Urovant ramps up spending on Codexis ingredient ahead of commercial production

By Nick Taylor

- Last updated on GMT

(Image: Getty/undefined undefined)
(Image: Getty/undefined undefined)

Related tags: Commercialization, Production line, Enzyme, Fda

Urovant Sciences’ preparations to file for US approval of vibegron add to Codexis’ sales in the second quarter.

Codexis entered into an agreement to provide Urovant with a proprietary enzyme in 2017. The deal tasked Codexis with meeting all of Urovant’s demand for the enzyme and gave it a minimum purchase commitment of $3.75m (€3.34m).

Subsequent updates suggest the contract could be worth far more than that to Codexis. Urovant bought more than $1m worth of enzyme in the first quarter and was again singled out by the Codexis CEO John Nicols in the most recent results.

Nicols said, “Urovant Sciences was among the leaders for our product sales, as they lined up supplies for their planned NDA filing with the FDA in early 2020 for vibegron, a potential treatment for overactive bladder.​”

Urovant is currently performing stability studies on the new 75mg dose of vibegron. Once it has the stability data, Urovant will be able to file for approval, meaning it may be able to get a submission to the FDA slightly ahead of the schedule sketched out by Nicols.

If Urovant succeeds in bringing vibegron to market, the contract could provide an ongoing source of revenue for Codexis, which is the sole supplier of a proprietary enzyme used in the production of the drug. Under the terms of Urovant’s agreement with Codexis, it will source the enzyme from the supplier for the first six years after vibegron is first approved in either the US, Europe or Canada.

Urovant licensed vibegron from Merck, one of Codexis’ key customers. Merck, known as MSD outside the US and Canada, sources an enzyme used in the production of the active ingredient in diabetes drug Januvia from Codexis. As usual, that contract was worth more than $1 million to Codexis in the second quarter.

Nicols has previously said that vibegron is “not going to be as big as a Januvia enzyme sale, but it's a nice size target​.” Codexis is supplying the enzyme to Urovant and Kyorin, which owns the rights to vibegron in parts of Asia and has already won approval in Japan.

Mounting losses

Another top 25 pharma customer bought $1m worth of product from Codexis in the quarter ahead of a planned 2020 launch of a new product, furthering the supplier’s efforts to diversify beyond the Januvia contract.

However, Codexis’ results nonetheless fell short of analyst expectations. Codexis posted a loss of $0.08 per share, around double the deficit expected by analysts. Increased spending on facilities and staff dragged on performance in the quarter.

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