On January 30, 2017 Incyte Corporation (NASDAQ:INCY) and Calithera Biosciences, Inc. (NASDAQ:CALA) report that the companies have entered into a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology (Press release, Incyte, JAN 30, 2017, View Source;p=irol-newsArticle&ID=2240498 [SID1234517849]). CB-1158 is currently being studied in a monotherapy dose escalation trial and additional studies are expected to evaluate CB-1158 in combination with immuno-oncology agents, including anti-PD-1 therapy.

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"Arginase-expressing tumor-infiltrating myeloid cells have been shown to play an important role in orchestrating the immune suppressive microenvironment in cancer; but, to date, therapeutic targeting of the arginase enzyme has remained elusive," said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "The addition of this first-in-class, small molecule arginase inhibitor, CB-1158, to our portfolio expands our innovative immuno-oncology pipeline and allows us to continue to advance our mission of discovering and developing immune-active combination therapies to treat patients with cancer."

"In this strategic partnership with Incyte, CB-1158 is expected to be evaluated in multiple trials of novel therapeutic combinations, accelerating its development across hematological and oncology indications," said Susan Molineaux, Ph.D., Calithera’s Chief Executive Officer.

Terms of the Collaboration
Under the terms of the collaboration and license agreement, Calithera will receive an up-front payment of $45 million from Incyte. In addition, Incyte will make an equity investment in Calithera of $8 million through the purchase of shares at a price of $4.65 per share.

Incyte will receive worldwide rights to develop and commercialize CB-1158 in hematology and oncology and Calithera will retain certain rights to research, develop and commercialize certain other arginase inhibitors in certain orphan indications.

Incyte and Calithera will jointly conduct and co-fund development of CB-1158, with Incyte leading global development activities. Incyte will fund 70 percent of global development and Calithera will be responsible for the remaining 30 percent. In the event of regulatory approvals and commercialization of CB-1158, Incyte and Calithera will share in any future U.S. profits and losses (receiving 60 percent and 40 percent, respectively) and Calithera will be eligible to receive over $430 million in potential development, regulatory and commercialization milestones from Incyte. Per the terms of the agreement, Calithera will have the right to co-detail CB-1158 in the U.S. and also be eligible to receive from Incyte tiered royalties based on future ex-U.S. sales, with rates ranging from low-to-mid double-digits.

The agreement also provides that Calithera may choose to opt out of its co-funding obligations. In this scenario, Calithera would no longer be eligible to receive future U.S. profits and losses but would be eligible to receive up to $750 million in potential development, regulatory and commercialization milestones from Incyte and, if the product is approved and commercialized, also be eligible to receive reimbursement based on previous development expenditures incurred by Calithera and tiered royalty payments on future global sales of CB-1158, with rates ranging from low-to-mid double-digits.

The transaction is expected to close in the first quarter of 2017, subject to customary closing conditions.

On January 31, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported financial results for three quarters of fiscal year 2016 ending March 31, 2017 ("FY2016") (Press release, Astellas, JAN 30, 2017, View Source [SID1234517620]).

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"We achieved many milestones including the acquisition of Ganymed Pharmaceuticals, a Germany-based pharma company, last December. The acquisition of Ganymed will enable Astellas to further expand its oncology pipeline with a late stage antibody program for the treatment of gastroesophageal cancer," said Yoshihiko Hatanaka, President and CEO, Astellas. "We remain committed to creating innovative medical solutions and delivering value for stakeholders including patients, as we reinforce our strategic plan through maximizing the product value, creating innovation and pursuing operational excellence."

Consolidated Financial Results (April 1, 2016 – December 31, 2016) (core basis) (Millions of yen) First nine months of FY2015 First nine months of FY2016 Change (%) Sales 1,065,666 1,005,587 -60,079 (-5.6%) Core operating profit 233,863 241,837 +7,974 (+3.4%) Core profit for the period 169,379 177,189 +7,810 (+4.6%) Basic core earnings per share (yen) 78.16 83.62 +5.46 (+7.0%)

Revenue Highlights for First Nine Months

Sales in the first nine months of FY2016 decreased by 5.6% compared to those in the corresponding period of the previous fiscal year ("year-on-year") and resulted in 1,005.6 billion yen. Sales decreased due to the impact of foreign exchange as well as the impact of the NHI drug price revision in Japan enforced in April 2016. On a constant currency basis, however, sales increased by approximately 3% year-on-year.

