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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.

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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.

Jubilant to acquire Draxis Health

On April 4, 2008 Jubilant Organosys Ltd. ("Jubilant") (BSE: 530019, NSE: JUBILANT) and DRAXIS Health Inc. ("DRAXIS") (TSX: DAX) (NASDAQ: DRAX) reported that they have entered into an arrangement agreement whereby a wholly-owned subsidiary of Jubilant Organosys Ltd (Press release, Jubilant Life Sciences, APR 4, 2008, View Source [SID1234527424]). ("Jubilant") will acquire all the outstanding common shares of DRAXIS at a price of US$6.00 per share in cash by way of a plan of arrangement. The total value of this transaction is approximately US$255 million.

The purchase price represents a 22.4% premium over yesterday’s closing price of DRAXIS’s shares on NASDAQ and a 41.2% premium over the closing price of DRAXIS’s common shares on NASDAQ on March 13, 2008, the last trading day on NASDAQ prior to the request by securities regulators to explain increased trading in DRAXIS’s common stock on March 14, 2008.

The transaction was unanimously approved by the Board of Directors of DRAXIS on April 4th, 2008 following receipt of the recommendation of its Special Committee. DRAXIS’s Board has resolved to recommend to its shareholders that they vote in favor of the transaction on the basis that it creates immediate value for DRAXIS shareholders. As well, the Board expects the transaction to provide operational and technical resources to accelerate the growth of DRAXIS’s business and its customer base.

Commenting on the acquisition, Mr. Shyam S. Bhartia, Chairman & Managing Director and Mr. Hari S. Bhartia, Co-Chairman & Managing Director of Jubilant Organosys Ltd. said, "DRAXIS represents a unique opportunity in the North American market, offering Jubilant entry into the attractive, regulated, high growth and high margin radiopharmaceutical business. It also enables Jubilant to consolidate its position in the sterile and non-sterile contract manufacturing business. With this acquisition Jubilant will become one of the leading providers of contract manufacturing of small volume parenterals to large pharmaceuticals and biotech companies in North America. DRAXIS has an excellent regulatory track record, with its management and employees having a wealth of experience and expertise in radiopharmaceuticals and contract manufacturing. Jubilant is committed to grow DRAXIS by supporting management and employees through new product launches, entry into new markets and expansion of customer base."

About the Transaction

The transaction will be carried out by way of a statutory plan of arrangement pursuant to the Canada Business Corporations Act and must be approved by the Québec Superior Court and the affirmative vote of DRAXIS’s shareholders at a special meeting of shareholders. The proposed transaction is expected to close in the second quarter of 2008, shortly after receipt of shareholder and court approvals. The completion of the transaction is subject to customary closing conditions. The arrangement agreement contains customary non-solicitation provisions, but permits DRAXIS, in certain circumstances, to terminate the arrangement and accept an unsolicited superior proposal, subject to fulfilling certain conditions. DRAXIS has agreed to pay Jubilant a break fee of $10.5 million in such circumstances and certain other limited circumstances if the transaction is not completed. Jubilant plans to fund the acquisition through a combination of cash-on-hand and debt. The transaction is not contingent on any financing condition. Details regarding these and other terms of the transaction are set out in the arrangement agreement, which will be filed by DRAXIS on the Canadian SEDAR website at www.sedar.com and at the SEC’s EDGAR website at www.sec.gov. Further information regarding the transaction will be contained in a proxy circular that DRAXIS will prepare and mail to holders of common shares in connection with the special meeting of shareholders to be held to approve the transaction. It is expected that these materials will be mailed in April 2008 for a meeting to be held in May 2008. Once mailed, the proxy circular will be available at www.sedar.com and www.sec.gov. All shareholders are urged to read the proxy circular once it is available. Banc of America Securities Canada Co. has acted as financial advisor to DRAXIS and McCarthy Tétrault LLP is legal counsel to DRAXIS. Fasken Martineau is legal counsel to the Special Committee of the Board. Lazard has acted as financial advisor to Jubilant and Osler Hoskin & Harcourt LLP is acting as legal counsel to Jubilant.