Labopharm Reports Results for Third Quarter F...(s inspection of the manufacturing facili...),Health

Date:11/6/2009

s inspection of the manufacturing facility in June and July of this year. The Company continues to prepare for commercialization of its novel antidepressant and, pending FDA approval, intends to launch in the U.S. in the first half of 2010.

NDS Accepted for Review by Health Canada - Labopharm's new drug submission (NDS) was accepted for review by the Therapeutic Products Directorate (TPD) of Health Canada. TPD has assigned a targeted action date of August 4, 2010.

Twice-Daily Tramadol-Acetaminophen Formulation

Completed Distribution and Supply Agreement with Grunenthal - Labopharm completed a distribution and supply agreement with Grunenthal GmbH for its twice-daily tramadol acetaminophen formulation for a number of countries in Europe. Under the terms of the agreement, Labopharm received 3.5 million Euros on signature and will receive up to 4 million Euros in milestone payments upon achievement of certain regulatory and product reimbursement approvals prior to the launch of the product.

Once-Daily Tramadol

Product Maintained Number One Position in Canada for Fifth Consecutive Month and Moved Into Number One Position for Year-to-Date - In September, Labopharm's product (marketed under the brand name Tridural(TM) in Canada) held the leading market share position among all tramadol products (excluding combination products) in Canada in terms of prescriptions for the fifth consecutive month. Labopharm's product also moved into the number one position in terms of market share for the 2009 year to date.

Financial Results

Three-Month Period Ended September 30, 2009

Revenue from product sales in all territories for the third quarter of fiscal 2009 increased to $5.2 million from $3.9 million for the third quarter of fiscal 2008. Revenue from product sales to territories other than the U.S. was $4.5 million compared with $3.9 for the third quarter of fiscal 2008. The increase was
'/>"/>

SOURCE Labopharm Inc. Copyright©2009 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Related medicine news :

1. Labopharm to present data on its novel trazodone formulation at three upcoming international medical meetings
2. Labopharms response for novel trazodone formulation accepted by FDA as complete - Designated as Class 2 resubmission
3. Labopharm submits response to FDA for novel antidepressant
4. Labopharm Reports Results for Second Quarter Fiscal 2009
5. Labopharm to present at Canaccord Adams 29th Annual Global Growth Conference
6. Labopharm to host conference call Friday, August 7, 2009 at 8:30 a.m. (ET)
7. Labopharm receives complete response letter from the U.S. FDA for novel antidepressant
8. Labopharm amends debt facility agreement with Hercules
9. Results of phase III study on Labopharms novel antidepressant published in Psychiatry (Edgemont) Journal
10. Labopharm Reports Results for First Quarter Fiscal 2009
11. Labopharm announces details for first quarter results conference call and annual meeting