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Yes, impossible to predict. When I saw the CRL this weekend I checked Linked In to see if there was anything there about the CRL, and Braeburn's employee headcount was 105. It's now 94, but a number of Braeburn employees in sales positions state "Looking of New Opportunities"...so I am starting to believe the layoffs really did occur, in which case rights should be returning to Titan but not without some negotiations.
It's not as simple as terminating the license agreeement. Braeburn has to transfer the entire NDA back to Titan. Braeburn owns all the marketing/promotional materials (and the tools for inserting/removing implants...remember that Titan had to come up with their own for the Parkinsons Implant trials). And Braeburn licensed rights to Knight in Canada, so there is the question of what happens to that.
Hey Turks, the Pro-Neura probuphine patent actually expires in April 2024.
In terms of competition for probuphine, I think it will all depend on how successful it eventually becomes. Anything less than $50 million in sales per year, and I doubt anyone will enter the market. If it is successful, then anyone filing an ANDA for a generic will not be allowed to use the 505(b)(2) pathway...requiring full Phase 3 trials.
Plus, Titan has another patent application pending on improvements to the entire ProNeura system (for use with any drug) that would not expire until 2031 if granted.
Also, Titan has a ProNeura-Parkinson's patent, which may turn out to be a whole lot more lucrative than opioid abuse given the challenging reimbursement environment, that doesn't expire until 2032.
Yes, it would be ironic if Braeburn's flop actually ended up great for us long-term stockholders who have been complaining about them for years. With 100% of the rights again for an approved drug, Titan could negotiate a much better license deal. My instinct is that if they were to get probuphine back, along with 100% of Parkinsons and T3, they would test the market for a sale transaction before outlicensing it again.
Well, if the report about firing the sales force is true then I believe Braeburn had made the decision ahead of time to divest itself of probuphine if they got a CRL on the injectables. They may have communicated that to TTNP, which could explain why we saw the press release yesterday.
You can't satisfy this requirement of the license agreement with no sales force:
1.17 “Commercially Reasonable Efforts” means, with respect to (a) Braeburn, that degree of skill, effort, expertise, and resources normally used (including the promptness in which such efforts and resources would be applied) consistent with standards generally accepted in the pharmaceutical industry, including with respect to the diligent development, manufacture and commercialization of pharmaceutical products of similar market and profit potential at a similar stage in development or product life as the Product; provided, however, that in determining the level of efforts and resources to be employed, Braeburn shall not be permitted to take into account any Second Product being developed or commercialized by Braeburn or any of its Affiliates
Great minds think alike...I checked that this morning. They can only transfer in connection with a sale of Braeburn as a whole...cannot just transfer the probuphine rights without Titan's consent.
If true, Braeburn has no bargaining position on the return of probuphine. They have to give the drug back with no strings attached.
Braeburn Fires All Sales Reps?
Not sure if this is true, but if so TTNP is getting probuphine back in a hurry.
http://www.cafepharma.com/boards/threads/all-braeburn-sales-reps-fired-on-1-22-18.617666/
I would hope something happens soon. There was $45 billion over ten years proposed by the Republicans in the attempt to reform the ACA, but that didn't pass. More recently, $25 billion over two years has been proposed by the Senate Democrats in the budget negotiations, but the Republicans wil likely want to come up with their own plan.
A whole lot of politics, but absolutely no leadership (or money).
https://www.cnn.com/2018/01/23/health/patrick-kennedy-opioid-commission-sham/index.htm
https://www.vox.com/policy-and-politics/2018/1/23/16909984/trump-opioid-epidemic-2017
Anybody notice in the press release:
"Titan has retained Canaccord Genuity to assist in this effort as part of an evaluation of strategic and financial alternatives."
In other words, this is just part of what CG is working on for Titan, including "strategic" alternatives. They make their money in advising in buying and selling companies (i.e., as a broker). They are the real deal.
https://en.wikipedia.org/wiki/Canaccord_Genuity
Starts next month on Showtime
http://www.sho.com/documentaries
In other news, this got very little press...
https://www.politico.com/magazine/story/2018/01/20/opioid-crisis-tom-petty-prince-america-216490
You may be right. Endo returned Belbucca (buprenorphine film) to BDSI for free. (https://seekingalpha.com/article/4070312-biodelivery-sciences-belbuca-transition-appears-worked).
They don't deserve anything, but it's how the game is played...if it goes to a lawsuit, this will be tied up for years.
