BUSINESS INSIGHTS

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

GoodRx | April 18, 2022

GoodRx Closes
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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PHARMACY MARKET

Ultivue Announces Co-Marketing Agreement with Aignostics for Unique Spatial AI-Powered Imaging Solutions for Translational Medicine

Ultivue, Inc., | March 10, 2022

Ultivue, Inc., an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies, and Aignostics GmbH, a global leader in Artificial Intelligence (AI) powered precision diagnostics focused on pathology to assist with research, clinical trials and CDx development, announced a partnership to collaborate on the co-development of AI-powered spatial multiplexed immunophenotype solutions for translational research groups and Biopharma. The companies have already been working together since early 2021 to adapt Aignostics’ client platform to support visualization and analysis for some of Ultivue’s products and services, as well as provisioning of results and corresponding reports. The resulting co-developed platform will now be made available to joint clients. Additionally, proof of concept work conducted on the Ultivue 12-plex Immunophenotyping biomarker panel in over 1,000 clinical NSCLC cases has demonstrated encouraging results for the capacity of AI-based analysis of multiplexed images for more consistent and reproducible readouts at scale. These results will be published later this year and respective AI models made available via the platform. The companies are now expanding their relationship under a co-marketing agreement to offer the multiplex immunofluorescence (mIF) platform to their respective biotech and pharma clients, initially for research use, with a GCP-compliant version to follow later this year. Moreover, Ultivue and Aignostics will offer AI-powered image analysis services within the platform via Aignostics “Explainable AI” approach for the consistent and precise analysis of mIF cohorts at scale, for both translational research and clinical trial research services in Ultivue’s CLIA accredited clinical research laboratory. “We are excited to extend our workflow offering to include mIF AI for highly automated image analysis by partnering with Aignostics,” says Florian Leiss, VP Digital Health at Ultivue. “Improved viewing capabilities enable us to interactively explore the interplay of mIF-labeled cell populations in the histological context of same-slide H&E.” “We believe that development of Ultivue’s assays with our AI-powered image analysis will create insights from data at scale that are unprecedented in spatial biology today. We are excited to start offering this approach to our clients for translational science and clinical trials,” Viktor Matyas, CEO of Aignostics Besides offering research and development services to its clients, Ultivue and Aignostics will also develop products for standardized analysis of certain Ultivue products, paving the way for more widespread use of these technologies in both clinical trials and clinical routine. About Ultivue Ultivue provides researchers and scientists in translational medicine with multiplex biomarker assays for tissue phenotyping and digital pathology. Its proprietary InSituPlex® technology enables advanced exploration and interrogation of tissue samples for precision medicine research. These highly customizable solutions coupled with our scientific consultative approach strengthen and accelerate biomarker discovery and drug development programs. About Aignostics Aignostics, a Berlin based company with offices in the US, is a digital pathology company dedicated to novel precision diagnostics through the use of a proprietary “Explainable AI” platform in pre-clinical and translational research and clinical trials. The use of such technology is expected to be crucial to implementation of AI-powered algorithms in routine diagnostics in order to verify (explain) the model’s decision outputs. Additionally, through its close alignment to Charité and TU Berlin amongst other collaborators, only Aignostics offers the combination of data access, sample testing and pathology expertise to develop digital pathology algorithms spanning multi-modal biomarker assay detection systems such as H&E, IHC and mIF, amongst others.

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BUSINESS INSIGHTS

Arrowhead Initiates Project to Build New Manufacturing and Lab Facilities

Arrowhead Pharmaceuticals | December 21, 2021

Arrowhead Pharmaceuticals, Inc. announced that it has completed a transaction to purchase 13 acres of land in the Verona Technology Park in Verona, WI, which is planned to be the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities. Arrowhead intends to invest between $200 million and $250 million into the buildout of the facilities. The Company expects that the new facilities will result in the creation of approximately 250 new jobs in the local area. Construction is scheduled to begin in the first quarter of 2022. Arrowhead will continue to operate additional research and development facilities in Madison, WI, and San Diego, CA. “For more than a decade, Arrowhead has been a dedicated member of the biotech community in the greater Madison, Wisconsin, area. We have built strong local relationships and are pleased to continue our growth with the new Arrowhead campus that will include a new GMP manufacturing facility and associated lab and office facility. This investment reaffirms our commitment to the Wisconsin biotech ecosystem, and we would like to thank the local agencies, who have been a pleasure to work with. Arrowhead’s pipeline of what we believe are industry leading investigational RNAi medicines continues to expand rapidly. The new Arrowhead campus will allow us to support our growing pipeline and positions us well to advance the manufacturing process, including at commercial scale, of our TRiM™-enabled drug candidates. We view this as a strong competitive advantage as we approach potential commercialization of our rapidly progressing clinical candidates.” Christopher Anzalone, Ph.D., Arrowhead’s president and CEO Major project team members include Eppstein Uhen Architects, DPS Group, D’Onofrio Kottke & Associates, Smocke & Associates, Cresa Madison, and Vogel Brothers Building Company. John Chapman, Vice President and Design Principal at EUA, said, “We are privileged to be collaborating again with Arrowhead on an inventive building design which will enable their employees to treat some of the most challenging diseases.” Completion of the lab and office space is anticipated in the first quarter of 2023 and completion of the manufacturing facility is expected in the fourth quarter of 2023. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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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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BUSINESS INSIGHTS

Oramed Completes Patient Enrollment in Phase 2 Oral Insulin NASH Trial

Oramed Pharmaceuticals Inc. | March 17, 2022

Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis. An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The double-blind, multi-center trial with clinical sites in the U.S. and Israel is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including safety and percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline are measured via MRI-PDFF following 12 weeks of dosing. "There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. We look forward to analyzing and reporting topline data, which we expect will confirm our prior pilot study's efficacy and safety results," Oramed Chief Executive Officer, Nadav Kidron The global market for drugs to treat NASH is expected to reach $84 billion by 2029, according to a publication by Research and Markets on the Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market. About NASH Non-alcoholic steatohepatitis is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few treatment options. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1.

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