Cytodyn Inc (CYDY)

[fred198484]

The name of their drug is Ibalizumab and it is targeting patients that are resistant to three classes of HAART (multidrug resistant or MDR). It is similar but it works on all tropisms of HIV whereas PRO 140 works only with the one which accounts for only a small piece of the MDR market. The FDA granted Ibalizumab Breakthrough Therapy and Orphan Drug status and recently accepted Ibailzumab's BLA, giving it Priority Review status and a 1/3/18 PDUFA date (although most expect it to be approved much earlier than that). PRO 140's combo test looks a lot like Ibalizumabs, but the FDA refused to give PRO 140 Orphan Drug status (apparently because it sees PRO 140 serving a market larger than the MDR market) and has yet to finally rule on BTD for PRo 140. Both drugs work well and have no side effects. Ibalizumab will initially be administered by IV once every two weeks but should be available in an intramuscular injection form about 12-15 months from approval. Pro 140 is a weekly subcutaneous injection.

Both drugs should eventually play a role in treating HIV patients (assuming the phase III data for PRO 140 looks good) but Ibalizumab will be doing so shortly and will likely be relegated to the small MDR market for quite some time, if not forever. PRO 140 should have a much broader market available to it and this seems to be where the FDA is pushing the drug. So, perhaps PRO 140 could be used in patients with just one or two resistances in combo therapy - this is a much larger market than the MDR market. If that is where PRO 140 ends up, it will be very lucrative for the bulls here. If they also get approved for monotherapy (much harder to accomplish, but the data so far seem to indicate that might be doable) then CYDY is a huge, huge winner.

Also, there is a small possibility Thera and CYDY team up. Thera has the sales force CYDY needs and CYDY would be able to keep much more of the sales from PRO 140 if they did a deal with Thera to market it, just like TaiMed (Ibalizumab's developer) did. If they partner with a big pharma company, they will get far less in royalties, but they would still do very well.

But, we need to see the phase III combo data looking good as this trial seems more challenging than past PRO 140 trials and CYDY needs to get its finances in order. My guess is the data will look good but the financing issue should keep everyone here very nervous.