Thanks again for your article. I appreciate the shout-out at the beginning.
I do not believe we have any competition for sparsentan. We're the only drug company developing an ERA for FSGS and other severe proteinuric conditions. We also do not fear competition, and believe (as in the case of ACTH), competition is often a very good thing in pharmaceuticals.
There are no approved drugs for FSGS, so this is a wide open space that could and should attract many players. The only other drug being develop for FSGS is fresolimumab, a TGF-beta antibody. Interest for this agent has been low and rumors are it is being terminated. I wish our competitor luck with the product, as it seems to have some promise. We hope another FSGS drug is approved, first for the patients who suffer from this vicious disease, as well as because several entrants often grow a drug market. For years people fear competition only to find it to be helpful! (see TNF-alpha, SSRIs, etc).
We've discussed, at great length, our strategy for Syntocinon IP and believe that it will be a long-lasting product. I think you might be mistaking how hard it is to genericize an intranasal product. Also consider that no generic could be approved to Syntocinon because a putative generic company would actually have to source generic supply to do a BE study. There are about a dozen considerations here and it doesn't make sense to sweep it under the 'that will go generic' bucket.
I believe the Syntocinon data in autism and schizophrenia are riveting, especially in the context of the $5m upfront we paid to acquire it. These are two awful illnesses and any positive impact will be embraced. I'm not sure the preclinical data cited are relevant.
We've been working on and studying ACTH for years. Sometimes you buy it, sometimes you build it (you might accelerate said building when you fail to buy it). All of our disclosed information is accurate. We started work on ACTH when we said we started work on ACTH. I could go into great depth, but if you've ever been in litigation, it makes sense for me to leave that to the courtroom. However, you seem to find it curious that we would be developing our own ACTH while pursuing the acquisition. This is perfectly logically consistent as we actually would have had to source our own materials regardless of whether we succeeded or failed in the acquisition. Sometimes talking about buying something piques your interest so high that you want to get started on development ASAP. We spent a lot of money surveying the ACTH landscape, interviewing physicians, thinking about lifecycle plans, etc. None of that is unusual.
We're on schedule to begin trials for RE-034 as indicated. I feel very comfortable. We've met with FDA and know what we need to do. We have an extremely detailed plan and are ahead of schedule.
Our development of ACTH is not a "stunt to gain publicity". We are a kidney focused company seeking to develop great drugs in this area. Trying to date Katy Perry is as far I'll go to try and gain publicity. In all seriousness, this statement is a significant insult to the 50+ people at Retrophin who work very hard to develop drugs to save peoples lives. Behind all the Wall Street bullshit, this is a company of brilliant people trying to bring an important therapy, ACTH and its derivatives, to a group of patients who need it. The data for ACTH are not as clear as they could be for NS and we will change that.
-001 and -003
We're still developing RE-001 and RE-003, recombinant proteins for DMD and SMA. They're lower priority given the technical and manufacturing risk. As I've said to all of our shareholders, these are the highest-risk and highest-reward programs at Retrophin. All proteins are very hard to make, and these two have particularly brutal challenges to overcome.
We did do a small buyback as noted. The buyback rules are designed to prohibit "gaming" the stock. The immaterial amount of our buyback relative to value-traded of the stock should be telling.
We did not exercise any greenshoe option even though we had a large amount of demand for our deal. This indicates our discipline to not dilute shareholders unnecessarily. We raised the absolute minimum required to list on NASDAQ.
Once again, I thank you for sticking to the facts and engaging in a good discussion. We did not respond to you promptly as you appeared to be an angry internet gnome. Never feed the gnomes.