Wockhardt Ltd.

1. Amylyx: AMX0035Indication: Amyotrophic Lateral Sclerosis (ALS) Clinical Trials: Phase 3 On March 8th, Amylyx Pharmaceuticals announced the top-line data from the Phase 3 clinical trial of AMX0035 for the treatment of Amyotrophic Lateral Sclerosis (ALS), dubbed PHOENIX, which did not meet its primary and secondary endpoints. Amylyx will communicate with regulatory authorities, including plans for a voluntary withdrawal from the market. AMX0035, a combination of sodium phenylbutyrate and taurursodiol, was approved by the FDA for marketing in September 2022, with a pricing of $158,000 per year. The PHOENIX study enrolled 664 ALS patients, and results did not meet the primary endpoint, which was a significant statistical difference in the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) score at week 48 compared to the placebo group (p=0.667). Additionally, the study failed to meet secondary endpoints including patient-reported assessments of quality of life, overall survival, and respiratory function measured by Slow Vital Capacity (SVC). 2. Acadia: PimavanserinIndication: negative symptoms of schizophrenia Clinical Trials: Phase 3 On March 11, Acadia Pharmaceuticals announced that the latest research results from the Phase 3 clinical trial ADVANCE-2 for the treatment of negative symptoms of schizophrenia with Pimavanserin did not meet the primary endpoint. The primary endpoint of the study was the change in total score on the NSA-16 (Negative Symptom Assessment-16) from baseline to week 26. The treatment group and the placebo group had NSA-16 score changes of -11.8 vs -11.1% at week 26, respectively, which were not statistically significant. The safety and tolerability were consistent with previous clinical trials, with a low incidence of adverse events. As a result of this news, the stock price of Acadia Pharmaceuticals fell by 15% after hours. 3. Merck: Lynparza (olaparib)Indication: metastatic non-squamous non-small cell lung cancer (NSCLC) Clinical Trials: Phase 3 On March 21, Merck announced that its phase III KEYLYNK-006 trial of the PD-1 therapy Keytruda in combination with the maintenance PARP inhibitor Lynparza (olaparib) as a first-line treatment for certain patients with metastatic non-squamous non-small cell lung cancer (NSCLC) did not meet the dual primary endpoints of overall survival (OS) and progression-free survival (PFS). In addition, in December 2023, Merck also terminated a phase III study of Keytruda + Lynparza for metastatic squamous non-small cell lung cancer. The termination was due to the Independent Data Monitoring Committee (DMC) reviewing data from the planned interim analysis (IA3), which found that patients treated with Keytruda + Lynparza after combination chemotherapy with Keytruda did not show an improvement in overall survival (OS) compared to those treated with Keytruda plus placebo after the same chemotherapy regimen. Progression-free survival also lacked statistical significance. Previously, in August 2022, Merck had announced that two phase III clinical trials of Keytruda had failed to meet their endpoints. These were the results of a phase III clinical trial for newly diagnosed liver cancer using Keytruda in combination with Eisai's lenvatinib (Lenvima), and for metastatic castration-resistant prostate cancer treated with Keytruda + Lynparza after prior therapy. 4. Chugai: EnspryngIndication: generalized myasthenia gravis (gMG) Clinical Trials: Phase 3 On March 21st, Chugai Pharmaceutical, a partner of Roche, announced the Phase III LUMINESCE study results for the treatment of generalized myasthenia gravis (gMG) with Enspryng. Although statistically significant data was observed for its primary endpoint, the outcomes did not meet the expected level of clinical benefit. Enspryng is an interleukin-6 (IL-6) receptor antagonist that was approved by the U.S. FDA in August 2020 to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies. Subsequently, in May 2021, satralizumab was approved for marketing in China, becoming the first therapeutic drug for neuromyelitis optica spectrum disorder in the country. CP Pharmaceuticals stated that these study results do not affect the use of Enspryng in patients with NMOSD. The company is also developing Enspryng for other neuro autoimmune and inflammatory diseases. 5. Altimmune: HepTcellIndication: hepatitis B Clinical Trials: Phase 2 Altimmune faced a setback in its fight against hepatitis B. The therapy in development, intended for potential partnerships, couldn't clear the required benchmarks during a mid-stage clinical trial. This led to the decision by the company to discontinue the drug’s progress and pivot its attention to a different therapy targeting the dual receptors of GLP-1 and glucagon. The biopharmaceutical firm located in Maryland had crafted its therapeutic candidate, named HepTcell, with the intention of mobilizing the body's T cells to combat the viral infection. Initial results from a phase 1 clinical trial were promising, showing that HepTcell spurred an increased T-cell reaction to the antigens associated with hepatitis B. Motivated by these preliminary outcomes, Altimmune initiated a larger study that enrolled 80 participants and utilized a placebo for comparison, hoping to establish the treatment’s efficacy in reducing or potentially eliminating the presence of the hepatitis B surface antigen. Nevertheless, the conclusions from this larger trial indicated a less than satisfactory overall effectiveness, leading to the decision that it was not justifiable to proceed with the HepTcell's development. Subsequently, Altimmune ceased any further work on this therapeutic approach.

