CRT and Cancer Research UK establish Lipid Metabolism Research Team

On September 29, 2011 Cancer Research Technology (CRT) – Cancer Research UK’s commercial arm – reported it has established a group of scientists with expertise in lipid metabolism – getting energy from fats and making building blocks for cell growth – to develop targets for potential new cancer drugs (Press release, Cancer Research Technology, SEP 29, 2011, View Source [SID1234523320]).

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Five world-class research groups will collaborate on an initial two-year research project. They will study dependency of cancer cells on enzymes involved in lipid metabolism to develop future drug discovery and development programmes. The groups will receive a total of £600,000 over two years, jointly funded by Cancer Research UK and AstraZeneca.

The groups are led by: Professor Eyal Gottlieb at Cancer Research UK’s Beatson Institute; Dr Almut Schulze at Cancer Research UK’s London Research Institute; Professor Adrian Harris at The University of Oxford; Professor Eric Aboagye at Imperial College London and Professor Michael Wakelam at The Babraham Institute.

An increase in lipid production is an important characteristic of cancer. A cell must replicate its DNA and double in size in order to divide. And rapidly-dividing cells require large amounts of construction materials – fats, proteins and nucleic acids – as well as having huge energy demands.

But tumour cells, which have poorly developed blood vessels, only receive a restricted supply of the nutrients they need. So, to meet the demand for energy and construction materials, cancer cells have developed a remarkably different way of generating energy compared with healthy cells.

The research groups will prove the importance of lipidomic enzymes – proteins which generate fats – as new therapeutic targets*. They will use genetic approaches to block the unique metabolism fuelling the uncontrolled growth and spread of cancer cells.

Dr Keith Blundy, chief executive of CRT, said: "Drugs that can selectively target metabolism are likely to delay, if not stop disease spread.

"This specialist consortium of hand-picked experts will use the latest imaging and analytical techniques to develop ways to block the unique lipid metabolism found in cancer cells. We hope the discoveries from this work will contribute to the development of drugs to increase survival from cancer."

Professor Eyal Gottlieb, head of apoptosis and tumour metabolism at Cancer Research UK’s Beatson Institute for Cancer Research, said: "The role of metabolism in driving the growth, division and spread of cancer cells can’t be overstated.

"Cancer cells have developed different routes to generate energy and increase their size. But, the detail of this isn’t yet well understood. It’s incredibly exciting to be working alongside other experts in this important field to decipher the unusual ways tumours produce their power supply – and add pace to the development of future drugs to block these processes."

AstraZeneca will partner with the collaboration to commercialise discoveries through its existing three-year Tumour Metabolism Alliance with CRT.**
Susan Galbraith, vice president and head of oncology innovative medicines at AstraZeneca, said: "The collaboration with Cancer Research UK and CRT represents an exciting opportunity for AstraZeneca to work with some of the leading UK scientists in cancer lipid metabolism. Importantly, the collaboration builds on the effective partnership already in place between AstraZeneca and CRT aimed at developing novel therapies that exploit cancer metabolism. We are very pleased to now extend this relationship with the anticipation of validating novel cancer targets."

Harpal Kumar, Cancer Research UK’s chief executive, said: "Our research, funded entirely by the generosity of the public, has contributed to the progress that’s seeing survival rates from cancer continuing to increase. But there’s more to be done. Cancer still causes one in four deaths each year and we urgently need to find new effective treatments.

"This incredibly important collaboration of world-class scientists which unites our expertise with support from industry partners will unravel the mystery of how cancer cells meet their huge energy demands. This knowledge will pave the way for scientists to develop more treatments to help more people beat cancer."

(Filing, 10-K, Myrexis, SEP 13, 2011, View Source [SID:1234506937])

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EISAI TO ACCELERATE LATE-STAGE CLINICAL DEVELOPMENT OF
NEW DRUGS BY EFFECTIVELY LEVERAGING EXTERNAL RESOURCES

On September 7, 2011 Eisai reported that it has entered into a collaborative development agreement with SFJ Pharma Ltd. ("SFJ"), a wholly-owned subsidiary of SFJ Pharmaceuticals, LP., II in an effort to further accelerate the late-stage clinical development of its new drug pipeline by effectively leveraging external financial resources (Press release Eisai, SEP 7, 2011, View Source [SID:1234500286]).
With a rich late-stage clinical pipeline, Eisai will effectively leverage internal resources as well as build a new partnership scheme under which it accepts funding from external parties to conduct pivotal Phase III studies for promising new drug candidates in order to push forward with numerous development programs simultaneously and as quickly as possible.
As part of this partnership scheme, Eisai has entered into a collaborative development agreement with SFJ to conduct Phase III studies with E7080 (lenvatinib) in thyroid cancer. Under this agreement, these late-stage studies will be conducted by Eisai and wholly funded by SFJ, with Eisai paying SFJ milestone payments only if E7080 obtains regulatory approval. If and when the compound is approved, all commercial rights shall remain with Eisai.

