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I know, too good to be true, right? But if we can figure that out, so can Braeburn...they would be absolutely foolish not to take Titan out quickly. And who wouldn't be thrilled for a purchase this year at $20 to $25 a share?
Everyone compares us to BDSI, who sells BUNAVAIL to a wholesaler for crying out loud, who then sells to "sub-wholesalers." Braeburn is training and certifying 1,500 physicians...not even close in terms of sales strategy.
I mean if those trained and certified physicians prescribe 1 probuphine treatment per week, the results seem too good to be true. Perhaps 1 a week is overly optimistic, but given the opioid crisis I wonder...
For the six months following approval, with 1,500 physicians prescribing 1 probuphine treament ($2,000) each week, there would be 36,000 treatments in 6 months, for total revenues of $72 million and a royalty to Titan of about $12-$14 million.
Second six months, same new sales and same royalty. Plus let's say 80% of patients treated in the prior period "re-up" for a new probuphine 6 month treatment (given 90% of trial participants said they would keep using probuphine)...so total sales are up to around $130 million and a royalty of $20 to $25 million. Plus we cross $100 million in sales which is probably a sales milestone...another $10 million or so.
Third six months following approval, same new sales and same royalty, plus 80 of patients previously treated "re-up" for total sales around $175 million and royalty of $30-$35 million. Plus we cross $250 million in total sales...probably another sales milestone of $10 or $15 million. Plus NDA for chronic pain is submitted...$10 million or so in regulatory milestones.
I would assume someone at Braeburn sees this all too clearly...
I wish I had the answer. I am torn between what logic and the numbers appear to tell me (which is very, very good) and the cautious voice in the back of my head telling me this is too good to be true.
If there is a buyout, Braeburn is the most logical acquirer. Titan fits their "pill-free" nitch, and they already own 10% of Titan. And if Braeburn is the acquirer, waiting only costs them more money. The more probuphine they sell, the more they do to advance chronic pain, etc. only makes Titan more expensive, and the royalty check they have to cut to Titan bigger. If they are going to move, they will move quickly. Here's why:
Logic tells me that, fully diluted, Titan has about 25-26 million shares, with about 20 million outstanding right now. Take out the Braeburn and other big holder shares, and its only 16 million in the public float. That’s not many shares to satisfy what I would expect to be a high demand upon approval.
Demand will come initially from those waiting on the sidelines for approval and remember we have over 1 million shorts who presumeably will have to cover. The publicity brought by approval, the revised DATA 2000 prescription limits and the government’s response to the opioid crisis should bring in quite a few new investors as well.
Longer term, demand for shares will come from institutions, especially after Titan crosses the $5 dollar threshhold. The average Nasdaq biotech has over 50% institutional ownership. Titan has less than 1%. Institutions tend to buy slower and over time, but over the course of the next six months we can expect at least 10 million shares to be purchased by institutions.
I’m not too worried about a secondary offering. For one, despite management’s flaws, they have been careful not to incur debt after their disasterous experience with Deerfield, and so there is no need for cash to pay off borrowed funds. In addition to the $15 million milestone on approval, Titan has around 3 million warrants exercisable for $14 million in cash which I fully expect to be exercised in the months following approval, adding another 14 million to the treasury (and resulting in dilution of course). Even if they did do a secondary, Nasdaq rules limit it to 20% of the outstanding, which would be about 4 or 5 million shares…not a disaster, and if they can get a good price that might be a prudent decision.
What really excites me are the additional price increase catalysts in the horizon. For example, $165 million of sales milestones, and $35 million in regulatory milestones…including milestones upon submission and approval of an NDA for chronic pain….all catalysts. To meet the timeline Braeburn gave in January 2016 for approval of probuphine for chronic pain in 2H 2018, trials will need to begin this year. That will be a catalyst as well.
A lot to look forward to.
Yes, the agency has to draft the regulation, and get approval from all the stakeholders there, and then it goes to the White House for approval as well before its published in draft form...two month comment period, and then final regulations.
