Crazy Week for Suboxone

Originally Posted 3/3/2013
What a crazy week for buprenorphine.  I’ve written about the FDA slapping the face of Reckitt Benckiser by denying their Citizens’ Petition.  Adding insult to injury, the FDA then approved two generic formulations of Suboxone tabs (actually, the correct name is buprenorphine/naloxone combination tabs).  Stock in RB dropped about 5%, but shares regained most of their price within a couple days, reflecting the balance of pessimism vs. optimism in the company’s ability to maintain stellar profit growth going forward.
In case anyone is wondering, I do not own shares in Reckitt Benckiser, and I have never owned shares in Reckitt Benckiser.  One nice thing about NOT having significant savings, I supposed, is that I can report my holdings (or lack of holdings) without too much effort!
If I WAS an investor, though, I’d wonder about the future of Reckitt Benckiser’s Suboxone, now that two generic competitors are hitting the market.  Some patients clearly prefer the tablet over the film;  will state medicaid agencies go back to covering the tablet, which will likely be cheaper than the film?  Will insurers cover the tabs?  Or will both groups continue to buy into the marketing scheme of Reckitt-Benckiser, and the company’s claim that only the film is ‘safe’?
Many patients strongly favor the tablet over the film, and if given the opportunity to choose would definitely choose generic tablets over film.  So here is where things get interesting…..   if the generic tablets become popular, will RB go back to making tabs?  After their RADARS-assisted claim about the danger of tabs, such a move would be a clear indicator of the company’s truthfulness on the issue.

Reckitt Benckiser Citizen Petition for Suboxone: DENIED

Posted 2/23/2013
For those who missed my explanation, I’m adding these old posts to reconstruct the archive.  The site’s database was damaged by something, somehow… New posts coming soon.
Find a copy of the response here, or at this url:www.suboxonetalkzone.com/cpresponse.pdf

Suboxone Maker's Petition Denied by FDA

Originally Posted 2/23/2013
I’ve written in detail about the bold move by Reckitt-Benckiser, maker of Suboxone, that few people outside the company saw coming.  In brief, the company has been cruising across the Atlantic for the past ten years, fueled by stellar growth of its flagship medication, even as the expiration of the patent on Suboxone loomed ahead (y’know– like an iceberg).
But unlike the Titanic, RB had a secret plan to deal with icebergs.  A couple months ago, the company hired a company that investigates bad drugs to look into its OWN product, Suboxone tabs, and used those findings to tell the FDA that the source of their profits for the past ten years is a BAD DRUG.  In fact, it is SO bad that they insisted on doing the right thing—file a Citizens Petition with the FDA to make sure that NOBODY ever makes that bad drug again.
By coincidence, RB happened to have a DIFFERENT drug with a fresh, new patent expiration date that they promised was much safer than the drug they used to make.  And by coincidence (insert more sarcasm), this all happened a year or so after the patent on the bad drug ran out, so RB was willing to just get rid of the bad drug completely.    Never mind that a bunch of other companies were about to make less-expensive generic forms of Suboxone; RB asked the FDA to protect the American people by banning those awful Suboxone tabs that used to make them so much money.
But on Friday, the FDA essentially told RB ‘thanks for the warning… but we’re cool.’  They denied RB’s request to block the tablets, opening the door to generic manufacturers to consider making less-expensive forms of buprenorphine/naloxone, what RB calls ‘Suboxone.’
RB (stock symbol RBGPF) has been dodging icebergs for ten years.  I’ve wondered over the years how they would navigate through some very treacherous passages.  How did they get everyone to buy into the idea that Suboxone is significantly different than plain, cheap buprenorphine?  How did they get state Medicaid agencies to cover ONLY the branded product, when the generic buprenorphine is clinically identical to Suboxone?  A glance at the price of shares in RB shows that they have been doing it well—at least up to now.

Reckitt-Benckiser Stock Price
Reckitt-Benckiser Stock Price

But the seas are getting choppy.  There are two lawsuits directed at the company, accusing RB of running a grand scheme to block generic manufacturers from entering the buprenorphine market.  And in denying of the Citizens Petition the FDA adds credence to the lawsuits, even writing that they will refer concerns over anti-competitive business practices to the FTC.  Amazing how quickly things can change; one minute you’re sitting in a deck chair, whistling a happy tune with the wind in your hair… the next, everyone is looking for a lifeboat.
I’ve been writing for years that the company that wants to be viewed as a shiny rescue vessel has been acting more like a pirate ship.  Hopefully last week’s collision will give them pause, and help then realize that it’s not about being the first ship to get to those in need;  it’s more about making sure, once there, that other ships are on the way—and that everybody gets a seat in a lifeboat.

