, a potential
generic version of Copaxone®1 for the
treatment of relapsing remitting multiple sclerosis is currently
being reviewed by the U.S. Food and Drug Administration
Pfizer Inc. and Synthon, an international pharmaceutical company
specializing in the development of complex generic medicines, today
announced they have entered into an agreement whereby Pfizer has
acquired the exclusive commercialization rights in the United
States to glatiramer acetate, a potential generic version of the
originator medicine Copaxone® for the treatment of relapsing
remitting multiple sclerosis (RRMS).
In November 2011, Synthon filed an Abbreviated New Drug
Application (ANDA) with the U.S. Food and Drug Administration (FDA)
for a once daily 20mg/ml formulation of glatiramer acetate. In
early 2014, Synthon filed an ANDA for a three times a week 40mg/ml
formulation of glatiramer acetate with the FDA. In addition,
Synthon believes its glatiramer acetate 40mg/ml filing may be
eligible for 180 days of shared marketing exclusivity under the
provisions of the Hatch-Waxman Act.
“Neurologic diseases such as multiple sclerosis represent some
of the most debilitating illnesses of our time,” said Diem Nguyen,
regional president of North America, Pfizer Global Established
Pharma business. “Pfizer’s significant experience in successfully
bringing meaningful medicines to market together with Synthon’s
scientific expertise in neurodegenerative diseases will enable us
to leverage our core capabilities in support of improving patient
health in the United States.”
Under the terms of the agreement, Pfizer will have exclusive
rights to commercialize both dosage formulations of Synthon’s
glatiramer acetate in the United States. Synthon is responsible for
the clinical development, manufacture and supply of glatiramer
acetate. Pfizer is solely responsible for the commercialization of
glatiramer acetate in the United States. Financial terms of the
agreement were not disclosed.
“We are very pleased to partner with Pfizer on the introduction
of glatiramer acetate to patients and healthcare providers in the
United States,” said Jacques Lemmens, chief executive officer of
Synthon. “Our partnership will ensure the rapid introduction of a
high quality product through Pfizer’s well-established presence in
the United States, which in turn may result in savings on an
important MS medication for patients and payors.”
About GATE:
A Phase III Glatiramer Acetate clinical trial To assess
Equivalence with Copaxone® (GATE) was set up following Scientific
Advice received from the European Medicines Agency (EMA) with the
aim to show equivalence of Synthon’s glatiramer acetate (Synthon
GTR) with Teva’s Copaxone® in a well-controlled 3-arm double-blind
equivalence study. The open-label part of the study further aimed
to provide 2-year efficacy, safety and tolerability data on
Synthon’s generic glatiramer acetate and to show safety of
switching from Copaxone® to Synthon’s generic. The large-scale,
multicenter study consisted of a nine-month double-blind efficacy
comparison followed by a 15-month open-label extension and was
executed in RRMS patients in Europe (including Russia, Ukraine and
Belarus), Mexico, South Africa and the United States.
About Multiple Sclerosis:
Multiple sclerosis (MS) is an unpredictable, often disabling
disease of the central nervous system which interrupts the flow of
information within the brain, and between the brain and body. Signs
and symptoms vary widely, depending upon the amount of damage and
which nerves are affected. Symptoms range from numbness and
tingling to blindness and paralysis. These problems may come and go
or persist and worsen over time. Relapsing Remitting Multiple
Sclerosis (RRMS) is the most common form of MS characterized by
clear episodes of inflammatory activity known as relapses, followed
by remission. RRMS affects approximately 85 percent of newly
diagnosed patients.
According to the National Multiple Sclerosis Society, most
people with MS are diagnosed between the ages of 20 years and 50
years, with at least two to three times more women than men being
diagnosed with the disease. MS affects more than 2.3 million people
worldwide. In the United States, the number of people with MS is
estimated to be about 400,000.
About Synthon:
Synthon, with headquarters in Nijmegen, the Netherlands, is an
international pharmaceutical company and a leader in the field of
complex generic medicines. The company started its
biopharmaceutical franchise in 2007 and is building a promising
portfolio of next generation medicines. Synthon is developing
rapidly into a specialty pharmaceutical company, focusing on the
therapeutic areas of auto-immune diseases and oncology. Synthon
products are currently approved by regulatory agencies in over 90
countries worldwide and marketed through strategic partnerships and
– in dedicated areas – through direct sales. Synthon employs about
1,500 staff worldwide, and in 2014 it recorded a turnover of EUR
218 million. For more information, go to www.synthon.com.
Pfizer Inc.: Working together for a
healthier world™
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety, and value
in the discovery, development, and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments, and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments, and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us
at www.pfizer.com.
DISCLOSURE NOTICE: The information
contained in this release is as of August 3, 2015. Synthon and
Pfizer assume no obligation to update forward-looking statements
contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information regarding
Synthon’s potential generic version of Copaxone, glatiramer
acetate, and an agreement between Synthon and Pfizer for the
commercialization of glatiramer acetate once daily 20m/ml and three
times a week 40mg/ml dosages formulations in the United States that
involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including whether and when applications with the FDA may be
approved, which will depend on the assessment by the FDA of
Synthon’s ANDA submission and related documentation; decisions by
the FDA regarding labeling and other matters that could affect the
availability or commercial potential of glatiramer acetate; the
ability to successfully commercialize such products in the United
States; and competitive developments.
A further description of risks and uncertainties related to
Pfizer can be found in Pfizer's Annual Report on Form 10-K for the
fiscal year ended December 31, 2014 and in its subsequent reports
on Form 10-Q, including in the sections thereof captioned "Risk
Factors" and "Forward-Looking Information and Factors That May
Affect Future Results", as well as in its subsequent reports on
Form 8-K, all of which are filed with the SEC and available
at www.sec.gov and www.pfizer.com
1 Copaxone® is a registered trademark of Teva Pharmaceuticals
Industry Ltd.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150803005640/en/
Pfizer Media:Mackay Jimeson, 212-733-2324orPfizer Investor:Ryan
Crowe, 212-733-8160orSynthon:Fabienne Douven, 31(0)24 37 27 700
Pfizer (NYSE:PFE)
Historical Stock Chart
From Feb 2024 to Mar 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2023 to Mar 2024