Key European committee backs GWs Epidyolex, Bayers Vitrakvi and more

Fiercepharma | July 26, 2019

In a busy meeting this week, experts with the European Medicines Agencys Committee for Medicinal Products for Human Use endorsed four new drugs, a Mylan generic, and numerous new indications for already-marketed meds. All the recommendations will go to the European Commission for final approval. Aside from those decisions, the committee also endorsed a new generic from Mylan to Novartis’ Exjade, which treats chronic iron overload. The drug generated $578 million outside the U.S. last year. And the experts signed off on label expansions from several meds including Merck’s Keytruda, Alexion’s Soliris, Johnson & Johnson’s Stelara and Roche’s Tecentriq. Some drugs CHMP previously rejected will get new reviews. UCB's Evenity for osteoporosis will get another look after a previous rejection, and experts will review label expansions for Novartis’ Revolade and PTC Therapeutics’ Translarna after rejecting earlier bids.

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PHARMACY MARKET

The McQuade Center for Strategic Research and Development and Mindset Pharma Collaborate to Develop Psychedelic Medicines

McQuade | January 06, 2022

The McQuade Center for Strategic Research and Development, LLC, a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs. “Exploring multiple paths is essential as we work to address the unique needs of individuals living with mental health conditions. We look forward to collaborating with Mindset on these assets and are hopeful that medical psychedelics could be approved to treat mental illness in the future.” Robert McQuade, Ph.D., president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc MSRD, which identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders, will financially and operationally support the development of two families of Mindset’s novel medical psychedelic compounds through Phase 1a and Phase 1b clinical trials. MSRD has made an upfront cash payment of $5 million USD to Mindset and under the terms of the agreement, MSRD and Mindset may agree to expand the collaboration to continue to develop the compounds as pharmaceutical products. In addition, Mindset has granted MSRD a right of first refusal with respect to any asset sale, exclusive licensing or collaboration opportunities pertaining to the drugs and a right of first negotiation with respect to a merger, acquisition or asset sale related to Mindset, both in exchange for the upfront payment, further collaboration, and funding of the development of Mindset’s novel compounds. MSRD also has the ability to potentially receive single-digit percentage royalty payments under certain circumstances when the right of first refusal is not consummated or the agreement is terminated. “It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials,” said James Lanthier, chief executive officer of Mindset. “There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimized and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.” Mr. Richard Patricio, chairman of Mindset’s board, added, “This transformational transaction is a validation of what our team has accomplished over the last several years. We are ecstatic that Otsuka has chosen to collaborate with Mindset in the novel psychedelic drug development space and see this as a pivotal moment in Mindset’s maturation. Our team is excited to work closely with MSRD to help meet the unmet needs of millions of people worldwide suffering with a variety of mental disorders. The future is truly exciting.” About Mindset Pharma Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. For further information on Mindset, About the McQuade Center for Strategic Research and Development (MSRD) Established in 2019, by the Otsuka pharmaceutical business in the U.S., the mission of MSRD is to search for, identify, and fund innovative early-stage research and development programs that have the potential to build the future portfolio of Otsuka products. Otsuka is dedicated to investing in innovative and creative products in areas of unmet need and MSRD was created as an extension of this commitment to support and identify early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

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PHARMACY MARKET

AIkido Pharma Reports Improved Manufacturing Process and New United States Patent for Pancreatic Drug

AIkido Pharma Inc. | March 04, 2022

AIkido Pharma Inc.reported an improvement in the manufacturing process for its pancreatic cancer drug, DHA-dFdC, licensed from the University of Texas at Austin. The Company also reported the issuance of an additional U.S. patent covering the drug, and the filing of a continuation patent application intended to expand patent coverage to other facets of the drug. With respect to manufacturing process, the Company reported the successful development of a new means for the scaled production and isolation of the key intermediate compound in the manufacture of DH-dFdC. The Company has now executed a further contract with its contract manufacturing organization, Parimer Scientific, to employ the new process to produce several thousand milligrams of the drug for use in formulation development and stability studies. The Company also reported that the U.S. Patent Office recently issued new U.S. Patent No. 11,219,633, which provides additional intellectual property protection for the drug compound. The term of the patent is expected to continue until May of 2035 with the payment of required maintenance fees. Prior to the patent issuance, the Company authorized the timely filing of a patent continuation application, U.S. Serial No. 17/539,682, in which additional claims related to various aspects of the drug and formulation will be pursued. "This new process significant step forward in the development of our pancreatic cancer drug and should permit production of the drug on a commercial scale at a lower cost. I am also pleased that we can continue to report expansion of the patent estate." Anthony Hayes, CEO of AIkido Richard T. Pace, Owner and Principal Scientist of Parimer Scientific, stated, "The newly developed manufacturing method is a large step forward for this innovative technology. I believe it will reduce cost per unit and at the same time increase batch production volumes." About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

