Pharmacy Market

AstraZeneca and R-Pharm sign an agreement to cooperate on COVID-19 vaccine development

AstraZeneca | December 22, 2020

The Russian Direct Investment Fund (RDIF, Russia's sovereign abundance reserve), The Gamaleya National Center, AstraZeneca and R-Pharm have consented to an arrangement focused on the turn of events and usage of a clinical exploration program to survey the immunogenicity and security of the consolidated utilization of one of the segments of the Sputnik V immunization created by the Gamaleya Center, and one of the segments of the AZD1222 antibody, created by AstraZeneca and the University of Oxford.

The arrangement was declared on a video-gathering with Vladimir Putin, the President of Russia.

The gatherings have likewise consented to create logical and business relations and investigate the opportunities for joint utilization of the Sputnik V antibody and the AZD1222 antibody to make more viable and long haul inoculation against potential new Covid diseases.

Clinical preliminaries of the mix of AZD1222 antibody with Sputnik V's human adenoviral vector type Ad26 will start soon. R-Pharm will be among the associations financing the preliminary.

Sputnik V is among the world's best and safe immunizations because of its novel innovation consolidating two diverse human adenoviral vectors accommodating a more grounded and longer-term resistant reaction contrasted with antibodies utilizing similar part for the two vaccinations.

The routine with two distinctive adenoviral vectors for a prime and a lift vaccination is an extraordinary and momentous disclosure of the Gamaleya Center researchers. It serves to totally dodge invulnerability to the main vector, which is shaped after the principal vaccination, and hence to raise adequacy and make long haul resistance. This routine is one reason why the antibody shows viability of over 90%, with 100% adequacy in serious cases. Among the main COVID-19 antibodies just Sputnik V is utilizing the two-vector innovation.

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Everest Medicines Announces Partner Calliditas Therapeutics Receives FDA Priority Review for Full Approval of Nefecon®

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. About Nefecon® 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.

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Mitsubishi Tanabe Pharma America Highlights Latest Research in Parkinson's Disease at EAN and WPC 2023 Congresses

prnewswire | July 06, 2023

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of seven abstracts in Parkinson's disease (PD) at the 9th Congress of the European Academy of Neurology (EAN), which was held in Budapest, July 1-3, and the 6th World Parkinson Congress (WPC), being held in Barcelona, July 4-7. "Our presence at EAN and WPC this year underscores MTPA's dedication to investigating potential treatment options to tackle the current unmet needs and challenges of Parkinson's disease," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We're excited to share our progress with the global scientific community, including the presentation of key findings from a number of clinical trials evaluating ND0612 in people with Parkinson's disease experiencing motor fluctuations." Clinical development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), MTPA's parent company. If regulatory approval for ND0612 is obtained, MTPA intends to commercialize the therapy in the U.S. Presentations at EAN Presentations highlighted findings from two ongoing studies of investigational ND0612 in people with PD with motor fluctuations, including topline results from the Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of ND0612, in addition to three-year outcomes from the Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612. Additionally, results were shared from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LD/CD). Summary of results from a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612 (Nelson Lopes, M.D.; NeuroDerm) ePoster #EPO-610 Continuous subcutaneous levodopa/carbidopa infusion for PD: Summary of results from the 3-Year data from the BeyoND study (Nelson Lopes, M.D.; NeuroDerm) ePresentation #EPR-282 Relative bioavailability of levodopa administered as a subcutaneous infusion with ND0612 versus oral IR levodopa/carbidopa (Sophia Sopromadze, M.D.; NeuroDerm) ePresentation #EPR-066 Presentations at WPC New data from a post-hoc analysis from the 28-day open-label Study 006 will be presented, evaluating the early efficacy of investigational ND0612 in reducing motor fluctuations in study participants treated with a 24-hour ND0612 infusion regimen, along with findings from four case studies describing the long-term (up to five years) experience of participants in the Phase 2b BeyoND study receiving ND0612 treatment. Additional presentations will highlight the development of a Motor Fluctuations Patient Journey Map (MFPJM) for people with PD to describe the holistic patient experience from pre-diagnosis through hospice care with a focus on motor fluctuations, and details on enrollment characteristics of randomized study participants in the Phase 3 BouNDless study. All posters will be on display in the Exhibit Hall during Poster Session 1 from 11:30 a.m. – 1:30 p.m. CEST on July 5. About ND0612 ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson's disease (PD) experiencing motor fluctuations. About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to commercialize approved pharmaceutical products in North America. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates.

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PHARMACY MARKET

Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment

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.

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