Generic Imitrex approved by the FDA
GSK has tentatively lost patent protection on two of its popular drugs: Coreg and Imitrex. Imitrex is the more profitable of the two, with 2004 sales of $1.1 billion in the US, but the loss of Coreg is substantial as well. Together the two had combined sales of almost $2 billion in 2004. 2005's were even more impressive: $1.4 billion in the US and over $2.42 billion globally for Coreg. The announcement of the FDA's approval of Mylan's generic sumatriptan comes hot on the heels of Imigran (the UK name for Imitrex) going over-the-counter in that country in an effort to retain some of its sales.
Mylan will now have a mandatory 180 day monopoly on the sale of three strengths of Imitrex: 50mg, 100mg, and 150mg tablet forms thanks to the Hatch-Waxman Act that I've talked about before, provided GSK doesn't pay them to not sell it so they can extend their effective patent life by another 6 months, which is certainly a possibility. Injectable and intranasal forms of Imitrex remain covered by patent, and I don't think we'll see Imitrex tablets going OTC in this country anytime soon.
[tags]Imitrex, GSK, Sumatriptan, medicine, pharmacy, Coreg, carvedilol[/tags]
Medicine as a partisan issue
As someone who has had to deal with the new Medicare Part D benefit since pretty much Day 1, my feelings have run the gamut.
- Happiness because seniors would be able to afford the medications they need.
- Exasperation at trying to explain the benefit.
- Pulling my hair out because no one had their benefit cards, and we had to spend hours on the phone to get the necessary information.
- Satisfaction because it all worked out in the end, and most seniors are reaping real benefits from the program.
Briefly: Nexium, Prilosec, ZES, Crohn's, and malaria
- A press release by AstraZeneca indicates that Nexium is effective in helping decrease acid secretion in patients with Zollinger-Ellison syndrome. Not a terribly big surprise: I'm sure that generic omeprazole would work just as well at controlling gastric acid secretion. But there's no money to be made in trials testing Prilosec — whose patent protection has ended — so tests weren't conducted using it.
- Hot on the heels of unfounded concerns over Humira causing lymphoma comes a study that suggests that the monoclonal is effective at controlling Crohn's disease, even allowing some patients to come off of corticosteroids. If it is approved by the FDA for use in Crohn's patients, it will be the second biologic drug available to Crohn's patients (The other being Remicaid.)
- Along the same lines, UCB hopes to have an anti-TNF treatment for Crohn's available in the next year or so as well, as Cimzia is showing quite a bit of promise.
- Novartis is apparently going to start researching cures for Falciparum malaria — one of the leading child killers in Africa. I wonder if they are expecting Africa to be a viable source of income in the "10 to 15 years" it will take to bring a Falciparum drug to market. Yeah, I guess that makes me a cynic.
[tags]Nexium, Prilosec, medicine, Crohn's disease, Cimzia, malaria, Novartis[/tags]
Needle-free fentanyl-delivery system approved
Johnson&Johnson got their needle-free opiate delivery system approved by the FDA this past Tuesday. The new system, called Ionsys (PDF), delivers a set amount of fentanyl per actuation by using a weak electric current to deliver the drug across an adhesive strip on the skin and into the bloodstream.
Ionsys is J&J's creative way of getting more mileage out of one of their drugs that lost patent protection last year: transdermal Duragesic. (This practice is called "evergreening.") It is the first needle-free, patient-actuated system to deliver opiates to manage pain, and like its grandfather, the morphine pump, it will have built-in safety measures so that patients can't overdose themselves.
Analysts expect that Ionsys will generate $40 million in sales during the second half of this year, rising to $275 million by 2009. While these numbers might sound good, they really aren't anything to brag about: most patients in a hospital or managed care setting will be intubated already, and it's likely that the institutions that would use such a system would opt for less expensive alternatives — like the morphine pump. Ionsys does look like it's designed to be a competitor to substitutable Duragesic, but I'm not sure how successful it will be — I can't see it being a huge money-maker for J&J, but then again, it doesn't have to be. With generic fentanyl patches now available, anything J&J can make from evergreening the drug is gravy.
