GlaxoSmithKline wins Benlysta US label expansion for children

pharmatimes | April 30, 2019

GlaxoSmithKline has announced the US Food and Drug Administration expansion of its intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age. The approval, which marks the first medicine in the US approved for children with systemic lupus erythematosus (SLE), was based on data from a post-approval PLUTO commitment study, which assessed the efficacy, safety and pharmacokinetics of 10 mg/kg intravenous doses. The proportion of children achieving a clinically meaningful improvement in disease activity was higher in patients receiving Benlysta than it was in the control group, at 52.8% compared to 43.6%, in study results first presented at the 2018 American College of Rheumatology (ACR).

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BUSINESS INSIGHTS

Vifor Pharma drives transformation with divestment of non-core finished drug manufacturing to CordenPharma

Vifor Pharma Group | December 17, 2021

Vifor Pharma Group announced the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization of APIs, Excipients, Drug Products, and associated Packaging services. This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio. “In support of our ambitious growth strategy, optimizing our manufacturing footprint will enable us to build an even stronger, more efficient organization focusing on core capabilities in nephrology, and to maximize and leverage our market-leading expertise and intellectual property in iron deficiency. With CordenPharma, we have found the best suitable solution for our manufacturing employees and the drug production activities in Fribourg, Ettingen and Lisbon. With this agreement, Vifor Pharma is well positioned to continuously drive the company sustainably and profitably over the long term, for all our stakeholders.” Abbas Hussain, CEO of Vifor Pharma Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma said: “The acquired Vifor Pharma sites have competent teams with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities. By incorporating these three Vifor Pharma manufacturing facilities into our global network, we look forward to not only supplying Vifor Pharma as a manufacturing partner, but also closing gaps in our service offering for oral solid dosage drug product manufacturing and increasing our overall capacity. In addition, this acquisition further strengthens our fully-integrated solutions to our customers.” Under the terms of the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA, Fribourg, and OM Pharma SA, Lisbon, thus taking over Vifor Pharma’s finished drug product manufacturing operations at the three sites. The divestment will trigger an asset impairment, to be reported with Vifor Pharma’s 2021 financial results. The companies have agreed not to disclose financial terms of the agreement. CordenPharma will integrate the new facilities into its existing CDMO network of Current Good Manufacturing Practice and R&D plants across Europe & the US, and organize the operations of the Fribourg, Ettingen and Lisbon sites under its Small Molecule Platform. It plans to utilize the existing manufacturing workforce, while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group. Vifor Pharma and CordenPharma will jointly ensure long-term continuity of supply for customers and patients who depend on them. This divestment, including all financial implications, has been disclosed to CSL Limited in the course of the due diligence process preceding the publication of the pre-announcement of the public tender offer by CSL Limited on 14 December and in so far has no impact on such tender offer. Vifor Pharma and CordenPharma anticipate closing the transaction in Q1 2022, contingent on customary closing conditions. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CordenPharma CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group, is a full-service partner in the Contract Development & Manufacturing of APIs, Excipients, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.

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PHARMACY MARKET

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

MediPharm Labs Corp. | February 24, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies. "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world." Bryan Howcroft, CEO, MediPharm About MediPharm Labs Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

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BUSINESS INSIGHTS

Elligo Health Research® Partners With Peoples Rx

Elligo Health Research | April 21, 2022

Elligo Health Research, the largest healthcare-enabling research organization, announced they are expanding partnerships to include Peoples Rx, an Austin, Texas-based pharmacy chain. “We’re in a unique position at Peoples Rx to help inform more people about how they can participate in clinical research opportunities. Working with Elligo to offer research as healthcare to our customers helps support our mission to empower people to make educated health decisions.” Stephen Erickson, Peoples Rx president One of the first studies Peoples Rx will be working to share with Elligo is a study for people to advance screening diagnostics for cancer. “Our patients may not hear about clinical research opportunities otherwise, and this empowers patients with knowledge to become more proactive in their own healthcare journey while simultaneously supporting the advancement of health sciences,” Erickson said. Elligo began its mission to provide easy access to clinical research as care to more patients nearly six years ago. Specifically, Elligo is focused on accelerating clinical trials through healthcare by maintaining the integrity of the trusted patient and physician relationship, building local healthcare communities, and leveraging electronic health records. “Accomplishing this mission is made possible by the partnerships we have with real-world healthcare,” said Elligo CEO John Potthoff, Ph.D. “Peoples Rx has a positive impact on our local community and is a trusted partner for healthcare. This is also Elligo’s first partnership with a pharmacy, and it is our hope that this will lead to further opportunities to collaborate with more providers in the healthcare spectrum on similar initiatives and continue contributing to the changing clinical research landscape.” About Elligo Health Research® Elligo Health Research accelerates clinical trials through healthcare with access to known patients and their HIPAA-compliant healthcare data, our IntElligo® Research Stack technology, and our hybrid enrollment model, PatientSelect. Coupled with the largest Known Patient Access Network, Elligo’s Site Solutions enable healthcare practices and research sites to participate in clinical trials. By adaptive engagement of known patients and physicians, we accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products. About Peoples Rx Peoples Rx has been the local favorite pharmacy and wellness headquarters in Austin for over 40 years. Our integrative approach to health and wellness starts with our knowledgeable and experienced pharmacists and wellness specialists, and our cutting-edge, holistic, and professional products. We also compound custom medications in our state-of-the-art lab to meet customers’ specific needs. And because food is medicine too, our own in-house delis serve up scratch-made meals and snacks with the highest quality ingredients. With a mission to empower people to make educated health choices, several of our 170+ employees, including clinical nutritionists, herbalists, naturopaths, and homeopaths also offer their expertise through private consultations and educational events.