The draft regulations are scheduled to be published in April. Nice if probuphine was approved at the time they are published. Nicer still if buprenrophine injections and implants are not subject to the limitation on prescriptions...there is absolutely no reason they should be, because they alleviate all of the abuse concerns the prescription limit is meant to fight against. If they are subject to the limit in the draft regulations, I personally expect some lobbying from Braeburn on that subject...at least a comment letter along with others from nonprofit groups pointing out the probuphine should not be subject to the prescription limitation.
BDSI
BDSI filed its 10-K recently and dedicated a portion to describing probuphine. From the 10-K:
“In terms of additional competition, Phase 3 trials were completed for Probuphine, a subcutaneous depot delivery system containing buprenorphine from Titan Pharmaceuticals (OTCBB:TTNP). Results of clinical studies demonstrated efficacy and safety, and Probuphine was submitted for FDA review in October 2012. Probuphine was anticipated to address the needs of the subset of patients undergoing treatment for opioid dependence who are unable to maintain compliance with alternative formulations or those who may be at high risk for diversion. In December 2012, Titan announced the signing of a license agreement with Braeburn Pharmaceuticals Sprl. The license grants Braeburn exclusive commercialization rights in the United States and Canada. In April 2013, the FDA issued a Complete Response Letter for Probuphine and requested additional data regarding its efficacy. An additional Phase 3 study assessing the efficacy and safety of Probuphine was initiated in April 2014. In June 2015, Titan announced favorable results in their Phase 3 study and subsequently submitted an NDA. In January 2016, an FDA Advisory Panel voted in favor of the approval of Probuphine though several panelists noted that the drug’s label must be clear about patient selection for the medication, since the product is only intended for patients who have been stabilized on 8 mg daily buprenorphine or less. Given the need for surgical implantation and removal as well as dosing limitations. We do not expect Probuphine is not expected to be a significant competitive threat to BUNAVAIL®.”
It is interesting to note that BDSI characterizes probuphine as not being a significant competitive threat, but dedicates more space in their Annual Report to probuphine than any other competitor.
I would also dispute their characterization of the subset of patients for which probuphine is designed: (1) its not patients “unable to maintain compliance,” its patients that, understanding they are addicts, want to assure compliance, and (2) what opioid addict isn’t “at high risk for diversion” (relapse rates are astonishingly high for opioid addicts, even those who have managed to put together substantial periods of sobriety).
Talk about a company not understanding their market. They have a rude awakening awaiting them.
Apparently not quite...looks like the domain name is not registered to Braeburn or Titan. Oh well, it was fun while it lasted...
THIS MADE MY FRIDAY!
http://www.probuphineimplant.com/
I don't know what it means really. But the NIDA initial funding of probuphine occurred back in 2009-10, and this appears new. Sometimes in budgets, if money is appropriated in one year and not spent in the next, the amount remains the same, and so perhaps that is what is going on.
In any event...if $9 million is going to probuphine development, it's a good thing. Perhaps it's going to Braeburn, which is why there has been no PR?
Senate passes opioid abuse bill
http://thehill.com/blogs/floor-action/senate/272531-senate-passes-opioid-abuse-bill
Thanks, very interesting. I remembered that way back when the NIH contributed towards probuphine's development...
http://www.titanpharm.com/press/2009/091001-press-rel-probuphine.htm
However, what you found appears to represent a commitment for new funding up to $9 million...perhaps paying for a Phase IV post-marketing study or --fingers crossed--trials for chronic pain.
Implant might help heroin addicts stay clean
This time with the broadcast...
Yes, pretty much the same old presentation, except they discussed the Advisory Committee meeting. Also clarified that they are still on track to commence the Phase I/II for ropinrole in 4Q 2016.
Nothing new on chronic pain, which is disappointing in light of the projected milestones Braeburn provided (probuphine approval for chronic pain in 2H of 2018) in its presentation at the the JP Morgan Healthcare conference in January.
By the way...why would Braeburn be at the JP Morgan conference anyway? They are a private company after all, so it's not to promote their stock. Maybe to raise funds...for an acquisition possibly? Who would a self-described "pill-free" drug company be interested in?
