Strong quarter for AstraZeneca as FDA panel backs Brilinta

by | 29th Jul 2010 | News

AstraZeneca shares are on the rise this morning after the firm posted a strong set of financials for the second quarter and celebrated a recommendation for approval from US advisory panel for its bloodthinner Brilinta.

AstraZeneca shares are on the rise this morning after the firm posted a strong set of financials for the second quarter and celebrated a recommendation for approval from US advisory panel for its bloodthinner Brilinta.

The Anglo-Swedish drugmaker has reported a 1% rise in sales (at constant exchange rates) to $8.18 billion and operating profits of $3.03 billion (+5%), helped by the continued strong performance of Crestor (rosuvastatin). Sales of the cholesterol drug increased 23% to $1.43 billion and in the USA, Crestor total prescriptions increased 12%, four times the percentage growth for the US statin market as a whole.

Sales for Toprol XL/Seloken (metoprolol) were down 25% to $317 million, hit by generic competition, while revenues for the antiulcerant blockbuster Nexium (esomeprazole) were flat at $1.26 billion. The asthma combo Symbicort (budesonide and formoterol) increased 20% to $664 million, while the antipsychotic Seroquel (quetiapine) franchise rose 8% to $1.35 billion, boosted by the performance of Seoquel XR (up 92% to $303 million).

As for oncology sales, Arimidex (anastrozole) was down 10% to $439 million, while generic competition to Casodex (bicalutamide) saw the drug fall 40% to $151 million. Zoladex (goserelin) brought in $280 million (-1%) and Iressa (gefitinib) climbed 19% to $93 million.

The new diabetes compound Onglyza (saxagliptin), partnered with Bristol-Myers Squibb, brought in $14 million and after a slow start, AstraZeneca believes the drug is finding its place. Its share of total prescriptions in the US dipeptidyl peptidase-4 (DPP-4) inhibitor market reached 6.9% in the week ending July 16 and Onglyza’s share of patients newly starting DPP4 treatment was 24.7%.

Chief executive David Brennan said the results reflect continued strong growth in emerging markets and good performance for key brands. He added that while revenue and earnings comparisons “become more challenging in the second half of the year”, due to increased generic competition, “we have increased our full year financial targets.”

AstraZeneca has raised its earnings forecast for 2010 to $6.35-$6.65 from a previous guidance of $6.05-$6.35 per share. It now expects “a low single-digit decline in revenue” in constant currency terms and has announced that its share repurchase programme has been increased to $2 billion for 2010, up from initial $1 billion target given at the beginning of the year.

The results came out just as US Food and Drug Administration Cardiovascular and Renal Drugs AdvisoryCommittee recommended Brilinta (ticagrelor) to reduce the risk of major adverse cardiac events in patients with acute coronary syndromes. The panel voted 7-1 in favour of two questions that asked whether the drug should be approved for use in patients undergoing percutaneous coronary intervention, as well as in patients being medically managed and not expected to undergo surgical treatment.

Such a strong vote in favour was particularly good news for AstraZeneca given that earlier in the week documents from FDA staffers drew attention to the fact that in the 18,624-patient PLATO study, the Phase III head-to-head trial comparing the drug plus aspirin with Sanofi-Aventis/Bristol-Myers Squibb’s big-selling bloodthinner Plavix (clopidogrel), also with aspirin, there was a difference in effectiveness between US and non-US participants in the trial.

The company believes that higher aspirin doses in the USA may explain the difference and the panel said the reason for the lack of benefit in that subgroup is unclear. However, Tim Anderson, an analyst at Sanford Bernstein issued a research note saying that “we continue to feel that Brilinta will face meaningful commercial hurdles”. He added that “competitors will have marketing materials pointing to the unfavourable US data and payers may block the product just like they’ve done with Effient”, Eli Lilly/Daiichi Sankyo’s prasugrel.

All in all, a good day for AstraZeneca and its shares were up 4.9% to £33.60 at 11.30 (UK time).

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