On September 25, 2018 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, and CSPC Pharmaceutical Group Limited (HKEx: 1093) (CSPC), a leading pharmaceutical company in China, reported their entry into an exclusive licensing agreement for CSPC to develop and commercialize Verastem Oncology’s COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all oncology indications in China (Press release, Verastem, SEP 25, 2018, View Source;p=RssLanding&cat=news&id=2368922 [SID1234529591]). COPIKTRA received approval from the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.
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COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Under the terms of the agreement, Verastem Oncology shall receive an upfront payment of $15 Million USD. Verastem Oncology is also entitled to receive additional development milestone payments of $30 Million USD, plus potential sales milestone payments and double-digit percentage royalties based on future net sales of COPIKTRA in China. CSPC will receive exclusive rights to develop and commercialize COPIKTRA and hold the marketing authorization and product license for COPIKTRA in China. CSPC will have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities and will share pro-rata in the cost.
"This agreement with Verastem Oncology brings to our pipeline an overseas approved innovative oncology drug with the potential to help Chinese patients battling cancer, including some high unmet need hematologic malignancies," said Cai Dongchen, Chairman of CSPC. "Our long-standing development and commercial experience in the Chinese pharmaceutical market, together with Verastem Oncology’s expertise with COPIKTRA, will ensure the timely and efficient development of this exciting therapy. At CSPC, we are dedicated to developing and commercializing innovative medicines and we are honored to form this strategic alliance with Verastem Oncology to advance COPIKTRA."
"We are delighted to be working with CSPC, a respected leader in developing, manufacturing and commercializing pharmaceuticals in China," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "CSPC successfully markets multiple oncology products, including DUOMEISU (doxorubicin hydrochloride liposome injection), JINYOULI (PEG-rhGCSF injection) and KEAILI (paclitaxel for injection (albumin-bound)). CSPC is a constituent stock of the Hang Seng Index and is recognized as one of the most valuable brands in China. We believe this partnership underscores the global potential of COPIKTRA and complements the growing list of strategic partners focused on bringing COPIKTRA to patients worldwide. As we execute the launch of COPIKTRA in the U.S., we will work collaboratively in parallel with CSPC to rapidly advance COPIKTRA through the hospitals in China and ultimately to cancer patients in need."
About COPIKTRA (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.