In terms of global products, sales of XTANDI grew while sales of overall OAB treatments Vesicare (solifenacin succinate) and Betanis / Myrbetriq / BETMIGA decreased due to the impact of foreign exchange. Prograf (tacrolimus) sales also decreased. < Sales by Region1 >

Sales in Japan decreased by 4.2% year-on-year to 380.1 billion yen. Sales in the Japanese market decreased by 7.2% year-on-year to 358.2 billion yen mainly due to the impact of the NHI drug price revision. There was growth in sales of products including overall OAB treatments (Vesicare and Betanis ), Celecox (celecoxib), Symbicort (budesonide and formoterol fumarate dihydrate) and Suglat (ipragliflozin). Sales of XTANDI decreased due to the impact of the NHI drug price revision. Sales of vaccines declined due to the continued impact of shipping restraints by the manufacturer in FY2015 (shipments of some of the products have 1 Based on location of sellers 3 already recommenced). Revenues were impacted by the decline in sales of products including Lipitor (atorvastatin calcium) and Gaster (famotidine) mainly due to the impact of generics.

Sales in the Americas decreased by 11.6% year-on-year to 308.1 billion yen; however sales on a U.S. dollar basis increased by 0.8% year-on-year to 2,889 million USD. The increase in sales of CRESEMBA (isavuconazonium sulfate) contributed to the sales growth. Sales of products including XTANDI , overall OAB treatments (VESIcare and Myrbetriq ) and Lexiscan (regadenoson) decreased due to the impact of foreign exchange, while the sales of each product on a US dollar basis increased. Sales of Prograf decreased.

EMEA2 saw a 0.6% increase in sales year-on-year to 252.9 billion yen, with growth from XTANDI . Sales on a euro basis increased by 14.6% year-on-year to 2,143 million euros. Sales of overall OAB treatments (Vesicare and BETMIGA ) and Prograf declined due to the impact of foreign exchange.

In Asia and Oceania, sales decreased by 6.3% year-on-year to 64.5 billion yen, while the sales on a constant currency exchange rate basis increased by 9.5%. XTANDI and overall OAB treatments (Vesicare and BETMIGA ) contributed to the revenue growth. Sales of Prograf and Harnal (tamsulosin hydrochloride) declined mainly due to the foreign exchange impact. Other Financial Highlights Based on the transfer of the global dermatology business in April 2016, the sales and expenses of the transferred products were not included in the first nine months of FY2016; however the consideration for the business transfer was recognized as revenue over certain periods. As a result, there were certain positive impacts on sales and profit for the first nine months of FY2016. Latest Strategic Highlights Astellas continues to create sustainable growth over the mid-to long-term through the pursuit of three main strategies – "Maximizing the Product Value," " Creating Innovation" and "Pursuing Operational Excellence." The company achieved multiple 2 EMEA: Europe, the Middle East and Africa 4 accomplishments during the third quarter of FY2016 (October 1, 2016 – December 31, 2016) including the most recent highlights outlined below. Maximizing the Product Value

Continued to maximize the growth of the oncology franchise centered on XTANDI and the OAB franchise comprised of Vesicare and Betanis / Myrbetriq / BETMIGA with new launches across various countries and growth in sales Creating Innovation

Advanced multiple strategic collaborations including: – Completion of acquisition of Ganymed Pharmaceuticals Pursuing Operational Excellence Optimal allocation of resources: – Transfer of commercial rights for Qutenza (capsaicin 8% patch) to Grünenthal in Europe, Middle East and Africa

Continually enhance organization structure: – Outsourcing of facility and equipment management support in Japan, and dissolution of Astellas Business Service Company Limited NOTE: For further information on the results, please refer to the reference documents: Financial Results, Supplementary Documents, Overview of R&D Pipeline and Presentation Material for Information Meeting available on the Astellas website.

On January 30, 2017 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, officially reported that PharmaCyte has retained Facet Life Sciences, Inc. (Facet) to guide PharmaCyte through its pancreatic cancer therapy development lifecycle with the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 30, 2017, View Source [SID1234517605]). Facet has been working with PharmaCyte and Translational Drug Development (TD2) since September 2016 and was instrumental in expediting PharmaCyte’s pre-IND meeting with the FDA.

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The Chief Executive Officer of PharmaCyte explained retention of Facet, "After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.

"Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet."

The Facet Life Sciences team is comprised of drug development, regulatory affairs and regulatory writing experts who have scientific degrees and over 100 years of combined experience in the pharmaceutical, biologics, biopharmaceutical and medical device industry. The services offered by Facet span the full spectrum of services that PharmaCyte will need for regulatory approval of its therapy for pancreatic cancer. Facet is the U.S. Agent for PharmaCyte before the FDA and will assist with regulatory and clinical strategy, preparation and support for regulatory meetings, regulatory submission leadership, gap analyses, product labeling, risk management and medical writing in a number of areas.

The President and CEO of Facet, Ken VanLuvanee, commented on Facet’s retention by PharmaCyte saying, "We are extremely pleased to have been selected to work with PharmaCyte on its novel live-cell encapsulation therapy for pancreatic cancer. This is cutting edge technology that presents one of the most complex regulatory product candidates on which we have ever worked. In spite of its complexity, when compared to a single chemotherapy drug for example, we believe that successful development of PharmaCyte’s therapy may change the way tumors of the pancreas and other solid tumors are treated in the future. It’s truly an exciting time for us and PharmaCyte alike."

