On January 13, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has entered into a 15-year, non-exclusive partnership with Illumina to broaden the adoption of distributable next-generation sequencing (NGS) based testing in oncology (Press release, Hoffmann-La Roche, JAN 13, 2020, View Source [SID1234553094]). As the understanding of the genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring.

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This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed.

Under the IVD terms of the agreement, Roche will develop, manufacture and commercialise AVENIO IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Roche and Illumina will develop and pursue CDx claims on TSO 500 for both existing and pipeline Roche oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process and will continue to manufacture, supply and commercialise TSO 500. Roche will support the development of the claims and regulatory filings.

"As a leader in diagnostic innovation that helps save and improve lives, Roche is pleased to enter into a collaboration agreement with Illumina to leverage our combined expertise in clinical oncology and next-generation sequencing," said Thomas Schinecker, CEO of Roche Diagnostics. "This collaboration is uniquely positioned to improve medical value and clinical decision making globally by combining the unique capabilities of the Roche Group including Foundation Medicine with Illumina and will provide more patients with access to NGS to characterise their disease and identify the right treatment for them. This builds upon our strategy of accelerating clinical research, streamlining workflows and expanding assay menus to broaden access to genomic data and lower barriers to routine use."

About Roche in Genomic Sequencing
With Roche Sequencing Solutions and Foundation Medicine, Roche is dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. Foundation Medicine offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Roche Sequencing Solutions provide reagents and software needed for labs to determine the genomic characteristics of solid and liquid-based samples through a single DNA workflow. With the research-use-only and future IVD AVENIO family of Next Generation Sequencing oncology assays, Roche aims to make sequencing simple and accessible for everyday use.

On January 13, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), along with its subsidiaries together referred to as "Dr. Reddy’s", reported that the Company will be presenting at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California, USA (Press release, Dr Reddy’s, JAN 13, 2020, View Source [SID1234553093]).

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Erez Israeli, company’s Chief Executive Officer will present on Tuesday, January 14th, 2020 at 1:30 PM PST [3:00 AM IST on January 15th, 2020].

On January 13, 2020 Genocea Biosciences presented the corporate presentation (Presentation, Genocea Biosciences, JAN 13, 2020, View Source [SID1234553092]).

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On January 13, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that it has entered into a global collaboration and licensing agreement with Incyte Corporation to further develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab (Press release, MorphoSys, JAN 13, 2020, View Source [SID1234553091]). Tafasitamab is an Fc-engineered antibody against CD19 currently in clinical development for the treatment of B cell malignancies.

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Under the terms of the agreement, MorphoSys will receive an upfront payment of $750 million. In addition, Incyte will make an equity investment into MorphoSys of $150 million in new American Depositary Shares (ADS) of MorphoSys at a premium to the share price at signing of the agreement. Depending on the achievement of certain developmental, regulatory and commercial milestones, MorphoSys will be eligible to receive milestone payments amounting to up to $1.1 billion. MorphoSys will also receive tiered royalties on ex-U.S. net sales of tafasitamab in a mid-teens to mid-twenties percentage range of net sales.

In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, with MorphoSys leading the commercialization strategy and booking all revenues from sales of tafasitamab. Incyte and MorphoSys will be jointly responsible for commercialization activities in the U.S. and will share profits and losses on a 50:50 basis. Outside the U.S., Incyte will have exclusive commercialization rights, and will lead the commercialization strategy and book all revenues from sales of tafasitamab, paying MorphoSys royalties on ex-U.S. net sales.

Furthermore, the companies will share development costs associated with global and U.S.-specific trials at a rate of 55% (Incyte) and 45% (MorphoSys); Incyte will cover 100% of the future development costs for trials that are specific to ex-U.S.countries.

The agreement between MorphoSys and Incyte, including the equity investment, is subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act as well as by the German and Austrian antitrust authorities, and will become effective as soon as these conditions have been met.

About Tafasitamab

Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. Re-MIND, the real-world data lenalidomide alone matched control cohort met its primary endpoint in October 2019, demonstrating clinical superiority of the tafasitamab/lenalidomide combination compared to lenalidomide alone. The ongoing phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On January 13, 2020 Charles River (NYSE: CRL) reported a multi-year drug discovery collaboration with Takeda Pharmaceutical Company Limited ("Takeda"). Together, Charles River and Takeda will launch multiple integrated programs across Takeda’s four core therapeutic areas—oncology, gastroenterology, neuroscience, and rare disease—with the ultimate goal of delivering preclinical candidates that Takeda can advance into clinical development (Press release, Charles River Laboratories, JAN 13, 2020, View Source [SID1234553090]).

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Collaboration in Drug Discovery

The alliance combines Charles River’s extensive integrated drug discovery expertise and deep scientific bench with Takeda’s investments in human data and translation to deliver transformative medicines for patients aligned with Takeda’s therapeutic strategies in oncology, gastrointestinal disease, neuroscience and rare disease. Charles River will leverage its end-to-end drug discovery and safety assessment platform to explore potential therapeutic approaches and progress these programs towards candidate status. Takeda will then have the option to advance the preclinical candidates through their clinical development pipeline.

Under the terms of the agreement, Takeda will pay Charles River a one-time, upfront fee to establish the collaboration. Charles River will be eligible to receive development payments with a potential value of over $50 million per program in preclinical and clinical milestones for candidates that progress to registration. The agreement also includes additional potential commercial milestones of up to $120 million plus royalties on launched products.

Integrated Drug Discovery Approach

By leveraging an integrated drug discovery approach, Charles River provides Takeda with an effective, cohesive, external one-team solution for driving programs forward. Charles River’s drug discovery and development teams have experience across a wide range of therapeutic areas, allowing them to drive these programs forward.

Approved Quotes

"We are pleased to expand our relationship with Takeda, who shares our commitment to bring innovative, safe, and effective medicines to patients as quickly and efficiently as possible. We expect the expertise of Charles River and Takeda will prove to be a powerful combination in delivering novel drug candidates." –James C. Foster, Chairman, President and Chief Executive Officer at Charles River
"By utilizing an integrated drug discovery and development approach, our goal is to deliver quality preclinical candidates to Takeda, helping to drive forward their innovative work in key therapeutic areas." –Birgit Girshick, Corporate Executive Vice President, Discovery & Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services at Charles River
"Takeda has a long history of working with Charles River across our drug discovery and development portfolio and are confident in their breadth of experience and commitment to excellent science. Leveraging Charles River’s integrated discovery capabilities is a natural extension of our relationship." –Steve Hitchcock, Ph.D., Global Head of Research at Takeda.