China has just rejected one of Gilead’s patents for Sovaldi. Patient advocacy groups had challenged the patent, saying it wasn’t inventive enough. Tahir Amin, intellectual property director for one of the groups, said this could begin a shift toward lower-priced, generic hep C drugs in China and other countries.
The patent is also being challenged in in Ukraine, Russia, Argentina and Brazil.
Solvadi, Olysio (Galexos in Canada), and Harvoni account for most of the programs’ spending. Medicaid, the U.S. program that funds health care for the poor, spent $1.2 billion on the drugs in the first nine months of 2014.
Given that many people were still getting interferon treatment through much of 2014, the 2015 costs could climb much higher. Competition, rationing, or compassion from drug companies could lower the costs, of course.
It was great to learn today that accessing two of the new hepatitis drugs has become easier in British Columbia. Pharmacare has just approved Solvaldi and Harvoni, both Gilead products. Many extended health plans pay for only Pharmacare-approved drugs.
In France the charity Medicins du Monde has just challenged Gilead’s patent on Sovaldi, because of the exorbitant of the drug. Meanwhile in the United States, the Southeastern Pennsylvania Transportation Authority is suing Gilead over the drug’s $84,000 price tag. In India, where the patent office rejected Sovaldi because of its similarity to another compound, Gilead is the plaintiff in an appeal of that decision.
Meanwhile, other drugs are set to compete in the hep cure marketplace. One to keep an eye on is Achillion’s NS5A inhibitor. Combined with Sovaldi in a small trial last year, it cured 100% of patients in six weeks. The company is now looking at a 4-week trial. Granted, Gilead is still involved, but other competition from AbbVie, Bristol-Meyers Squibb, Johnson & Johnson, and Merck portend a very different playing field. There’s lots and lots more to come on this.
This week Merck told the Federal Drug Administration that it will stop selling Victrelis (generic name boceprevir) in the United States. The protease inhibitor hit the market in 2011 along with Incivek. Both improved hepatitis C cure rates and often shortened treatment times. Both drugs, though, had to be used with interferon.
At the height of boceprevir’s popularity in 2012, Merck made $502 million on the drug. Incivek (telaprevir) generated $1.2 billion for Vertex that year. But these old drugs are fading as Harvoni, Solvaldi, Olysio, and Viekira Pak are making treatment much, much easier. In fact, Merek is now developing its own one-pill power-pack. Interferon injections and dreaded side-effects are disappearing as more people, like me, are quickly being cured.
It seems that competition is hot and heavy. If the free market actually works, in the next few years prices should come down. But who can wait years while their liver is heading getting thicker by the minute?
Last fall Gilead Sciences Inc. made a deal with seven drug makers in India to allow them to market Sovaldi for a 7% royalty. Gilead has been selling the drug in India for $900 for a 12-week course. The company stood to earn up to $700 million there, where an estimated 12 million people have HCV.
This week, the Indian government rejected Gilead’s patent on Sovaldi, saying the drug incorporates only minor changes from a previously developed compound. The ruling will allow other Indian companies to set their own price for the drug, which costs less than $140 to manufacture, according to a Médecins Sans Frontière (Doctors Without Borders). Undoubtedly, if the pricing gets very competitive, Gilead’s profits from the huge Indian market will slump.
But this shouldn’t be too big a blow to Gilead. It charges 100 times the Indian price when it sells Sovaldi to hep C patients in the U.S.A. And don’t expect any changes to the patent there. The U.S. Patent Office has a history of being sympathetic to big industry, and pharma is a giant.
Hep C made me hungry–not for food, but for information. I’ve been reading websites galore, magazine articles, news articles, and books about hepatitis. You’ll find references to my favorite reading discoveries in the Research Notes page of this blog. Although books, by nature, take the most time to read, I find that my reading speed picks up and often flies when I’m immersed in the right book. Deadly Monopolies by Harriet A. Washington is one of them.
The book tells the story of many drug discoveries, as well as drugs taken out of production or never developed because of the big pharma profit quest. In the pursuit of those profits drug companies have sought patent protection for almost every medical breakthrough they can possibly lay claim to. These include patents on genes and even human tissue. Did you know there was a patent on the hepatitis C genome? Yep. It was held by Chiron Corporation. The California firm patented the virus in 1987. It used the patent to quash another drug company’s efforts to sell a low-cost test for the virus. Washington has a lot more to say about drug costs and about hepatitis as well. Her book is an engaging, revealing, and somewhat frightening read.
I checked my investments today. Out of several mutual funds and one metals stock, I lost $2,560 during the first week of 2015. That’s almost the average monthly take-home pay for Canadians ($2700). I’m lucky to have saved enough to weather the downdraft in oil prices that has blown down stock market profits. And I’m amazingly lucky to have gone through hepatitis C treatment without having spent my entire retirement savings on pills.
Naturally, I checked the price of Gilead Sciences Inc. stock–not that I own any. Gilead’s shares (GILD on NASDAQ) are up 5.54% over the last five days. Over the past year, the stock increased 36.69% and it outperformed the S&P 500 index. After taking a hit in my meager portfolio, I am considering buying shares in the Sovaldi maker.
I believe that Gilead’s Sovaldi (and Janssen’s Galexos) saved my life. But would it be ethical for me to buy shares from a company that prices its medicines far out of the range of hundreds of thousands of hep C sufferers whose pay is maybe just average? If anyone reading this blog has an opinion on this, please let me know.