March 25, 2016
By Mark Terry, BioSpace.com Breaking News Staff
The analysts at Thomson Reuters have consulted their crystal balls and come up with seven drugs coming out this year that will likely hit blockbuster status—defined as marking more than $1 billion annually.
1. Obeticholic Acid
Intercept Pharmaceuticals, Sumitomo Dainippon Pharma
First up is obeticholic acid, manufactured by New York-based Intercept Pharmaceuticals (ICPT) to treat chronic liver diseases such as primary biliary cirrhosis and non-alcoholic steatohepatitis (NASH). NASH, in particular is lacking in effective approved treatments, and if this drug is approved, could make $2.62 billion by 2020.
There have been recent rumors that Intercept might be an acquisition target of Dublin-based AstraZeneca plc , although not much has come of it.
Other companies working on NASH treatments include Gilead Sciences with Simtuzumab and Tobira Therapeutics with cenicriviroc.
2. Emtricitabine and Tenofovir Alafenamide
Gilead Sciences and Japan Tobacco
Foster City, Calif.-based Gilead Sciences (GILD), with Japan Tobacco, has two drugs for HIV-1 infection, emtricitabine and tenofovir alafenamide (F/TAF). The drugs come in daily single doses and the company hopes they will fill in the gap that will happen when its current HIV drugs lose patent protections in 2017.
3. Tenofovir Alafenamide and Emtricitabine and Rilpivirine
Gilead Sciences and Janssen R&D
Gilead again, this time with Janssen, a Johnson & Johnson company, has a combination therapy of tenofovir alafenamide and emtricitabine and rilpivirine (R/F/TAF) for HIV-1 infection, with potential sales of $1.57 billion by 2020.
4. MK-5172A (Grazoprevir and Elbasvir)
Merck & Co.
Number four is an interesting case. Merck (MRK) is jumping into the hepatitis C market, which is pretty much dominated by Gilead’s Harvoni and Sovaldi, with AbbVie’s Viekira Pak a runner up. Those products are very expensive—although very effective—so if Merck’s going to be able to break into this hot market, it might have to do so with an aggressive pricing strategy. If they can carve out part of the market, potential sales could hit $1.54 billion by 2020.
It was also reported yesterday that a federal court has ordered Gilead Sciences to pay Merck $200 million for infringing on two of Merck’s patents related to hepatitis C. That’s much less than the $2 billion Merck was requesting, but the jury upheld the patents’ validity.
5. Venetoclax
AbbVie
AbbVie (ABBV) is on the list with venetoclax for chronic lymphocytic leukemia (CLL). CLL is generally resistant to chemotherapy and the drug had a 79.4 percent response rate in patients with relapsed CLL and is being tested for non-Hodgkin’s lymphoma and other blood cancers, as well as a potential combination therapy with tomoxifen in breast cancer. Sales are projected at $1.48 billion by 2020.
6. Nuplazid
Acadia Pharmaceuticals
San Diego-based Acadia Pharmaceuticals (ACAD) is facing a make-or-break decision for its Nuplazid to treat Parkinson’s disease psychosis. This disorder affects up to 40 percent of Parkinson’s patients and if approved, would be the only drug on the market for it. Analysts predict, if approved, it could have peak sales of around $2 billion. Writing for The Motley Fool in February, Brian Feroldi noted that, “Acadia Pharmaceuticals’ stock isn’t for the faint of heart—nearly all of its market value is riding on the success of Nuplazid. If the FDA gives the greenlight, it’s likely Acadia’s stock will soar, but if the FDA decides to reject the drug, the company’s stock will be crushed.”
7. Uptravi
Nippon Shinyaku and Actelion
And finally, Kyoto, Japan-based Nippon Shinyaku and Actelion offer Uptravi to treat pulmonary arterial hypertension. It launched in January and is projected to hit $189 million in sales this year with potential sales up to $1.27 billion by 2020. In a large clinical trial, the drug cut the risk of death from pulmonary arterial hypertension by 39 percent compared to patients receiving the placebo.
