SiriusDecisions Expands Benchmarking Performance Capabilities and Global Coverage

SiriusDecisions | July 10, 2017

SiriusDecisions has expanded its core industry benchmark database, the SiriusIndex™, the only one of its kind in the b-to-b industry, with new metrics across four major categories, including readiness, activity, output and results, and offered its clients unparalleled access to data from their peers with the introduction of its new Command Center™ platform. Now commercially available, it will enable business leaders to drive strategic and tactical changes informed by insights, best-in-class frameworks, readiness and performance metrics, and peer comparisons with the data, and qualitative guidance from SiriusDecisions analysts they know they can trust. With the data to support a variety of decisions from investments and organizational structures, to strategy development and process design, SiriusDecisions’ Command Center™ helps marketing, sales and product leaders realize competitive advantages, ensure smarter allocation of budget and human resources, and respond more nimbly to specific situations and opportunities.“We have made a major investment in data collection, analysis and the reporting engine fueling our client delivery portal called the SiriusDecisions Command Center™, which provides real-time access to more than 750 b-to-b industry metrics at your fingertips,” said Bruce Brien, Chief Technology Officer of SiriusDecisions. “The new platform will empower leaders to move quickly to energize their organizations’ performance and seize opportunities, with wiser organizational investment and resource allocation.”

Spotlight

The vast majority of endotoxin tests for pharmaceuticals and medical devices, as well as their in-process intermediates and raw materials, are microplate-based. They require tedious reconstitution and dilution steps for preparation of Control Standard Endotoxin (CSE) dilutions and Positive Product Controls (PPCs). These time-consuming manual handling steps can result in substantial variability and a significant number of invalid results that demand repeat testing. To address these issues, as well as to reduce the time for microplate preparation, we have developed a ready-to-use microplate the GOPLATE embedding required CSE amounts in dried format. Thus, the conventional standard dilution has become completely obsolete; in turn, the GOPLATE significantly lowers the risk for human error and cost-intensive test repetition. The GOPLATE is included in a complete test kit, ENDOZYME II GO. The new microplate is the first of its kind, ready-to-use and enables high reduction in handling time as well as consistent standard curve and PPC accuracy.


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BUSINESS INSIGHTS

Prime Medicine Expands Leadership Team with Key Appointments to Support Continued Growth and Advancement of Prime Editing Technology and Portfolio

Prime Medicine | July 29, 2022

Prime Medicine, Inc. a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, Prime Editors, to address the widest spectrum of diseases by deploying Prime Editing technology “Prime Medicine is advancing a first-of-its-kind technology intended to expand the number of patients who may benefit from genetic medicines. We are thrilled to welcome Richard, Niamh and Fubao to the team. Together, they bring strong business acumen, extensive clinical and regulatory experience and leadership of successful teams that position us well to achieve our mission. These esteemed leaders have deep expertise across their respective focus areas, each of which is key to the advancement of our novel Prime Editing technology.” Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine Richard Brudnick, Chief Business Officer, brings extensive industry experience, including leading successful business development transactions, across multiple stages of development and an array of therapeutic areas. Mr. Brudnick was previously Chief Business Officer and Head of Strategy at Codiak BioSciences and, before that, was Executive Vice President of Business Development and Alliance Management at Bioverativ, Inc., a company he helped found in 2016. Mr. Brudnick joined Bioverativ at the time of its spinoff from Biogen where, over the course of nearly 15 years, he initiated, led and completed numerous transactions, including for several of the company's marketed products and late-stage pipeline, including Tecfidera, Spinraza and its biosimilars joint venture with Samsung. Previously, Mr. Brudnick was the Chief Executive Officer of a regional pharmaceutical distribution business that he sold to a strategic buyer, co-founded two companies, and was a strategy consultant at Bain & Company. Mr. Brudnick earned his undergraduate degree in management science from MIT and his M.S. in management from the Sloan School of Management at MIT. Niamh Alix, Chief Human Resources (HR) Officer, is a human resources leader who brings nearly 20 years of experience helping to grow teams from small, early-stage organizations to global enterprises. She joins Prime from Orchard Therapeutics, where she was Vice President, Global Talent and HR Business Partner. Prior to that, Ms. Alix held multiple global and regional roles at Lonza, including HR Business Partner for Americas, Mexico, and Canada where she led the HR team and people strategy for a 5,000+ employee population across corporate and manufacturing clients, and across multiple scientific platforms including cell and gene therapy. Prior to that, she held senior HR roles of increasing responsibility at Novartis and Bristol Myers Squibb. She holds a master’s degree in HR strategies from Dublin City University and a B.Sc. in management from the Technological University of Dublin. Fubao Wang, Ph.D., SVP, Head of Regulatory, has substantial experience leading product development of genomic medicine products, as well as regulatory strategies and execution for both clinical and commercial-stage products. Before Prime, Dr. Wang served as Senior Vice President, Head of Regulatory Affairs at Asklepios BioPharmaceutical where he built and led the regulatory team to support the development of clinical-stage AAV-based gene therapy products. Earlier, he was Vice President, Head of Regulatory CMC at Sarepta Therapeutics, where he supported the development of AAV gene therapy and RNA products, including the FDA approvals of Vyondys and Amondys. He also served as Associate Vice President, U.S. Site Head, CMC Dossiers at Sanofi to support the BLA approval of Dupixent, a monoclonal antibody product. Prior to that, he held a 16-year tenure at Merck serving in research, development and regulatory roles of increasing responsibility, most recently as director, global and emerging markets regulatory affairs, led and contributed to the discovery and development of a variety of vaccine and biologics products. Dr. Wang holds a Ph.D. in molecular biology from Heidelberg University and completed his postdoctoral work in molecular biology at Stanford University. About Prime Medicine Prime Medicine, Inc. is a biotechnology company committed to delivering a new class of differentiated, one-time, curative genetic therapies to address the widest spectrum of diseases. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position within a gene. With the theoretical potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing, if approved, could offer a one-time curative genetic therapeutic option to a broad set of patients.

