Business Insights

NovaBay Pharmaceuticals Collaborates with Harrow Health’s ImprimisRx to Promote Prescription Avenova

NovaBay Pharmaceuticals | July 20, 2021

NovaBay Pharmaceuticals, Inc., a pharmaceutical firm focused on commercializing Avenova for the eye care market, has announced a collaboration with ImprimisRx, one of the nation's top ophthalmology-focused pharmaceutical companies, to promote prescription Avenova. ImprimisRx, a wholly-owned subsidiary of Harrow Health, Inc., will offer national sales, marketing, and distribution support for NovaBay's FDA-cleared 0.01% hypochlorous acid Avenova in 40 ml bottles. Avenova is a clinically approved antimicrobial lid and lash solution used to treat various chronic eye conditions.

Avenova serves a large and rapidly growing dry eye market, with 30 million Americans suffering from chronic eye diseases such as blepharitis and meibomian gland dysfunction. It is the only lid and lash spray made with NovaBay's patented pure hypochlorous acid and is suitable for daily usage. In addition, Avenova is usually prescribed by ophthalmologists and optometrists before and after cataract and Lasik procedures, making it a complementary therapy for many ImprimisRx's existing products.

About ImprimisRx
ImprimisRx is one of the nation's top ophthalmology-focused pharmaceutical companies, with 40 proprietary ophthalmic formulations serving thousands of ophthalmologists and optometrists throughout all 50 states.

About Harrow Health
Harrow Health, Inc. is a healthcare company specializing in ophthalmology. ImprimisRx, the leading ophthalmology-focused pharmaceutical company, and Visionology, a direct-to-consumer eye care subsidiary focusing on chronic eye disease, are owned and operated by the company. Harrow Health also owns stakes in Eton Pharmaceuticals, Surface Ophthalmics, and Melt Pharmaceuticals, all of which began as Harrow Health subsidiaries. Harrow Health also has royalty rights to four clinical-stage drug candidates developed by Surface Ophthalmics and Melt Pharmaceuticals.

About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focused on high-quality, differentiated anti-infective consumer products such as Avenova, the top antimicrobial lid and lash spray, CelleRx Clinical Reset, a game-changing product in the beauty category, and NeutroPhase Skin and Wound Cleanser for wound healing. NovaBay products include its patented, pure, stable, pharmaceutical-grade hypochlorous acid, replicating the antimicrobial chemicals used by white blood cells to combat infection. NovaBay's hypochlorous acid products cause no stinging or irritation, are nontoxic, and are non-sensitizing, making them entirely safe for daily usage. In addition, Avenova is the first commercial hypochlorous acid lid and lash spray product that has clinically proven to reduce bacterial load on ocular skin surfaces, effectively addressing the underlying cause of bacterial dry eye.

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Learn about the industry’s first pharmaceutical supply chain solution that is reducing the cost of care and ensuring access to critical medications for hospitals and health systems.

Spotlight

Learn about the industry’s first pharmaceutical supply chain solution that is reducing the cost of care and ensuring access to critical medications for hospitals and health systems.

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Business Insights, PHARMACY MARKET

Verista Announces New Partnership with Sware to Transform Digital Validation in the Life Sciences Industry

PRNewswire | August 09, 2023

Verista, a leading business and technology services company offering specialized solutions for the life sciences industry, is delighted to announce a new partnership with Sware. This collaboration underscores Verista's commitment to its clients to provide advanced and innovative digital validation solutions, helping them realize Pharma 4.0. By incorporating Sware's Res_Q platform, clients can enhance, streamline, and optimize the flow of content and data, effectively addressing the challenges posed by static documents and disjointed workflows in the validation discipline. Together, Verista services and Res_Q provide a powerful combination, offering customers a comprehensive and efficient risk-based approach to validation processes in the life sciences industry. "In this partnership, Verista will drive the efficient execution of digital transformations with Res_Q enabling clients to modernize their processes and leverage the latest regulated technologies in compliant ways," says Manny Soman, CEO of Verista. "We are delighted that Verista and Sware share the same goal to reduce and manage validation efforts while helping clients unleash the full potential of digital transformation to bring their products to market more quickly and safely." "Digitizing the validation process is crucial for compliance-focused life sciences companies to be able to meet stringent global regulatory requirements, but digitizing processes means much more than putting paper processes on glass," says Bryan Ennis, Co-Founder and CEO of Sware. "Our partnership with Verista couples our deep digital technology expertise with robust industry experience to deliver the most comprehensive, intelligent and digital validation solutions on the market today." ABOUT VERISTA Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from clinical to commercialization, manufacturing and distribution. Verista's experts continually deliver consistent, safe, and high-quality results across the product development lifecycle in the areas of enterprise and lab solutions, technology solutions, manufacturing solutions, and regulatory compliance and product management. ABOUT SWARE Sware is changing how the life sciences industry manages validation – helping companies deliver safer therapies through better technology. Sware provides one validation solution crafted specifically for the entire life sciences industry. Res_Q by Sware automates validation – effortlessly navigating through each step of the validation process for both GxP and non-GxP systems.

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Pharmacy Market

Palatin Announces Direct-to-Consumer Telehealth Partnership with UpScriptHealth™ for Vyleesi®

PRNewswire | August 08, 2023

Palatin Technologies, Inc. a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that it has entered a strategic partnership with UpScriptHealth, a leading direct-to-consumer telemedicine company providing telemedicine services to pharmaceutical and medical technology companies. Under terms of the agreement, UpScriptHealth will make Vyleesi available to the hundreds of thousands of patients in its proprietary Women's Telehealth Platform. Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). "We are excited to partner with UpScriptHealth, a pioneer in telehealth," stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "This partnership fortifies our existing telehealth programs and provides a platform to create greater awareness of HSDD and access to Vyleesi through UpScriptHealth's patient base of hundreds of thousands of women." "UpScriptHealth's Women's Telehealth Platform was launched in 2015 to provide women with a convenient way to consult healthcare providers and obtain therapies to improve the quality of their lives," stated Peter Ax, Founder and Chief Executive Officer of UpScriptHealth. "The addition of Vyleesi furthers our female health strategy and provides our patient base with education surrounding HSDD as a significant and common condition, and importantly, access to a meaningful treatment option." About Vyleesi® (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD) Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD. Palatin is actively seeking Vyleesi collaborations for the United States and for territories outside the currently licensed territories of China and South Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. About UpScriptHealth UpScriptHealth™ is the leading comprehensive, direct-to-consumer telehealth and virtual prescribing platform that has been innovating the way customers receive care and obtain medications for more than two decades. UpScriptHealth is committed to improving the lives of consumers by providing immediate and long-term convenient access to medical therapies. UpScriptHealth's philosophy of providing extraordinary care is strengthened through their core values of transparency, integrity and the relentless pursuit of excellence.

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PHARMACY MARKET

Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients

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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