With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition

Takeda is going to bat for Velcade's exclusivity protection in a FDA citizen petition.

Takeda’s multiple myeloma blockbuster Velcade is quickly running out of patent protection, but the drugmaker has filed a citizen petition it hopes can stave off competition for a little while longer.

The Japanese pharma giant asked the FDA to hold off on approving any Velcade copies until February 2018 at the earliest, arguing that changes to its med’s label should in turn extend its exclusivity at least into next year. One exclusivity period for the drug stretches into 2022, the company says.

Plus, some of the proposed copycats include different ingredients and should require further testing, Takeda contends.

In its proposed knockoff, Fresenius Kabi substitutes boric acid and other ingredients for the mannitol in Velcade, Takeda says, arguing that the change “raises significant safety and efficacy issues that must be adequately investigated.” In its petition, Takeda requests that any copycats containing boric acid instead of mannitol be supported by preclinical and human data showing they are safe and effective.

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Velcade, a lyophilized powder reconstituted into an injectable solution, contains bortezomib in the mannitol ester form before reconstitution. Now that some companies are working on versions that don’t contain mannitol ester, Takeda is asking the FDA to switch Velcade’s active ingredient from the monomeric boronic acid bortezomib, which exists only after reconstitution, to the mannitol ester of bortezomib.

“The active ingredient must be identified in the form it exists in the lyophilized powder and not the reconstituted solution,” Takeda says in its petition, adding that the “distinction is critically important” considering the copycats under development don’t include mannitol.

A Fresenius spokesperson declined to comment on the petition.

Takeda suffered an unexpected blow with Velcade back in 2015, when a federal judge invalidated a key 2022 patent, opening a window for potential generic competition this year. But Takeda hopes its petition may buy it some more time for patent-protected sales.

The drugmaker is also questioning whether generic copycats can “carve out” the first-line mantle cell lymphoma use in their application, granted to Velcade in 2014. At a minimum, Takeda is requesting the FDA seek public comment on the issue.

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In their analysis of the petition, Bernstein analysts wrote Monday morning that there is a chance the action could delay generic entry. Velcade is among the industry’s top patent losses for 2017, with $1.1 billion in U.S. sales last year.

Regardless of when Velcade faces generic competition, Takeda is aiming to take the revenue loss in stride. The company’s follow-up oral med, Ninlaro, is a “significantly bigger” opportunity, CEO Christophe Weber has said. Takeda has predicted Ninlaro’s sales could exceed $3 billion per year.