Newswire | July 05, 2023
Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76% vs. 42% for comparators) and a significantly better complete cure rate.
MOB-015 has been recommended for national approval in 13 European countries, which will be commercialized through partners such as Bayer and Allderma, and is expected to be launched in Nordic countries such as Sweden during 2023.
Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of Onychomycosis (nail fungus) based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $82 million CDN at December 31, 2022 with a single product having over 90% market share.
Craig Mull, Interim CEO of Cipher commented, "This is a fantastic achievement whereby the European Union has recognised MOB-015 as delivering quick visible improvements to patients living with nail fungus. We are excited about our partnership with Moberg Pharma, who have a strong track record developing and commercializing nail fungus products previously in both Europe and North America. This approval is a tremendous step in the right direction towards ultimately receiving market approval in Canada and the United States. We will continue to work closely with Moberg in making this clinically proven effective treatment available to Canadians as soon as possible."
Moberg Pharma continues to invest and advance MOB-015 through an additional phase 3 trial of a total of 350 patients with sites across the United States and Canada. The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union. Patient enrollment in the clinical trial is progressing according to plan with full enrollment expected in 2023.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticalsis a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America.
About Moberg Pharma
Moberg Pharma AB is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023.
PRNewswire | July 24, 2023
PharmaKinnex (PK), an inside sales solution provider for the pharmaceutical industry, and Data360, a data and engagement solutions provider for healthcare marketers, today announced a strategic partnership to further enhance client reach and improve patient outcomes.
From rare disease to oncology and beyond, this unique partnership is designed to deliver increased profits to clients, enable more advanced and secure data analysis, and most importantly, connect patients with life-saving treatments. PharmaKinnex and Data360 are proud to be a part of this newest revolution in pharmaceuticals and medicine, deploying Fingerprint AI solutions.
"The strategic partnership aligns perfectly with our mission to bring unprecedented value to our clients," said Michael White, CEO of PharmaKinnex. "Data360's powerful solutions to identify, target, and engage individuals, while providing valuable analytics about those audiences, will extend our reach to more potential patients and prescribers, providing a sizable edge in the rare disease sector."
Integration of Data360's deep insights with PK's marketing expertise will improve PK's call plans, allowing PK to message to new audiences and reach prescribers ahead of the competition. The partnership positions PK as the only inside sales organization with access to such a high level of data, offering a unique and powerful industry advantage.
"We are eager to partner with PharmaKinnex and contribute our solutions that identify and engage relevant audiences throughout their digital life, and so improve the patient journey experience," said James Miller, president & CEO of Data360. "For this unique market offering, Data360 will identify health care professionals (HCPs) and patients searching online for rare diseases by activating our Fingerprint AI solution. By providing insights for timeliness, relevance, and intent behavior, Data360 will equip PK with valuable insights and reach to elevate its services to clients."
Data360's Fingerprint AI technology is sparking a revolution in healthcare marketing, fueling omnichannel programs with its ability to hyper-target both HCP and patient or caregiver audiences based on online behavior and in-market search criteria.
Data360's datasets, coupled with the Fingerprint AI solution, empower brand teams, healthcare marketers, clinical trial teams, and now PK to leverage audience intent. Its service achieves high-quality, segmented, and targeted leads for HCP marketing, patient engagement, and clinical trial recruitment.
PharmaKinnex is the leading multichannel marketing company in the U.S. that exclusively serves Life Sciences clients. PK is also the longest-tenured independent company in its competitive set, with over 18 years of continuous support of its industry partners. The PK Call Center successfully executes high-ROI product detailing, inside sales and customer service programs. Each solution is designed with the support of the experienced, award-winning PK leadership team and is tailored to target every important constituency identified, including but not limited to office-based prescribers (physicians, NPs, PAs) across every specialty, hospitals and health systems.
With the mission to turn data into intelligence, Data360 provides solutions and services to effectively identify, target, and engage audiences. We empower healthcare marketers seeking broader and better access to physicians, HCPs, patients, and caregivers. We deliver unequaled first-party data, proprietary technology (Fingerprint AI) for access to audience intent and behavior, and a focus on cost-effective and compliant ways to activate and engage healthcare audiences.
businesswire | September 26, 2023
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada.
“Children with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “We are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.”
Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients.
ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet).
In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe. Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR® technology.
“Quillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,” said John McKendry, president at KYE Pharmaceuticals. “Our strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.”
About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.
About KYE Pharmaceuticals
Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team’s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada.