March 25, 2010 / 8:01 AM / 7 years ago

UPDATE 2-SkyePharma in process of filing Flutiform in EU

* Asthma/COPD drug being filed for European approval

* 2009 net loss 1.4 mln pounds vs 2008 loss 28.7mln

* CEO says will have meeting with FDA in the summer

* Shares down 1.6 pct after gaining as much as 7 pct

(Adds CEO interview, analyst reaction, latest shares)

By Ben Hirschler and Paul Sandle

LONDON, March 25 (Reuters) - British drug delivery specialist SkyePharma SKP.L said it was in the process of filing its Flutiform asthma drug for European approval, following recent setbacks in the United States.

SkyePharma will complete the filing of documents with European regulators by the end of March, Chief Executive Ken Cunningham said on Thursday.

Clinical trials with the drug in Japan, the world's second largest pharmaceutical market, remain on track, the company said in its annual results statement.

SkyePharma shares have halved in value since January after the U.S. Food and Drug Administration (FDA) refused approval for Flutiform and its U.S. partner Abbott (ABT.N) handed over control of the U.S. application to the company.

Cunningham said the company would meet the FDA in the summer.

"We will be seeking clarity on some of the points in the complete response and we are going back with our own proposals," he said in an interview.

The company believes it will need to do additional Phase I or Phase II studies to satisfy questions from the agency about the dose selected in the final-stage Phase III programme.

"We think that is something we can do," Cunningham said.

Abbott will be involved in the process and will attend the meeting with the FDA, he added.

"It's clear they will be taking a view on what they do moving forward but at the moment Abbott is our partner," Cunningham said.

The inhaled drug, which is being developed for asthma and chronic obstructive pulmonary disease (COPD), is SkyePharma's most important asset.

If approved, Flutiform will compete with two big and well-established fixed-dose asthma combination drugs -- GlaxoSmithKline's (GSK.L) market-leading Advair and AstraZeneca's (AZN.L) Symbicort.

SkyePharma reported a net loss of 1.4 million pounds ($2.10 million) for 2009, sharply down on the loss of 28.7 million in 2008, following a programme of cost cutting. Revenue in 2009 were down 10 percent to 55.9 million due to lower milestones in 2009 and non-recurring manufacturing revenues in previous year.

Shares in the company rose as much as 7 percent following the results, which Piper Jaffray said were well ahead of expectations, but slipped back to stand 1.6 percent lower by 1145 GMT.

"Until SkyePharma meets with the FDA to garner clarity on these requirements, we retain a cautious stance on the shares," Piper Jaffray analysts said in a note.

For 2010, SkyePharma expects a lower operating result, mainly due to one-off costs of approximately 3.0 million pounds to prepare for commercial manufacturing for the launch of Flutiform in Europe, where the drug is partnered with Mundipharma.

Kyorin (4569.T) is the partner for Flutiform in Japan. ($1=.6664 Pound) (Editing by Karen Foster)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below