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AstraZeneca Probes Aspirin Impact on Brilinta Trial

http://www.bloomberg.com/apps/news?pid=20601102&sid=aJ744vImT8cY#

By Trista Kelley

Oct. 29 (Bloomberg) -- AstraZeneca Plc is looking into whether greater use of aspirin reduces the effectiveness of its experimental clot-busting medicine Brilinta, which analysts had estimated would bring in $1 billion a year.

AstraZeneca’s Brilinta beat Sanofi-Aventis SA and Bristol- Myers Squibb Co.’s blood thinner Plavix in a study, preventing 16 percent more heart attacks, strokes and deaths. The trial included more than 18,000 patients in 43 countries. Those in North America may have done worse on Brilinta, a finding that raised questions among analysts about potential U.S. sales. London-based AstraZeneca said today that researchers noticed a link between higher doses of aspirin and Brilinta’s potency.

Brilinta is one of four medicines AstraZeneca planned to seek approval for this year to offset declining sales of products that will lose patent protection. The U.K. drugmaker withdrew its application for lung cancer therapy Zactima yesterday after an analysis showed the drug didn’t improve patients’ survival. Third-quarter profit rose 23 percent.

“Of the four drugs due for filing this year: Zactima has been pulled; Brilinta looks very weak to us now, and that leaves two,” said Navid Malik, an analyst at Matrix Corporate Capital in London, in a note to clients. “With 40 percent of revenues going generic in the next five years, we would be highly concerned about AstraZeneca’s future earnings and sales potential.”

Shares Fall

The shares fell 37 pence, or 1.3 percent, to 2,752 pence at in London. AstraZeneca has fallen 2 percent this year, compared with a gain of 4.1 percent in the Bloomberg Europe Pharmaceutical Index.

AstraZeneca said aspirin use is one of several possible explanations for the Brilinta results being examined. The company still expects to file the drug for U.S. approval later this quarter and sought European approval on Oct. 26.

“While no definitive explanation has been found to date, further analyses suggest a possible association between aspirin dose and the primary efficacy results” for Brilinta, AstraZeneca said in a statement. “The company and the trial investigators are continuing to explore these and other hypotheses, as well as other follow-on analyses of the trial data set, and plan to publish in due course.”

AstraZeneca reached an “agreement in principle” in September to pay $520 million to settle a U.S. investigation over allegations the company marketed its antipsychotic drug Seroquel for unapproved uses, U.S. spokesman Tony Jewell said today.

Seroquel Investigation

“The investigation also related to selected physicians who participated in clinical trials involving Seroquel,” he said in an e-mailed statement. He said he couldn’t provide further details.

AstraZeneca faces several lawsuits by individual states brought on behalf of Medicaid programs, alleging the company withheld information about the risks of Seroquel and promoted the drug for off-label purposes. The states, which include South Carolina and Pennsylvania, are seeking reimbursement of funds spent on prescriptions and alleged injuries to patients.

“AstraZeneca continues to defend itself” in these lawsuits, Jewell said in an interview.

The federal agreement settlement follows similar settlements by makers of rival antipsychotic drugs including New York-based Pfizer Inc. and Eli Lilly & Co. of Indianapolis.

Profit Rose

Net income was $2.12 billion, up from $1.73 billion a year earlier, AstraZeneca said today. Earnings excluding restructuring and other one-time costs gained to $1.68 a share from $1.32, beating the $1.38 mean estimate of 19 analysts surveyed by Bloomberg.

The U.S. ordered 40 million doses of AstraZeneca’s nasal spray vaccine against swine flu, adding $453 million in revenue for the second half.

The sales boost comes as AstraZeneca makes headway with a plan to eliminate 11 percent of its workforce by 2010 and faces cheaper copies of seven drugs by 2014, including its three biggest sellers: Nexium for ulcers, the Crestor cholesterol- lowering treatment, and the antipsychotic Seroquel. AstraZeneca won U.S.approval for Onglyza, a diabetes treatment it markets with Bristol-Myers, on Aug. 3.

Earnings Forecast

Third-quarter earnings were bolstered by manufacturing setbacks that halted shipments of Novartis AG’s generic version of heart medicine Toprol XL, triggering a fourfold increase in U.S. sales to $293 million for the quarter. The delays continue to boost earnings, Chief Financial Officer Simon Lowth said on a conference call.

AstraZeneca expects full-year earnings per share to be $6.20 to $6.40, up from a previous forecast of $5.70 to $6, in constant currency terms. The appreciation of the dollar during the quarter eased costs, which are in pounds and Swedish kronor, while hampering revenue. Third-quarter sales gained 5.4 percent to $8.2 billion, compared with 21 analysts’ mean estimate of $7.97 billion.

GlaxoSmithKline Plc, AstraZeneca’s larger London-based rival, yesterday reported a 30 percent increase in third-quarter profit after currency gains and orders for the Relenza flu drug boosted revenue.