On November 26, 2013 Boston Strategics reported a new drug development partnership with FUJIFILM Pharmaceuticals U.S.A., Inc. (FPHU), Boston, MA, a global pharmaceutical development center of FUJIFILM Corporation, Tokyo, Japan (Press release, Boston Strategics, NOV 26, 2013, View Source [SID:1234501881]). This strategic collaboration is the first of its kind between a Japanese pharmaceutical company and a pharmaceutical research and development provider, creating a novel and comprehensive approach to global pharmaceutical development.

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Under this agreement, Boston Strategics will be the primary provider for FPHU global drug development services and resources for FPHU Oncology programs. This agreement will build on Boston Strategic strengths covering the spectrum from preclinical and early clinical development through Phase I and II human Proof-of-Concept (POC). Utilizing Boston Strategics’ internal oncology development expertise and ability to identify and collaborate with the best resources around the world, FPHU will expand its global reach in oncology drug development.

Boston Strategics will optimize and execute the global strategy of FPHU Oncology drug development programs. In this capacity, Boston Strategics will leverage its "True Open InnovationTM" network to deliver superior outcomes, using highly efficient execution strategies and proven partners, such as the University of Texas MD Anderson Cancer Center, Houston TX (MD Anderson).

"True Open InnovationTM overcomes any limitations by reducing the need for large infrastructure, and draws on critical drug development expertise based on the unique needs of a particular program," says Keizo Koya, Ph.D., CEO of Boston Strategics. "Our strong business relationships with our global resource networks are poised to assist pharmaceutical/biotech companies with strategy and launch of quality global drug development programs, and rapidly execute them to the next decision step/value inflection point. We are deeply committed to giving a new pharmaceutical R&D platform for FPHU, which look for an innovative and efficient way of globally developing their unique oncology pipelines. Entering into a special alliance of Boston Strategics this year with MD Anderson, a world leader in cancer treatment and oncology research, Boston Strategics will use this opportunity to provide global clinical development supports for FPHU."

The ultimate goal of this unique partnership is to develop FUJIFILM’s oncology drug candidates globally using innovative approaches coupled with industry benchmark-beating timelines, quality, and financial investment.

On November 21, 2013 Covagen and Tanabe Research Laboratories U.S.A, Inc. (TRL), a fully owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), reported that they expanded their strategic research collaboration. MTPC and TRL have nominated a first bispecific FynomAb for formal preclinical development which triggered an undisclosed milestone payment (Press release Mitsubishi Tanabe Pharma, NOV 21, 2013, View Source [SID:1234501611]). MTPC and TRL also exercised an option for a second bispecific FynomAb program based on the parties’ research and licensing agreement signed in October 2012. Under the agreement, Covagen will use its proprietary Fynomer-antibody platform to generate bispecific antibodies (FynomAbs) against a second target pair selected by TRL and MTPC.

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"We believe Covagen’s FynomAb platform is a source of innovative bispecific antibodies with excellent biophysical properties that will allow more effective treatment of inflammatory and oncologic diseases," said Roland Newman, Ph.D., chief scientific officer of TRL. "We look forward to continuing our cooperative work with the Covagen team as we advance the first FynomAb into preclinical development and look towards discovery of the second FynomAb as part of this expanded collaboration.".

Through payment of an undisclosed option fee, MTPC secured global, exclusive rights to bispecific FynomAbs against a second target pair in oncology. Under the agreement, MTPC will fund all research activities and be solely responsible for the development, manufacturing and global commercialization activities. Upon achievement of certain research, development and regulatory milestones, Covagen is entitled to receive payments of up to €108.25 million for the second program as well as tiered royalties on worldwide net sales of products resulting from the collaboration.

"The expansion of our collaboration with MTPC and TRL provides substantial validation of Covagen’s bispecific FynomAb technology as we advance several therapeutic programs toward the clinic in 2014 and 2015," said Julian Bertschinger, Ph.D., chief executive officer of Covagen.

Dragan Grabulovski, Ph.D., chief scientific officer of Covagen, added, "The expansion to a second bispecific FynomAb program is the result of the successful discovery and early preclinical development of the FynomAb from the original collaboration. This FynomAb was generated less than one year after initiating the joint research collaboration and showed excellent activity in pre-defined in vitro and in vivo studies. Our work with the MTPC and TRL team has been extremely productive, and we are eager to continue development of both projects."

