(Filing, 10-K, Ligand, MAR 3, 2011, View Source [SID:1234502815])

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(Filing 10-K , Exelixis, FEB 22, 2011, View Source [SID:1234501028])

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Invivoscribe Announces Collaboration Agreement to Develop Companion Diagnostic Test

On February 15, 2011 Invivoscribe Technologies reported that they have entered into a collaboration agreement with Novartis to develop and commercialize a companion diagnostic test. The test aims to identify FLT3 positive acute myeloid leukemia (AML) patients for specific use in connection with the Novartis development compound, midostaurin (PKC412) (Press release Invivoscribe Technologies, FEB 15, 2011, View Source [SID:1234501208]). Midostaurin, a targeted small molecule inhibitor of FLT3 tyrosine kinase, is currently in Phase III clinical development for newly diagnosed patients with FLT3 mutated AML who are receiving midostaurin or a placebo in combination with chemotherapy (NCT00651261). FLT3 is mutated in approximately one-third of all AML patients and FLT3 mutations are associated with poor prognosis.

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The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)(R) and the National Comprehensive Cancer Network(R) recommend testing for the FLT3 mutation in all patients diagnosed with AML — determination of FLT3 mutation status has become a standard of care for patients diagnosed with AML. The Laboratory for Personalized Molecular Medicine (LabPMM(TM)), a subsidiary of Invivoscribe, is currently the only clinical laboratory with an exclusive license to the patents required to generate a FLT3 result that can be used toward regulatory approval of a companion diagnostic.

"Developing an FDA-approved FLT3 companion diagnostic for midostaurin will be a significant milestone for our companies, Invivoscribe and LabPMM," said Dr. Jeffrey E. Miller, founder, chief scientific and chief executive officer of Invivoscribe and LabPMM. "We are delighted to collaborate with one of the world’s leading healthcare companies in a manner that enables us to leverage our expertise in both molecular diagnostic product development and personalized molecular medicine."

Invivoscribe and LabPMM will develop, manufacture and work with the Novartis Molecular Diagnostics (MDx) unit to obtain regulatory approval for the companion diagnostic. Invivoscribe and Novartis MDx will then work together to make the companion diagnostic for treatment of AML available throughout the world.

International Cancer Genome Consortium announces $20 million Canadian research project to decode the prostate cancer genome

On February 15, 2011 The International Cancer Genome Consortium (ICGC) reported the launch of a $20 million Canadian research project that will map the genetic structure of prostate cancer and provide new information that could greatly improve the diagnosis and treatment of the disease (Press release, International Cancer Genome Consortium, FEB 15, 2011, View Source [SID1234571045]). The new project, called The Canadian Prostate Cancer Genome Network (CPC GENE), is one of 36 other currently funded ICGC research projects in 13 jurisdictions around the world.

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CPC GENE aims to crack the prostate cancer genetic code by identifying changes or mutations in the DNA sequences of prostate cancers. Information about mutations in these DNA sequences could be used to better detect tumours, determine tumour aggressiveness and identify the best treatment needed to personalize prostate cancer medicine for individual patients.

Up to $15 million in funding will be provided by Prostate Cancer Canada (PCC) and $5 million from the Ontario Institute for Cancer Research (OICR).

"Prostate Cancer Canada is excited to be leading this important international study which will lead to collaboration and knowledge sharing. From a patient perspective and the 1 in 6 Canadian men who will be diagnosed with prostate cancer in their lifetime, this should result in improved diagnostics and better treatment strategies" said Steve Jones, President & CEO of Prostate Cancer Canada.

"I lost my father at age 63 to prostate cancer and too many of my friends struggle with this illness. Our government is making this investment to hasten the day when we can talk about prostate cancer in the past tense," said Glen Murray, Ontario Minister of Research and Innovation.

