BUSINESS INSIGHTS, PHARMA TECH
Northstar and Inhibrx | January 09, 2023
NorthStar Medical Radioisotopes, LLC, announced a collaboration with Inhibrx, Inc., to develop and produce new radiopharmaceuticals for cancer treatment.
Inhibrx will develop a new generation of targeted alpha treatments utilizing its improved single-domain antibodies (sdAbs). With a long history of sdAb innovation, it has created a library of sdAbs targeting tumor-associated antigens. Its high binding affinity and specificity for tumor cells or antigen-expressing cells within the tumor microenvironment make sdAbs an ideal biological targeting agent for radioisotope delivery. In addition, alpha-emitting radioisotopes have a small range of activity and high energy transfer, allowing for the targeted destruction of cancer cells with minimum damage to adjacent healthy tissue.
NorthStar is expanding its position as an industry leader in the rapidly-growing field of therapeutic radioisotopes, and it is now prepared to become the first commercial-scale manufacturer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67).
Under the terms of this agreement, NorthStar will provide the supply of Ac-225 and access to its comprehensive radiopharmaceutical contract development and manufacturing organization (CDMO) services to assist the development of a predetermined number of Inhibrx's novel biologic medicines. NorthStar will also prepare Inhibrx patient dosages for clinical studies and, upon approval, may manufacture and supply radionuclides for its commercial use.
About NorthStar Medical Radioisotopes, LLC
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company with a mission to provide patients with global access to game-changing radiopharmaceuticals. The company uses ecologically preferable technologies to create, manufacture, and distribute diagnostic imaging and therapeutic radiopharmaceuticals. It is the only commercial U.S. producer of molybdenum-99, an essential diagnostic imaging radioisotope (Mo-99). The FDA-approved RadioGenix® System (technetium Tc 99m generator) uses US-manufactured, non-uranium-based Mo-99 as the source material to generate technetium-99m (Tc-99m), which is used to assess heart disease and cancer.
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.
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).
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.