Back grey_arrow_rt.gif
J&J Has to Resolve Hepatitis C Drug Conflict, Medivir CEO Says
By Andrea Gerlin - Jul 13, 2011 3:37 AM ET
Johnson & Johnson (JNJ) has to decide how to resolve the potential conflict in selling both Medivir AB (MVIRB)'s and a competitor's hepatitis C drugs if the Swedish company's pill is approved, Medivir's chief executive officer said. Medivir is developing its TMC435 tablet with New Brunswick, New Jersey-based J&J's Tibotec Pharmaceuticals Ltd. unit. The Huddinge, Sweden-based biotechnology company said last week the experimental treatment will get a faster review from the U.S. Food and Drug Administration. The medicine may go on sale in late 2013, Medivir CEO Ron Long said in an interview yesterday in London.
J&J is working simultaneously with Cambridge, Massachusetts-based Vertex Pharmaceuticals Inc. (VRTX) on Incivek, another hepatitis C drug that won U.S. marketing approval on May 23. J&J has agreed with both companies to use its "best efforts" to sell the drugs, so its sales force can't promote one product over the other in pitches to doctors, Long said.
"They have to resolve that issue," Long said. "You can't use best efforts if you are prioritizing one drug over the other. I think their position is unsustainable and I've told them so."
J&J declined to comment on how the two drugs would be marketed if Medivir's product wins approval.
"It's not something to be speculated on today given that 435 is still in phase 3" testing, said Karen Manson, a spokeswoman for the Tibotec unit, in a telephone interview. "These are discussions we need to have at the appropriate point in time. Do we have a plan in place today? No, absolutely not."
Study Results
In a mid-stage trial, 83 percent of patients who took TMC435 were cured, compared with 79 percent who took Incivek and 66 percent on Merck & Co.'s Victrelis in late-stage trials, Long said. TMC435 is taken once daily. Incivek and Victrelis are taken three times a day.
J&J will have separate teams divided by a "firewall" to help sell TMC435 and Incivek, he said. If TMC435 reaches the market, physicians may be confused by sales representatives from the same company giving different pitches for the two products, he said.
"That can work until 435 gets to the market," Long said. "When it does get to the market, I think they have a very difficult position because the clinician prescribing the drug will be hearing two stories from the same organization, which is very difficult to sustain."
Long has "no insight into what is in other agreements," Tibotec's Manson said.
Buying Stock
The CEO said he bought shares in his company because he believes Medivir will be successful and Swedish executives aren't typically rewarded with stock.
"I bought a lot of shares in Medivir," Long said. "I wouldn't do that if I wasn't confident."
Hepatitis C is caused by a virus that leads to chronic disease in 75 percent to 85 percent of those infected, according to the U.S. Centers for Disease Control and Prevention in Atlanta. About 170 million people carry the virus worldwide, the CDC said on its website.
J&J's success with Hep C partners might hit a snag
July 13, 2011 - 9:17am ET | By Ryan McBride
Johnson & Johnson is one of the best in the business at tapping outside developers for new drugs, but the Big Pharma's success on this front in the hepatitis C arena appears have brought with it some controversy.
Even though its Hep C drug is still in late-stage development, Swedish biotech Medivir isn't comfortable with the fact that its partner J&J is promoting Vertex Pharmaceuticals' hot drug against the liver disease, Incivek, Medivir CEO Ron Long told Bloomberg. And Long wants J&J to resolve the potential conflicts of having one company promote two different drugs for the same disease to the same doctors.
"They have to resolve that issue," Long said, as quoted by Bloomberg. "You can't use best efforts if you are prioritizing one drug over the other. I think their position is unsustainable and I've told them so."
Medivir's issues with J&J might become more common with so many biotechs looking to Big Pharma to market their drugs, and large drug companies doing the smart thing and spreading their bets in key therapeutic areas. As we all know, history tells us that most of the drug programs won't reach the market as they fail at some point in the development process. On the other hand, J&J saw its partner Vertex win FDA approval of Incivek with flying colors in May, and Medivir's TMC435 showed that it might be able to provide even better cure rates than Incivek, according to a mid-stage trial.
Still, Medivir, whose 435 wouldn't likely hit the market until 2013, still has to prove that its drug can have that kind of success in late-stage trials. J&J might want to see whether its Swedish partner's drug can pass the big test in the clinic before it starts to divide its kingdom. But with so much riding on the success of 435, it's no surprise to see the CEO voicing some concern over the potential conflict.
  icon paper stack View Older Articles   Back to Top