Oakrum Pharma and Biophore Announce Product Development and Commercialization Partnership

prnewswire | April 22, 2019

Oakrum Pharma, LLC (Oakrum) announced today that it has entered into an agreement with Biophore India Pharmaceuticals Pvt. Ltd. (Biophore) to develop and manufacture two prescription generic pharmaceutical products that are intended to be commercialized in the U.S. under the Oakrum label.  It is anticipated that both products will be sold through the specialty distribution market channel. The total market for the products in the U.S. exceeded $150 million in aggregate sales for the 12-month period ending December 31, 2018according to Bloomberg® data. Marco Polizzi, CEO of Oakrum, stated, "The partnership with Biophore will provide a vertically integrated solution to our growing product development pipeline.  Oakrum's vision to focus on underserved patient populations is in direct alignment with that of Biophore's.  Biophore provides unique API and finished dosage form product development capabilities which are expected to further contribute to Oakrum's objective of bringing more affordable specialty and rare disease prescription products to market."

Spotlight

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Spotlight

The spreadsheet conundrum... Joe Smith, sales director for Great Start-Up Number 5 Billion and Thirty-One, puts on a blindfold and reaches out blindly for something, ANYTHING, to help him organize his team’s deals and commissions. He’s hopeful. He’s waiting. He knows he’ll come back with something. We’re talking metaphorically, of course. He’s not actually HOLDING a spreadsheet, he’s using Excel—because it’s the lowest hanging fruit. It’s free and easy to learn. And for a while, you know what? It works great. He can use VLOOKUPS and shortcuts to navigate. He can import booking results and activity metrics from Salesforce or his CRM. He can get so good at it that packaging complex algorithms becomes second nature.

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PHARMA TECH

Biomind Labs Announces Design of a Pharmaceutical Form for Psychedelic Drug Delivery Using 3D Printing

Biomind Labs | November 25, 2021

Biomind Labs Inc. a leading biotech company in fast-acting psychedelics is pleased to announce the successful design of an oromucosal solid pharmaceutical form obtained by 3D printing using selective laser sintering. The form contains as its active ingredients certain psychedelic molecules that the Company has in its portfolio of psychedelic candidates. This pharmaceutical form is aimed at alleviating neurological and psychiatric disorders, and acting as an anti-inflammatory agent for various inflammatory disorders. “We believe we are the first company in the world to design a pharmaceutical form for psychedelic drug delivery using 3D printing. This paramount step in our rapid evolution towards becoming a pharmaceutical company, was achieved by our team of scientists who have designed a novel pharmaceutical form to be used with our psychedelic candidates. We are very proud of how our research and development division advances in the development of complex products, on-demand products, and customized products, aimed to address a wide range of needs from patients with different mental health conditions. 3D printing allows creating three-dimensional objects layer by layer, thereby achieving products with variable geometries. Inside the universe of pharmaceutical technology, 3D printing allows combining of shapes and stratification of materials; thus, possibly controlling the time and place of drug release. One of the most interesting and potentially exciting results is that doses can be adjusted in real time for the specific needs of each patient. 3D printing of psychedelics could be key to the future of the industry, not just because it allows us to personalize medicine but also for creating sustainable production, while reducing the environmental burden”, commented Alejandro Antalich, CEO of Biomind Labs. About Biomind Labs Inc. Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of the main psychedelic molecules, DMT, 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to provide patients access to affordable and modern-day treatments and use cases.

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PHARMA TECH

InnovaCare Signs Agreement with MedAvail to Open Three SpotRx Locations in Florida

