PHARMA TECH
PR Newswire | January 09, 2024
AION Labs, the first-of-its-kind venture studio spearheading the adoption of AI technologies and computational science to solve therapeutic challenges, announced today a new strategic partnership with Amiti Ventures, one of the leading early-stage venture capital firms in Israel. The partnership further strengthens the alliance of global leaders in pharma, biotech, and technology investment, expanding its offering as a venture studio and partner for new startups.
"With a proven track record of identifying the best teams for the mission and investing early in the most innovative deep tech startups that shape the future, Amiti Ventures will bring important complementary capabilities and expert investor knowledge to the AION Labs partnership," said Mati Gill, CEO of AION Labs. "We thank Amiti for its vote of confidence in our model of innovation for groundbreaking AI and computational biotech ventures. We further appreciate Amiti's recognition that Israel's ecosystem is poised to lead the world in bringing AI and biotech together to solve our biggest drug discovery challenges."
By joining forces with Amiti, AION Labs is enhancing its expertise and capabilities in the deep tech and computational technology domains, areas that are critical to the success of biotech innovation. Amiti's extensive experience and track record in these fields will bring invaluable investor knowledge and insights to AION Labs, enabling it to more effectively develop and support early-stage startups focused on AI and computational biology. Amiti's first investment in the venture studio will entail investment in DenovAI Biotech's Seed round of funding. Launched in 2022, DenovAI is developing an AI-powered biophysics solution for de novo antibody and protein design.
AION Labs builds and invests in early-stage startup teams focused on AI and computational biology in drug discovery and development, offering them top-notch resources and mentorship while working closely with them to develop new technologies that meet the most significant challenges in the pharmaceutical industry. The partnership with Amiti Ventures will help AION Labs to advance healthcare towards patient-centric precision medicine and create a significant contribution to the health and well-being of humankind by helping to bring new treatments to market faster and more efficiently.
"We believe that AION Labs is uniquely positioned to identify the biggest challenges to accelerate drug discovery and development and then evaluate the best computational bio approaches and entrepreneurs," said Ben Rabinowitz, Founder and Managing Partner of Amiti Ventures. "AION Labs' venture studio model bridges the gap between outstanding academic research, huge leaps forward in generative AI, and the biggest challenges and opportunities in the development of new medicines, and we look forward to working closely with our new partners to make this a reality.
"We also have been amazed by the can-do spirit of the AION Labs team," added Rabinowitz. "It is that readiness to create, pull themselves up by the bootstraps and forge ahead with amazing innovation that makes AION and Israel's entire startup ecosystem so special."
About AION Labs
AION Labs is a first-of-its-kind alliance of Astrazeneca, Merck, Pfizer, Teva, the Israel Biotech Fund, Amiti Ventures, and Amazon Web Services (AWS), powered by BioMed X with the support of the Israeli Government via the Israel Innovation Authority, that have come together with one clear mission: to create and adopt groundbreaking new AI technologies that will transform the process of drug discovery and development in order to contribute to the health and well-being of all people world-wide.
AION Labs is a unique venture hub where brilliant innovators and scientist-founders convene from around the world to solve the biggest R&D challenges guided by years of accumulated know-how, data and experience in pharma. The lab leverages its partners' wealth of knowledge and a new multidisciplinary mindset with the ingenuity, agility and innovative power of Israel's startup ecosystem, to develop strong companies with clear long-term strategies, that will pave the way to the future of healthcare. AION Labs cultivates innovation from within; its unique venture creation process bridges the gap between outstanding academic research in the field of AI and the biggest R&D needs in the discovery and development of new medicines for the benefit of patients.
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PHARMA TECH
PR Newswire | January 03, 2024
ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a leading Spanish pharmaceutical company selected ValGenesis VLMS – the industry's most trusted electronic validation lifecycle management system – to digitize its corporate validation process.
Founded in Spain over eight decades ago, the company focuses on developing over the counter (OTC) drugs and products. Since then, it has grown its production to include prescription (RX) drugs and launched its first generic product on the Spanish market.
The company's decision to transition from conventional paper-based methods signifies its move toward 100% digital operations, marking a new era in efficiency and traceability in manufacturing operations. The ValGenesis VLMS provides an all-encompassing digital solution to fully manage their validation lifecycle, ensuring accuracy, data integrity, and compliance with worldwide regulatory standards.
"We are pleased to onboard our first Spanish customer and first partner deal in the region," says Steve Reynolds, Chief Revenue Officer at ValGenesis. "This win represents a step-change in the way ValGenesis and its partners collaboratively address the industry's needs. We look forward to helping our customer leverage cutting-edge digital validation technology on their path to digital transformation, balancing speed with strict adherence to regulatory compliance."
About ValGenesis
ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.
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PHARMA TECH
PR Newswire | January 08, 2024
Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) has added three new endocrinology therapies to its specialist portfolio, following an exclusive distribution agreement with Danish company Ascendis Pharma A/S.
Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFA (lonapegsomatropin), hypoparathyroidism treatment YORVIPATH (palopegteriparatide) and investigational achondroplasia therapy TransCon CNP (navepegritide).
The agreement spans ST's key regions of Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam.
Two of the products included in this agreement are already internationally approved:
Once-weekly SKYTROFA is a human growth hormone (hGH) approved in the United States for the treatment of paediatric patients aged >1 years weighing >11.5 kg with growth failure due to inadequate secretion of endogenous growth hormone (GH)1 and in the European Union for growth failure in children and adolescents aged from 3 to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]).
YORVIPATH is a first-in-class parathyroid hormone (PTH) replacement therapy to treat chronic hypoparathyroidism, a rare and potentially serious condition where the body produces no or abnormally low levels of PTH. It is approved in the European Union for the treatment of adults with chronic hypoparathyroidism.
The third product – TransCon CNP – is in development by Ascendis Pharma for the treatment of achondroplasia (ACH), the most common genetic form of skeletal dysplasia and resulting disproportionate short stature, following successful Phase 2 trial results.
Australian endocrinologist Dr Veronica Preda noted that YORVIPATH would be the first specialist therapeutic option for Australian patients living with hypoparathyroidism.
"Hypoparathyroidism can seriously impact quality of life and has potentially life-threatening consequences," Dr Preda said.
"To have an option that is able to treat the underlying cause of the disease, moving beyond standard oral calcium and active Vitamin D, is a great step forward."
Announcing the partnership, ST Chief Executive Officer Carlo Montagner said this agreement was an important company milestone, signalling ST's expansion into both endocrinology and paediatric medicine.
Mr Montagner commented: "We are delighted to have been selected as Ascendis Pharma's exclusive partner for commercialising their portfolio in Oceania and these South-East Asia countries and look forward to launching these critical endocrinology products in our regions as soon as possible.
"All three products are valuable inclusions to our broad therapeutic pipeline and our international business, as we continue to leverage our substantial experience commercialising specialist medicines across multiple regions.
"We look forward to working with endocrinologists across our territories to make these endocrine therapies available to all eligible patients who may benefit."
Ascendis Pharma Executive Vice President and Chief Commercial Officer Camilla Harder Hartvig said ST had been selected to launch the endocrinology portfolio in these countries based on its strong track record commercialising specialist products in multiple regions.
"We are delighted to partner with Specialised Therapeutics to broaden the reach of our endocrinology rare disease portfolio, contributing to our shared goal of making a meaningful difference for patients facing unmet medical needs," she said.
About Specialised Therapeutics
Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA).
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