Date: 2015-06-18
Type of information: Product launch
Product name: Glatopa® (first generic version of Teva's Copaxone®)
Compound: glatiramer acetate injection
Therapeutic area: Neurodegenerative diseases
Action mechanism:
Company: Momenta Pharmaceuticals (USA - MA) Sandoz (Switzerland)
Disease: relapsing-remitting multiple sclerosis (RRMS)
Latest news: * On June 18, 2015, Sandoz, a Novartis company, announced the US launch of Glatopa®, the first generic version of Teva's Copaxone® (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy. 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. Under the terms of its collaboration agreement with Sandoz, Momenta will receive a $10.0 million milestone payment upon first commercial sale. Momenta is also eligible to receive up to $120 million in remaining milestone payments upon the achievement of certain U.S. commercial and sales-based milestones for the Glatopa product. Glatopa was determined by the FDA to be therapeutically equivalent to daily Copaxone® 20 mg, with the same active ingredients, route of administration, strength and dosage form. Glatopa's high quality U.S.-based supply chain and manufacturing process meet rigid FDA standards, and Glatopa is fully substitutable at the pharmacy level. Sandoz has also introduced a patient support service offering that includes financial support to eligible patients, personalized injection training and 24-hour access to nurses to answer non-clinical questions. * On April 16, 2015, the FDA approved Glatopa®, the first generic version of Copaxone® (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). Sandoz has received FDA approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection. Under the terms of its collaboration agreement with Sandoz, Momenta is eligible to receive up to $140 million in milestone payments upon the achievement of certain U.S. regulatory, commercial and sales-based milestones for Glatopa®, including a $10.0 million payment earned upon sole FDA approval of the ANDA, and another $10.0 million milestone payment upon first commercial sale. Transient chest pain was noted in 13% of glatiramer acetate patients vs. 6% of placebo patients. While some episodes of chest pain occurred in the context of the immediate post-injection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment. At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy. Because glatiramer acetate can modify immune response, it may interfere with immune functions. For example, treatment with glatiramer acetate may interfere with recognition of foreign antigens in a way that would undermine the body's tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this, but there has not been a systematic evaluation of this risk. The most common adverse reactions with glatiramer acetate vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%). ISRs were one of the most common adverse reactions leading to discontinuation of glatiramer acetate. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with glatiramer acetate than placebo. * On August 28, 2014, Momenta Pharmaceuticals has announced that the FDA has accepted for review the Abbreviated New Drug Application (ANDA) for a three-times-a-week generic Copaxone® (glatiramer acetate injection, 40 mg/mL), submitted by Sandoz Inc., Momenta\'s development and commercialization partner for this product candidate. Based on publicly-available information, Momenta believes that, should the ANDA be approved, it would be eligible for 180-day first-to-file exclusivity under Hatch-Waxman. The product could be on the market as early as the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines. Since the 40 mg/mL formulation contains the same drug substance as the 20 mg/mL ANDA currently under review by the FDA, Momenta anticipates the FDA review process can be completed within the same time frame.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2015-04-16
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
