Tyme Technologies And Eagle Pharmaceuticals Announce Collaboration To Advance Oral SM-88 For Treatment Of Patients With Cancer; Tyme Entitled To Receive Total Of $40M In The Form Of Upfront Payment And Milestones

Collaboration leverages combined capabilities of Tyme Technologies and Eagle Pharmaceuticals to maximize potential of oral SM-88 by advancing pivotal trials and commercialization. TYME recently launched the

Benzinga · 01/07/2020 12:23
  • Collaboration leverages combined capabilities of Tyme Technologies and Eagle Pharmaceuticals to maximize potential of oral SM-88 by advancing pivotal trials and commercialization.
  • TYME recently launched the TYME-88-PANC pivotal trial to evaluate oral SM-88 for third-line treatment of patients with metastatic pancreatic cancer.
  • TYME is entitled to receive up to a total $40 million as follows:
    • an initial $20 million upfront. In return, Eagle will receive 10 million restricted shares of TYME's common stock at $2.00 per share.
    • a second $20 million milestone payment upon achieving primary endpoints in pivotal trial results or approval of a cancer indication in the U.S. for SM-88. This payment will be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price.
  • Eagle will be responsible for 25% of the promotional sales effort of SM-88 and will receive 15% of net revenues of SM-88 in the U.S.
  • TYME retains all commercial rights to SM-88 outside the U.S. and reserves the right to repurchase Eagle's U.S. co-promotion right for $200 million.
  • Oral SM-88 represents a novel therapeutic approach designed to selectively disrupt protein synthesis in cancer cells with demonstrated tumor responses in 15 different cancer types across multiple studies.
  • In a Phase II study of patients with actively progressing metastatic pancreatic cancer who had failed previous therapy, evaluable patients on SM-88 demonstrated median overall survival of 6.4 months as of April 25, 2019; patients who achieved stable disease or better had a statistically significant (p=0.02) improvement in survival with a 92% reduction in risk of death.