Novartis AG NVS announced that its generic arm, Sandoz has received FDA approval for Glatopa, the first generic version of Teva Pharmaceuticals’ TEVA multiple sclerosis (MS) drug, Copaxone 20mg (one time daily).
Glatopa, the first substitutable generic version, was developed by Sandoz in collaboration with Momenta Pharmaceuticals MNTA for the treatment of patients suffering from relapsing forms of MS, including those who have experienced the first clinical episode and have magnetic resonance imaging features consistent with MS.
As per the terms of the agreement, Sandoz will be responsible for commercializing Glatopa, although the launch timing was not disclosed by either company. On the other hand, Momenta is eligible to receive up to $140 million in milestone payments for Glatopa. This includes a $10 million payment earned as the FDA approved the Abbreviated New Drug Application (ANDA), while another $10 million milestone payment is due upon the first commercial sale.
Our Take
Copaxone is one of the leading drugs in Teva’s portfolio, generating sales of $3.1 billion (combined 20 mg/mL and 40 mg/mL) in 2014 in the U.S. Hence, this approval will be a major setback for Teva.
The higher dose of the drug, Copaxone 40mg/mL (three-times-weekly formulation), was launched by Teva in Jan 2014 in the U.S. Thereafter, patients who were previously treated with the once-daily formulation have been gradually switching to the three-times-weekly formulation. Consequently, the market growth prospects for the once-daily formation have decreased, and may continue to do so as more patients migrate from once-daily Copaxone to three-times-weekly Copaxone.
Nevertheless, approval of the generic version came as a big boost for Momenta. Shares were up 6.1% on the news. The company had earlier received a setback when the U.S. Supreme Court ruled in favor of Teva in the patent infringement lawsuit related to the generic version of Copaxone (20 mg/mL). Momenta also filed an ANDA with the FDA for the generic version of Copaxone 40mg/mL.
Meanwhile, the approval will further strengthen the leading position of Novartis’ Sandoz in the generics and biosimilars markets.
Both Novartis and Momenta currently carry a Zacks Rank #4 (Sell). Right now, Mallinckrodt plc MNK looks nicely placed with a Zacks Rank #1 (Strong Buy).
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