SMC approves new cancer drugs, among others

pharmatimes | May 14, 2019

The latest round of Scottish Medicines Consortium (SMC) decisions have brought medicines for breast cancer, skin cancer and schizophrenia into the spotlight and recommended them for use on the NHS in Scotland.The governing body has firstly accepted Eli Lilly's Verzenios (abemaciclib) for the treatment of advanced or metastatic breast cancer in two different settings. The drug was accepted for use in combination with aromatase inhibitors as an initial therapy in patients who have not had previous endocrine (hormone) based therapy, and works by prolonging the time breast cancer takes to progress and delays the need for chemotherapy. It was also accepted for restricted use in combination with fulvestrant for patients whose condition has progressed on or after endocrine therapy or during first-line endocrine-based therapy. MSD's Keytruda (pembrolizumab) was also accepted for advanced melanoma, following consideration through Post-acute care enablement (PACE), for use after surgery. As there is no other active treatment available at this stage of the disease, the current management is just surveillance through routine monitoring and scans. NHS funding was also agreed for Recordati's Reagila (cariprazine) for the second line treatment of schizophrenia in adult patients where the symptoms are diagnosed as being ‘predominantly negative’, including emotional withdrawal and inability to feel pleasure. The decision provides another welcome treatment option for patients with these symptoms as existing anti-psychotic medicines can be limited in their effectiveness.

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BUSINESS INSIGHTS

CCT Research Announces New Partnership with BEKHealth

CCT Research | February 18, 2022

CCT Research has announced an exciting partnership with BEKHealth. The collaboration streamlines access to electronic medical records (EMR) data, across CCT sites and drives a data-driven approach to trial execution and management. CCT has established itself as an innovator in conducting clinical trials. Using BEKHealth, a provider of software solutions for enhancing clinical research processes, will enable CCT to more accurately identify and fit studies to its sites. The deep commitment by both companies to improving the outcomes of clinical trials made the relationship a natural fit. “One of CCT’s driving forces is to promote an environment of innovation and continuous improvement. Our partnership with BEKHealth strengthens our ability to identify potential research participants, ultimately creating greater accessibility to clinical trials.” Jennifer Kocour, President, CCT Research More than just a “technology” partnership, this collaboration with BEKHealth is also patient-centric– which remains a top priority for CCT. Once studies are awarded, it will power onsite research by identifying patients who fit studies best, saving sites, patients, and staff time and hassle. “At the individual site level, our goal is to optimize research to be as beneficial to the practice and its patients as possible with minimal disruption to the clinics day-to-day operations. We view data and technology as central to that strategy and couldn’t be more excited to work with BEKHealth,” said Kyle McAllister, Vice President, Data & Analytics, CCT Research. “The breadth and depth of CCTs network was an exciting opportunity. The ability to leverage technology to centralize key drivers of success such as feasibility, site selection, patient recruitment and analytics drives a new paradigm in clinical research,” said Jason Baumgartner, CEO and Founder, BEKHealth. “Our platform is secure and activation creates a minimal burden on IT teams. What this means for the provider and patient is our collaboration will have a major impact quickly.” “We provide an integrated clinical operating platform that enables companies to streamline research across multiple key processes,” said Josh Ransom, PhD, Vice President, Customer Experience, BEKHealth. “Ultimately this means our partners can scale their businesses faster by improving operational efficiency while taking out manual and inefficient steps.” About CCT Research CCT Research is a network of clinical research sites embedded in the offices of skilled physicians conducting clinical trials to offer patients with innovative medical treatments and safe, effective care options. CCT Research was founded in 2017 and has more than 20 locations across Arizona, Georgia, Kentucky, Nebraska, Nevada, and Utah. The sites are located within physicians’ offices, within ACO networks, and several dedicated research centers. CCT supports research in Neurology, Family Practice, and Dermatology, with plans to include additional therapy areas soon. The company's unique model simplifies the process for trial participants and provides pharmaceutical sponsors with high-quality data.

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RESEARCH

DisperSol Technologies Announces Collaboration with Ajax Therapeutics to Develop Enhanced KinetiSol Drug Formulations

DisperSol Technologies | December 18, 2021

DisperSol Technologies LLC announced that it is has entered into a research collaboration with Ajax Therapeutics, Inc. to apply its KinetiSol technology to enhance the bioavailability of an Ajax drug candidate in development for the treatment of hematologic malignancies. “Ajax is taking an innovative approach to developing a pipeline of selectively targeted small molecules and we look forward to applying our proprietary KinetiSol technology to help enhance the bioavailability of one of these promising drug candidates. This collaboration is another example of our partnering strategy with our KinetiSol technology platform to help improve the bioavailability of next generation targeted therapies to provide new treatments for patients in need.” Dr. Edward Rudnic, CEO of DisperSol Technologies About DisperSol Technologies DisperSol is a clinical-stage drug development company focused on developing new treatments for patients utilizing its proprietary KinetiSol® technology platform. KinetiSol has proven capable of creating novel therapeutics from poorly bioavailable drugs to deliver unique clinical benefits to patients. The platform enables a drug development path forward to patients when other options fail to make a difference. DisperSol’s active programs include, DST-0509 about to enter Phase 3 for iron overload disorder and DST-2970 in Phase 2 for refractory metastatic prostate cancer. Additional earlier-stage programs include DST-5407 for non-squamous non-small cell lung cancer. About Ajax Therapeutics Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel therapies targeting key cytokine signaling pathways that drive hematologic malignancies. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms from our founding partner, Schrödinger, Inc., we aim to discover and develop more precisely designed therapies to address significant unmet needs for patients with hematologic malignancies.

