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Biodel's Ultra-Rapid-Acting Insulin Unlikely to Reach Market before Early 2014

Published: 4/30/11
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Earlier in April, Biodel management updated the timeline for the development of its ultra-rapid-acting insulin candidates. As a reminder, in October 2010 the company's original ultra-rapid-acting insulin candidate Linjeta failed to receive FDA approval (see NewNowNext in diaTribe #27). Consequently, Biodel has chosen not to pursue Linjeta any further; instead, the company is now investigating two other formulations (BIOD-105 and BIOD-107), which should be more tolerable than Linjeta while maintaining similar drug properties (e.g., rate of absorption, duration of effect) and comparable effects of the drug on the body. The two new candidates have only recently entered a phase 1 trial; in the new timeline, the two pivotal phase 3 trials could be initiated before the end of 2012. Accounting for patient recruitment, and assuming a five-month study period for the phase 3 trials, time for data analysis, and a six-month FDA review period, it appears the absolute earliest Biodel's ultra-rapid-acting insulin candidate could be approved would be early 2014.

Unfortunately, no ultra-rapid-acting insulin will likely become available in the near future. In January, the FDA decided not to approve MannKind's ultra-rapid-acting inhalable insulin Afrezza, requesting two additional clinical trials (see NewNowNext in diaTribe #29); as such, Afrezza is unlikely to reach the market until late 2012 at the earliest (assuming timely meetings with the FDA and favorable clinical trial results). Meanwhile, Haloyzyme's PH20, a therapy that aims to bring about faster insulin absorption when mixed with insulin, remains in phase 2 studies. On the bright side, Halozyme recently released promising results from its first pump study, in which it was demonstrated that PH20 sped up insulin absorption and shortened the duration of action of the insulin. All things said, the development of ultra-rapid-acting insulin certainly remains an important need and an essential component of the artificial pancreas. With that in mind, we hope to hear of more focus on this area by large and small companies alike.  –VW

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