Gilead Says FDA Won't Accept Filing for AIDS Pill
By Rob Waters - Jan 25, 2011 6:40 PM ET
Gilead Sciences Inc., the world's largest maker of AIDS drugs, said U.S. regulators didn't accept an application for a combination AIDS pill pairing Gilead's Truvada with Johnson & Johnson's experimental drug TMC278.
The Food and Drug Administration asked for additional information about the chemistry and manufacturing of the proposed once-daily drug, the Foster City, California-based company said today in a statement. Regulators want to know more about an impurity the company found while testing the product, said Norbert Bischofberger, Gilead's executive vice president for research and development and chief scientific officer.
Gilead has been trying to develop new drugs because it faces generic competition for its three top-selling AIDS treatments starting in 2018. While the FDA action may delay the new pill, investors had low expectations for it, said Jason Kantor, an analyst for RBC Capital markets in San Francisco.
Wall Street had heavily discounted this program so the actual impact to Gilead particularly in 2011 should be pretty small," Kantor said in a telephone interview. "I don't think it changes the long-term program at all for this drug. This should be something they can straighten out."
Gilead declined 76 cents, or 2 percent, to $37.40 at 5:57 p.m. New York time in extended trading after falling 15 cents to $38.16 at the close of Nasdaq Stock Market composite trading.
During testing of the new combination pill, Gilead discovered a "degradation product" was present in the drug at a level that required it to be evaluated, Bischofberger said during a conference call with analysts. "The impurities have to be qualified to be sure they don't pose a risk," he said.
Gilead will provide the requested information to the FDA by the end of March, the company said in the statement.
Because the FDA had originally agreed to complete a priority review of the drug in six months, the agency decided not to accept the application so the clock wouldn't start ticking, Bischofberger said
"I am confident this will result in only a minor delay in bringing this important new treatment to patients," John Martin, Gilead's chief executive officer, said during the conference call.
J&J's Tibotec unit submitted a marketing application to the FDA for TCM278 after conducting two large clinical trials, Gilead said in the statement. The application for the Truvada- TCM278 combination was supported by a bioequivalence study showing that the drugs together reached the same levels in the bloodstream as each drug separately, Gilead said.
Truvada, a two-drug combination, forms the base of all first-line AIDS regimens recommended by the U.S. Department of Health and Human Services. Combining Truvada with TMC278 would make a three-drug combination that's an alternative to Gilead's Atripla, its best-selling AIDS drug that is also a triple-drug medicine.
In the new combination, TMC278 replaces Sustiva, Bristol- Myers Squibb Co.'s drug in Atripla. For Gilead, a TMC278 combination pill may attract customers seeking to avoid Atripla's side effects, and the company would pay J&J less than it pays New York-based Bristol-Myers for Sustiva.
Research presented in July at the International AIDS Conference in Vienna showed TMC278 suppressed the AIDS virus as well as Sustiva, according to Michael Saag at the University of Alabama at Birmingham. The study also showed that Sustiva kept more patients' viruses from rebounding, at 4.8 percent compared with 9 percent for TMC278.
The rate of resurgent infections with TMC278 may be viewed as a "shortcoming," Kantor wrote in a July 21 note to investors.
To contact the reporter on this story: Rob Waters in San Francisco at firstname.lastname@example.org.
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Gilead has lower qtrly profit, setback at FDA
* U.S. FDA turns back application for new AIDS drug
* Forecasts 2011 product sales of $7.9 to $8.1 billion
* Q4 adjusted EPS $0.95 vs Wall Street view $0.95
* Additional share buybacks planned
* Shares fall 2 percent (Adds company comment, background, updates share price)
By Deena Beasley
LOS ANGELES, Jan 25 (Reuters) - Gilead Sciences Inc's (GILD.O) fourth-quarter profit fell 22 percent as higher sales of its core AIDS drugs failed to offset a drop in royalty revenue and higher expenses.
The company also said U.S. regulators did not accept -- citing insufficient information -- a marketing application for an experimental HIV drug that it is developing with Johnson and Johnson (JNJ.N) and Gilead's shares fell 2 percent after hours.
"It sounds very scary, but they said they could refile at the end of this quarter," said BMO Capital Markets analyst Jason Zhang. "If they can do that, it is not going to be a big problem."
The new HIV pill, which combines Gilead's Truvada with J&J's TMC278, is seen as key to Gilead's future because it could be used instead of Atripla -- a once-daily pill that combines Truvada with Sustiva, an older drug made by Bristol-Myers Squibb Co (BMY.N).
Gilead earns no profit on the Bristol drug and all of the Atripla components lose patent protection in the next few years.
Under the deal with J&J, Gilead would keep up to 30 percent of TMC278 sales.
The regulatory setback is "a minor delay" associated with a change in methodology for measuring degradation of the medicine, Gilead Chief Scientific Officer Norbert Bischofberger said on a conference call. Before the delay, the FDA had been expected to approve the drug by May 23.
For the full year, Gilead forecast 2011 product sales of between $7.9 billion and $8.1 billion, which brackets analyst estimates.
But the company also forecast higher research and other costs for this year, "thus suggesting that consensus EPS estimates may be too high," according to ISI Group analyst Mark Schoenebaum.
The company's fourth quarter net income fell to $629.4 million, or 76 cents a share, from $802.2 million, or 87 cents a share, a year earlier.
Gilead Sciences Receives Refuse to File Notification From U.S. FDA on New Drug Application for Single-Tablet Regimen of Truvada(R) and TMC278
- Additional CMC Information Required Before Resubmission of New Drug Application -
FOSTER CITY, Calif., Jan 25, 2011 (BUSINESS WIRE) --
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it has received a "refuse to file" notification from the U.S. Food and Drug Administration (FDA) regarding Gilead's New Drug Application (NDA) for the single-tablet regimen of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. In its communication, the FDA requested additional information with respect to the Chemistry, Manufacturing and Controls (CMC) section of the Truvada/TMC278 NDA submission. The letter stated that the application does not contain sufficient information on the analytical methodology to establish acceptable levels of recently identified degradants related to emtricitabine.
"We are working to validate the methodology to resolve this issue and provide the required information to the FDA," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "We expect to be in a position to resubmit the Truvada/TMC278 NDA with the additional requested information prior to the end of the first quarter of this year."
The FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on November 23, 2010.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to Gilead's ability to resubmit the NDA in the timeline currently anticipated. In addition, the FDA may not be satisfied with the additional informational submitted by Gilead and may not approve Truvada/TMC278 for the treatment of HIV-1 infection in adults. Further, any marketing approval, if granted, may have significant limitations on its use. Further, Gilead and Tibotec may make a strategic decision to discontinue development of the Truvada/TMC278 if, for example, the market for the product fails to materialize as expected. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).
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