Is there life beyond Keytruda? Merck makes its case in first investor event in 5 years

fiercepharma | June 20, 2019

Merck CEO Ken Frazier kicked off Thursdays Investor Day presentation by acknowledging that the companys most recently lauded blockbuster, immunooncology drug Keytruda, is also its biggest challenge. “Everywhere I go, the key question I hear from people is ‘What do you have beyond Keytruda?’” Frazier said in his introduction to the investor presentation—the company’s first such event in five years. “But I think what we’re going to be able to show you today is that we do have tremendous growth opportunities beyond Keytruda.” It’s no wonder Frazier finds himself constantly facing the Keytruda question, considering how dominant that one product has been in Merck’s financial reports over the last few years. Even as recently as the first quarter of this year, when Keytruda’s sales leaped 60% to $2.3 billion, the company touted the recent successes that Frazier and his colleagues vowed would drive growth even more, including its new FDA approval for the first-line treatment of non-small cell lung cancer patients who have low levels of the biomarker PD-L1. During Investor Day, Merck’s chief commercial officer, Frank Clyburn, pointed out that Keytruda is just now starting to forge another new market—renal cell carcinoma. He reported that at the recent conference of the American Society of Clinical Oncology (ASCO), clinicians told him the data in kidney cancer would be “practice changing.” Oncologists were also excited about the potential of the drug in adjuvant melanoma, both in the U.S. and overseas, he said. CFO Rob Davis said he is confident that as Merck moves away from selling drugs mostly to a primary-care audience toward more hospital-administered products, the company’s profit margins will expand. Operating expenses will grow at a rate “meaningfully below sales,” he said. And the resulting margin expansion “will translate to accelerated earnings-per-share growth,” he vowed.

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Adare Pharma Solutions announces divestiture of postbiotics pioneer Adare Biome to dsm-firmenich

prnewswire | July 04, 2023

Adare Pharma Solutions, a global technology-driven CDMO focused on oral dosage forms, today announced the completion of its divestiture of its Adare Biome business unit, a pioneer in the development and manufacturing of postbiotics, to dsm-firmenich, innovators in nutrition, health, and beauty. The transaction represents an enterprise value of €275 million, an estimated 2023 EV/EBITDA multiple of 18x. Tom Sellig, CEO of Adare Pharma Solutions, commented: "dsm-firmenich is the ideal company to take Adare Biome to the next level and realize the growth potential of postbiotics. They have the infrastructure, together with strong commercialization and science capabilities, to scale the significant scientific research that we've achieved over the years. This divestiture will provide Adare Pharma Solutions with additional resources for our core CDMO business and allow us to further grow our position as a world-class outsourcing partner to the pharmaceutical industry." dsm-firmenich intends to extend the availability of Lactéol®, Adare Biome's over-the-counter postbiotic supplement for relieving gut upsets, through its B2C unit, i-Health. Further development of postbiotic B2B ingredients will include opportunities in dietary supplements, early-life nutrition, medical nutrition, and nutritional improvement for the under-nourished. The acquisition of Adare Biome will also position dsm-firmenich as a leader in the growing microbiome management market for pets, and expand its animal health range, where the stability of postbiotics means they can be incorporated into premix feed solutions. Philip Eykerman, dsm-firmenich's President Health, Nutrition & Care, said: "Adare Biome, as a global leader in the research and manufacturing of postbiotics with over a century of pioneering science in its heritage, is a perfect fit for dsm-firmenich that will complement three of our four Business Units. The Adare Biome teams bring great knowledge in this area which will greatly help in driving our 'Health from the Gut' strategy and enable us to accelerate the creation of next-generation biotics to support the health of people and animals. We are excited to welcome the Adare Biome people to the dsm-firmenich family and about the new opportunities this move will unlock. dsm-firmenich's strong global presence and reach in local markets will enable us to deliver Adare Biome products to customers in a faster, more efficient way to bring the proven benefits of postbiotics to a wider range of people around the world." About Adare Pharma Solutions Adare Pharma Solutions is a global, technology-driven CDMO providing product development through commercial manufacturing expertise, with a focus on oral dosage forms for the pharmaceutical industry. Adare's specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare has developed and manufactured more than 65 products sold by customers in more than 100 countries globally. More information can be found at www.adarepharmasolutions.com. About dsm-firmenich As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.

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Pharmacy Market

Frontage Acquires Nucro-Technics Inc. and Nucro-Technics Holdings, Inc.

