Is Over-the-Counter Lipitor in the Cards? One year's sales could cover original R&D costs!

Is Over-the-Counter Lipitor in the Cards? One year's sales could cover original R&D costs!

The Wall Street Journal (see here) reports that Pfizer is considering seeking approval from the FDA to sell Lipitor over-the-counter (OTC). Although OTC sales of Lipitor are likely to be only a fraction of the the annual $10 billion in global Lipitor sales currently enjoyed by Pfizer, OTC Lipitor may generate up to $1 billion in annual sales. That's almost enough to cover the original costs of bringing Lipitor to market in the first place; that is, if you accept the industry's estimate of $800 million to $1.2 billion as the cost of development for an Rx drug.

How did I estimate the annual sales of OTC Lipitor? I used the Claritin Rx-to-OTC switch as a model. According the the WSJ article:

"Merck's Claritin OTC generated $401 million in sales for 2010. In comparison, annual sales of the prescription version of Claritin once exceeded $3 billion before the drug lost U.S. patent protection nearly a decade ago"

$3 billion in 2000 dollars is worth about $3.9 in 2010 dollars. Therefore, $401 million represents about 10% of pre-OTC income. If the same OTC/Rx sales ratio holds true for Lipitor, Pfizer can potentially sell $1 billion worth of OTC Lipitor in the first year (keep in mind that Claritin treats seasonal allergies and sales probably spike in the spring, whereas Lipitor sales would be sustained all year long).

But it is unlikely that Pfizer will depend entirely on OTC Lipitor sales to maintain this all important anti-cholesterol brand. It may do what Merck did after Claritin went OTC, which was to develop a new Rx formulation of the drug; ie, Clarinex.

Is Pfizer currently working on a new formulation for Rx Lipitor? I have no idea. It did, however, fail spectacularly to bring a new anti-cholesterol drug (torcetrapib) to market in 2006 (see "torcetrapib: '$800 Million' Failure but Kindler Safe"). Perhaps, after recent cutbacks, Pfizer no longer has the R&D resources to be as innovative as it once was.

One other thing to consider is this: the WSJ articles points out that Merck has been unsuccessful in its attempt to switch its anti-cholesterol statin drug Mevacor from Rx to OTC. FDA shot them down 3 times. The argument against OTC statins such as Mevacor (and presumably Lipitor as well) is that these drugs can be highly toxic to the liver if not used properly and require periodic blood tests to monitor such problems.

Adding to the debate is a benefit/risk analysis of statins based on a little-known but useful statistic, the number needed to treat. You can read more about that here: "The Statin Lottery: Number Needed to Treat Statistic". According to Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles, people could do as well dieting and exercising to lower cholesterol while avoiding the cost and potential side effects of taking a statin every day. BTW, people pay out of pocket for OTC drugs that were covered by insurance when the drugs were Rx. Those costs could exceed copays.

I note with interest that Pfizer is currently in the middle of a direct-to-consumer (DTC) advertising campaign that disses diet and exercise as a way to lower cholesterol; see "New Lipitor Ads Dis Exercise & Healthy Diet. Are You Kidding Me?". I wonder if the target of this ad campaign is the FDA rather than the general public? Hmmmm....

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Branded Pharma Wages War Against Generic and OTC Medicines: COLCRYS vs. colchicine Case Study

Branded Pharma Wages War Against Generic and OTC Medicines: COLCRYS vs. colchicine Case Study

The drug industry often claims that it is facing an unprecedented "patent cliff" -- ie, a point when many branded drugs lose their patents and generic drug versions enter the market to compete.

To forestall falling off that cliff, many pharmaceutical companies engage in practices akin to war -- at least war as it practiced today -- using bribes, technology, and legal skirmishes, all aimed at generic drug manufacturers (see, for example, "Pharma's 'pay-for-delay' deals leave American consumers footing the bill" and "Sanofi Pays Doctors to Dis Generic Version of Lovenox").

All these tactics involve protecting innovative drugs first developed and brought to market by brand drug companies. When these drugs go off patent, generic drug companies can seek FDA approval to bring "equivalent" no-name, cheaper versions of the drug to market, and thus increase competition.

Occasionally, however, a drug company invades OTC (over-the-counter) drug company turf by obtaining new patents and exclusive marketing approval for a drug that once was OTC. I've posted about this before; ie, regarding LOVAZA, an FDA-approved version of OTC Omega-3 Fatty Acid Supplements (see "Drug Industry Innovation: GSK's LOVAZA Vs. OTC Omega-3 Fatty Acid Supplements" and "Proof That Pharma Marketing Works: Lovaza sold more than $1 B in 2010!").

Another case that recently came to my attention was COLCRYS, an FDA-approved version of colchicine, which has been available as a unbranded medicine prescribed by physicians or perhaps even "over-the-counter" without a prescription for ages -- and sold cheaply. According to Wikipedia, colchicum extract was first described as a treatment for gout in De Materia Medica by Pedanius Dioscorides in the first century.