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BUSINESS INSIGHTS

Can-Fite Granted Key NASH Patent in Israel

Can-Fite BioPharma Ltd. | May 17, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced that its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" has been granted by the Israel Patent Office. This patent has been issued in approximately 40 countries and territories including Japan, South Korea, Hong Kong, Mexico, and in the European Union. It addresses the use of the A3 Adenosine Receptor ligand, the target receptor for Can-Fite's drug platform technology, for the treatment of ectopic fat accumulation particularly in fatty liver as manifested in non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. The treatment of NASH is a market estimated to reach $35 billion by 2025. Can-Fite is currently enrolling and treating patients in a Phase IIb NASH study of its liver drug candidate Namodenoson. The multi-center, randomized, double blind, and placebo controlled study of biopsy-confirmed NASH patients will measure efficacy periodically through biomarkers, with a primary efficacy endpoint determined by liver biopsy at the end of the treatment period. In a prior Phase IIa study, Namodenoson met endpoints including reduced liver fat content, anti-inflammatory effects, and decreased body weight with excellent safety. “The treatment of NASH is an enormous unmet need that Can-Fite seeks to meet through our advanced stage clinical trial and our expanding patent estate for the use of our target A3AR in the treatment of fatty liver disease,” Can-Fite CEO Dr. Pnina Fishman About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. Namodenoson is being evaluated in a pivotal Phase III trial as a second line treatment for hepatocellular carcinoma, and in a Phase IIb trial as a treatment for non-alcoholic steatohepatitis. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson has completed enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

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BUSINESS INSIGHTS

Acorda Therapeutics and Biopas Laboratories Announce Agreement to Commercialize INBRIJA® in Latin America

Acorda Therapeutics, Inc. | May 12, 2022

Acorda Therapeutics, Inc. and Biopas Laboratorie announced that they have entered into distribution and supply agreements to commercialize INBRIJA® in Latin America. INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. Under the terms of the agreements, Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA in Latin America in exchange for supply of the product. Acorda will also receive sales-based milestones. Biopas will have the exclusive distribution rights to INBRIJA in nine countries within Latin America, including Brazil and Mexico. According to current population estimates, there are at least 400,000 people living with Parkinson's disease in Latin America1. Biopas plans on seeking marketing authorization in all countries to make Inbrija available for patients as quickly as possible. “BIOPAS is the leader in commercializing CNS therapies in Latin America and we are delighted to announce these agreements to make INBRIJA available there to people with Parkinson’s disease who suffer from OFF periods. We are also in active discussions with other companies for the rights to commercialize INBRIJA in additional countries.” Ron Cohen, M.D., President and CEO of Acorda Therapeutics “We are excited to be collaborating with Acorda to make INBRIJA available to people with Parkinson’s disease in Latin America. This important partnership supports Biopas’ mission to cover unmet medical needs of patients from Argentina to Mexico. Inbrija further strengthens Biopas’ complete and innovative CNS portfolio now consisting of nine original treatments: for Parkinson’s disease, epilepsy, movement disorders, sialorrea, multiple sclerosis, anxiety, and sleep disorders,” said Pascal Forget, CEO of Biopas. About Acorda Therapeutics Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® Extended Release Tablets, 10 mg. About Biopas Laboratories Biopas is a leading and differentiated Latin American Pharmaceutical company, focused on in-licensing, marketing and selling cutting-edge specialty pharmaceutical products. Biopas offers the best-in-class capabilities in sales, marketing, medical, support functions and provides integral services to support the launch and development of products. All its functions operate in compliance with international standards and regulations. Biopas covers 20+ countries in LatAm through fully owned subsidiaries and is a trusted partner of reputable multinational pharmaceutical companies, and has products in leading positions in CNS, Immunology, Rare Disease, Oncology, and Dermatology.

