Dicerna enters alliance to develop hepatitis B drugs

Pharmaceutical Technology | November 01, 2019

Dicerna Pharmaceuticals has signed a research collaboration and licensing agreement with Roche to create treatments for chronic hepatitis B virus (HBV) infection. The partnership will leverage Dicerna’s GalXC RNAi platform, designed to develop RNAi-based therapies that silence genes, which cause diseases in the liver and other organs. Initially, the companies will work to develop and commercialise Dicerna’s investigational drug, DCR-HBVS, worldwide. DCR-HBVS is currently in Phase I development for chronic HBV infection treatment. It uses RNA interference to target specific genes associated with the formation of HBV messenger RNA (mRNA) and the virus entry into liver cells. The companies also intend to use their technologies to identify and develop therapies that act on various viral and human genes involved in HBV infection. Dicerna Pharmaceuticals president and CEO Douglas Fambrough said: “With its deep expertise in HBV and established global infrastructure, Roche is ideally suited to help us accelerate the development and commercialisation of DCR-HBVS, pursue a cure for chronic HBV infection and address this serious global threat to public health.”

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Pharmaceutical or biotechnology companies looking to outsource their API production are planning for success by looking at the entire development cycle. The growing desire to select one API partner to work with throughout the drug development process, and to potentially also synthesize commercial quantities, put an increased importance on the selection process.


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PCI Pharma Services Selects Thoughtworks for Digital Platform Transformation with Agile Approach

Thoughtworks | July 11, 2022

Thoughtworks a global technology consultancy that integrates strategy, design and engineering to drive digital innovation, today announced the signing of a multi-year agreement with PCI Pharma Services, a leading global contract development and manufacturing organization. Thoughtworks will help PCI in its journey to digitize its supply chain, with the goal of accelerating the time it takes to bring clients’ life-changing therapies to market for patients. By co-developing tools for digital business modernization, Thoughtworks will help PCI improve client visibility into its clinical and commercial drug supply chains for pharmaceutical and biotech companies of all sizes in 100+ countries. By digitizing the supply chain, Thoughtworks will help PCI deliver greater insights to clients to increase their overall efficiency, support their business goals and ultimately produce high quality treatments for patients. The agreement includes expanding and adapting pci | bridge, an industry first-of-its-kind, end-to-end data platform that provides real-time status of projects, automatically identifies risks, spots trends and provides business analytics insights. With this modern application programming interface (API), clients have the ability to seamlessly integrate their systems with PCI’s, creating greater transparency and a more simplified process for decision-making. “Digital transformation has been a key differentiating factor for PCI’s business strategy, and the evolution of pci | bridge will be critical to increasing client engagement and maximizing the value of data and analytics for PCI and our external partners. With Thoughtworks’ 28+ years of experience at the forefront of innovation, we look forward to making our clients’ lives easier through this partnership." Wayne Hull, Chief Digital and Technology Officer, PCI Pharma Services With a shared commitment to customer-centricity, the Thoughtworks and PCI product and engineering teams will create a new level of intuitive self-service solutions for clients. The partnership will also simplify the collection and analysis of information to reach business insights faster and streamline processes to develop useful new products for clients. The teams will do this by working side-by-side using agile development methods, including pair programming, test-driven development and continuous integration/continuous delivery (CI/CD) automation. “Recognized as a leader in global CDMO services, PCI Pharma Services is well on its digital transformation journey, providing clients with sophisticated supply chain solutions and a digitally integrated experience unlike anything else in the industry,” said Chris Murphy, Chief Executive Officer, Thoughtworks North America. “We are thrilled to partner with PCI Pharma Services as it empowers its clients to make even more powerful, life-impacting decisions through their expansive data and analytics ecosystems.” About PCI Pharma Services PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives. For more information, please visit pci.com About Thoughtworks Thoughtworks is a global technology consultancy that integrates strategy, design and engineering to drive digital innovation. We are 11,000+ people strong across 49 offices in 17 countries. Over the last 25+ years, we’ve delivered extraordinary impact together with our clients by helping them solve complex business problems with technology as the differentiator.

