PHARMACY MARKET

CURE Pharmaceutical Receives Patent Approval for Its CUREfilm Blue™ Technology

CURE Pharmaceutical Holding Corp. | November 17, 2021

CURE Pharmaceutical Holding Corp. (OTC: CURR), a technology focused, vertically integrated drug delivery and product development company focused on pharmaceutical and health & wellness products, announced today that it received an issue notification from the U.S. Patent Office (USPTO) stating that U.S. Patent No. 11,179,331 (the ’331 patent) is set to issue on November 23, 2021. The ’331 patent, entitled “Oral Soluble Film Containing Sildenafil Citrate,” covers the product CUREfilm Blue™, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra®1) for the treatment of erectile dysfunction (ED). CURE is seeking approval of this product via the 505(b)(2) regulatory pathway.

CUREfilm Blue™ utilizes the Company’s patented and proprietary fast-dissolving drug delivery platform, known as CUREfilm™, to deliver the active pharmaceutical ingredient (API) sildenafil citrate. By innovating beyond the traditional pharmaceutical delivery of pills and solutions, CURE is advancing this uniquely discrete, convenient and portable oral film product for achieving a better patient experience. The ’331 patent highlights several key aspects of the CUREfilm Blue™, such as a balance of performance characteristics (e.g., fast-dissolving and early onset of action) and physical parameters (e.g., large mass and small thickness), while it can be administered with or without water or beverage.

The global erectile dysfunction drug market is projected to grow at a CAGR of 6% and reach approximately USD$6.6 billion by 2025 with sildenafil representing a majority of the market, according to a report by QYR Research.

About CURE Pharmaceutical Holding Corp.
CURE Pharmaceutical® is the pioneering developer of CUREform™, a patented drug delivery platform that offers a number of unique immediate- and controlled-release drug delivery vehicles designed to improve drug efficacy, safety, and patient experience for a wide range of active ingredients. As a vertically integrated company, CURE’s 25,000 square foot, FDA-registered, NSF® and cGMP-certified manufacturing facility enables it to partner with pharmaceutical and wellness companies worldwide for private and white-labeled production. CURE has partnerships in the U.S., China, Mexico, Canada, Israel, and other markets in Europe.

Forward Looking Statement
Statements CURE makes in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. CURE intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. The forward-looking statements in this press release reflect CURE’s judgment as of the date of this press release. CURE disclaims any intent or obligation to update these forward-looking statements

Spotlight

The current pool of existing molecules potentially re-positioned, re-formulated or combined with new technological platforms and services might offer therapeutic alternatives and opportunities for patients and health care systems. Even if this concept has been known for many years, no common terminology has been agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. In this context, Medicines for Europea established one single terminology for these medicines known as value added medicines, defined as “medicines based on known molecules that address health care needs and deliver relevant improvements for patients, health care professionals and/or payers”.

Spotlight

The current pool of existing molecules potentially re-positioned, re-formulated or combined with new technological platforms and services might offer therapeutic alternatives and opportunities for patients and health care systems. Even if this concept has been known for many years, no common terminology has been agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. In this context, Medicines for Europea established one single terminology for these medicines known as value added medicines, defined as “medicines based on known molecules that address health care needs and deliver relevant improvements for patients, health care professionals and/or payers”.

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BUSINESS INSIGHTS

Stevanato Group and Gerresheimer AG Announce Collaboration on the Development of an Innovative Ready-To-Use Vial Platform

Gerresheimer and Stevanato Group | September 08, 2022

Stevanato Group S.p.A. a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, and Gerresheimer AG, a leading global provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics, announce that they have jointly developed a high-end Ready-To-Use (RTU) solution platform with an initial focus on vials, based on Stevanato Group’s market-leading EZ-fill® technology. This collaboration is projected to help customers gain efficiencies, improve the quality standard, increase speed to market, reduce total cost of ownership (TCO) and help mitigate supply chain risk. Stevanato Group and Gerresheimer AG are addressing rising demand for RTU vials in the market and the partnership serves as a market enabler to fully support customers’ evolving needs and establish a gold standard in the industrial filling process. The collaboration aims to make RTU vials a standard, available to a wide number of pharma companies globally – offering premium quality solutions to patients and reducing complexity for pharma operations. The new solution will be available to other players in the market to standardize fill-finish operations from early phase drug development to commercialization. The new RTU solution platform from Stevanato Group and Gerresheimer AG will share the same secondary packaging, production process and sterilization method, ensuring consistent available capacity and a reliable double sourcing to the pharmaceutical industry. A hallmark of the new RTU platform is a significant reduction in particles, improving the overall quality and performance of the RTU solutions. In addition, customers can count on a high-end solution made by two major players in the drug containment industry with a long history of innovation. The new jointly developed vial platform and trademark will be presented in detail to the market at the CPhI Worldwide in Frankfurt in November 2022. “Our EZ-fill® vial platform is the market’s most established choice for pre-sterilized containers, and this enhanced version for RTU vials will bring to the market its full potential in terms of quality, flexibility and value for Pharmaceutical Companies and CMOs. Through our collaboration with Gerresheimer AG we are responding to market demand, and we expect to achieve another important milestone in creating a reliable ecosystem to support, accelerate and de-risk the conversion from bulk to EZ-fill® vials already underway in the market.” Mauro Stocchi, Chief Business Officer at Stevanato Group “The new developed RTU vial platform stands out in terms of quality, TCO and sustainability and takes the use of RTU solutions like vials and, in the future, cartridges to a new level,” said Dr. Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. "Due to the strong reduction of the particle load, the quality is significantly increased. Our new innovative solution will convince the market to significantly accelerate the conversion from bulk to RTU vials.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. About Gerresheimer AG Gerresheimer AG is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the commercial product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2021 of around EUR 1.5b. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