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BUSINESS INSIGHTS

GoodRx Closes Acquisition of vitaCare, A Tech-Enabled Pharmacy Services Platform

GoodRx | April 18, 2022

GoodRx, a leading consumer-focused digital healthcare platform announced the completion of its previously announced acquisition of vitaCare for $150 million in cash, with an additional $7 million of consideration contingent payment upon vitaCare’s financial performance through 2023. VitaCare is a pharmacy services platform that expands GoodRx’s offering to pharmaceutical manufacturers while helping to improve patient access and adherence to affordable brand drugs. The acquisition will enable GoodRx to help more patients receive their prescriptions in an efficient, affordable, and transparent manner, and stay on their prescribed therapies as long as appropriate. In addition, the acquisition is expected to further strengthen our rapidly growing Pharma Manufacturer Solutions offerings which span medication awareness, access, and adherence with unique capabilities. “The vitaCare acquisition gives us unique capabilities to facilitate the brand prescription process from start to finish, expanding our capabilities beyond our digital platform and into the patient’s pharmacy journey. We look forward to growing our reach across consumers and providers, along with our established relationships with manufacturers, to help more patients access the brand drugs they need." Doug Hirsch, co-CEO and co-founder of GoodRx GoodRx plans to provide an update on the impact of vitaCare to its 2022 financial guidance during its first quarter 2022 earnings conference call scheduled for Monday, May 9, 2022. About GoodRx GoodRx is a leading consumer-focused digital healthcare platform. Our technology delivers strong savings, trusted information and access to care to make healthcare affordable and convenient for all Americans. Since 2011, we have helped consumers save over $35 billion and are one of the most downloaded medical apps over the past decade.

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BUSINESS INSIGHTS

Omnicell Completes Acquisition of ReCept

Omnicell, Inc. | December 30, 2021

Omnicell, Inc. a leading provider of medication management solutions and adherence tools for health systems and pharmacies, has completed the previously announced acquisition of ReCept Holdings, Inc. The addition of ReCept’s specialty pharmacy management services for health systems, provider groups, and federally qualified health centers expands Omnicell’s Advanced Services portfolio to address the growing and complex specialty pharmacy market. ReCept provides implementation and managed services for health systems and other provider organizations to optimize their specialty pharmacy programs and the related pharmaceutical aspects of patient care. This total solution supports on-site management, including payor contracting, staffing, licensing, quality assurance, 340B administration, and preferred pricing agreements designed to improve margin and profitability, while keeping the patient at the center of care. “ReCept’s specialty pharmacy management services capabilities naturally complement Omnicell’s intelligent infrastructure, giving us deeper expertise to address the growing market need for managing complex specialty medications as part of a broader, more comprehensive medication management strategy,” Randall Lipps, chairman, president, CEO, and founder of Omnicell Under the terms of the purchase agreement, the acquisition price was $100 million, subject to customary adjustments, as provided for in the agreement and plan of merger. The ReCept business that is being acquired recorded annual recurring revenue of $24 million (unaudited) for the 12 months ended September 30, 2021, and is expected to accelerate Omnicell’s Advanced Services revenue growth. Omnicell used cash on its balance sheet to fund the transaction, which is expected to be accretive to Omnicell’s non-GAAP EBITDA beginning in the first quarter of 2023. About Omnicell Since 1992, Omnicell has been committed to transforming the pharmacy care delivery model to dramatically improve outcomes and lower costs. Through the vision of the autonomous pharmacy, a combination of automation, intelligence, and technology-enabled services, powered by a cloud data platform, Omnicell supports more efficient ways to manage medications across all care settings. Over 7,000 facilities worldwide use Omnicell automation and analytics solutions to help increase operational efficiency, reduce medication errors, deliver actionable intelligence, and improve patient safety. More than 60,000 institutional and retail pharmacies across North America and the United Kingdom leverage Omnicell's innovative medication adherence and population health solutions to improve patient engagement and adherence to prescriptions, helping to reduce costly hospital readmissions.

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Our Chief Patient Officer, Dr. Freda Lewis-Hall gives tips on some ways to help relieve motion sickness symptoms on The Doctors.

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