If TTNP were to get probuphine back, and had ropinirole and T3 in development, then....buyout this year in my opinion.
Wow.
Let me state that again, wow.
Kinda suspected a CRL after the REMS commentary in Braeburn's Ad Comm, but never in a million years expected Titan to drop a pair and get in Braeburn's face. Well done Titan.
Now Braeburn not mentioning probuphine at the Presidential Opioid Commission or press releases makes a whole lot more sense.
As has been posted on this board before, Braeburn is in flat out breach of the license agreement. They have failed to use commercially reasonably efforts to launch probuphine in a number of ways...particularly laying off half their sales force in July.
My guess is the fight is about money now. I speculate that Braeburn wants some royalty percentage back for turning over probuphine rights.
Braeburn is private so they don't have to announce anything. Nothing from FDA (they issue press releases for approvals, but nothing for CRL's).
Agreed that it would be a positive, I just don't think people will connect the dots to the extent it would affect TTNP's stock price. It's gone down in price since Braeburn raised $110 million this month, which makes absolutely no sense.
If approved, I would guess a non-event. If not approved, we could see some short activity.
I've only seen positive reviews of the product, but sales haven't been there to date. Addiction is a really tough market. Insurance coverage is a big factor (including prior authorization requirements). Also, many addicts are on medicare/medicaid which, in most states, doesn't cover the implant.
I have been so wrong on stock price I wouldn't want to guess about a bottom.
I think it would have been in 2008 or earlier.
Titan's most recent pre-IND was for its ropinirole implant.
Sorry about that...Scott Smith, a Titan Director, is an officer of Celgene.
https://www.titanpharm.com/about/board-of-directors
Haven't heard anything about Braeburn's NDA.
Long shot, but if they are looking for acquisition candidates, their President and COO is on Titan's board.
https://finance.yahoo.com/news/celgene-celg-looking-over-juno-140002594.html
Medicaid's Role In Addressing Opioid Epidemic
The chart shows part of the problem as well.
Of adults with opioid addiction, 17% are uninsured. They aren't going to be probuphine users.
38% have insurance...so they are potential probuphine users.
37% are on medi-caid...this is where federal dollars could help open things up.
https://www.kff.org/infographic/medicaids-role-in-addressing-opioid-epidemic/
I’ve thought about it a bunch, and I don’t think it’s a question of sales and marketing investments or strategies or even patient acceptance; in my opinion it’s all about money and risk of loss between the insurance company, manufacturer, doctor and patient.
For both the implant and the injectable formulations, this situation involves expensive drugs with REMS that require use of a specialty pharmacy. In nearly all cases, prior authorization is required by insurance companies. Even if authorization is obtained, payment can be delayed for months (for Medicare and Medicaid, the situation is much worse, with payment being delayed over a year in many cases).
So hurdle #1 is that, even if a patient meets all the requirements for probuphine, a doctor has to obtain prior approval which can take months. During that period, some patients lose interest, some get frustrated and cancel and some relapse. Hopefully, the entry of Indivior into the market, additional pressure from Congress and the threat of lawsuits over violations of mental health parity laws will pressure insurance companies into dropping the prior approval requirements (Cigna and others already have).
But hurdle #2 is the buy and bill system. The doctor is required to buy the implants, and then bill insurance for reimbursement. So, even if prior approval is not required, there is a risk of denial of coverage and, even if coverage is granted, the risk of delayed payment. A doctor forced to purchase a $6,000 probuphine kit essentially has to carry that cost until payment is received from the insurance company. Doctors are not running charities, and many of them are just not going to be interested in floating that level of risk unless they work for larger healthcare systems that can afford to float the cost.
It seems to me the most logical solution would be for Braeburn or Indivior to assume the risk of nonpayment. They cannot bill the insurance company directly, but they could change the terms of payment so that doctors are not required to pay until they are paid by the insurance company. There would be a risk that in some cases, no payment would be received, but even so that is better than the current stalemate.
You're right, it's tomorrow.
Braeburn PDUFA date is today...wonder if price this morning is somehow related. FDA announces approvals, but not CRLs.
Funny to see analysts make the same mistake with sublocade that they did with probuphine...a detailed forecast predicting sales of $1.4 billion by 2023 but absolutely no discussion of insurance coverage, prior authorization, etc.
https://clarivate.com/blog/life-sciences-connect/sublocade-approval-likely-game-changer-u-s-fight-opioid-addiction/
Turks,
I really don't believe its a matter of catching on with patients. It's insurance coverage, prior authorization requirements etc. and price.
