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CRT OPENS DRUG DISCOVERY LABORATORY IN CAMBRIDGE

On May 15, 2008 Cancer Research Technology Ltd (CRT), the specialist oncology development and commercialisation company, reported the opening of a drug discovery laboratory in Cambridge, adding to Cancer Research UK’s strong presence in the region (Press release, Cancer Research Technology, MAY 15, 2008, View Source [SID1234523532]).

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CRT Cambridge will house around 25 medicinal chemists, biochemists and biologists in its building off Coldham’s Lane – conveniently located for access to the University of Cambridge and Cancer Research UK’s Cambridge Research Institute – with space for significant further expansion.

This is the first multi-disciplinary Discovery Laboratory for CRT to be established outside the main London laboratory at UCL’s Wolfson Institute for Biomedical Research. In addition, small CRT laboratory groups are also being established at Cancer Research UK’s existing institutes in Manchester and Glasgow. This follows the placement of CRT knowledge transfer managers in these locations to be closer to the science and the scientists.

CRT’s Discovery Laboratories build on Cancer Research UK’s investment in world-class research, identifying potential novel therapies based on the cancer targets identified and validated in academia.

The need for expansion is driven by the successful progression of ground-breaking cancer discovery projects from early stage through to more resource intensive later stage projects. The expansion is also testament to the number of projects initiated on the back of discoveries arising from basic research funded by CRT’s parent charity, Cancer Research UK, and other partners throughout Europe and the US.

Dr Hamish Ryder, recently appointed to the role of Director of Discovery at CRT, said: "We’re delighted to be opening this unique drug discovery resource in Cambridge. It will help us to meet growing demand and enable projects to be completed more quickly, ensuring potential therapies are identified and progressed efficiently. We also hope to create many new partnerships with leading biotechnology and pharmaceutical companies to supplement their drug development pipelines."

The announcement comes ahead of CRT’s presence at BIO2008, the world’s largest biotech conference, taking place in San Diego, USA, where CRT will launch partnering activities related to several exciting programmes from CRT’s laboratories.

CRT’s Discovery Laboratories execute both small molecule and biotherapeutic projects. Staff are drawn from academia and industry – and both communities will benefit from the expansion of these laboratories. CRT Cambridge consolidates CRT’s leading global position in translational drug discovery and biotherapeutic development.

Dr Keith Blundy, CEO of CRT, said: "The opening of CRT Cambridge forms part of our five-year expansion plan, which aims to locate CRT research staff close to or within major Cancer Research UK Institutes. We hope this exciting period of development will increase integration of basic and applied research, and ultimately benefit patients."

REGiMMUNE Raises $8,000,000 in Series B Financing

On May 6, 2008 REGiMMUNE Corporation, a privately held biopharmaceutical company, reported that it has closed its Series B financing for a total of $8 million U.S. Proceeds from the financing will be used to advance the company’s lead program, RGI-2001, to human clinical trials for graft versus host disease (GvHD) (Press release, REGimmune, MAY 6, 2008, View Source [SID1234642239]). Preclinical development for GvHD associated with bone marrow transplantation has been completed and an Investigation New Drug application is expected to be filed in late 2008.
"This financing underscores our ability to make significant progress towards the clinic and eventual product commercialization," commented Haru Morita, President and Chief Executive Officer of REGiMMUNE. "To thrive as REGiMMUNE has, in a very difficult business environment for many biotech companies in Japan, is a particularly great achievement."
New and existing investors include NIF SMBC Ventures Co., Ltd.; CSK Venture Capital Co., Ltd.; Japan Asia Investment Co., Ltd. and Yasuda Enterprise Development Co., Ltd.
The company’s proprietary technology platform, MultiVax, induces antigen-specific immune tolerance via induction of Tregs, a T-cell subset that plays a central role in controlling immune responses to self-antigens and pathogens when administered at the time of exposure to disease-causing antigens. Because of its specificity in targeting immune suppression, MultiVax is anticipated to exhibit higher efficacies with more favorable safety profiles over current immunomodulatory drugs.

