Replies to post #766 on Halozyme Therapeutics Inc (HALO)

[fgnoms]

Fred - all I said was the Biodel Phase 3 trials ended in failure. What's fuzzy about that? I'm not trying to spread any fear - just pointing out the facts! They tried to cut costs by trialling in India and screwed up.
On the other matter someone said that Halo would be making a 505(b)(2) approval application. That is usually for ANDA's. If Halo is not selling a generic but a new patented Insulin compound, can they do that with a 505(b)(2) approval application. I'm also unclear as to how they could get access to say HumalinR as Eli Lilly are the only firm allowed to sell it in the US even though it is off-patent. Its rather confusing.

[rod5247]

Fred,

Regular insulin patents expired. Read the following from Biodel.

"-- Biodel entered into a supply agreement with Organon on July 7, 2008 to purchase specified quantities of recombinant human insulin for use in the company's VIAdel(TM) insulin formulations. The company believes that its current supplies of insulin, together with the quantities of insulin that Organon has agreed to supply, will be sufficient to complete the company's current and anticipated clinical trials of VIAject(TM) and support the company's needs for approximately three years following the commercial launch of VIAject(TM)."

Humulin R and Novolin R are trademarks for Regular Insulin.
Dr. Lim stated the 505 b 2 pathway and if a partner was not found, they would develope co-formulation for Regular Insulin inhouse. Anyone with serious questions such as how they can get Regular Insulin should contact company since that has not been made public and does not seem to be a legitimate point of concern but a good way to spread FUD.