Views and Analysis
PRNewswire | August 21, 2023
Everest Medicines announced that U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for Nefecon® from its partner Calliditas Therapeutics AB and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is Dec. 20, 2023.
"We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-disease therapy to all IgAN patients at risk of progression. It is another testament to Nefecon® as an important, disease-modifying medicine with significant eGFR treatment benefit observed across the entire study population that can substantially delay onset of dialysis for patients at risk," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As IgAN prevalence in Asia is much higher than the rest of the world, we look forward to receiving NDA decision for Nefecon® in mainland China in the second half year and filing NDAs in other Asian territories as soon as possible."
The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The full data from the NeflgArd Phase 3 trial was published in The Lancet in August 2023.
The trial demonstrated a statistically significant benefit of Nefecon® over placebo (p-value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year study period, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off the study drug. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline, and showed a difference between TARPEYO and placebo in 2-year eGFR total slope of approximately 3mL/min per year using a robust regression method of analysis.
The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon® for the treatment of IgAN in November 2022, with a decision expected in the second half year of 2023. The NMPA has also granted Nefecon® break-through therapy designation and NDA priority review. Nefecon® was the first non-oncology drug to receive break-through therapy designation in China.
Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
Nefecon® was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon® over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include renal diseases, infectious diseases, mRNA platform and autoimmune disorders.
prnewswire | July 04, 2023
Adare Pharma Solutions, a global technology-driven CDMO focused on oral dosage forms, today announced the completion of its divestiture of its Adare Biome business unit, a pioneer in the development and manufacturing of postbiotics, to dsm-firmenich, innovators in nutrition, health, and beauty. The transaction represents an enterprise value of €275 million, an estimated 2023 EV/EBITDA multiple of 18x.
Tom Sellig, CEO of Adare Pharma Solutions, commented: "dsm-firmenich is the ideal company to take Adare Biome to the next level and realize the growth potential of postbiotics. They have the infrastructure, together with strong commercialization and science capabilities, to scale the significant scientific research that we've achieved over the years. This divestiture will provide Adare Pharma Solutions with additional resources for our core CDMO business and allow us to further grow our position as a world-class outsourcing partner to the pharmaceutical industry."
dsm-firmenich intends to extend the availability of Lactéol®, Adare Biome's over-the-counter postbiotic supplement for relieving gut upsets, through its B2C unit, i-Health. Further development of postbiotic B2B ingredients will include opportunities in dietary supplements, early-life nutrition, medical nutrition, and nutritional improvement for the under-nourished. The acquisition of Adare Biome will also position dsm-firmenich as a leader in the growing microbiome management market for pets, and expand its animal health range, where the stability of postbiotics means they can be incorporated into premix feed solutions.
Philip Eykerman, dsm-firmenich's President Health, Nutrition & Care, said: "Adare Biome, as a global leader in the research and manufacturing of postbiotics with over a century of pioneering science in its heritage, is a perfect fit for dsm-firmenich that will complement three of our four Business Units. The Adare Biome teams bring great knowledge in this area which will greatly help in driving our 'Health from the Gut' strategy and enable us to accelerate the creation of next-generation biotics to support the health of people and animals. We are excited to welcome the Adare Biome people to the dsm-firmenich family and about the new opportunities this move will unlock. dsm-firmenich's strong global presence and reach in local markets will enable us to deliver Adare Biome products to customers in a faster, more efficient way to bring the proven benefits of postbiotics to a wider range of people around the world."
About Adare Pharma Solutions
Adare Pharma Solutions is a global, technology-driven CDMO providing product development through commercial manufacturing expertise, with a focus on oral dosage forms for the pharmaceutical industry. Adare's specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare has developed and manufactured more than 65 products sold by customers in more than 100 countries globally. More information can be found at www.adarepharmasolutions.com.
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.
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.