Isotechnika Pharma releases shareholder letter

EDMONTON, AB, Nov. 1, 2011 /CNW/ - Isotechnika Pharma Inc. (TSX:ISA) issued the following shareholder letter today from Dr. Robert Foster, Chairman & CEO

Dear Shareholder,

Thank you for the opportunity to update you about our company, Isotechnika Pharma.  After reading this letter, I hope you will have a clear understanding of where we are going and how we plan to get there.  This letter will focus on the support behind our decision to move into Phase 3 for the prevention of kidney transplant rejection, and the key process steps and timelines required for initiation of this late stage clinical program.  Looking forward, I am confident that you will share my optimism for the future prospects of our company.

Transplantation - Our Greatest Opportunity

Our lead drug, voclosporin, is an immunosuppressant that has utility across many indications.  Thus, in the past, we pursued partnerships across different potential indications in order to diversify risk and engage in cost sharing.  Nevertheless, it is important to remember that the transplant market is our company's key focus.  That is where we believe our greatest opportunity to build shareholder value resides.

We have been intensely focused on initiating the Phase 3 development of voclosporin for the prevention of kidney transplant rejection.  There are three key factors that support our commitment to the organ transplant rejection development pathway:  the market opportunity, the scientific rationale, and the clinical support.

(i)     The Market Opportunity

Voclosporin belongs to a class of drugs called Calcineurin Inhibitors (CNIs), the cornerstone of therapy for the prevention of organ transplant rejection.  This drug class includes two currently available drugs, cyclosporine and tacrolimus.  Worldwide sales of CNIs are approximately US$3 billion1, of which two thirds is tacrolimus, and one third is cyclosporine.  As you can see, this is a very, very attractive market with few competitors.  Even a moderate penetration of this market could prove to be very profitable to our company.  Importantly, voclosporin is the only new CNI in development, which means limited future competition in the CNI class.  Furthermore, leading experts in the transplantation field have been increasingly outspoken about the important role of CNIs to prevent transplant rejection.

(ii)     The Scientific Rationale

Voclosporin was invented at Isotechnika, and is a derivative of cyclosporine, a drug that is still widely used today to prevent organ transplant rejection.  While cyclosporine and tacrolimus are effective in preventing rejection, each has safety and side effect issues that can often be very serious.  These include headache, nausea, diarrhea, high blood pressure, tremors, and kidney toxicity.

Voclosporin was engineered to be very effective in preventing organ rejection, while minimizing the safety and side effect issues that are drawbacks of the other CNIs.  Additionally, voclosporin has a wider therapeutic window (safety range), which is the specified range of drug concentration in a patient's blood outside of which the patient is likely to experience side effects and toxicity.  A wider therapeutic window makes it easier for doctors to monitor their patients, and easier for them to keep their patients' drug levels within this safety range.  We believe that voclosporin is a novel CNI with important advantages over both cyclosporine and tacrolimus, and this has been borne out in clinical testing conducted to date.

(iii)     The Clinical Support

Voclosporin has successfully completed a comprehensive phase 2 clinical program in which it demonstrated compelling safety and efficacy.  Since tacrolimus is now the more commonly used CNI, transplant physicians are looking for a drug that is equivalent in efficacy to tacrolimus, with a better side effect profile and easier dosing and monitoring.  In a phase 2 trial versus tacrolimus, voclosporin showed (i) similar efficacy, (ii) a wider therapeutic window, and (iii) lower incidence of NODAT (New Onset Diabetes After Transplantation).

One of the most important key benefits of voclosporin over tacrolimus is the markedly reduced incidence of NODAT.   This condition is difficult to manage, significantly adds to overall costs, and greatly compromises the life-saving benefit of a transplant by causing increased organ rejection and death.  NODAT is an important concern with tacrolimus.  The literature demonstrates that, on average, patients with NODAT lose their transplanted organ 3 years earlier, have a 23% increase in death after 5 years post transplant, and cost the medical system an additional $12,0002,3,4 when compared to patients without NODAT.  We have good reasons to believe that voclosporin can provide a superior profile versus tacrolimus on this key issue, as well as cause less diarrhea and tremors.  Furthermore, the clear relationship between blood concentrations of voclosporin and clinical outcomes is another distinct advantage as it should enhance ease of dosing and monitoring for both physicians and patients.

The strength of the scientific and clinical data, combined with the enthusiasm of transplant physicians and their patients, has convinced us to move voclosporin into a phase 3 program.  We hope you will agree that the rationale to develop voclosporin for the prevention of organ transplant rejection is extremely compelling.

