In the old days, an HIV patient would get through the day by taking as many as 30 tablets. Nowadays a single pill a day, such Gilead's (NASDAQ:GILD) Atripla, will do.
Still, the drug must be taken for life and can cause long-term damage to the liver, pushing drugmakers to look for even safer and less burdensome therapy.
Shots Vs. Pills
Patients usually prefer pills rather than needles. However, HIV patients take their pills for life. Gilead and others have greatly reduced the number of antiviral drugs patients need to swallow every day. Still, many patients would choose injections received once a month or even less frequently.
According to results presented at the International AIDS Society's meeting in Kuala Lumpur in June, 40 healthy volunteers took a combination of Glaxo's GSK744 and J&J's TMC278 and sustained drug levels above a predetermined threshold considered necessary to control HIV, during the trial and for four months after the last shot.
The study suggests that the shots may one day provide a safer, more convenient treatment option compared to daily pills.
A survey has been conducted about the preference. Out of 400 HIV-infected patients, 84 percent said they would probably or definitely try monthly injectable therapy, according to a study published in the journal Nanomedicine in April.
As a vaccine, quarterly shots may also prove useful. Gilead's Truvada pill has been tested as a vaccine and it was proven that it would reduce the chances of uninfected people getting the virus, however, in real life the inconvenience and side effects of taking a daily medicine may deter many from using it.
One constituent of the experimental combination, J&J's TMC278, also known as Edurant, has been approved in oral form by the FDA since 2011.
The drug is a version of dolutegravir, Glaxo's upcoming new drug, which is expected to win U.S. regulatory approval by August and could earn Glaxo more than $1 billion in sales by 2018, according to estimates compiled by Bloomberg.
In the trial, healthy participants took GSK744 in tablet form once a day for two weeks, then stopped treatment for a week before receiving one of three different combinations of the injections once a month for four months. A fourth group received two injections three months apart.
GSK and J&J have already continued testing the combo in HIV-infected patients.
China is potentially a huge market for HIV treatments.
Officially the population of HIV-infected people in China is numbered in the 800,000s, but many believe that unofficially that number is at least twice as big.
Hangzhou, China-based Ascletis is a biopharma startup, developing a candidate, called TMC310911, as an affordable and superior treatment for Chinese HIV patients.
The company has acquired the compound from Johnson & Johnson. The CEO of Ascletis, Jinzi Wu, had previously been head of HIV drug development at GlaxoSmithKline.
Wu expects the market for HIV treatments in China to grow at 30 percent annually for the next several years, faster than the overall pharma market in China. With the licensing deal from Janssen, Ascletis has the chance to be the first local company to manufacture and sell an HIV protease inhibitor in the growing market.
The Chinese government pays for the majority of HIV treatments in the country, yet most patients have been unable to access some of the latest antivirals because of the cost. Patients are taking first-generation HIV drugs since they cost less than the newer pills.
J&J's TMC310911 (which Ascletis will rename to ASC-09) offers both a best-in-class HIV protease inhibitor and provides a treatment at a price that fits health budgets in China. Ascletis plans to sell the drug for $4,000 to $5,000 per year.
J&J's Janssen has already developed TMC310911 through Phase 2, and it stands to gain royalties from Ascletis on sales of the drug in China. Janssen has kept its rights to the drug in all other markets.
Ascletis was launched two years ago with a $100 million venture capital led by Hangzhou Binjiang Investment Holding, an operation of the Chinese real estate magnate Jinxing Qi.
GSK and Pfizer set up the joint venture ViiV three years ago, with both committing HIV/AIDS assets to the venture and splitting ownership 85 percent to 15 percent.
Last year a major restructuring took place.
Japanese company Shionogi received a stake in the venture in return for giving up its rights to the HIV investigational drug dolutegravir. Under the terms of the agreement, ViiV acquired the exclusive global rights to dolutegravir and other early-stage integrase inhibitor compounds. In return, Shionogi receives a royalty on sales "averaging in the high teens" and became a 10 percent shareholder in ViiV, also getting a seat on the board.
Analysts think that at some point ViiV will be turned into an independent company, offering a direct challenge to Gilead.
In a head-to-head study, dolutegravir was compared directly to Gilead's Atripla, and dolutegravir came out ahead.
Dolutegravir blocked all signs of the virus in 88 percent of the patients after 48 weeks, compared to 81 percent for Gilead's Atripla, as reported in July 2012,.
The data persuaded JPMorgan (NYSE:JPM) to raise the chances of regulatory success to a certainty.
Gilead has been the number one player in the AIDs market for years, building a blockbuster HIV franchise primarily with drugs from its own pipeline.
The combo program represents a strategy with which Glaxo and allies are trying to counter Gilead's weight in the industry by joining forces and developing new branded HIV drugs.
Against Gilead's HIV franchise in pills today, it appears that Glaxo and J&J own the most advanced long-lasting injected therapy.
In a strategic move, GSK and its minority partner Pfizer both gave up a portion of their equity in Viiv Healthcare to Shionogi in exchange for a controlling interest in dolutegravir that has demonstrated success at barring HIV from penetrating cells. And J&J joined in the creation of the new injected combo.
This development brings a refreshing competition into the HIV marketplace and is good news for both doctors and patients, as it may slow down the never-ending rise in the prices of HIV drugs.
Investors who wish to bet on upcoming HIV therapies have more options, too.