Reckitt Benckiser is Smarter than I Thought

Originally published 10/14/2012
Regarding a prior post, I carefully read through the entire Citizens Petition’ filed with the FDA by Reckitt-Benckiser.  I have a better understanding of what, exactly, was accomplished by that action by the manufacturer of Suboxone.
The document explains that the company hired an independent group, RADARS (Researched Abuse, Diversion, and Addiction-Related Surveillance), to investigate the exposure of small children to Suboxone tabs and Suboxone Film.  The results are spelled out in detail in the Citizens Petition.
They show an increase in exposure to Suboxone Tabs over the past ten years.  They also show an increased rate of exposure, i.e. number of exposures, divided by the number of tabs prescribed.  Reckitt-Benckiser wrote that they instituted REMS over the past few years to counter that increase. What are REMS, you ask?
From the FDA site:  ‘The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.’
To meet that requirement, RB claims that they instructed their sales force to be double, extra-especially careful to tell doctors to remind patients to avoid giving Suboxone tablets to their children.  No, I’m not making this stuff up… although the ‘double, extra-especially’ part is my own hyperbole.  I don’t remember exactly how it was worded in the petition.
RB wrote that the warning is actually part of their mitigation strategy—that they expect an impact on pediatric exposure, if their salespeople tell doctors to tell patients to keep the pills out of the hands of children.  Gosh—good thing they did that!  I’m picturing all those people who having their 2-year-old kids managing their Suboxone!
But telling doctors to tell patients this ridiculous bit of information did not solve the problem, so RB claims they needed to do more.  They decided that every dose of Suboxone must be individually packaged.  But they had problems with the stability of naloxone while producing individually-packaged Suboxone Tabs, leading them to make the Film form of the drug.
To read the petition, the expiration of their patent on the tabs had nothing to do with anything.  And the long, new patent on the Film has nothing to do with anything.
I have a couple questions at this point.  First, the obvious one—did RB REALLY have a discussion about having their salespeople remind doctors to remind patients to protect their children?  Do they really think that patients and doctors are that stupid—that their salespeople can make a difference in that regard?
Second, do they really find it necessary to individually wrap each dose of Suboxone, a combination of an opioid partial agonist plus an opioid antagonist, when oxycodone, hydromorphone, hydrocodone, and other potent opioid agonists are sold by the bottle?  I could go on and on about this issue… most patients on Suboxone guard each tablet carefully, as they are prescribed to match up with the number of days in each month… whereas opioid agonists are usually prescribed to take ‘as needed’, meaning the tabs are much more likely to end up in kitchen cupboards or otherwise unaccounted for.
Why would a company hire another company to find fault with their product?  One might think that the manufacturer of a substance would be, if anything, pointing out the safety of their product—not arguing that it is unsafe.  This is where cynicism starts to set in; where I wonoder if they are really just ‘Here to Help.’ I’m supposed to believe that RB discovered a problem with their product, hired a company to assess that problem, and then voluntarily withdrew the product from the market.
To believe the RB line, I have to accept a number of coincidences.  They wrung profits out of the tabs for almost ten years, and just happened to figure out this danger within a year after patent expiration—just when generic pharmaceutical companies were able to manufacture cheaper forms of buprenorphine.  The company has been dreading the flow of generics for years;  heck, their reps spend more time talking about THAT issue than they do about pediatric exposures!  It is also an odd coincidence that RB just happened to be pushing the Film like crazy to insurers and Medicaid agencies, well before their ‘discovery’ of the danger of pediatric exposure to tablets.
To really understand the situation, you must read all the way to the top of page 29 of the Citizens Petition.  There, the attorneys for RB point out to the FDA that if a manufacturer voluntarily withdraws a medication for safety reasons, the FDA is not allowed to approve any new drug application for a generic that is based on the withdrawn medication.
Wow.  They have some darn good attorneys at RB.

