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Cancer Research UK and AstraZeneca collaborate to trial combinations of new cancer drugs

On January 13, 2011 Cancer Research UK’s drug development office (DDO) reported it has signed a Strategic Combinations Alliance with AstraZeneca to take combinations of experimental cancer drugs into early phase clinical trials (Press release, Cancer Research Technology, JAN 13, 2011, View Source [SID1234523329]).

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The move will increase patient access to trials of potential new cancer treatments that combine molecularly targeted experimental drugs developed and owned by AstraZeneca. The trials will also test these combinations alongside conventional chemotherapy radiotherapy and other novel agents.

It is hoped that combination therapy using a number of molecularly targeted drugs may decrease the chance of patients developing resistance to any individual drug. This is because different types of drugs attack the faults in cancer cells at different points.

The trials will be managed and run through the Cancer Research UK/ UK Health Departments Experimental Cancer Medicine Centre (ECMC) Network* at hospitals across the UK with support from Cancer Research UK’s Drug Development Office. AZ will provide access to its drugs to be trialled through the alliance as well as additional financial support. The charity will also hold workshops with the ECMC Network and AZ to identify promising combinations of experimental treatments to trial.

Kate Miller, head of the combinations alliance at Cancer Research UK’s DDO, said: "We are delighted to be collaborating with AstraZeneca through the combinations alliance. This initiative will provide a huge boost to the UK research community in developing exciting new combination therapies and will mean that more UK patients will be able to take part in important clinical trials of potential new treatments".

"We are actively looking for additional partners who are interested in collaborating with us.

"Our plan is to take the model we’ve established with AstraZeneca forward by developing cross company agreements and providing access to a larger number of potential combinations to help us beat cancer."

Cancer Research UK’s Drug Development Office is adding value by mediating between the cross company partners and across the ECMCs.
Professor Andrew Hughes, vice president, Oncology Clinical Innovative Medicines, said: "As we further understand the heterogeneity of cancer, we not only need to redefine the disease but also our solutions to it with the ultimate aim of restoring patients’ lives. The collaboration with Cancer Research UK and the ECMCs provides a key opportunity to redefining our solutions to cancer through combination treatments."

Cancer Research UK and the ECMC Network have established clear processes to run early phase combination clinical trials through the ECMC Network. This includes peer-review of the scientific data and trial endorsement through Cancer Research UK’s New Agent’s Committee**.

Kate Miller added: "This partnership with AstraZenenca has enabled us to create a standardised way of evaluating and delivering combination studies through the ECMC network."

Dr Sally Burtles, director of the Experimental Cancer Medicine Network, said: "It is incredibly exciting to have the opportunity to run trials of these promising new drugs which could potentially be used to treat a range of different cancers.

"The ECMC network brings together cancer doctors, nurses and scientists to make it easier to run clinical trials of powerful new tailored treatments – and it is thanks to the generosity and time of patients that it is possible to develop these new approaches which could benefit thousands of people in the future."

Epizyme Announces Strategic Alliance to Develop Epigenetic Therapeutics

On January 10, 2011 Epizyme reported a worldwide strategic alliance with GlaxoSmithKline (GSK) to discover, develop, and market novel small molecule therapeutics targeting histone methyltransferases (HMTs), an important class of epigenetic enzymes, for the treatment of cancer and other diseases (Press release, Epizyme, JAN 10, 2011, View Source [SID:SID1234515218]).

This alliance leverages Epizyme’s unique HMT discovery platform, including its proprietary chemical library, expertise, and intellectual property, to discover and develop HMT therapeutics against the set of targets to be included in the collaboration. Under the terms of the agreement, Epizyme will receive an upfront payment of $20 million, as well as research funding. Epizyme is eligible to receive more than $630 million in total milestone payments if medicines are commercialized for all targets in the collaboration. Additionally, Epizyme is eligible to receive up to double--digit royalties on net sales of products resulting from the alliance. For each target in the collaboration, Epizyme will be primarily responsible for research up to development candidate selection, and GSK will be solely responsible for development and commercialization.

