By Drew Armstrong
June 13, 2013
AbbVie’s trial for an unnamed multidrug therapy is in the last of three stages typically required for U.S. approval and is moving quickly, Scott Brun, the company’s head of drug development, told investors (ABBV) today at a conference in New York. Gilead is seeking to bring its own multidrug regimen with its therapies sofosbuvir and ledipasvir to market next year.
“We’ve got a very good shot at being first,” Brun said at the conference hosted by Goldman Sachs Group Inc. “It is a very tight race.”
Multidrug regimens by AbbVie, Gilead and Bristol-Myers Squibb Co. (BMY) will offer hepatitis C patients more tolerable options that do away with weekly shots of interferon, a current standard of treatment that causes flu-like side effects. Gilead estimated in May that 150,000 patients may seek treatment in the U.S. once the new class of all-oral drugs is on the market, compared with 85,000 patients taking therapies last year.
“The idea is Gilead will be first, AbbVie will be on roughly the same timeline, Bristol-Myers will be somewhere after that,” said Marshall Gordon, a New York-based analyst with Legg Mason Inc.’s ClearBridge Investments affiliate.
With Gilead’s and AbbVie’s drugs possibly coming onto the market about the same time, their success may depend on what their effectiveness looks like in the final phase of trials, and how they’re priced.
“We don’t know where the efficacy is ultimately going to fall out,” Brun said on the two companies’ drugs.
Hepatitis C attacks the liver and can lead to liver cancer. The virus affects about 150 million people worldwide and the market for new pills is estimated at $20 billion. Gilead’s drug is projected to have annual sales of $6.03 billion by 2016, according to an average of 10 analysts’ estimates (GILD) compiled by Bloomberg.
AbbVie, spun off from Abbott Laboratories, has risen 26 percent since the shares began trading on the open market in January. The stock rose less than 1 percent today to close at $43.15 in New York. Gilead, the world’s largest maker of HIV medicines, increased 1.5 percent to $51.95.
“AbbVie is not getting nearly the credit that Gilead is,” ClearBridge’s Gordon said in a telephone interview. “It’s funny to me that it’s a foregone conclusion that Gilead has dominated the market.”
In a Phase II trial, Gilead’s all-oral hepatitis C treatments sofosbuvir and ledipasvir cured 95 percent of patients after eight weeks of the therapy. The Foster City, California-based company is moving the drugs into a third of three stages of clinical trials. The treatment may be sold as a single pill taken once a day.
AbbVie’s treatment will require three pills in the morning and one at night, according to Brun. In a Phase II trial with the drugs, 90 percent of patients who completed the eight-week regimen had the virus cleared from their body.
“To be fair, Gilead’s drug looks better, but not that much better,” Gordon said.
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