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BUSINESS INSIGHTS

Catalent Announces New Operating Structure

Catalent, Inc | July 06, 2022

Catalent, Inc. the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced changes to its operating structure and executive leadership team that went into effect July 1. This new organizational structure includes a shift from four reporting segments to two, each representing roughly half of the total company revenue. According to Alessandro Maselli, Catalent’s President and Chief Executive Officer since July 1, the segment changes reflect evolving customer and industry trends and position the company to deliver its next level of growth and achievement. “Our industry continues to demonstrate steady growth, and this new structure will allow us to be more agile in meeting and anticipating customer needs and expectations. Among other benefits, it will create commercial synergies for our customers, as they will be better able to access the full range of Catalent services applicable to their molecules.” Maselli Dr. Aris Gennadios was named Group President of Catalent’s newly formed Pharma and Consumer Health segment. The new segment consolidates the company’s prior Softgel & Oral Technologies segment, which Gennadios had led since 2013, and its Oral & Specialty Delivery and Clinical Supply Services segments. “Combining our businesses focused on the development and supply of pharmaceutical and consumer health products will provide our customers with more integrated solutions, streamlined service, and simplified delivery of the solutions they need to accelerate their path to patients and consumers,” said Dr. Gennadios. The new Pharma and Consumer Health segment will encompass the offerings of the three prior segments, including the company’s market-leading softgels, Zydis® fast-dissolve technologies, gummy dosage forms, clinical development and trial supply services, and global pharma manufacturing platforms. Dedicated teams will focus on Catalent’s pharmaceutical, consumer health, and clinical development and supply solutions to further drive value for customers and the opportunity for accelerated growth of these businesses. The scope of Catalent’s other reporting segment, Biologics, continues without any change. This organizational restructuring has also been accompanied by a few additional leadership changes. Jonathan Arnold, who previously served as President, Oral & Specialty Delivery, since 2017, is Catalent’s new Senior Vice President, Chief Commercial Officer, and Head of Transformation. He will be dedicated to ensuring a best-in-class customer experience and working closely with others on the leadership team to optimize the company’s growing portfolio. Additionally, Steven Fasman, who previously served as Senior Vice President and General Counsel since 2014, will be Catalent’s Executive Vice President and Chief Administrative Officer, a newly created position. Mr. Fasman will oversee certain administrative functions of the company, including legal & compliance, information technology, engineering, procurement, governmental affairs, and various ESG-related departments. Finally, Karen Flynn has announced her decision to retire from her role as Catalent’s Senior Vice President and Chief Commercial Officer. “Karen has played a critical role on the Executive Leadership Team since joining Catalent in early 2020. I am immensely grateful for her leadership, innovative thinking, and steadfast commitment to the company,” said Maselli. About Catalent, Inc. Catalent, Inc. an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the industry’s preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year.

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Spotlight

The vast majority of endotoxin tests for pharmaceuticals and medical devices, as well as their in-process intermediates and raw materials, are microplate-based. They require tedious reconstitution and dilution steps for preparation of Control Standard Endotoxin (CSE) dilutions and Positive Product Controls (PPCs). These time-consuming manual handling steps can result in substantial variability and a significant number of invalid results that demand repeat testing. To address these issues, as well as to reduce the time for microplate preparation, we have developed a ready-to-use microplate the GOPLATE embedding required CSE amounts in dried format. Thus, the conventional standard dilution has become completely obsolete; in turn, the GOPLATE significantly lowers the risk for human error and cost-intensive test repetition. The GOPLATE is included in a complete test kit, ENDOZYME II GO. The new microplate is the first of its kind, ready-to-use and enables high reduction in handling time as well as consistent standard curve and PPC accuracy.

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