Biotech Values

[turtlepower]

potentially improved insulin analogs

What is the basis to assume that Biodel has the ability to produce an improved insulin analog? Their website has very little information about their technology. Do they have expertise in a specific technology that other companies do not? Their technology page is severely lacking.

http://www.biodel.com/content/technology/overview.htm

The 10K has the following on the tech used for linjeta

Linjeta tm is our proprietary formulation of injectable human insulin to be taken at mealtime. Linjeta tm is designed to be absorbed into the blood faster than the currently marketed rapid-acting insulin analogs. One of the key features of our formulation of insulin is that it allows the insulin to disassociate, or separate, from the six molecule, or hexameric, form to the single molecule, or monomeric, form and inhibits re-association to the hexameric form. We believe that by favoring the monomeric form, Linjeta tm allows for more rapid delivery of insulin into the blood as the human body requires insulin to be in the form of a single molecule before it can be absorbed into the body to produce its desired biological effects. Based upon our preclinical and clinical data, we believe Linjeta tm may produce a profile of insulin levels in the blood that approximates the natural first-phase insulin release following a meal that is normally seen in persons without diabetes.

However the 10K also goes on to say the following

Development status. In light of the extensive nature of the FDA’s comments regarding our NDA, we do not anticipate commencing new pivotal Phase 3 clinical trials with our current formulation of Linjeta tm prior to meeting with the FDA and, separately, determining whether one of our other proprietary rapid-acting insulin or insulin analog formulations should be advanced in its place. These alternate formulations generally use the same or similar excipients as Linjeta tm , but may present improvements with regard to injection site discomfort. In fiscal year 2011, we intend to conduct preclinical studies and Phase 1 clinical trials to determine whether one or more of our newer insulin formulations is likely to offer a combination of pharmacokinetic, stability and tolerability characteristics that is preferable to Linjeta tm . Following our meeting with the FDA regarding Linjeta tm and based on our analysis of the preclinical and Phase 1 clinical data for our alternate formulations, we will determine the number, type and duration of additional trials we intend to conduct prior to initiating Phase 3 clinical trials with a proprietary rapid-acting insulin.

Given that the only improvement that Biodel is advertising is injection comfort why would the alternate formulations be more efficacious than Linjeta?