BUSINESS INSIGHTS
Businesswire | May 22, 2023
Closed Loop Medicine Ltd, a leading TechBio company, developing combination prescription drug plus software therapy products that enable personalized dose optimization, and Pharmanovia, a global pharmaceutical company that commercializes novel medicines and revitalizes, extends and expands the lifecycle of established medicines, today announced that they have entered a global co-development partnership.
The partnership will initially focus on the development and launch of a drug + software combination version of a first-line anti-hypertensive in the UK, before phased global roll-out and additional therapies are added.
Hypertension is the leading preventable cause of morbidity and premature death worldwide, impacting over 1 in 4 men and 1 in 5 women, and costing the NHS alone over £2.1 billion/year (1, 2). Managing high-blood pressure through medication and lifestyle modifications significantly reduces associated health risks and improves quality of life; research in the US demonstrating improved standards of care could prevent 91,900 heart attacks, 139,000 strokes and 115,400 cardiovascular deaths within just 5 years (3). However, poor drug tolerability and treatment-related side effects significantly impact adherence, with less than 50% of patients maintaining their treatment regimen after a year, ultimately hindering treatment effectiveness, patient outcomes and overall disease management (4).
As part of this partnership, Closed Loop Medicine’s proprietary Software-as-a-Medical Device (SaMD) dosing optimization technology will be combined with Pharmanovia’s established anti-hypertensive medicines, under a single prescription. Recent preliminary clinical trial results have demonstrated that Closed Loop Medicine’s technology may provide the ability to dose optimize drug therapy, improve blood pressure control, and minimize side effects (5). By developing a new class of combination products for the treatment of hypertension, both companies aim to support patients and healthcare professionals to better manage high blood pressure.
Dr. Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine, commented: “This pioneering partnership is a great example of where the power of software integration can add value to iconic medicines to make them more effective for patients. Through this co-development agreement, we will bring our IP, insight and technical know-how of dose optimized drug plus software integration alongside Pharmanovia’s innovative business model, to enable well-known and trusted brands to be positioned as value-driven precision medicine product solutions globally.”
Dr. James Burt, CEO of Pharmanovia, said: “Combining our experience in lifecycle management with Closed Loop Medicine’s unique approach and technology is an exciting next step in our strategy. It enables us to use innovative technology to enhance established medicines and bring much needed innovation to an area of large-scale unmet need. Together we aim to deliver a first in class combination regulated software and medicine – with the aim of delivering better patient outcomes, while enabling healthcare systems to reduce costly hospital procedures through better adherence and patient engagement.”
AboutPharmanovia
Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by enhancing established medicines either by rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and through strategic partnerships.
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BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 30, 2023
Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced it has expanded its exclusive license and supply agreement with Atnahs Pharma UK Limited (“Pharmanovia”), a global pharmaceutical company that revitalizes, extends and expands the lifecycle of established medicines, for Libervant™ Buccal Film to cover the rest of the world, excluding the United States, Canada, and China. The original licensing agreement with Pharmanovia announced in September 2022 covered the European Union, United Kingdom, Sweden, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA).
“We are pleased to announce the expansion of our collaboration with Pharmanovia,” said Daniel Barber, Chief Executive Officer of Aquestive. “We believe Pharmanovia’s experience and geographic footprint align well with our goal of providing patients throughout the world with access to Libervant. This announcement also aligns with our mission to put the patient at the center of everything we do. We will continue to advocate for patient access, patient choice, and patient empowerment on a global basis.”
Pharmanovia CEO, James Burt, commented, “Following a strong start to our collaboration with Aquestive Therapeutics, we’ve expanded our agreement to include many more territories. Our experience with diazepam marketed under an established brand in Valium®, combined with Aquestive Therapeutics’ unique PharmFilm® technology, provides a potentially significant delivery option to caregivers and patients in times of critical need and enables us to optimize an existing medicine to better meet the needs of patients, healthcare professionals and payors.”
Pursuant to the expanded agreement, Aquestive Therapeutics will serve as the exclusive sole manufacturer and supplier for the product and Pharmanovia will be responsible for all regulatory and commercialization activities. Aquestive will receive an undisclosed upfront payment and, if approved for market access, milestone payments, and double-digit royalties on net sales of the diazepam buccal film in the licensed territories.
About Aquestive Therapeutics
Aquestive Therapeutics, Inc. is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.
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BUSINESS INSIGHTS, PHARMA TECH
Indivior | March 06, 2023
Indivior PLC, a global pharmaceutical company, recently announced its successful acquisition of Opiant Pharmaceuticals, Inc. The acquisition strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets. In particular, OPNT003, an investigational opioid overdose treatment, aims to provide an effective treatment option to address the current wave of opioid overdose caused by powerful synthetic opioids such as fentanyl.
Indivior acquired Opiant for an upfront consideration of $20.00 per share in cash, summing to approximately $145 million and up to $8.00 per share in contingent value rights (CVRs). The CVRs will become payable if OPNT003 meets certain net revenue milestones within seven years after approval and launch. The acquisition was completed after meeting customary conditions, and Indivior funded the upfront consideration with its existing cash. It expects OPNT003 to generate net revenue of 150 million to 250 million dollars and the acquisition to be earnings accretive after the second year of launch. The company plans to provide updated guidance for FY 2023 with its Q1 results announcement on April 27, 2023.
OPNT003 is a patent-protected intranasal formulation of nalmefene. It employs an absorption-enhancing technology to improve its pharmacokinetic and pharmacodynamic profile, resulting in a fast-acting and long-lasting duration of action that helps OPNT003 as a possible new treatment option for opioid overdose. On December 22, 2022, Opiant completed its rolling NDA for OPNT003. OPNT003's FDA PDUFA date is May 22, 2023. One formulation patent (expiry 2038) and five other patent applications cover various aspects of OPNT003, including treatment methods. National Institutes of Health, National Institute on Drug Abuse (NIDA) is funding the development of the program, as well as an agreement from Biological Advanced Research and Development Authority (BARDA).
About Indivior
A global pharmaceutical company, Indivior, is working to support patients in changing their lives by developing medicines that help in coming out of addiction and severe mental illnesses. The company aims to provide access to evidence-based treatment to all patients globally for chronic conditions and co-occurring disorders of substance use disorder (SUD). It is committed to transforming substance use disorder from a worldwide human crisis to a recognized and treated chronic illness. In addition, it has a pipeline of product candidates designed to build on its global portfolio of OUD treatments and potentially address other chronic conditions and co-occurring disorders of SUD, such as alcohol use disorder and cannabis use disorder.
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