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| |  Caverject for Male Impotence Approved for Marketing TORONTO, June 12, 1996 -- Pharmacia & Upjohn (Canada) announced today that it has received clearance to market Caverject(R) Sterile Powder (alprostadil for injection) for the diagnosis and treatment of erectile dysfunction, commonly known as male impotence. This medication is the first prescription medication for the treatment of erectile dysfunction approved for marketing by Health Canada. The product has already gained marketing clearance in 50 countries, including the United States, United Kingdom, France, Spain and Italy. Erectile dysfunction is the consistent inability to attain and maintain a penile erection that is satisfactory for intercourse. The condition affects an estimated one in 10 men and various studies put the number of impotent men at between one and two million in Canada.(1) Available by prescription only, Caverject is administered via a small, thin needle injected into an area along the shaft of the penis known as the corpus cavernosum. The drug works by relaxing smooth muscle tissue, which enhances blood flow to the penis creating an erection. Caverject, which is approximately 80 per cent effective, can be used to treat erectile dysfunction caused by vascular, neurological, psychological or mixed causes. It is administered through 10 or 20 microgram unit doses for intracavernosal self- injection. "Caverject represents a significant development in the treatment of erectile dysfunction,'' said Bob Little, President of Pharmacia & Upjohn (Canada). Caverject contains a synthesized version of alprostadil, a naturally occurring form of prostaglandin E(1) (PGE(1)), which is found in human tissues and fluids and plays a role in the mechanism producing a natural erection. In a different formulation, PGE(1)) is used to keep open a vital artery in infants who may require surgery to repair a heart defect. It is marketed in Canada as Prostin VR. "I have supervised many patients who have experienced success in treating their erectile dysfunction with self-injection therapy,'' said Dr. Jeremy Heaton, MD, FRCPC, Associate Professor in the Department of Urology at Queen's University. "It is important for men experiencing erectile dysfunction to consult with a medical expert in this area. Only a trained physician should diagnose and treat erectile dysfunction with this new medication.'' Diagnosis of erectile dysfunction includes a medical and sexual history of the patient followed by a physical examination, basic laboratory tests and, if needed, additional specialized tests. In the physician's office, Caverject will be used to help diagnose the condition and to determine individual dosing for self-injection treatment. Patients can self-administer once they have been thoroughly trained in the self-injection technique. Risk factors associated with erectile dysfunction, include advancing age, arteriosclerosis (hardening of the arteries), high cholesterol levels, high blood pressure and diabetes mellitus. Other risk factors linked to erectile problems include vascular impairment, which can result from poor diet, lack of exercise, excessive alcohol consumption and tobacco smoking. Psychological factors such as sexual performance anxiety are also associated with erectile dysfunction. Additional information about Caverject is available by contacting Pharmacia & Upjohn's World Wide Website at http://www.impotent.com. There are more than 200 published studies on self-injection therapy with alprostadil. Adverse reactions associated with an injection of Caverject include penile pain, usually reported as mild or moderate, and, less frequently, priapism (prolonged erection). There is also a risk of fibrosis (hardening and scarring of the tissue) with long-term use. Caverject should not be used by patients with a known hypersensitivity to the drug or for whom sexual activity is inadvisable. Men whose conditions might predispose them to priapism and men with anatomical deformations of the penis also should not use Caverject. Pharmacia & Upjohn Inc.., is a research-based, pharmaceutically focused company dedicated to helping people around the world live longer and fuller lives. The company was formed through a merger of the worldwide operations of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia & Upjohn is a provider of human health care and related products and operates on a global basis. The company has a corporate management centre in London, England and major research and manufacturing centres in the U.S., Sweden and Italy. The Canadian operations are temporarily located at the former Upjohn site in Don Mills, Ontario. ------------------------- (1) This figure calculated from Statistics Canada figures and estimates by I. Goldstein and D.G. Hatzichristou. Epidemiology of impotence. In: Impotence, diagnosis and management of erectile dysfunction. A. Bennett Ed, W.B. Saunders Co, 1994, pages 1-17; and estimates from the Massachusetts Male Aging Study. ------------------------- CAVERJECT STERILE POWDER QUESTIONS & ANSWERS Q WHAT IS CAVERJECT? A Caverject is a self-injected medication indicated for the treatment of erectile dysfunction. It contains prostaglandin E(1) (alprostadil), a naturally occurring vasoactive agent that has been available since the 1980's for the pre-surgical treatment of premature babies with congenital heart defects. Prostaglandins occur naturally in human tissues and fluids and play a role in the mechanism of natural erection.
