Labopharm and Angelini to Establish Joint Venture to Commercialize OLEPTRO(TM) in the United States
- U.S. Launch of OLEPTRO(TM) on Track for Third Quarter 2010 -
“This joint venture builds on the foundation of mutual trust and a track record of execution that underlies the co-development relationship we established with Angelini more than four years ago,” said
The joint venture, Angelini Labopharm, will be 50 percent owned by each of Labopharm and Angelini and will be initially managed by
“The global drug development and marketing experience of Labopharm combined with the extensive commercial capabilities of an international enterprise will position us for a strong U.S. launch of OLEPTRO(TM) in the third quarter of this year,” stated Heino. “The commercial readiness to launch OLEPTRO(TM), including manufacturing, supply logistics and distribution channels, is now finalized, as are managed market access strategies and medical affairs.”
As part of the joint venture agreement, Labopharm will grant Angelini Labopharm the exclusive right to market and sell OLEPTRO(TM) in
“We are pleased to re-enter the U.S. market with Labopharm’s OLEPTRO(TM), a novel formulation of a successful drug that our Company originally developed in our research labs,” said Gianluigi Frozzi, Chief Executive Officer of the Pharmaceutical Division, Gruppo Angelini. “Angelini markets trazodone around the world thanks also to out-licensing and export agreements with about 50 partners and we look forward to working together with an experienced partner like Labopharm as we launch OLEPTRO(TM). We also look forward to potentially exploring additional opportunities to leverage the joint venture for OLEPTRO(TM) line-extensions, as well as the introduction of additional products to the U.S. market.”
About the Angelini Labopharm Joint Venture
In consideration of granting Angelini Labopharm the exclusive license to market and sell OLEPTRO(TM) in
Labopharm and Angelini will each initially contribute
As a result of the joint venture agreement, the 2007 cross-licensing agreement between Labopharm and Angelini will be amended such that the royalty on end user U.S. net sales to be paid by Labopharm to Angelini is 1.5 percent on end user net sales in excess of
Under the joint venture documentation, each of Angelini and Labopharm will be entitled, in certain circumstances, to acquire the interest of the other party in the joint venture. Terms of the joint venture agreements will be available in Labopharm’s related regulatory filings with SEDAR and EDGAR.
Angelini, a privately owned, international group, is a leader in the healthcare and wellbeing market in the pharmaceutical and mass market sectors. Angelini was founded in
About Labopharm Inc.
OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets is a novel once-daily formulation of the antidepressant trazodone for the treatment of major depressive disorder (MDD) in adults.
OLEPTRO(TM) is an extended release formulation of trazodone hydrochloride, and uses CONTRAMID(R), Labopharm’s clinically validated technology, to control the release of active substances within oral medications, whether taken whole or scored. CONTRAMID(R), in its dry state, acts as a free-flowing, highly compressible powder. When in tablet form and wetted, it forms a long-lasting, uniform surface membrane that is ideally suited to controlled release of orally administered drugs under a broad range of in-body conditions.
Important Safety Information
Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. OLEPTRO(TM) is not approved for use in pediatric patients.
Warning and Precautions
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior, or unusual change in behavior, whether or not they are taking antidepressant medications.
Patients should be monitored for clinical worsening and suicidality and for the appearance of any of the following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Families and caregivers should be alerted about the need to monitor patients.
The development of a potentially life-threatening serotonin syndrome, or neuroleptic malignant syndrome (NMS)-like reactions has been reported with antidepressants, and may occur with OLEPTRO(TM), particularly with concomitant use of other serotoninergic drugs.
PLEASE REFER TO THE FULL PRESCRIBING INFORMATION FOR OLEPTRO(TM) FOR ADDITIONAL WARNINGS AND PRECAUTIONS AVAILABLE AT http://www.labopharm.com/docs/022411lbl.pdf.
The most common adverse reactions (incidence greater than or equal to five percent and twice that of placebo) are: somnolence/sedation, dizziness, constipation, blurred vision.
These are not all the possible adverse events of OLEPTRO(TM). PLEASE SEE FULL PRESCRIBING INFORMATION AVAILABLE AT http://www.labopharm.com/docs/022411lbl.pdf.
This press release contains forward-looking statements, including statements concerning the timing and ability of the parties to obtain all necessary approvals, statements concerning the successful completion of the partnering transaction with Gruppo Angelini, statements concerning the commercial potential of OLEPTRO and the ability of the joint venture to timely launch and market OLEPTRO(TM) in
OLEPTRO(TM) is a trademark of Labopharm Inc.
CONTRAMID(R) is a registered trademark of Labopharm Inc.
SOURCE Labopharm Inc.