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BUSINESS INSIGHTS

Societal CDMO Selected To Provide Tech Transfer And Manufacturing Services To Support Clinical Development Of An Oral Solid Dose Product In Europe

Societal CDMO, Inc. | July 21, 2022

Societal CDMO, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected to provide CDMO services to support the ongoing clinical development of a novel drug candidate in Europe. The compound is an oral solid dose anti-viral therapy product approved for the prevention and treatment of human immunodeficiency virus in select countries in Europe and Societal’s work is focused on supporting the expansion of the product’s indications. Under terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material to support the initiation and execution of Phase 2 studies of the drug candidate. This work will include production, packaging and labeling of both the active compound and matching placebo for the study. “This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalize on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the U.S. from other regions around the globe. We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe. We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.” David Enloe, chief executive officer of Societal CDMO About Societal CDMO Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

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PHARMA TECH

Zerion Pharma and Hovione extend partnership to cover use of the Dispersome® technology platform in nutraceuticals

Zerion Pharma and Hovione | August 24, 2022

Hovione and Zerion Pharma announced an extension of their collaboration on Zerion's Dispersome® technology into the nutraceutical/dietary supplements field. Many dietary supplements suffer from low solubility. This results in poor bioavailability and consequently limits the physiological effect of the supplement. To overcome these limitations, the two companies will collaborate and apply the solubility enhancing Dispersome® technology for the development and commercialization of certain nutraceutical products. The first product candidate selected for joint development is an antioxidant with multiple health benefits and known for its extremely low solubility and bioavailability. By applying the Dispersome® technology, Zerion has been able to demonstrate significant solubility improvements of this antioxidant. Under their collaboration, Hovione and Zerion will now upscale and develop commercial formulations of the antioxidant using the Dispersome® platform and make these products available for distribution by partners globally. Under the terms of the collaboration agreement, the two companies will share income from the commercialization of these products according to their respective contributions. In addition to the joint development projects, Zerion has granted Hovione an exclusive license to exploit the Dispersome® technology for other nutraceuticals/dietary supplements. In return, Hovione will pay Zerion license fees and royalties on sales of the licensed products. "The low oral bioavailability of some of the health-promoting nutraceutical compounds is a well-known challenge. The problem is compounded by the fact that some of the solutions used in pharma cannot be used in foods. Hovione is thrilled to be Zerion´s exclusive partner for the application of Dispersome® to the fields of nutraceuticals and dietary supplements. The Dispersome® platform and its enabling ingredient – beta-lactoglobulin or BLG – afford formulators new options which address unmet needs of the industry." Jean-Luc Herbeaux, CEO of Hovione "I am extremely pleased with this extension of our collaboration", says Ole Wiborg, CEO of Zerion and continues: "The Dispersome® technology is actually very well suited for use in dietary supplements because it employs BLG as its solubility enabling component. BLG is a sustainable natural material and in itself a beneficial nutritional product that we source in high quality from Arla Food Ingredients. Since we as a company only have limited resources to exploit these promising applications of the Dispersome® technology in the nutraceutical field, the collaboration with Hovione is a win/win situation." In February 2022, Zerion and Hovione announced a strategic partnership aimed at commercializing the Dispersome® technology within the drug development field. Under this partnership, Hovione and Zerion are offering pharma and biotech companies worldwide access to an innovative drug delivery platform combined with an unparalleled experience in formulation development, scale up and GMP manufacturing. This unique combination provides customers in the pharma industry with a line of sight over the entire drug development life cycle from the preclinical phase to commercial drug product. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Zerion Pharma A/S Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems. By applying the Dispersome® technology, the solubility of poorly soluble, oral drugs is greatly enhanced, which improves their bioavailability and therapeutic outcomes for the patients. Zerion was established in 2019 as a spinout from the University of Copenhagen based on almost a decade of research.

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