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CTI BioPharma And Servier Announce Exclusive License And Collaboration Agreement To Develop And Commercialize PIXUVRI

On September 17, 2014 CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) and Servier reported that they have entered into an exclusive license and collaboration agreement to develop and commercialize PIXUVRI (pixantrone) in a transaction valued at up to €103.0 million (approximately $133.5 million) if all milestones are achieved (Press release, CTI BioPharma, SEP 17, 2014, View Source;p=irol-newsArticle&ID=1968777 [SID1234529057]). Under the agreement, CTI retains full commercialization rights for PIXUVRI in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the United Kingdom and the U.S., with Servier having exclusive rights to commercialize PIXUVRI in all other countries.

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PIXUVRI is conditionally approved in the European Union for patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who failed two or three prior lines of therapy. PIXUVRI is the first monotherapy treatment option for this patient group and the only therapy licensed for third and fourth line use in aggressive B-cell NHL patients, which includes diffuse large B-cell lymphoma (DLBCL). As of this announcement, PIXUVRI was available in 11 countries and has achieved reimbursement decisions under varying conditions in England/Wales, Italy, France, Germany and the Netherlands. Under the terms of the agreement, CTI will receive an upfront payment of €14 million (approximately $18.1 million) and is eligible to receive additional sales, clinical and regulatory milestone payments, as well as royalties on sales, such royalty payments being subject to certain reductions.

"We believe Servier represents the ideal strategic partner to achieve the full potential of PIXUVRI, particularly in those regions of the world where CTI does not currently have, or plan to have a presence," said James A. Bianco, M.D., President and CEO of CTI. "Our two companies share a vision for bringing PIXUVRI to patients and believe this collaboration will not only maximize the development, commercialization and market potential of PIXUVRI, but will also help accelerate potential development expansion into new indications. We believe Servier’s development expense contributions could help us achieve a net positive contribution margin for PIXUVRI this year and profitability in 2015 and beyond."

"Servier is conducting a comprehensive chemistry and biology research program in the field of oncology with the aim to develop and bring novel effective therapies to patients with cancer," said Jean Pierre Abastado, Head of the Oncology Therapeutic Innovation Center at Servier. "In addition, Servier has entered into several scientific collaborations with Academic Institutions as well as a number of other partnerships in the field of oncology and hematology. This new partnership will nicely fit within Servier’s portfolio by bringing an immediate therapeutic solution for patients suffering from aggressive B-cell non-Hodgkin lymphoma (NHL) who failed two or three prior lines of therapy."

"This partnership around PIXUVRI will also enable Servier to build its hemato-oncology capabilities for market access and medical information in many countries, thereby preparing for the arrival of an extensive portfolio of innovative treatments that are currently in clinical development," said Pascal Touchon, Vice President Scientific Collaboration and Business development at Servier.

Merck Serono and Sutro Biopharma to Partner on Development of Antibody Drug Conjugates

On September 17, 2014 Merck Serono reported a collaboration and license agreement to develop antibody drug conjugates (ADCs). ADCs are composed of an antibody linked to a cytotoxic drug. The antibody is thought to specifically target and deliver the cytotoxic drug to the cancer cells (Press release Sutro Biopharma, SEP 17, 2014, View Source [SID:1234500754]).

The collaboration will allow Merck Serono to take advantage of Sutro’s technology platforms in its oncology programs to develop ADCs for multiple undisclosed targets. Both companies believe that ADCs have the potential for directly targeting cancer cells while safeguarding healthy tissue, and will combine Merck Serono’s knowledge about target biology with Sutro’s technological and discovery capabilities to jointly develop ADCs. By following a strategic approach of creating partnerships, Merck Serono and Sutro aim to develop drug candidates that may ultimately address the unmet needs of patients.

“We continue to explore opportunities that will allow us to better understand the potential ADCs have in directly targeting cancer cells,” said Andree Blaukat, Senior Vice President and Head of Translational Innovation Platform Oncology at Merck Serono. “This collaboration with Sutro is reflective of our ongoing commitment to advancing innovation that may provide new therapies for patients.”

“This partnership will help us to advance our position as a leading drug discovery partner to renowned pharmaceutical companies like Merck,” said William J. Newell, chief executive officer of Sutro. “Together with Merck Serono, we will further advance our efforts to develop antibody therapeutics, engineered to deliver a cytotoxic agent to cancer cells. Our technology has been developed to allow loading of an antibody with multiple different agents, and to enable a potential higher uptake of the drug in the tumor cell through an improved stability of the ADC.”

