) reported third-quarter fiscal 2013 loss of 66 cents per share,
wider than the year-ago loss of 52 cents and the Zacks Consensus
Estimate of 37 cents per share.
Biodel did not generate revenues in the reported quarter and also
in the year-ago comparable quarter.
Research and development (R&D) expenses increased 20% to $3.6
million due to costs incurred on a phase II study on BIOD-123.
Biodel has finished dosing patients in the phase II randomized,
open label, parallel group study conducted across approximately
33 U.S. sites. Approximately 132 patients suffering from type I
diabetes were randomized to receive either BIOD-123 or
Eli Lilly and Company
) Humalog as meal-time insulin during the therapy duration of 18
weeks. In the study, the primary endpoint is HbA1c control. The
secondary endpoints are postprandial glucose excursions, glycemic
variability, hypoglycemic event rates and weight changes.
Biodel expects to report top-line data from the study in the
third quarter of calendar 2013.
Meanwhile, Biodel presented encouraging data from a phase I study
on its two insulin Lispro-based formulations, BIOD-238 and
BIOD-250, at the American Diabetes Association. Both candidates
showed a significantly more rapid rate of absorption compared to
Humalog and also compared favorably to Humalog where injection
site tolerability is concerned.
Biodel made a strategic move during the reported quarter for its
Glucagon program by entering into a 15-year supply agreement with
). Under the agreement, Biodel acquired exclusive worldwide
rights to Unilife's proprietary auto reconstitution technology
from the EZMix platform of dual chamber devices for use with
Glucagon for the treatment of severe hypoglycemia in diabetics.
General and administrative expenses decreased by 5.6% to $1.7
Currently, Biodel carries a Zacks Rank #3 (Hold). Companies like
Gilead Sciences Inc.
) look well-positioned with a Zacks Rank #1 (Strong Buy).
BIODEL INC (BIOD): Free Stock Analysis Report
GILEAD SCIENCES (GILD): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
UNILIFE CORP (UNIS): Free Stock Analysis
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