On October 22, 2014 Astellas Pharma reported the revision of the package insert for the oral androgen receptor signaling inhibitor XTANDI Capsules 40mg (generic name: enzalutamide, "XTANDI") (Press release Astellas, OCT 21, 2014, View Source [SID:1234500855]).

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Based on the results of the Phase 3 AFFIRM trial for the treatment of advanced castration-resistant prostate cancer ("CRPC") in patients who have previously received docetaxel (chemotherapy), XTANDI, which is being jointly developed and commercialized with US-based company Medivation Inc. (NASDAQ MDVN), obtained the marketing approval in Japan for use in CRPC treatment in March 2014 and went on sale in May 2014.

The Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in chemotherapy-naïve metastatic CRPC patients recognized the clinical benefits and favorable tolerability of XTANDI for metastatic CRPC patients who have not received chemotherapy. The item "Indication" of the package insert has been revised based on the results of the PREVAIL trial, which means the sentence, "The efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy", has been deleted from the "Precautions regarding indication" item. Also, the items "Side effects" and "Clinical results" of the package insert have been revised.
In addition to the revisions, "thrombocytopenia" has been added to the "Significant side effects" in the "Side effects" item in accordance with Authorities’ instruction.

The revision of the "Precautions regarding indication" item of the package insert triggers a $45 million milestone payment to Medivation under its collaboration agreement with Astellas.

On October 20, 2014 Cancer Research Technology (CRT), the development and commercialisation arm of Cancer Research UK, reported the launch of Ximbio (www.ximbio.com), an online reagents portal for the life science community (Press release, Cancer Research Technology, OCT 20, 2014, View Source [SID1234523221]). Ximbio has been developed to change the way that research reagents are searched, sourced and shared, to broaden the range of tools available to scientists globally and support and advance life science research.

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Ximbio provides a portal for the life science community to exchange knowledge and trade reagents. Researchers and technology transfer offices can virtually deposit their reagents to Ximbio. Life science reagents companies can use the portal to easily source new products to augment their portfolios via a straightforward commercialisation process. Ximbio returns a share of product-based revenues to the depositing institution.

For scientists looking for specific reagents to use in their experiments, Ximbio offers a fully searchable database, extensive datasheets, and supplier options, and in future will also feature peer reviews of listed products. Each reagent record can be linked to the originating inventor, enabling scientists and institutions to be credited for their work. Ximbio will operate as a business unit of CRT, and will focus on all areas of biology.

Keith Blundy, Cancer Research Technology’s Chief Executive Officer, commented: "Over the past 25 years CRT has successfully built one of the world’s largest and most well-respected collections of life science reagents. Ximbio now provides us with the opportunity to extend our reach globally to provide an enhanced offering that better meets the needs of researchers, technology transfer offices, and life science companies."

Melanie Hardman, Head of Ximbio, commented: "Through in-depth analysis of our partnerships with technology transfer offices, life science reagents companies, and the research community, we recognised a real need for an easy to use, online reagents portal. This has been validated by the extensive stakeholder research we have undertaken over the past 8 months. We have created Ximbio to be a place where scientists and technology transfer offices can share their research, and reagents companies can source new products, in a streamlined process that saves both time and resource, maximising the visibility and impact of all research reagents. By unifying the reagent community in this way, to make tools more widely and easily available, we hope to accelerate life science research."

On October 16, 2014 Aduro BioTech reported that it has entered into its second agreement with Janssen Biotech part of the Janssen Pharmaceutical Companies of Johnson & Johnson, granting an exclusive, worldwide license to certain product candidates engineered for the treatment of lung cancer and certain other cancers based on its novel LADD immunotherapy platform (Press release Aduro BioTech, OCT 16, 2014, View Source [SID:1234500839]). Under the agreement, facilitated by the Johnson & Johnson Innovation center in California, Aduro will receive a $30 million up-front payment and is eligible to receive significant development, regulatory and commercialization milestone payments up to a potential total of $817 million. In addition, Aduro is eligible to receive high single-digit to double-digit tiered royalties on worldwide net sales upon successful launch and commercialization.

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Under the agreement, Janssen will have exclusive rights to develop and commercialize LADD product candidates in lung cancer and will assume responsibility for all research, development, manufacturing, regulatory and commercialization activities for the licensed products. Aduro may provide assistance in any of these areas upon request and will receive additional fees for these support activities.

"Since our initial agreement with Janssen in May of this year for new immunotherapies for prostate cancer, they have been terrific partners and we’ve established a strong collaboration focused on advancing our technologies forward in their licensed indications," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe our LADD technology also offers tremendous promise as a potential treatment for lung cancer and we are pleased to expand our relationship with Janssen, a company with significant experience and resources focused in both lung and prostate cancer. Separately, Aduro continues to make progress with our broad array of immunotherapy platforms in a number of other oncology indications, including pancreatic cancer, mesothelioma and glioblastoma among others."

The transaction is subject to clearance by the US antitrust authorities under the Hart-Scott-Rodino Act and will become final as soon as such clearance has occurred.

In May of this year, Aduro announced its first agreement with Janssen Biotech, Inc. granting the company an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on its novel LADD immunotherapy platform. Under that agreement, also facilitated by the Johnson & Johnson Innovation center in California, Aduro is eligible to receive up to $365 million in upfront and development and commercialization milestones.

On October 16, 2014 Pharmacyclics reported that it has entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and preliminary efficacy of IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor, in combination with GAZYVA (obinutuzumab), a new CD20-directed antibody that attacks targeted cells both directly and together with the body’s immune system, in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (Press release Pharmacyclics, OCT 16, 2014, View Source [SID:1234500840]). The agreement allows for multiple studies to be considered and conducted. Initially, a Phase 3 study will be conducted by Pharmacyclics in CLL/SLL. Plans to evaluate the combination for NHL currently are in development. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

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Both products are approved and marketed for the treatment of CLL. IMBRUVICA is used to treat CLL in patients who have received one prior therapy, and in CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients. GAZYVA is used with the chemotherapy drug, chlorambucil, to treat CLL in patients with previously untreated chronic lymphocytic leukemia. The use of these products in combination is investigational only.

"We are committed to evaluating the potential activity of IMBRUVICA as a single agent and in combination with other agents to determine the benefits that IMBRUVICA may provide through a variety of uses across several hematologic malignancies," said Bob Duggan, Chairman & CEO, Pharmacyclics. "We look forward to a rewarding and productive partnership with Roche to evaluate our product with GAZYVA in order to deliver new treatment options to patients with NHL and CLL."

The study of the investigational combination of IMBRUVICA and GAZYVA through several investigator-sponsored trials also is being considered. Additional details of the agreement were not disclosed.

(Press release, CanTx, OCT 16, 2014, View Source [SID:1234505855])

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