Xeris | November 24, 2022
Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that it has entered into a research collaboration and option agreement with Horizon Therapeutics plc. Under the terms of the agreement, Xeris will use its proprietary formulation technology platform, XeriJect™, to develop an ultra-concentrated, ready-to-use, subcutaneous injection of teprotumumab and Horizon will have an option to license the Xeris technology. Teprotumumab is the first and only medicine approved by the U.S. Food and Drug Administration for the treatment of Thyroid Eye Disease a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States. Xeris will receive an upfront payment, and may be entitled to receive development milestones, regulatory milestones, and salesbased milestones, as well as royalties based on future sales if the commercial license option is exercised. Specific financial terms of the agreement were not disclosed.
“We are excited to announce our collaboration with Horizon for the development of a subcutaneous formulation of teprotumumab using our XeriJect technology to potentially enhance the patient experience and delivery of the treatment for Thyroid Eye Disease. This partnership demonstrates the potential value of our technology to enable large molecule subcutaneous injections that provide a more patient friendly regimen that is effective, safe, and more convenient, with potential for improved adherence.”
Paul R. Edick, Chairman and CEO of Xeris
XeriJect formulations are innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >400mg/mL, enable small volume subcutaneous injections and do not settle on storage. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
BIOCORP and Merck KGaA, Darmstadt, Germany | October 11, 2022
BIOCORP a French company specialized in the design, development, and manufacturing of innovative medical devices, and Merck KGaA, Darmstadt, Germany, a leading science, and technology company, have entered into an agreement for the development and supply of a specific version of Mallya device as an accessory for one of Merck KGaA, Darmstadt, Germany's drug delivery devices.
Manufactured in Clermont-Ferrand Mallya is a Bluetooth enabled clip-on device for pen injectors that collects dose and time of each injection and transfers information in real time to a companion software. Mallya is the first in its category to receive the CE-mark and commercial versions for insulin pen injectors are already available and distributed in Europe and other geographies. Major agreements have already been signed by BIOCORP with Sanofi, Novo Nordisk and Merck KGaA, Darmstadt, Germany, to develop specific versions of the technology in the field of Insulin and Human Growth Hormone (HGH).
Healthcare companies BIOCORP and Merck KGaA, Darmstadt, Germany, will develop a new version of Mallya to help patients monitor their injection during their treatment. The device will automatically keep track of doses injected with timestamp and indicate that the product is administered properly, aiming to support patients with self-injections and to provide reassurance to patients.
Financial details of the partnership include payments from Merck KGaA, Darmstadt, Germany, up to 5 million € for the development of the product within the first three years of the collaboration. Additional revenues are estimated to reach up to 8 million € during the first 5 years after launch depending on commercial milestones and adoption of Mallya devices by Merck KGaA, Darmstadt, Germany patients with further upside potential in the subsequent years.
"We are delighted with this new partnership with Merck KGaA, Darmstadt, Germany, extending our collaboration to additional therapeutic areas. We had already announced that there is a great opportunity for our connected device Mallya in various therapeutic areas. As in diabetes, Mallya aims to reduce patients' stress and improve compliance with their treatments to optimize and secure the results “,
Éric Dessertenne, CEO of BIOCORP
Recognized for its expertise in the development and manufacture of medical devices and delivery systems, BIOCORP has today acquired a leading position in the connected medical device market thanks to Mallya. This smart sensor for insulin injection pens allows reliable monitoring of injected doses and thus offers better compliance in the treatment of patients with diabetes. Available for sale from 2020, Mallya spearheads BIOCORP's product portfolio of innovative connected solutions. The company has 74 employees. BIOCORP is listed on Euronext since July 2015.
Sumitovant Biopharma Ltd. | October 03, 2022
Sumitovant Biopharma Ltd. in conjunction with parent company Sumitomo Pharma Co., Ltd. announced it has submitted a non-binding proposal to the Audit Committee of the Board of Directors of Myovant Sciences Ltd. offering to acquire all outstanding shares of Myovant not already owned by Sumitovant for $22.75 per share in cash. The proposed transaction, if completed, would result in Myovant being delisted from the New York Stock Exchange.
The proposed acquisition consideration represents an equity value for Myovant of $2.4 billion and an enterprise value of $2.5 billion. The proposed per share consideration represents a premium of approximately 27% to Myovant's closing share price on September 30, 2022, and a premium of approximately 31% to the 60-day volume weighted average price of Myovant's shares through September 30, 2022.
The Proposal is a natural step in the well-established relationship between Sumitovant and Myovant, and represents an unprecedented opportunity to combine expertise, platforms, and resources to deliver innovative therapies addressing unmet patient needs in women's health and prostate cancer. Sumitovant and Sumitomo Pharma have been impressed with the culture and significant accomplishments of Myovant's employees. If a transaction is completed, we will continue to provide support and resources to Myovant to enable achievement of its mission to redefine care for the patients they so passionately serve.
Since the investment in Myovant in December 2019, both Sumitovant and Sumitomo Pharma have enjoyed a collaborative and successful relationship with Myovant that has facilitated the continued development and commercialization of Orgovyx® and Myfembree® in prostate cancer and women's health in and outside of the U.S. Further, Sumitovant and Sumitomo Pharma believe that the Proposal is financially compelling and will create significant and immediate value for Myovant's shareholders.
The Proposal provides that the proposed transaction will be subject to the approval of the shareholders of Myovant holding a majority of the shares not owned by Sumitovant.
In addition, Sumitovant and Sumitomo Pharma informed the Audit Committee in the Proposal that, in Sumitovant's capacity as a majority shareholder in Myovant, Sumitovant and Sumitomo Pharma are interested only in acquiring the shares of Myovant not already owned by Sumitovant and that in such capacity, Sumitovant has no interest in selling any of the Myovant shares it owns, nor would Sumitovant support any alternative sale, merger, or similar transaction involving Myovant.
The Proposal does not create any binding legal obligation between Sumitovant or Sumitomo Pharma and Myovant. Neither Sumitovant, Sumitomo Pharma nor Myovant will have any obligation or liability to the other with respect to a transaction unless and until definitive transaction documents are executed and delivered by the parties.
About Sumitovant Biopharma Ltd.
Sumitovant is a technology-driven biopharmaceutical company accelerating development and commercialization of new potential therapies for patients with rare conditions and other diseases. Through our proprietary computing and data platforms, scientific expertise and diverse company portfolio, Sumitovant has supported development of multiple FDA-approved products and a robust pipeline of early- through late-stage investigational assets addressing unmet patient needs in pediatrics, urology, oncology, women's health, specialty respiratory and infectious diseases. Sumitovant is a wholly owned subsidiary of Sumitomo Pharma.
About Sumitomo Pharma Co., Ltd.
Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with about 7,000 employees worldwide. Sumitomo Pharma defines its corporate mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide."