On April 8, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that it has entered into a promotion agreement in which Immunomedics will provide detailing services to Janssen Biotech Inc. (Janssen), for erdafitinib in the U.S (Press release, Immunomedics, APR 8, 2019, View Source [SID1234535071]).

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"We are delighted to be collaborating with Janssen and we look forward to working closely with the Janssen team to help promote erdafitinib," said Brendan Delaney, Chief Commercial Officer of Immunomedics. "We have built strong commercial capabilities at Immunomedics and this agreement allows us to leverage our experienced oncology sales force to educate the U.S. market on this potential new treatment option for patients with metastatic urothelial cancer upon FDA approval."

Under the terms of the agreement, Immunomedics’ sales team will provide product detailing from the launch of erdafitinib until the end of the First Quarter 2020, but only requires Immunomedics to support the product in first position detail until the FDA approval of sacituzumab govitecan. Immunomedics is eligible to receive low double digit royalties and milestone payments based on U.S. sales throughout 2019 and 2020, subject to sales thresholds in each year, respectively.

A New Drug Application (NDA) for erdafitinib is currently under review by the U.S. Food and Drug Administration for the treatment of patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, pan-FGFR kinase inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018

On April 8, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that Ilia Tikhomirov, CEO of Forbius, will be presenting at the 18th Annual Needham Healthcare Conference (Press release, Forbius, APR 8, 2019, View Source [SID1234535070]).

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Mr. Tikhomirov’s presentation will take place Tuesday, April 9th at 1:30 PM EST in Track 1, 3rd floor, at the Westin Grand Central Hotel in New York.

On April 8, 2019 Oncolys BioPharma Inc. (hereafter, "Oncolys") and Chugai Pharmaceutical Co., Ltd. (hereafter, "Chugai") reported the both companies have entered into an agreement that Oncolys will grant an exclusive license, with sublicensing rights, to Chugai concerning the development, manufacturing and marketing in Japan and Taiwan for "Telomelysin (OBP-301)" (hereafter, "Telomelysin") an oncolytic viral immunotherapy which is currently under development by Oncolys (Press release, Chugai, APR 8, 2019, View Source [SID1234535069]). In addition, licensing agreement that grants exclusive option rights concerning the worldwide development, manufacturing and marketing of Telomelysin, excluding Japan, Taiwan, China, Hong Kong and Macau to Chugai has also been concluded. Moreover, both companies agreed that Oncolys will newly issue common stock worth approximately 800 million yen, and Chugai will accept all the stocks. The start of this licensing agreement and the payment accompanying the issuance of new shares by third-party allotment are planned on April 24, 2019.

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Chugai shall pay 550 million yen as an upfront payment for the exclusive licensing agreement, with sublicensing rights, in Japan and Taiwan. If a certain level of efficacy has been confirmed in the clinical study of Telomelysin, and in case Chugai exercised the exclusive option rights described above, the total value of the licensing agreement which Chugai shall pay to Oncolys will be 50 billion yen or more. In addition, after the launch of Telomelysin, Chugai shall pay to Oncolys, sales royalties according to Chugai’s amount of sales of Telomelysin, apart from the total value of the licensing agreement.

The capital and business tie-up agreement described in this release is announced separately by Oncolys on April 8, 2019, in the "Notice of Capital and Business Alliance and Issuance of New Shares through Third Party Allotment."

Comments by the Management
Yasuo Urata, President & CEO, Oncolys BioPharma Inc.
"Chugai is an expert in the development of oncology drugs including antibody pharmaceuticals, and we feel that we were able to form the best partnering in developing Telomelysin, an oncolytic viral immunotherapy. Telomelysin is an oncolytic virus drug originated in Japan, and we are extremely delighted that Chugai had highly valued the clinical effects of the drug against esophageal cancer. We hope that Chugai will greatly expand the indications of Telomelysin, going forward."

Tatsuro Kosaka, President and CEO, Chugai Pharmaceutical Co., Ltd.
"Telomelysin is an oncolytic viral immunotherapy with a novel mode of action, expected to provide new value to oncology patients. We are committed to maximize the value of this new innovative drug created by Oncolys in order to deliver it to patients as quickly as possible, and also expand its indications to other types of cancer, by considering the combination with cancer immunotherapies, which could provide true value to patients and their families. We strongly believe that Chugai, as one of the shareholders of Oncolys, can contribute to increasing corporate and shareholder values of Oncolys in the medium- to long-term perspective."

Oncolys believes that the conclusion of this licensing agreement and the third-party allocation of shares will contribute to enhancing its corporate value as well as shareholder value. At this point, however, the concrete amount of impact they would have on Oncolys’ business performance of the term ending December 2019 is unclear. The impact on the consolidated financials for the fiscal year ending December 2019 of Chugai is expected to be minimal.
As written in the financial statements for the business term ended December 2018, released on February 8, 2019, Oncolys has not announced its business performance forecasts for the term ending December 2019, since the company views it difficult to calculate appropriate and reasonable numerical value due to the existence of numerous uncertain factors that impact the business performance at this point.

On April 8, 2019 Based on its exclusive license related to photoimmunotherapy, Rakuten Medical Inc., which is developing a cancer therapy to target cancer cells, reported that ASP-1929 received Sakigake designation under the Sakigake Designation System*, which is a Fast Track designation from the Japanese Ministry of Health, Labour, and Welfare as a treatment for head and neck cancer patients (Press release, Rakuten Aspyrian, APR 8, 2019, View Source [SID1234535068]).

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ASP-1929 qualified on all four criteria of the Sakigake Designation System: innovativeness of the product, the severity of the target condition, prominent effectiveness of the treatment, and with a plan to file the initial application first or simultaneously with others in Japan. This designation was referred for Sakigake Designation System based upon the results of analysis of a Phase I trial in Japan and a Phase I/IIa trial in the United States. The results of these studies in comparison to past data of the currently available standard treatments in a group of head and neck cancer patients suggest the potential for improved survival time.

Based on receipt of this designation, Mickey Mikitani, chairman and CEO of Rakuten Medical said, "Every day, we receive messages from many patients waiting for this treatment. To those people, I am delighted to be able to make an announcement today that brings them hope. This is a major step forward toward delivering a new treatment for head and neck cancer patients. We are aiming to get this therapy to as many patients as possible, and as soon as possible, by rigorously following the process established by the Sakigake Designation System."

ASP-1929 received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of head and neck squamous cell carcinomas (HNSCC) in the first quarter of 2018. Under the mission of Rakuten Medical, we will accelerate the development of photoimmunotherapy applying ASP-1929 to cancers of the head and neck.

*The Sakigake Designation System is the Japanese Fast Track designation which started as a national strategy and was announced by the Ministry of Health, Labour and Welfare on June 17, 2014. The measures included the creation of this designation system for groundbreaking drugs developed in Japan and identified in the early clinical trial phase as being likely to be remarkably effective. This would offer priority examination that would reduce the length of the approval examination period before commercialization.

On April 8, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its first quarter 2019 financial and operating results on Tuesday, May 7, 2019, before the U.S. financial markets open (Press release, Regeneron, APR 8, 2019, https://www.prnewswire.com/news-releases/regeneron-to-report-first-quarter-2019-financial-and-operating-results-and-host-conference-call-and-webcast-on-may-7-2019-300826362.html [SID1234535060]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.