Galen takes over POA Pharma, expands reach

PharmaTimes | January 08, 2020

Irish pharma firm Galen has announced the completion of its POA Pharma (POA) acquisition. The company has stated that the multi-million pound takeover will help to “significantly expand” its global reach and product portfolio in exciting new therapy areas, such as rare metabolic disease. The deal first got underway back in April 2016, when Galen signed a distribution agreement with POA, allowing the company to market and sell POA’s metabolic product portfolio in the UK and Ireland. As a results of the acquisition, Galen hopes to extend its global footprint into the Nordic territory and Northern Europe, as POA currently represents 16 producers from 10 countries and retains a “strong portfolio of products and an extensive network worldwide.”

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A novel azapeptide editing method provides potential for new drug development, Feinstein Institutes research shows

Feinstein Institutes | November 29, 2022

Peptides, short sections of proteins made up of chains of amino acids, are an important area of new drug development due to their potential for increased specificity and fewer side effects. Their main drawback is the rapid degradation by the body’s own enzymes, which has led to the need to develop longer-lasting peptide alternatives. Azapeptides are one type of peptide alternative that has shown great potential as therapeutics, exemplified by the HIV drug, Atazanavir. A new paper published in the journal Nature Communications by researchers at The Feinstein Institutes for Medical Research details proprietary reagents and methods that can selectively replace only those amino acids known to be targeted by enzymes with more stable versions to create azapeptides. The paper, authored by Yousef Al-Abed, PhD, co-director of the Institute of Bioelectronic Medicine at the Feinstein Institutes, describes the proprietary building blocks and method used to conduct systematic and robust peptide editing, replacing targeted amino acids with aza-amino acids to form more stable and efficient azapeptides. The azapeptides created could expedite the novel therapies to treat many diseases and conditions, including metabolic disease, influenza, pulmonary arterial hypertension, Crohn’s disease, arthritis, and irritable bowel diseases, among others. The paper, titled “Thiocarbazate building blocks enable the construction of azapeptides for rapid development of therapeutic candidates,” provides multiple examples of azapeptide construction, screening, and selection using a known peptide inhibitor of inflammation and bradykinin. “Peptides as drug candidates are easy to discover yet difficult to develop as final drugs because of their fast degradation in our body. A technology that circumvents these problems inherent to native peptides will change the future landscape of drug discovery. Our technology provides a platform of tools that enable minimal modification of any peptide at highly prone degradation sites, thereby increasing its life span in our body, allowing it more time to find its target and neutralize it.” Dr. Al-Abed Through peptide editing, going from peptide to azapeptide, using methods that Dr. Al-Abed and his team detail in the new paper, scientists can create potential therapies that have enhanced characteristics compared to natural peptides, like longer stabilities in a more efficient manner. Dr. Al-Abed and his team have precisely engineered thiocarbazates (a novel functional group) in the proprietary process to achieve an almost universal and more efficient means to selectively replace amino acids in a peptide chain. “Peptide drugs are a crucial resource for patients and the global pharmaceutical industry,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “Dr. Al-Abed and his team invented a fully automated chemical strategy using novel chemistry to make new peptide drugs which is an important new avenue for peptide drug discovery.” About the Feinstein Institutes The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine.

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RESEARCH

Corium Announces Publication of ADLARITY® Clinical Trial Data: Drug Exposure Equivalent to Oral Donepezil With Favorable GI Side Effect Profile

Corium, Inc. | September 20, 2022

Corium, Inc., a fully-integrated biopharmaceutical company leading the development and commercialization of novel central nervous system therapies, announced publication of its phase 1 healthy volunteer study results for ADLARITY in the peer-reviewed Journal of Alzheimer's Disease. The article, "Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil," reports that Corium's novel once-weekly Alzheimer's dementia treatment delivered drug exposure equivalent to oral donepezil while presenting lower gastrointestinal (GI) adverse events overall compared to oral donepezil. The article is currently available online and expected to be published in the hardcopy of the Journal of Alzheimer's Disease, Volume 90, Issue 1, on October 25, 2022. "Transdermal delivery offers meaningful potential benefits over oral administration, including ease of use, maintenance of steady concentrations of drugs, reduced gastrointestinal adverse effects, and better treatment compliance. The availability of a transdermal formulation of donepezil gives clinicians, patients, and their caregivers an important new option to consider when treating dementia of the Alzheimer's type," said study co-author Pierre N. Tariot, M.D., director of the Banner Alzheimer's Institute in Phoenix, AZ. "The study demonstrated the equivalent exposure of Adlarity to oral donepezil and supports the use of ADLARITY as a compliant and safe once-weekly dosing regimen for treatment of patients with dementia of the Alzheimer type. The trial also shows Corium's commitment to addressing the unmet needs of patients with CNS disorders." Charles Oh, M.D., Chief Medical Officer of Corium ADLARITY Transdermal System: Equivalent to Oral Donepezil Exposure, Fewer GI Adverse Events Overall In the trial, investigators compared the extent of donepezil exposure from the once-weekly ADLARITY to a once-daily oral donepezil formulation in 60 healthy adults (NCT04617782). The trial included three treatment periods of 5 weeks each. In the first period, all the participants received ADLARITY weekly, which provided 5 mg/day of donepezil. In the second period, participants were randomized to receive either 10 mg/day once-weekly ADLARITY or 10 mg/day daily oral donepezil, followed by switching to the alternative treatment, ADLARITY or oral donepezil, in the third period. All the participants knew which treatment they received in this open-label trial. Investigators examined the amount of donepezil in the participants' blood, including the maximum plasma concentration (Cmax) and the total amount of drug exposure (area under the curve or AUC). About Alzheimer's Disease Alzheimer's disease is a progressive and irreversible brain disorder. It involves changes in brain tissue including abnormal buildup of proteins as well as loss of neuron function. The resulting damage leads to the loss of remembering, reasoning, and thinking abilities. The related behavioral changes include the loss of independence in activities of daily living and self-care. Dementia ranges in severity from mild, when it is just beginning to affect a person's functioning, to moderate, to severe, when the person must depend on others for the basic activities of day-to-day life. Patients with advanced Alzheimer's disease may be unable to chew and swallow easily. About Corium Corium, Inc., is a fully-integrated biopharmaceutical company that is leading the development and commercialization of CNS therapies that provide physicians with innovative treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved products, ADLARITY and AZSTARYS. About Gurnet Point Capital Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, GPC is able to deliver differentiated results for its investors and partners.