Epigenetic enzymes are an important class of proteins that regulate whether genes are turned off or on. The HMT family of epigenetic enzymes contains as many as 96 members, many of which have been associated genetically with cancer and other diseases. Targeting specific HMTs with potent and selective small molecule therapeutics offers the possibility of controlling pathways of gene expression that contribute to diseases.

Robert Gould, Ph.D., CEO and President of Epizyme, said: "Epizyme’s mission is to develop personalized therapeutics for genetically--defined patients based on our understanding of the driving role played by many HMTs in human disease. We are excited to be working with GSK. This collaboration validates our unique discovery platform and the targeted approach we bring to HMT therapeutics."

Cell Medica Signs an Exclusive License Agreement and Strengthens Collaboration With the Center for Cell and Gene Therapy, Baylor College of Medicine

On January 6, 2011 Cell Medica, a leading cellular therapeutics company which develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, reported an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV) (Press release, Cell Medica, JAN 6, 2011, View Source [SID:1234513475]). Financial terms were not disclosed.

Cell Medica’s expertise and experience in the development and manufacturing of cellular immunotherapy products in combination with the CAGT’s leading position in the research and development of cell therapies targeting EBV-related disease will accelerate the development of this potentially curative treatment for EBV-associated lymphoma and nasopharyngeal carcinoma (NPC). Cell Medica has already introduced its first cell therapy product in the UK which is based on antigen-specific T cells and is pioneering the manufacturing strategy for high volume production of patient-specific cell therapies.

EBV is present in 90% of the human population and the virus resides in a latent state in B cells and epithelial cells in the nasopharynx. EBV was one of the first viruses to be associated with malignancies. The expression of EBV antigens by cancerous cells provides the opportunity to use EBV antigen-specific cytotoxic T lymphocytes (EBV CTLs) for therapy. EBV CTLs can be recovered from the patient and activated through an ex vivo procedure to enhance their ability to target and kill tumor cells. Re-infusion of these activated T cells into the patient has been shown to be safe and effective as a curative treatment for EBV associated malignancies.

The CAGT has treated more than 250 patients over the past 15 years and has collected an impressive body of clinical data which indicate that EBV-CTLs can induce long-term cancer remission and prevent cancer relapse. An improved product design is currently being tested in an ongoing clinical trial[1] involving the treatment of EBV-associated Hodgkin lymphomas and non-Hodgkin lymphoma. A total of 33 evaluable patients in two treatment groups have received the cell therapy to date and no immediate toxicity was observed following infusion. Of 17 patients in remission but at high risk of relapse at the time of treatment, 16 remain in remission for a median of 2.5 years (ranging six months to more than five years). Of 16 patients with active disease refractory to standard treatment, 11 had clinical responses, including 8 complete responses, with a median duration of the clinical responses at 1.5 years.

In the NPC application, the CAGT recently reported indications of positive clinical results in patients with locoregional disease and further investigation is ongoing.[2]

Based on the positive clinical results Cell Medica and CAGT will collaborate to establish a commercially viable and fully GMP compliant manufacturing process as part of a plan to launch a confirmatory multicenter Phase II/III trial by 2012. Cell Medica believes the potential market size for successful treatment of EBV associated Hodgkin lymphoma, non-Hodgkin lymphoma and nasopharyngeal carcinoma could exceed $1.0 billion based on the application of the cellular therapy in first or second line treatment for these diseases.

Professor Malcolm Brenner, Director of the Center for Cell and Gene Therapy, said: "The results from our ongoing lymphoma clinical trial demonstrate that cellular immunotherapy can be used very effectively to target cancerous cells which co-express viral antigens. Based upon our recent success with an improved product design, we are looking forward to working with Cell Medica to take this therapy into advanced clinical trials and regulatory approval."

