Sandoz announces US launch of Glatopa(TM), the first generic competitor to Copaxone® 20mg

Novartis International AG / Sandoz announces US launch of Glatopa(TM), the first generic competitor to Copaxone® 20mg . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Glatopa is the first FDA-approved, substitutable generic version of Copaxone^®  20mg, a treatment for relapsing forms of multiple sclerosis
• Sandoz has begun shipping to US customers following recent FDA approval
• Novartis and Sandoz are driving access to a full range of differentiated, high-quality MS therapeutic options, complemented by a full range of support services

Holzkirchen, Germany, June 18, 2015 - Sandoz, a Novartis company, today announced the US launch of Glatopa^TM, the first generic version of Teva's Copaxone^® (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy.  

"Sandoz, together with Momenta, is proud to announce the US market launch of a fully substitutable generic version of this important therapy, following FDA approval" said Peter Goldschmidt, President of Sandoz US. 

MS is a debilitating disease affecting about half a million individuals in the US alone; only half of those diagnosed are currently treated.^[1]

Glatopa, developed in collaboration with Momenta and produced entirely in the US, is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS. 

The Sandoz service offering will include financial assistance to qualified patients, personalized injection training and 24-hour access to nurses for non-clinical questions.

Fighting MS, together with other CNS disorders, is central to the Novartis mission, and Sandoz's Glatopa joins a broad MS portfolio including two approved therapies and one late-stage development compound.

Important Safety Information
Glatiramer acetate is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Approximately 16% of glatiramer acetate patients vs. 4% of those on placebo experienced a constellation of symptoms immediately after injection that included at least 2 of the following: flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and urticaria. These symptoms generally have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.