“From our first collaboration
in 1992, Pfizer has been an excellent
drug development partner. Pfizer’s
development strength, together with
Neurogen’s expertise in
neuropharmaceuticals, has been
a winning combination.”
John Tallman, Ph.D.,
Executive Vice President,
Scientific Director,
Neurogen Corporation
|
Health Care – Pharmaceuticals (cont'd)Central Nervous System Disorders
Zoloft has become one of the world’s leading medicines for central nervous system (CNS) disorders, and Pfizer is developing several new CNS products to broaden its product offerings.
 The improved side-effect profiles of the selective serotonin reuptake inhibitors (SSRIs) have helped improve patient compliance and greatly expand the opportunities of mental health professionals to adequately treat depression, the most common mental disorder. It is estimated that 17 million Americans now suffer from depression, and it costs the U.S. economy more than $43 billion each year in health care costs, worker absenteeism, and low productivity. One in every 10 men and 1 in every 4 women can expect to develop depression at some point during their lives.
Zoloft, a leading SSRI, continued to show steady growth in 1997, with sales increasing 13 percent to $1.5 billion. Newly approved uses for treating obsessive-compulsive disorder and panic disorder have been launched in the United States, and successful initial launches of the product occurred in France and Germany in 1997. Pfizer is conducting clinical trials of Zoloft for the treatment of post-traumatic stress disorder and expects to file a U.S. NDA for this indication in 1998. Zoloft retains U.S. patent protection until December 2005.
Pfizer helps physicians and patients by providing not only safe, effective, and convenient pharmaceuticals but also innovative disease management programs. For example, primary care physicians can use the PRIME-MD program to diagnose depression. The Rhythms program helps educate patients about the various stages of the treatment of depression and encourages them to stay on their medication to avoid relapse.
Eisai Co., Ltd., a leading Japanese pharmaceutical company, discovered and developed Aricept, a new treatment for mild-to-moderate cases of Alzheimer’s disease. Eisai and Pfizer successfully launched Aricept in the United States, the United Kingdom, Canada, Germany, Italy, and other major markets in 1997, with worldwide sales reaching $195 million. These sales are primarily recorded by Eisai. Pfizer records its revenues from Aricept as Alliance Revenue.
By inhibiting the breakdown of the neurotransmitter acetylcholine, thought to be crucial in cognitive functioning, Aricept has been shown to be effective in enhancing or maintaining cognition in people with mild-to-moderate Alzheimer’s disease. The disease is estimated to affect 10 percent of people aged 65 or older, and as many as 47 percent of people over the age of 85. While Aricept is not a cure for Alzheimer’s, during controlled clinical trials of up to six months in over 900 patients, more than 80 percent of patients taking Aricept experienced improvement or no further decline in tests of cognition. The compound has produced no evidence of liver toxicity in clinical trials and, therefore, carries no requirement for liver function monitoring. Other benefits include once-daily dosing and no need for titration to reach an effective dose.
Pfizer submitted regulatory filings in the United States in March 1997 and in Europe in May 1997 for Zeldox, a novel agent for treatment of schizophrenia. As many as 1 person in every 100 suffers from this severely debilitating disorder, which often strikes in early adulthood. It manifests itself in positive symptoms, such as hallucinations and irrationality; in negative symptoms, such as lack of emotional response and social withdrawal; and in depression. About 10 percent of schizophrenics die by suicide.
In clinical trials, Zeldox demonstrated strong efficacy against positive, negative, and depressive symptoms of schizophrenia. It has been shown to have a low incidence of the often disabling movement disorder that characterizes long-term use of older agents, and only low incidences of weight gain, somnolence, dry mouth, and sexual dysfunction. Zeldox’s excellent tolerability with long-term administration may be important for achieving long-term control of psychosis. Unlike many other available medications, effective treatment with Zeldox may start immediately with no need to titrate up to an effective dose. In December 1997, the Company also submitted a U.S. regulatory filing for an intramuscular dosage form, which can be used to stabilize acutely agitated patients.
Pfizer expects to file for regulatory approval in late 1998 for eletriptan, a fast-acting, highly effective treatment for migraine. Approximately 10 percent of Americans suffer from migraine, two thirds of them women. Migraine often affects people during their most productive years, with significant impact on work productivity, school performance, and family life. Nevertheless, close to half of the people with migraine have never been diagnosed by a physician or adequately treated with prescription medication.
Eletriptan in clinical studies has demonstrated rapid onset of action during the crucial first two hours of an attack, with high overall response rates.
Promising clinical programs in the CNS area include neutrophil inhibitory factor (NIF) for stroke and CP-101,606 for head trauma. Stroke kills or incapacitates more than half a million U.S. patients every year, at a cost of $35 billion to the nation’s health care system. About 90 percent of strokes are caused by the lodging of a clot in the brain and are often accompanied by an inflammatory response from the immune system, including the activation of white blood cells called neutrophils. When these cells pass into brain tissue, they can extend the damage caused by occlusion of the blood vessel. NIF, a compound produced by hookworms to inhibit the effects of neutrophils, limits the extent of this secondary event of the stroke.
Massive head injury often triggers the release of the neurotransmitter glutamate, which can lead to the damaging influx of calcium across the cell membranes of neurons. CP-101,606, currently in clinical trials, shows promise in inhibiting this process. |
