As the world awaits a potential solution to counter the Covid-19 pandemic, a number of pharma and biotech companies have their candidates going through different stages of trials.
The total number of confirmed Covid-19 cases across the globe is nearing the 12 million mark, with over 3 million in the U.S. alone. Governments have thus been putting increasing pressure on scientists and pharmaceutical companies to come up with a drug or a vaccine to handle the situation. The process has been slow, which was expected as a successful treatment has never before been developed for any other type of coronavirus, and some companies are performing better than others.
Gilead Sciences (NASDAQ:GILD) has proven to be a star as its remdesivir drug has shown positive results in the clinical trains and has already been accepted in the European as well as Indian markets. The European Commission has conditionally approved remdesivir to be marketed under the brand name of Veklury for the treatment of Covid-19 pneumonia patients with a minimum age of 12 years requiring supplemental oxygen. This conditional approval is initially valid for one year but can be extended depending on additional confirmatory data. Similarly, the company's licensee Mylan (NASDAQ:MYL) has announced that the Drug Controller General of India has approved remdesivir for restricted emergency use for severely ill hospitalized Covid-19 patients in India. Mylan is expected to launch its version in India under the brand name Desrem.
It is worth highlighting that the U.S. Department of Health and Human Services announced a purchase agreement with Gilead for 100% of Gilead's projected production of remdesivir for July 2020 and 90% of the same for the months of August and September over and above the allocation for clinical trials. Europe is also putting in its fair share of efforts as European Union (EU) health commissioner Stella Kyriakides is interacting with the Gilead management to try and secure the supply of remdesivir for 16 EU countries. Gilead claims to have multiple manufacturing partners across the globe that are capable of producing large volumes of remdesivir to cater to the massive global demand.
Pfizer data is pressurizing small players
Pfizer (NYSE:PFE) is the other star that has been engaged in the development of a Covid-19 vaccine along with German biotech firm BioNTech SE (NASDAQ:BNTX). The management recently announced the highly encouraging results from an ongoing Phase 1/2 clinical trial evaluating the safety, tolerability and immunogenicity of escalating doses of their most advanced Covid-19 vaccine candidates. The companies have four investigational vaccine candidates, and the studies were carried out on the most advanced of the lot. Its results have put smaller players like Inovio Pharmaceuticals (NASDAQ:INO) and Moderna (NASDAQ:MRNA) under a lot of pressure.
Inovio's vaccine candidate INO-4800 is very light on data as compared to the one from Pfizer and BioNTech in the Phase 1 clinical trial. The stock price did manage to recover well after the management announced the receipt of $71 million from the U.S. Department of Defense to scale up the manufacturing of Cellectra 3PSP smart devices and to purchase additional Cellectra 2000 devices. Both these devices are used in the process of administering INO-4800.
On the other hand, the Phase 3 study of the mRNA-1273 vaccine by Moderna that was expected to start on July 9 has been delayed owing to changes in the protocol. This was expected to be a 30,000-patient study and Moderna's management was expecting to see promising results by thanksgiving. However, the company recently announced the completion of the enrollment for its Phase 2 study of mRNA-1273 and also the fact that they have now finalized the Phase 3 study protocol based on feedback from the FDA. This comes as a big relief for all of its investors.
NanoViricides Emerges Strong
NanoViricides (AMEX:NNVC) has emerged as a true dark horse in the Covid-19 drug race. The company had been in the news for testing its drug candidates in a lethal lung infection model in rats using a different coronavirus that uses the same ACE2 receptor as SARS-CoV-2, the virus that causes Covid-19. Its drug candidates showed strong effectiveness in the animal model as well as cell culture studies, which prompted the management to go ahead with a safety and tolerability study. The company tested three different drug candidates at three different dosage levels and vehicle control through separate groups of mice intravenously in its safety and tolerability study, which provided excellent results.
The results indicated that tested drug candidates were safe and well-tolerated with no clinical signs of immune or allergic reactions. The results showed no observable changes in any organs, including the large intestine or colon, on post mortem in gross histology. The positive result has now cleared the path for NanoViricides for further development of its candidates and moving forward to human trials.
Prior to filing for human clinical trials, the management plans on conducting studies to carry out clinical candidate selection and possibly request a pre-IND (Investigational New Drug) meeting with the FDA for regulatory guidance. The company's progress has been truly remarkable, which is why its stock has seen a triple-digit appreciation over the past year.
Final thoughts
Apart from the companies mentioned above, there are various players from India, China, Israel, Russia and many other countries that are attempting to develop a drug or a vaccine to counter Covid-19.
Whether the solution comes from a giant like Pfizer or a small company like NanoViricides, the key factor that matters to the world as of today apart from its effectiveness is the speed of execution.