Pain Medication Implant May Be Solution To Opiate Pill Misusage
http://www.msunites.com/pain-medication-implant-may-be-solution-to-opiate-pill-misusage/
I'd love for that guy to get handed his lunch shorting Titan.
The numbers are from before the extension of the PDUFA date...I don't think it signifies anything other than traders like to trade.
While maybe I'm crazy for being long right now, you really have to be a bit loco to be short...approval could come at anytime and will at least double the price.
Short Interest
40% increase, now over a million shares.
http://www.nasdaq.com/symbol/ttnp/short-interest
In-Depth with the U.S. Secretary of Health and Human Services: Fighting the Opioid Epidemic
https://www.thefix.com/interview-hhs-secretary-sylvia-matthews-burwell?page=all
Yes, I suppose the last thing Titan wants to do is antagonize the FDA with some statement characterizing the nature of the feedback they received. And you raise a good point: if they are going forward with testing, it must have been relatively positive.
Not really sure what this means...Based on the FDA's feedback on the development plan submitted in December 2015, Titan is proceeding with the required non-clinical studies to support the potential submission of an investigational new drug (IND) application in the fourth quarter of 2016, followed by the initial pharmacokinetic and proof-of-concept clinical study.
So, was the feedback good or bad? Are the "required non-clinical studies" something requested by the FDA in the commentary, or were they planned all along. And IND filing in 4Q means Phase I/II pharmacokinetic and proof-of-concept trial beginning when?
Implant might help heroin addicts stay clean
http://local12.com/news/local/implant-might-help-heroin-addicts-stay-clean
I think it will probably be Braeburn making the filing...I'm not sure what the regulatory soup is, but instead of an IND I think the filing will be for an sNDA. I believe the process is for them to meet with the FDA to determine what would be required. They should be able to use probuphine's safety data, and they would be using the 503(b) "short-cut" because buprenorphine has already been approved for chronic pain. That would probably mean 2 or 3 Phase III studies that would be run concurrently.
I think it is positive, as has been 95% of the press on probuphine, abuse deterrent formulations and the FDA's belated recognition of the opioid abuse epidemic. Within the 44 billion dollar pain market, there are a number of patient subpopulations that would benefit from an implant, in particular those that cannot be "trusted" to properly self-administer oral medication. The two that come to mind: those with a pre-existing opioid dependence or a history of addiction that make them susceptible to cross addictions (including recovering alcoholics); and the elderly, who might be at risk for accidentally overdosing because of confusing medications, etc. Probuphine is a logical solution.
Unfortunately, the FDA's history in this area has not been heavy on logic. I do suspect a bias on their part for pill forms that have been engineered at the molecular level to be abuse deterrent. Of course that doesn't assure patient adherence, but in a weird way, the FDA seems to think that's not their problem. Despite the certainty that comes with an implant, they are very wary of anything that can't be orally administered.
I am hopeful that things are about the change for the positive.
Fighting Drug Addiction With Drugs Works, but Only if Doctors Sign On
http://www.nytimes.com/2016/03/03/upshot/fighting-drug-addiction-with-drugs-works-but-only-if-doctors-sign-on.html?_r=0
Almost one million American physicians can write a prescription for an opioid painkiller like Vicodin and OxyContin — one pathway to opioid addiction. But, because of regulatory hurdles and other factors, fewer than 32,000 doctors are permitted to prescribe buprenorphine, a medication to treat such addiction.
That’s a statistic worth thinking about since opioid painkillers and heroin contributed to the deaths of nearly 30,000 Americans in 2014, triple the number in 2000. Perhaps many of these lives could have been saved with buprenorphine. The Obama administration intends to increase access to it — and its proposed budget would commit hundreds of millions of dollars to do so — but it won’t be easy.
Taking buprenorphine or methadone, alongside counseling, is the most effective approach to opioid addiction treatment. Because the drugs relieve patients’ cravings for heroin or narcotic painkillers, patients taking them can focus more on recovery and less on getting high. When taken properly, the drugs can help addicted patients and their families get their lives back to normal while reducing the risk of fatal overdose, crime and their societal costs. But the need for these treatments far outstrips available supply. Less than half of the 2.5 million Americans who could benefit from medication-assisted treatment for opioid addiction receive it.
