In October, Boehringer Ingelheim (BI) won FDA approval for Pradaxa, a blood thinner that reduces stroke risk in patients with non-valvular atrial fibrillation. As the first alternative to warfarin, which launched in the 1950s, it's got blockbuster potential. Leading the charge to market is Wa'el Hashad, VP of cardiovascular and metabolic disease marketing at BI.
“We believe Pradaxa will be a huge blockbuster and a flagship for BI,” he says. “It'll be with us until the 2020s, and we're committed to make the most out of the brand. We're setting a very high bar for any subsequent compound, driven mainly by additional reduction in risk of stroke versus warfarin.”
Other companies, including J&J and Bayer, Pfizer and Bristol-Myers Squibb, are trying to enter the market. Hashad says it's been difficult to develop a treatment that even matches warfarin's efficacy and overcomes its weaknesses—mainly that patients require regular monitoring as factors such as dietary habits and other medications can impact efficacy and safety.
“Almost every company has dreamed of overcoming [warfarin's] narrow therapeutic window and providing the same efficacy,” he explains. “That was the initial idea of bringing Pradaxa to market. Trial results showed we overcame the convenience hurdle and significantly reduced stroke risk—more than we thought. Our goal is to maximize that excellent efficacy profile and highlight the benefits. The more efficacy, usually the more risk of bleeding. In our case, that didn't happen. ”
“J&J and Bayer released highlights of studies on their product [in late October],” Hashad continues. “It didn't establish any further reduction in risk to stroke compared to warfarin. Our efficacy is higher; we show reduction in two types of stroke; and also have benefits in some elements of bleeding. We take our competition seriously, but we're fully prepared to take advantage of being first to market. Pradaxa will offer, for the time being, a unique and different profile in addition to being first to market.”
Launch strategy is rooted in three years of market segmentation work. Phase one focuses on healthcare providers and payers, with early adopters of new technology targeted first. So far, Hashad reports a “very positive” reception. He expects to have physicians up to speed on Pradaxa by the beginning of 2011, after which consumer outreach will begin.
Though declining to specify the number of sales reps behind Pradaxa, Hashad says three sales forces—hospital, cardiovascular and primary care physicians—will be in play. “We're covering all bases,” he says. “PCPs write more than 50% of prescriptions. Cardiovascular [specialists] don't treat more than 50% of patients, but they are referred to by PCPs almost all of the time.” The hospital business is small, but nearly seven in 10 patients are in the hospital at least once a year.
BI began tilling consumer ground in September with an unbranded disease awareness campaign. Elements include facingafib.com, direct marketing, ads and pharmacy outreach. As of October 31, Hashad reports 102,000 enrolled patients, all of whom opted to receive information about new medicines.
Born in Salt Lake City to Egyptian parents, Hashad says at least 17 cousins are physicians, and he always wanted to work in healthcare. After graduating from pharmacy school in Cairo, he alternated between pharma sales and marketing and earned an MBA. When not working, Hashad “cherishes” time with his wife and three daughters. He's proud of his heritage, and his family visits Egypt every summer.
Before joining BI in 2009 Hashad spent nearly 20 years at Eli Lilly, where his responsibilities included managing the launch of new indications for Cymbalta. While noting that it's hard to compare drugs, Hashad feels Pradaxa is “probably the most significant product” he's ever promoted. “Warfarin is very efficacious, but there are still over 200 strokes every day in the US,” he says. “If patients would convert to Pradaxa, we're talking 70 less strokes every day.” —Tanya Lewis