Why Invest?
With over 25 years combined experience in drug development, immunosuppression, chemistry and pharmacokinetic-pharmacodynamic (PK-PD) relationships, our Company has worked toward building a solid and complementary drug pipeline.
Our focused approach to drug discovery has resulted in one lead drug with big potential. Additionally, our extensive understanding of PK-PD relationships has allowed us to identify therapeutic dosing at an earlier stage accelerating the drug development process.
Phase 3 Company
On May 27, 2008, the Company announced the successful completion of the Phase 2b kidney transplant (PROMISE) trial. Patients completing the six month trial were given an opportunity to continue treatment with voclosporin as part of an extension to the initial trial. This six month extension period will provide longer-term safety and efficacy data for the drug in de novo kidney transplant patients.
The second indication under development for voclosporin is for the treatment of plaque psoriasis. The Phase 3 psoriasis trial currently ongoing in Europe and Canada completed enrollment with 642 patients in July 2007. It is a 60 week, double-blind trial with both placebo and cyclosporine control arms. While efficacy can be determined as early as 12 weeks, the trial has been designed to remain blinded for the entire 60 week duration so that longer-term safety data remains unbiased. It is expected that the last patient will complete the study in December 2008. On March 31, 2008, the Company announced that an independent data monitoring committee (DMC) met and reviewed the interim data from the ongoing blinded Phase 3 psoriasis (ESSENCE) trial. The review included 24-week data from approximately 50% of the patients enrolled in the trial. Based on their review of the safety and efficacy data, the DMC did not raise any concerns that would require a change to the original study design.
On May 24, 2006, the Company signed an agreement with Lux Biosciences (Lux) granting them worldwide rights to develop and commercialize voclosporin for the treatment of prophylaxis of all ophthalmic diseases. Their most advanced development in uveitis has a worldwide market size of 500,000 patients. Lux received both "Fast Track" and "orphan" drug status for this indication. Positive Phase 3 trial results were announced in March 2009. It is anticipated that Lux will file a New Drug Application (NDA) for uveitis in the near future and it will therefore likely be the first commercialized indication of voclosporin.
Our partner, Atrium Medical Corporation, received approval from the Belgian Competent Authority to investigate voclosporin as the drug utilized in the CINATRA TM Drug Coated Stent system. Patient enrollment for the trial commenced on June 9, 2008.
Market Potential
There is an unmet medical need for safer and efficacious drug therapies for people suffering from psoriasis and organ transplant recipients alike. The combined market potential for Calcineurin Inhibitors, such as voclosporin; for TOR Inhibitors, such as TAFA93; and for DNA Synthesis Inhibitors is estimated at $3.8B US.
Partnerships
Partnerships with Isotechnika Inc.:
Atrium Medical Corporation has an exclusive worldwide licensing agreement for use of voclosporin and TAFA93 with drug-eluting devices for non-systemic treatment of vascular, cardiovascular, target vessel and tissue disorders.
Lux Biosciences Inc. was granted worldwide rights to develop and commercialize voclosporin for the treatment and prophylaxis of all ophthalmic diseases.
Patents
Isotechnika currently has been issued 82 patents related to voclosporin and has 124 patents pending related to this compound. These patents cover synthesis, composition of matter, method of use and formulation. Isotechnika has been issued 6 patents related to its TAFA93 compound with an additional 15 patents pending covering composition of matter. A total of 7 patents have been issued for the Company's Diatest® and 3 patents are currently pending.
Capitalizing on Opportunities
Isotechnika intends to capitalize on opportunities form both in-licensing and out-licensing perspectives. With this exciting perspective in mind, our team is actively discussing the Company's internally developed pipeline of products with potential collaborators and partners worldwide. In order to maximize shareholder value, it is important to time any potential partnership with the achievement of successful clinical milestones.
Unique possibilities also exist from potential in-licensing collaborations. While the Company has focused its attention on internal programs, this team will also explore opportunities to develop and collaborate with others on an in-licensing basis for products that have near term market potential.
The horizon of opportunities in biotechnology offers a wealth of possibilities. Isotechnika has recognized that its future can be dramatically enhanced through partnerships with pharma and biotechnology companies as well as relationships with academic institutions.