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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RESEARCH
PR Newswire | January 09, 2024
DotLab, a medical diagnostics company, announced top-tier pharmaceutical research clients for its DotEndo platform. The customers include global companies with interests in diagnosing or monitoring endometriosis on a Research Use Only basis in clinical trial subjects to support the development of new medicines.
"We're proud to share the news of our global pharmaceutical partners, which are complementary to our planned, large clinical offering for commercial endometriosis tests based on our technologies," said DotLab's founder, Heather Bowerman. "Our pharma partners conducted rigorous diligence of our science and intellectual property prior to the execution of our contracts, and they view our platform as the first of its kind and the leader in this space."
The DotEndo™ platform's AI/ML technology was developed via DotLab's EMPOWER clinical trial, a prospective, observational, multi-center study run at endometriosis centers of excellence across the United States. EMPOWER is the most robust clinical study of its type ever performed for diagnosing and monitoring endometriosis, making it an excellent foundation for the platform. Based on these successes, DotLab announced Morgan Stanley as a new investor in late 2023.
"We intend to continue to offer our pharma clients – and, ultimately, clinicians – a comprehensive endometriosis menu of tests and tools. Endometriosis is notorious for its complex biology, and there has long been a need for tests and tools to diagnose and monitor endometriosis – and ultimately, to improve endpoints for the disease in therapeutic trials," said Bowerman.
About DotLab
Dot Laboratories, Inc. ("DotLab") is solving some of the world's most significant diagnostic challenges via the latest advancements in multiomics and computational biology. The company delivers clinical innovations to areas of significant unmet need via novel, cutting-edge biomarkers and the power of machine learning to deliver non-invasive tests. The company has driven a paradigm shift in the identification and management of endometriosis. DotLab is female-founded and female-led.
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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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