Phase 3 Clinical Program - Process Steps and Timelines

Our Phase 3 program will consist of two clinical trials, each enrolling approximately 600 new kidney transplant patients.  One trial will be conducted primarily in the United States and Canada, while the second trial will enroll patients primarily in Europe.  The cost of the clinical trials are estimated to be in the range of $27.5 to $30 million each.  Importantly, we have already secured funding for the North American trial through our strategic partner, ILJIN Life Sciences.  Ideally, we aim to run both trials in parallel so we can shorten the time to market.  We are actively assessing opportunities to fund the European trial, preferably through a strategic partnership with a pharmaceutical company interested in the transplant field.

Our Phase 3 clinical trials aim to demonstrate non-inferiority in a composite endpoint, primarily driven by biopsy proven acute rejection (BPAR), compared to tacrolimus.  A key secondary endpoint will be the incidence of NODAT, as well as the overall safety and tolerability of voclosporin relative to tacrolimus.

On the regulatory front, we recently received positive Scientific Advice5 from the European Medicines Agency (EMA) on our proposed phase 3 clinical trial protocol for voclosporin.  Receipt of positive Scientific Advice ensures that we have a clear regulatory path forward in the European Union.  This marks a huge step for us on the path to initiate final testing of voclosporin to prevent kidney transplant rejection.  We now await a similar outcome with the FDA in the US so that we can finalize our clinical plans.

In parallel with the regulatory activities, we have been actively engaged in the preparatory clinical work required prior to the enrolment of the patients.  These activities include the selection of clinical trial sites, obtaining non-disclosure agreements with all parties, working with the data management clinical research organization (CRO) to design and test the electronic documents to be used by the clinical trial sites, and developing the project plans and processes with our CRO and other providers.

Alongside the regulatory and clinical preparations, another key process step is having active pharmaceutical ingredient (API) ready to be administered to patients.  A new batch of voclosporin has been ordered from the manufacturer and should be ready for patient use in the first half of 2012.

The table, in the attached PDF (see link at the bottom of the page),  outlines the process steps and timelines that we aim to meet or exceed in getting voclosporin into Phase 3 development. I encourage you to track our progress.

Looking to the Future

We at Isotechnika are all very excited and optimistic about the future prospects for voclosporin and for your company.  We believe we have a "Best in Class" novel CNI that has a superior safety profile and lower development risk.  We will be entering late stage development in the prevention of kidney transplant rejection, a very attractive target indication, with one of our Phase 3 trials funded by a strategic partner.  Lastly, our company trades at a very attractive valuation, and is poised to deliver on some important value-generating milestones in the coming months.  We are more confident than ever that we have a drug that can get to market, make a difference in the lives of patients, and generate significant shareholder value.

I look forward to sharing more information with you, and to updating you on future developments in the coming months.  Thank you for this opportunity to speak with you, and for your continued support.

Yours Sincerely,

Robert T. Foster, PhD
Chairman & CEO
Isotechnika Pharma Inc.

About Isotechnika Pharma Inc.

Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of immunomodulating therapeutics designed to offer key safety advantages over currently available treatments.  Its lead drug, voclosporin, is a calcineurin inhibitor, and is targeted at the estimated US$3.0 billion market for this class of immunosuppressants.  Isotechnika Pharma Inc. trades on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at www.isotechnika.com or www.sedar.com.

We seek Safe Harbour.

           
1 Datamonitor (includes both branded and generic versions)
2 Patient Survival and Cardiovascular Risk After Kidney Transplantation: The Challenge of Diabetes, FG Cosio, AJT 2009
3 Jindal, RM et al. Impact and management of posttransplant diabetes mellitus. Transplantation 2000; 70:SS58.
4 Diabetes mellitus after renal transplantation: as deleterious as non-transplant associated diabetes?  Miles AM et al Transplantation 1998 Feb 15;65(3):380-4
5 Scientific Advice is a procedure offered by the EMA that provides advice to a company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following the Agency's advice increases the probability of a positive outcome.


 

PDF with caption: "Voclosporin Phase 3 Development Timelines". PDF available at: http://stream1.newswire.ca/media/2011/11/01/20111101_C9257_DOC_EN_5871.pdf

SOURCE Isotechnika Pharma Inc.

For further information:

Dr. Robert Foster 
Chairman & CEO
Isotechnika Pharma Inc. 
780-487-1600 (x247) 
rfoster@isotechnika.com
        Dr. Launa Aspeslet
Chief Operating Officer
Isotechnika Pharma Inc.
780-487-1600 (x225)
laspeslet@isotechnika.com

Profil de l'entreprise

Isotechnika Pharma Inc.

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