Dear CEO

This is a repost of an article from 10/2/2012
I’m going to start by paraphrasing John Le Carre’s comments in his book The Constant Gardener: “Nobody in the letter below is based upon an actual person or outfit in the real world. But I can tell you this; as my knowledge of the pharmaceutical world increases, I come to realize that, by comparison with the reality, my letter is as tame as a holiday postcard.”
Dear Fictional CEO,
I have a question about your company.
Over a decade ago, you took an action unprecedented among cleaning-supply companies by gaining FDA approval to market a combination of two generic compounds. I do not know if you thought that compound N was necessary to gain approval of the medication, or if someone at your company had the prescience to know how things would eventually play out in your marketing department.  Kudos if it was the latter.
You now know, I suspect, that compound N is irrelevant to the use of Product S to treat opioid dependence. You are aware that many people, even prescribers, often confuse the actions of compound B and compound N, mistakenly thinking that compound N does something to reduce cravings or improve the safety of Product S. It isn’t your fault that people get it wrong. True, you spent only fractions of your huge profits on educating psychiatrists, surgeons, ER doctors, and nurses. But just because their ignorance plays into your marketing strategy does not prove that you WANTED them to remain ignorant. Perhaps you figured that education about your product was the responsibility of someone else.
Speaking of education, 12 years ago you fooled the FDA by showing cases of several French people who died from improperly using compound B, and used the cases to justify adding compound N to your product. Never mind that those deaths would not have been prevented by compound N, a low-affinity, short half-life opioid antagonist with little ability to out-compete compound B at the mu receptor— the idea– that the compound N would precipitate withdrawal if Product S is injected, yet do nothing when taken properly, was pretty cool– especially compared to the drudgery of making rat poison!
Maybe the FDA needs more cynics, because they didn’t notice that adding compound N was an effective way to turn a cheap, generic compound– B– into Product S, a cash cow for your company. Even if they had noticed, would anyone really expect you to save opioid addicts WITHOUT the huge profits? I don’t think so!
So I cannot blame you for how things have played out up to now.  Almost all is fair, in the world of business.  And I understand how horrible it must have been over the last five years, as generics threatened to kill off that cash cow.  You needed a strategy to protect Product S.  That unfair Patent Office only gave you a few (well, 8 or 10) years to rake in profits, before going back to the unglamorous, less-profitable world of cleaning supplies.  No limos for those guys!  Time flies when you’re making money… and next thing you know ANYONE can make Product S!  How uncool is that– suddenly you would have to live on only typical profit margins, or even invent a new product like other companies have to do to keep the cash flowing.  Bummer.
I get a bit confused at this point.  Let me get this straight…  after making tons of money off Product S, knowing that someone ELSE is going to make their own cheaper version of Product S, you decide to kill off Product S for EVERYONE?  You make Product S-F, and go back to the FDA (heck, they covered your back once!), and say that the product that made us ALL THAT MONEY is a BAD PRODUCT.   And you just figure this out now, at the same time your patent expired—just when other people are able to make Product S.  Am I getting it right?
Correct me if I’m wrong, but it looks like you somehow got a whole bunch of people—insurance companies, state Medicaid agencies, etc— to require the use of  ONLY Product S-F.  You told everyone that Product S (that you were still selling tons of) wasn’t as ‘safe’ as Product S-F, so they should only use S-F.  It somehow worked; you got close to 70% of those people to require patients to take Product S-F… even though your claims about safety were pretty silly.  Never mind—they actually believed you!
I admit that I do not understand why those insurers and Medicaid agencies were so short-sighted.  Surely they knew what was going on—that you were only trying to destroy Product S for everyone, and take away a market for generic competitors.  Didn’t they recognize that whatever discounts you bribed them with, would be peanuts compared to the savings they would eventually get from generics?  How did you pull it off?
The icing on the cake… I read last week that you are PULLING Product S and ONLY selling Product S-F.  You hired a company (YOU hired THEM!) to show that Product S was unsafe, to justify pulling it.  Again, you did this just as other companies were in a place to make Product S themselves… at a much lower cost than YOUR product.  Your people are saying that 4 kids died from Product-S over the past 5 years.  They didn’t mention that Product-S saved tens of thousands of teenagers over the same time, and they didn’t say that the companies about to make it so much cheaper would save tens of thousands more.  I guess that is a tough calculation— I mean, who is worth more, 4 young kids or 20,000 teenagers?
Most people would be satisfied with the sequence of events and call it a day.  In fact, most people would feel a bit shameful, knowing that they just completed a strategy that 1. Mislead medical science into buying your product for ten years, when plain old compound B would have done the same thing all that time—at a fraction of the cost; 2. Prevented effective education about compound B that could have saved many thousands of those who died from overdose over the past ten years; 3. Bypassed the usual conditions in the world of pharma where a company can make billions of dollars for years, but eventually allows generics to make the product, so that poor people and people without insurance get a chance to save THEIR lives too; and 4. Tricked insurers and agencies into forcing patients to use not the cheaper drug, like they usually do, but your EXPENSIVE drug—causing those same groups to limit life-saving use of the drug to only a year or two, since they can’t afford to cover your expensive one indefinitely.
You’ve accomplished quite a bit.  But I just read that you aren’t resting on wilted laurels.  Even though insurers and agencies are forcing people to buy your expensive product, there are people with no insurance and no Medicaid who have the gall to buy a generic form of compound B.  Sales of the generic are only a fraction of your sales, and some reasonable people would say that even poor people have the right to take life-saving medication, just like the rest of us.   But you are filing a ‘citizens’ petition’ with the FDA to have that medication—the affordable one that is saving all those poor people—taken OFF THE MARKET.
And now my question:
Are you SERIOUS?

$uboxone Clinically Identical to Buprenorphine??

