PHARMA TECH
PR Newswire | October 03, 2023
Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technology, today announced that it has completed the acquisition of MedAlliance, a Switzerland-based developer of drug-eluting balloon technology. This acquisition adds a key growth driver to the company's coronary and peripheral vascular portfolios as we expect SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloons (DEB) will be the first Sirolimus DEB to market in key geographies.
SELUTION SLR™ DEB technology is designed to balance both safety and efficacy with its use of MicroReservoirs made from biodegradable polymers intermixed with the anti-proliferative drug Sirolimus. The MicroReservoirs control the sustained release of the drug and is designed to provide the longest and most effective pharmacokinetic release profile of any device on the market. SELUTION SLR™ DEB has demonstrated early efficacy across studies in both the coronary and peripheral vasculature and is now being studied in 4 FDA IDE trials to gain US market access.
"This acquisition is key in advancing Cordis' legacy of cardiovascular innovation," said Shar Matin, CEO of Cordis. "We are creating leverage by joining the MedAlliance team and their world-class innovation with the reach and breadth of Cordis' global infrastructure. This combination will add value to millions of patients and clinicians, revolutionizing vascular care."
Ron Waksman, a cardiologist at the Washington Hospital Center and Primary Investigator of the SELUTION SLR™ DEB Coronary De Novo study added, "Cordis introduced the first coronary drug-eluting stent to the market over twenty years ago. SELUTION SLR™ DEB has a similar opportunity to improve the health of patients and revolutionize the way clinicians deliver vascular care."
"The Cordis acquisition will accelerate access to this breakthrough technology for patients suffering from coronary and peripheral disease around the globe," said Jeffrey B. Jump, Founder, Chairman and CEO of MedAlliance. "The team set out to disrupt the coronary and peripheral markets and provide physicians with a new safe and effective technology. The arsenal of SELUTION SLR™ DEB clinical data is designed to change medical practice and improve patient outcomes."
About Cordis
Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology with a more than 60-year history of pioneering breakthrough cardiovascular technologies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis established a legacy of innovation in high-quality and minimally invasive cardiovascular products and built a strong global footprint with operations in more than 70 countries around the world. Cordis is backed by private equity firms Hellman & Friedman and KKR.
About MedAlliance
MedAlliance is headquartered in Nyon, Switzerland. It specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products, initially for the treatment of coronary and peripheral artery disease. The SELUTION SLR™ DEB, is a novel sirolimus-eluting balloon platform technology.
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PHARMACY MARKET
Business Wire | 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.
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PHARMA TECH
Business Wire | October 05, 2023
OM1, a leading real-world data, AI, and technology company with a focus on chronic diseases, announced the launch of two new clinical datasets, Chronic Rhinosinusitis (CRS) and Asthma. Both datasets are derived from longitudinal follow-up of patients seen by specialists and focus on patient characteristics, symptoms, treatments, clinical outcomes and healthcare resource utilization. Rapidly growing, the CRS and Asthma datasets each follow approximately 500,000 patients in the U.S.
The research-grade, real-world data available in the OM1 Respiratory & ENT Network is built with an exclusive partnership between OM1 and the American Academy of Otolaryngology and Head and Neck Surgery Foundation (AAO-HNSF). With access to thousands of clinicians and more than 25 million patient visits across all 50 states, the data is rich with the most representative network available, including patient reported outcomes, social determinants of health, and patient subtypes and classification data.
Millions of Americans are impacted by respiratory diseases, and the number continues to rise as respiratory illnesses become more common and air quality declines. Taking a deeper look, it’s estimated that 25 million people in the United States are diagnosed with asthma and 5-12% of the global population is affected by CRS. Not only do the numbers continue to rise, it’s common for patients with respiratory diseases to have multiple illnesses. Studies show that up to 67% of people with CRS with nasal polyps, small noncancerous growths that increase the severity of the disease, also have asthma.
"Having access to deep clinical information on clinical presentation, treatments, and outcomes opens a world of incredible opportunity to improve care at both the population and individual patient level,” said Dr. Richard Gliklich, CEO, OM1.
Alongside AAO, OM1 and Dr. Gliklich will be participating and presenting at the AAO-HNSF Annual Meeting and OTO Experience in Nashville, October 1-4.
About OM1
With specialization in chronic conditions, OM1 is re-imagining real-world evidence and insights by developing large electronically connected networks of clinicians and health data in dermatology, rheumatology, gastroenterology, cardiology, metabolism, respiratory, mental health, neurology and other specialty areas. Leveraging its data automation platform, OM1 Aspen, extensive clinical networks and artificial intelligence (AI) platform, PhenOM™, OM1 offers industry-leading enriched healthcare datasets, retrospective and prospective studies, advanced analytics, and AI-driven guidelines adherence and decision-support around diagnosis, risk management, and treatment. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.
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