Drug Development

Eyeing a potential market launch, Astellas orders up a $95M third course of Cytokinetics’ pipeline

Whatever Astellas learned about Cytokinetics $CYTK in the three years since first signing on as a collaborator, the experience must have given its research team plenty of confidence in the biotech’s future. Astellas is announcing today that it’s coming back for a bigger share of the pipeline, its third big portion of Cytokinetics’ technology and muscle activation therapeutics.

Astellas is committing $95 million in the deal. That covers $65 million up front in exchange for an option on the development and commercialization of tirasemtiv, Cytokinetics’ lead muscle drug now in late-stage development, for amyotrophic lateral sclerosis (ALS). And there’s another $30 million to pay for a mid-stage ALS study for another muscle activator in the pipeline, CK-2127107. If Astellas picks up its option, Cytokinetics can gain a total of more than $100 million in the deal.

Shares of Cytokinetics surged 6% this morning.

Once the Phase II is done, the partners plan to work together on a pivotal study for the experimental therapy, with Cytokinetics in line for additional milestones and royalties if these drugs are approved. Another drug, omecamtiv mecarbil, is partnered with Amgen on heart failure.

For the South San Francisco-based biotech’s executive team, the Astellas deal positions the company for its next long hoped-for strategic advance into commercialization, spurring plans to prep for their first market launch.

“We are developing compounds that are directly acting on muscles,” CEO Robert Blum tells me, first amplifying muscles for patients in a range of diseases, but also keeping in mind a future where new therapies that can amp up muscles could have a big impact on the emerging field of healthy aging.

It hasn’t all been upbeat news at the company. Back in 2014 tirasemtiv failed a critical Phase IIb study for ALS. But Cytokinetics kept the faith, encouraged by its effect on slowing the decline of respiratory failure.

“In fact,” Blum says, “we believe that our trial was the only that ever demonstrated an effect on ALS patients’ muscle strength.”

So they’re now testing the drug with respiratory capacity as the primary endpoint, measuring against factors like time to respiratory failure or time before patients require mechanical ventilation to stay alive. That data is coming up in the second half of next year, and Blum hopes that it will take the partners to the threshold of marketing approval.

Their focus on 7107 reflects some dose-limiting problems with tirasemtiv, which Blum attributes to the lead drug’s ability to slip through the blood brain barrier. That’s not so much the case for 7107, which could make it more successful — if it gets through the clinic.

Astellas’ first move with Cytokinetics occurred back in 2013, when they partnered on non-neuromuscular conditions. A year later, the Japanese pharma came back for a deal in the neuromuscular area, taking a position on spinal muscular atrophy.

If it all leads to global approvals, Cytokinetics will lead commercialization on tirasemtiv in North America and Europe and a few other countries, while Astellas has its sights set on Asia and a few other countries outside the biotech’s commercial turf. The co-development deal on CK-2127107 leaves the biotech co-promotion rights on key markets.

There are still plenty of potential pitfalls along the way, but the latest Astellas deal leaves the company in better shape for whatever comes next.

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