As I give my last post more thought….  I wonder if there is ANY clinical difference between $uboxone at $7 per dose, vs. generic buprenorphine at $2.33 per dose?  Researchers out there– can anyone send me a reference?
Read my last post for details– but the essence is that naloxone is destroyed when Suboxone is taken properly (orally, sublingually), and has no action whatsoever– on that issue there is scientifc agreement (although there is a great deal of ignorance among prescribers about this fact).  The ONLY think naloxone does, is to supposedly serve as a deterrent to IV injection of buprenorphine.
Sounds good, but…  we know that people divert Suboxone intravenously, naloxone and all.  Buprenorphine binds opioid receptors very tightly- so tightly that the naloxone doesn’t effectively compete with buprenorphine.
The State of WI requires Medicaid patients to take expensive Suboxone Film, whereas in other cases they require prescribing the generic.  What is the argument for requiring the film?  RB would argue (now that the tablet has lost the luster of being on-patent) that the film is harder to ‘divert’– i.e. to inject.  But frankly, the intravenous diversion of buprenorphine is a tiny issue compared to things like heroin addiction and a budget crisis.  Most of the diversion of buprenorphine, either Suboxone or generic, is not injected, but rather taken orally to ward off withdrawal– and the film makes no difference in that case.
Insurers, likewise, are wasting millions of dollars (literally) by paying for Suboxone— sometimes exclusively(!)  Have the bean counters fallen asleep on this issue?
I have nothing personal against Reckitt-Benckiser, beyond the fact that they refuse to engage in conversation with me.  If the good Brits at RB have discovered a way to suck millions of dollars from the weakest members of society, more power to them.  But I am a big fan of intellectual honesty, particularly in regard to the science behind medical practice.  So if someone has evidence that $uboxone is clinically different than generic buprenorphine, whether used properly or injected, please send it my way.

The Suboxone Business Fix

I have shared my thoughts about ‘Suboxone Film,’ a product that serves only one purpose:  to block generic competition from entering the Suboxone market.  Below I’ve copied a Bloomberg article that discusses the current nature of the buprenorphine/naloxone business, and the efforts by RB to prevent market penetration by generics– something that would lead to price reductions for healthcare consumers.

Suboxone Doctors act dumb with buprenorphine
Dumb about naloxone?

Unfortunately, the Bloomberg article overlooks the most significant threat to the profits of Reckitt-Benckiser.  This threat is mitigated only by the ignorance of many of the physicians who prescribe Suboxone.  The threat to profits consists of a simple fact that RB does not want anyone to realize:  that the generic equivalent of Suboxone is already available, in the form of orally-dissolving tablets of buprenorphine.

I encourage physicians who doubt my comments to do their own ‘due diligence’ and break out their old pharmacology textbooks.  I have a hard time understanding how people who graduated from accredited medical schools can get things as wrong as they do with this issue.  I sometimes present opinions, but not with this post.  The facts about buprenorphine and naloxone that I’m about to describe are described in any pharmacology textbook— e.g. Goodman and Gilman—and are not in dispute in any way.

Suboxone consists of buprenorphine plus naloxone.  Naloxone is an opioid antagonist that is added to reduce diversion of Suboxone in the form of intravenous injection of a dissolved tablet.  Naloxone is NOT ACTIVE when not injected.  The molecule is poorly absorbed through the oral mucosa because of the molecule’s size and poor lipid-solubility.  Instead, naloxone is swallowed, absorbed from the small intestine, and totally destroyed at the liver before reaching the systemic circulation through a process called ‘first pass metabolism.’

I suspect that some physicians confuse naloxone with the similarly-named substance naltrexone, an opioid antagonist (blocker) that IS orally active. There is NO naltrexone in Suboxone.

All of the beneficial aspects of Suboxone come from the partial agonist buprenorphine.  The ceiling effect of buprenorphine causes a reduction in cravings through a process that I’ve described in earlier posts.  Naloxone, on the other hand, does absolutely nothing to reduce cravings, to increase safety, to reduce euphoria, etc, provided that the medication is not injected.

The confusion surrounding buprenorphine essentially consists of intellectual laziness or intellectual dishonesty by the physicians who prescribe the medication and the pharmacists who dispense it.  I realize that not all doctors are cut out to be ‘physician scientists’ who understand pharmacology in great detail.  But I am particularly disappointed that the large organizations that supposedly oversee the science of addiction treatment have dropped the ball on this issue. I don’t know why groups like ASAM and SAMHSA don’t get it– whether the problem is ignorance, or whether there are mutually beneficial relationships between these organizations and RB that encourage the organizations to foster ignorance among
patients and doctors.  I don’t belong to the organizations primarily for this reason– and I blame ASAM and SAMHSA for the current status of addiction treatment as the ‘no science zone’ of modern medicine.

 A few examples of intellectual laziness: 

Example 1:  Physicians who prescribe Suboxone often say that one shouldn’t use buprenorphine ‘because it doesn’t have the opioid blocker and therefore….’ (add whatever here– it causes euphoria, it is addictive, it isn’t safe– any or all of these comments). The statement is partially correct. Generic buprenorphine does not have the opioid blocker naloxone— but naloxone is irrelevant to the actions of Suboxone!

