MannKind fans and critics line up for Sanofi's Afrezza pre-game show

Afrezza's inhaled insulin drug/device combination--Courtesy of Mannkind

Who doesn't like to watch a drug launch? It's pharma's version of a spectator sport, complete with cheerleaders (and boo-ers). And for Sanofi's ($SNY) upcoming rollout of Afrezza, the inhaled insulin developed by MannKind, the crowd is already assembling.

Two reasons: One, Afrezza's road to market was long, and MannKind ($MNKD) developed a host of enthusiastic fans and rabid critics as time went by. Two, Sanofi's diabetes business is under a spotlight, thanks to former CEO Chris Viehbacher's abrupt departure, not to mention the pessimistic forecasts he issued just before he left.

So, at Sanofi's investor confab late last week, a certain share of visitors zeroed right in on any comments about Afrezza--and any hints they might give about Sanofi's launch plans and their likelihood of success.

Some observers noted that Sanofi didn't trot out any physicians to talk up Afrezza, as it did with other soon-to-be-launched meds like Toujeo (the Lantus follow-up) and LixiLan (the Lantus-Lyxumia combo med). Bad sign, some said. Good sign, said others, noting that the docs discussed meds that aren't yet approved in the U.S.

Splitting hairs? Maybe. The hard and fast info on Afrezza's launch was scarce. Sanofi's Riccardo Perfetti, senior medical officer in diabetes, did say the company plans to target diabetic patients who don't want to start insulin therapy--and that's a lot of diabetics, given the fact that two-thirds of patients resist the move. On average, patients wait 5 years to add insulin to their oral meds.

Another target: Patients who are using a basal insulin like Lantus but need another insulin at mealtimes. Those patient populations, combined, could reach 3 million, RBC analyst Adnan Butt said in a recent investor note.

Selling points? No injections, obviously. As an inhaled insulin, Afrezza is an odd duck that could just possibly grow up to be a big-selling swan. According to Sanofi's market research, 39% of patients using oral meds didn't want to start insulin therapy specifically because they wanted to avoid injections. To about 60% of surveyed patients, Afrezza was a preferable alternative to a pen injector. Almost as many said they'd prefer to use Afrezza daily than add injections at mealtime.

Meanwhile, Sanofi is preparing to test other Afrezza dosing regimens, hoping to get some positive tweaks to the drug's official labeling. It's in negotiations with the FDA on post-approval studies. Launch date is still set for the first quarter of next year, regardless of change at the top of Sanofi.

- read the Barron's blog post

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