Levine Leichtman Capital Partners Portfolio Company Capsa Healthcare Acquires RoboPharma

Capsa Healthcare | August 14, 2020

Capsa Healthcare ("Capsa"), a portfolio company of Levine Leichtman Capital Partners ("LLCP"), announced today that it has acquired NewRobo Development B.V. and subsidiaries (collectively, "RoboPharma"). RoboPharma, based in Waalwijk, Netherlands, creates and implements pharmacy automation solutions for some of the largest pharmacies in Europe. Capsa is a leading provider of innovative, highly engineered workflow products that increase efficiency and reduce costs, enhance medication security, and tighten inventory control across healthcare settings worldwide. Capsa's core offerings include mobile workstations, medication management solutions, and pharmacy automation products sold to over 3,000 end customers, including leading health systems, senior care communities, and major retail and institutional pharmacies. Capsa was founded in 1958 and is headquartered in Portland, Oregon with additional production facilities in Columbus, Ohio and Agua Prieta, Mexico.

Spotlight

Modern drug discovery is a complicated process that requires identification of disease targets, bioactive substances that act upon those targets, and finally optimization of those drug candidates.

Spotlight

Modern drug discovery is a complicated process that requires identification of disease targets, bioactive substances that act upon those targets, and finally optimization of those drug candidates.

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PHARMACY MARKET

Valemetostat New Drug Application Submitted in Japan for Treatment of Patients with Adult T-Cell Leukemia/Lymphoma

Daiichi Sankyo | December 29, 2021

Daiichi Sankyo Company, Limited announced that it has submitted a New Drug Application to Japan’s Ministry of Health, Labour and Welfare for valemetostat, a potential first-in-class dual inhibitor of EZH1 and EZH2, for the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma. ATL is a rare and aggressive type of peripheral T-cell lymphoma that occurs with greater frequency in parts of Japan and other regions.1,2 Patients with ATL face a poor prognosis with current therapies.3 Nearly 90% of patients relapse after completing intensive first-line treatment, at which point there are few options available.1,4 The Japan NDA submission of valemetostat is based on pivotal phase 2 study results in Japanese patients with three aggressive subtypes of relapsed/refractory ATL, recently presented at the 2021 American Society of Hematology (ASH) Annual Meeting. Valemetostat previously received Orphan Drug designation from the Japan MHLW for treatment of patients with relapsed/refractory ATL. “Valemetostat would potentially be the first dual inhibitor of EZH1 and EZH2 to be approved anywhere in the world and could provide a new type of targeted therapy option for patients with relapsed/refractory ATL, which represents one of the most significant unmet medical needs in Japan. Valemetostat is the fifth innovative oncology medicine from our pipeline to be submitted for regulatory approval in Japan in the past three years.” Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo About Adult T-Cell Leukemia/Lymphoma Adult T-cell leukemia/lymphoma is a rare and aggressive type of peripheral T-cell lymphoma that is caused by human T-cell lymphotropic virus type 1.1 More than 3,000 new cases of ATL are diagnosed each year worldwide.5 ATL occurs with greater frequency in regions where the HTLV-1 virus is endemic including southwest Japan, Central and South America and central Australia.3 Cases are also observed in North America and Europe, and incidence of ATL is rising in non-endemic areas.3 In Japan, there are approximately 1,000 new ATL cases and over 1,000 deaths due to ATL annually.6 ATL has the poorest prognosis compared to other types of PTCL, with a five-year overall survival rate of about 14%.7 A median survival time of approximately eight months (252 days) was reported for patients in Japan with the most common acute ATL subtype.5 Treatment of ATL is based on subtype and consists primarily of intensive multi-drug chemotherapy regimens.3 Nearly 90% of patients relapse after completing intensive first-line treatment, at which point there are few options available.1,4 Additional therapies are needed to improve the prognosis of ATL in Japan and worldwide.1,3 About Valemetostat Valemetostat is a potential first-in-class dual inhibitor of EZH1 and EZH2 currently in clinical development in the Alpha portfolio of Daiichi Sankyo. A potent and selective small molecule inhibitor, valemetostat is designed to counter epigenetic dysregulation by targeting both the EZH1 and EZH2 enzymes.8 The valemetostat development program includes VALENTINE-PTCL01, a global pivotal phase 2 trial in patients with relapsed/refractory PTCL and ATL; a pivotal phase 2 trial in patients with relapsed or refractory ATL in Japan; and, a phase 1 study in patients with relapsed/refractory NHL in the U.S. and Japan. Valemetostat received ODD from the U.S. Food & Drug Administration for the treatment of PTCL in December 2021, ODD from the Japan MHLW for the treatment of relapsed/refractory ATL in November 2021 and SAKIGAKE Designation from the Japan MHLW for the treatment of adult patients with relapsed/refractory PTCL in April 2019. Valemetostat is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established. About the Pivotal Phase 2 Study The pivotal, open-label, multi-center, single-arm phase 2 study evaluated efficacy and safety of valemetostat as monotherapy in patients with relapsed/refractory ATL who were previously treated with mogamulizumab or at least one systemic chemotherapy in case of intolerance/ contraindication for mogamulizumab and with no history of allogenic hematopoietic stem cell transplant. The primary endpoint is objective response rate assessed by independent efficacy assessment committee. Secondary endpoints include investigator-assessed ORR, best response in tumor lesions, complete remission rate, tumor control rate, time to response, duration of response, progression-free survival, overall survival and safety. A total of 25 patients were enrolled in the study in Japan. About Daiichi Sankyo Oncology The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025. About Daiichi Sankyo Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”