RGI-2001 for GvHD
REGiMMUNE plans to start development of its MultiVax product RGI-2001 to treat GvHD following allogeneic stem cell transplantation (SCT) primarily for bone marrow transplants. A major clinical challenge associated with allogeneic SCT is to maintain a fine balance of the immune system to prevent GvHD, serious infection, and/or recurrence of malignancy. This balance is critical because intensive immune suppression will result in infection and recurrence of malignancy while insufficient immune suppression may cause GvHD.
Serious GvHD occurs in up to 40% of HLA-matched allogeneic SCT cases, and 100% in haploidentical, related allogeneic SCT. Current treatment is prophylactic use of immunosuppressants such as cyclosporine A. High-dose steroids are administered once GvHD occurs but the condition often progresses to steroid refractory status and there is no proven second-line therapy for steroid refractory GvHD. Prevention and treatment of GvHD thus represent high unmet medical needs addressing serious, life-threatening conditions. If alloantigen specific, selective immune suppression can be induced with RGI-2001, it would be possible to suppress GvHD while maintaining protective immune responses to infection and recurrence of malignancy.

Cancer Research UK creates ‘Crack Teams’ to solve cancer’s greatest mysteries

On April 28, 2008 World leading scientists were reported to be targeted by Cancer Research UK and its development and commercialisation arm Cancer Research Technology (CRT), in an effort to tackle some of cancer’s most pressing scientific challenges(Press release, Cancer Research Technology, APR 28, 2008, View Source [SID1234523380]).

The initiative will see the charity hand pick ‘crack teams’ of up to five world class scientists – each a leader in their own discipline – who will be joined by some of the world’s foremost pharmaceutical companies. The teams will focus on an emerging cancer field identified by Cancer Research UK, and work towards translating basic science into new treatments and diagnostic tools to help beat cancer.

The first project, which will look at utilising cellular senescence – putting cancer cells to sleep to prevent the spread of cancers such as melanoma, has been identified – and a team of UK-based scientists put in place. The team has the expertise to harness this natural phenomenon and design tests to ‘screen’ for new potential drugs that can kick-start senescence in cancer patients. Two further projects are planned for 2009 and 2010, which will focus on cancer stem cells and the histone code, respectively.

Each new project will form a limited company, managed by CRT’s business team. Initially the projects will receive up to half a million pounds from Cancer Research UK over a two-year period. It is hoped each team will attract an industry partner which will bring know-how and further finance to the project. In return they will benefit by becoming a shareholder in the company and draw on Cancer Research UK’s expertise in translating basic scientific discoveries into new treatments for cancer.

Once the early development phase is complete, the industrial partner has the option to acquire the company and progress any joint discoveries into clinical compounds.

CRT’s senior business manager and scheme leader, Simon Youlton, said: "This initiative creates a unique opportunity for us to hand-pick a ‘crack team’ of scientists wherever they may be based – rather than being tied to a particular academic institution or team which approaches us for funding.

"It enables us to pose an industrially relevant problem that Cancer Research UK wants solving and we hope it will help bridge the gap between academia and industry by combining commercial and scientific know how with the best and most dedicated brains in science."

Any profits arising from the success of the work will be shared between the charity and the research partners involved, with Cancer Research UK re-investing any proceeds in its future research work. The business relationships will be managed by CRT, who have more than 20 years experience in licensing patents and developing opportunities for new cancer drugs and diagnostics, working closely with licensees and the pharmaceutical industry.

The first company to be established in this scheme is being headed up by Nicol Keith – a University of Glasgow professor of molecular oncology at Cancer Research UK’s Beatson Laboratory in Glasgow. Professor Keith will be joined by scientists from London, Cambridge and Liverpool – and Horizon Discovery, a young oncology focused service company set up in Cambridge to engineer new cancer cell lines.