InnovaCare | November 09, 2021

MedAvail Holdings, Inc. a technology-enabled retail pharmacy company, will be opening an initial three SpotRx locations with InnovaCare Health in Florida in the fourth quarter of 2021. In-clinic SpotRx kiosks and courier home delivery, supported by onsite SpotRx clinic account managers, will be available to patients at three Trinity Medical Center clinics in the Lakeland area. Trinity Medical Center is part of the InnovaCare Health clinical network. SpotRx Pharmacy is the retail pharmacy brand owned and operated by MedAvail in the United States, which deploys and operates the MedAvail MedCenters. “Our physician-led models and innovative technology have placed InnovaCare on the forefront of healthcare transformation for 20 years. We are excited to be continuing this tradition through our partnership with MedAvail and embedding the SpotRx pharmacy in our clinicsWe believe that this collaboration with our skilled clinical teams will result in improved health outcomes for our patients – it is a game-changing technology and the future for pharmacy services.” Connie Garcia, Pharm D., Pharmacy Manager of InnovaCare Health and Trinity Medical Center InnovaCare Health operates more than 30 clinics and is recognized as a leader in transforming care delivery. With the SpotRx embedded pharmacy model, InnovaCare Health patients will receive: Immediate access to prescriptions at the three Trinity Medical Center clinics Free contactless next-day home delivery for all prescriptions and over-the-counter medications Follow up care calls from a local SpotRx pharmacist after receiving the prescription Refill reminder calls on all chronic medications to schedule free delivery or in-clinic pick-up Instant access to SpotRx pharmacists via kiosk or phone “We are honored to support InnovaCare in its efforts to deliver compassionate, high-quality care tailored to each distinct patient population it serves,” said Ed Kilroy, Chief Executive Officer of MedAvail. “Our partnership is another key part of our continued expansion in Florida with our embedded pharmacy solution. We are committed to collaborating with InnovaCare over time to meet its patients’ medication access and adherence needs.” About InnovaCare InnovaCare Health improves the lives of members and physicians through innovative solutions for value-based healthcare. Through an integrated portfolio of health plans, medical service organizations, clinical networks and more, the company manages more than 500,000 lives, including more than 150,000 dual-eligible beneficiaries. InnovaCare’s Medicare Advantage plans have received NCQA accreditation and 4.5-star quality ratings from the Centers for Medicare and Medicaid Services (CMS). About SpotRx SpotRx places control of the pharmacy experience back in the hands of consumers. SpotRx is a telehealth platform that delivers remote pharmacist consultations through an on-site dispensing kiosk, supplemented with home delivery capability. About MedAvail MedAvail Holdings, Inc. (NASDAQ: MDVL) is a technology-enabled pharmacy organization, providing turnkey in-clinic pharmacy services through its proprietary robotic dispensing platform, the MedAvail MedCenter, and home delivery operations, to Medicare clinics. MedAvail helps patients to optimize drug adherence, resulting in better health outcomes.

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PHARMACY MARKET

Takeda is poised to commercialize next generation Hunter's disease therapy through collaboration with JCR Pharmaceuticals

