Pain at injection site - solved. That is good news.
BIOD-105 and BIOD-107 show faster absorption and comparable tolerability vs. Humalog
BIOD-105 and BIOD-107 show slower declines fro peak effect than Humalog, which may limit target profile.
To understand this go to slide 25 of the JMP securities presentation. The issue with the data is that both 107 and 107 have longer washout periods (relative to Humalog), which is the backside or descending part of the pharmacokinetic curve. However, in terms of subcutaneous injection, clearly the formulations had quicker onset than Humalog.
Now go to the following link:
paste that into your browser and you should come up with a package insert for Humalog.
Under section 12.3 notice that there is a comparison between the pharmacokinetics of insulin versus Humalog. Also notice that the insulin has a longer washout period than the Humalog, similar to the curves in slide 25 from the presentation above.
Formulations affect the absorption of drugs. That is the first part of the pharmacokinetic curve as it rises from zero after injection. Once the drug is absorbed, then the distribution and elimination (back side or descending part of the curve) is a function primarily of the drug. NOT THE FORMULATION. Slide 25 in the JMP presentation shows a longer washout because when you compare the distribution and elimination of Humalog with insulin (see package insert) you will see that insulin has a longer washout phase. There is nothing that a formulation can do for this, it is a function of insulin vs. Humalog.
The mistake that many people are making when looking at this data is that they think the formulation did not work and that BIOD has had to abandon the approach. This is not the case. In order to compete with Humalog in a phase I trial you have to use another analog because Humalog has a shorter duration - faster washout - then insulin.
Simple as that...the formulation worked but you can't compete head to head with Humalog unless you are using insulin. So BIOD has to switch to an analog.
The formulations work, and the injection site pain has been solved. We were stuck using insulin for this last trial because that is how this whole mess started; that is all the material they had on hand and originally it was insulin vs. insulin. Because of recruitment issues they had to switch to Humalog as a comparator. But now they are going to use an analog and are finally on the right track, IMO.
Investors will have to wait and be patient but I suspect that a small trial with an analog will finally yield the results we have all been waiting for.
Last I checked Humalog goes off patent May 2013, and it brings in just over 1 billion in sales. If Lilly can extent their patent with a new formulation then they would be crazy not to use BIOD technology. However, they may have a formulation of their own. Whatever happens Lilly has to do something in the next year.
I thought my eyes were deceiving me when I first saw your post. It was intelligent and insightful. A very rare thing for the Yahoo message boards. I agree fully. Those looking to make a killing on a medium risk, high reward stock should look no further.
nice post! All I'm waiting for is MTA with provider and bringing analogs into a small phase 1.
This whole process since the India data has been a mess, but I think if they can execute a MTA things will start to look up.
Agree 100%, it's not the formulations that are at fault they did what they were suppose to do. The only problem is that management made it look like they were at fault to investors at the last webcast? Why would they possibly do that? The old adage of cutting your nose off despite your face comes to mind. I hope they have a big ace up their sleeves or things will not look good for a long time. We shall find out very soon if they do or not...
Sorry I have had no time to post since the results came out. I had to do this post in a hurry. When I said:
"head to head with Humalog unless you are using insulin", I meant, "unless you are using an insulin analog".
I totally agree with what you wrote. You clearly understand the washout issue. There is a lot of misperception out their because of the 105 and 107 issues. Getting a nice analog sourcing agreement will help move this along and I think Biodel shareholders will eventually be rewarded. I'd love to see a nice PR from the company in the next few weeks on the analog source. Hopefully from Lilly.