Nick Adams, director of business development at Antisoma – giving a pharmaceutical industry perspective – said: "Cancer Research UK is in an excellent position to select the emerging areas of science suitable for this kind of work and ensure success.

"This development programme fits well with industry’s approach to harnessing the potential of scientists based at key cancer research institutes, and has the potential to turn exciting scientific discoveries into real, marketable technology which can be used to help fight cancer."

Cancer Research UK’s chief executive Harpal Kumar said: "In order to help more people survive a diagnosis of cancer, we urgently need to find new and effective ways of diagnosing and treating the disease. To do this we must continue to invest in early-stage laboratory research to help us get to the bottom of some of the deepest mysteries that cancer poses."

"This exciting scheme represents a new way to take forward the potential of our early scientific research in a cost effective manner, and to work with businesses which have a proven record in achieving success. "

Cancer Research UK and AstraZeneca announce innovative deal for promising anti-cancer compound

On April 19, 2008 Cancer Research UK and Cancer Research Technology (CRT) – the charity’s development and commercialisation arm – reported an innovative new arrangement to progress into clinical development a potential anti-cancer compound from AstraZeneca (Press release, Cancer Research Technology, APR 19, 2008, View Source [SID1234523381]).

AstraZeneca’s AZD0424 – a tyrosine kinase inhibitor* – is the first drug to enter the charity’s Clinical Development Partnerships (CDP) programme. CDP was launched in 2006 to support the continuing development of promising anti-cancer agents. It offers companies an alternative model to traditional out licensing, which enables them to retain rights to the compound throughout the development programme. The compound is expected to enter phase I trials within the next 18 months.

Dr Keith Blundy, chief executive of CRT, said: "This Clinical Development and Option Agreement is very exciting for the charity and CRT. The signing of our first deal in the Clinical Development Partnership programme demonstrates how the charity and CRT can work with industry to provide innovative solutions that advance cancer discoveries and drugs towards the patient".

Under the terms of the partnership deal, Cancer Research UK’s highly experienced Drug Development Office will conduct the clinical trials at no cost to AstraZeneca. In addition, AstraZeneca retains the option to assume further development and marketing of the drug, with the charity receiving a share of any revenues. Potential downstream royalties have not been disclosed.

Dr Keith Blundy added, "Pharmaceutical and biotechnology companies have to prioritise which agents they take into clinical development. This, inevitably, leaves potentially effective treatments on companies’ shelves. AZD0424 is an interesting drug with real potential for patient benefit".

Brent Vose, VP Astra Zeneca’s Oncology Therapeutic Area said: "AstraZeneca is committed to the research and development of new, targeted anti-cancer therapies to improve the lives of cancer patients. We have a number of promising candidates in development and look forward to seeing the results of some key studies this year.

"In the meantime, we are actively pursing innovative new ways to progress the many new drug candidates being discovered by our dedicated cancer scientists. The CDP initiative presents an exciting opportunity to supplement our own development activities and ensure that we can develop as many of our candidates as possible. We’re looking forward to working with Cancer Research UK on this potential new treatment."

Harpal Kumar, chief executive of Cancer Research UK, said: "Increasing the number of new treatments for cancer patients is one of Cancer Research UK’s key goals. Opening up a seam of previously unmined but promising new anti-cancer drugs through the CDP programme, will be instrumental in achieving this."

Takeda to Acquire Millennium for Us$25.00 Per Share in an All Cash Tender Offer Valued at $8.8 Billion

On April 10, 2008 Takeda Pharmaceutical Company Limited ("Takeda", TSE: 4502) and Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) reported that they have entered into a definitive agreement pursuant to which Takeda will acquire Millennium for approximately $8.8 billion through a cash tender offer of $25.00 per share (Press release, Takeda, APR 10, 2008, View Source [SID:1234514750]). The transaction was unanimously approved by the Boards of Directors of both companies. Upon completion of the acquisition, Millennium will become a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, and will continue operations in Cambridge, Massachusetts, as a standalone business unit. Millennium will be known as Millennium Pharmaceuticals, Inc., a Takeda Company.