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PHARMACY MARKET

IAMA Therapeutics Partners with the Italian Institute of Technology to Embark on Landmark Research on Neuroscience Drug Discovery

IAMA Therapeutics | March 31, 2022

IAMA Therapeutics, a Series A preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, today announced a strategic collaboration with the IIT-Istituto Italiano di Tecnologia where they will design and profile new classes of compounds targeting cation cotransporters in the CNS area. This partnership consolidates a scientific collaboration between IAMA Therapeutics and IIT, which signed, together with the Telethon Foundation earlier in 2021, a license agreement, granting IAMA therapeutics an exclusive, worldwide license to research, develop, manufacture, and commercialize a novel class of modulators of intracellular chloride concentration. "We are pleased with and excited by this partnering opportunity with IAMA Therapeutics, a clear example of IIT technology transfer approach. We are setting the Italian way of producing science and tech-based innovation, where the collaboration among brilliant researchers, important founding agencies like Fondazione Telethon, and investors creates the right ecosystem enabling new businesses to emerge." Dr. Matteo Bonfanti, Director of Technology Transfer at Istituto Italiano di Tecnologia "We are very happy for the partnership between IAMA Therapeutics and IIT," said Francesca Pasinelli, General Manager of Fondazione Telethon. "This collaboration is based on innovative science, which was selected and nurtured earlier on by Fondazione Telethon. As part of our focus on fostering development, we funded the project and supported researchers through the technology transfer process together with IIT. Now, this promising research avenue is accessing the resources and competencies necessary to take and accelerate the long and expensive path to patients. It shows what can be accomplished through a timely and coordinated effort to maximize research impact". About IAMA Therapeutics IAMA Therapeutics is a pharmaceutical company that couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline. We have developed a platform to identify and advance diverse classes of small molecules to selectively inhibit the sodium potassium chloride cotransporter and other therapeutic targets relevant to treating central nervous system disorders characterized by neuronal imbalance, including primary and secondary autism, epilepsy, and movement disorders. About Istituto Italiano di Tecnologia Istituto Italiano di Tecnologia is a foundation established jointly by the Italian Ministry of Education, Universities, Research, and the Ministry of Economic and Finance to promote excellence in basic and applied research and contribute to Italy's economic development. The primary goals of the IIT are the creation and dissemination of scientific knowledge and the strengthening of Italy's technological competitiveness. To achieve these two goals, the IIT cooperates with academic institutions and private organizations, fostering scientific development, technological advances, and training in high technology. About Fondazione Telethon Fondazione Telethon is a major biomedical charity in Italy whose mission is to advance biomedical research to cure rare genetic diseases. Throughout its 32 years of activity, Fondazione Telethon has invested almost €600 million in funding over 2,700 projects to study 580 diseases, involving more than 1,600 researchers in Italy. As part of its goal to foster development and maximize the therapeutic impact of research, Fondazione Telethon further pursues cooperation with academia, industry, and venture capital through the creation of partnerships and start-ups.

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BUSINESS INSIGHTS

Acorda Therapeutics and Biopas Laboratories Announce Agreement to Commercialize INBRIJA® in Latin America

Acorda Therapeutics, Inc. | May 12, 2022

Acorda Therapeutics, Inc. and Biopas Laboratorie announced that they have entered into distribution and supply agreements to commercialize INBRIJA® in Latin America. INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. Under the terms of the agreements, Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA in Latin America in exchange for supply of the product. Acorda will also receive sales-based milestones. Biopas will have the exclusive distribution rights to INBRIJA in nine countries within Latin America, including Brazil and Mexico. According to current population estimates, there are at least 400,000 people living with Parkinson's disease in Latin America1. Biopas plans on seeking marketing authorization in all countries to make Inbrija available for patients as quickly as possible. “BIOPAS is the leader in commercializing CNS therapies in Latin America and we are delighted to announce these agreements to make INBRIJA available there to people with Parkinson’s disease who suffer from OFF periods. We are also in active discussions with other companies for the rights to commercialize INBRIJA in additional countries.” Ron Cohen, M.D., President and CEO of Acorda Therapeutics “We are excited to be collaborating with Acorda to make INBRIJA available to people with Parkinson’s disease in Latin America. This important partnership supports Biopas’ mission to cover unmet medical needs of patients from Argentina to Mexico. Inbrija further strengthens Biopas’ complete and innovative CNS portfolio now consisting of nine original treatments: for Parkinson’s disease, epilepsy, movement disorders, sialorrea, multiple sclerosis, anxiety, and sleep disorders,” said Pascal Forget, CEO of Biopas. About Acorda Therapeutics Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® Extended Release Tablets, 10 mg. About Biopas Laboratories Biopas is a leading and differentiated Latin American Pharmaceutical company, focused on in-licensing, marketing and selling cutting-edge specialty pharmaceutical products. Biopas offers the best-in-class capabilities in sales, marketing, medical, support functions and provides integral services to support the launch and development of products. All its functions operate in compliance with international standards and regulations. Biopas covers 20+ countries in LatAm through fully owned subsidiaries and is a trusted partner of reputable multinational pharmaceutical companies, and has products in leading positions in CNS, Immunology, Rare Disease, Oncology, and Dermatology.

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Did you know? Just one extra dollar spent on medicines for adherent patients with congestive heart failure, high blood pressure, diabetes and high cholesterol can generate $3 to $10 in savings on emergency room visits and inpatient hospitalizations.

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