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.”
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.
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.
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.
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.
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.
PR Newswire | October 19, 2023
Halozyme Therapeutics, Inc. announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds. In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers. The injection was delivered successfully to all 23 participants and was well tolerated.
"To our knowledge, this is the first clinical study of its kind," said Mike LaBarre, chief technical officer of Halozyme. "Traditional subcutaneous auto-injector delivery methods are typically limited to volumes less than 2 mL or require long delivery times at slow rates for higher volumes. By enabling rapid subcutaneous injection of high volumes of biologic products, our ENHANZE drug delivery technology in combination with our proprietary HVAI has the potential to improve the patient experience for multiple therapies."
In the study, a representative biologic, immunoglobulin 10%, was delivered to 23 healthy volunteers. The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE® and HVAI technologies.
96% of participants stated that they would be willing to receive the injection again.
90% of participants indicated feeling either no pain or mild pain immediately after injection.
Erythema, swelling, and induration were generally minimal to mild and resolved by 90 minutes or less.
Biologics delivered subcutaneously through auto-injectors are typically restricted to doses of 1-2 mL. This limitation is caused by hyaluronan, a molecule that inhibits fluid dispersion in the subcutaneous space. Halozyme's ENHANZE® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally degrades hyaluronan in the subcutaneous space. This temporarily increases the permeability of the tissue under the skin, allowing space for the biologic to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream.
"These results support our continued dedication to providing innovative drug delivery options to patients," said Helen Torley, chief executive officer of Halozyme. "Our ENHANZE drug delivery and HVAI technologies have the potential to rapidly deliver large volume therapeutics subcutaneously with the potential for meaningful clinical benefits."
Halozyme's HVAI is available to partners for clinical use.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Pfizer and Idorsia Pharmaceuticals.