Millennium is a leading biopharmaceutical company. In the United States, Millennium markets VELCADE (bortezomib) for Injection—a novel, market-leading oncology product approved in more than 85 countries. Millennium has an innovation-driven discovery and development organization, which is advancing a pipeline of novel product candidates in oncology and inflammation. This includes a potential therapy for inflammatory bowel disease (IBD), which is expected to enter Phase III clinical trials in late 2008/early 2009. Millennium reported total revenues of approximately $528 million for 2007.

The acquisition of Millennium accelerates Takeda’s vision of becoming a global leader in oncology with critical mass in the areas of oncology discovery, development, regulatory affairs and commercialization. Millennium and Takeda have complementary research, development and commercialization capabilities, which have the potential to create a powerful new drug development engine and accelerate the potential of an emerging drug pipeline.

"Millennium greatly strengthens Takeda’s global oncology portfolio, led by the flagship product VELCADE, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda Pharmaceutical Company Limited. "Takeda is committed to becoming a global leader in oncology by delivering novel therapies that improve the standards of care for patients. Millennium has strong discovery, development and commercial capabilities led by a well-established management team. We are pleased that Dr. Deborah Dunsire, Millennium President and Chief Executive Officer, and the current management team intend to continue to lead the Company. Our strong desire is to retain Millennium employees, who have created an entrepreneurial and innovative culture."

"We are extremely proud of the commitment and passion of our employees, who have built this vibrant organization. We look forward to continued success as we join the Takeda Group," said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium. "Both companies share a common vision to develop breakthrough medicines for patients, become a global leader in oncology and expand the global reach of our IBD product candidates. We expect this transaction to help accelerate that vision and deliver tremendous value to patients, shareholders and our employees."

Key Strategic Benefits
Takeda expects that the acquisition of Millennium will:

• Provide access to a fully-integrated oncology discovery, development and commercial platform with a seasoned management team and talented employee base;
• Add VELCADE, a growing and market-leading oncology product with near-term worldwide blockbuster potential;
• Supply access to Millennium world-class drug discovery organization, including expertise in the novel research area of protein homeostasis;
• Capitalize on Millennium proven drug development capabilities and regulatory expertise, which allowed the Company to bring VELCADE to market rapidly;
• Leverage the Millennium experienced sales force, established relationships with oncology thought leaders and highly-regarded marketing capabilities to launch future products; and
• Expand Takeda’s global pipeline in GI, adding a novel anti-α4β7 antibody and an oral CCR9 inhibitor for the treatment of IBD.
Financial
Takeda will finance the acquisition through cash on hand. There is no financing condition to the tender offer or second step merger.

Takeda expects that the acquisition will enhance Takeda’s earnings starting in the fiscal year ended March 2010 before transaction related amortization. The addition of Millennium will enhance Takeda’s growth profile immediately.

Transaction Terms
The acquisition is structured as an all cash tender offer for all of the outstanding shares of Millennium common stock, followed by a merger in which remaining shares of Millennium would be converted into the right to receive the same US$25.00 cash per share price paid in the tender offer.

The transaction has been unanimously approved by the Boards of Directors of Millennium and Takeda.

The transaction is subject to the tender of a majority of Millennium common stock on a fully diluted basis as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close in the second-quarter of 2008.

Takeda America Holdings, Inc., which is wholly-owned by Takeda, has established Mahogany Acquisition Corp. as a wholly-owned subsidiary to effect the transaction. In the merger that follows completion of the tender offer, Mahogany Acquisition Corp. will be merged into Millennium, and the surviving entity will be an indirect wholly-owned subsidiary of Takeda.