From the CEO in a PR dated 6/10/10 -Part 1
"Our goal in HCV care is to increase patient cure rates up to 90%. We envision two pathways to reach this goal:
Our Hemopurifier(R) as an adjunct treatment to enhance the benefit of SOC therapy; or
Our Hemopurifier(R) in combination with a candidate therapy to replace SOC therapy.
The achievement of our goal would significantly impact the HCV treatment industry as SOC therapy succeeds in providing sustained viral responses (SVR) in only 30% to 50% of patients who initiate treatment. HCV infection is considered cured when a SVR of undetectable viral load is maintained more than six months after completing treatment. Prior to discussing the clinical rationale supporting our treatment goals, I want to clarify the magnitude of the HCV treatment opportunity.
It is estimated that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with HCV. To provide perspective, this represents a patient population approximately 5-6 times larger than those infected with HIV/AIDS and over 100 times larger than the population of end stage renal disease (ESRD) patients who require kidney dialysis. However, unlike kidney dialysis and HIV therapeutics, we actually have the opportunity to participate in curing HCV-infected individuals. The global market for therapies to treat HCV is projected to reach $9.1 billion by 2015, and in the United States, the annual cost of advanced liver disease resulting from HCV infection is anticipated to jump to $85 billion in the next two decades. As a result, Medicare costs are anticipated to soar 500%, from $5 billion to $30 billion. As the stakes to treat HCV are high, the competition for new drugs is intense with more than sixty treatment candidates reported to be in development. As we target the use of our Hemopurifier(R) as a drug enhancement device in HCV care, we are positioned to improve treatment outcomes as an adjunct to both SOC therapy and new drug candidates that evolve to challenge SOC therapy in the marketplace.
Significant challenges exist for drugs seeking to supplant SOC therapy, as new candidates must demonstrate substantially greater patient benefit in order for the medical community to consider discontinuing administration of the SOC treatment regimen. As an example, Albuferon, an HCV treatment candidate from Human Genome Sciences (HGSI), recently demonstrated phase III treatment outcomes comparable to SOC therapy with half the number of required injections. As a result, the value of HGSI shares was reduced by 57% the day the study data was released. I can't help but wonder how Albuferon might have performed in combination with our Hemopurifier(R)? Regardless, a drug candidate wishing to supplant SOC therapy in the market will need to Bob Beamon (surpassed world long jump record by almost two feet at the 1968 Olympics) beyond the capabilities of SOC therapy.
For this reason, the primary strategy for most HCV drug candidates is to incrementally improve treatment outcomes as an adjunct to SOC therapy. The challenge facing these candidates is the effect of stacking new drug toxicity on top of established SOC toxicity, which is known to trigger fatigue, bone marrow suppression, anemia and neuropsychiatric effects. Many patients fail SOC therapy because they are unable to endure the toxicity of the 24-48 week regimen on its own. Based on clinical data, Telaprevir, a 3x-day oral drug from Vertex Pharmaceuticals is considered the leading adjunct candidate based on outcomes of a recent phase II study, which documented that 51% of patients that previously failed SOC had a sustained virologic response (SVR) when retreated with SOC and Teleprevir in combination. When considering that only 14% of patients in the study control arm responded to SOC alone, there is certainly valid justification for Telaprevir to be considered the lead adjunct drug candidate by the medical and the financial community. This is reinforced by the reality that Telaprevir represents a significant value component of Vertex (VRTX), which as I write this letter is valued at more $5 billion in the public markets. In regards to deal values in the HCV space, VRTX paid almost $400 million in March to acquire ViroChem, a drug developer with two experimental stage HCV drugs. TheStreet.com, who provides excellent HCV market coverage, reports the following on the Telaprevir clinical outcome; "The data keeps Telarevir ahead of its hepatitis C rivals because no other drug has yet shown the ability to improve the cure rates for both patients new to therapy as well as those who have failed prior therapy." The key phrase in that statement is "no other drug".
