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 EPA’s recent focus on pharmaceutical waste management has been influenced by increasing evidence of pharmaceuticals in drinking water. An Associated Press series on pharmaceutical waste in May 2009, reported that EPA has found traces of pharmaceuticals in the drinking water of over 41 million Americans. There is cause for concern regarding the unknown human and ecological impacts of trace amounts of pharmaceuticals in the water we drink and the water that is crucial habitat for our flora and fauna.

Spotlight

The EPA’s recent focus on pharmaceutical waste management has been influenced by increasing evidence of pharmaceuticals in drinking water. An Associated Press series on pharmaceutical waste in May 2009, reported that EPA has found traces of pharmaceuticals in the drinking water of over 41 million Americans. There is cause for concern regarding the unknown human and ecological impacts of trace amounts of pharmaceuticals in the water we drink and the water that is crucial habitat for our flora and fauna.

Related News

Jazz Pharmaceuticals Announces New Research Collaboration with Redx Pharma to Discover and Develop Two Targeted Cancer Therapies

Jazz Pharmaceuticals | September 09, 2020

Jazz Pharmaceuticals plc today announced that the company has signed a new research collaboration agreement with Redx Pharma plc (AIM: REDX) to discover and develop drug candidates for two cancer targets in the Ras/Raf/MAP kinase (MAPK) pathway. This research collaboration follows the previously announced sale of Redx's pre-clinical pan-RAF inhibitor program to Jazz for the potential treatment of Raf and Ras mutant tumors in July 2019. Under the terms of the research collaboration agreement, Jazz will make an upfront payment to Redx of $10 million followed by another $10 million in year two, provided research work is continuing. Following delivery of an IND-ready molecule, Redx will be eligible to receive up to a further $200 million from Jazz in development, regulatory and commercial milestone payments for each program

Read More

PHARMA TECH

Medable Acquires Mobile Applications from LEO Pharma, Expands Global Engineering Team and European Presence

Medable Inc. | February 03, 2022

Medable Inc., the leading software provider for patient-centered clinical trials, tannounced that it has acquired LEO Innovation Lab’s Omhu A/S, a Denmark-based digital health tech company. Omhu was launched in 2020 to develop new ways of supporting patients and doctors when diagnosing, managing, and treating skin conditions. As part of the agreement with LEO Pharma A/S (owner of LEO Innovation Lab), Medable will take over the Omhu mobile applications and a talented team of 38 people with significant experience in digital health and artificial intelligence. The acquisition expands Medable’s global engineering talent and gives Medable a third location in Europe, building on its European headquarters in Dublin, Ireland launched last July, along with a Switzerland office outside the Greater Zurich area established last fall. Omhu’s software applications include Imagine, a skin-tracking mobile app that helps people document how skin condition changes over time by taking photos with their smartphone; Omhu Care, a telemedicine app where users can receive an assessment of their skin symptoms by Omhu’s in-house dermatologists; and Hudsvar, a triage telemedicine solution designed to help consumers understand the likelihood of having specific skin conditions based on remote assessment of their photos and medical history by a dermatologist. “LEO Innovation Lab has a strong track record developing transformative patient-centered digital solutions, and the technology and team at Omhu exemplify that. We’re thrilled to add Omhu’s patient-centered solutions to our platform, and we welcome the innovative and talented Omhu team to Medable.” Tim Smith, chief technology officer and co-founder of Medable Omhu was launched in 2020 after five years of research and development within the LEO Innovation Lab. The team strives to improve patient access and treatment options for skin conditions, which account for up to 30 percent of all primary care consultations in Europe. In Denmark, for example, a shortage of dermatologists means patients wait up to 23 weeks to see a specialist, severely impacting their daily life and well-being. “Like Medable, Omhu combines medical and scientific expertise, a thorough understanding of the needs of patients and their doctors, and the research into applying artificial intelligence for the benefits of patients and doctors,” said Christian Sejersen, formerly Omhu CEO and now site lead for Medable Copenhagen. “We couldn’t have found a better home for our team, and we are excited to continue delivering innovation that makes lives better for patients.” Anne Fleischer, CEO of LEO innovation Lab, said: “By spinning off Omhu completely in this divestment to Medable, we ensure that the great technologies developed by the highly skilled people in Omhu will reach and help even more people globally and improve their outcomes significantly. We are very proud to have landed this deal with Medable.” Medable has deployed its software-as-a-service platform via more than 150 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants globally. Medable’s customers have achieved impressive results with decentralized and hybrid trials – including 200% faster enrollment, 90% retention rates and 50% cost reductions. A new study from Tufts Center for the Study of Drug Development shows that, on average, decentralized trials can achieve net financial benefits ranging from five to 14 times for Phase II and Phase III trials, due to reduced trial timelines and other factors. About Medable Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies. The company’s digital platform streamlines design, recruitment, retention and data quality for decentralized trials, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution. Medable connects patients, sites and clinical trial teams to improve patient access, experience, and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California. About LEO Pharma LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10.133 billion.

Read More

RESEARCH

Parexel and Veeva Collaborate to Speed-Up Clinical Trials

Parexel, Veeva Systems | May 04, 2021

Parexel and Veeva Systems announced a strategic partnership today to accelerate clinical trials through technological and process innovation. The unique partnership blends the best of each company's expertise through thousands of tests worldwide – Parexel as a pioneering CRO and Veeva as the technological innovator powering trials – to boost study performance and bring innovative therapies to patients faster. Parexel is standardizing Veeva's suite of clinical operations software, including Veeva Vault eTMF, Vault CTMS, and Vault Study Startup, as part of the agreement to streamline operations. Parexel's clients will now have access to Veeva Vault CDMS for clinical data storage as a free product. The companies will work together to continually develop Veeva's cloud technology and Parexel's clinical trial delivery processes based on the insights from sponsors, sites, and patients. Parexel will provide early access to and give feedback on Veeva's clinical products, such as innovations to support sites and patients in decentralized clinical trials (DCT), risk-based quality management (RBQM), and community-based sites. "By implementing Veeva's clinical solutions, we can streamline trial procedures, increase performance, and make trial implementation and attendance simpler for promoters, locations, and patients," Parexel CEO Jamie Macdonald said. "Through this extended relationship with Veeva, we hope to have more value to customers and have a much greater effect on the lives of patients." "We're happy to work with Parexel to fuel customer success and accelerate clinical research innovation," said Peter Gassner, Veeva's founder, and CEO. "By working together, we will help our customers get new vaccines, diagnostics, devices, and therapies to patients in need" About Parexel Parexel encourages the development of new innovative drugs to improve patient health. It provides services to clients in the life sciences and biopharmaceutical industries all over the world to help them transform scientific discoveries into new treatments. The therapeutic, technological, and functional ability is underpinned by a strong conviction in what we do, from decentralized clinical trials to regulatory advisory services to exploiting real-world insights. An independent council for Informa Pharma Intelligence voted Parexel the "Best Contract Research Organization" in December 2020. About Veeva Systems Veeva is the world's leading provider of cloud software for the life sciences industry. Veeva represents over 975 clients, ranging from the world's leading pharmaceutical firms to new biotechs, and is dedicated to innovation, product excellence, and customer success. Veeva is committed to balancing the needs of all stakeholders, including customers, employees, shareholders, and the industries it serves, as a Public Benefit Corporation.

Read More