BUSINESS INSIGHTS, PHARMA TECH
Epredia | January 19, 2023
On January 18, 2023, PHC Group, a healthcare company renowned in diagnostics and life sciences, announced that it would join the RegeneratOR Innovation Accelerator to grow its presence in regenerative medicine. The Wake Forest Institute for Regenerative Medicine (WFIRM) and the RegenMed Development Organization (ReMDO) are the two institutions expediting the discovery and translation of regenerative medicine therapeutics located in the Innovation Quarter.
PHC Group, being an early partner of ReMDO's RegeneratOR Test Bed, offered advanced tissue processing technologies as well as support to researchers for prototype and product development. In addition, another ReMDO program, the Innovation Accelerator, was formed to give space and support to companies with innovative or emerging regenerative medicine technologies.
PHC Group is now opening a local office within the Innovation Accelerator. Its holding companies and partners include Epredia, a precision cancer diagnostics company whose products are used by researchers and pathologists worldwide, and Aiforia, a medical software company that develops artificial intelligence software for image analysis in pathology. Aiforia's collection of preclinical and clinical pathology instruments is distributed globally by Epredia.
The firms work together to deliver slide imaging and AI-based solutions that enable researchers to investigate and extract information beyond the scope of human visual perception. Thus, clinical research, drug discovery, and translational studies with the goal of better understanding disease states are all linked together through diagnostic microscopic imaging and artificial intelligence.
PHC Group's presence, along with Epredia and Aiforia's superior technology assistance at the Innovation Accelerator, will also pave the path for RegeneratOR's newest initiative, the RegenMed Clinical Trials Catalyst.
As a part of Wake Forest University School of Medicine and the academic core of the newly merged Advocate Aurora Health and Atrium Health, the Catalyst will have access to 5.5 million patients, serving 67 hospitals in North Carolina, Wisconsin, South Carolina, Georgia, Alabama, and Illinois.
Epredia is a leading comprehensive laboratory solutions provider for instruments and consumables in anatomic pathology, histology, and cytology. It was established through an acquisition by PHC Group from Thermo Fisher Scientific. The company provides solutions for cancer diagnostics through its renowned brands: Richard Allen Scientific, Erie Scientific, Microm, Shandon, and Menzel-Glaser. Epredia is committed to realizing its aim of advancing cancer diagnostics for patients worldwide in order to save lives.
BUSINESS INSIGHTS, PHARMA TECH
Arrowhead and Amgen | December 21, 2022
Arrowhead Pharmaceuticals Inc. announced a $25M milestone payment from Amgen. This milestone was triggered by the first subject enrolled in Amgen’s Phase 3 trial of olpasiran. Arrowhead is further eligible to receive up to an additional $535 million in aggregate development, regulatory, and sales milestone payments from Amgen and Royalty Pharma plc.
“We are pleased with the great progress on the clinical development of olpasiran, which was developed using Arrowhead’s proprietary TRiMTM technology. This is an important milestone for the program and for Arrowhead, as this is the second TRiMTM-enabled candidate to enter Phase 3 studies. Importantly, as our pipeline continues to advance expeditiously, we anticipate multiple Arrowhead therapies will also reach Phase 3 trials over the coming year.”
Christopher Anzalone, Ph.D., Arrowhead’s president and CEO
Olpasiran is a small interfering RNA originally developed by Arrowhead using its proprietary Targeted RNAi Molecule, or TRiM, platform and licensed to Amgen in 2016. It is designed to lower levels of lipoprotein(a) (Lp(a)), a genetically determined risk factor for cardiovascular disease. Phase 2 study results from the OCEAN(a)-DOSE study were presented at the American Heart Association Scientific Sessions 2022, where olpasiran demonstrated a significant and sustained reduction in Lp(a) levels over 36 weeks. These data were simultaneously published in the New England Journal of Medicine on November 6, 2022.
Lp(a) is genetically determined1-3 and a presumed independent risk factor for cardiovascular disease. Although an agreed upon threshold for elevated Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).1 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.3
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.
Douglas Pharmaceuticals | January 27, 2023
A clinical advisory board has been established to support Douglas Pharmaceuticals' lead program R-107, an oral extended-release dose of racemic ketamine being developed as an adjunctive or stand-alone therapy for treatment-resistant depression.
Douglas Pharmaceuticals is a New Zealand-based pharmaceutical company specializing in the development of specialty generic and repurposed medications (TRD).
Peter Surman, Chief Scientific Officer expressed, "We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107." "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD," he added.
(Source – Cision PR Newswire)
Some of the members of the clinical advisory board are as follows:
• Prof. Paul Glue [MB, ChB (Otago), MD (Bristol), FRCPsych]
• Prof. Alan F. Schatzberg, [MD] • Prof. Sanjay J. Mathew [MD]
• Prof. Allan Young [MB, ChB, MPhil, Ph.D., FRCP (Edin.), FRCPC, FRCPsych]
• Prof. Wiesław J. Cubała, [MD, PhD]
• Prof. Colleen Loo [MBBS (Hons), FRANZCP, MD]
About Douglas Pharmaceuticals
New Zealand's largest private pharmaceutical and healthcare firm, Douglas Pharmaceuticals, employs over 700 people and exports to over 40 countries. The company provides creative, competitive, and high-quality healthcare solutions to 'improve lives'. It designs, manufactures, and distributes unique and generic products, preferring those with significant intellectual property and technological complexity in high-unmet need sectors. The company's presence in international markets continues to grow, exposing New Zealand to the world. It is dedicated to improving people's health all around the globe. Some of the products that the company works with cutting-edge partners to develop, make, market, and distribute are pharmaceuticals, nutraceuticals, automated compliance systems, and consumer healthcare items.