Mylan gains FDA approval for three-times weekly formulation of Teva's Copaxone

Mylan announced that the FDA approved its generic version of Teva's three-times weekly formulation of Copaxone (glatiramer acetate) and will begin shipping the product "imminently." Mylan noted that it was one of the first applicants to submit a substantially complete filing for the 40mg version of the multiple sclerosis therapy, and may be eligible for 180 days of generic drug exclusivity.

In addition, Mylan said that the FDA approved its generic version of once-daily Copaxone at a dose of 20mg. Both drugs are indicated for the treatment of patients with relapsing forms of multiple sclerosis, with sales of the once-daily version reaching $700 million for the 12 months ended July 31. Meanwhile, revenue from the three-times weekly version of Copaxone, which was first cleared in the US in 2014, reached $3.6 billion over the same period.

Shares in Mylan climbed as much as 17 percent on the news, while Teva's stock slipped up to nearly 10 percent. Mylan has partnered with Natco Pharma on generic versions of Copaxone, with shares in the Indian drugmaker jumping as much as 20 percent on the FDA approvals. For further analysis, read ViewPoints: A fatal blow to Teva's Copaxone empire?

Commenting on the news, Teva interim CEO Yitzhak Peterburg remarked "we have planned for the eventual introduction of a generic competitor to [Copaxone]," adding that the company will "continue to promote and support the product." He said since "we are closing the third quarter, it is too soon to officially comment on any change to our full-year business outlook," but more details are expected to be provided at Teva's third-quarter earnings call on November 2. Still, the drugmaker warned that "any launch by Mylan of a generic version of [three-times weekly Copaxone] prior to final resolution of the pending patent appeals and other patent litigation should be considered an 'at-risk' launch."

FirstWord reports in this therapy area - KOL Insight Multiple Sclerosis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Teva noted that it is appealing a January 2017 ruling by a US district court that invalidated certain claims of four patents covering the thrice-weekly version of Copaxone. The company said it is also appealing inter partes review decisions rendered last December by the US Patent Trial Appeal Board, which had determined that all of the claims of three Copaxone patents were unpatentable. Further, Teva stated that it is suing five drugmakers that have filed for generic approval of Copaxone, including Mylan, alleging infringement of a patent covering a manufacturing process for the product.

Meanwhile, Mylan CEO Heather Bresch commented that the latest approvals "reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market." The clearances come shortly after FDA Commissioner Scott Gottlieb unveiled a number of initiatives designed to hasten the approval of complex generic drugs. In August, Mylan lowered its annual guidance, partly as a result of delays to the launch of its generic version of Copaxone in the US (for related analysis, see ViewPoints: Mylan confirms feeling the pain but not gain of generics peers).

To read more Top Story articles, click here.