Astellas bites off $490M deal to develop muscle drugs with Cytokinetics

Cytokinetics is on a roll. After topping off its long-term heart drug development deal with Amgen ($AMGN) last week with a $75 million licensing deal covering Japan, the South San Francisco-based biotech is back with a $490 million licensing and discovery deal with Astellas concentrating on muscle weakness and fatigue.

Cytokinetics ($CYTK) also pulled off a 1-for-6 reverse stock split last night, which radically boosted its share price. Cytokinetics shares were trading over $13 this morning, up 558% on the split. 

The Tokyo-based pharma company is paying $40 million in upfront cash and near-term R&D support to team up with Cytokinetics on new research on treatments for muscle weakness while partnering on the early-stage program for CK-2127107. And the deal is back-ended with up to $450 million in milestones for successful development work. Cytokinetics will be responsible for wrapping the Phase I and some pre-Phase II work on CK-2127107 with Astellas picking up the reins in Phase II as the partners explore some next-gen therapies that can follow in the pipeline.

Cytokinetics has been working on small molecules that can boost body muscle where it counts. By carefully stimulating the cardiac muscle myosin motor protein, for example, the company aims to bolster a weakened heart without increasing intracellular calcium concentration--a key to preventing side effects. Heart drugs can be incredibly lucrative, but are also one of the most expensive to develop, as regulators insist that developers clear a high bar on safety and efficacy.

Amgen initially stepped in as a partner in 2006, then expanded the deal in 2009 with a pact for omecamtiv mecarbil, a cardiac myosin activator that has now been put through multiple Phase I and Phase II studies for heart failure. Amgen added Japan to its global rights last week, making this one of its most important mid-stage treatments.

"We view the news as a clear positive for CYTK since the company maintains worldwide rights to (the ALS treatment) tirasemtiv; while it brings in additional capital, it can use for its further development, maintaining the option to license it down the line, including after the BENEFIT-ALS data," noted Cowen's Simos Simeonidis this morning. What's next?  "Completion of enrollment in the BENEFIT-ALS Phase IIb trial of tirasemtiv in ALS is expected in mid-2013; 2) Data from the 600-patient, Phase IIb ATOMIC-AHF trial, which is now fully enrolled, are expected at ESC Labor Day; 3) The full data from the BENEFIT-ALS trial are expected around YE 2013; 4) In 2014, we expect the COSMIC-HF data from the oral omecamtiv mecarbil trial; followed by 5) the Phase III trial(s) of omecamtiv mecarbil."

"Through this collaboration, we intend to jointly investigate the potential role that CK-2127107 and follow-on skeletal muscle activators can play in providing functional improvements in patients with diseases characterized by muscle weakness and fatigue," said Cytokinetics CEO Robert Blum.

- here's the press release