AbbVies rising immunology star Skyrizi scores nod from Englands cost watchdog.

fiercepharma | July 15, 2019

With long time immunology blockbuster Humira on the decline, AbbVie is looking to next-gen competitor Skyrizi to chip in. A nod from England's cost watchdog could help. The National Institute for Health and Care Excellence (NICE) recommended (PDF) Skyrizi as a second-line treatment for severe plaque psoriasis in adults who've failed on conventional treatments such as ciclosporin, methoxotrate and phototherapy. In its final appraisal, NICE said second-line Skyrizi was more effective for plaque psoriasis than Humira and Johnson & Johnson’s Il-12/23 med Stelara and similar in health benefits to J&J’s Tremfya, a head-to-head IL-23 competitor. AbbVie has touted Skyrizi as a cost-effective alternative to its closest immunology rivals. That growing field includes the aging anti-TNF class, IL-23 and IL-12/23 inhibitors, and next-gen IL-17 inhibitors like Novartis’ Cosentyx, Eli Lilly’s Taltz and Bausch Health’s Siliq. That cost edge is one reason Skyrizi rolled out a pricing plan in April to include an $88,500 first-year price on the new med—inclusive of two starter doses—and $59,000 maintenance doses.

Spotlight

The idea of combining a drug to a targeting molecule as a ‘Magic Bullet’ was first suggested by the German Physician Paul Erhlich in the early 1900’s.1,2 Antibody Drug Conjugates (ADCs) comprises a monoclonal antibody, linker region, and cytotoxic warhead. The Antibody head binds to specific antigens on the tumor surface. When the ADC is internalized by the tumor cell, the linker is degraded releasing the cytotoxin, leading to cell death.


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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

UCB Showcases Strength of the Expanding Dermatology Portfolio at the 31st EADV Congress

UCB, Inc. | September 02, 2022

UCB, a global biopharmaceutical company, today announced that it will present 20 abstracts across its dermatology portfolio at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy, September 7-10. The abstracts, accepted for poster presentation, underscore UCB's commitment to delivering innovative solutions that aim to address the unmet needs of people living with dermatological diseases. "We are proud to present new data from our expanding dermatology portfolio at the 31st EADV Congress. At UCB, our ambition is to transform the lives of people living with severe diseases such as psoriasis and psoriatic arthritis, and the strength of scientific data at this year's congress reaffirms our long-standing commitment to raising standards of care," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. Key data to be presented on UCB's investigational product bimekizumab include new results from the BE BRIGHT open-label extension study evaluating maintenance of response with bimekizumab through three years in patients with moderate to severe plaque psoriasis who responded at week 16 during Phase 3 clinical studies. New analysis of pooled safety data from up to three years of treatment with bimekizumab in the treatment of moderate to severe plaque psoriasis across Phase 2 and 3 clinical trials will also be presented. Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S. and it is not approved by the U.S. Food and Drug Administration (FDA). For CIMZIA® (certolizumab pegol), data to be presented include three-year data from three Phase 3 trials evaluating the association of patient-reported outcomes (Dermatology Life Quality Index, DLQI 0/1) with relative skin clearance improvements (Psoriasis Area and Severity Index, PASI) in subgroups of adult patients with moderate to severe plaque psoriasis. About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB).

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VIEWS AND ANALYSIS

Enteris BioPharma Publishes White Paper Examining Factors to Consider While Evaluating Oral Administration of Peptides

Enteris BioPharma | September 13, 2022

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation announced the publication of a new white paper in Drug Development & Delivery entitled, "Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration." The paper, authored by John Vrettos, PhD, Director of Formulation Development for Enteris BioPharma, and Kalpana Ramakrishnan, PhD, Manager of Business Development for Enteris BioPharma, explores the barriers to developing oral delivery of peptides and how pharmaceutical companies can overcome them. Oral administration of peptides offers several advantages while treating chronic conditions such as diabetes and obesity as they are less invasive and more cost effective compared to injections. "Molecule size, potency, and solubility are some of the key physicochemical properties that determine a peptide's suitability for oral delivery. The healthcare industry is in need of enabling drug delivery technologies with the capability to overcome barriers in oral delivery of peptides. Importantly, orally delivered medications may encourage patient compliance compared with more invasive approaches to administering drugs. Approximately 75% of peptides are delivered by injective routes, including subcutaneous injections which can be painful and difficult to incorporate into a daily routine." Dr. Vrettos Dr. Vrettos continued, "Enteris' Peptelligence® platform offers a 'triple-action' solution comprised of our enteric coating, protease inhibitor, and permeation enhancer. When combined, these technologies have demonstrated an ability to improve the solubility and permeation of orally delivered peptides. These properties can potentially enable oral delivery of some peptide drugs for the first time, and we are excited to share our knowledge on oral delivery of peptides through this informative whitepaper." Peptelligence is a novel formulation technology designed to enhance the oral delivery and bioavailability of selected drugs by enhancing the permeation of such compounds that are typically injected, including peptides and BCS class III and IV small molecules, and preventing their breakdown in the digestive tract. About Enteris BioPharma Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation offering total integrated contract development and manufacturing services for innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®, and contract manufacturing (CMO) services using non-proprietary technologies. The company's proprietary technologies have been the subject of numerous feasibility studies and active development programs, some of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option.

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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

The idea of combining a drug to a targeting molecule as a ‘Magic Bullet’ was first suggested by the German Physician Paul Erhlich in the early 1900’s.1,2 Antibody Drug Conjugates (ADCs) comprises a monoclonal antibody, linker region, and cytotoxic warhead. The Antibody head binds to specific antigens on the tumor surface. When the ADC is internalized by the tumor cell, the linker is degraded releasing the cytotoxin, leading to cell death.

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