On November 20, 2017 Samsung Bioepis Co., Ltd. reported the European Commission’s (EC) marketing authorization of ONTRUZANT, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer (Press release, Samsung Bioepis, NOV 20, 2017, View Source [SID1234522145]). ONTRUZANT is the first trastuzumab biosimilar to receive regulatory approval in Europe.

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The EC approval of ONTRUZANT applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. ONTRUZANT will be commercialized by MSD, which is known as Merck in the United States and Canada.

"Breast cancer remains the most common form of cancer affecting women. We hope ONTRUZANT will play an important role expanding patient access to trastuzumab across the region," said Christopher Hansung Ko, President & CEO of Samsung Bioepis. "Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars."

ONTRUZANT is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis has also received marketing authorizations for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).

PVS-RIPO, more commonly referred to as the re-engineered poliovirus, is the Sabin type 1 polio vaccine, genetically modified so it cannot harm or kill normal cells (Company Web Page, Istari Oncology, NOV 19, 2017, View Source [SID1234522139]).
We believe there are several important advantages of PVS-RIPO as an immunotherapy for cancer treatment:
The poliovirus receptor CD155 is expressed in virtually all solid cancers, as well as dendritic cells, macrophages and other immune cells.
PVS-RIPO infects and kills tumor cells that express CD155.
PVS-RIPO infection of immune cells facilitates induction of an antitumor immune response.
PVS-RIPO is the only oncolytic virus that is not destroyed by the Type 1 interferon response caused by these viruses.
Other oncolytic viruses kill or limit dendritic cells. PVS-RIPO stimulates dendritic cell activity and immune function.
Cancer patients who are immune to polio and have been boosted with the Salk vaccine experience a recall immune response upon intratumoral PVS-RIPO infusion.
For targeting glioblastoma, the vaccine is delivered by direct intratumoral delivery via convection-enhanced delivery (CED), which by-passes the blood-brain barrier and reduces systemic toxicity. CED is commonly used, and we believe it is reproducible in multiple centers. Less than 5% of the tumor volume needs to be injected to achieve high drug concentrations throughout the tumor. BrainLAB and Therataxis software allow highly accurate and reproducible drug distribution and injection accuracy.
The FDA granted PVS-RIPO Breakthrough Therapy Designation on May 10, 2016. Breakthrough Therapy Designation conveys all fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior FDA managers, and eligibility for rolling review and priority review.
The FDA also granted PVS-RIPO Orphan Drug designation for glioblastoma on May 26, 2016. Benefits of this designation include tax credits of 50% of the clinical drug testing cost awarded upon approval, waiver of NDA/BLA application fee, and seven years of data exclusivity upon approval (that is, it bars the FDA from approving any other application for the same drug for the same orphan disease or condition for seven years).

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On November 17, 2017 PledPharma AB ("PledPharma") (STO: PLED) and Solasia Pharma K.K. ("Solasia") (TSE: 4597) reported that they have entered a license agreement pertaining to the clinical development and commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea and Taiwan (Press release, Solasia, NOV 17, 2017, View Source [SID1234532512]).

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Under the terms of this agreement, PledPharma grants exclusive development and commercialization rights to PledOx in the territories mentioned and Solasia will pay upfront, development, regulatory and sales milestones of up to ~USD 83 million (SEK 700 million)*. In addition, Solasia will pay industry standard royalty rates on sales applicable for a deal pertaining to an in-licensed asset in Phase III development. Solasia will also fully finance an expansion of the Phase III program to include Asian patients subject to regulatory consultations.

The license agreement is initially focused on the use of PledOx as prevention of chemotherapy induced peripheral neuropathy in colorectal cancer patients. The agreement with Solasia facilitates an expansion of the recently announced global Phase III-program for PledOx with Asian patients, subject to regulatory consultations, aiming to gain sufficient documentation for regulatory approvals in the major Asian markets. In addition, a Phase I study in Japanese and Caucasian Healthy Volunteers with focus on safety, tolerability and pharmacokinetics will be conducted. Following potential regulatory approvals, Solasia will be responsible for the commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea, and Taiwan.

"We are very excited to announce our partnership with Solasia – an ideal partner during the development, regulatory process and commercialization of PledOx in this very important region. The collaboration will ensure an optimized expansion of the Phase III program to include Asian patients, aiming at further realising the global commercial potential of our drug candidate," said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.

"We are convinced that PledOx, as a novel first in class therapy, will play an important role in fulfilling the significant unmet medical need of preventing chemotherapy induced peripheral neuropathy. Solasia is ideally equipped to support PledPharma during the remaining clinical development and local regulatory processes in Japan, and to effectively launch the product in key Asian markets," said Yoshihiro Arai, President and Chief Executive Officer, Solasia.

As PledPharma announced earlier in November, following interactions with the regulatory authorities, EMA and FDA, the company has finalized the design of the global Phase III program for the drug candidate PledOx. The Phase III studies are anticipated to be initiated at the end of 2017 with top line results expected during 2020.

* The total value of upfront and milestone payments is up to JPY 9.3 billion. The amount given in USD and SEK is subject to exchange rate.

Invitation to corporate presentation
PledPharma will attend the Redeye Life Science Seminar on November 24 at 11:00 CET where PledPharma will provide a company update and an overview of the license agreement with Solasia. The event will be live streamed from Redeyes website www.redeye.se. After the event, the presentation will be available on PledPharma’s website.

On November 17, 2017 Novogen reprorted that following the Company’s Annual General Meeting held on Wednesday 15 November, where shareholders voted to approve all resolutions, the Company is pleased to advise that the name Kazia Therapeutics Limited has been formally adopted after registration by ASIC (Press release, Kazia Therapeutics, NOV 17, 2017, View Source [SID1234525997]). The ASX has been informed and the Company will trade under the new ticker of KZA from Tuesday 21 November 2017. The Company will also trade under the NASDAQ ticker of KZIA.

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CEO Dr James Garner said: "Our new brand, Kazia Therapeutics, reflects the innovative, focused and agile company that we have become. I am delighted that shareholders voted in support of our new name and future."

On November 17, 2017 ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer, reported that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Piper Jaffray 29th Annual Healthcare Conference on Tuesday, November 28, 2017 at 11:30am ET (Press release, ChemoCentryx, NOV 17, 2017, View Source [SID1234522130]). The conference will be held at the Lotte New York Palace Hotel in New York, NY.

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A live audio webcast of the fireside chat discussion can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. A replay of the webcast will be available on the Company’s website for two weeks following the live discussion.