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UPDATE 2-Vectura must wait for Novartis lung drug payment

Thu Oct 22, 2009 4:38am EDT

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* Start of QVA149 Phase III studies now expected in 2010

* Associated $7.5 mln milestone seen in next fiscal year

* Novartis now says won't file QVA149 before 2012

* Vectura shares slide 2.6 percent

(Adds Novartis filing timeline, analyst comment, latest shares)

LONDON, Oct 22 (Reuters) - Britain's Vectura (VEC.L) will not receive a hoped-for $7.5 million payment until its next financial year because Swiss partner Novartis (NOVN.VX) has delayed studies on a new two-in-one lung drug.

Novartis will now only start final-stage Phase III trials of QVA149 during 2010, resulting in receipt of the associated milestone payment in the year ending March 31, 2011, the British inhaled drug specialist said on Thursday.

QVA149 -- which combines Vectura's "smoker's lung" drug NVA237 with Novartis's QAB149, or indacaterol -- had been expected to enter Phase III in the fourth quarter of this year.

But Novartis received a so-called Complete Response Letter from U.S. regulators on Oct. 16 requesting additional information on the dosing proposed for indacaterol, which has delayed the combination drug programme.

Novartis, which reported third-quarter results on Thursday, said in slides posted on its website that it did not now expect to file QVA149 for regulatory approval in chronic obstructive pulmonary disease before 2012. It had previously targeted 2011.

"Clearly this news is disappointing for Vectura," said Nomura Code analyst Michael King.

"But this type of regulatory response is not unusual, particularly from the respiratory division of the FDA (U.S. Food and Drug Administration), and we do not believe that there is an issue with the safety of QAB149."

King maintained his "buy" on Vectura but reduced the share price target to 93 pence from 95p. The stock was down 2.6 percent at 85.25p by 0815 GMT.

Phase III trials with NVA237 on its own, which commenced in June 2009, are proceeding to plan, Vectura said. (Reporting by Ben Hirschler, editing by Will Waterman)



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