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Good point...the "partner" will be more of distributor (no R&D spend) so Titan's % should be a lot higher.
The words "rapidly" and "Titan Pharmaceuticals" don't go together, so I'm not sure what they mean.
IMHO, don't hope for too much on a EU deal. They have repeatedly emphasized in conference calls the EU market is 1/10th of the US market.
Well, Tom Price ,who was a big obstacle to evidence based treatment, is gone, so hopefully the new Secretary of HHS will be more empathetic. I would guess the President is waiting for the full report, which won't be issued until November 1st.
Next up before the Commission...insurance companies. Love to see how these worms justify the obstacles they put in the way of treatment.
https://www.federalregister.gov/documents/2017/10/04/2017-21360/notification-of-a-public-meeting-of-the-presidents-commission-on-combating-drug-addiction-and-the
This language from the most recent press release is, IMHO, more exciting than the Opiant deal.
"Additional ProNeura feasibility evaluations are ongoing in the area of chronic pain treatment with a peripherally acting Kappa opioid receptor agonist, and in the treatment of type 2 diabetes with currently approved peptides."
Remember, Titan has said it will not initiate any new product develop programs unless it has a partner/government funding source from Day 1 (apparently they will keep parkinsons and T3 for themselves until a later date).
I'm 99% sure the kapa opioid receptor agonist partner would be Cara Therapeutics, who has the cash to fund development.
The most likely partner for type 2 diabetes with currently approved peptides would be Novo Nordisk, who held the recently expired patent on Victoza and will be anxious to retain market share.
Yep. Agree with Serenity that Alkermes can't afford for another company to come to market with what is essentially a Vivitrol implant.
Also interesting that this happened this Summer...and shortly thereafter Titan announced a feasibility study for a kappa opioid agonist like CR845. Since CR845 has issues with being orally bioavailable, it would make sense for Cara to investigate an implant. They have a lot of money invested in this drug.
https://www.forbes.com/sites/kenkam/2017/07/06/cara-therapeutics-new-pain-drug-still-has-value-after-failed-clinical-trial/#505ff3631272
They sold off a portion of their royalty rights for Narcan to get cash upfront...doesn't really change my opinion that they won't want to provide the cash to develop an implant. But I think Alkermes, Braeburn and Indivior would all be very interested.
If preclinical testing is positive for Opiant, then my guess would be it will be outlicensed as quickly as possible. Neither Opiant or Titan have the money to develop on their own. Maybe to Alkermes as a compliment to Vivitrol.
Yeah, it's starting to get a little confusing with all the different development studies.
Opiant is best known for developing NARCAN. They did it quickly: it was conceived, licensed, developed, approved by the FDA, and commercialized in less than three years.
But they also have a lot of experience with "mu opioid receptor" antagonists, which completely block opioid's effect and are meant for people who are completely clean from opioids. (Vivitrol is another opioid antagonist; Buprenorphine, on the other hand, is an agonist...it allows some opioid effect). Opiant has two proprietary, patented opioid antagonists (OPNT 001 and OPNT 002) that they are currently testing for alcohol abuse, cocaine abuse and binge eating disorder. I would guess they want to test OPNT 001 and OPNT 002 in implant formation for opioid addiction. That's what they bring to the table.
Cara's peripherally acting kappa opioid receptor agonist, called CR845, is not an antagonist...it allows some opioid effect. It hasn't been developed for opioid abuse, but for chronic pain. It looks like initial testing shows it is not addictive, but is best used in IV form (problems with bioavailability). So I'm guessing they are working with Titan to see if they can use it through an implant for pain.
Turks:
To me, "not orally bioavailable" = pills don't work at all or don't work very well. That's why most of their development efforts for this drug have been for intravenous (IV) forms of delivery. And we know Pro Neura is just like having a six month IV.