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BUSINESS INSIGHTS

OptimizeRx Acquires EvinceMed, a Specialty Drug Prescription Initiation Platform

OptimizeRx Corporation | March 16, 2022

OptimizeRx Corp. a leading provider of point-of-care technology solutions helping patients start and stay on therapy, announced a definitive agreement to acquire the EvinceMed platform and related assets. EvinceMed is a leader in delivering end-to-end automation for specialty pharmaceutical transactions. The acquisition includes the full Market Access Management Platform supporting pharma manufacturers, hub providers and pharmacies to improve patient access, speed to therapy and activation of affordability programs. With the EvinceMed platform, OptimizeRx will be able to help patients get access to the drugs they need by simplifying the prescribing process for specialty products, automating manual steps to determine drug eligibility and affordability, and introducing electronic enrollment and medical documentation within workflow across the OptimizeRx network of over 300 electronic health record (EHR) systems, ePrescribing platforms, and account-based marketing technologies spanning more than 700 thousand providers. The integration of the EvinceMed and OptimizeRx platforms has already begun with an exclusive collaboration that began last year. Full integration of the technology assets will further the Company’s ability to help patients start and stay on therapy. While specialty drugs account for only 2.2% of total prescription volume in the U.S, they accounted for over 45% of total pharmacy spend, or $218.6 billion in 2019 1,2. The cost and increasing use of specialty medications has exposed unique barriers to the prescription and patient access process. Manufacturer support programs provide much-needed services to prescription medication access, affordability, and adherence. However, a recent survey of 10,000 patients across multiple therapeutic areas found that only 20% of patients were aware of such programs3. Doctors and their staff can assist patients with enrollment into these programs, yet the enrollment process is often time-consuming, and doctors remain dissatisfied with current patient support options available. In addition, less than 10% of patient enrollment into these support programs is currently completed electronically4. “We are thrilled to have EvinceMed transition from an exclusive technology partner over the last year to being part of the team. Given the success we saw working together, this combination strengthens our position to serve our pharma customers across the full HCP network and throughout the patients’ journeys – from the moment the doctor logs into their EHR right through the point of dispense at the pharmacy. This acquisition offers significant high margin cross-selling opportunities across our growing customer base of leading life science companies, while further fortifying our business through vertical integration, and helping drive upward momentum to our key performance indicators. We expect this acquisition to benefit revenue growth in 2023 as we further develop our network around connectivity to additional partners.” William Febbo, CEO of OptimizeRx David Jackson, CEO of EvinceMed commented, “We are very excited to be joining the OptimizeRx team. The impact of our combined technologies and the reach and scale that OptimizeRx has with pharmaceutical manufacturers is a game-changer to patient access to specialty medications. By automating the processes and tasks required to be completed prior to the fill and dispense of specialty medications, we can get patients on treatment much faster and at a lower overall cost.” OptimizeRx chief commercial officer, Steve Silvestro, added, “Our commitment to leveraging technology to assist providers and patients in accessing the tools they need to improve outcomes is a mission-driven effort. The EvinceMed assets give us additional resources to accomplish that while also expanding the network’s reach to point-of-dispense, a goal we have long pursued. Prescribing support through automation for providers will both accelerate workflows and remove barriers to the specialty prescribing process ensuring patients are able to readily access the life-changing innovative therapies that they need.” OptimizeRx is committed to investing in innovation to bring more digital in-workflow solutions to execute against the commercialization goals of life science organizations. OptimizeRx currently provides solutions to 19 of the 20 largest pharma manufacturers and seeks to continue driving long-term, sustainable ROIs for its clients while supporting initiatives that improve health outcomes. Recent market research commissioned by OptimizeRx revealed specialty drug access support as being a $12B+ market. This acquisition further diversifies OptimizeRx revenue streams as the Company scales to address the client needs in this space.

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