PHARMACY MARKET
GlobeNewswire | September 12, 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 acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024.
Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027.
“The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.”
About Libervant
Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access.
About Aquestive
Aquestive 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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PHARMACY MARKET
PR Newswire | October 12, 2023
Indivior PLC a leading addiction treatment company, announced that it has gained exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of long-acting injectable formulations that release a prodrug1 of buprenorphine at varying durations, including its lead long-acting injectable ("LAI") candidate, ALA-1000.
ALA-1000 is a sustained-release LAI prodrug of buprenorphine. With dosage intervals of potentially up to four times per year, ALA-1000 could address unmet opioid use disorder ("OUD") patient needs with a longer duration of treatment, which could provide an option for patients seeking a less frequent maintenance therapy regimen, for patients living in remote areas without easy access to care, and for high-risk patients, such as those transitioning from the Justice system.
Under the agreement with Alar, Indivior will pay $10 million to secure exclusive global rights to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates. The $10 million payment is in addition to an initial $5 million option payment made by Indivior to Alar in Q1. Alar is entitled to potential milestone payments if various developmental, regulatory, and commercial goals are achieved.
"Alar provides Indivior with a unique opportunity to further address unmet patient needs in the treatment of OUD with potentially the first three-month buprenorphine LAI," said Christian Heidbreder, Chief Scientific Officer. "By providing a therapeutic option for patients who might benefit from less frequent dosing, ALA-1000 has the potential to broaden the spectrum of care for OUD treatment as well as enhance the addressable patient population."
ALA-1000 is an investigational drug and is positioned to be the first three-month buprenorphine administered subcutaneously entering the clinical stage. Results from a single-ascending dose ("SAD") study, announced by Alar in January 2022, demonstrated the safety, tolerability and sustained release profile of ALA-1000 over 12 weeks in patients with OUD2. Alar has been granted composition of matter and formulation patents for ALA-1000 covering sustained-release buprenorphine formulations with expiry in 2037 and 2039.
Based in Taichung, Taiwan, Alar is a drug development company which focuses on developing long-acting drug products for central nervous system ("CNS") disorders and chronic diseases, utilizing its proprietary depot technology. Compared with other long-acting subcutaneous injection technologies, its proprietary platform has been associated with distinctive characteristics such as low viscosity solution, small injection volume and sustained drug release profile.
The transaction is not expected to have a material impact on the Group's FY 2023 adjusted results.
About Indivior
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder (SUD). Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in 39 countries worldwide.
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PHARMA TECH
Business Wire | September 14, 2023
GoodRx a leading resource for healthcare savings and information, and MedImpact, the independent pharmacy benefit manager (PBM) and health solutions company, announced a new savings solution designed to integrate GoodRx’s prescription pricing in a seamless experience at the pharmacy counter. Now, when an eligible MedImpact member fills a prescription for a generic medication, it will automatically compare their benefit and the GoodRx price and then deliver the lowest one. The amount paid will be applied to the member’s deductible.
“This solution allows us to meet Americans where they are by providing them with low prices on their prescriptions without the need for them to compare costs on their own,” said Cynthia Meiners, Strategic Program Development Officer at GoodRx. “We are bringing together the best of what GoodRx does with the best of what MedImpact does to make it incredibly convenient for MedImpact’s members to start and stay on their prescribed treatments, and to fully integrate their clinical data. We truly feel the future of healthcare lies in these types of integrations.”
The collaboration achieved by integrating GoodRx’s price comparison technology with MedImpact’s advanced technology platform allows both companies to deliver more savings without any additional work on the part of the consumer. In addition, members will benefit from the seamless data integration this program provides. Through MedImpact’s rigorous drug safety review, which includes thousands of health and safety checks, patients will be alerted about any negative drug interactions.
“We are delivering to clients a full portfolio of health, wellness and savings solutions and we see this program as an important part of it,” Marcus Sredzinski, Pharm D, General Manager and MedImpact Senior Vice President. “This delivers hassle-free savings to members, while helping payers capture clinical and adherence data they may have otherwise missed.”
GoodRx is actively working to access new lives by expanding its prescription savings reach by partnering with pharmacy benefit managers and their plan sponsors to collaboratively integrate into the insurance benefit market. Through these programs with CVS Caremark, Express Scripts, and MedImpact, GoodRx savings are seamlessly integrated at point-of-sale with three major PBMs that reach over 60% of insured lives.
This new program will become available to eligible MedImpact members starting January 1, 2024.
About GoodRx
GoodRx is a leading resource for healthcare savings and information that makes healthcare affordable and convenient for all Americans. We offer consumers free access to transparent and lower prices for brand and generic medications, affordable and convenient medical provider consultations via telehealth, and comprehensive healthcare research and information. Since 2011, we have helped consumers save over $60 billion and are one of the most downloaded medical apps over the past decade.
GoodRx periodically posts information that may be important to investors on its investor relations website at https://investors.goodrx.com. We intend to use our website as a means of disclosing material nonpublic information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors and potential investors are encouraged to consult GoodRx’s website regularly for important information, in addition to following GoodRx’s press releases, filings with the Securities and Exchange Commission (the “SEC”) and public conference calls and webcasts. The information contained on, or that may be accessed through, GoodRx’s website is not incorporated by reference into, and is not a part of, this press release.
About MedImpact
For more than 30 years, MedImpact has been building, delivering, and reimagining pharmacy benefit solutions for healthcare payers who face complex and dynamic challenges. As the leading independent PBM, we offer clients the clarity they need to make care and cost decisions; control over a powerful suite of solutions that manage pharmacy spend; and confidence that comes from a proven PBM partner who is fully aligned with their goals and invested in their future.
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