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