On December 16th, 2012 Vivalis and Intercell reported that they have agreed the terms of a
merger to create the newly-named Valneva, a leading European biotechnology company in
vaccines and antibodies (Press release Valneva, DEC 16, 2012, View Source;file=2012_12_16_PR_Intercell_and_Vivalis_ENG_final.pdf [SID:1234500598]).
The merger will create an integrated company with greater scale and diversification,
strengthened financial profile and complementary talent and capabilities:
* Complementary business models operating across the value chain with innovative
technology platforms, discovery and development capabilities, state-of-the-art
manufacturing and commercialization expertise
* Diversified revenue streams from a marketed vaccine against Japanese Encephalitis Virus
and income from multiple commercial technology licenses
* A broad portfolio of promising partnered product candidates including a pandemic Influenza
vaccine in Phase III, a Pseudomonas vaccine in Phase II/III and a Tuberculosis vaccine in
Phase II
* A portfolio of validated and commercialized technology platforms including the EB66 cell
line for human and veterinary product development which is becoming the industry
standard, the VIVA|ScreenTM antibody discovery platform and the IC31 novel adjuvant
* EUR 5-6 million of expected cost synergies, on an annual run-rate basis, achieved within
two years following completion of the merger
* Substantially improved financial profile with a combined cash balance of EUR 94 million as
at 30 September 2012 (adjusted for the planned EUR 40 million rights issue and the
repayment of Intercell’s outstanding convertible bond). This improved financial position will
enhance the development of Valneva’s vaccine and antibody portfolio and will de-risk the
path to profitability
* A complementary and experienced management team led by Thomas Lingelbach as
President and Chief Executive Officer, Franck Grimaud as President and Chief Business
Officer, Majid Mehtali as Chief Scientific Officer and Reinhard Kandera as Chief Financial
Officer
Franck Grimaud, CEO and Majid Mehtali, CSO, co-managers of Vivalis, commented: "The
merger with Intercell is an important step towards Vivalis’ strategic goal of building a profitable,
product-based biopharmaceutical company and laying the foundations for rapid revenue and
profit growth going forward. The merger will significantly complement our core capabilities, in
particular towards product development, while also adding strength and breadth to our R&D
portfolio. As a result of multiple revenue streams, Valneva will also enjoy enhanced financial
strength to fund its future growth."
Thomas Lingelbach, CEO of Intercell, commented: "Our strategy is to build a sustainable
biotech company with a well-balanced and diversified value proposition enabling us to develop
innovative products with a strong focus on preventing and treating infectious diseases. The
merger will help achieve this goal by combining Vivalis’ discovery and technology capabilities
with Intercell’s development, manufacturing and commercialization expertise. The increased
financial strength will provide us greater capabilities to progress our pipeline. We expect both
sets of shareholders will substantially benefit from the strengthened capabilities of the combined
company."

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On December 13, 2012 Kyowa Hakko Kirin reported the initiation of a Phase 3 clinical trial (NCT01728805) in the United States to evaluate the efficacy and safety of mogamulizumab (generic name / code name: KW-0761) in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL) (Press release Kyowa Hakko Kirin, DEC 13, 2012, View Source [SID:1234500289]). Mogamulizumab has been granted orphan-drug designation for the treatment of CTCL by the U.S. Food and Drug Administration and the European Commission.
Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC).
Mogamulizumab was approved in Japan in March 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL), and is being investigated world-wide in a number of clinical studies for other potential indications.

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Discontinued development of obatoclax in lung cancer (Presentation, Teva Investor Day, Teva, DEC 11, 2012, View Source [SID:1234500811]).

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On December 10, 2012 Amgen (NASDAQ:AMGN) and deCODE Genetics reported that the companies have entered into a definitive agreement under which Amgen will acquire deCODE Genetics, a global leader in human genetics, headquartered in Reykjavik, Iceland (Press release, Amgen, DEC 10, 2012, View Source;p=irol-newsArticle&ID=1765710 [SID:SID1234515199]). The all-cash transaction values deCODE Genetics at $415 million, subject to customary closing adjustments, and was unanimously approved by the Amgen Board of Directors.