DUBLIN, Aug. 23, 2022 /PRNewswire/ -- The "Rapid Acting Insulin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering. The global rapid acting insulin market size reached US$ 7 Billion in 2021. Looking forward, the publisher expects the market to reach US$ 9.3 Billion by 2027, exhibiting a CAGR of 4.85% during 2021-2027. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic. These insights are included in the report as a major market contributor. Rapid acting insulin is a medication used to control glucose levels in patients with diabetes. It is either inhaled or administered into the bloodstream with a syringe, a pre-filled pen, or an insulin pump. It is taken prior to meals and snacks to bring overly high blood glucose to a normal level and surge the level of bolus insulin. At present, new insulin formulations like novel ultra-paid-acting insulins that enhance absorption are considered a suitable option for people who cannot achieve postprandial glycemic targets with other bolus insulins. Diabetes mellitus (DM) and poorly controlled blood glucose can increase the risk of mortality and severity among patients with coronavirus disease (COVID-19). This represents one of the key factors fueling the need for rapid acting insulins to monitor blood glucose levels. Apart from this, the growing prevalence of type 1 diabetes on account of exposure to viruses and other environmental factors and low levels of vitamin D acts as another factor propelling the demand for rapid acting insulins across the globe. This can also be attributed to the increasing instances of neonatal jaundice in newborns, in confluence with improving diagnostic modalities. In addition to this, as the risk of developing diabetes increases with age, the rising global geriatric population is facilitating the market growth. Furthermore, leading market players are introducing ready-to-use rapid acting insulin kits that are fast, accessible in vials and a pen presentation, and help enhance glycemic control in both adults and children. These players are also focusing on mergers and acquisitions (M&A), which is anticipated to contribute to the development of new-generation product variants. Competitive Landscape: The competitive landscape of the industry has also been examined along with the profiles of the key players being Adocia, Biocon Limited, Eli Lilly and Company, Gan & Lee Pharmaceuticals Co. Ltd., Geropharm, MannKind Corporation, Merck & Co. Inc., Novo Nordisk A/S, Sanofi S.A., and Wockhardt Ltd. Key Questions Answered in This Report: How has the global rapid acting insulin market performed so far and how will it perform in the coming years? What has been the impact of COVID-19 on the global rapid acting insulin market? What are the key regional markets? What is the breakup of the market based on the product? What is the breakup of the market based on the indication? What is the breakup of the market based on the distribution channel? What are the various stages in the value chain of the industry? What are the key driving factors and challenges in the industry? What is the structure of the global rapid acting insulin market and who are the key players? What is the degree of competition in the industry? Key Topics Covered: 1 Preface 2 Scope and Methodology 3 Executive Summary 4 Introduction 4.1 Overview 4.2 Key Industry Trends 5 Global Rapid Acting Insulin Market 5.1 Market Overview 5.2 Market Performance 5.3 Impact of COVID-19 5.4 Market Forecast 6 Market Breakup by Product 6.1 Lispro Insulin 6.1.1 Market Trends 6.1.2 Market Forecast 6.2 Aspart Insulin 6.2.1 Market Trends 6.2.2 Market Forecast 6.3 Glulisine Insulin 6.3.1 Market Trends 6.3.2 Market Forecast 7 Market Breakup by Indication 7.1 Type 1 Diabetes 7.1.1 Market Trends 7.1.2 Market Forecast 7.2 Type 2 Diabetes 7.2.1 Market Trends 7.2.2 Market Forecast 8 Market Breakup by Distribution Channel 8.1 Hospital Pharmacies 8.1.1 Market Trends 8.1.2 Market Forecast 8.2 Drug Stores and Retail Pharmacies 8.2.1 Market Trends 8.2.2 Market Forecast 8.3 Online Stores 8.3.1 Market Trends 8.3.2 Market Forecast 9 Market Breakup by