Expanding the use of methadone will be difficult. Methadone is provided only in dedicated clinics, which patients must visit daily. But many communities resist clinics because they attract patients with addictions, a highly stigmatized population. Work by Christopher Jones, a pharmacist and public health researcher, showed that the number of patients treated at them has barely increased in over a decade. Most methadone clinics operate at or near capacity, and some have waiting lists.
Expanding buprenorphine use could be simpler, but is still fraught with challenges. Though used to treat opioid addiction, buprenorphine, like methadone, is an opioid-based medication, so it too can be abused if improperly used. However, it does have a lower overdose risk than methadone. Since 2000, buprenorphine can be prescribed by qualified doctors to a limited number of patients to take at home. Buprenorphine use has expanded as a result, but availability is limited by regulation. Doctors may prescribe it only after taking an eight-hour course and applying for a special license. No such hurdles are required for prescribing any opioid painkillers.
Buprenorphine use got a boost in 2006 when another change in the law permitted physicians who have held the special license for at least a year to prescribe buprenorphine to as many as 100 patients at a time, up from 30. Because the drug can be misused or diverted for illicit sale, the limit is in place to prevent the emergence of buprenorphine “pill mills” — clinics that make a buck from high rates of prescription and with insufficient patient oversight.
A study led by Dr. Bradley Stein of the RAND Corporation found that this change increased access to treatment. But the regulated supply has not kept pace with the need. Dr. Jones’s study found that even if all doctors who are approved to prescribe buprenorphine did so to the maximum number of patients permitted by law, one million patients who could benefit from it would still be unable to obtain it.
Last fall, Sylvia Burwell, the Health and Human Services Secretary, announced plans to remove regulatory obstacles to buprenorphine. The agency wants to increase the number of doctors who prescribe the drug and will also consider expanding the types of clinicians who are permitted to do so. H.H.S. is also planning to revise the rules governing the number of patients to whom doctors can prescribe the drug, though precisely how has not been announced.
Now, the bad news. Many doctors are reluctant to prescribe buprenorphine; only 2.2 percent have met the regulatory requirements. Most of those limit the number of patients they treat below the maximum allowed by law, so increasing that maximum alone would probably have little to no impact.
Of 78 primary care physicians surveyed for one study published in 2014, 64 percent had obtained approval to prescribe buprenorphine, but only 28 percent did so. And half of those treated only three patients, well below the lawful maximum. Chief barriers to increased prescribing cited by these physicians were lack of confidence in managing addiction and insufficientmental health support in doing so.
“Increasing availability of medication-assisted treatment will require far more than just allowing doctors to prescribe buprenorphine to more patients,” Dr. Stein told me. “Fostering greater ability and willingness among doctors to effectively manage the growing numbers of addicted patients is an uphill battle.”
It is funny how, on other boards, people's valuation of Titan's worth post-approval has been affected by the reverse stock split.
Pre-split, about a year ago, most people were saying Titan should be around 2.50 to 3 a share following approval, which translates to about $13.75 to $16.50 post split or a market cap of $275 to $330 million.
Now, everyone is saying $7 to $10 following approval, which pre-split would be $1.27 to $1.81 per share (market cap of $140 to $200 million).
Strange, given Titan's prospects..with opioid abuse being in the spotlight, chronic pain a near certainty and ropinrole on the way...are a lot brighter than they were a year ago.
I was happy to see Dr. Califf's statement about the focus on abuse deterrent formulations...probuphine cannot be diverted; cannot be stolen, sold or lost; cannot be abruptly stopped by the patient; carries no risk of accidental pediatric exposure; and cannot be accidentally overdosed.
So...we wait.
New FDA Chief Cites Promise of Harder-to-Abuse Pain Drugs
http://abcnews.go.com/Health/wireStory/fda-chief-cites-promise-harder-abuse-pain-drugs-37315202
FDA Science Board Addresses US Opioid Epidemic
"At the outset of the meeting, newly confirmed FDA Commissioner Rober Califf told the panel -- which is advising FDA on the role of pharmaceuticals in pain management, development of alternative medications and postmarketing surveillance activities – that the agency will look to back more opioids that have abuse-deterrent properties."
http://www.raps.org/Regulatory-Focus/News/2016/03/01/24447/FDA-Science-Board-Addresses-US-Opioid-Epidemic/
I have no idea how they get away with it.
