Significant Impact of COVID-19 on Favipiravir in Pharmaceutical Industry
COVID-19 Impact on Favipiravir in Pharmaceutical Industry OVERVIEW A novel corona virus, SARS-CoV-2, appeared in December 2019 in Wuhan, China, spreading much faster than its predecessors and the virus has already infected millions of patients worldwide as of April 19, 2020. As the scope of the current COVID-19 outbreak has reached proportion of pandemics, major international efforts in public health are underway to control the outbreak. However, as definitive treatments for confirmed COVID-19 are yet to be identified, there is considerable interest in repeating existing antiviral drugs for use against COVID-19. Favipiravir triphosphate is a purine nucleoside analogue. This acts as a competitive inhibitor of RNA-dependent RNA polymerase. It has activities against influenza A and B, including oseltamivir- and zanamivir-resistant influenza viruses, several antimicrobial antiviral drugs, such as SARS-CoV-2. Favipiravir is approved for influenza strains that do not respond to standard antiviral therapy in Japan. IMPACT ON PRICE A large number of challenges are being faced by various market players due to the coming of the novel coronavirus, one such issue is the uncertainty surrounding the impact of covid-19 on favipiravir demands. Due to the increased demand of favipiravir for coronavirus treatment and stiff competition between the market players the rice of favipiravir has decreased. According to the data available even as physicians share the benefits of Favipiravir for mild to moderate COVID-19 patients, a number of general launches are anticipated to intensify the price war that has already begun., Last month, Glenmark Pharma has receive a regulatory approval for Favipravir which has lowered its tablet price to Rs 75 each from Rs 103 earlier, anticipating market competition. 8 other favipiravir brands are at least expected to be launched in the upcoming days. At a price of Rs 59 per tablet, the Hetero Pharma became the third company to launch its generic version of Favipiravir, called Favivir. Previously, Mumbai-based Jenburkt Pharma put the low cost brand to date, Favivent, at Rs 39 per tablet. The company has started stockpiling in Mumbai and aims to expand its share of Maharashtra before it expires nationwide. With the increasing demand and increasing sale of favipiravir drugs, the competition between the favipiravir drugs manufacturers has increased market, leads to the fall of favipiravir drugs price. IMPACT ON DEMAND The Corona virus zone is the result of various markets around the world. This is the cause of the widespread closures and isolation that are affecting world economic activity. In Japan Favipiravir which is an oral antiviral drug approved for the treatment of influenza. It specifically inhibits RNA polymer, which is necessary to copy the virus. Japan has begun a Phase 3 clinical trial. In the United States, a phase 2 study will involve approximately 50 patients with COVID-19, in collaboration with Brigham and the Women's Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School. In India, a Phase 3 trial began combining two antiviral drugs, favipiravir and umifenovir, in May 2020. Chemists and pharmacists are in the high demand for the antiviral drug Favipiravir, which was launched under the brand name "fabi-influenza" by Glenmark drugs. It has been approved for limited emergency use in for the COVID-19 patients with mild to moderate symptoms by (ICMR) Indian Council of Medical Research. The impact of COVID-19 has created an opportunity for the number of patients as there are high chances of adverse health effects of COVID-19 on the people. IMPACT ON SUPPLY As the epidemic intensifies, supply chains can be at significant risk due to over-located locations that can potentially be disrupted. The supply chain of drugs has been disrupted. The spread of COVID-19 makes it difficult for governments to use these drugs; the availability of these systems faces constant challenges due to their components of use as well as limited initial needs. Lasa Supergenerics already has export orders from abroad. The drug is sought after in Turkey, Jordan, Spain, and Portugal and so on where it is used in COVID-19 patients. Exports have no restrictions as they are based on our own specifications and not under the name of specific pharmacology. This is an opportunity to confirm that India is indeed the 'Pharmacology of the World'. As the world seems to be using reusable drugs to control COVID-19 until an effective and safe vaccine is developed, India has played a key role in providing some key drugs such as hydroxychloroquine (HCQ) and favipiravir for humanitarian and commercial purposes. The trade restrictions have chosen nothing more than to produce the necessary medicines domestically. During the pandemic, when the demand increases, counterfeiting and price increases of imported goods increase. This signifies that even during the COVID-19 pandemic the market players are able