) signed a research supply and technology development agreement
with HEC Pharm for ultra-rapid-acting insulin aspart. Insulin
aspart is the active pharmaceutical ingredient (API) in
Biodel will use insulin aspart supplied by HEC to develop
aspart-based ultra-rapid-acting insulin formulations. Under the
terms of the deal, HEC has the option to acquire an exclusive
license to develop and market any of Biodel's aspart-based
candidates in China. However, Biodel retains rights to these
candidates in other markets.
We note that recent positive early-stage top-line results on two
lispro-based ultra-rapid-acting insulin formulations, BIOD-238
and BIOD-250, encouraged Biodel to procure supply of insulin
aspart to develop aspart-based insulin formulations.
Meanwhile, Biodel continues to focus on its lead candidate for an
ultra-rapid-acting insulin formulation, BIOD-531. The company has
plans to advance BIOD-531 to phase II studies for assessing its
benefits on post prandial control of glucose in diabetic
Recently, Biodel and
) signed a long-term manufacturing agreement for a dual-chamber
glucagon rescue device under the Glucagon Emergency Management
(GEM) development program. Biodel intends to submit an
Investigational New Drug application for the device to the U.S.
Food and Drug Administration (FDA) in the second half of 2014.
Currently, the diabetes market is highly crowded with several
players including Novo Nordisk. Approved drugs in this market
include Victoza and Bydureon among others.
We expect investor focus to remain on further pipeline updates
Biodel carries a Zacks Rank #2 (Buy). A better-ranked stock in
the health care sector is
) with a Zacks Rank #1 (Strong Buy).
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