There are TWO opioid blockers in Suboxone, but only one is clinically relevant—the one that is in both Suboxone and generic buprenorphine.  What is the relevant ‘opioid blocker’ that IS
in both Suboxone and generic buprenorphine?  Buprenorphine!   As a partial agonist, buprenorphine has antagonist properties that are responsible for ALL of the effective clinical properties of Suboxone.

Example 2:  Refusing to consider the cost of medication as a factor that determines access to treatment.  Some docs make ‘fear of diversion’ the only factor in determining what to prescribe.  Discussions with hundreds of opioid addicts over the years have convinced me that buprenorphine is rarely a drug of choice.  Rather, it is used by addicts who are sick and tired and want a break from using without withdrawal, or by addicts who have no money or access to agonists.  In such cases, buprenorphine or Suboxone are equally effective– and equally diverted.  When I ask addicts new to treatment about their injecting habits, I often ask whether they injected buprenorphine or Suboxone.  The typical response is either ‘can you do that?’ or ‘why would I do that, since heroin is cheaper?’

In my area, an 8 mg tab of buprenorphine costs as low as $2.33.  This low cost should be part of the equation for choice of medication, just as it is for other illnesses.  Does anyone doubt that there are some people kept from treatment by a price differential of 300%?!  Is it ethical to fear diversion so greatly that treatment is effectively withheld– for a condition with the fatality rate of opioid dependence?!   I’m sure readers know my answer, especially when there are effective ways to reduce diversion, such as close monitoring of prescribed doses, a ‘no replacement’ policy, and drug testing, among others.

Example 3:  There is some question whether the naloxone in Suboxone does anything to reduce diversion. Buprenorphine patients on my forum  who have injected Suboxone in the past have claimed that they did not experience withdrawal from either Suboxone or buprenorphine, consistent with what I would expect from combining a low-affinity antagonist with a high-affinity partial agonist.

Note: Injecting ANYTHING is in essence taking your life in your hands, and I strongly encourage anyone in such a position to seek treatment immediately.   Really—don’t do it.

Example 4:  Insurers generally refuse to cover generic buprenorphine (the generic form of the RB drug Subutex), even though it is much cheaper than Suboxone.  The one time they WILL cover Subutex or buprenorphine is for women who are pregnant or nursing.  The argument is that we shouldn’t expose the fetus/infant to one more drug (naloxone), since that drug isn’t necessary to the actions of Suboxone.  I agree with the argument, and wonder why it is extended only to the fetus?  Why does mom or dad have to be exposed to an extra substance(naloxone) that isn’t necessary to the actions of Suboxone?

I struggle to understand the insurance issue, as I would expect that someone at some major insurer would know enough about pharmacology to save money on Suboxone by favoring gen
eric buprenorphine.

The ultimate of silliness is that the State of Wisconsin requires that people on Medicaid use only Suboxone FILM.  Getting Abilify for a patient is virtually impossible without first using a variety of older, cheaper medications… but the squishy arguments in favor of Suboxone Film push the med up the formulary chain past an alternative that sells at a fraction of the cost.  The film/Medicaid situation is doubly dubious, as we have the arguments for buprenorphine over Suboxone, and the even less-sound argument for Suboxone Film being favored over the tablet.

RB apparently convinced the state that for Medicaid patients, only the film was safe– and that the film should be required instead of the tablet form of Suboxone, placing future generics at a great disadvantage.  It is especially impressive that RB accomplished this feat after selling a million units of the tablets themselves!  I can picture the person making the point:  ‘the tablet is unsafe…. Starting NOW!’

I’m going to write all night if I don’t wrap this up.  To summarize, the Bloomberg article below describes why RB is winning the battle with generics, but the writers of the article, along with most doctors, miss the bigger issue– that misplaced fears, intellectual laziness, and misinformation have protected Suboxone sales from a much greater foe-– generic buprenorphine.  If doctors, states, and insurers ever get their acts together and prescribe according to science, brand name Suboxone profits will go down the toilet faster than the cleaning products made by RB.

The Bloomberg piece:

Reckitt Benckiser Kicks Heroin Tablet Habit With Film: Retail

By Clementine Fletcher

Reckitt Benckiser Group Plc may be kicking its heroin problem.

After losing U.S. patent protection in 2009 for its Suboxone tablet, designed to help heroin users quit, Reckitt Benckiser has said that the entrance of a generic competitor could erode pharmaceutical sales and profit by 80 percent (note by JJ:  What a shame?!  Consider the benefit of such a price reduction for addicts in need of treatment!).

Reckitt Benckiser, which gets most of its revenue from selling home and personal-care products like Lysol cleaners and Durex condoms, has faced calls to sell the business before a generic comes to market. Instead, the London-based company aims to divert the showdown by switching users to a film form of the drug — one whose last patent doesn’t run out until 2025 (note by JJ:  NOW do you see why they made the film?!)

