Pharm Exec's 2012 Pipeline Report - Pharmaceutical Executive


Pharm Exec's 2012 Pipeline Report

Pharmaceutical Executive

Rheumatoid Arthritis: Will Pfizer Challenge the Big Three?

Coming out of the November American College of Rheumatology meeting in Chicago, Weintraub says Pfizer's data on its oral Janus kinase (JAK) inhibitor, toficitinib, generated "a ton of excitement ... it will be quite competitive with the TNF inhibitors, which are already a successful class." Pfizer knows about the success of the TNF inhibitors; it licensed Enbrel from Amgen, and co-promotes the drug, one of the big three in rheumatoid arthritis (RA). The others are Humira and Remicade, and together they earned $9.5 billion in 2010, according to IMS data. Humira and Remicade patents will remain strong until at least 2018, and Amgen, through a protracted maneuver at the US Patent and Trademark Office, was recently able to get a new patent on Enbrel, protecting it from generic competition until 2028.

However, all three TNF inhibitors are administered by either injection or infusion, so patients would doubtlessly prefer an oral option, assuming efficacy and side effects measure up. But do they? It appears so. Halfway through Pfizer's 12-month ORAL Standard study, ACR20 rates—a measure that requires a patient to have a 20 percent reduction in the number of swollen and tender joints, and a reduction of 20 percent in three of five categories dealing with physician assessment of disease activity and pain, degree of disability, and protein or erythrocyte sedimentation rate in the blood—were slightly better than data from patients on Humira, although serious adverse events were more common with tofacitinib. Two cardiovascular deaths occurred during tofacitinib testing, but Saeed Fatenejad, Pfizer's head of Inflammation medicines development group, told investors on Nov. 7 that Pfizer "has not seen a signal of increased high blood pressure with tofacitinib."

"People are very positive on tofacitinib," says Selvaraju. "If you're obviating the need for patients to get jabbed with a needle, or go to the hospital to endure a very unpleasant infusion, and you're enabling them to pop a pill instead, that's a big deal." Tofacitinib will "probably come onto the market in late 2012 or early 2013, if all goes well," says Selvaraju. Whether it will challenge the TNF inhibitors right out of the gate, or hang back as a second- or third-line treatment at first, will depend in large part on the label FDA grants Pfizer. Adis R&D Insight predicts blockbuster sales by 2015.

Multiple Sclerosis: BG-12! BG-12!

It's difficult to dig up something negative to say about Biogen Idec's BG-12, an oral MS drug expected to finally hit the market as soon as next year. Huge clinical trials, the most recent of which (aptly named clinical trial DEFINE) found that 240 milligrams of BG-12, taken twice or three times a day, reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with a placebo. The problem with other oral agents, such as Novartis' Gilenya—the first-to-market oral MS drug—is that the efficacy-to-side-effect profile isn't nearly as favorable, according to Selvaraju. "The side effect profile [for BG-12] is virtually innocuous ... you've only got GI symptoms, and maybe some nasopharyngitis. In the case of Gilenya, you have a lot of side effects, which have basically precluded its use in early stage, relatively mild cases of MS ... In Europe, it's only prescribed to people who have failed a prior therapy." Selvaraju says Gilenya's "supposed" side effects, including slowed heart rate, compromised lung function, increased incidence of opportunistic infection, etc., have been overstated, and that usage will gradually increase. But with BG-12, "the efficacy is so good that you would even see it take market share away from Gilenya," and for early-stage patients, "it's a dream come true," says Selvaraju.

Biogen Idec expects to file BG-12 at the beginning of next year, or possibly even this year, according to Selvaraju. "I would expect it to be on the market well before the end of 2012," he says. "When that happens, Teva will take a big hit, because would-be Copaxone patients are going to get BG-12 first." A survey of neurologists conducted by Decision Resources found that a whopping 73 percent "indicate that they would prescribe [BG-12] for the treatment of relapsing-remitting MS ... The findings likely reflect neurologists' positive perception of BG-12's clinical profile, which combines strong efficacy, good tolerability, convenient formulation, unique mechanism of action, and a favorable safety profile to date." That's a lot of positives. Adis R&D Insight has BG-12 earning $500 million next year, and turning blockbuster by 2013. Thomson Reuters forecasts $2.1 billion by 2016. Selvaraju says the MS market will grow from $9 billion or $10 billion now, to $15 or $16 billion by 2015-2016. "It's very lucrative, because only a limited number of players will be allowed in the sandbox, since Phase III clinical trials take three to four years," he says.


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