Biodel Inc. (BIOD)
F4Q 2012 Earnings Call
December 18, 2012 8:00 am ET
Paul Bavier - General Counsel, Secretary
Errol De Souza - President, Chief Executive Officer, Director
Gerard Michel - Chief Financial Officer, Vice President - Corporate Development, Treasurer
Alan Krasner - Chief Medical Officer
Jason Butler - JMP Securities
Matthew Kaplan - Ladenburg Thalmann Securities
Liana Moussatos - Wedbush Securities
Richard Reznick - William Blair & Company
Marc Stutman - Trimark
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I will now turn the conference call over to Paul Bavier, Biodel's Corporate Secretary and General Counsel.
Thank you. Good morning, and welcome to our fourth-quarter fiscal-year 2012 conference call. On the call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that are described more fully in our filings with the SEC, which are also available on our website.
Forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we disclaim any obligation to do so even if our estimates change.
Joining us on today’s call are Dr. Errol De Souza, Biodel’s President and Chief Executive Officer; Gerard Michel, our Chief Financial Officer and Vice President of Corporate Development; and Dr. Alan Krasner, our Chief Medical Officer. After their prepared remarks, we will open the call to your questions.
Now I will turn the call over to Errol.
Errol De Souza
Thank you, Paul. Good morning, everyone. Since the last quarter we have continued to build on the momentum in advancing our three key programs. In today's call, we will discuss details regarding the ongoing Phase 2 clinical trial of our ultra-rapid acting formulation of recombinant human insulin or RHI, the Phase 1 clinical trial of our ultra-rapid acting insulin analog-based formulations and developments in our liquid glucagon program.
Allow me to begin with the RHI based component of our ultra-rapid acting insulin program. In September, we announced the initiation of a Phase 2 clinical study of our lead candidate BIOD-123. As a reminder, in a Phase 1 clinical trial, BIOD-123 demonstrated a pharmacokinetic or PK and pharmacodynamic or PG profiles similar to Linjeta and absorption rates significantly faster than insulin lispro sold as Humalog, while demonstrating injection site toleration superior to Linjeta and similar to Humalog.
The Phase 2 trial is a randomized, open label parallel group study being conducted at approximately 30 investigative centers in the U.S. Subjects with Type I diabetes are being randomized to receive either BIOD-123 or Humalog as their mealtime insulin. Both arms of the study use insulin glargine, sold as Lantus, as the basal insulin.
The 18-week treatment of approximately 130 subjects will evaluate HbA1c control as the primary endpoint and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes. Even though we nearly doubled the number of subjects reported in our original trial design, site initiation and enrollment has been progressing well and we remain on track to report top line data in the third calendar quarter of 2013.
Turning now to the insulin analog-based prong of ultra-rapid acting program. We are pleased to report that we successfully initiated a Phase 1 clinical study in Australia of BIOD-238 and BIOD-250 to evaluate the pharmacokinetic and injection site toleration profiles of these formulations relative to a marketed rapid acting insulin analog using a crossover design in approximately 12 patients with Type I diabetes. These formulations are manufactured from a marketed presentation of the analog using our proprietary excipients.
In parallel, we are continuing our formulation development work to improve the stability characteristics of our ultra rapid acting insulin analog-based formulations as well as developing formulations using the active pharmaceutical ingredient rather than a marketed presentation of insulin analog which will enable us to bridge two commercial candidates for subsequent clinical development. Patient enrollment in the study has progressed well and we remain on track to report Phase 1 clinical top line data in the first calendar quarter of 2013.
In addition to our ultra rapid acting insulin formulation program, we are developing a liquid glucagon formulation for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia of very low concentrations of blood glucose. Our minimum target product profile for this indication has been a liquid glucagon formulation in an autoinjector presentation with at least 18 months of projected stability under refrigerated conditions.
As we mentioned during our analyst and investors' day meeting in October, we are also working on a room temperature stable presentation that might represent a follow-on product. We previously anticipated submitting an NDA by the end of the second calendar quarter of 2014. In the course of our development efforts, we have continued to deepen our scientific knowledge and understanding of the potential competitive landscape in the liquid glucagon market.
Based on this, we have determined that it is in our best interest to prioritize our efforts on developing room temperature presentations that we believe would penetrate the market to the greatest extent. We have deferred manufacture of the registration lot of a refrigerated liquid glucagon formulation which was a key determinant of the timelines for submission of an NDA.