PRNewswire | August 17, 2023

Frontage Laboratories, Inc. and its wholly-owned subsidiary, Frontage Canada, Inc., completed the acquisition of Nucro-Technics Inc. and its affiliate Nucro-Technics Holdings, Inc. Nucro-Technics is a pharmaceutical contract research organization that conducts analytical chemistry, microbiology, toxicology, bioanalytical, and stability sample storage and testing services. In addition, it provides consulting services, especially in quality control and assurance as well as in Natural Health Product Regulations. Nucro-Technics, located in the Toronto, Canada metropolitan area, operates in a state-of-the-art 60,000 square foot facility and employs personnel having expertise in testing both large and small molecules designed to treat various medical conditions. For over 50 years, Nucro-Technics has been conducting studies for various clients including major pharmaceutical, biotech, and medical device companies, as well as smaller organizations including industry trade groups and academia. Nucro-Technics has successfully developed and validated numerous methods, as well as participated in providing comprehensive IND packages to clients for regulatory submissions. Nucro-Technics, an ISO 9001:2015 certified organization, conducts studies that are in compliance with GLP and GMP regulations. "Today marks a momentous and an exciting occasion. It is a day to celebrate two great companies coming together. It is with great pleasure that I welcome the extraordinary Nucro-Technics team to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "Nucro-Technics has been recognized as a leader in the Canadian CRO market for over 50 years, and its unparalleled client services is a perfect match for the culture of Frontage Laboratories. This acquisition not only significantly strengthens our presence in Canada, but also will enable the combined organization to offer a more expansive suite of services to clients across the globe. We are looking forward to partnering with the Nucro team to deliver the world-class expertise that clients have come to expect from us." According to Dr. Song Li, Founder and Chairman of Frontage: "Nucro has developed a remarkable platform with a truly impressive team of experts. The closing of this transaction marks the next step in our ongoing effort to build Frontage into one of the major players in the global CRO market. In doing so, we will continue our focus on delivering the highest levels of quality, technology and expertise to our clients." "I'm delighted to announce that we will be partnering with Frontage Labs for the next phase of Nucro Technics' growth journey. Since founding the business in 1970, we've worked hard to become the North American boutique in pre-clinical and drug product release testing services. Partnering with Frontage Labs marks an exciting chapter in the evolution of our efforts to support and accelerate pharmaceutical research and development," said John Fanaras of Nucro Technics. Frontage was advised by Borden Ladner Gervais LLP (BLG) while Nucro-Technics was advised by Dentons and PricewaterhouseCoopers Corporate Finance Inc. About Frontage Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals.  Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.

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Pharmacy Market

Signant Health Extends the Power of Clinical Supply Management Software to the Small and Mid-Size Market Through Updated

PRNewswire | July 11, 2023

Signant Health, the leader in evidence generation for modern clinical trials, announced expanded flexibility and capabilities for its leading Signant SmartSignals Supplies software, empowering small and mid-size customers to experience the advantages of technology-driven clinical supply management. Relaunched as Signant SmartSignals Supplies GxP Inventory, the solution provides sponsors and contract research organizations (CROs) with efficient, comprehensive management and oversight of the end-to-end supply chain. Unlike spreadsheet-based supply chain management, the GxP Inventory solution offers centralized, full visibility of clinical trial material creation, release, and distribution activities within a single system. Available as either an Essential or Enterprise option, clinical research sponsors can select the optimal solution for their needs, which is often dictated by size or trial volume. The Essential option enables sponsors to deploy quickly using our pre-configured system for inventory manufacturing, management, and QA/QP release. The Enterprise option provides more advanced features for larger customers with internal supply chain capabilities to meet more individualized requirements, sponsor-specific terminology/labels, and additional workflow/process options. Both options are SaaS-based for cost-effective implementation, reduction of internal technology investments, and ease of ongoing maintenance. "Signant is extremely proud of its heritage as a leading provider of GxP inventory management solutions to many top-20 sponsor organizations. Our Essential option now extends the same benefits to smaller sponsors and CROs who wish to have the same level of inventory control, regulatory compliance, and visibility in a more compact, per-protocol commercial offering," said Sanjiv Waghmare, Signant's chief product officer. Technology-based solutions make clinical trials safer for patients through better visibility and control of supplies, particularly with respect to investigational products. From sourcing drug substance ingredients to randomized patient kits, these solutions ensure that all supply chain data is in one place, and not distributed across spreadsheets, emails, and external inventory management systems. With the launch of the Essential option, we are making the technology-based solution for clinical supply management accessible to sponsors of all sizes. About Signant Health Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics.

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