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First Novel Antifungal Agent In 40 Years, Cancidas*, 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

Merck Frosst Canada & Co. is one of the country's leading research-based pharmaceutical companies. The Merck Frosst Centre for Therapeutic Research, one of the largest biomedical research facilities in Canada, has a mandate to discover new therapies for the treatment of respiratory, inflammatory and other diseases. In 2001, the company invested nearly $120 million in research and development in Canada. For its part, Merck Frosst Canada Ltd. markets an extensive line of cardiovascular products for high blood pressure, elevated cholesterol and heart failure as well as a broad range of vaccines.

Merck Frosst is a recognized leader in the treatment of arthritis, asthma, osteoporosis, HIV/AIDS, glaucoma, prostate disease, migraines and infectious diseases. Based in Kirkland, Québec, Merck Frosst employs approximately 1,900 people including 300 of the world's leading scientific personnel. It is also firmly committed to science education and sponsors a number of programs designed to spark young people's interest in science. Merck Frosst Canada & Co. and Merck Frosst Canada Ltd. are affiliated companies of Merck & Co., Inc. of Whitehouse Station, New Jersey. Merck & Co., Inc. is a publicly traded company on the New York Stock Exchange under the symbol MRK.


* Trademark Merck & Co., Inc. Used under license.

References:
1. Health Canada, Bureau of Infectious Diseases, Construction-related Nosocomial Infections for Hospitalized Patients: Decreasing the Risk of Aspergillosis, Legionella and other Infections, March 1999
2. Nicolle et al., Canadian Journal of Infectious Diseases, Vol. 9, No. 6 1998; 347-352


SOURCE: Merck Frosst Canada

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