Consider the source with that article...it sounds like a private clinic that is making money selling its own implants that haven't been approved by the FDA...probably for an exorbitant price. Now along comes probuphine about to end their gravy train, and the head of the clinic has reservations about probuphine...go figure.
I saw that one too...the Naltrexone implants are not FDA approved. Not sure how they get away with that one!
FDA March 1st Opioid Summit
FYI: The background materials for the March 1st Scientific Advisory Committee meeting have been released.
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm487037.htm
Health Care Provider
Reviewing the REMS documentation included in Braeburn's briefing materials for the Advisory Committee meeting, I was struck by the use of the term "health care provider" throughout the REMS. Why not just say doctor? I looked it up and apparently its a term of art....I believe Braeburn is pushing for nurse practitioners to be able to administer probuphine...which would greatly reduce the cost compared to only allowing MD's to do it. Also, I remember reading in one of the articles Truth posted that there is pressure to expand access to buprenorphine by allowing nurse practitioners to prescribe it.
This is just reading the tea leaves of course, but I noticed that, in Titan's press release regarding the PDUFA extention, the "About Opioid Addiction" section changed. I've always just glazed over it as boilerplate, but the bolded sections were new:
About Opioid Addiction
According to recent estimates, there are 2.5 million people with opioid addiction in the U.S. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Before the year 2000, medication-assisted therapies for opioid dependence had been sanctioned to a limited number of facilities in the U.S. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatments (MAT). In 2015, the U.S. Health and Human Services Department announced it would move to expand access to MAT even further by revising regulations that cap the number of patients who can be treated with buprenorphine products by physicians. The HHS revision to the regulation will be developed to provide a balance between expanding the supply of buprenorphine-based treatment, encouraging use of evidence-based MAT, and minimizing the risk of drug diversion. Sales of buprenorphine drug products for treatment of opioid addiction in 2014 were approximately $1.75 billion in the United States.
I know I sound like a broken record, but the new DATA 2000 regulations could be huge for Titan.
Not so sure. Sunil would have knowledge of an imminent offer (from Braeburn at least) which would prevent him from purchasing under federal securities laws.
I am going to buy more tomorrow. Just a heads-up for the well documented "Dr. Detroit Effect"...10 to 20% decrease in price immediately after I invest!
Titan is up and the market is down...when is the last time that happened?
March 1st will be very interesting indeed.
Believe me, I hear where you are coming from. When I saw the press release, I think they heard me drop the f-bomb in a five mile radius. But now that I've calmed down a little (the dog is still hiding from me), I thinks its important to focus on what the press release did not say:
The FDA did not ask for additional data regarding efficacy or dosage.
If there were an issue on efficacy or dosage, the FDA would have issued a CRL. It might even have been a chance for them to show they were getting tough on approving opioids (buprenorphine is one after all). But they did not. They wanted Braeburn to revise the REMS.
In the briefing materials and at the Ad Comm, the FDA did not identify any new safety concerns related to systemic buprenorphine usage. Safety issues that were discussed revolved around implantation and removal of the Probuphine implant.
After such much needed reflection, I think it's a good sign.
Three Months...
is the mandatory extension for any amendment made within 90 days of the PDUFA date. http://www.eyeonfda.com/eye_on_fda/2010/08/when-does-fda-extend-a-pdufa-date.html
So I guess I can put my conspiracy theory away for the time being.
Okay, thanks for talking me down off the ledge! I see where you're coming from, I just don't put anything past the FDA.
There's nothing preventing them from approving earlier than May 27th. I didn't notice (reading comprehension goes down while enraged) that three months is the standard time delay.
I obviously hope you're right. But think about it...they need three months to review a revised REMS? A month, well okay maybe. Three months says to me there is a lot of heat on opioids since January 1st and we want the conversation to move on to something else.