Medicines in Development for Women Backgrounder

Backgrounder: Selected Medicines in Development for Women

Breast cancer affected an estimated 207,090 American women and killed 39,840 in 2010, according to the American Cancer Society. One medicine now in clinical trials for metastatic breast cancer combines two treatment approaches into one medicine – a targeted monoclonal antibody and an already-approved anti-cancer drug. The medicine targets cells that are overproducing HER2 (a cause of some breast cancers) and delivers a powerful chemotherapy agent to the tumor where it kills the cancer cells with limited treatment-related side effects. In clinical trials, the medicine shrunk tumors in 25 percent of women with HER2-positive breast cancer.

Chronic obstructive pulmonary disease (COPD), mainly comprised of chronic bronchitis and emphysema, has killed more women than men for seven consecutive years, according to the American Lung Association. One medicine in development for the treatment of COPD selectively targets certain receptors in the lung that can cause constriction of the smooth muscle that is observed during bronchoconstriction. The optimized inhaled powder may offer a long-acting, once-daily treatment.

Fibromyalgia, a chronic pain syndrome, affects 3 million to 6 million Americans, up to 90 percent of whom are women, according to Fibromyalgia-Symptoms.org. Symptoms can be debilitating and are characterized by chronic and widespread pain throughout the body, often accompanied by severe fatigue and poor sleep. A medicine in development focuses on the three main symptoms of the disease -- pain, fatigue and sleep disturbances. In clinical trials, patients experienced substantial improvement in pain relief and additional improvement in fatigue, sleepiness, sleep quality and physical functioning.

Lupus affects at least 1.5 million Americans, and 90 percent of them are women, according to the Lupus Foundation of America. In lupus, the body develops antibodies that react against normal tissue, leading to inflammation, pain, tissue injury and major organ damage. A new monoclonal antibody in development potentially modulates B-cells that produce antibodies against the body’s own cells and tissue, causing the immune system to turn on itself, resulting in inflammation and tissue damage.

Migraine is a painful neurological condition that affects 26 million Americans, 80 percent of them women, according to MAGNUM: The National Migraine Association. One first-in-class medicine in development selectively blocks transmission of pain signals to the brain through the activation of receptors in the central nervous system.

Multiple sclerosis affects about 400,000 Americans and strikes women at least two to three times more as men, according to the National Multiple Sclerosis Society. Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system. Relapsing remitting multiple sclerosis (RRMS) is defined by attacks (called relapses or flare-ups) that are followed by partial or complete recovery periods (remissions). Approximately 85 percent of patients are initially diagnosed with this type of multiple sclerosis. One medicine in development for RRMS is an oral immunomodulator with a dual mechanism of action that has both cytoprotective (protecting cells from harmful agents) and immunosuppressive/anti-inflammatory properties. In clinical trials it has been shown to inhibit a certain protein that plays a key role in regulating pro-inflammatory genes.

Ovarian cancer affects an estimated 13,850 women died from it in 2010. A potential first-in-class medicine in development works by selectively inhibiting the polo-like kinase-1 (PLK-1), an enzyme crucial for cell division. PLK-1 is expressed in proliferating cells and most tumors. Inhibiting its activity disrupts cell division, which induces cell death and reduces cancer growth.

Rheumatoid arthritis affects approximately 1.3 million people in the United States, with women outnumbering men 2.5 to 1, according to the Arthritis Foundation. Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the joints. One potential medicine in development is a nanomedicine (an antibody-derived therapeutic protein) that targets tumor necrosis factor alpha (TNF-alpha), which plays a key role in the inflammation process associated with rheumatoid arthritis.

* From Medicines in Development for Women 2011, PhRMA, May 2011.

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