Merck to spin off women’s health and biosimilar drug businesses

The Globe and Mail | February 05, 2020

Merck & Co Inc said on Wednesday it will spin off its women’s health, biosimilar drugs and older products into a separate publicly traded company as it tightens its focus on growth drivers like cancer drug Keytruda and vaccines. The new company’s assets currently make up around 15 per cent of Merck’s total sales and around half of its drugs that treat people. Merck will retain its animal health business, as well as drugs used for acute care in hospitals such as Bridion, which reverses the effects of anesthesia. Merck shares fell 3.7 per cent to $85.12 after the U.S. drugmaker also reported quarterly Keytruda sales below Wall Street’s lofty estimates. The spinoff is a culmination of the drugmaker’s strategy of concentrating on a few key areas, particularly oncology, where Merck has turned the immunotherapy Keytruda into one of the world’s top selling drugs, Merck Chief Executive Ken Frazier said in an interview.

Spotlight

In the fields of medicine, biotechnology, and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery.


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BUSINESS INSIGHTS

NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

NanOlogy | September 21, 2022

NanOlogy LLC, a clinical-stage interventional oncology drug company, announced that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel has been published in Drug Delivery and Translational Research. The review article entitled Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune‑mediated tumoricidal effects: preclinical and clinical studies provides a review of preclinical research that supports tumor-directed LSAM-DTX as well as promising results from the high-risk nonmuscle invasive bladder cancer arm of a clinical trial of local LSAM-DTX in urothelial carcinoma, which were published earlier this year in The Journal of Urology. The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel published in DDTR in 2020. In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers. The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity. Taxane particles are covered by composition of matter patents issued in the US Canada, Europe, Japan, China, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology. About NanOlogy NanOlogy, LLC is a private clinical-stage interventional oncology drug company formed in 2015 to improve the treatment of solid tumors based on a proprietary particle engineering technology platform for tumor-directed drug therapy to maximize drug in tumor and minimize systemic toxicity.

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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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BUSINESS INSIGHTS

DisperSol Appoints Tim Scott New President and CEO; Company Changes Name to AustinPx™, Pharmaceutics and Manufacturing

AustinPx | August 29, 2022

DisperSol Technologies, LLC, a specialty pharmaceutical company announced the appointment of Tim Scott as president and chief executive officer of the company. At the same time, the company announced that it is changing its name to AustinPx™, Pharmaceutics and Manufacturing, to better reflect the company’s new direction as a contract development and manufacturing organization. Mr. Scott also joins the board of directors of AustinPx. The hiring of Mr. Scott and the company name change to AustinPx, Pharmaceutics and Manufacturing, are part of a shift in the focus of the pharmaceutical technology company that first developed KinetiSol® technology, a patented amorphous dispersion technology for improving drug bioavailability. The company will now provide pharmaceutical chemistry services including analytical and formulation development and cGMP manufacturing at its site in Austin, Texas. Mr. Scott was the co-founder and president of Pharmatek Laboratories from 1999 until 2016, when he sold the company to Catalent Pharma Solutions (NYSE: CTLT). He currently serves as board chair of Biocom, a trade organization supporting 2,000 life science companies. Mr. Scott also serves on the Medical Research Advisory Committee for the Conrad Prebys Foundation, providing grants to innovative research in the health sciences. “I can think of no one better to lead the transformation of AustinPx than Tim. He brings a wealth of experience in building a contract development and manufacturing business, and he has strong connections throughout the industry. We are delighted to have his leadership as we build AustinPx into a world class CDMO.” Shaun Kirkpatrick, President at Research Corporation Technologies and board chair of AustinPx “Our goal is to build a client-centric organization that provides drug development and manufacturing services for pharma companies worldwide,” says Scott. “The name AustinPx represents where we come from and what we do. Px stands for Pharmaceutics. To our core, we are a pharmaceutics company. Our approach is data-driven and agnostic, which means our formulation strategy for each drug is based on the unique physiochemistry of that compound. And for poorly soluble compounds, we have one of the most powerful tools available in KinetiSol, a truly next generation technology for rendering active pharmaceutical ingredients amorphous.” KinetiSol is a proprietary technology for improving drug bioavailability. This advanced technology transforms active pharmaceutical ingredients into amorphous solid dispersions, thereby enhancing the physiochemistry and PK of drugs. KinetiSol offers many advantages over other amorphous dispersion technologies. It provides a broader formulation design space and a more efficient scale-up. Additionally, KinetiSol’s significantly smaller ecological footprint makes it a greener technology. About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. The company specializes in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules – including its next generation amorphous dispersion platform, KinetiSol®. AustinPx’s lead investors include Research Corporation Technologies, Inc. and Acadia Woods.

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BUSINESS INSIGHTS

Hovione expands drug product offering with a new manufacturing line dedicated to Continuous Tableting

Hovione | September 07, 2022

Hovione, the leader in spray drying and particle engineering, announced that it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is now coming online at the Loures site in Portugal. In addition, to support Hovione's commitment to providing access and services for continuous tableting, Hovione has further strengthened its capabilities by establishing a highly experienced multi-disciplinary global team in continuous tableting and upgrading its labs with the tools needed to support the drug product lifecycle, thereby further guaranteeing competency and capacity from research & development to production. Continuous manufacturing is expected to change the landscape of drug product development and commercial production. The Food and Drug Administration (FDA) is partnering with the International Council for Harmonization and leading a global initiative to advance continuous manufacturing of small molecules and other pharmaceutical modalities. Hovione is offering customers a commercial continuous tableting platform prepared to support key control needs and deliver on operational excellence, mechanistic modeling, and appropriate process analytical technology (PAT). Additionally, Hovione´s quality system has been designed to support the release of continuous tableting products through automated in-process controls, deployment of real time release, and compliant digital infrastructure. This cutting-edge technology offers a distinct set of features and advantages including faster development of simpler processes, agile manufacturing for variable demand, robust control strategies and high process quality standards. "Hovione has been historically focused on innovative technologies that benefit our customers and patients. With this investment in continuous tableting, our customers can rely on our support to bring much needed medicines to the market as fast as possible with the highest quality and manufacturing standards. We are investing to accelerate the adoption of this technology as we continue to innovate and enhance our offering around our areas of expertise." Jean-Luc Herbeaux, Hovione´s CEO "This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering and responds to the growing customer interest." says Filipe Neves, Hovione´s Strategic Business Director. This latest investment in Continuous Tableting is part of Hovione´s broader strategy to build differentiated and enabling capabilities and assets to meet customers unique needs for oral dosage forms manufacturing. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API and formulation development to devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

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Spotlight

In the fields of medicine, biotechnology, and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery.

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