Emergent Biosolutions Inc. has announced the completion of its purchase of exclusive worldwide rights to Tembexa from Chimerix.
Tembexa is the first oral antiviral to be given the go-ahead by the U.S. Food and Drug Administration (FDA) to treat smallpox in patients of all ages. It got approval in June last year to be used for the treatment of smallpox illness in adult and pediatric patients alike.
The acquisition was finalized following a waiver by both parties of all closing conditions under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Paul Williams, Senior Vice President MCM Business at Emergent, stated, “The addition of Tembexa to our smallpox medical countermeasure franchise, which consists of our smallpox vaccine and therapeutic for smallpox vaccine complications, creates a more comprehensive offering to combat this deadly public health threat. We look forward to supporting the U.S. government’s smallpox preparedness strategy on a broader scale by executing on this BARDA contract.”
The initial contract, which Chimerix was given late last month, has a duration of 10 years and a price tag of more than $680 million. It entails providing up to 1.7 million treatment courses of Tembexa tablets and suspension formulations to the U.S. government. Additionally, the initial product procurement will cost approximately $115 million, with an optional future procurement of more than $550 million at BARDA’s discretion.
According to the final BARDA agreement, Emergent will pay Chimerix $238 million upfront, with potential milestone payments of over $120 million set to follow if the U.S. government exercises the procurement options. As far as royalties go, Chimerix will receive 15% on gross profit from the antiviral’s sales outside America, and 20% on gross profit from sales within the country above and beyond the 1.7 million treatment courses. Chimerix could also receive an additional $12.5 million if certain development-related milestones are reached, so overall, the company stands to gain significantly from a financial standpoint.
Regarding Tembexa, it comes in 100 mg tablets and a 10 mg/ML oral suspension that should be taken once a week for two weeks. The formulation is particularly crucial for patients who face difficulties swallowing because of their age or health.
Currently, researchers haven’t been able to adequately determine how effective Tembexa is for treating smallpox in humans. There are two major factors behind this. One, comprehensive and well-planned field trials haven’t proven feasible yet, and two, it’s not ethical to induce smallpox in humans to study the efficacy of the drug. So the efficacy may be based just on studies in animals suffering from immune deficiency.
Smallpox is an extremely contagious illness brought on by the variola virus. With a startling 30% fatality rate, it is one of the deadliest diseases in recorded history. Smallpox was successfully eradicated in the 1970s, but worries about its reemergence—whether due to an unintentional release or as a result of bioterrorism—have persisted ever since. There’s also the issue of the virus’ ability to evolve – much like the coronavirus. As a result, the US has prioritized adding new products to stop its spread.