The asthma drug AstraZeneca Plc. plans to bring to the United States next year could be just what the doctor ordered for the pharmaceutical giant as it works to rebuild a drug development pipeline hamstrung by the termination of several once-promising prospects.
In mid-2007, AstraZeneca, whose U.S. headquarters is in Fairfax and which employs about 5,000 statewide, plans to roll out Symbicort.
Symbicort is an asthma inhaler that combines two drugs to treat both the swelling of the airways and constriction of the muscles around the airways.
First introduced by AstraZeneca in Sweden in 2000 and sold in 70 countries, Symbicort is already one of the company's biggest sellers outside the U.S., with sales topping $1 billion in 2005 -- a 22 percent rise from 2004.
The Food and Drug Administration approved Symbicort in July for sale in the U.S. The drug's prospects look bright in a country with an estimated 20 million people diagnosed with asthma, only about half of whom are on asthma medication. There may be as many as 13 million more undiagnosed asthmatics in the U.S.
According to the American Lung Association of Delaware, about 46,000 Delawareans suffer from asthma, a potentially fatal disease of the lungs' airways marked by wheezing, coughing, chest tightness and shortness of breath.
"I think Symbicort could be a billion dollar drug [in the U.S.] if they market it right," says Thani Jambulingam, who chairs the department of pharmaceutical marketing at St. Joseph's University in Philadelphia.
Max Herrmann, an analyst with ING in London, agrees. He expects Symbicort's sales in the U.S. to reach $1.7 billion by 2007.
That kind of revenue would cushion AstraZeneca's bottom line as it spends money to bolster a pipeline that has suffered some big blows recently. In the past year, the drug maker dropped clinical trials of its Exanta blood thinner and Galida diabetes drug amid safety concerns. Last month, it halted development of its stroke drug NXY-059 after a late-stage clinical trial showed it failed to significantly reduce stroke-related disability.
"It's an important product launch at a time when they don't have other major product launches," Herrmann says.
Symbicort, a twice-daily treatment approved for patients 12 and older, is a combination of two drugs in an inhaled form that improve lung function within 15 minutes and provide long-lasting relief.
It combines budesonide, an inhaled corticosteroid, and formoterol, a beta agonist. Together, they improve lung function in patients with moderate-to-severe asthma.
Hermann forecasts that Symbicort could eventually grab as much as a third of the U.S. market for combination asthma therapy inhalers, a market which GlaxoSmithKline Plc.'s Advair now has all to itself.
There are a variety of different asthma treatments in the $10 billion U.S. market for asthma control, including AstraZeneca's Pulmicort and Merck & Co.'s Singulair.
But when it comes to combination inhaled asthma therapy products in the U.S., Advair is the only one currently on the market here.
As a result, Advair has developed into Glaxo's biggest-selling product with U.S. sales in 2005 of $3.07 billion. It had worldwide sales of $5.47 billion last year.
Advair is such a big player, about one in four new prescriptions written last month for all forms of asthma medications were prescriptions for Advair, according to ImpactRX, a health information company.
Hermann, the ING analyst, says that despite Advair's head start in the U.S., Symbicort can slice into its market share and grab a substantial number of patients who are on other asthma drugs or aren't taking any medication. He expects the market for combination asthma therapy drugs to more than double, to $7 billion in 2011.
"Currently, in the rest of the world, Advair is winning the battle as it benefits from an earlier launch, strong data and greater marketing effort," Herrmann wrote in a July 3 research note to clients, about three weeks before the FDA approved Symbicort. "However, Symbicort is a growing product that offers alternative benefits to Advair. Both products will be key beneficiaries from the growth of the respiratory disease area and, consequently, both products will be successful."
AstraZeneca declined to provide pricing details or sales projections for Symbicort sales in the U.S.
"We're confident that the U.S. market will welcome an additional choice for patients with this illness,'' says Sheila Frame, commercial brand leader for Symbicort at AstraZeneca.
A tool for patients
Asthma control is a major problem for patients because many of them don't take their medication as often as they should, says Dr. Albert Rizzo, a pulmonologist on staff at Christiana Care Health System.
"Medication compliance is a big problem with patients," Rizzo says. "Many people want to just treat the acute flair-ups rather than stay on medication to prevent the flare-ups," he said.
The marketing focus, AstraZeneca's Frame says, will be on "patients who don't currently have their asthma controlled."
That, says Dr. Mitchell Goldman, senior medical director in the respiratory group at AstraZeneca, means focusing on patients with moderate-to-severe asthma, whose condition isn't being controlled by other asthma treatments. A major selling point for Symbicort is that it relieves asthma symptoms within 15 minutes, something Advair doesn't do.
"It will be somewhat helpful, and people will appreciate the quick onset," says Dr. William Geimeier, a Newark allergist.
In targeting patients whose asthma isn't being controlled by other products, AstraZeneca would follow a strategy similar to the one that it used to build its Crestor cholesterol-reducer into one of its biggest products.
The pharmaceutical company markets Crestor as a product for high-risk patients who haven't lowered their cholesterol enough with competing drugs.
For their part, Glaxo officials don't express any worry about having to share turf they've enjoyed all to themselves. They point to continuing strong sales in Europe, where Advair and Symbicort compete.
"Advair has been available in the U.S. for five years and physicians have a wide breadth of experience with the medicine, which is reflected in the 74 million prescriptions dispensed since its introduction," said Patricia Johnson, a Glaxo spokeswoman.