Current Pipeline=
Approved: Buprenorphine for Opioid Addiction
Phase I/II: Ropinirole for Parkinson’s
Pre-Clinical:
T3 for Hypothyroidism
Mu Receptor Antagonist for Opioid Addiction
Kappa Receptor Agonist for Chronic Pain
Liraglutide (Victoza) for Type 2 Diabetes
Piperaquine for Malaria
I'd put my money on Cara's CR845. Being tested in both IV and oral formulations, but the following caught my eye: "However, CARA indicated in the poster on the preclinical profile of CR845 the compound was not orally bioavailable."
https://juniperpublishers.com/jpcr/pdf/JPCR.MS.ID.555588.pdf
Who knows, but as Sherlock likes to say "Once you eliminate the impossible, whatever remains, no matter how improbable, must be the truth."
It's impossible that Titan is developing its own peripherally acting Kappa opioid receptor agonist...they don't research drugs, just the application of drugs through pro neura.
Cara Therapeutics states: Cara Therapeutics is developing the first peripherally acting kappa opioid receptor agonist (KORA) called CR845.
So if this is really "the first" peripherally acting Kappa opioid receptor agonist, and it's only in preclinical development, is it impossible for Titan to be working with anyone else?
Sherlock Holmes might make something of this...
From today's press release: "Additional ProNeura feasibility evaluations are ongoing in the area of chronic pain treatment with a peripherally acting Kappa opioid receptor agonist, and in the treatment of type 2 diabetes with currently approved peptides. "
From the "Pipeline" section of Cara Therapeutics website:
"Cara Therapeutics is developing the first peripherally acting kappa opioid receptor agonist (KORA) called CR845."
http://www.caratherapeutics.com/pipeline-technology/kappa-opioid-receptor-agonists/
Didn't realize Vivitrol was used for alcoholism as well. An implant for alcoholics could have legs....
I wish we could have seen the look on Derkacz's face when Opiant made that announcement!
Yeah, I know.
Opiant Deal
Described at 1:14.
Nothing will happen too soon IMO...this year, it remains all about probuphine sales (or lack thereof).
There could be some interesting partnerships coming up...
We don't know much, but I would guess they are doing some cooperative research based on a joint development agreement. If the research pans out, they will enter into a license.
This solves the mystery of the feasibility study for a "mu opioid receptor antagonist" listed in TTNP's most recent corporate presentation. Basically, this is a six month (or maybe even one year) implant of naltexetone (e.g. Vivitrol).
Now, as for the kappa opioid receptor agonist for neuropathic pain also mentioned as being in a feasibility study, I bet they are partnering with someone on that as well.
Same with liraglutide (Victoza) for type 2 diabetes,
USA Today
Opiant Pharmaceuticals, the company that created Narcan, the opioid reversal drug that states use regularly to revive overdose victims, is working with Titan Pharmaceuticals on an implant that acts as an opioid antagonist, said chief executive Dr. Roger Crystal.
https://www.usatoday.com/story/news/nation-now/2017/09/27/pharma-execs-urge-quicker-fda-approval-opioid-alternatives/710296001/
....also new code for implant procedure has been approved and will go into place next year. Should price doctors with about twice the cash they currently receive under the old procedure code, which was for contraceptive implants.
Listened to the Cantor Fitzgerald Presentation...
1. Maybe he caught the red-eye or something, but Sunil sounds tired and beaten. Absolutely no energy.
2. Not much news
-so far, 90% of those who have gotten probuphine have elected to get a second implant.
-the maintenance market is about 30% of the buprenorphine market. Titan needs 20% of that 30% to reach $300 million a year in sales...which means 6% of the entire market.
-they will begin ropinrole testing possibly still this month (first cohort appears to have been enrolled). They estimate the phase 3 for ropinirole will require $30 million because they have to provide the FDA with at least 500 patients of safety data.
I do like the fact he isn't on cable news all the time or giving interviews...I like the underpromise and overdeliver approach.
According to linkedin, they got rid of 24% of the sales force over the last three months...underperformers were shown the road.