Takeda Pharmaceutical Company Limited | October 01, 2021

Takeda Pharmaceutical Company Limited and JCR Pharmaceuticals Co., Ltd. today announce a geographically focused exclusive collaboration and license agreement to commercialize JR-141, a recombinant fusion protein under development of a next-generation antibody against the human transferrin receptor and the enzyme iduronate- 2-sulfatase (IDS), used to treat Hunter's disease (also called mucopolysaccharidosis type II or MPS II). Hunter's disease is caused by the lack of IDS and manifests itself in different forms. Administered with J-Brain Cargo®, JCR's proprietary blood-brain barrier (BBB) ​​technology, the JR-141 was designed to deliver the therapeutic enzyme across the blood-brain barrier directly to the brain and somatic and address neuronopathic manifestations of the disease, Under the exclusive collaboration and license agreement, Takeda will exclusively market the JR-141 outside of the United States, including Canada, Europe, and other regions (excluding Japan and certain other Asia Pacific countries). JCR will receive an upfront payment for the ex-US license and is eligible to receive additional development measures and commercial milestones as well as multi-tier royalties on potential product sales. Both companies will work together to provide this form of therapy to patients as soon as possible after the completion of the global Phase III program run by JCR. Takeda has an option under a separate option agreement that allows Takeda to acquire an exclusive license to commercialize JR-141 in the United States upon completion of the Phase III program. Takeda is committed to continuously improving the therapy it offers to treat Hunter's disease. JR-141 introduces a new way of delivering proteins by crossing the blood-brain barrier. This will overcome our current challenges in treating the underlying neuronopathic manifestations of Hunter's disease and help maintain or improve cognitive function in these patients, We will work closely with JCR to apply our expertise in enzyme replacement therapies with the hope of delivering this potentially transformative form of therapy to patients as soon as possible. - Dan Curran, MD, Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda. JR-141 met its primary endpoint in an open-label Phase II / III study in Japanand was able to show a significant reduction in heparan sulfate (HS) concentrations in the CSF. HS is a biomarker for assessing the effectiveness of the drug in reducing the disease-causing substrate in the central nervous system. This proof could be provided in all patients for whom measurements were available after 52 weeks of treatment. Somatic disease control was retained in patients switched from standard enzyme replacement therapy (ERT). The study also showed an improvement in somatic symptoms in participants who had not received standard ERT prior to the start of the study. In addition, an assessment of neurocognitive development in 21 of 25 patients at one year showed the maintenance or improvement of age-appropriate function.1 About JR-141 JR-141 is a recombinant fusion protein of an antibody against the human transferrin receptor and the enzyme iduronate-2-sulfatase. This enzyme is absent or defective in patients with Hunter's disease. It is expected to be effective against neuronopathic manifestations of the disease by crossing the blood-brain barrier (BBB) ​​through transferrin receptor-mediated transcytosis using J-Brain Cargo®, JCR's proprietary BBB technology. Uptake into the cells is mediated by the transferrin receptor and the mannose-6-phosphate receptor. JCR has driven development activities by allowing the company to maintain the necessary evidence from the molecular design phase through to the non-clinical and clinical study phases. In addition, JCR has confirmed that using J-Brain Cargo® technology, enzymes are absorbed into different brain tissues. A decrease in substrate accumulation could also be confirmed in an animal model of Hunter's disease. 2,3,4 In several clinical studies with JR-141, JCR was able to show a reduction in CSF heparan sulfate concentrations. This is a biomarker for assessing the effectiveness of drugs by reducing the disease-causing substrate in the central nervous system. This is done in accordance with the results obtained in non-clinical studies. JCR also produced clinical results that could show the positive effects of JR-141 on neurocognition. 5,6,7,8 JR-141 is approved by the Ministry of Health, Labor and Social Affairs and has been marketed under the brand name "IZCARGO® IV Infusion 10mg" since May 2021. About Hunter's Disease Hunter's disease is a severely debilitating, rare lysosomal disease caused by insufficient activity of the enzyme iduronate-2-sulfatase. This enzyme has the task of breaking down substances known as glycosaminoglycans (GAG) in the body. 9 The absence of this enzyme (GAG) can trigger a number of symptoms. 9,10 Around two in three people with Hunter's disease also experience progressive loss of cognitive function. 11 Hunter's disease affects 1 in 162,000 live births and almost exclusively male patients. 12th About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited is a global, values-based, leading group with a focus on research and development in the biopharmaceutical sector headquartered in Japan. His pursuit of life-changing treatments is shaped by his dedication to patients, people, and the planet. Takeda's research and development efforts focus on four therapeutic areas: Oncology, Rare Genetic Diseases and Hematology, Neuroscience and Gastroenterology (GI). We also invest parts of our research and development budget specifically in therapies with plasma derivatives and vaccines. We focus on developing highly innovative drugs that help improve people's quality of life. To this end, we are opening up new treatment options and using our improved, synergistic research area and our combined skills to create a robust pipeline based on different modalities. Our employees are committed to improving the quality of life for patients and work with our healthcare partners in around 80 countries and regions. About JCR Pharmaceuticals Co., Ltd. JCR Pharmaceuticals Co., Ltd. is a global specialty pharmaceutical company that is redefining expectations and expanding opportunities for those with rare hereditary diseases around the world. We continue to build on our 46 year tradition in Japan as we expand our presence in the United States, Europe and Latin America. We improve the lives of patients by applying our scientific expertise and unique technologies to research, develop and deliver next generation therapies. Our approved products in Japan include therapies for the treatment of stunted growth, Fabry disease, acute graft versus host disease and renal anemia. Our test products, which are being developed around the world, aim, among other things, at the treatment of rare diseases, including MPS I (Hurler's disease, Hurler-Scheie and Scheie syndrome), MPS II (Hunter's disease) and Pompe disease. JCR strives to expand the possibilities for patients as the company accelerates medical advancement on a global basis. Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we reach greater heights.

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