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PHARMACY MARKET

IAMA Therapeutics Announces Initiation of Preclinical Development Studies in Drug-resistant Epilepsy Under a Service Agreement with Psychogenics

IAMA Therapeutics | July 26, 2022

IAMA Therapeutics, a preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, and PsychoGenics Inc., a leader in AI-enabled phenotypic drug discovery and preclinical CRO services, today announced that the companies have entered into a service agreement to identify the efficacy of novel drug candidates in drug-resistant epilepsy. Under the terms of the agreement, PsychoGenics will evaluate the preclinical anti-seizure efficacy of first-in-class selective-NKCC1 inhibitors, which aims to reduce intracellular chloride concentration and restore the physiological hyperpolarizing and inhibitory GABAergic transmission in an animal model of refractory epilepsy. "PsychoGenics is a leader in preclinical behavioral neurobiology with a successful track record of anti-epilepsy drug testing through translational EEG approaches, including electrographic and behavioral identification of seizure. We look forward to leveraging our collective expertise in neuroscience drug development to identify and evaluate the anti-seizure efficacy of new drug candidates, to enhance further and complement our pipeline of differentiated therapeutic opportunities for epilepsy, neurodevelopmental and cognitive disorders." Andrea P. Malizia, Ph.D., MBA, Chief Executive Officer of IAMA Therapeutics “We are excited to embark of these studies with IAMA Therapeutics” said Stephen Morairty, Ph.D., Vice President of Translational Neuroscience at PsychoGenics. “Using our pre-clinical MTLE model, will carefully evaluate the efficacy of these first-in-class selective-NKCC1 inhibitors.” About IAMA Therapeutics IAMA Therapeutics is a preclinical-stage pharmaceutical company focused on discovering, developing, and commercializing novel medicines to make a difference in the lives of children and adults suffering from epilepsy, neurodevelopmental and cognitive disorders. IAMA Therapeutics couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline to selectively inhibit the sodium-potassium chloride cotransporter and other therapeutic targets relevant to brain disorders characterized by neuronal imbalance. The company's preclinical pipeline consists of the lead candidate IAMA-6 for the treatment of idiopathic autism, IAMA-097 for the treatment of secondary and rare forms of autism, and other compounds for treating refractory epilepsy and other brain disorders. About PsychoGenics Inc. PsychoGenics is a leader in vivo phenotypic drug discovery. The company applies its proprietary technology platforms in partnership with pharmaceutical and biotechnology companies to discover the next generation of drugs for neuropsychiatric disorders. PsychoGenics' capabilities include standard behavioral testing, electrophysiology, translational EEG, molecular biology, and state-of-the-art microdialysis. In addition, the company offers a variety of in-licensed transgenic mouse models that support research in areas such as Huntington's disease, Autism spectrum disorders, psychosis/schizophrenia, Alzheimer's disease, Parkinson's disease, sleep, and Spinal Muscular Atrophy muscular dystrophy and other muscle disorders.

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BUSINESS INSIGHTS

BD Completes Acquisition of Parata Systems

BD | July 19, 2022

BD announced it has completed the acquisition of Parata Systems. Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. "Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations." Tom Polen, chairman, chief executive officer and president of BD The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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BUSINESS INSIGHTS

Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

Akorn Pharmaceuticals | August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1 "We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics." Akorn President and CEO Douglas Boothe Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2 The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix. According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million. About Cetrorelix Acetate for Injection 0.25 mg Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation. About Akorn Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.

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Spotlight

Pharmaceutical or biotechnology companies looking to outsource their API production are planning for success by looking at the entire development cycle. The growing desire to select one API partner to work with throughout the drug development process, and to potentially also synthesize commercial quantities, put an increased importance on the selection process.

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