Also, senior management is leaner and meaner. A lot of missing faces from the past...
https://www.braeburnpharmaceuticals.com/leadership
Wow...they have dropped probuphine for chronic pain, and the risperidone implant for schizophrenia. My guess is Apple Tree wants them at a profit before investing more on R&D...good news because focus will be on bottom line rather than drugs in development.
Marketing efforts increasing in 2nd Quarter...let's hope it translated to third quarter sales.
http://blog.dtwresearch.com/
Question for management would be...if, as claimed, the initial research shows that kappa opioid receptor agonists can treat pain without addictive side effects, why do you need an implant?
Possibly, titration issues make an implant/depot more effective?
More groundless, baseless speculation:
BioCorRX makes an naltrexone implant which is NOT FDA approved,and usage has been limited to a few clinics. However, they've recently announced an R&D program to seek FDA approval of the implant. http://www.biocorrx.com/news-media/press-releases/detail/57/biocorrx-launches-rd-initiative-to-pursue-fda-approval-for
Possibly, Alkermes sees this as a threat and may want to partner with Titan to get their own implant?
I don't see Titan funding this on their own...
WAG #2 Can't find any currently marketed Kappa opioid receptor agonist "peripheral neuropathic pain," but one is being developed. Could TTNP be working with these guys...
https://www.practicalpainmanagement.com/resources/news-and-research/new-kappa-opioid-receptor-agonist-curbs-pain-avoids-side-effects
Complete WAG: Treatment of opioid addiction with a mu opioid receptor antagonist is one of TTNP's current "feasability evaluations."
Approved mu opioid receptor antagonists are commonly known as naltexetone.
Vivitrol is a month long depot injection of naltexetone.
Could it be that Alkermes (Vivitrol) is trying to play in the 6 month implant market given Braeburn's going to be competing with them for the monthly injectable market?
It would be awesome to have the Pro Neura delivery systems providing both drugs...the more the merrier after all, its all royalties to Titan.
New corporate presentation out....
Pretty much everything we knew already, but, under "OTHER PRONEURA OPPORTUNITIES Feasibility Evaluations" we find:
• Treatment of Type 2 diabetes with currently approved peptides
---(We knew this already...liraglutide (Victoza), which is off patent so TTNP can pursue the 505(b)(2) pathway)
• Treatment of peripheral neuropathic pain with a Kappa opioid receptor agonist
• Treatment of opioid addiction with a Mu opioid receptor antagonist
---(These two are new! Given management's statement that it will only pursue opportunities with immediate funding available, they likely represent potential partnerships).
Yeah, notice they just say "buprenorphine implant" and never mention the word probuphine or Braeburn. So it was done without them.
I haven't been posting this little stories I find from time to time, but I thought this one was significant...not for the content, but because its sponsored by Blue Cross Blue Shield. Maybe they are finally making some headway with insurers...
Yes, it's doubtful. But I found some significance in the statements in the last conference call that they are only investigating new drug candidates where early financial partnerships would be available and them singling out liraglutide, a $3 billion drug. Maybe something there. But probably not.
If Trump wanted to do so, he could pass it. Senate Dems would vote yes along with Portman, Collins, Capito and other Republican senators from states severely affected by the opioid crisis. Same with the House of Representatives. He may just do so to spite McConnell and Ryan. We will see.
Yeah, I'm puzzled why there isn't any inside buying unless the existence of some confidential material information is preventing it. They also haven't updated their corporate presentation since May despite a lot happening since then...Malaria, Parkinsons, etc.
The overdose totals are horrible...but keep in mind they do not count suicides by addicts in those totals.
And still nothing...
A Month Has Passed Since Trump Declared an Opioid Emergency. What Next?
https://www.nytimes.com/2017/09/10/us/politics/trump-opioid-emergency.html?mcubz=1
No news, no expectations, no excitement.
Just the way Titan likes it.
I think its unlikely to happen.