As Amgen seeks to can Aimovig collaboration, Novartis sues to save the deal

Amgen | April 04, 2019

Novartis and Amgen were the first to tap into a hot market with their CGRP migraine prevention med Aimovig, but dueling lawsuits outline a serious division in the collaboration. Amgen is trying to cut the partnership less than a year into the drug’s launch, while Novartis has sued to save the deal. Novartis on Thursday sued Amgen in Manhattan federal court for trying to inappropriately back out of their collaboration. Amgen originally had rights to the drug, but Novartis in 2015 partnered on the med and has since spent $870 million on development and commercialization, the suit says. Amgen, for its part, sued back. The company says Novartis breached the agreement by helping bring a potential competitor to market. Novartis' Sandoz unit has teamed with Alder BioPharmaceuticals on a potential rival, Amgen says, so it moved to terminate the agreement.

Spotlight

As the cost of drug development and time to market increases to exorbitant levels.

Spotlight

As the cost of drug development and time to market increases to exorbitant levels.

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PHARMACY MARKET

Insilico Medicine Announced Strategic Collaboration with EQRx

Insilico Medicine | March 25, 2022

A clinical-stage end-to-end artificial intelligence driven drug discovery firm, Insilico Medicine announced the formation of a strategic partnership with EQRx, a company dedicated to creating and delivering novel medications to patients at much-reduced costs. The cooperation will use Insilico's Pharma.AI technology to accelerate the design and creation of de novo small molecules and EQRx's clinical development and commercialization experience. In addition, EQRx and Insilico will form a co-development partnership in which each party will get a profit share according to its investment level. The collaborative agreement identifies and selects up to three therapeutic targets using Insilico's AI-powered platform, Pharma. AI. From small molecule hit identification through lead optimization and preclinical candidate nomination, Insilico will guide the drug discovery process. EQRx will be in charge of clinical development, regulatory affairs, and commercialization. In addition, Insilico may invest in the product candidate(s) at different phases of clinical outcome in exchange for enhanced commercialization income. "Both EQRx and Insilico Medicine strive to accelerate the discovery and development of new medicines and make effective therapeutics more accessible and affordable. This partnership will combine our end-to-end AI-powered drug discovery capabilities with EQRx's innovative partnership model and expertise in clinical development and patient access to accelerate innovative therapies' discovery and development, " Alex Zhavoronkov, Ph.D., founder and founder CEO of Insilico Medicine "We are pleased to partner with Insilico Medicine, a leader in AI-based drug discovery," said Carlos Garcia-Echeverria, Ph.D., chief of Rx Creation at EQRx. "This collaboration will further expand our early-stage R&D efforts to fuel potential pipeline growth as we continue to apply the best of today's innovation in biomedical sciences and digital solutions to discover high-quality, innovative, and more affordable medicines."