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PHARMA TECH

Bexson Biomedical and Stevanato Group Awarded PDA Drug Delivery Innovation Award

Bexson Biomedical | October 20, 2022

Bexson Biomedical, Inc., a biopharmaceutical company focused on disrupting the $189 billion small molecule injectable market and enabling home health solutions, announced Bexson and Stevanato Group a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, have been jointly awarded the Parenteral Drug Association's 2022 Drug Delivery Innovation Partnership Award. At PDA's annual conference in Palm Springs, CA on October 18th, PDA's leadership presented the award to Bexson Biomedical's Sr. VP of Drug Delivery, Sheldon Moberg, and to Stevanato Group's DDS Business Development Director, Paolo Golfetto. This award recognizes the collaboration between Bexson Biomedical and Stevanato Group to optimize Stevanato Group's innovative wearable device On Body Delivery System with Bexson's formulation technology. OBDS is a wearable infusion device that allows controlled drug dosing and delivery over extended durations, and which is positioned to enable patient therapy in the home setting. "I am pleased PDA has recognized the collaborative approach that Bexson Biomedical and Stevanato Group have taken to develop this innovative device for non-opioid pain management. In addition, merging Bexson's SEVALENT™ formulation technology with Stevanato Group's vertically integrated development capabilities has been a very rewarding program, and has great potential beyond the initial therapy." Bexson's Sheldon Moberg "It is an honor for Stevanato Group to receive this award, which recognizes the long collaboration with Bexson," adds Stevanato Group's, Paolo Golfetto. "Our work will continue to extend Stevanato Group's OBDS wearable device to additional therapeutic areas with Bexson's formulation platform. The common goal remains to offer patients more flexible and comfortable treatment modalities, reducing the impact on quality of life, along with overall treatment costs for pharmaceutical companies." Bexson Biomedical, Inc. Bexson Biomedical, Inc. is a biopharmaceutical company focused on disrupting the small molecule injectable market and enabling home health solutions through new formulations designed for subcutaneous delivery. Bexson's proprietary platform, SEVALENT™, can be applied to small molecules across a broad range of drug classes, enabling IV therapies to be delivered subcutaneously. Bexson's lead therapy, BB106, is a low-dose ketamine treatment for post-operative pain management, a $36B global market and leading driver of opioid addiction. Additionally, management believes its BB106 formulation technology can be utilized to address various mental health indications. Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group's core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.

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PHARMA TECH

Three iA Employees Honored with Top Women in Health Awards

iA | November 18, 2022

iA, a provider of software-enabled pharmacy fulfillment and automation solutions, celebrated three of its employees being recognized at Drug Store News’ Fourth Annual Top Women in Health, Wellness & Beauty Awards held in Chicago, Illinois. Rachael Clark, Vice President of Commercial Sales, received a Rising Star award. As Vice President of Commercial Sales, Rachael works with large-scale retail chain grocery stores, mainstream pharmacies, and digital pharmacies, as well as independent mom-and-pop operations. Rachael is responsible for a team of account executives that work to promote iA’s technology across North America and globally by developing long-term strategies, while also organizing and maintaining sales operations. Bobbi Jamriska, Senior Vice President, Product Management, received an award for Business Excellence. Bobbi leads the Product Management team at iA that is responsible for the iA portfolio of solutions, where she manages the strategy, development, and go-to-market planning. She has been a pharmacy tech for 12 years, and has led global product management initiatives as well as new product development experiences. Stacey Weber, Senior Director of Customer Operations, received an award for Business Excellence. Stacey oversees the customer support division, where she manages a team of 35 remote technicians who assist customers in using iA’s Rx fulfillment solutions, which include automated prescription filling robots and innovative warehouse management systems. In addition to ensuring customers receive timely and helpful assistance, she also oversees standardization and process improvement for iA’s call center and for the customers that use iA solutions. “We are incredibly proud of our team members. Rachael, Bobbi, and Stacey all represent the best of iA, and we are very lucky to be able to work with them every day.” Tom Utech, President and Chief Operating Officer About iA iA is a leading-edge provider of software-enabled pharmacy fulfillment solutions. With over 30 years in pharmacy fulfillment, iA has invented and developed a suite of software-driven pharmacy automation solutions. From NEXiA software to automated modular hardware and sophisticated counting and collation devices, iA pharmacy automation solutions and technology empower pharmacists. iA can run the prescription fulfillment process from end to end, helping pharmacies manage fulfillment and inventory to help lower costs, improve efficiency and provide comprehensive Rx tracking and real-time support.

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How advances in imaging technology and the use of artificial intelligence and analytics are improving the accuracy and cost of medical imaging for early cancer diagnosis, and increasing confidence in vital preventive screening programs.

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