Cases of monkeypox have been identified in several European countries Spain, Portugal, the United Kingdom, as well as in the United States, Canada and Australia. New cases have been reported in Belgium, France and Germany, as previously reported on PHARMPROM.
COVID shows that timely vaccine development can lead to enormous cash flows. This year Pfizer expects Comirnaty sales to reach around $32 billion.
Emergent Biosolutions (EBS 11.49%), Chimerix (CMRX 6.82%), and SIGA Technologies (SIGA 43.35%) all have successful poxvirus programs of their own. Investors with monkeypox on their minds have already started pushing up their stock prices.
Emergent Biosolutions develops vaccines and treatments that are aimed at some of the most terrifying pathogens of all time. One of its vaccines is ACAM2000, the only single-dose smallpox vaccine licensed by the FDA. The vaccine contains an active, but relatively innocuous virus related to smallpox.
With just a handful of cases confirmed in the U.S., it’s highly unlikely that we’ll see a mass distribution of ACAM2000. If monkeypox case counts continue climbing, though, health officials could quickly decide ACAM2000 is worth the risk of side effects.
Last June, the FDA approved Tembexa, this Chimerix’s antiviral treatment for smallpox. The biotech stock recently imploded after the company agreed to sell Tembexa to Emergent Biosolutions for $225 million up front, milestone payments that could reach $100 million, and a royalty percentage of future sales.
Chimerix’s deal with Emergent didn’t please investors because the company also noted these terms could be adjusted based on the actual amount of Tembexa sold. Chimerix investors were also unhappy about the company’s pivot to oncology drug development.
Last year, Chimerix acquired a cancer drug developer called Oncoceutics to access an experimental treatment for brain cancer in late-stage development called ONC201. It turns out that ONC201 isn’t as far along the development pathway as hoped. Chimerix stock also tanked because the company admitted it will have to run a long and expensive phase 3 trial before submitting an application to the FDA.
This biotech already developed one FDA-approved treatment but it’s important to remember there weren’t any smallpox patients available to run a typical clinical trial. This means we really have no idea if Tembexa is an effective treatment for monkeypox. Increasing expenses from ONC201 plus highly uncertain cash flows from Tembexa make this a stock to avoid for now.
If there’s a larger monkeypox outbreak, Tembexa will compete with Tpoxx. This is SIGA Technologies’ antiviral treatment for smallpox. On May 19, the FDA approved an intravenous version of Tpoxx to be administered to patients who can’t swallow oral capsules of Tpoxx. Shares of the stock climbed in response.
Shares of SIGA Technologies rose more sharply than Chimerix because, in Europe, Tpoxx is already approved to treat monkeypox in addition to smallpox. In the U.S., the FDA has approved Tpoxx and Tembexa to treat smallpox but the agency still hasn’t weighed in on either for the treatment of monkeypox.
According to SIGA Technologies, Tpoxx has already been used to treat cases of monkeypox. The company also said EU member states where cases have been found are already beating a path to its door.