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PHARMA TECH

Angelini Pharma Selects AiDEA’s Artificial Intelligence to Boost Its Growth

Angelini Pharma | March 11, 2021

Trueblue, a main supplier of AI answers for Operational and Analytical CRM in the Life Science industry reports that Angelini Pharma, as a feature of a significant global computerized change measure, has picked AiDEA, the principal AI-Digital Cloud Pharma CRM arrangement dependent on Microsoft Dynamics 365. Angelini Pharma is a main pharmaceutical organization focused on aiding patients in the remedial zones of Central Nervous System (CNS) and Mental Health (including Pain), Rare Diseases and Consumer Healthcare. Angelini's new computerized vision is to reposition and lift its Customer Engagement abilities utilizing Artificial Intelligence by actualizing a creative AI-Driven CRM system. This layouts a make way towards Digital, yet in addition the eagerness to go worldwide through accepted procedures that empower connections with key customers while supporting the organization's global development, along these lines advancing its business and operational abilities. Angelini Pharma will execute the AiDEA CRM suite in excess of 24 subsidiaries around the world, offering its workers a wide scope of Artificial Intelligence applications. The main Pharma Company will accordingly exploit noteworthy bits of knowledge and omni-channel optimization algorithms intended to augment the utilization of assets, optimize Customer Engagement Activities on all channels and better address the issues of every stakeholder. After an intensive assessment interaction of the ideal accomplice and because of a previous fruitful Data Warehouse and Corporate Business Intelligence project, Angelini Pharma picked Trueblue's, which exhibited the abilities, advancement, adaptability and business benefit of its foundation dependent on Microsoft technologies. “We decided to boost the deployment of our Multichannel strategy to better support our ongoing transformation, and while advancing significantly, we realized the need to further accelerate also expanding to solutions based on the use of Artificial Intelligence," says Pierluigi Antonelli, Angelini Pharma’s CEO. "Trueblue's AiDEA Suite enables us to leverage our existing investments while accelerating our AI transformation to ensure our subsidiaries can better serve their customers". On a global level, organizations that are deliberately scaling artificial intelligence report a profit from investment almost multiple times more noteworthy than those that are merely experimenting. "We are excited about this relationship that has been lasting for several years and that makes Angelini Pharma the main player of a new paradigm, in this particularly important historical moment for the pharmaceutical context," says Marco Bonesini - CEO & Co-founder of Trueblue. "Our goal is to contribute to the growth of Angelini Pharma at international level with the strength of AiDEA and all the potential of an omni-channel AI-Driven solution based on Microsoft Dynamics 365, which is truly ready to change the CRM market in the pharmaceutical sector".

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RESEARCH

eDeviation the Latest Protocol Deviations Cloud Software Solution

eDeviation | April 21, 2021

Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol deviations (PD) are a recognized problem for clinical trials because they can jeopardize subjects' safety, rights, and welfare, as well as the study's data integrity, and thereby violate Good Clinical Practice standards. PDs must be established and submitted to the Institutional Review Board of clinical trials (IRB). They may also be classified as major or minor based on the effect on patient care and data integrity. Finally, corrective measures must be taken to ensure that the PDs do not reoccur, and all decisions and actions must be reported for GxP compliance. Clinical research teams face a significant administrative burden when it comes to managing and assessing PDs. In this context, a software platform that can support and document both PD assessment and management activities will significantly simplify the work of clinical research teams. "With eDeviation®, Ethical's portfolio of clinical research software solutions continues to expand to help our customers run their trials more efficiently and effectively," says Mimmo Garibbo, Director of Ethical GmbH. "In an era of increasingly complex clinical trials, we are pleased to have a solution that will assist sponsors, CROs, and EC/IRBs in minimizing the risk associated with protocol deviations." About Protocol Deviations A protocol deviation is any change, divergence, or departure from the approved protocol, consent agreement, recruitment process, or study materials (e.g., questionnaires) originally approved by the EC/IRB. The expression "protocol deviation" refers to protocol exceptions, modifications made to avoid immediate damage to subjects, and protocol violations. Protocol deviations may be classified as major or minor based on their effect on patient safety and data integrity. About eDeviation eDeviation® is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.

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