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$BIOD - Biodel Lays Out Clear Clinical and Regulatory Path for Linjeta

publication date: Mar 14, 2011
 | 
author/source: Mark Messier
After months of uncertainty following its 10/31/10 CRL, BIOD has provided an important update and clinical outline for Linjeta.  Take a look at their press release below.  We have added the bolding:

http://investor.biodel.com/releasedetail.cfm?ReleaseID=556478 >

"DANBURY, Conn., Mar. 14, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) announced today that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates.  The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins.  Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with Type 1 diabetes.  This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog® each on separate occasions.  This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog®.  In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year.

If this Phase 1 study is successful, Biodel now anticipates initiating a Phase 2 study in patients with Type 1 diabetes in the fourth calendar quarter of 2011.  The Phase 2 study is intended to follow the same overall design that would be implemented in Phase 3 studies, which would include two separate pivotal trials-- one in patients with Type 1 diabetes, and the other in patients with Type 2 diabetes.  Biodel recently received initial guidance from the U.S. Food and Drug Administration (FDA) on the design of two pivotal Phase 3 clinical trials.  Based on this guidance, Biodel plans to design the Phase 2 and 3 studies as randomized parallel group studies using Humalog® as a comparator in which active dose titration will occur in the first two months after randomization followed by three months of relatively stable dosing.  In these studies, Biodel plans to evaluate efficacy using HbA1c as well as measures of postprandial glucose profiles.  If the results of the Phase 2 testing are successful, the company plans to launch Phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013.

"We look forward to obtaining initial clinical data for BIOD-105 and BIOD-107," said Dr. Alan Krasner, Chief Medical Officer of Biodel.  "Based on pharmacokinetic data obtained in the diabetic swine model, these formulations appear to be very rapidly absorbed, similar to rates of absorption seen with the previously studied Linjeta™ formulations.  Based on last year's clinical data from related formulations BIOD-102 and BIOD-103, we anticipate improved injection site tolerability with BIOD-105 and BIOD-107.  We were very pleased with our end of review meeting with the FDA in which they confirmed study details including the use of Humalog® as a comparator in future clinical trials.  The FDA also confirmed that data from the development program for the new formulations would be classified as a Class 2 resubmission with a 6 month review time."

"We have identified two new formulations with commercial target product profiles that appear to be superior to any of our previous ultra-rapid-acting human insulin drug candidates," said Dr. Errol De Souza, president and CEO of Biodel.  "By achieving our candidate selection milestone and receiving constructive feedback from the FDA during our end of review meeting, we have accelerated the clinical development program of these formulations and plan to initiate Phase 1 clinical testing this month and could initiate Phase 3 testing before the end of 2012."

Biodel now expects to complete the Phase 1 study and launch Phase 2 testing in the third and fourth calendar quarters of 2011, respectively."

Uncertainty is a killer of share price in biotechs, so a clear and established plan with the assistance of the FDA is a very positive sign for Biodel.  The downside is that these catalysts will take months/years to develop which will lead to a slow and lengthy climb from this point forward.

However, in the PR BIOD does hold out this 'nugget of hope' for short term share price movement:

Dr. De Souza will address these accelerated time lines and other updates in a presentation at the Roth 23rd Annual OC Growth Stock Conference Wednesday, March 16th at 1:00 p.m. Pacific Time (4:00 p.m. Eastern Time). 

Disclosure:
Long BIOD $2 and $2.50 March Calls