to maintain supply chain. STRATEGIC DECISIONS OF GOVERNMENT AND MANUFACTURERS As the coronavirus continues to spread to various countries, concerns are growing about disruptions in drug production and distribution. Collaborations, agreements, initiatives of market participants such as Fujifilm Corporation in the pharmaceutical market have helped them to expand their market. This in turn will help to increase the demand for the product among the consumers and thus increase the future sales of the company. Market players have already taken different initiatives to combat the corona virus. For instance, · In July 2020, Hyderabad's Hetero group announced that the generic drug Favipiravir would be introduced in India under the brand name "Favilavir" for the treatment of mild to moderate COVID-19. Hetero obtained approval from the Indian Anti-Doping Agency (DCGI) to manufacture and market the generic drug. · In July 2020, Cipla Limited announced that it has received the approval of the Indian anti-doping agency (DCGI) to place favipiravir in the country under the Ciplenza brand. Early approval for the manufacture and marketing of the drug aims to meet the urgent and undeveloped medical need for COVID-19 treatment options in the country with limited emergency use. It has been developed jointly by Cipla and the CSIR (Council of Scientific and Industrial Research) - Indian Institute of Chemical Technology (IICT). As part of this partnership, CSIR-IICT has successfully developed a convenient and cost-effective process for Favipiravir. The whole process and the active ingredient (API) of the medicine have been transferred to Cipla to manufacture and market the medicine in magnitude. · In July 2020, The Indian pharmaceutical company giant Dr. Reddy's Laboratories (Dr Reddy's) has signed a tripartite agreement with Fujifilm Toyama Chemical and Dubai Response Global Aid (Dubai) for the development, production and sale of the favipiravir innovation brand Avigan. Under the terms of the agreement, it is assumed that FUJIFILM will receive a license fee and commissions for sales from Dr. Reddy and GRA. Dr Reddy has exclusive rights to manufacture Avigan, while both GRA and Dr Reddy have joint the rights to develop, sell the market the drug worldwide except Japan, China and Russia. · In June 2017, In India, Glenmark Pharmaceuticals has started in Phase III clinical trials of the drug. The results of the Glenmark study, which records up to 150 patients, will be available in July or August 2020. · In April 2017, Fujifilm Corporation (Tokyo, Japan) has initiated a clinical trial in II. Stage study to evaluate the safety and efficacy of the influenza antiviral drug Avigan tablet (synonymous with favipiravir) in patients with COVID-19, a respiratory tract infection caused by the novel SARS-CoV-2 coronary heart virus. Avigan was the first antiviral drug approved for use in the treatment of COVID-19 in China. At the beginning of March, when production in Avigan began, the company was producing approximately 40,000 treatment courses per month. The company plans to gradually increase this to up to 100,000 treatment courses per month by the end of July (approximately 2.5 times more). The overall goal, according to FUJIFILM, is to accelerate the production of up to 300,000 treatment courses per month by September 2020. With the increasing demand and increasing sale of favipiravir drugs, are fueling the growth of favipiravir drugs market in the near future. As such, market participants are involved in the production of favipiravir drugs expanding their business through a variety of programs, including collaboration, contracts, and pipeline development, collaboration, and market expansion. It is expected that the strategic decisions of these companies will provide significant opportunities for market participants operating in the favipiravir market. CONCLUSION The available clinical evidence suggests that favipiravir is relatively safe for total cell carcinoma, as well as serious gastrointestinal side effects. However, an increase in the blood uric acid is still a safety issue, as shown in a pooled analysis of larger studies, with evidence of increased dose-dependent development. Further safety concerns, such as the possibility of Corrected QT Interval (QTc) malformation and prolongation, have not yet been adequately investigated. There is an evidence to support the safety and tolerability of favipiravir during short-term treatment. However, more evidence is needed to assess the effects of long-term treatment. Given the limitations of the evidence and the specific safety concerns that remain, the widespread use of favipiravir against pandemic COVID-19 should be justified. Various manufacturers have allowed their manufacturers to remotely operate the production of favipiravir at various production sites in safe areas around the world and help them maintain a stable supply chain. In addition, increased demand for favipiravir for the treatment of coronavirus has increased profits.