First Novel antifungal in 40 years , cancida s*,is Merck’s latest discovery

Overwhelms the fungal infection not the patient

 MONTREAL, QC — June 5, 2002 —

As Merck’s latest discovery, CANCIDAS* (caspofungin acetate), which was approved by Health Canada, is the first of a new class of antifungal drugs called echinocandin (a glucan synthesis inhibitor).

Used to treat certain life-threatening fungal infections that are becoming more prevalent, this new medicine has been long awaited by physicians for patients with compromised immune systems.

Caspofungin acetate is indicated for the treatment of invasive aspergillosis (pronounced as-per-jill-oh’-sis) in patients who do not respond to or who cannot tolerate the other antifungal therapies, amphotericin B, lipid formulations of amphotericin B and/or itraconazole. “Patients who are infected with this fatal fungus are usually seriously ill to begin with, so CANCIDAS* works to eradicate the fungal infection and not harm the patient,” said Dr. Coleman Rotstein, Professor of Medicine and Director, Infectious Diseases Residency Training Program at McMaster University, Hamilton.

 “CANCIDAS* has demonstrated efficacy with very favourable tolerability in a very ill patient population.” Demonstrated antifungal efficacy against failed treatments In an open-label, non-comparative study in 58 immunocompromised patients with invasive aspergillosis who were unresponsive to or intolerant of other antifungal therapies, 41 per cent of the 54 patients who received at least one dose of caspofungin acetate responded successfully to treatment. For those patients who received more than seven days of therapy, 49 per cent responded successfully to treatment with caspofungin acetate.

The mean duration of therapy was 31.1 days, with a range of one day to 162 days. Duration of treatment was based on the severity of the patient’s underlying disease, recovery from immunosuppression, and onset of clinical response.

Well-tolerated among patients with serious medical conditions The overall safety of caspofungin acetate was assessed in 612 individuals who received single or multiple doses of caspofungin acetate.

Of the 612 individuals, 58 patients with invasive aspergillosis were enrolled in an open-label non comparative study. Even though the majority of these patients had serious underlying medical conditions, such as cancer or HIV, or had received a bone marrow or organ transplant, caspofungin acetate was generally well tolerated.

 Discovered within Merck & Co. world-wide research organization The unique mechanism of action of caspofungin acetate attacks the fungal cell wall by inhibiting the synthesis of b (1,3)-D-glucan, an integral component of the fungal cell wall that is not found in human cells. “The ability to treat deadly fungal infections such as invasive aspergillosis is limited and we are  very proud that Merck’s research network brought this discovery to the world,” said Dr. Alan Brox, Director of Clinical Research at Merck Frosst. “A result of over 15 years of research, CANCIDAS* is testimony to our ongoing commitment to develop effective new treatments for patients who are susceptible to life-threatening infections.”

Caspofungin acetate is administered intravenously with a recommended single 70 mg loading dose administered on day one, followed by 50 mg once daily thereafter. The standard daily 50 mg dose of caspofungin acetate costs $440. Nature’s deadly fungus Aspergillosis is a life-threatening fungal infection in high-risk patient populations, especially cancer patients, organ and bone marrow transplant recipients, and patients with HIV/AIDS.

The infection stems from aspergillus which is a fungus commonly found in nature (e.g. soil, water and decaying vegetation). Since aspergillus spores are very small and settle slowly, they can remain suspended in the air for prolonged periods of time. This increases the possibility that they may be inhaled.

When this happens, they can infect the lungs, spread through the bloodstream to other parts of the body and affect the heart, brain, kidneys and eyes of people with a compromised immune system. Despite current treatments, the mortality rates in patients with invasive aspergillosis range from 65 to 100 per cent.1 Approximately 100 Canadians are infected

with invasive aspergillosis each year.2

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