On November 18, 2013 Patrys reported that it has been granted a second Australian patent for clinical anti-cancer product PAT-SM6 (Press release Patrys, NOV 18, 2013, View Source [SID:1234500548]).
The Australian Patent Office has issued the official "Notice of Grant" on a key patent in the PAT-SM6 family; application number 2007355108 entitled "Novel glycosylated peptide target in neoplastic cells". It offers patent protection through to November 2027.
This is the second patent to be granted in Australia.
This patent is one of a series of patent applications that have been submitted to cover the PAT-SM6 product, target and mechanism of action. The claims in this patent cover the PAT-SM6 antibody and binding fragments and methods of use of the antibody and binding fragments for treatment of various cancers including multiple myeloma. In February 2012, Patrys was granted a patent by the US Patent Office that contains claims that cover the PAT-SM6 antibody which binds to apolipoprotein B containing low-density lipoprotein (LDL) and apolipoprotein B containing oxidised LDL which are part of the complex, multistep mechanism of action for the product. To date, seven patents in the PAT-SM6 family have been granted in various jurisdictions including Europe, Japan, the US and Australia.

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On November 18, 2013 Sanofi reported that the decision to halt all clinical trials and cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib (SAR302503).
Following a thorough risk-benefit analysis, including consultation with the U.S. Food and Drug Administration (FDA), study investigators, independent expert neurologists and neuro-radiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients (Press release Sanofi, NOV 18, 2013, View Source [SID:1234500448]).
This decision follows recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in fedratinib clinical trials. The FDA directed Sanofi to put all fedratinib trials on clinical hold while the company thoroughly investigated these cases to ensure the safety of fedratinib for patients. Sanofi took immediate action requesting that study investigators discontinue fedratinib treatment for patients in the trials.
Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials. Patients currently in fedratinib trials should consult with their treating physician to determine the best alternative course of therapy for their myelofibrosis.

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On November 15, 2013 Baxter International and Cell Therapeutics jointly reported that they have entered into an exclusive worldwide licensing agreement to develop and commercialize pacritinib (Press release CTI BioPharma, NOV 15, 2013, View Source;p=RssLanding&cat=news&id=1877358 [SID:1234500578]). Pacritinib is a novel investigational JAK2/FLT3 inhibitor with activity against genetic mutations linked to myelofibrosis, leukemia and certain solid tumors. Pacritinib is currently in Phase III development for patients with myelofibrosis, a chronic malignant bone marrow disorder.

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Under the terms of the agreement, Baxter gains exclusive commercialization rights for all indications for pacritinib outside the United States and Baxter and CTI will jointly commercialize pacritinib in the United States. Baxter will make an upfront payment of $60 million, which includes an equity investment in CTI of $30 million. In addition, CTI is eligible to receive clinical, regulatory, and commercial launch milestone payments of up to $112 million, $40 million of which relates to clinical milestones that may be achieved in 2014. Assuming regulatory approval and commercial launch, CTI may receive additional sales milestone payments. CTI will receive royalties on net sales of pacritinib in ex-US markets, and the companies will share U.S. profits equally. Baxter will record a special pre-tax in-process research and development charge in the fourth quarter of 2013 of approximately $30 million.

”The collaboration will complement Baxter’s existing oncology business and growing oncology pipeline, and will leverage our global commercialization capacity to extend the availability of pacritinib, which we believe has the potential to address a significant unmet medical need,” said Ludwig Hantson, Ph.D., President of Baxter BioScience. ”As an established leader in hematology and rare diseases, we are committed to advancing novel therapies in an effort to broaden patient access to care.”

”We believe Baxter represents the ideal strategic partner to achieve the full potential of pacritinib,” said James A. Bianco, M.D., President and CEO of CTI. ”Our two companies share a dedication to oncology and a vision for bringing this unique oral JAK2/FLT3 inhibitor to patients with certain blood cancers and solid tumors. This collaboration will provide additional financial resources and commercial expertise to position us to pursue the development, commercialization and market potential of pacritinib.”

Pacritinib is an oral tyrosine kinase inhibitor (TKI) with dual activity against JAK2 and FLT3. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of certain blood related cancers including myeloproliferative neoplasms, leukemia and lymphoma.