PHARMA LITERATI

Glenmark Pharmaceuticals on Tuesday said it has initiated Phase 3 clinical trials on antiviral drug Favipiravir to check its efficacy on COVID-19 patients in India. The Mumbai-based company had received approval from Drug Controller General of India (DCGI) last month to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients. Glenmark Pharmaceuticals is the first company in the country to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India, it said in a statement. Clinical trials have commenced and over ten leading government and private hospitals are being enrolled for the study, it added. Glenmark estimates study completion by July/August 2020, it said. As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 symptoms will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment dura...

One of the earliest Indian drugmakers to have focused on innovative R&D, Glenmark Pharma is now spinning off its R&D business into a separate company that would be based in the US. Glenmark Pharma has hired a former executive from Gilead & Novartis to head the new company. All innovative molecules in the pipeline, including preclinical assets and technology, the R&D centres in Switzerland, Paramus, and Navi Mumbai, and the biologics manufacturing facility in Switzerland, along with 400 employees associated with innovative drug discovery will be part of the new company in the next six to nine months. Glenmark's current innovation pipeline consists of eight assets, including new chemical entities and new biologic entities in various stages of development. These are in the areas of immunology, oncology and pain management. But will the latest move enable Glenmark to succeed in its quest for discovering an innovative drug? Several of its peers, including ...

In another milestone for Indian pharmaceutical major Glenmark Pharmaceuticals, the company has announced positive data from its phase 2a study of GBR 830, an investigational anti-OX40 monoclonal antibody for treating atopic dermatitis. In the double-blind, placebo-controlled study, researchers randomly assigned 62 patients (52% male) with moderate-to-severe atopic dermatitis to measure the safety, biological and clinical activity and prokinetics of GBR 830 over 12 weeks, according to a news release. Thirty-one patients were evaluated on multiple endpoints following the last study visit, after receiving two doses with two viable biopsies. Seventeen out of 23 patients in the GBR 830 cohort experienced at least a 50% reduction in the Eczema Area and Severity Index (EASI) scores at day 57 when compared to baseline, according to the release. Improvement in clinical response time was also supported by EASI 75 scores, according to the release. GRB 830 had a similar safet...

Glenmark, which has graduated to a global organisation in a very short span with its expanded manufacturing footprint, international operations and global employee base, reported a 276.08 per cent rise in revenue since 2012 The company that emerged as India’s third fastest growing company in the Rs 5,000 crore to Rs 9,999 crore turnover category in   BW Businessworld’s Fastest Growing Companies list 2017 , says its strategic roadmap is completely synergised with its business, and its aim is to move up the value chain to become an innovation-led company with a solid foundation in the generics business. According to chairman and managing director Glenn Saldanha, the company’s primary objective has always been to facilitate its evolution from a generics organisation to a fully-integrated, globally commercialised pharmaceuticals company with innovative products. Glenmark has always focussed on long-term growth strategy, while meeting short-term growth objectives. As a result...

Glenmark to spend 11% of its revenue on research and development annually over the next few years Glenmark Pharmaceuticals Ltd is relying on its specialty and innovative drugs pipeline, focused mainly on three therapeutic areas—oncology, dermatology and respiratory -- to play out in the coming years and expects to launch specialty products in the US by 2020 and innovative drugs by 2025. To counter the challenging pricing environment in the US, the biggest market for Indian pharmaceutical companies, top generic drug makers in the country have started making significant investments in developing a pipeline of complex generics and specialty products, which are generally high-value and limited-competition drugs. Unveiling a roadmap for growth over the next 10 years, Glenn Saldanha, chairman and managing director of Glenmark said the company will focus on enhancing presence in existing markets, increasing portfolio of complex generics, launching specialty and innovative produ...