A Little bit of INFOTrends driving the formulations themselves are efficacy, economy, and increasingly, convenience. Bertrand Bolduc, president and chief executive officer of the Canadian firm Mistral, spoke to these points: "There's certainly a trend to tailor products to make life easier for patients. I still work in a pharmacy one evening per month -- I see ordinary people, and its very hard for them to understand the minute they get more than two pills, more than two inhalers. . . . It's complicated." One way to simplify the therapeutic day is to produce combination therapies. "We're seeing more and more combination products, like Pfizer's Caduet [a calcium channel blocker plus a statin]." Not only does this strategy extend patent life, but it makes life physically easier for patients, and, as Mr. Bolduc has observed, there's also a psychological effect for his customers: "If you take one pill a day instead of two, you think you're less sick. Really, people think like that! If asked, people don't say, 'I take three types of medication.' They say, 'I take eight pills a day.'"
Cutting down on the number of drugs is great, but Bolduc would also like to address the issue of timing, via chronotherapy. Using novel technology licensed from GlaxoSmithKline, Mistral is developing a combination of an anti-inflammatory and an anti-ulcer medication for arthritis sufferers: MIST-B03. "It's about getting the right level of drug at the right time of day. For arthritis, the pain is usually the worst in the morning. But if you take an anti-inflammatory in the morning you risk stomach upset." Using a chronologic approach, the drug is taken the night before and, because of its proprietary structure, becomes active only after the gut has been protected from irritation.
While both active agents in MIST-B03 are generic, the reformulation approach with combinations is increasingly prevalent as blockbusters fall off patent -- a unique opportunity for the contract service provider. Mr. Bolduc commented on two recent reformulations developed in partnership with Pozen: One, partnered with GSK, is soon to be approved, and the other, recently announced, is partnered with AstraZeneca. "Consider what the guys at Pozen have done with the migraine drug Trexima [a combination of sumatriptan and naproxen]. They started the project much before they talked to GSK – and with AstraZeneca as well -- obviously it's the same formulation [a branded drug combined with the generic naproxen]. Pozen started the project, filed patents for it and then approached AZ -- I'm sure that's how it went."