Kedalion Therapeutics, | November 16, 2021
Kedalion Therapeutics is pleased to announce the completion of its Series B financing led by Novartis and involving a combination of new and existing investors. The Novartis investment includes an Exclusive Option to Acquire the company and its AcuStream™ technology. This agreement follows a Feasibility Study agreement with the AcuStream™ technology signed earlier this year. The subsequent feasibility study has been completed with successful results. Collaboration between the two parties is ongoing. The financial and other terms of this transaction are not disclosed.
Kedalion’s AcuStream™ platform is a highly innovative, digitally connected, electromechanical topical ocular delivery device that aims to address a potential unmet need for a convenient, user-friendly device that reliably, accurately, and comfortably delivers topical ocular therapy with improved efficiency and patient comfort, and reduced reliance on patient skill and instillation technique when administered by a physician.1 The multi-dose, preservative-free platform strives to enable intended aim, potential for a comfortable patient experience, micro-dosing capability, and in phase 1 proof of concept studies, has shown a potential for a reduction in delivery dose of an intended therapy.1-4 Kedalion will continue to move forward with the development of the AcuStream™ platform across multiple disease categories, drug classes and compositions, including the treatment of presbyopia. The AcuStream™ technology has a potential to enhance the patient experience and optimize treatment outcomes of the company’s highly advanced portfolio of topical ocular drug products in development.
The company looks forward to the opportunity to collaborate with Novartis Innovative Medicines as a valued investor and partner in developing our technology platform and therapeutic targets.
“At Novartis, we are committed to reimagining medicine and investigating innovative approaches that have the potential to address unmet patient needs. The AcuStream™ technology is a novel platform with broad applicability in ophthalmics and we envisio that it could help us deliver transformative solutions to the patients who rely on our therapeutics to treat a range of eye conditions.”
Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals
Dr. Mark Blumenkranz, the Chairman and Chief Executive of Kedalion Therapeutics, commented that “this transaction and associated further studies will help us accomplish our goal of revolutionizing the way drugs are delivered to the eye. The AcuStream™ technology, which strives to enable easier aiming, micro-dosing capability, and a potential for a reduction in delivery dose of an intended therapy, has the potential for a comfortable patient experience for patients worldwide.1 The platform could potentially provide convenience and enable micro-dosing capability for various ocular diseases.1 We see our capabilities coupled with the scientific and market leadership of Novartis in ophthalmics to be a winning formula for both organizations.”
About Kedalion Therapeutics
Kedalion Therapeutics is a venture-backed, clinical-stage biotechnology company whose mission is to bring to market transformative topical ophthalmic therapies for new and existing indications. Kedalion’s proprietary AcuStream™ platform technology delivers topical drugs to the eye in a precise and accurate manner that enables comparable effect with up to an 80% reduction in dose compared to standard eye drops. Kedalion is based in Menlo Park, CA.
Moderna | June 08, 2021
Moderna, Inc., a biotechnology company that pioneered messenger RNA (mRNA) therapeutics and vaccines, and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, announced today a new agreement to commercialize the Moderna COVID-19 Vaccine in Central Eastern Europe and Israel.
Poland, Czech Republic, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia, and Herzegovina, Kosovo, North Macedonia, Montenegro, and Israel are among the nations included by the pact.
"We are excited to work with Moderna in 20 markets, covering over 175 million people across the whole Central Eastern Europe region and in Israel," stated Meir Jakobsohn, Medison Pharma's Founder and CEO. "With Moderna's ground-breaking mRNA vaccine and Medison's international commercialization platform for highly innovative treatments, our collaboration is a perfect fit."
"We value this new collaboration with Medison Pharma to ensure the successful launch of our mRNA COVID-19 vaccine," stated Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna. "By delivering our vaccines in collaboration with our partners, we stay consistent in our commitment to fighting the pandemic."
About Medison Pharma
Medison is a global pharmaceutical company that focuses on commercializing highly innovative therapies in international markets. Medison offers a full range of integrated services for companies looking to establish a presence in international markets, drawing on a 25-year track record and collaborations with major biotech companies.
Medison also has a corporate venture arm with a dedicated research and evaluation team with significant scientific and commercial expertise.
Moderna has evolved from a science research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant. Moderna maintains alliances with a diverse range of domestic & global government and commercial collaborators, allowing for the pursuit of both ground-breaking science and rapid manufacturing scale.
Nuventra, CATO SMS | May 27, 2021
CATO SMS, a global provider of regulatory and clinical research services, announced today the acquisition of Nuventra, Inc., to expand its offering into the critical area of clinical pharmacology. Nuventra, headquartered in Durham, North Carolina, is a leading company in clinical pharmacology science and services. The acquisition expands CATO SMS's portfolio of specialized solutions that help biopharmaceutical companies with drug development by providing a key set of skills targeted at significantly reducing development risk, costs, and timelines.
CATO SMS now provides customers cutting-edge clinical pharmacology services such as strategic consulting, pharmacokinetics/pharmacodynamics (PK/PD), pharmacometrics (population PK), and biosimulation. Nuventra is well-known for its track record of transforming complex data into meaningful insights for over 650 biopharmaceutical companies across a wide range of therapeutic areas. Its team of scientific experts and senior consultants use the most advanced mathematical modeling tools in the industry to inform clinical design and predict trial outcomes.
Nuventra's range of solutions include:
• pharmacokinetics and pharmacodynamics (PK/PD), which describes the movement of drugs through the body from absorption to elimination (PK), as well as the body's biological response to drugs (PD) to determine optimal dosing paradigms, safety margins, and efficacy characteristics.
• population pharmacokinetics (popPK and popPK/PD), which studies the variability in drug concentrations among individuals in a group of interest receiving clinically relevant doses of a drug.
• clinical pharmacology strategic consulting, which includes overall and targeted clinical pharmacology strategy in support of marketing applications for drugs and biologics.
• physiologically based pharmacokinetic (PBPK), which incorporates blood flow and tissue composition of organs to predict the absorption, distribution, metabolism, and excretion (ADME) of drugs.
• quantitative systems pharmacology (QSP), which models the interplay of the drug (dose, dosing regimen, etc.) with target biology, using computational systems to characterize the interaction between drugs, biological systems, and disease processes.
• model-informed drug development (MIDD), which uses modeling techniques to improve the decision-making process in drug development, thereby leading to clinical trial efficiencies and, in some cases, replacing trials altogether.
Nuventra is the pharmaceutical industry's preferred provider of clinical pharmacology, pharmacokinetics, and pharmacometrics consulting services. Nuventra provides pharmaceutical companies and contracts research organizations (CROs) with unique access to a hands-on team of industry-leading consultants with extensive experience in complex studies and analyses. By taking complex pharmacokinetic and pharmacometrics concepts and making them understandable and usable for common sense drug development, we embrace the notion that simplicity and clarity lead to smart decisions.
About CATO SMS
CATO SMS is a provider of specialized clinical research solutions formed in 2019 by the merger of Cato Research and SMS-oncology. CATO SMS, with over 30 years of professional experience focusing on the needs of small and emerging biopharmaceutical companies, effectively designs and executes studies from strategy to approval in complex indications and modalities throughout a wide range of therapeutic areas, with a proven center of excellence in oncology. The regulatory, therapeutic, and operational expertise of CATO SMS enables the company to meet and exceed expectations.