To get people to make the switch, Reckitt Benckiser is thinking more like a consumer company than a pharmaceutical one. It’s drawing on a marketing technique first pioneered by Coca- Cola Co. more than 100 years ago: coupons. By offering up to $45 a month toward a user’s co-payment in the U.S., the company is making the film version, which looks like a Listerine Pocketpak, close to free. That offers patients who get part of the bill subsidized by health insurance little incentive to transfer to a generic pill once it appears on the market.

“They’ve done a good job of making a silk purse out of a not very compelling situation,” said Martin Deboo, an analyst at Investec Securities Ltd. in London.

Reckitt Benckiser’s shares have risen 55 percent in the last five years, outpacing Unilever and Procter & Gamble Co. Under Chief Executive Officer Bart Becht, who stepped down last month, the company more than doubled sales in a decade. The stock has dropped 3.7 percent this year, compared with Unilever’s 4.7 percent gain and P&G’s 1.2 percent gain.

Drugs Growth

The company is due to report third-quarter results tomorrow and will probably say revenue adjusted for purchases and asset sales rose 7 percent at the drugs division, analysts led by Andy Smith at MF Global in London estimate, compared with a 3.9 percent increase for the rest of the business. Profit likely rose 0.9 percent to 430 million pounds, they said.

The film version of Suboxone, introduced in September 2010, accounted for 41 percent of the drug’s U.S. sales by the end of the first half (note by JJ:  Thanks, Wisconsin Badgercare!). That surpassed the company’s own expectations, Becht said on an Aug. 30 conference call arranged by Sanford C. Bernstein. Becht was succeeded by Rakesh Kapoor, a company veteran.

Generic Delay

The film “has been a phenomenal success,” Becht said, according to a transcript of his remarks. “To make the business completely sustainable, we would like to have a share which is clearly much higher than where we are.” He added that the company aims to grow that share every month.

Right now, time is on his side. Teva Pharmaceuticals Industries Ltd., the world’s biggest maker of generics, began the year saying it might launch a Suboxone copy in 2011. Now the company has backed off, saying it no longer expects the product to win regulatory approval this year.

Biodelivery Sciences International Inc., another drugmaker going after Suboxone, said a study comparing its own version of the drug to a placebo failed to show a statistical difference in the treatment of chronic pain. A test in patients addicted to opioids, which include heroin and codeine, is scheduled to begin
later this year. Titan Pharmaceuticals Inc. on Aug. 31 said it’s preparing to seek approval of an upper-arm implant that would deliver buprenorphine, one of
the active ingredients in Suboxone, directly into the bloodstream (note by JJ:  the ONLY active ingredient in Suboxone!)

‘Massive Benefit’

“This delay has been a massive benefit,” said Andrew Wood, an analyst at Sanford C. Bernstein. “With every day that goes by, RB has an extra day to convert users.” Suboxone is either harder-than-expected to copy or generic-drug makers are having second thoughts about targeting addicts, according to Bernstein.

About 1 million people in the U.S. are addicted to heroin, the National Institute on Drug Abuse estimates. As many as 325,000 people use Suboxone to quit the drug or painkillers, says Pablo Zuanic, an analyst at Liberum Capital in London.

The medicine combines buprenorphine, a painkiller derived from the opium poppy that shares some of its properties, with naloxone, a chemical that blunts
withdrawal symptoms (note by JJ:  This is simply WRONG.  BLATANTLY WRONG.  Really–  an opioid antagonist BLUNTING withdrawal symptoms?  Shame on the writers!). The film sells for about $4.63 to $8.23 a dose at Walgreens stores, according to Liberum, depending on its strength and pack size. That means the strongest dose costs about $247 a month.  (note by JJ—a pharmacy near my practice sells generic buprenorphine dissolvable tabs, 8 mg, for $2.33 per tablet—a medication that works EXACTLY the same way IF NOT INJECTED INTRAVENOUSLY)

More than half of people on Suboxone use private insurance with co-pay, Zuanic says. Reckitt Benckiser offers $45 towards co-pay for the film, he said, meaning an insured patient who’d contribute $50 to the cost of the drug may end up spending $5.

‘Near Zero’

“The actual cash cost for some patients buying the film with private insurance could be near zero,” Zuanic said in a note to clients this month. (note by
JJ:  but we are all paying the cost in higher insurance premiums, and some insurers, notably Humana, have draconian policies that stop covering—forcing instant withdrawal- if a patient receives a prescription for a sleep medication such as Ambien, so many people are left paying cash).

Meantime, Suboxone is only becoming more important to Reckitt Benckiser. The drugs division, whose sales grew five times as quickly as the main business last year, accounted for almost 9 percent of sales and 24 percent of profit, up from 7.6 percent and 20 percent in 2009. Sales a
t the unit will probably rise 12 percent to 829 million pounds ($1.3 billion) this year, according Nomura International Plc estimates.

The maker of French’s mustard is even considering making an injectable Suboxone and developing new products for cocaine, alcohol and cannabis addicts.
The plan has met skepticism.

