Dimethyl Fumarate DR Capsules is indicated as monotherapy for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability.
PrSandoz® Dimethyl Fumarate Delayed-Release Capsules is an important generic product that will enable major cost savings for the healthcare system in addition to improving access for patients.
This is the second multiple sclerosis treatment added to the Sandoz Canada portfolio.
Boucherville, October 4, 2021 – Sandoz Canada announced today the launch of PrSandoz® Dimethyl Fumarate Delayed-Release Capsules, a generic equivalent to Biogen Canada’s PrTecfidera*. It is indicated as a monotherapy for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability.
PrSandoz® Dimethyl Fumarate Delayed-Release Capsules is availablein a blister pack of 56 capsules in two strengths (120 mg and 240 mg). The patient-friendly packaging includes indicators to help track medication usage during the week.
The new product will be covered by Sandoz Continüm™ Patient Support Program, which is already working with a network of clinics specialized in multiple sclerosis treatment across Canada. The program will include services to help patients get reimbursement from insurers, financial assistance, and educational material for pharmacists serving patients who take Dimethyl Fumarate Delayed Release Capsules.
“Relapsing remitting multiple sclerosis is a severe chronic condition. With this second MS treatment in our portfolio, we are continuing our mission to make life-enhancing medicines more accessible by launching quality generics and providing the best possible support to patients and healthcare professionals,” says Michel Robidoux, President and General Manager of Sandoz Canada.
TM/® Trademark and registered trademark owned or used under license by Sandoz Canada Inc. * Registered trademark owned by its respective registrant.
This press release contains forward-looking statements, including, but not limited to, potential future revenues from the sale of PrSandoz® Dimethyl Fumarate Delayed-Release Capsules. You should not place undue reliance on these statements. These forward-looking statements reflect management's current beliefs and expectations regarding future events and involve known and unknown risks and significant uncertainties. Should one or more of these risks or uncertainties materialize, or should any of the underlying assumptions prove incorrect, actual results could differ materially from those set forth in the forward-looking statements. There can be no assurance that PrSandoz® Dimethyl Fumarate Delayed-Release Capsules will be submitted or approved for other additional indications or labelling in other markets, or at any particular time, nor can it be guaranteed that PrSandoz® Dimethyl Fumarate Delayed-Release Capsules will be approved by a regulatory body or will be commercially successful in the future. In particular, management’s expectations regarding PrSandoz® Dimethyl Fumarate Delayed-Release Capsules could be affected by a number of factors, including: uncertainties inherent in research and development, including unexpected clinical study results and additional analysis of existing clinical data; unexpected regulatory actions, delays or government regulations in general; the company’s ability to obtain or maintain intellectual property protection; general economic and industry conditions; the global trend towards streamlining healthcare costs, including constant pressure regarding pricing; impacts of the COVID-19 pandemic; unexpected manufacturing problems, and other risks and factors mentioned in form 20-F filed by Novartis AG with the US Securities and Exchange Commission. Sandoz is providing the information in this media release as of today and does not undertake any obligation to update any forward-looking statements described herein as a result of new information, future events or otherwise, except as required by law.
Sandoz International GmbH is a world leader in generics and biosimilars and a division of the Swiss multinational Novartis.
Sandoz Canada is a pioneer, a leader and trusted supplier of quality generics and biosimilars with over 65 million prescriptions per year, based on decades of global experience and capabilities in the development, manufacturing and commercialization of its products. Sandoz launched the first biosimilar in Europe in 2006 and in the Canadian market in 2009.