(Press release, Cannabis Science, NOV 9, 2012, http://www.cannabisscience.com/2012/591-cannabis-science-provides-corporate-guidance-on-preclinical-initiatives-and-recent-corporate-developments-for-its-shareholders-cbis-announces-plans-for-1st-q-of-2013-webinar-investor-call [SID:1234505819])

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(Filing, 10-Q, Myrexis, NOV 9, 2012, View Source [SID:1234506938])

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Menarini Group and Oxford BioTherapeutics Collaborate for Development and Manufacture of Novel Antibody-Based Cancer Drugs

On October 29, 2012 Menarini and Oxford BioTherapeutics (OBT) reported a major strategic alliance to develop a portfolio of antibody-based drugs in the field of cancer (Press release Oxford BioTherapeutics, OCT 29, 2012, View Source [SID:1234500496]). The agreement covers five of OBT’s antibody and antibody drug conjugate (ADC) programs, each of which addresses a different cancer indication via a different novel oncology target. The deal brings together OBT’s discovery expertise with Menarini’s clinical knowledge, and expanding capabilities in the manufacture and development of biologics, to build value for both companies as they work to bring this exciting portfolio of next generation antibody-based cancer drugs to market.

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Under the collaboration, Menarini will lead the efforts in the manufacture and clinical development of each program, supported by OBT, while OBT will provide the proprietary cancer target, antibody and arming technologies. Once clinical proof of concept has been achieved, OBT will complete the clinical development and commercialize these novel antibody-based products in North America and Japan, whilst Menarini will develop and commercialize the products in Europe, CIS, Asia and Latin America.

DelMar Pharmaceuticals Expands Collaboration with Guangxi Wuzhou Pharmaceutical Company

On October 29, 2012 Del Mar Pharmaceuticals (BC) Ltd. ("DelMar") reported a strategic collaboration with Guangxi Wuzhou Pharmaceutical Company, a subsidiary of publicly traded Guangxi Wuzhou Zhongheng Group Co., Ltd (SHG 600252) for the development of VAL-083, known as "DAG for Injection" in China (Press release, DelMar Pharmaceuticals, OCT 29, 2012, View Source [SID1234556371]).

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DAG for Injection in China, is approved by the Chinese State Food and Drug Administration (SFDA) as a cancer chemotherapy for the treatment of Chronic Myelogenous Leukemia (CML) and lung cancer. Guangxi Wuzhou Pharmaceuticals is licensed by SFDA to manufacture and sell VAL-083 in China for these indications.

DelMar is conducting clinical studies using the Guangxi Wuzhou Pharmaceutical’s drug product in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

In addition, DelMar is conducting research aimed at demonstrating the utility of DAG for Injection in cancers refractory to current therapies. Recently published data elucidated sub-types of CML and lung cancer that are uniquely prevalent in persons of East Asian decent and highly resistant to treatment by tyrosine kinase inhibitors (TKIs). DelMar’s research demonstrates activity against cancer cell lines resistant to TKI therapy.

The Companies plan to use new data being generated through DelMar’s clinical programs to expand the market in China and to seek regulatory approval for the drug in multiple indications on a global basis.

The collaboration expands the exclusive supply relationship between DelMar and Guangxi Wuzhou Pharmaceuticals to include the Chinese market and all markets outside China. The companies will work together to insure the product specifications meet global standards in order to accelerate international development and regulatory approval. Wuzhou Pharmaceuticals will be the exclusive supplier of DAG for Injection and DelMar will be responsible for development and commercialization.

"This expanded collaboration positions DelMar to unlock the value of our research by benefiting patients in China where our VAL-083 is already approved as a cancer chemotherapy," said Jeffrey Bacha, President & CEO of DelMar.

