PHARMACY MARKET

Xeris Pharmaceuticals Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)

Xeris Pharmaceuticals, Inc. | September 01, 2021

Xeris Pharmaceuticals, Inc., a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that the company has completed enrollment and successfully dosed all participants in a Phase 1 study of levothyroxine (XP-8121) to evaluate the pharmacokinetics, safety and tolerability, and potential for weekly dosing of the investigational, novel, subcutaneous (SC) injection for the treatment of hypothyroidism.

XP-8121 is a novel formulation that could potentially mitigate many of the challenges associated with oral formulations, such as identification of an ideal dose due to absorption variation and medication adherence for patients who have difficulty maintaining a stable, therapeutic serum level. Preclinical studies of SC XP-8121 showed a sustained plasma exposure profile and similar maximum plasma concentration (Cmax) when compared with equivalent doses of the oral formulation.

The Phase 1 clinical study of levothyroxine (XP-8121) is a single ascending dose crossover design in 30 healthy participants to compare matching doses of oral levothyroxine (Synthroid®) and subcutaneous (SC) XP-8121. The primary endpoints of the study are to characterize the absorption and elimination kinetics of XP-8121 and compare bioavailability of XP-8121 to oral levothyroxine. Secondary endpoints are safety and tolerability of XP-8121. The study is being conducted in partnership with Dr. Danielle Armas and Celerion, a leading contract research organization with extensive experience performing first-in-human studies.

“The potential for a once weekly subcutaneous injection of levothyroxine would represent a promising novel approach in treating patients with hypothyroidism. Drug non-compliance, resistant hypothyroidism, and limited GI absorption are some of the major reasons for treatment failure or suboptimal treatment with oral levothyroxine. These challenges could be mitigated by XP-8121 and translate into the long-term health benefit of achieving a euthyroid state for patients,” said Dr. Armas, Senior Principal Investigator, Celerion.

“Because our levothyroxine formulation enables a small volume SC injection, as an injectable maintenance therapy, it may facilitate less frequent dosing. This may provide clinical advantages over the established oral daily route, by providing predictable bioavailability, comparable safety, and ease of use,” said Dr. Ken Johnson, Xeris’ Senior Vice President of Global Development and Medical Affairs.

About Levothyroxine and Hypothyroidism.
The thyroid gland is responsible for the synthesis, storage, and release of metabolic hormones including thyroxine (T4) and triiodothyronine (T3) [Colucci et al, 2013]. These hormones are crucial in the regulation of critical metabolic processes and are vital for normal growth and development during fetal life, infancy, and childhood. Therapeutically, levothyroxine is administered when the body is deficient in the endogenous hormone. The goal of therapy is restoration of the euthyroid state which can reverse the clinical manifestations of hypothyroidism and significantly improve quality of life [Winther et al, 2016]. The treatment of choice for correction of hypothyroidism is levothyroxine, which is the mainstay of thyroid hormone replacement therapy. It is one of the most widely prescribed drug products in the United States, but the complexity of maintaining biochemical and clinical euthyroidism in patients undergoing treatment with oral levothyroxine cannot be underestimated. It has been reported that nearly 40% of patients undergoing treatment with oral levothyroxine are either over- or under-treated [Laurent et al, 2018] due to factors that include, but are not limited to, drug formulation, use of the drug with food, adherence to the drug, use of concomitant medications, and pre-existing medical conditions. Many patients failing to reach target TSH levels are generally managed by simply increasing their levothyroxine daily dose [Chiovato et al, 2019]. However, levothyroxine is a drug with a narrow therapeutic index [Vita et al, 2014], meaning that relatively small deviations from the proper dose can cause a clinically meaningful shift in pharmacological effects when administered to a patient; thus, the titration of levothyroxine oral drug may be a tailored and incremental process.

About Xeris Pharmaceuticals, Inc.
Xeris is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable drug, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system. Xeris is headquartered in Chicago, IL.

Spotlight

CRISPR is now one of the most affordable forms of gene editing causing a boom in R&D over the last few years. However, the technique does have its limitations which include maintaining end to end control on geneti manipulation, avoiding off targets effects and pathway recovery post double strand break. Ahead of the 2017 CRISPR summit Javier Terriente, CSO, ZeClinics and Danilo Maddalo Lab Head ONC Pharmacology, Novartis Institutes for BioMedical Research discuss the latest regarding CRISPR delivery challenges and applications within Pharma.

Spotlight

CRISPR is now one of the most affordable forms of gene editing causing a boom in R&D over the last few years. However, the technique does have its limitations which include maintaining end to end control on geneti manipulation, avoiding off targets effects and pathway recovery post double strand break. Ahead of the 2017 CRISPR summit Javier Terriente, CSO, ZeClinics and Danilo Maddalo Lab Head ONC Pharmacology, Novartis Institutes for BioMedical Research discuss the latest regarding CRISPR delivery challenges and applications within Pharma.