Q WHAT IS ERECTILE DYSFUNCTION? A Erectile dysfunction (ED), also known as impotence, is the inability to achieve or sustain an erection adequate for sexual intercourse. ED is a common, treatable condition affecting an estimated one to two million men in Canada alone. Yet, data suggest that less than 10 percent of affected men actually receive treatment. The small number who receive treatment is thought to be related to the reluctance of many men to discuss ED with their doctors. In addition, some physicians are not comfortable addressing the topic with their patients.
Q WHAT CAN CAUSE ERECTILE DYSFUNCTION? A Most men experience occasional erectile failures at some time during their lives, usually as a result of fatigue, temporary stress or excessive alcohol consumption. Temporary loss of erectile capability is not something to worry about. However, when the condition persists or interferes with a man's normal sexual activity, medical advice should be sought. Until recently, many in the health care profession believed erectile dysfunction was caused by mental or emotional conflicts. Patients were often told, "It's all in your head.'' Today, experts believe that up to 70 percent of all ED cases may be due to physical conditions (organic), with psychological factors accounting for the remaining 30 per cent. In many cases, however, there are both psychological and physical reasons for the condition.
Q HOW DOES CAVERJECT WORK? A The drug works by relaxing smooth muscle tissue and also acts as a vasodilator. Blood flows into the penis and is stored causing an erection of sufficient rigidity and duration to allow for intercourse.
Q HOW EFFECTIVE IS CAVERJECT? A Studies show that Caverject is a highly effective therapy for the treatment of erectile dysfunction. Caverject induced erections in more than 80 percent of men whose impotence was caused by neurologic, vascular, psychological or mixed causes. Caverject induces erections that may have a duration of 30 to 60 minutes. In addition, Caverject can be used up to three times a week. Because of its rapid action (usually within 5 to 20 minutes), high efficacy and relative safety, Caverject is expected to quickly become an important treatment option for erectile dysfunction.
Q ARE THERE SIDE EFFECTS ASSOCIATED WITH CAVERJECT? A The most frequent adverse reaction is an aching or pain in the penis. In clinical trials this pain was reported by 37 percent of men on at least one occasion (overall reported incidence, 11 percent). In the majority of cases, the penile pain was rated mild or moderate in intensity. Only three percent of men discontinued treatment because of pain. Hematoma at the site of injection occurred in five percent of men. Prolonged erection (one that lasts between four and six hours) was four percent. The overall rate of penile fibrosis (scarring), including Peyronie's disease, was reported at three percent. I n0one self-injection clinical study lasting up to 18 months, the incidence of fibrosis was 7.8 percent.
Q WHO IS A CANDIDATE FOR CAVERJECT? A Injection therapy with Caverject has proved to be effective in men when other ED treatments have failed. It is particularly helpful in restoring erectile function in patients who have neurological damage (such as spinal cord injury), mild or moderate vascular blockage (caused by conditions such as atherosclerosis), or ED due to psychological causes or of mixed etiology.
Q HOW OFTEN CAN CAVERJECT BE TAKEN? A While Caverject is proven to be a safe and effective treatment for erectile dysfunction, physicians recommend that the medication not be used more than once in a 24-hour period and not more than three times a week.
Q IS CAVERJECT AVAILABLE IN OTHER COUNTRIES FOR ERECTILE DYSFUNCTION? A Yes. Caverject is available in other countries, including the U.S., France, England, Italy, Australia, New Zealand, Singapore, Hong Kong, Colombia, Guatemala and Peru.
Q ARE THERE OTHER TREATMENTS FOR ERECTILE DYSFUNCTION? A There are surgical and mechanical methods available for treating the condition as well as penile prostheses and vacuum devices. Surgical treatment can only help a fraction of the men suffering from erectile dysfunction. -------------------------------- PHYSICIAN CONTACTS FOR CAVERJECT Ontario Dr. Jeremy Heaton, Dr. Richard Casey
Quebec Dr. Gerry Brock
Dr. Francois Benard
Alberta Dr. Mike Chetner Dr. Randall Abele Dr. Stuart Ross
British Columbia Dr. Stacy Elliott
PATIENT CONTACTS FOR CAVERJECT (x) Ontario Bill
Quebec Golden Michael ------------------------- (x) Available for telephone interviews only. Some anonymity requested.
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