BAD HOMBURG, Germany (AFP) - German drug maker Altana said that it had postponed its application for approval of its new asthma treatment Roflumilast in the United States because additional clinical trials on the drug were taking longer than expected.
Roflumilast, a phosphodiesterase inhibitor being studied for the treatment of chronic obstructive pulmonary disease and asthma, had already been tested on more than 4,400 patients in 16 clinical trials.
But 10 additional trials were taking longer than expected owing to delays in the enrolment of the 4,100 patients needed. And that meant the application of US approval of the drug would have to be set back, Altana said in a statement.
"It is now expected that the application for approval, originally planned for the first half of 2005, will take place later," Altana said.
Altana spokesman Thomas Gauly insisted that "neither safety issues, nor negative efficacy data" were involved in the decision to postpone the application for marketing approval.
It was simply because other pharmaceutical companies developing similar drugs were also enrolling thousands of patients for their own clinical trials, and that meant enrolment for Altana's 10 additional trials was taking longer than expected, Gauly said.
He declined to name a new date for filing for approval.
The announcement nevertheless marked the second apparent setback in a week for Altana's new potential blockbuster asthma drugs.
Blockbuster drugs are defined as drugs with annual sales potential of around one billion euros (1.27 billion dollars).
And Altana is hoping that the launch of new blockbusters will help make it less dependent on its best-selling stomach ulcer drug Pantoprazole, which accounts for around 40 percent of overall group sales.
Earlier this week, industry sources had said that Altana and its French partner Sanofi-Aventis had received only an "approvable letter" from the US Food and Drug Administration for their new inhaled asthma treatment Alvesco, rather than straightforward approval.
That meant that several conditions still had to be fulfilled before the drug could be marketed in the all-important US market.
Analysts said they expected Alvesco to be launched in the United States only in 2006, instead of next year.
The Roflumilast news, coming so soon after the Alvesco setback, sent Altana shares into a tailspin on the Frankfurt stock exchange.
Altana shares slumped 2.67 euros or 6.2 percent to an intraday low of 40.58 euros in early trading on Thursday. But they subsequently recovered some of their losses and were showing a loss of 2.02 euros or 4.67 percent at 41.23 euros by late morning. The overall blue-chip DAX 30 index was higher.
"While the reason for the delay sounds plausible, it's not the first delay and scepticism is therefore growing," remarked Alexander Groschke, analyst at Landesbank Rheinland-Pfalz.
Altana filed for EU approval of Roflumilast in February this year, which was also a delay of two months.
Altana's marketing partner for Roflumilast in the US and other markets is US giant Pfizer. A cooperation agreement has also been signed with Tanabe Seiyaku in Japan.
The World Heath Organisation estimates that chronic obstructive pulmonary disease affects 600 million people worldwide and kills more than 2.75 million people each year.
WHO also estimates that asthma affects more than 300 million people worldwide and kills 180,000 people each year.
Altana is scheduled to publish third-quarter earnings on November 4.
10/28/2004 - 15:32 GMT - AFP