NEW YORK & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Tyme Technologies, Inc. (Nasdaq: TYME), an emerging biotechnology company developing cancer metabolism-based therapies, and Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX), 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’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, oral SM-88 has demonstrated complete or partial responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and blood cancers with minimal serious grade 3 or higher adverse events.
“TYME’s approach is unique and transformational. Targeting cancer’s metabolism by disrupting protein synthesis has advantages over existing treatment approaches in terms of both efficacy and safety,” said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals. “This collaboration provides an excellent opportunity to continue expanding our presence in the oncology space, as well as to evaluate potential combination opportunities with SM-88 in our existing pipeline. We look forward to leveraging our oncology sales infrastructure to maximize the commercialization of SM-88 in the U.S., if approved. As always, our goal remains to deliver innovative, next-generation therapeutics to address patient needs and to create value for our shareholders,” concluded Tarriff.
Terms of the Agreements
Under the terms of the securities purchase agreement, TYME will receive a $20 million upfront cash payment for 10 million restricted shares of TYME common stock at $2.00 per share. In addition, TYME will receive a $20 million milestone payment upon the successful completion of the first to occur of the following three events: (1) achievement of the primary endpoint of overall survival in its TYME-88-Panc pivotal trial; or (2) achievement of the primary endpoint of overall survival in the PanCAN Precision Promise? SM-88 registration arm; or (3) U.S. Food and Drug Administration (FDA) approval of SM-88 in any cancer. This payment would 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’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.
Under the terms of the co-promotion agreement, Eagle Pharmaceuticals will undertake 25% of the promotional sales effort for SM-88 in the U.S. oncology market and receive 15% of the net U.S. revenues of SM-88, and TYME will be responsible for the remaining promotional effort. TYME will also be responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. TYME retains the remaining 85% of net U.S. revenues and reserves the right to repurchase Eagle’s co-promotion right for $200 million.
As part of this partnership between TYME and Eagle, there is also the potential to evaluate oral SM-88 in combination therapy or as monotherapy through leveraging Eagle’s oncology pipeline and expertise in oncology settings, which may include trials in breast or lung cancers and other tumor types.
“We are extremely pleased to establish this collaboration with Eagle Pharmaceuticals who shares our passion and commitment to improving the lives of patients with advanced cancers. After a thorough due diligence process by both parties, each came away with great respect for each organization’s capabilities and potential,” said Steve Hoffman, Chairman and Chief Executive Officer of TYME. “This alliance provides TYME with the commercial and capital resources to advance our leadership position in the field of cancer metabolism and the potential to expand our capabilities and accelerate clinical programs that will create value for all of our stakeholders, most importantly for the patients we serve.”
About SM-88
SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.
About Advanced Pancreatic Cancer
Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease.2 The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer - adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.
About Precision Promise?
Precision Promise? is an adaptive randomized Phase III registration-ready clinical trial. The objective of Precision Promise? is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities. The primary goal of SM-88’s inclusion is to study SM-88 as a monotherapy treatment arm for patients who have failed one prior line of chemotherapy. Additionally, it is planned that SM-88 will be evaluated in combination with gemcitabine (Gemzar ®) and nab-paclitaxel (Abraxane ®) for first-line patients. The primary end point of these randomized trials is overall survival.
About Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cancer cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.
About Eagle Pharmaceuticals
Eagle is a specialty pharmaceutical company focused on developing and commercializing innovative and differentiated injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Additional information is available on the Company’s website at www.eagleus.com.
