On December 19, 2018 On December 19, 2018, BeiGene, Ltd. (the "Company") reported that it received notice from Merck KGaA ("Merck KGaA") that Merck KGaA was terminating for convenience the parties’ License Agreement dated December 10, 2013, as amended, for the Company’s investigational RAF dimer inhibitor lifirafenib (BGB-283) in the People’s Republic of China ("PRC") (Filing, 8-K, BeiGene, DEC 19, 2018, View Source [SID1234532301]). As a result of such termination, Merck KGaA’s exclusive right of first negotiation to acquire exclusive commercialization rights under the lifirafenib RAF dimer program in the PRC was terminated and the Company is no longer required to pay Merck KGaA royalties on sales of lifirafenib in the PRC or entitled to receive future milestone payments from Merck KGaA for lifirafenib. The Company’s ex-PRC agreement with Merck KGaA on lifirafenib was terminated in March 2017.

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On December 18, 2018 Immedica is reported that from 1 September 2018, it has become the exclusive distributor for the innovative anti-cancer drug Yondelis in the United Kingdom (Press release, Immedica Pharma, DEC 18, 2018, View Source [SID1234555253]). Yondelis is an established treatment for patients suffering from soft tissue sarcomas (STS) and platinum sensitive ovarian cancer. "I believe Immedica will fill an important role as a facilitator for making Yondelis available for patients in the United Kingdom", says Anders Edvell, CEO of Immedica.

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About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close to 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

On December 18, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the independent Data Safety Monitoring Board (DSMB) of the Registration trial for Patients with Hepatic Dominant Ocular Melanoma (The FOCUS Trial) completed another pre-specified review of safety data for treated patients in the trial (Press release, Delcath Systems, DEC 18, 2018, View Source;p=RssLanding&cat=news&id=2381000 [SID1234532112]). This review was conducted on data collected from both the prior randomized protocol and the amended single-arm protocol for the FOCUS Trial. The DSMB again recommended continuation of the study without modification.

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In July, the Company announced that it has amended the protocol for the FOCUS trial, which is now enrolling as a single-arm, multi-center open label study. Safety data collected have not been modified as a result of the amendment, and safety data from both the randomized and single-arm protocols will be pooled in any analyses submitted to the Food & Drug Administration as part of a New Drug Application.

The FOCUS trial, now entitled A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), is enrolling a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled under the prior randomized protocol continue to be treated and evaluated as part of the amended trial, and periodic DSMB reviews will continue to be conducted.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath, said, "We are pleased with the safety profile observed by our therapy in the trial thus far, and the trial remains on track to complete enrollment by June 2019."

On December 18, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast its presentation at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 (Press release, Regeneron, DEC 18, 2018, View Source [SID1234532128]). The presentation is scheduled for 10:30 a.m. Pacific Time (1:30 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A breakout session will immediately follow the formal presentation and can also be accessed on our website. An archived version of the presentation and the breakout session will be available for 30 days.

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On December 18, 2018 Qualigen, Inc., and Advanced Cancer Therapeutics, LLC (ACT) reported that Qualigen has licensed certain ACT patents, intellectual property and know-how associated with the antiproliferative activity of G-rich oligonucleotides ACT-GRO-777 (also known as AS1411) and methods of using these to bind to nucleolin, a protein that is present on the surface of tumor cells (Press release, Qualigen, DEC 18, 2018, View Source [SID1234532129]). AS1411 is a novel aptamer-based anticancer technology and a key component of Qualigen’s anti-nucleolin agent-conjugated nanoparticle drug (AS1411-GNP) that can be used to treat virtually any type of cancer. The AS1411 aptamer has been tested as a drug in over 100 patients and is well tolerated with no evidence of severe side effects, with at least 7 patients having long-lasting clinical responses, where their cancers either disappeared or shrank substantially. Under this License Agreement, Qualigen will obtain the exclusive rights to develop and commercialize ACT-GRO-777/AS1411 and related compounds. In return, ACT will receive potential equity in Qualigen, along with cash payments on the achievement of certain milestones and royalties on future drug sales.

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"We are delighted to add ACT-GRO-777/AS1411 to our portfolio of anticancer drug technologies. This is a unique opportunity to continue development of a compound that has already undergone extensive preclinical characterization and shown promise in prior clinical studies. We believe that Qualigen’s new AS1411-GNP formulation will lead to a significant improvement in potency and absorption in humans, enabling the drug to fulfill the promise seen in the earlier studies," noted Michael S. Poirier, Chairman, CEO and President of Qualigen.

"We are excited to work with Qualigen on the product development of our aptamer-based drug to fight cancer," said Randall Riggs, Board Member of ACT.