* FY profitability depends on 2 FDA approvals - CEO
* Confident of FDA approval for Abstral, Fortesta
* Meeting FDA regarding more efficacy data on Rectogesic
* Posts positive EBITDA in first four months of 2010
* Shares up 1.3 pct (Recasts; adds CEO’s comments, details; updates stock movement)
By Aditi Samajpati
BANGALORE, May 18 (Reuters) - Loss-making speciality pharmaceuticals firm ProStrakan PSK.L said it expected to post a maiden pretax profit in 2010 or 2011 and reported EBITDA profitability during the first four months of the year.
The Scottish company, which makes drugs for age-related diseases and cancer, said it was confident of getting U.S. regulatory approval for its breakthrough-cancer-pain drug Abstral and Fortesta testosterone gel soon.
“Whether we hit an operating profit by Dec. 31, 2010, is dependent on some events that are not entirely in our control, but the path to profitability is very clear,” Chief Executive Wilson Totten told Reuters on Tuesday.
In the next few weeks, ProStrakan will meet the U.S. Food and Drug Administration to discuss issues that led to a delay in approval of its Rectogesic ointment for pain related with chronic anal fissures, Totten said.
Analysts on average expect ProStrakan to report a pretax loss of about 0.6 million pounds for the year to end-December 2010, according to Thomson Reuters I/B/E/S.
Fortesta, which is being refiled in the United States by ProStrakan’s partner Endo Pharmaceuticals (ENDP.O), is already sold in the European Union as Tostran and will generate a large milestone payment if approved in the United States.
ProStrakan currently has only one product -- Sancuso, a transdermal patch for cancer patients -- available in the U.S. market. Sancuso sales rose 7 percent to 2.6 million pounds in the period to end-April.
For the first four months of the year, the company’s total revenue rose 21 percent and product sales grew 29 percent, helped by growth in the European Union and the United States.
Sales of pan-EU products like Tostran, Rectogesic and Xomolix injection for post-operative nausea rose 23 percent.
Shares of the company were up 1.3 percent at 79 pence at 1123 GMT on the London Stock Exchange. (Reporting by Aditi Samajpati in Bangalore; Editing by Vinu Pilakkott)