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"deCODE Genetics has built a world-class capability in the study of the genetics of human disease," said Robert A. Bradway, president and CEO at Amgen. "This capability will enhance our efforts to identify and validate human disease targets. This fits perfectly with our objective to pursue rapid development of relevant molecules that reach the right disease targets while avoiding investments in programs based on less well-validated targets."

Founded in 1996, deCODE Genetics is a global leader in analyzing and understanding the link between the genome and disease susceptibility. Using its unique expertise and access to a well-defined population in Iceland, deCODE Genetics has discovered genetic risk factors for dozens of diseases ranging from cardiovascular disease to cancer.

"One of the ways to truly realize the full value of human genetics, is to make our research synergistic with drug development efforts where target discovery, validation and prioritization efforts can be accelerated," said Kari Stefansson, M.D., Dr. Med., founder and CEO at deCODE Genetics. "We believe Amgen’s focus and ability to incorporate our genetic research into their research and development efforts will translate our discoveries into meaningful therapies for patients."

This transaction does not require regulatory approval, and is expected to close before the end of 2012.

On December 7, 2012 The University of Texas MD Anderson Cancer Center and GlaxoSmithKline (GSK) have signed a research collaboration and license agreement to develop new therapeutic antibodies that promote an immune system attack against cancer (Press release MD Anderson, DEC 7, 2012, View Source [SID:1234500845]).

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Under terms of the agreement, MD Anderson grants GSK exclusive worldwide rights to develop and commercialize the antibodies, which activate OX40 on the surface of T cells. They were discovered by Yong-Jun Liu, M.D., Ph.D., and colleagues when he was professor and chair of MD Anderson’s Department of Immunology.

MD Anderson, through its new Institute for Applied Cancer Science (IACS), will collaborate with GSK to conduct preclinical research on the antibodies.

"This agreement is not only a tribute to the ability of MD Anderson scientists to discover new targets and potential therapies against those targets for cancer patients, it’s also a testament to the vision shared by GSK and MD Anderson that successful clinical development of oncology drugs requires seamless integration of drug development expertise and deep biological knowledge," said Giulio Draetta, M.D., Ph.D., IACS director. "The IACS was formed to enable precisely such integration to expedite the accurate translation of great science into drugs."

The overall potential value of the agreement to MD Anderson over the life of the agreement is estimated at more than $335 million. Under the terms of the agreement, MD Anderson will receive an upfront license payment and funding for IACS research collaboration activities, as well as payments for reaching development, regulatory and commercial milestones. In addition, MD Anderson will also be entitled to royalties deriving from the commercial sales of products developed under the collaboration.

"We’re excited about this opportunity with GSK to improve cancer treatment," Draetta said. "The IACS is a drug development engine with industry-seasoned scientists embedded in a comprehensive cancer center, and as such is ideally suited for this type of collaboration."

The institute is a vital platform resource for MD Anderson’s recently announced and unprecedented Moon Shots Program, which focuses resources and diverse expertise to significantly reduce mortality in the short term and promote cures long term, beginning with eight inaugural cancers.

Unleashing the immune system

Malignant cells are an abnormality that usually attracts a response from the body’s immune system, yet cancer often survives by evading or thwarting anti-tumor immunity. Consistently unleashing the power of the immune system against cancer would be a major step forward for cancer patients.

T cells are lymphocytes, a type of white blood cell produced by the thymus, equipped with receptors that recognize and bind to antigens, which may include abnormal cells.

"T cell recognition of a tumor antigen is not enough to activate the T cells against cancer cells, they need a secondary signal to tell them ‘that antigen you have is a bad thing, you have to attack,’" said Liu, who is now chief scientific officer and vice president of the Baylor Research Institute of the Baylor Health Care System in Dallas.

OX40 is one of these secondary or co-stimulatory receptor proteins. Liu and colleagues found that when it’s activated, it enhances immune attack and blocks suppressors of immune response.

Liu and his MD Anderson colleagues generated and screened hundreds of antibodies that could potentially act as on switches for OX40 by mimicking its natural activator, OX40L, a molecule that binds to OX40. Years of research narrowed the candidates to a handful of activators, or agonists, which were tested in mice and then altered for human use.

"It’s gratifying to see MD Anderson and GSK take this important step towards translating a basic science discovery into a potential new therapy that can proceed to clinical trial," Liu said.

Initial clinical trials will occur only after necessary preclinical drug development conducted under the agreement succeeds.