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WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”) today announced that Eagle and the University of Pennsylvania (“Penn”) have agreed on terms of a new exclusive worldwide license agreement for the development of dantrolene sodium for the potential treatment of people living with Alzheimer’s disease, including an agreement to fund additional research and provisions regarding commercialization of products developed under the license.
“Our collaborationSee More
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”) today announced that the Company has resubmitted its New Drug Application (“NDA”) for RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (“EHS”), in addition to body cooling, to the U.S. Food and Drug Administration (“FDA”). Eagle believes that this submission addresses the Complete Response Letter received in July 2017. A Prescription Drug User Fee ActSee More
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.
NEW YORK & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Tyme Technologies, Inc. (Nasdaq: TYME) ("TYME"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), and Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), today announced the formation of a U.S. strategic collaboration focused on the co-promotion of TYME’s lead CMBT candidate oral SM-88 in advanced cancers. CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’See More