) recently announced that it has completed enrolling patients in
a phase II study on its diabetes candidate BIOD-123.
In the study, BIOD-123 will be compared with
Eli Lilly and Company'
) Humalog with respect to various parameters such as measures of
HbA1c, weight changes, postprandial glucose excursions, glycemic
variability and hypoglycemic event rates.
We note that the randomized, open label, parallel group study
is being conducted across approximately 30 US sites. During the
study approximately 130 patients suffering from type I diabetes
will receive either BIOD-123 or Humalog as meal-time insulin
during the therapy duration of 18 weeks. In the study the primary
endpoint will be the evaluation of HbA1c control. The secondary
endpoint will consist of postprandial glucose excursions,
glycemic variability, hypoglycemic event rates and weight
Biodel expects to report top-line data from the study in the
third quarter of calendar 2013. Biodel's fiscal year ends on Sep
We note that Biodel focuses on the development and
commercialization of innovative therapies for diabetes. In Jan
2013, the company announced encouraging top-line results from a
phase I study on BIOD-238 and BIOD-250. BIOD-238 and BIOD-250 are
combinations of the company's proprietary excipients with the
marketed version of Humalog.
We believe that the successful development and
commercialization of the candidates will bring in significant
revenues to Biodel since the diabetes market offers significant
Currently Biodel carries a Zacks Rank #2 (Buy). However,
Lannett Company Inc.
) look more attractive with both carrying a Zacks Rank #1 (Strong
BIODEL INC (BIOD): Free Stock Analysis Report
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