Meals and Drug Administration.

Meals and Drug Administration , and the company plans to progress ALKS 5461 into stage 3 development in early 2014. Alkermes is developing ALKS 5461 for the treatment of patients with major depressive disorder who’ve inadequate response to standard therapies. The ongoing organization and the FDA agreed on key elements of the development program, including clinical and preclinical requirements for the New Drug Application, the confirmatory study plans, the incorporation of innovative study styles that include the use of sequential parallel evaluation design , the primary endpoint and the statistical methodology.Isotechnika will receive an upfront non-refundable licensing payment of US$1.5 million. Isotechnika can receive ongoing royalties based on product sales of voclosporin by 3SBio also. 3SBio will invest the US$4.5 million in Isotechnika through a three-year convertible debenture which will pay interest of 7 percent payable semi-annually. Isotechnika gets the substitute for pay interest in money or to issue fresh shares at the prevailing price when the interest is normally payable. 3SBio gets the right to convert the debenture anytime into common equity of Isotechnika at a conversion price of C$0.155 per share. At maturity, any remaining stability will become paid by the issuance of common shares at a price of C$0.155 per share. 3SBio will also nominate one member to Isotechnika’s Board of Directors.