The expanded collaboration, was announced at a joint press conference and signing ceremony in Wuzhou China on October 24, 2012. During the ceremony, Chen Ming, Vice Chairman of Zhongheng Group, outlined six key areas of focus for the collaboration:

Seek approval from regulatory authorities outside China, including the FDA, EMEA and other international jurisdictions to commercialize DAG for Injection for the treatment of GBM and other indications;
DelMar will support Wuzhou Pharmaceuticals by developing and providing new clinical and non-clinical data for the approved indications in China in order to support marketing and sales of DAG for Injection in China;
Wuzhou Pharmaceutical will assist and provide financial support for DelMar to initiate development work in one or more Clinical Centers in China as part of an international multi-center clinical development strategy;
DelMar will provide clinical and non-clinical data to support Wuzhou Pharmaceuticals to obtain approval of DAG for Injection from SFDA for new indications, including GBM;
DelMar and Wuzhou Pharmaceuticals will work together to enable Wuzhou Pharmaceuticals to obtain FDA certification as a cGMP manufacturer of DAG for Injection; and
Through co-development of DAG for injection, the collaboration will seek to maximize the value of Wuzhou Pharmaceuticals business in China and create a foundation for sales in international markets.
Xu Shuqin, Chairman of Zhongheng Group said, "It is understood that, through this collaboration, we will seek to establish approval of DAG for Injection through international authorities including FDA and EMEA and other international jurisdictions outside China for multiple indications including brain cancer. DelMar will assist Wuzhou Pharmaceuticals within China to support sales and marketing of the product and promote the optimization of production and quality assurance to meet international standards. Wuzhou Pharmaceuticals will assist DelMar by supporting international multi-center clinical trials. We will work together to jointly develop and promote Wuzhou Pharmaceuticals business in China, to maximize the value of products sold in the international market, and to lay the foundation for more extensive collaboration opportunities."

Astex Pharmaceuticals, CRT and Newcastle University sign strategic drug discovery alliance

On October 29, 2012 Astex Pharmaceuticals, Inc. (Nasdaq: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, Cancer Research Technology Limited (CRT) and Newcastle University reported they have signed a major five-year strategic drug discovery alliance (Press release, Cancer Research Technology, OCT 29, 2012, View Source [SID1234523268]). The partners will discover and develop new cancer drugs in collaboration with researchers at the Cancer Research UK Drug Discovery Program at the Northern Institute for Cancer Research (NICR, Newcastle University).

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During the five-year alliance, Astex will provide £1M funding annually to Newcastle University to support research across biology, chemistry, pharmacology and imaging at the NICR to identify and develop new cancer drugs and associated biomarkers to develop tests to determine which patients to treat and if new drugs are working.

Harren Jhoti, PhD, director and president of Astex Pharmaceuticals, said: "We are delighted to enter into this broad strategic drug discovery alliance with one of Cancer Research UK’s leading drug discovery centers as it allows Astex to access world-leading translational research in oncology.

"This new alliance builds on a previous collaboration between Astex, Newcastle and CRT on FGFr, a key cancer target, which led to the development of a clinical candidate that our partners at Janssen have recently taken into a Phase I clinical trial, and we look forward to discovering more new potential therapies for cancer patients."

Astex will retain an option to an exclusive worldwide license to develop and commercialize pharmaceutical products from each alliance project. CRT and Newcastle are eligible to receive development and regulatory milestone payments on exercise of the options, and on products that Astex takes into development (and royalties on sales of products). Financial terms of the milestone payments and royalties were not disclosed.

Professor Herbie Newell, co-director of the Cancer Research UK Drug Discovery Program at the NICR, Newcastle University, said: "This exciting alliance represents an innovative route to the development of more effective cancer drugs by combining the partners’ expertise and experience.

"The research will bring together pre-clinical drug and biomarker discovery approaches using molecular, genetic and clinical data to identify new targets in cancer cells that can be treated with drugs, and ultimately medicines to take into clinical trials that will provide new ways to treat the disease and increase survival."

Dr Keith Blundy, Cancer Research Technology’s chief executive, said: "This major collaboration, which builds on the successes and impressive track record of all partners, will further develop Cancer Research UK’s world-class research into cancer treatments.

"Risk-sharing partnerships like this enable us to maximise the development of our basic research portfolio into new treatments for patients.

"The success of our existing network of partnerships is seen in our drug development pipeline which is the largest and most diverse of any academic partner worldwide with more than 30 cancer therapies in clinical development, and a further 175 discovery/pre-clinical projects in our portfolio, of which 55 are partnered with industry."