Ever since URL Pharma got FDA approval for marketing COLCRYS for treatment of gout, it has been difficult for gout sufferers to get "generic" colchicine. This may be due to FDA's and URL Pharma's coordinated effort to wage war against colchicine.

URL Pharma's War against "generic" colchicine was recently in the news when it was discovered that its attorneys sent threatening letters to doctors who were prescribing "generic" colchicine. Some doctors had advocated use of a cheaper version of the drug, whose active ingredient is colchicine. In response, URL Pharma's general counsel sent letters to several of the critics asking them to "clarify the record" and saying there were "potential risks and liability" associated with using unapproved versions (see "Pharma Company Sends Letters to Docs Who Criticized Drug Online").

Not only doctors are complaining about this, so are patients. I recently received this letter from a reader:

"I have to write this in the dark and I can’t send it to you via the internet as the FDA, the drug companies, and the US Patent Office have me under surveillance.

"This colchicine thing is just the beginning of wiping out low price and low profit generic drugs. Preparation H could be next!

"How is it that – as you can see from my CVS receipt in January, the cost for 60 colchicine pills (one month’s supply) was $27.80 - $8 paid by me and $19.80 paid by my Part D Medicare insurance. This has been the cost ballpark for the 10 years or so that I have been taking colchicine. (My copay under Part D is 20%, so I should have paid $5.56, but I have an $8.00 minimum copay).

"But then something happened, and all of a sudden, colchicine became a “new” super drug, even though it’s been around since the days of the Roman Empire. It is now called Colcrys, and you can see from my May receipt that my 20% copayment under Part D was $51.43, meaning that the full price is now $257.15. Funny thing though – the Medication Guide that comes with Colcrys says that it is colchicine. Hmmm? But I don’t need Colcrys – I’ll take the generic colchicine – sorry, there is no generic – this is a new drug with the common name colchicine and when your doctor prescribes colchicine, this is what you will get whether you like it or not – what you were taking before is not recognized by the FDA and is not allowed to be prescribed and sold.

"What? It worked just fine, and it was really cheap. Can I get it over the counter, like fish oil or flax seed with chick pea cream sauce? Wouldn’t it be OK over the counter like all those other health junk pills? No? Why not?

"Did the FDA test and fail the original colchicine for some reason? Did the patent office actually issue a patent to AR Scientific for colchicine in direct conflict with the doctrine of prior art? (like giving me a patent for the invention of the wheel – there is no patent for wheels just like there was no patent for colchicine, so I think I’ll apply for a wheel patent and talk to General Motors about royalties.)

"What say you and your friends who monitor the drug industry about this event? Speaking of fish oil!

"From Tony – the leader of gout sufferers of America – we have enough pain as it is!"

What does URL Pharma have to say about this? In a statement title "COLCRYS® VS. UNAPPROVED COLCHICINE," URL Pharma says, among other things:

"Unapproved colchicine products are sometimes incorrectly referred to as 'generic' colchicine. The term 'generic' drug means a drug that has been approved by FDA. In reality, there are no generic colchicine tablets."

So, there is no colchicine product that is approved by FDA as a "generic." OK, you say "generic," I say "over-the-counter." This is really semantics because the only REAL difference between OTC and branded colchicine is dosage form: FDA claims that COLCRYS is safer than colchicine primarily because it is a lower-dosage form and that "patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose:"

"FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose." [See this Safety Alert.]

You say "COLCRYS" and I say "colchicine"
You say "LOVAZA" I say "Omega-3 Fatty Acid"
"COLCRYS" "colchicine", "LOVAZA" "Omega-3 Fatty Acid"
Let's call the whole thing off

Oh, if we call the whole thing off
Then we must part and
Oh, if we ever part
That would save me MONEY!

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

OTC Drugs and Children

OTC Drugs and Children

Recently, the news media and Congress focused our attention on the recall of contaminated over-the-counter (OTC) children's medication manufactured by McNeil Consumer, a division of Johnson & Johnson (see "Despite Its Social Media Expertise, J&J Fails to Use It Effectively to Communicate to Consumers").

But there's an even more dangerous problem than contamination relating to OTC medication for children: incorrect dosing.

"There is an urgent need to review the use of children's over-the-counter medicines by parents," said Dr Rebekah Moles, University of Sydney, as part of her research, which concluded that many parents are incapable of giving their children the correct dose of liquid medicines.

The Australian study, presented in Lisbon, tested 97 adults and found 61% measured the wrong dose - 17% measured an overdose and 44% did not give enough (see "Many parents are incapable of giving their children correct dose of liquid medicine").

As reported by BBC: "Dr Moles said that almost half of the 119,000 calls received by the New South Wales Poisons Information Centre, which handles emergency calls from across Australia, concerned accidental overdose in children, with 15% needing hospitalisation."

I covered this topic last year when I interviewed the principals of a company that invented a solution for the problem of incorrect dosing of children's OTC medicine. Listen to this Pharma Marketing Talk podcast: "A Solution to the Problem of Inaccurate Dosing of OTC Pediatric Medicines."