Last year, Russia usurped Gilead’s intellectual property rights in that country in response to the worst global pandemic in the modern era. Gilead recently responded with a lawsuit, taking action in the highest Russian court—the Russian Supreme Court. But now a generic firm in Russia called Pharmasyntez will ship 1 million packs of a generic remdesivir called Remdeform to India, to help that country combat the pandemic’s surge there ,once authorized by Russia’s government. While Russia cited national security for its decision, that would be applicable to treating its internal population but not sending to India, which essentially represents therapeutic diplomacy.
Originally developed to treat Ebola, remdesivir was given considerable support in the clinical trials process in the United States, with close backing by the National Institutes of Health (NIH) National Institute of Allergy and Infectious diseases (NIAID). Remdesivir faced a patent conflict early on in China as reported by TrialSite. Now the stakes are bigger as Russia actually commandeered the IP rights there and Pharmasyntez moved in to produce generic replicates of the drug.
While remdesivir shows some benefit based on ACTT-1 and other clinical trials (reduce hospitalization duration from 15 days down to 11 days), other studies such as the World Health Organization (WHO) Solidarity trial revealed the antiviral did not really help subjects in that large study. Moreover, reports of safety issues have arisen, based at least on one case of preclinical research. TrialSite tracked the company’s moves with a critical eye.
Gilead has made a fortune on the drug, generating over $3 billion in less than a year. Already a blockbuster (e.g. over $1 billion), the company masterfully capitalized on its science, expertise, governmental networks, and research operation to position itself accordingly for emergency use authorization and the formal FDA approval later in 2020.
TrialSite has followed many stories based on interviews and other real world data that the drug does have some positive influence in the treatment of COVID-19. The drug is generally considered far overpriced by most countries at $2,340 and above for a five day course—plus, of course, the other costs to the patient. Again, the company secured considerable support during the preclinical and clinical development stages.
This is a first, as Russia issued an unprecedented health-focused compulsory license establishing precedent for Russia and other nations to take similar actions for drugs far from economical reach. A move to take on what are deemed arbitrary monopolistic prices, according to one blog, its reported that the Russian generic company will lower the price from $960 to $229 for the same five day treatment.
Now it’s reported in Reuters and elsewhere that the generic producer known as Pharmasyntez will send a shipment to India. Of course, India is in a dire situation, and its understandable to seek to help them but does this action conflict with Russia’s very reason for ordering the seizing of IP rights in the first place—nationals security?
Who is Pharmasyntez?
Moscow-based Pharmasyntez specializes in the development and production of antitubercular and antiretroviral medicines and hospital antibiotics. With a portfolio of about 170 products, the generic producer runs five factories. The company started back in 1997.