“We’re quite a long way from having any visibility on these products,” said Julian Hardwick, an analyst at Royal Bank of Scotland Group Plc in London. “Are they products that will work? Which will get approval?”

Prescription drugs are perceived as a bit of a misfit in the home of Vanish stain removers and Finish dishwasher tablets.

Misfit

“Reckitt Benckiser is basically a home and personal-care company with over-the-counter pharmaceuticals,” said Carl Short, an analyst at Standard & Poor’s in London. The drugs unit is “always going to be something that looks like it doesn’t fit with the rest.”

Reckitt Benckiser may look at selling the unit, which Becht himself has said is “not the No. 1 strategic part” of the company, once a generic form of Suboxone reaches pharmacy shelves, analysts said. (note by JJ:  i.e. after all of the profit has been wrung from suffering addicts).  But the company’s marketing savvy, coupled with delays in the launch of a generic, are giving Kapoor time to settle into his new job.

“This is a big job and he is coming in after someone’s done it for some considerable time and very well,” said Julian Chillingworth, who helps manage about 16 billion pounds in shares at Rathbone Brothers Plc, including Reckitt stock. “You wouldn’t want to come in as a CEO into a very successful business and start selling things off on the cheap.”

Not Time

Analyst valuations range from 2 billion pounds to 6.3 billion pounds, according to four estimates compiled by Bloomberg News. Estimates diverge because it’s hard to value the business without knowing how Suboxone sales will resist the generic challenge and whether the shift to film can counter some of that impact.

“Until you get generic competition for the tablet, I think it’s unlikely that prospective buyers would give you the full value for the business,” said Hardwick of RBS. “Now is not the time to sell.”

–With assistance from Naomi Kresge in Berlin. Editors: Celeste Perri, Marthe Fourcade.

 

 

Score One For Reckitt-Benckiser

I received notice today from the area’s Reckitt-Benckiser rep that the company has secured a mini-coup of sorts, requiring state of WI Medicaid subscribers on buprenorphine to use the Suboxone Film formulation.  Here is the notice I received:

RB share price vs S & P, Suboxone Talk Zone
Reckitt-Benckiser stock share price since Suboxone vs. S & P 500

Wisconsin State Medicaid has as of December 1st  today added Suboxone Sublingual Film as the preferred delivery system. I have attached a file description. Because of some of you large geography and some limited stocking in certain areas. I would suggest you begin prescribing the Film to all your Medicaid patients as soon as possible to insure pharmacy coverage moving forward. All pharmacies can receive for stocking and distribution to your patients with 24 hour notice.
For PA requests for Suboxone tablets, providers are required to indicate clinical information about why the member cannot use Suboxone film and why it is medically necessary that the member received Suboxone tablets instead of Suboxone film.
Ironically, I just completed a survey (not sure who sponsored it) asking my opinion about ‘Suboxone Film’—i.e. whether I think it is an important step forward, whether patients like it, etc.  I shared my thoughts- that it is essentially a marketing gimmick, and one that is apparently successful—at least when used on the people who run WI Medicaid. 
The supposed advantage of the film is that each dose is wrapped separately in a foil pouch.  This in theory makes it more difficult for a child to inadvertently swallow a handful of the tablets.  In reality, this is only beneficial if one limits his imagination to a scenario where a bottle of prescription medication is left out and available to a young child, and the child is somehow able to defeat the child-proof features of the cap.  I can envision another scenario—mom keeps several packets of Suboxone film in her purse, and her child pulls one out while looking for gum, tears it open, and decides to see what it tastes like.  One could argue that there would be LESS exposure to buprenorphine in the case of the film, as only one strip would be opened as opposed to a child swallowing a handful of tablets.  But the partial agonist nature of buprenorphine makes the number of tablets irrelevant.  One Suboxone tablet or film contains 8000 micrograms of buprenorphine—a huge dose.   A child would need to go to the hospital for observation whether one or 10 doses were ingested, and the effects from the medication would likely be the same in either case.
Let’s say I allow, though, that the requirement that people use the film will reduce the risk of accidental ingestion in children by at least some amount.  And let’s ignore the fact that we are taking away the choice that patients enjoy with other medications; we are talking about ‘addicts’ after all, right?  No need to treat addicts like ‘regular,’ responsible people!  And let’s tell the people who don’t like the gooey, slowly-dissolving nature of the film, or the rubbery aftertaste that some have described, that they are just ‘SOL.’  They’re addicts, so again, who cares?  And let’s tell the people who complain about their dose blowing away in the wind that they should learn to take it in a more reasonable place.
After we do all those things, what’s the big deal?
The big deal is for Reckitt-Benckiser.  The big deal is that the state of Wisconsin won’t allow people on Medicaid to use the almost-tasteless generic formulation of buprenorphine—something that many patients prefer—and that the state won’t save  a few million dollars in medication costs.  Reckitt-Benckiser had to sacrifice a small amount; they cut 50 cents off the $6 charge for one tablet of Suboxone.  But in return, they essentially hold hostage every patient getting medication through public assistance.  Talk about an effective marketing campaign!  And if they can use the bogus safety argument to fool the State people, who knows—maybe they can get private insurers to fall for it as well. RB has already managed to use fears of IV diversion to push insurers away from approving generic buprenorphine.  RB also prevents insurers from placing generic buprenorphine on formularies by keeping brand-name Subutex priced very high (insurers fear that if they approve generic Subutex, some people will end up getting the real, ridiculously-expensive Subutex due to pharmacy shortages of the generic).
The bottom line is that RB has eliminated the forces of ‘market competition’ that would otherwise force the price of buprenorphine downward.  If Dell, Gateway, and Sony could use this type of fear-mongering to control the market, we would all be paying fifty grand for a laptop!
And in a field where access is limited by resource costs, the excess profits gained by RB translate into fewer patients treated, one way or the other.  And ‘fewer patients treated’ translates into ‘death.’
THAT’S what I meant in an earlier post by ‘blood on their hands,’ by the way.  Congratulations, RB, on Suboxone Film.

