Significant Market for New Anal/Hemorrhoidal Products
The Delphi Group, Ltd. (White Plains, NY), a consulting firm specializing in the pharmaceutical and biotechnology sectors, has issued a comprehensive study evaluating the market potential of new therapies to treat hemorrhoids and anal fissures. The study concluded that these two combined markets represent more than $475 million of annual prescription sales worldwide. Unfortunately, the report also claims that except for surgical intervention, current treatments suffer from patient dissatisfaction and limited efficacy. One would think that this situation would cast a dark cloud over drug development for this type of product. Delphi, however, sees a silver lining.
"The results of our study suggest a significant opportunity for any product that can be proven to be safe and effective, particularly if it helps minimize pain while promoting healing," commented Matthew Heil, Delphi president and one of the study's authors. "Considering both the large patient population and the huge cost of numerous doctors' visits, medications, surgical fees, hospitalization and complications these patients often face, such a product would represent significant upside to the value of a company positioned to bring it to market."
The study, which assessed markets in the U.S., Europe and Japan, utilized Delphi's proprietary Product Opportunity Value (PROVE) analysis model to identify key market opportunities and their underlying pharmacoeconomic justifications. The analysis incorporated extensive global product information, interviews with physicians in each of the disease areas, as well as research into costs, treatment patterns and the most commonly used products. Delphi concluded that current non-surgical treatments for either of these conditions are largely ineffective in delivering relief or helping to heal the underlying condition.
"Using a set of conservative estimates built into the PROVE model, our studies indicate a strong pharmacoeconomic rationale for the introduction of a product that addresses these conditions in a non-surgical approach," Heil said. "As with other under-served product categories, the introduction of a new, effective treatment can significantly expand the market size."
Anogesic
The Delphi Group was commissioned to prepare the report by Cellegy Pharmaceuticals, Inc. (South San Francisco, CA), a biopharmaceutical company that has a proprietary drug, now in Phase III trials, with potential for treating hemorrhoids and anal fissures. The topical ointment, called Anogesic, relies on the action of nitroglycerin, a drug that has long been used to treat certain cardiovascular conditions. In anal fissures, nitroglycerin is a potent blood vessel dilator that also relaxes muscles surrounding the blood vessels, nourishing the anal tissue and promoting healing—potentially eliminating the need for surgery. Three articles published in the New England Journal of Medicine and The Lancet have confirmed these findings.
"The current prescription and nonprescription medications used for anal fissures and hemorrhoids are palliative, so current drug markets are small considering the prevalence of these conditions," said Richard Juelis, VP of Finance for Cellegy. "Delphi's analysis indicates how big the markets could be if a breakthrough product were available."
Juelis suggested that Anogesic could become this breakthrough product because of its novel mechanism of action. "Anogesic alleviates pressure on the internal anal sphincter, which can actually result in healing or cure, vs. simple mitigation of symptoms. Data from earlier human studies indicates Anogesic may work as well as surgery for anal fissures." Phase III studies on Anogesic are expected to be completed by the second half of 1999, with FDA approval, assuming successful study results, potentially coming in 2000.
Current Treatments
Anal fissures are tears in the anal tissue, which arise as a result of an involuntary contraction of the internal anal sphincter. The result is an increase in intra-anal pressure, which reduces blood flow to the lining of the anal canal, promoting tissue damage. Hemorrhoids are an enlargement of veins just beneath the anal tissue. Increasingly, physicians are coming to believe that a rise in intra-anal pressure also plays a significant role in their development.
An estimated 25 million people in the developed world suffer from hemorrhoids, with 10 million in the U.S. alone. Anal fissures, an even more painful condition, occurs in more than 600,000 people in the developed world. Although less common than hemorrhoids, fissures are serious and extremely painful, with approximately 40% of cases being chronic and usually requiring surgery. These figures may underestimate the magnitude of the problems, as they are based upon reported contacts between physicians and patients diagnosed with the conditions. Some patients are misdiagnosed or have not sought the advice of a physician due to embarrassment or a feeling that their pain is untreatable or unavoidable.
Current non-surgical therapy for both hemorrhoids and fissures includes the use of corticosteroid-containing creams to help soothe pain and inflammation. These drugs are available both over-the-counter and in stronger prescription forms. However, while they may be the most powerful drugs physicians have at their disposal, they do not address the underlying cause of the disorder. Prolonged use can also cause thinning of the anal canal lining, which can cause bleeding and prevent or delay effective healing.
Corticosteroids can also cause weight gain, unwanted hair growth, hyperglycemia and growth retardation in children. Patients may undergo diet modifications in addition to corticosteroid treatment, and take stool-bulking agents or frequent warm sitz baths. Again, however, these fail to treat underlying causes and often give only temporary relief.
When doctors must resort to surgery, it is most often an expensive, in-patient procedure involving powerful analgesic drugs to treat post-operative pain. The average cost of surgical procedures to treat hemorrhoids is about $3,500. Surgery for anal fissures normally runs between $600 and $900 and can be more expensive if hospitalization is required. Aside from these costs, all surgery involves a degree of risk associated with anesthesia, as well as complications associated with the procedure itself, including incontinence.
For more information: Matthew Heil, president, Delphi Group, Ltd., 70 West Red Oak Lane, White Plains, NY 10604, USA.Telephone: 914-697-7580. Fax: 914-697-7585.