Moderna is a drug company that’s been very secretive about what product they’re developing. The startup claims to be working on a new class of drugs that manipulate antibodies into producing drugs via therapeutic proteins (Vardi, 2016). It wasn’t until Acuitas filed a lawsuit in British Columbia that Moderna revealed exactly what they’re working on. Acuitas licensed a technology to Moderna that they don’t own. A third company, Arbutus, owns the technology and decided to terminate the license. Acuitas thought that by filing a lawsuit, they could protect the deal they had with Moderna. This triggered Arbutus to countersue and claim its deal with Acuitas didn’t cover the deal between Moderna and Acuitas. In the end, Moderna settled on three different drug technology methods, one for each company. Then Moderna turned back to Acuitas to gain access to the technology that Arbutus owned. Licensing, sublicensing, lawsuits, and countersuits demonstrate the length that Big Pharma will go to undercut each other and generate revenue for themselves.
A new initiative of the FDA to get more drugs reviewed is the granting of a Priority Review Voucher (PRV). If a drug company gets approval for one of their drugs that treat certain rare pediatric diseases, they are granted a transferrable voucher to expedite the FDA’s review of a future drug (Jarvis, 2015a). In 2015, two PRVs were used to speed up the approval of highly anticipated drugs. Sanofi used a PRV to get their PCSK9 inhibitor approved a month ahead of Amgen’s competing drug. On the surface, PRVs seem beneficial to getting drugs approved faster, but in reality they’re fueling the crooked, under-handed moves of the industry.
References
Jarvis, L. (2015a). 2015 was a bountiful year for new drugs. American Chemical Society: Chemical And Engineering News, (48), 18. Retrieved from http://cen.acs.org/articles/93/i48/2015-Bountiful-Year-New-Drugs.html
Vardi, N. (2016). Moderna’s Mysterious Medicines. Forbes. Retrieved from http://www.forbes.com/sites/nathanvardi/2016/12/14/modernasmysterious-medicines/#762336ec730e