businesswire | August 25, 2023
Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU).
Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment. In the EU only one drug therapy limited to a subset of DED patients with severe keratitis is currently approved.
CyclASol is ciclosporin, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. Dispensed in a unique 10 microliter small drop the solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity.
“Our in Heidelberg, Germany, invented water-free technology was designed to unfold the full potential of pharmaceuticals on the ocular surface,” said Christian Roesky, Ph.D., Chief Executive Officer of Novaliq. “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.”
The clinical development program for the MAA is based on six clinical studies, which evaluated the safety and efficacy of CyclASol in a total of 1,575 patients with dry eye disease. Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED. Continued improvement under therapy in both signs and symptoms of DED has been clinically demonstrated over a period of up to 56 weeks in an extension study of ESSENCE‑2. With its early onset of effect and its good tolerability profile CyclASol addresses unmet medical needs in DED.
CyclASol was approved by the U.S. Food and Drug Administration (FDA) as VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 30, 2023. VEVYE is the first and only FDA approved cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment and is commercialized in Northern America by Harrow Health Inc, a leading U.S. eyecare pharmaceutical company.
Novaliq is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® the worldwide first water-free ophthalmic technology.
Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases based on its proprietary water-free eyedrop technology. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023.
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.
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.
PRNewswire | July 21, 2023
Catalyst Clinical Research an industry-leading provider of specialized clinical development solutions, announced today it has acquired Genpro Research ("Genpro"), a Massachusetts-based global clinical research organization with staff in the US, India, and Ireland.
Genpro is a next generation services and technology partner for the pharmaceutical, biotechnology, and medical devices industry with expertise in biometrics, medical writing, RWE, and AI enabled automation product development. Genpro will continue to be led by Dr. Sachin Marulkar and the existing management team.
Commenting on the announcement, Catalyst CEO Nick Dyer said, "We are hugely enthusiastic about the addition of Genpro to our family. We share the opportunity to expand our global footprint, broaden and deepen our services, and to use the AI platform to create value for ourselves and customers in a range of labor-intensive document creation processes. In addition, our approach to prioritizing culture and treating our teams like family are similar and will act as a critical foundation for our combined company as we move forward."
Genpro CEO Dr. Sachin Marulkar added, "By joining Catalyst, we will continue to expand our biometrics, scientific reporting and technology offerings, have access to more opportunities globally, and provide our clients with additional products and services. We are excited to utilize the synergies in advancing our AI/ML technology platform to create beneficial new tools and improve the efficiency of clinical research. Catalyst is highly aligned with our purpose, values, and our relationship-driven focus. We look forward to stepping into these opportunities while still acting with the speed and flexibility our customers value and maintaining the collaborative culture that is so important to our employees."
This acquisition adds more than 120 team members in India with expertise in biometrics and medical writing further bolstering Catalyst's robust functional service offerings. This further enables biopharma, MedTech and CRO clients (current and future) to access Catalyst's specialized clinical research services, along with broader expertise in global time zones, new solutions, and early access to innovative automation platforms.
Melissa Church, Senior Vice President, Strategy at Catalyst, expressed the strategic significance of the acquisition, emphasizing its importance in advancing Catalyst's commitment to providing top-notch specialized clinical development solutions. She stated, "Catalyst is extremely intentional in its acquisition approach, ensuring we choose organizations that are additive to our capabilities and match well with our people-first culture. In Genpro we are gaining a very talented team delivering function specific biometrics and medical writing services which fits squarely in our strategic growth plan supporting both our Catalyst Flex and Catalyst Oncology solutions. This creates more value for our customers, collaborators, partners and investors long term."
Highlighting scientific and innovation focus of the deal, Kapil Khambholja, Genpro's CSO and Practice Head of Medical Writing, Real-World Evidence, and Health Economics and Outcomes Research (RWE & HEOR) emphasised both company's shared commitment for advancing therapies beyond milestones to transforming lives. Dr Kapil stated, "This partnership will propel Genpro's automation roadmap forward, aligning strategically with Catalyst's interests. We are also thrilled to see Genpro's scientific initiatives gaining momentum, and we eagerly anticipate collaborating with Catalyst's dedicated team to inspire advancements of breakthrough therapies touching lives."
About Catalyst Clinical Research
Catalyst is a clinical research organization (CRO) that provides highly customizable solutions to the global biopharmaceutical industry through two established, branded solutions: Catalyst Oncology and Catalyst Flex. The company provides full-service oncology CRO offerings through Catalyst Oncology and multi-therapeutic Client- or Catalyst-managed functional services through Catalyst Flex. With around 1000 staff and offices in the United States, Europe, and Asia-Pacific regions, Catalyst's flexible service model is built from more than a decade of listening to customers, devising customer-centric solutions, and helping customers drive breakthrough clinical studies by leveraging expert teams and innovative technologies.
Catalyst is a portfolio company of QHP Capital, a leading healthcare and life sciences investment firm.
About Genpro Research
Genpro Research is a technology and services partner dedicated to serving the pharmaceutical, biotechnology, and medical devices industries. By providing expertise in biostatistics, data sciences, medical writing & evidence synthesis, the focus has been on thoughtful service execution on clinical studies. And, as an experienced technology provider, Genpro uses Artificial Intelligence, Machine Learning, and Natural Language Processing algorithms for clinical development and post-launch activities, Genpro's central commercial platform called MaiA is used for Evidence Generation and Study Report Automation that brings depth and clarity to enable informed decision making.