Facet development experts work closely with client teams to successfully reach their corporate and product goals. Facet has created and managed critical development aspects for some of the industry’s fastest growing life sciences companies. Its specialists deliver expert services and cutting-edge technologies that are designed to help small life science companies with big goals optimize their product research and development efforts.

On January 30, 2017 Tempus, a technology company focused on helping doctors personalize cancer care, and the University of Michigan are partnering to help researchers and physicians to identify customized treatment opportunities for pancreatic cancer patients (Press release, Tempus, JAN 30, 2017, View Source [SID1234517597]).

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As part of the new collaboration, Tempus will provide genomic and transcriptomic sequencing and analysis for pancreatic cancer patients being treated at the University of Michigan. Utilizing bioinformatics and its machine learning platform, Tempus will help physicians analyze these data sets to identify patterns and potentially actionable treatments.

Pancreatic cancer is the third leading cause of cancer-related death in the United States and anticipated to become the second by around 2020. The disease kills more people than breast cancer and has a five-year survival rate of just nine percent.

"Though pancreatic cancer patients face some of the toughest odds, they do not yet have access to a host of targeted therapies with proven effectiveness in the same way that other diseases have, in part because there isn’t enough patient, treatment and outcome data to identify patterns that might lead to actionable treatments," said Eric Lefkofsky, Co-founder and CEO of Tempus. "At Tempus, we are proud to be leading an effort to make that data available to researchers and physicians on the frontlines of care."

The University of Michigan Comprehensive Cancer Center is one of 47 Comprehensive Cancer Centers in the U.S. designated by the National Cancer Institute, and has been a leader in pancreatic cancer, from both a clinical and research perspective, for the past several decades.

"The University of Michigan Comprehensive Cancer Center is committed to providing researchers and physicians with the tools and resources they need to battle pancreatic cancer," said Diane Simeone, Director of the Gastrointestinal Oncology Program. "We are pleased to partner with Tempus, a company that shares our commitment to innovation and collaboration in the pursuit of better treatment options for patients battling this disease."

Tempus provides molecular sequencing and clinical analytic solutions for top academic centers, hospital systems, associations, and healthcare providers.

On January 30, 2017) The Addario Lung Cancer Medical Institute ("ALCMI"), the Bonnie J. Addario Lung Cancer Foundation ("ALCF") and Scancell Holdings PLC ("Scancell") reported a collaboration to evaluate the use of Scancell’s second innovative cancer vaccine, SCIB2, from its ImmunoBody platform to treat non-small cell lung cancer ("NSCLC") (Press release, Scancell, JAN 30, 2017, View Source [SID1234517594]).

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Scancell’s ImmunoBody cancer vaccine platform is a novel immunotherapy treatment under development that stimulates the immune system to potentially treat and prevent cancer. The Company
recently successfully completed a Phase 1/2 clinical trial with SCIB1 in patients with melanoma.

The Addario Advanced Collaboration Program brings patients into clinical trials from ALCMI’s extensive research consortium of international researchers and member institutions and ALCF’s patient support programs. ALCMI plans to assist Scancell in the design and development of a Phase 1/2 clinical trial with SCIB2 in patients with NSCLC which is planned to begin in 2018 and complete approximately 18 months later.

"This partnership enables us to access an important clinical program that could also accelerate the development of this groundbreaking immunotherapy technology," said ALCMI President and COO
Steven Young. "Combining our two foundations’ unique resources will increase patient engagement with the goal to bring new treatment options to non-small cell lung cancer patients," added Bonnie J. Addario, a 12-year lung cancer survivor and founder and chair of ALCF and founder of ALCMI.

According to the Centers for Disease Control and Prevention, lung cancer accounts for 27 percent of all cancer deaths, more than breast, prostate and colon cancer combined. More than 228,000 people receive a cancer diagnosis in the United States alone and more than 160,000 will not survive. It remains one of the most difficult cancers to treat.

"Immunotherapy has dramatically improved many patients’ outcomes across various cancer types. One of the next steps is how we can further enhance the immune response to cancer. Early clinical data on ImmunoBody suggests it is extremely well tolerated and may significantly improve outcomes, which would be ideal. I’m excited to work with Scancell and hopeful that we will take another important step in the fight against lung cancer," said Jacob M. Sands, MD, assistant
professor, medical oncology, Lahey Hospital & Medical Center in Burlington, Massachusetts.

SCIB2 has the potential to complement existing treatments and has potential value where current treatments either do not work or are not available. By stimulating immune responses to specific lung
cancer antigens, SCIB2 should assist the body in targeting and fighting NSCLC, leading to longer survival rates.

"We have generated preclinical data that suggests that SCIB2 could be the ideal complement to existing and emerging checkpoint inhibitor therapies to treat NSCLC and so provide an effective new potential treatment option for patients with this devastating disease," said Scancell CEO Richard
Goodfellow.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).