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PHARMA TECH

Pace® Life Sciences Acquires Biopharma Global, Expanding FDA Regulatory Affairs Strategy and Consulting Capabilities

Pace® Life Sciences | September 09, 2022

Pace® Life Sciences, LLC, a full-service contract development and manufacturing organization and a subsidiary of Pace®, a science and technology company, announced today that it has acquired Biopharma Global. Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs. "Pace® provides great value in our marketplace through our technical expertise and by meeting the strong commitments we make to our clients that rely on us to successfully advance their programs through development. The acquisition of Biopharma Global extends our reach further into regulatory strategy, guidance, and support in key therapeutic areas and greatly extends the reach of Pace® into our markets." Eric Roman, CEO of Pace® ABOUT BIOPHARMA GLOBAL BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug developers advance treatments for the disease communities with high unmet medical needs. We have assembled a team of globally-recognized experts in the rare diseases and other under-served disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations and other expedited program submissions to their credit. We maintain a completely customer-centric, transparent process through the entirety of our projects. BIOPHARMAGLOBAL.com ABOUT PACE® LIFE SCIENCES Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. Part of the Pace® Science and Technology Company, Pace® Life Sciences operates a network of multiple CDMO sites, FDA-registered GMP analytical testing laboratories, and regulatory and manufacturing support service centers across the United States. ABOUT PACE® Pace® makes the world a safer, healthier place. For decades, Pace® people have been committed to advancing the science of the pharmaceutical and biotechnology industries in our Life Sciences laboratories and supporting businesses, industries, consulting firms, government agencies, and more through our Analytical Services laboratories. Pace® offers local-level service backed by a national laboratory network. For customers with in-house labs, Pace® provides a range of professional services to keep their operations moving forward. Pace® people work in partnership with customers by providing the service, science, and the data they need to make critical decisions that benefit us all. Learn how Pace® people are working to advance science through sustainable practices and continuous innovation.

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BUSINESS INSIGHTS

Accord BioPharma Partners with StoryMD to Deliver Advanced Prostate Cancer Educational Content to Clinicians and Patients

Accord BioPharma | September 21, 2022

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today a partnership with StoryMD. The StoryMD platform is a single, unified, personalized digital health information portfolio that curates the most relevant, visually rich content based on a patient's condition. Accord BioPharma has signed on as StoryMD's very first corporate partner, to support StoryMD's advanced prostate cancer content, allowing Accord BioPharma to provide a comprehensive, user-friendly tool to help patients and their caregivers navigate advanced prostate cancer, just in time for prostate cancer awareness month this September. "At Accord BioPharma, we recognize the need to go beyond biology – and beyond our responsibility of drug development – to help change the clinician and patient experience at all touchpoints in the care continuum where we can," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "StoryMD exemplifies that mission by providing clinicians with clear, easy-to-understand visuals, videos, and health information that help their patients understand their disease journey. Partnering with StoryMD on their advanced prostate cancer content felt like a natural fit given our recent drug launch." In March of this year, Accord BioPharma announced the U.S. launch of CAMCEVI® (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. CAMCEVI should not be used in patients with hypersensitivity to GnRN, GnRH agonist analogs as anaphylactic reactions to these drugs have been reported in the medical literature. Accord BioPharma is heading all commercial initiatives in the U.S. and Canada. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. Through a vast library of curated, clinically accurate disease-state information, graphics, and videos, StoryMD enables physicians to share an easy-to-understand disease journey with patients at the point of care, which can help increase patient retention of information and engagement, improve physician efficiency, and reduce the amount of misinformation patients may seek out on their own. "Accord BioPharma is making efforts to provide important patient and provider education in pursuit of our aim to offer latest treatment options to patients of advanced prostate cancer and we look forward to our collaboration with StoryMD to provide comprehensive and user-friendly tools for patients and care givers" said Binish Chudgar, Vice Chairman and Managing Director of Intas Pharmaceuticals Ltd, which is the parent company of Accord BioPharma. "Every once in a while, you meet a person and a partner who has a vision. Chrys Kokino has that vision to go beyond drug development and sees the value in advancing technology rather than being afraid of it. And that's exactly what we want – partners who recognize the gap in communication between physicians and patients and who want to work together to close that gap and fill an unmet need." Alexander Tsiaras, CEO and Founder at StoryMD On the importance of prostate cancer awareness, Tsiaras said, "I have a family member who works in the medical field, and when he was diagnosed with prostate cancer, it was amazing how little he knew. Cancer is such a confusing and overwhelming disease – 'Do I wait and watch? Should I be aggressive in treatment?' So, even for the most educated among us, it is a scary moment. Accord BioPharma and StoryMD are working together to go beyond offering patients drug options to impart knowledge and serve as a trusted resource." About Accord BioPharma Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient's experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patient's perspective and develop high-quality therapies that impact patient's lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies. About CAMCEVI® CAMCEVI® injection emulsion is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels (less than or equal to 50ng/dL) after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.

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PHARMA TECH

Sumitovant Biopharma and Sumitomo Pharma Announce Offer to Acquire Outstanding Shares of Myovant Sciences

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."

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