Gregg Sando, CEO of Cell Medica, commented: "We are very excited to be signing this exclusive license agreement and further strengthening our relationship with the CAGT who we believe is the clear leader in the use of research and development of cell therapies targeting EBV-related disease. Clinical results arising from the current trials indicate that this cell product is an excellent candidate for commercialization. Different types of cancer can be targeted in different ways, and EBV CTLs provide an effective approach to treat EBV associated malignancies. We will use our experience in the manufacturing scale-up, regulatory approval and reimbursement of cell therapies to bring this cell therapy into routine clinical practice as rapidly as possible."

[1] Bollard CM et al. Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood; 110:2838-2845 (2007).

[2] Louis CU et al. Adoptive Transfer of EBV-specific T Cells Results in Sustained Clinical Responses in Patients With Locoregional Nasopharyngeal Carcinoma. Journal of Immunotherapy; 33:983-990 (2010).

(Press release, Alvos Therapeutics, JAN 3, 2011, View Source;research-and-licensing-collaboration/ [SID:1234506811])

DSM to acquire Martek to add new Nutrition growth platform

On December 21, 2010 DSM (NYSE Euronext: DSM KON) reported that it is to offer US$31.50 for each share of Martek Biosciences Corporation (NASDAQ: MATK) in an all-cash transaction (through a tender offer) (Press release, DSM, DEC 21, 2010, View Source [SID:1234510803]).

Total consideration of US$1,087 million (about €829 million)

Offer price represents 35% premium to Martek’s closing share price on December 20, 2010

Martek Board of Directors recommends the offer

Acquisition adds new growth platform for natural, healthy Polyunsaturated Fatty Acids (PUFAs) nutrition ingredients (Omega-3 DHA and Omega-6 ARA)

PUFAs are clinically proven to have important human health benefits. Martek is a leader in this field with strong positions, especially in Infant Formula Nutrition applications

Acquisition positions DSM as a leader in PUFAs and in Infant Nutrition, greatly strengthens DSM’s presence in the United States and expands DSM’s complementary technology platform in the field of algal and other microbial fermentations

Martek’s growth will be accelerated by DSM’s global market reach, technology base and application skill capabilities, its insights in the food, beverage and global dietary supplements markets and its strength in industrial biotechnology and related applications

Acquisition is immediately EPS accretive

Martek signing
Royal DSM N.V., the global Life Sciences and Materials Sciences company, and Martek Biosciences Corporation today announce that they have entered into a definitive agreement under which DSM will acquire all the outstanding shares of common stock of Martek for US$31.50 in cash per share for total consideration of US$1,087 million. The transaction has been approved by DSM’s Supervisory Board and is recommended by Martek’s Board of Directors. Subject to customary conditions, the tender process is expected to close in February 2011, and the transaction is expected to close in the first or second quarter of 2011.

The agreed price represents a premium of 35% to Martek’s closing share price of US$23.36 on December 20, 2010, and 39% to the volume weighted average closing price of Martek’s common stock over the last 90 days.

The Transaction

The acquisition is structured as an all-cash tender offer for all the outstanding shares of Martek common stock to be followed by a merger in which each remaining share of Martek common stock would be converted into the same cash per share price paid in the tender offer. The tender offer is expected to commence between 10 January 2011 and 25 January 2011. The Martek Board of Directors has recommended that Martek stockholders accept the offer and tender their shares into the offer when it is made. The acquisition is subject to the satisfaction of customary conditions, including the tender of a majority of the outstanding shares of Martek common stock on a fully-diluted basis and the expiration or earlier termination of the Hart-Scott-Rodino antitrust waiting period and other regulatory approvals. The tender process is expected to close in February 2011, and the transaction is expected to close in the first or second quarter of 2011.

The transaction is not subject to a financing condition, and DSM intends to finance the acquisition from existing cash.

Strategic rationale

The purchase by DSM of Martek, a U.S. based producer of high value products from microbial sources that promote health and wellness through nutrition, will be the first major acquisition by DSM after its successful transformation into a Life Sciences and Materials Sciences company. This transaction is fully in line with DSM’s strategy for its Nutrition cluster "continued value growth" and adds a new growth platform for healthy and natural food ingredients for infant formula and other food and beverage applications, especially focused on Polyunsaturated Fatty Acids (PUFAs) such as microbial Omega-3 DHA (docosahexaenoic acid) and Omega-6 ARA (arachidonic acid).

There is significant, broad based scientific evidence about the link between health and nutrition. PUFAs have been clinically proven to have a positive impact on human health and Martek is a leader in this field. Martek therefore represents an attractive strategic acquisition for DSM. It will provide DSM with new opportunities in the infant nutrition segment as well as food and beverage and dietary supplements and create a strong platform for DSM to enter the fast growing Omega-3 and Omega-6 market through Martek’s microbial DHA and ARA products.

DSM will be able to leverage DSM’s global nutritional infrastructure (global market reach, application skills, R&D and manufacturing technology base) to channel and accelerate the growth of these products into other regions, applications and market segments beyond Martek’s current strong US-based position in infant formula ingredients and growing position in food and beverage and dietary supplement applications. As a result of the scale and resources that DSM can bring to the already solid businesses of Martek, DSM instantly becomes a leading player in the field of microbial PUFAs and through this attractive growth segment expects to drive compelling financial performance for its shareholders. The acquisition is immediately EPS accretive for DSM by 15 to 20 euro cents per ordinary share on a full year basis.

The two companies already have a longstanding relationship as DSM supplies Martek with the key base material for its ARA product. DSM has complementary intellectual property to the broad range of patents and intellectual property Martek owns, which will further extend the competitiveness of the combined company’s proprietary products.

DSM will also benefit from Martek’s recent acquisition of Amerifit, an attractive consumer business for branded dietary supplements with very specific health benefits, which it will be able to use as an additional marketing channel for both Martek as well as DSM ingredients.

Furthermore, Martek’s algal and other microbial-based biotechnology platform and its robust algal technology pipeline which complements DSM’s own biotechnology portfolio, is expected to deliver new nutritional and non-nutritional (industrial) growth opportunities.

The acquisition is expected to realize material revenue synergies through expanded distribution, marketing and product development as well as other operational efficiencies, and will accelerate DSM’s revenue growth.

Martek is headquartered in Columbia Maryland USA and had annual net sales of US$ 450 million for its fiscal year which ended October 31, 2010. Martek has five principal locations and some 600 employees.

Feike Sijbesma, CEO/ Chairman of the DSM Managing Board, said:

"Martek is a great company and a leader in the innovation, development, production and sale of high-value products from microbial sources that promote health and wellness through nutrition. DSM has enormous respect for Martek’s products, organization and people. We look forward to working with their highly skilled team.

"This acquisition is an attractive and logical next step for DSM. Martek’s leading position in healthy, natural ingredients and algal technology will add a new growth platform to our Nutrition business. DSM is a unique partner for Martek and, with our strong track record of growing businesses in competitive environments, we believe we can help to lift Martek to the next level."

Martek’s Chairman, Robert J. Flanagan, said:

"We are proud of the achievements of our company and are pleased to see the company’s value recognized by DSM. Following thorough analysis by our board of directors, we have determined that this transaction offers the best value for our stockholders."

Martek’s CEO, Steve Dubin, said:

"We are pleased to announce this transaction, and we believe that it is in the best interest of Martek and our stockholders. After careful analysis, our board of directors unanimously approved this transaction with DSM, which has a strong reputation and global operations. We are pleased that this transaction appropriately recognizes the value of Martek’s nutritional ingredients, technology platform, market position and skilled workforce, while providing significant value to our stockholders. We have worked collaboratively with DSM for many years, and we are confident that they share our vision for Martek’s future."