Pfizer and Synthon enter into U.S. commercialization agreement for potential generic treatment of multiple sclerosis

PfizerPfizer 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.

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.

Most Popular Now

The Merck Accelerator Program 2019

The Merck Accelerator is looking for real partners so that you can work together in shaping the future. With programs in the headquarters in Germany, in China and the Sat...

Pre-clinical success for a universal flu vaccine o…

Researchers from the University of Oxford's Department of Zoology have demonstrated pre-clinical success for a universal flu vaccine in a new paper published in Nature Co...

Imfinzi is the first immunotherapy to demonstrate …

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi durin...

Global survey reveals that physicians need more in…

Results from a new global survey revealed that more than one-third (36%) of the 310 physicians surveyed do not think they have sufficient information required to make inf...

In clinical trials, new antibody therapy controls …

Thanks to improvements in antiretroviral therapy, HIV is now a manageable condition. Yet even the best drugs do not entirely eliminate the virus, which latently lingers i...

Sandoz Healthcare Access Challenge #SandozHACk ret…

Sandoz, the Novartis generics and biosimilars division, today announces the launch of the second Sandoz Healthcare Access Challenge (HACk). The #SandozHACk is a global co...

The Nobel Prize in Physiology or Medicine 2018 was…

Cancer kills millions of people every year and is one of humanity's greatest health challenges. By stimulating the inherent ability of our immune system to attack tumor c...

Novartis licenses three novel anti-infective progr…

Novartis announced today that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug cand...

Pfizer to award more than $3 million in grants to …

Pfizer Inc. today announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants tota...

FDA approves first treatment for advanced form of …

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squam...

DNA islands effective as 'anti-bacterial drones'

Genomic "islands" that evolved from viruses can be converted into "drones" that disable Staphylococcus aureus, bacteria that are often resistant to antibiotics and pose a...

FDA awards 12 grants to fund new clinical trials t…

The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to...