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BUSINESS INSIGHTS

Zenas BioPharma Acquires Exclusive Worldwide Rights to Obexelimab from Xencor

Xencor, Zenas BioPharma | November 22, 2021

Xencor, Inc. a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and Zenas BioPharma (“Zenas”), a global biopharmaceutical company based in the USA and China committed to the development and delivery of immune-based therapies, today announced that Zenas has acquired from Xencor exclusive worldwide rights to develop, manufacture and commercialize the investigational antibody obexelimab. Obexelimab is a potential first-in-class bifunctional antibody that targets CD19 with its variable domain and uses Xencor's XmAb® Immune Inhibitor Fc Domain to target FcγRIIb, a receptor that inhibits the function of B-cells, which are important components in the immune system. Xencor demonstrated through early-stage clinical studies that obexelimab effectively inhibits B-cell function without depleting the cells and generates an encouraging treatment effect in patients with multiple autoimmune diseases. “Zenas is advancing a broad pipeline of differentiated drug candidates that are intended to bring best-in-class innovation to patients with underserved medical needs. Today, we are pleased to add obexelimab to our portfolio, and based on its clinical profile, we believe it is positioned as a first-in-class candidate with the potential to treat numerous autoimmune diseases.” Hua Mu, Ph.D., MD, president and chief executive officer at Zenas “Obexelimab’s highly potent and broad blockade of B-cell activation—without depleting B cells—differentiates it from other B-cell targeting therapies, and it has demonstrated disease-modifying activity in settings where B-cell inhibition is a proven strategy,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “In Zenas BioPharma, we have found a partner committed to broadly and aggressively developing therapeutics like obexelimab for patients with autoimmune diseases, enabling Xencor’s continued focus on the growing opportunities provided by our XmAb bispecific antibody and cytokine pipeline.” Under the terms of the new agreement, Zenas will issue to Xencor a warrant giving Xencor the right to acquire additional Zenas equity, such that Xencor’s total equity in Zenas would be 15% of its fully diluted capitalization following the closing of Zenas’ next round of equity financing, subject to certain requirements. Xencor previously received equity in Zenas under a separate license agreement. Xencor is also eligible to receive up to $480 million based on the achievement of certain clinical development, regulatory and commercialization milestones and is eligible to receive tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography. Zenas will have sole responsibility for advancing the research, development, regulatory and commercial activities of obexelimab worldwide. About Xencor, Inc. Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of proteins resulting in new mechanisms of therapeutic action. About Zenas BioPharma Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and delivery of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. Xencor Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to the development of obexelimab as a potential treatment for patients with autoimmune diseases; the commercial potential of obexelimab; the safety, tolerability, efficacy and pharmacokinetics of obexelimab; the quotations from Xencor’s president and chief executive officer; and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2020 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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BUSINESS INSIGHTS

INNOTECH and OSARO Collaborate to Build a Demonstration AI Picking Robot System for Rohto Pharmaceutical’s Next-generation Smart Factory

INNOTECH and OSARO | January 12, 2022

OSARO Inc. a global leader in the development and provision of advanced robotics automation, and INNOTECH CORPORATION, which provides advanced products for electronics and consumer industries, have announced a collaboration to create an innovative demonstration for Rohto Pharmaceutical Co., Ltd. using AI piece-picking robots. The two companies are jointly providing picking robots and jointly building a system for their introduction into a new factory production line, scheduled for completion in 2022. OSARO will take the lead in providing AI software to improve the efficiency of robot operations, and INNOTECH will provide support from demonstration testing to integration of the AI software. By automating the picking of bottle products, one of the most labor-intensive tasks in the production process, with robots, the collaboration aims to reduce the workload and improve productivity at the Rohto factory. Rohto produces OTC medicines, beauty products and supplements. In the eye care category, sales of OTC eye drops account for more than 40 percent of the Japanese market. “We are honored to have OSARO's picking technology recognized by the next-generation smart factory of Rohto Pharmaceutical Co. We believe that the ability to integrate with existing equipment is a great advantage to create a new model case for Japan’s future factories and warehouses.” OSARO CEO Derik Pridmore Yosuke Kaburaki, Director, INNOTECH CORPORATION stated: “We have been conducting basic experiments with Rohto Pharmaceutical using robots that incorporate OSARO's AI software. In the future, INNOTECH will continue to speed up the integration of OSARO's software technology into Rohto's production process to make it more effective and efficient.” About INNOTECH CORPORATION Yokohama City, Kanagawa Prefecture, Japan INNOTECH provides comprehensive technology and support solutions for customer product development and manufacturing. Since 2000, INNOTECH has engaged in the business of internally developed products, leveraging its technical knowledge, strengthened by its existing and expanding business relationships. Today, INNOTECH continues to evolve as a total solution company, with hardware, software, consulting and support offerings for customers’ design, development, and mass production activities, leading up to the introduction of their final products. About OSARO, San Francisco, CA, USA OSARO designs and deploys robotics automation solutions in the materials handling industry using software-defined robotics. OSARO automation systems bring together advanced machine learning for object recognition with powerful control software that adapts to customer data and environments. The company’s robotic piece-picking solution is optimized for grocery, cosmetic, and e-commerce markets, where key challenges include high SKU inventories, complex packaging, and fragile items requiring delicate handling. OSARO Solutions have been validated by the world’s leading retailers, system integrators, and third-party logistic companies.

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