Merus Labs International has completed the acquisition of the North American product rights for FACTIVE (Gemifloxacin Mesylate) tablets from Cornerstone Therapeutics Inc. Cornerstone recorded FACTIVE 320mg tablet net sales of approximately US$6.3 million in the United States for 2011. The product has not been commercialized in Canada.
The Company acquired FACTIVE for total consideration, as a multiple of Product cash flow, fully paid at closing. Other financial terms of the acquisition were not disclosed. Pursuant to the acquisition, Merus acquired the license to the FACTIVE trademark and patent, inventory on hand, and certain related intellectual property and other information and materials required to continue marketing the brand in the North American market. Merus has also entered into a sales and promotion agreement for FACTIVE with Vansen Pharma Inc. to market the product in the United States.
FACTIVE is the only FDA-approved quinolone with 5-day oral dosing indicated for the treatment of both acute bacterial exacerbation of chronic bronchitis and mild to moderate community-acquired pneumonia.
“FACTIVE marks our entry into the United States specialty pharma market and the second addition to Merus’ prescription pharmaceutical product portfolio,” said Ahmad Doroudian, Chief Executive Officer. “We look forward to the anticipated growth of the FACTIVE brand in the United States and expansion of our product portfolio in the near future.” In addition to the acquisition announcement, the board of directors of the Company is pleased to announce that on July 12, 2012, Mr. Elie Farah, the current President of the Company, will succeed Ahmad Doroudian as the Chief Executive Officer of the Company. At that time, Ahmad Doroudian will assume the position of Executive Vice-Chairman with specific business development and operational duties and will remain on the board of directors. “I am very pleased with the implementation of the CEO succession plan and look forward to Mr.
Farah leading the Company through its next stage of anticipated growth in the coming years,” said Ahmad Doroudian, Chief Executive Officer.
and Pierre Fabre Medicament todayannounced positive top-line results in a Phase III clinical trial of levomilnacipran, an investigational agent for the treatment of adults with major depressive disorder (MDD). Treatment with levomilnacipran significantly reduced depression symptoms in patients with MDD compared to placebo, as early as week one and at each subsequent visit as measured by the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR). This is the second, positive placebo-controlled Phase III study in this population. Further analyses of the data are ongoing. Results from an additional placebo-controlled Phase III fixed-dose study are expected in Spring 2012.
“We have successfully completed two positive Phase III studies for the treatment of MDD in adults and plan to file a new drug application for levomilnacipran with the FDA later this year,” said Dr. Marco Taglietti, Senior Vice President, Research & Development and President, Forest Research Institute.
“We are very pleased with these Phase III positive results. They confirm our strategy to make neuropsychiatry a major priority for our research and development in prescription drugs,” said Frederic Duchesne, President Pharmaceutical Division, Pierre Fabre Group.