Under the terms of the agreement, Sutro and Merck Serono will collaborate to discover and develop multiple ADCs utilizing Sutro’s cell-free protein synthesis platforms, Xpress CF and Xpress CF+. Sutro will be responsible for delivering ADCs for Phase I clinical trials. Merck Serono will be responsible for clinical development and commercialization of any resulting products.
Merck Serono will make an upfront payment to Sutro and will fund certain R&D activities. Sutro is also eligible to receive payments on completion of certain research, development and regulatory milestones potentially totaling approximately € 230 million as well as royalties on product sales. Further financial details are not being disclosed.

(Press release, JenKem Technology, SEP 16, 2014, View Source [SID:1234506402])

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Denovo Biopharma Acquires Late-Stage Oncology Drug From lilly For Development As A Personalized Medicine

On September 16, 2014 Denovo Biopharma reported that it has acquired enzastaurin, a late-stage oncology drug, from Eli Lilly and Company (Press release Denovo Biopharma, SEP 16, 2014, View Source [SID:1234501031]). Denovo gains all rights to develop, manufacture and commercialize enzastaurin globally, including transfer of all intellectual property and other rights, data, and information.

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Lilly developed enzastaurin in a variety of indications, including in Phase 2 and Phase 3 clinical trials for diffuse large B-cell lymphoma (DLBCL). In studies conducted by Lilly, enzastaurin achieved promising clinical results in the DLBCL induction setting in Phase 2 trials, but did not meet the primary endpoint in the DLBCL maintenance setting in the Phase 3 study. A meaningful subset of patients showed significantly improved progression-free survival and Denovo Biopharma intends to conduct genetic analysis to identify biomarkers that are related to this outcome. By identifying genomic biomarkers that correlate with patients’ responsiveness to treatment, Denovo plans to screen for appropriate patient subsets for enrollment in future clinical trials that the company plans to conduct.

"We appreciate Lilly’s extensive efforts in the development of enzastaurin to date. As our first late-stage asset acquired from a premier pharmaceutical company, this high quality data package will enable Denovo to conduct our retrospective biomarker discovery," saidMichael F. Haller, Ph.D., Denovo Biopharma’s Chief Operating Officer. "Our biomarker discovery efforts take only a few months, so when combined with Lilly’s existing data package, we should be able to rapidly initiate a biomarker validation clinical trial for the original indication (DLBCL). We are actively seeking to acquire additional drugs in late-stage development where we can utilize our biomarker discovery platform to personalize and advance other potential treatments in similar fashion."

TWO CANCER RESEARCH TECHNOLOGY DEALS SHORTLISTED FOR LEADING INDUSTRY AWARDS

On September 16, 2014 Cancer Research Technology (CRT) reported that they have received two nominations in the SCRIP Awards 2014 shortlist (Press release, Cancer Research Technology, SEP 16, 2014, View Source [SID1234523517]).

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Best Partnership Alliance: FORMA Therapeutics’ and Cancer Research Technology’s DUBs Drug Discovery Team

The Best Partnership Alliance Award seeks to reward innovative partnerships between companies in which they share the risks and rewards inherent in developing new drugs.

This agreement with FORMA Therapeutics pairs FORMA’s drug discovery capabilities with CRT’s expertise in translating academic discoveries through our Discovery Laboratories (CRT-DL) and the exclusive world-class academic network of Cancer Research UK Principal Investigators. The research initiative aims to discover innovative tools, technologies and therapeutic drug candidates against a variety of protein homeostasis regulators called deubiquitinating enzymes (DUBs).

To make the shortlist, our entry demonstrated the strong strategic input from both partners and the innovative nature of the deal structure.

Dr Hamish Ryder, CRT-DL’s director of discovery said: "This is well-deserved recognition for the DUBs team, who together are significantly accelerating our understanding of the relevant biological applications of DUBs. The nomination also endorses CRT-DL’s alliance model, which brings together the best minds from industry and academia to prosecute multiple targets in a themed area of cancer biology. This proven approach combines scientific expertise, cultivates innovation and reduces risk."

Licensing Deal of the Year: AstraZeneca and Cancer Research Technology for AZD2098

The second award recognises both the monetary and strategic value of the licensing deal and the benefits to both sides.

This agreement with AstraZeneca was made under the Clinical Development Partnerships (CDP) scheme, a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and CRT to bring new life to promising therapies that have been de-prioritised. The deal will enable DDO to complete preclinical development and carry out early stage clinical development of AZD2098, an experimental drug originally designed for the treatment of asthma, as a novel therapy for kidney cancer.

Dr Phil L’Huillier, CRT’s director of business development, said: "It’s fantastic that this CDP agreement has been recognised as one of the leading licensing deals of the year. CDP is an innovative initiative, designed to bring breakthrough treatments to cancer patients sooner."

The winners will be announced at a ceremony in London on 3rd December 2014.