Region 10 SWOT Analysis 11 Value Chain Analysis 12 Porters Five Forces Analysis 13 Price Analysis 14 Competitive Landscape 14.1 Market Structure 14.2 Key Players 14.3 Profiles of Key Players 14.3.1 Adocia 14.3.1.1 Company Overview 14.3.1.2 Product Portfolio 14.3.1.3 Financials 14.3.2 Biocon Limited 14.3.2.1 Company Overview 14.3.2.2 Product Portfolio 14.3.2.3 Financials 14.3.2.4 SWOT Analysis 14.3.3 Eli Lilly and Company 14.3.3.1 Company Overview 14.3.3.2 Product Portfolio 14.3.3.3 Financials 14.3.3.4 SWOT Analysis 14.3.4 Gan & Lee Pharmaceuticals Co. Ltd. 14.3.4.1 Company Overview 14.3.4.2 Product Portfolio 14.3.4.3 Financials 14.3.5 Geropharm 14.3.5.1 Company Overview 14.3.5.2 Product Portfolio 14.3.6 MannKind Corporation 14.3.6.1 Company Overview 14.3.6.2 Product Portfolio 14.3.6.3 Financials 14.3.6.4 SWOT Analysis 14.3.7 Merck & Co. Inc. 14.3.7.1 Company Overview 14.3.7.2 Product Portfolio 14.3.7.3 Financials 14.3.7.4 SWOT Analysis 14.3.8 Novo Nordisk A/S 14.3.8.1 Company Overview 14.3.8.2 Product Portfolio 14.3.8.3 Financials 14.3.8.4 SWOT Analysis 14.3.9 Sanofi S.A. 14.3.9.1 Company Overview 14.3.9.2 Product Portfolio 14.3.9.3 Financials 14.3.9.4 SWOT Analysis 14.3.10 Wockhardt Ltd. 14.3.10.1 Company Overview 14.3.10.2 Product Portfolio 14.3.10.3 Financials For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

An Indian manufacturer is shuttering its Illinois site due to manufacturing issues that have built up over several years. Morton Grove Pharmaceuticals, a generics manufacturer and subsidiary of Mumbai-based drug company Wockhardt, has agreed to discontinue all manufacturing, processing and drug distribution from its Illinois site after the Department of Justice accused it of selling adulterated drugs. The DOJ brought a suit against Morton Grove and Gopalakrishnan Venkatesan, VP of business development at Wockhardt, earlier this month that alleged the company’s syrups and nasal sprays made at the facility were not made in compliance with cGMP standards. Five FDA inspections between 2010 and 2021 at Morton Grove’s facility found that facilities and controls used for manufacturing, processing and holding were not in compliance with cGMP practices. This included a lack of controls and improper cleaning or sterilization of utensils, among other quality control failures. The suit also alleges that the facility has a history of noncompliance, with the facility having been docked for similar violations over the course of several FDA inspections. A federal court on Friday enjoined the company from manufacturing adulterated drugs, and ordered the company to destroy all drugs in its facility except those that are medically necessary. Morton Grove has entered a consent decree, in which it agreed to discontinue its operations, close the business and sell the Illinois site. Morton Grove may continue holding its noncommercial samples of drug products; however, these products cannot be commercially distributed. “Current good manufacturing practice requirements are the foundation of a safe and effective national drug supply. These manufacturing fundamentals are necessary to ensure the public is not put at risk from adulterated drug products. Today is a culmination of the dogged oversight needed to hold drug manufacturers accountable for the safety, efficacy and quality of the drug products they produce as we work to best protect public health,” said Donald Ashley, director of the FDA’s Center for Drug Evaluation and Research’s Office of Compliance, in a statement . Wockhardt, which produces a wide range of generic drugs, is certainly no stranger to the FDA, with a site in India having come under scrutiny in the past . Other Indian manufacturers have been under the FDA’s microscope this year, with Sun Pharma being the latest to get the 483 hit. The scrutiny, however, has not stopped Wockhardt’s expansion , as earlier this year it announced a partnership with Serum Life Sciences UK, a subsidiary of the Serum Institute of India, to help deliver a global vaccine program, with the companies building a new sterile fill-finish facility in North Wales.