If a biotech wants to become the next drugmaker with multiple blockbusters on the market, it has to start at the bottom with a single drug. We asked our biotech experts for their top picks for companies with just a single drug on the market.
Keith Speights: Medivation certainly deserves consideration for the best one-drug wonder for 2015. The company made earnings of more than $276 million from revenue of $710 million last year on the back of its only approved drug Xtandi.
The year 2015 looks to be even brighter for the prostate-cancer drug. Medivation projects U.S. sales of Xtandi to jump at least 54% year over year, to between $1.050 and $1.125 billion. The company splits the revenue with collaboration partner Astellas Pharma, but still stands to receive $600 to $650 million in revenue from U.S. sales alone. Adding in ex-U.S. sales and milestone payments should give a nice boost to Medivation's financial performance.
Several clinical trials are also underway for Xtandi that hold the potential to bring even more success. Medivation is conducting mid-stage and late-stage trials for additional prostate-cancer indications, as well as studies exploring Xtandi's effectiveness as a treatment for breast cancer.
It's possible that Medivation won't be a one-drug wonder down the road, though. The company exercised an option in December for pidilizumab, an immune modulatory anti-PD-1 monoclonal antibody originally developed by CureTech, Ltd. For the foreseeable future, however, Xtandi will drive Medivation's fortunes.
George Budwell: Orexigen Therapeutics might only have a single FDA-approved and marketed drug, weight-loss pill Contrave, but it is a stock with tremendous potential nonetheless. So far, Contrave has gotten off to a much stronger start in its U.S. launch than its rivals Belviq and Qsymia, reportedly gobbling up nearly a third of the total FDA-approved obesity drug sales this quarter, despite being on the market for a far shorter period of time.
The fat-fighting pill should also get another boost soon from a highly-anticipated approval in Europe, under the brand name Mysimba. A regulatory approval in Europe would probably catapult Contrave/Mysimba into the market-share lead among next-generation weight-loss drugs, and potentially put the drug on the path toward becoming the first blockbuster obesity drug in history.
Specifically, Orexigen's weight-loss pill is presently on track to generate around $400 million in net sales in the U.S. in 2016. And a green light in Europe might bump this number up into the $500 million range, only about two years into the drug's commercial launch. Despite some speed bumps regarding an early release of data against the FDA's wishes, Orexigen has my full attention right now as a potentially high performer in 2015.
Brian Orelli: I'm not picking Isis Pharmaceuticals for its one drug on the market. Kynamro is not too sexy for Right Said Fred's shirt. No one is going to ask, "Who let the Kynamro out?"
The cholesterol-lowering drug is approved to treat a rare genetic disorder that causes people to have dangerously high levels of cholesterol. But the potential for liver damage will likely keep it from getting used broadly for a larger patient population.
What makes Isis a wonder is its pipeline with 38 drugs in development. Many of those are partnered, so Isis isn't actually paying for the development of all of them, but will have a financial stake if they're approved, and often gets milestone payments along the way.
Isis has been able to develop so many drugs because it uses the same antisense platform to knock down the expression of different proteins. The hardest part of drug development -- figuring out which proteins to lower to help which diseases -- is typically discovered at academic institutions. Because the drug candidates use the same platform -- which Isis has been steadily improving the potency of -- the knockdown of the protein is relatively straightforward.
This year, Isis plans to report clinical data on at least eight of its compounds, including quite a few proof-of-concept phase 2 studies for molecules that it fully owns. By the end of the year, Isis could be partying like it's 1999.