Combivent

NEW YORK -- It's hard enough to imagine that there remains in the United States a disease state so poorly defined that general practitioners often fail to diagnose the condition. Tougher still is the realization that this hard-to-recognize disease currently ranks a-s the No. 4 leading cause of death in this country and is expected to continue to climb that morbid chart.

It's a disease state so prevalent that the total afflicted population-1-in-every-12 Americans--outstrips the number of Americans thought to have diabetes by some 6 million people. And like diabetes, a significant portion of that patient population is not being treated for it--only 10.5 million diagnosed, versus a total population of some 24 million.

Although it has flown under the radar for decades, chronic obstructive pulmonary disease is shaping up to have a breakout year for news in 2004. COPD is an umbrella condition that includes emphysema and chronic bronchitis, but not asthma.

"COPD is one of these unique marketplaces that is still undefined," remarked Stephen Beckman, vice president of corporate respiratory marketing at Altana, a German pharmaceutical company, noting that there is no standardized regimen of treatment for COPD. "It's one of the last areas [of disease management] before we get into things like gene therapy, where we really break new, plateaus of medical treatment.

The U.S. COPD Coalition is trying to raise awareness among general practitioners in an effort to have doctors routinely screen for COPD in patients over the age of 45. Physicians using a Spirometer can measure lost lung function effectively even if a patient isn't symptomatic.

The disease has a strong connection to smokers--as many as 90 percent of COPD cases can be linked to the nicotine habit. Many of the patients receiving COPD diagnoses today more than likely were avid smokers in the 1960s and 1970s, a time when the Marlboro Man freely roamed the airways in promoting the smoker's lifestyle and before smoking generally was considered bad for your health.

For that reason, smoking cessation products also may see a slight boost in sales as recalcitrant smokers are persuaded to quit.

Driving awareness on the prescription side of the equation, GlaxoSmithKline in November won a COPD indication for its Advair Diskus 250/50. Sales of Advair Diskus were tracking at $1.9 billion for the 10 months ended in October, according to IMS Health, and with the new COPD indication have been projected to crest at more than $5 billion in sales by 2007. That lift may in fact be sharper, but won t show up in sales data because almost half of the COPD patients receiving treatment today already have been prescribed an off-label, inhaled corticosteroid--a class of drugs that includes the combo therapy Advair.

Boehringer Ingelheim is preparing a COPD remedy to bow the first half of this year called Spiriva (tiotropium bromide). Boehringer received an approval letter from the Food and Drug Administration for Spiriva in December 2002 and currently is working with the FDA to resolve concerns around packaging and moisture sensitivity. "In every country, with the introduction of Spiriva, the product has exceeded our expectations, said Robert Harold, executive director of respiratory marketing at Boehringer. Those expectations were strong to begin with, he added, because of the demand and unmet need--especially in the area of COPD."

What's more, analysts have pegged Spiriva, a long-acting anti-cholinergic, as one of the next blockbusters--with $1 billion in worldwide sales by 2006--and there are more drugs seeking COPD indications in the pipeline that similarly are expected to achieve blockbuster status.

IMS Health has reported that the market potential for COPD drugs today stands at about $3 billion, a figure the market forecasters project to triple by 2010. Although IMS does not yet specifically track drugs used to treat COPD, commonly prescribed bronchodilators were tracking 3 percent up for the 10 months ended in October and will have reached $2.4 billion for 2003 at that rate.

Pfizer, which partnered with Boehringer in marketing Spiriva, has entered a similar arrangement with Altana on its potential blockbuster drug--the COPD treatment roflumilast--pending approval. Although Beckman declined to provide a firm timeline of a roflumilast new drug application, he said Altana plans to file with Europe in the immediate future and with the United States in the near future. If Altana were to file that NDA sometime this year, the soonest the drug likely would be introduced to the market is 2007.

Roflumilast is a phosphodiesterase-IV inhibitor. An FDA advisory committee in September voted down another PDE4-inhibitor, GlaxoSmithKline's Ariflo, calling for more long-term efficacy studies before it would consider Ariflo for a COPD indication. Nonetheless, analysts have speculated that Ariflo sales could reach $700 million if it is approved. Analyst estimates of roflumilast sales reach as high as $1.6 billion worldwide, and though it seems Pfizer is throwing two stones into the same pond, some drug company executives believe Spiriva and roflumilast will be complementary remedies prescribed in tandem.

Other drugs entering the COPD space include AstraZeneca's Symbicort Turbuhaler (budesonide/eformoterol), which was approved in Europe early last year and may come before the FDA in 2005.

Schering-Plough and Novartis also have plans to enter the market, as announced last April, collaborating on the development of a beta2-agonist/ corticosteroid product for both asthma and COPD that would marry Schering-Plough's Asmanex (mometasone furoate) and Novartis' Foradil (formoterol) into one product. Both products are approved for use in asthma, and Foradil is approved for use in COPD.

Doctors currently are prescribing the bronchodilators Atrovent (ipratropium bromide) and Combivent, both supplied by Boehringer, to treat COPD. Sales of Combivent for the 10 months ended in October totaled $433.9 million and were trending up 25 percent, according to IMS. Atrovent pulled in $189.6 million in that period, which tracked 5 percent below 2002 sales.

COPYRIGHT 2004 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2004 Gale Group