"We anticipate that within five years, gene-based diagnoses will help physicians in determining which patients require more intensive therapies and which patients would benefit from careful monitoring, a process called "watchful waiting". It is also expected that some prostate cancer mutations detected by CPC GENE will stimulate the development of new cancer drugs" said Dr. Tom Hudson, President and Scientific Director of OICR. CPC GENE will be led by Dr. Robert Bristow, Senior Scientist at the Ontario Cancer Institute, the research arm of the University Health Network’s Princess Margaret Hospital (PMH) and Genitourinary (GU) Radiation Oncologist at PMH. He said, "We are excited by the possibility to use precise genetic information from our patients to personalize their prostate cancer diagnosis and treatment. This personalized medicine approach will no doubt improve the quality of life for men worldwide diagnosed with the disease."

The highly collaborative project will bring together Canadian researchers working in Vancouver, Calgary, Toronto, Kingston and Montreal. These researchers will also work with international teams based in the United Kingdom, France and Germany.

In Canada, over 25,000 men will be diagnosed with prostate cancer and more than 4,000 will die of it. Side effects from prostate cancer treatment are often serious and long-term. Prostate cancer is currently evaluated by the stage of cancer, PSA blood test, and the Gleason score which is based on how aggressive the cancer cells appear under the microscope. However, these prognostic factors cannot accurately predict the clinical course or treatment required for an individual with prostate cancer. Investigating the genetic causes of the disease could identify the best treatment for each patient based on the unique DNA sequence of their cancer.

As of January 2011, the ICGC has received commitments from funding organizations in Asia, Australia, Europe and North America for research institutes in 13 jurisdictions. So far, funding organizations have committed more than $500 million for 38 projects. Projects that are currently funded are examining tumours affecting the bladder, blood, bone, brain, breast, cervix, colon, head and neck, kidney, liver, lung, oral cavity, ovary, pancreas, prostate, rectum, skin, soft tissues, stomach and uterus. Over time, additional nations and organizations are anticipated to join the ICGC. For more information and updates about ICGC activities, please visit the website at: www.icgc.org.

OICR, a not-for-profit research institute funded by the Government of Ontario, cofounded the International Cancer Genome Consortium. In addition to prostate cancer, OICR is responsible for an ICGC project on pancreatic cancer. OICR hosts the ICGC Secretariat that coordinates ICGC networking activities and the ICGC Data Coordination Centre, which assures that ICGC datasets generated by ICGC members in 13 countries is made available to the worldwide research community, to accelerate research into the causes and control of cancer. These initiatives have received additional support for equipment and operations from the Canada Foundation for Innovation and the Government of Ontario.

Lundbeck expands its commercial opportunities in Canada and Latin America

On February 8, 2011 Lundbeck reported that it has been granted commercial rights to several Cephalon products in Canada and Latin America (Press release , FEB 8, 2011, View Source [SID:1234500347]). As part of the agreement, Lundbeck will register and commercialize several key products which are currently available in the US and/or Europe on behalf of Cephalon. Key products in the agreement include Fentora() (fentanyl buccal tablet) [C-II], Provigil(), Treanda(), Trisenox() (arsenic trioxide) injection, Myocet( )(liposomal- doxorubicin) and Nuvigil().

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Also included in the deal is the leading Cephalon oncology product Treanda() which is to be commercialized by Lundbeck in Canada. Treanda() will add significantly to revenue and earnings in Lundbeck’s Canadian business. The new oncology franchise in Canada will be complemented by Trisenox() and the pain product, Fentora(). Treanda() has proven clinical activity in the treatment of hematological malignancies, including those refractory to conventional anti- cancer agents.

In 2008, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) recognized Treanda() as one of the major advances in cancer treatment. In 2009, Cephalon realized total revenue of USD 222 million on the product and in the first nine months of 2010 revenue reached USD 285 million in the U.S. Treanda( )is expected to be filed during 2011 in Canada and Lundbeck will establish a dedicated oncology sales organization in Latin America and Canada in order to achieve the full potential of the oncology portfolio.
The financial terms of the agreement have not been disclosed, but Lundbeck is to pay double-digit royalties on sales which will be the main overall revenue stream for Cephalon from these products in these territories.