) shares were down 3.5% immediately after the company reported
second quarter fiscal 2014 report. Overall, shares are down 6.9%
since the company released second quarter results.
The company reported a loss of 29 cents per share, narrower than
the year-ago loss of 37 cents but wider than the Zacks Consensus
Estimate of a loss of 26 cents per share.
Biodel did not generate any revenues in the reported quarter and in
the year-ago quarter.
The Quarter in Detail
R&D expenses increased 43.5% to $4.3 million. This increase was
primarily driven by expenses related to the development of Glucagon
Emergency Management (GEM) program.
G&A expenses decreased 20.4% to $1.7 million.
Biodel started dosing patients with BIOD-531 in the first of two
planned phase II meal studies (Study 3-151 and Study 3-152). The
study will assess its benefits on post prandial control of glucose
in diabetic patients. Results should be out in the fourth quarter
of calendar 2014.
Biodel received the U.S. Food and Drug Administration's (FDA)
feedback on the design of a proposed phase III study necessary for
the approval of BIOD-531. Biodel requested the agency to help in
defining the toxicology requirements in the study on BIOD-531. A
response from the FDA is expected in the third quarter of calendar
Meanwhile, Biodel finished dosing in rats in an ongoing GLP
toxicology study for the development of the GEM device as a rescue
treatment of severe hypoglycemia. Results should be out by the
third quarter of calendar 2014. The company plans to conduct at
least two studies on the GEM device in human patients in 2014.
Biodel intends to file a new drug application (NDA) for the device
in late 2015.
In the reported quarter, Biodel entered into agreements with
companies like HEC Pharm and
Emergent BioSolutions, Inc.
). Biodel signed a long-term commercial manufacturing agreement
with Emergent BioSolutions for the sale and finish of Biodel's GEM
device. Recently, the company signed a research supply and
technology development agreement with HEC Pharm for
ultra-rapid-acting insulin aspart.
Biodel carries a Zacks Rank #2 (Buy). Some better-ranked stocks in
the health care sector include
Cardiome Pharma Corp.
Avanir Pharmaceuticals, Inc.
). While Cardiome carries a Zacks Rank #1 (Strong Buy), Avanir
holds a Zacks Rank #2 (Buy).
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