[tags]Ionsys, J&J, fentanyl, pain management, medicine[/tags]
Increase in prescription spending slows in 2005
There's a report out stating that the amount of money spent on prescription drugs has slowed somewhat in 2005. Good news for employers and employees, and bad news for Big Pharma. The report suggests that the slowdown is due in part to the controversy over the CV complications of COX-2 inhibitors. While Bextra and Vioxx accounted for some $2.6 billion in sales in 2004, I don't know how accurate this assertion is: Celebrex is still on the market and undoubtedly picked up some of the COX-2 slack.
Overall, sales only increased 5.4% in 2005, down from an 8.5% increase in 2004. This data comes from Medco (the people behind the PAID PBM, one of the largest prescriptions insurers in the country), and their numbers cover a wide cross-section of the market, so they're probably representative of the industry as a whole. Big jumpers on terms of dollars spent were sleep aids: Lunesta and Ambien leading the pack, probably due in large part to direct-to-consumer advertising.
Curiosity got the better of me, and I did a little research, and here are the drugs that have either come off patent in 2006, or will in the next few months. The numbers in front are where the drugs listed stand on the top 200 list* for US sales:
- #2: Zocor
- #6: Zoloft
- #21: Pravachol
- #35: Allegra
- #44: Flonase
- Total sales: $13 billion
I suspect that we'll see a continuing downward trend when the numbers are released for next year. These drugs are some of Big Pharma's biggest hitters in terms of overall sales, and the total revenues for COX-2 inhibitors don't even compare to what is being lost in 2006. Great news for consumers and employers. Newer medications could pick up some of the slack, but super costly niche drugs like Humira and other monoclonals will never pack the revenue punch that widely-used statins, allergy meds, and SSRIs do.
* All numbers are from 2004, which is the most recent year for which data is available.
[tags]Prescription spending, COX-2 inhibitors, consumer spending, medicine[/tags]
Sumatriptan (Imitrex/Imigran) approved for OTC use in the UK
I must confess, I was shocked when I read about this. Imigran going over-the-counter (OTC) is huge for sufferers of migraines in the UK. Sold as Imitrex here in the US, it will be going OTC sometime during the middle of June. This is also big news for GSK, the makers of Imigran/Imitrex. Revenues for the drug in 2004 topped $1.10bn from the US alone, and while I can't find the numbers for the UK, I wouldn't be surprised if it was popular over there as well.
In the United States when a drug goes OTC, you typically see a huge price drop because people are unwilling to pay what it actually cost their insurers when a drug is prescription-only. I've touched on this briefly in the past — people have no concept of the costs associated with medicine. You see medications go OTC like this when their patent protection is about to run out: mandatory generic substitution robs Big Pharma of revenues if a drug stays behind the counter. In the case of a relatively safe, proven drug like Imigran/Imitrex, making it available OTC can only mean more money for the manufacturer. People know the brand name, not the generic one, so that's what they seek out. This is the same reason that Tylenol and Motrin outsell their generic counterparts.
Briefly: Cancer roundup; "animal rights;" biotech acquisitions
- CNN has a nice article on many of the new cancer treatments in Big Pharma's aggregate pipeline.
- GSK's CEO says the company will remain in the UK, and they will not be moved by the ridiculous (and dangerous) antics of the fringe animal rights crazies. Good for them.
- Since AstraZeneca's acquisition of Cambridge Antibody, investors are speculating that Medarex, a monoclonal biotech company with three could be next on the list of acquisitions by Big Pharma. Pfizer has announced that it is looking to make acquisitions, and Medarex would fit rather nicely into their portfolio, and it would give them 3 drugs with blockbuster potential in their niche areas. I will have to delve into the complicated world of biotech creation, licensure, and manufacturing at some point in the future, because it's all terribly muddled — just like everything else in the worlds of medicine and business.