Buprenorphine Film: Step Forward or Marketing Gimmick?

It i salways humorous when companies do what Reckitt-Benckiser recently did– make a small change in their product, then trash the old product in favor of the new, more expensive product.  “The OLD formulation is GARBAGE!  It poses huge risks! It is reckless and irresponsible to prescribe that tablet (the one that we’ve been marketing for years, that is…)”

buprenorphine film
The orange rectangle is buprenorphine film

For people who are confused, here is what happened…. Reckitt-Benckiser, the makers of Suboxone and Subutex, used to have a stranglehold on the market for buprenorphine.  Profits poured in from selling buprenorphine at ridiculous prices;  $6 per tablet in the Midwest for Suboxone, and over $11 per tablet for Subutex.  The prices were particularly obnoxious given that the company didn’t invent buprenorphine– in fact, buprenorphine has been around for 30 years, and could be purchased cheaply in bulk quantities.  All that RB did was come up with a sublingual formulation, and from that point forward they were essentially printing money.  Suddenly a cleaning product company is raking in the big bucks!
Of course at some point, patents expire.  Companies often sue to stretch out patents– and profits– as far as possible, but at some point the party comes to an end, and such is now the case with Reckitt-Benckiser and Suboxone.   The generic version of Subutex costs as little as $2.80 in my area;  RB has been stemming the bleeding from that generic by warning doctors that patients will dissolve and inject buprenorphine if naloxone is not mixed in– something that is exceedingly rare, given the long half-life of the medication, the aversion that most addicts have for needles, and the fact that most diversion of buprenorphine is by people seeking a way to stop using– not by people looking for a ‘buzz.’  But more recently Teva, a large manufacturer of branded and generic medications, received approval for their version of sublingual buprenorphine.  I have not seen it in pharmacies in the Midwest, at least not yet, but it will be more difficult for RB to deal with this form of buprenorphine– which will essentially be the same as branded Suboxone, only cheaper.
Some states, including Wisconsin, REQUIRE pharmacists to substitute less-expensive generics unless specifically blocked by the prescriber.  Insurers, both private and government, also require use of generics in the absence of a compelling reason to use the branded product.  That means that to get brand Suboxone, doctors will have to fill out paperwork explaining their reason for requesting the brand.  Doctors, of course, hate paperwork, and so I anticipate a huge shift to the generic product once it appears in pharmacies.
RB, then, is in a pickle.  So some marketing guy gets the idea to put buprenorphine in a listerine-style breath strip, sell it indiviually packaged, and tell everyone that individual tablets of Suboxone are a huge risk to the public.  They tell us that little kids put them in their mouths, that the packaging isn’t safe enough, or that the tablets absorb moisture, making their sublingual dissolution rate unpredictable.  Better use the strips intead, they say.
I tried one of the strips– one that was a ‘dummy strip’ that did not contain buprenorphine.  The instructions are to put it under your tongue, but as I have written here many times, there is nothing special about the under-the-tongue space, and they can be put on top of the tongue if that is easier;  the point is to get the molecule in contact with the mucous membranes that line the mouth.  I like the idea of the strip in theory;  the absorption of buprenorphine is driven by the concentration gradient of the molecule, and the film helps deliver a highly concentrated dose of buprenorphine to the surface of the oral mucosa.  The film could also conceivably be cut into small pieces using an exacto knife, to help with tapering the drug.  But in practice, the film was unpleasant to use.  It was thicker than I expected, sort of like a cross between a Listerine strip and a gummy worm.  It took longer to dissolve than I expected, and the taste was nasty.
So what is the conclusion?  Is the strip a leap forward in safety and convenience?  Or is it just an attempt to hang onto a brand?  I suppose that answer depends on how you see the world, and how you see a cleaning products company from the UK that struck it big on the backs of US opioid addicts.