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http://blog.pharmexec.com/2010/07/08/hiv-market-banking-on-fixed-dose-treatments/

HIV Market Banking on Fixed-Dose Treatments
By George Koroneos | Published: July 8, 2010

The HIV markets are expected to grow for the next two years, but major patent expirations in the following years will have a huge impact on pharmaceutical sales by 2019, according to a new report by DataMonitor.

Antiretroviral sales in 2009 were estimated at $11.8 billion. While that figure is forecast to hit $14.4 billion in the next ten years, the number of drugs exceeding $400 million in annual sales is expected to drop from 10 to just six due, in part, to the strength of cross-class, fixed-dose combination (FDC) treatments.

FDC regimens replace the drug cocktails that patients have relied on for years. First out of the gate was Gilead Sciences and Bristol-Myers Squibbs Atripla, which raked in $2.3 billion in sales in 2009, claiming 19 percent of the HIV market. The drugs market share is so dominant that companies that arent trying to compete with this type of drug will probably be in trouble.

Besides Atripla, Truvada/rilpivirine and the Quad pill are being tagged as major HIV players when they launch in the next few years. Atripla has been hugely successful, and we believe that follow-up FDCs will be just as successful, if not more, said Hedwig Kresse, head of Vaccines & Infectious Diseases, Datamonitor.

Kresse said that pharma companies that sell HIV drugs but dont have a combination treatment in their portfolio are going to have a tough time penetrating the market or keeping share in the market

One example that shows that the market is getting tougher is Avexas apricitabine, which was discontinued by the company because it couldnt find a development partner despite significant results in efficacy trials, said Nele Jensen, associate analyst, Datamonitor.

Merck-Schering-Plough faced similar problems with its CCR5 inhibitor, vicriviroc, after the treatment failed to meet end points in late-stage trials.

Reimbursement is also becoming an issue in light of the push for restricted healthcare spending in many countries. Traditionally, drug combinations were priced as the sum of the single agents. But with mandatory discounts on the way, pricing for HIV treatments will become a challenging environment, Jensen said.

The only single-pipeline agent predicted to be a success is Shionogi & Co and ViiV Healthcares integrase inhibitor S/GSK1349572, which has shown positive Phase II results.

HIV is a very sizeable market, and its a market that has been growing for the past decade, Kresse said. And for now, its a chronic market. You maintain patients for a very long period, which gives you a relatively stable revenue stream for good and efficacious drugs. But its getting harder to differentiate your drugs from the competition. And in light of the dominance of fixed-drug combinations, I think it wont become an easier environment in the next decadeI think it will become tougher.