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CRT’S DISCOVERY LABORATORY AUTOTAXIN PROGRAMME PROGRESSES TO LEAD OPTIMISATION

On September 1, 2011 CRT reported small molecule inhibitors of Autotaxin (ATX) have been discovered using an HTS approach and are currently undergoing lead optimisation (Press release, Cancer Research Technology, DEC 15, 2011, View Source [SID1234523522]). ATX cleaves choline from lysophosphatidylcholine (LPC) forming lysophosphatidic acid (LPA), a potent mitogen that has been implicated in the pathophysiology of cancer. ATX has been demonstrated to increase cell motility, neovascularization, proliferation and aggressiveness of tumours. It is upregulated in numerous tumour lineages (breast, glioblastoma, ovarian and prostate cancer).

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Richter and STADA cooperate for development of two biosimilar products, two monoclonal antibodies: Rituximab and Trastuzumab

On August 30, 2011 Gedeon Richter and STADA Arzneimittel reported that the two companies have signed two separate license and collaboration agreements in respect of the development and marketing of two biosimilar products, two monoclonal antibodies Rituximab and Trastuzumab (Press release Gedeon Richter, AUG 30, 2011, View Source [SID:1234501390]).

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​According to the agreement STADA receives non exclusive distribution rights for the area of geographical Europe and the CIS area, but due to regulatory reasons, excluding Russia, for the biopharmaceutical active ingredient Rituximab, which Richter is currently developing and whose approval from today’s perspective can be expected at the end of 2017. In addition to STADA and eventual own marketing, Richter may grant a maximum of one additional partner a relevant distribution license in the contract area. If such a partially exclusive license marketing in Russia become regulatory possible, STADA would also receive such a distribution license there from Richter.

Under the terms of the agreement in addition to a payment on the event of signing the contract, STADA is obliged to make further payments each depending on the progress of the project which amount in total to a low double-digit million Euro figure. STADA will exclusively purchase the Rituximab biosimilar from Richter for marketing and distribution of the product for which the major commercial terms are already agreed on.

STADA, as is known, has done preparatory work for the biopharmaceutical active ingredient Trastuzumab, which, however, was stopped at the end of 2010 because STADA made the strategic decision to pursue the lower-cost approach of an in-licensing. The stage of development that STADA had reached up until that point will now be acquired by Richter as part of a contract concluded today for a low single-digit million Euro figure, in order to thus accelerate the ongoing own development for a Trastuzumab biosimilar. In addition, STADA receives, at the time of the beginning of the clinical studies in approximately two years, a unilaterally for STADA exercisable option from Richter to acquire also for such a Trastuzumab biosimilar a distribution license at commercial conditions analogous to those of the Rituximab.

The CEOs both of STADA and Richter expressed their commitment to the established cooperation.

For Hartmut Retzlaff, Chairman of the Executive Board of STADA Arzneimittel AG, the cooperation agreed on today shows that the STADA strategy of refraining from its own cost-intensive biosimilar development and to instead rely on cooperations and licenses for these biosimilar projects was correct. "With today’s cooperation we have secured marketing access to two biosimilars with particularly high sales potential for our core markets in Europe at substantially more favorable conditions than with a development of our own – and that with such an outstanding partner like Richter which is known in the industry for its high degree of expertise and reliability", said Retzlaff.

Erik Bogsch, CEO of Gedeon Richter Plc., added following comments on today’s contracts:
„We always considered the development of biosimilar products as an important strategic initiative for Richter and we made significant efforts to establish our future presence in the field of biotechnology, thereby enhancing the proportion of high added value products. This agreement is considered to be a significant move in line with Richter’s aim to find strategic partners for the development, marketing and distribution of our biosimilar product portfolio. With STADA we gained an excellent, high class cooperation partner whose traditionally strong presence and expertise in the field of developing and marketing both generic and biosimilar product groups, will contribute to fulfil our long term strategy."

The development of both biosimilars will now be continued under the leadership of Richter. A supporting function from STADA for specific patent rights questions in both projects has also already been agreed upon today. STADA will also support if necessary the relevant approval processes with its own expertise in the area of EU approvals of biosimilars.