Alkermes didn't have to fight the insurance battle with Vivitrol: they were successful with Vivitrol in prisons and other government institutions by shady lobbying efforts and donations, and by selling the line that buprenorphine could be abused and was just "fighting a drug with a drug."
Braeburn came along and expected the market to imbrace them...but they were looking at the wrong market: patients and prescribers. The real market is the people paying for it: insurance companies.
In my opinion, the outcome will be determined by the fate of injectables. If Indivior (and Braeburn) can get injectables to have more favorable insurance coverage, then the same insurance coverage will apply to implants.
If not, then all of this was for nothing when it comes to opioid addiction in the US, although there still may be a small market in the EU and Canada where prices are subject to negotation with the government.
The Molteni deal for Europe will probably be next, but I don't know if by month end.
We'll see. A bunch of Indivior sales reps. are jumping ship to Braeburn, but it could be Braeburn is just getting the bottom of the barrel.
Indivior has a huge advantage, but I still think the refrigeration requirement could be an issue for Sublocade. If anywhere in the chain of custody the injection is not properly refrigerated, I assume it could lose its effect. That equals liability...and the doctor injecting it would be first to get sued. If I'm a doctor, I would take the safer alternative.
Well, probuphine got its nice press as well. But it didn't impress insurance companies.
I welcome Indivior. The more press the better. They can perhaps open doors that Braeburn could not in terms of reimbursement. And once insurance companies accept the idea of paying for implant/injectables, I would think implants would become the preferred treatment methodology because they are cheaper, and require fewer visits to the doctor.
Wash Post reports sublocade expected to have $767 million in sales by 2022.
https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2018/01/09/the-health-202-this-year-s-top-10-new-drugs/5a53bdb430fb0469e883ff8e/?utm_term=.b9d81906d353
Still have some hope that we see an outlicense to Asia/Australia also this year.
https://www.finder.com.au/opioid-band-aid
Personally, I think Derkacz sees that Sheldon went down in flames based on probuphine because the issues with selling probuphine (insurance prior authorizations or non-coverage, buy and bill limitations, and the REMS limitations) and he doesn't want any accountability for it. He's just kicking the can down the road, because injectables will have the same issues. Typical CEO behavior.
I don't think Behshad Sheldon intended to shelve it; although she made some mistakes, she did actively promote probuphine. The new CEO at Braeburn, Derkacz, doesn't appear to want to have anything to do with it.
Yes, I wasn't aware of the whole refrigeration requirement, which adds another level of risk...what happens if the power goes out, etc. Funny, I saw sublocade is being sold through Avella Specialty Pharmacy, just like probuphine. Indivior will have to get use to the "buy and bill" model as well.
Agreed probuphine has more potential, but results stink so far. I don't understand Braeburn's logic...they only pay $600 per 4 implants, so why $5,000 per treatment? Reduce the price to $2,500 and try to make some of your investment back with volume. Seems like common sense. But, maybe they are just in a waiting game, betting that the insurance companies/Congress will eventually fold any pay for it.
Well, in order to get the investors to pony up the cash they had to sell the dream rather than the reality. Noticed that Apple Tree is apparently trying to get others in to share the risk.
The $110 million will be used for general corporate purposes, which will include probuphine. But honestly, I cannot see what will change with injectables vis-a-vis probuphine. Still a huge gap between price and what insurance companies will cover, still need to use the buy and bill model.
I do believe as people taper down from the high levels of bupe in injectables there will be more of a natural migration toward probuphine.
Braeburn Announces Completion of $110 Million Financing
https://www.prnewswire.com/news-releases/braeburn-announces-completion-of-110-million-financing-300581077.html
Trump has to "renew" his emergency declaration this month. Maybe that will push them towards actually doing something.
Currently, the Fed. Gov't is spending $500 million a year on the opioid crisis which takes 50,000 lives and costs the economy $500 billion. In terms of action, it's all talk so far, but the talk is going in the right direction. In the Fall, Rob Portman of Ohio proposed $45 billion over ten years for the opioid crisis. This week, the two NH senators proposed $25 billion over two years, with a lot of it going to medicare and medicaid for actual treatment.
https://www.politico.com/story/2018/01/11/opioids-epidemic-trump-addiction-emergency-order-335848