A shingles vaccines and biologic generics
There's been a lot in the news about vaccines. Cervical cancer vaccines, avian flu vaccines, vaccines for ear infections. Now Merck has another new vaccine that has just been approved by the FDA to treat shingles in people age 60 and over. Shingles is typically treated with Valtrex or another antiviral once it flares up. Zostavax, though, keeps the virus from flaring up before it happens, and it is the only pharmaceutical capable of doing so.
This is just the latest trend in a newly-rekindled vaccination industry. Turns out there's money in vaccines after all.
But analysts reckon the vaccine market will grow much faster than the market for prescription drugs. "We're in a period where pharmaceutical sales are growing at 5% to 6% a year," says Novartis Chief Executive Daniel Vasella. "In contrast, the vaccine industry is looking at nearly 20% annual growth over the next five years."
Generic Plavix shenanigans
Sanofi-Aventis and BMS have settled a lawsuit against Apotex, a generic drug-maker for $40 million and manufacturing rights for 8 months. The two had sued Apotex for patent infringement on Plavix, a lawsuit which has pushed off the availability of a generic clopidogrel in the United States. Under the terms of the suit, Apotex will hold off selling their generic clopidogrel in this country until September 2011 — which is 8 months before the patent expires — and will receive $40 million from BMS and Sanofi-Aventis.
It's a clear victory for Big Pharma, and a loss for consumers and any company that's not Sanofi-Aventis or BMS. Plavix was #2 on the top 200 list in 2005, with sales totaling $5.2 billion. Had Apotex been successful and not settled out of court, there would have been a generic Plavix available relatively quickly. Unfortunately they settled for the guaranteed money, and exclusive rights for 8 months. As I've said before, the value of the generic drug market is tiny compared to Big Pharma — by taking the settlement BMS, S-A, and Apotex all win. (Personally if I was Apotex, I'd have pushed for a higher figure, just because Plavix is so valuable.)
As soon as the results were announced, ten lawsuits by health plans, unions, and other businesses were immediately filed in retaliation, alleging the deal violates federal antitrust laws. The FTC has said that they will examine the case to see if there are any laws being broken. Frankly, I don't know enough about antitrust law to speculate whether the new round of litigation holds any water. It will certainly be an interesting case to watch, and has implications for further back-room licensing deals between major pharmaceutical companies and generic drugmakers, though nothing as unique as this has happened in recent memory that I am aware of.
Don't be surprised to see the number of similar lawsuits mushroom over the next five years as pipelines run dry and patents expire — it will be the only way Big Pharma will be able to maintain their otherworldly revenues for a precious few extra years. I have not seen a change in the way Big Pharma conducts their R&D efforts, and even if they did, there would still be a multi-year dearth of new drugs in the near-term. The path Big Pharma chose back when direct-to-consumer advertising restrictions were lightened has resulted in fat profits when their focus shifted to marketing instead of R&D. Unfortunately for them and everyone else, this more litigation and fewer breakthroughs.
[tags]Medicine, Pharmacy, Sanofi-Aventis, BMS, Plavix, clopidogrel, Big Pharma, antitrust law[/tags]
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]
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.
A vaccine for cervical cancer and genital warts
Merck is waiting on approval from the FDA for its new vaccine, Gardasil, which block four types of the human papilloma virus (HPV) which causes genital warts and cervical cancer in women. As the AP article points out Merck could really use a new hit because of the 11,500 upcoming Vioxx lawsuits, and its blockbuster statin Zocor losing its patent protection in June.
Testing shows Gardasil is nearly 100 percent effective and works for at least five years, said Dr. Eliav Barr, Merck's head of biological clinical research. He said some of the first women and girls who got the vaccine will be followed for years to see if booster shots are needed.
The vaccine targets four of the roughly 40 types of human papilloma virus: HPV 16 and 18, which cause about 70 percent of cervical cancer cases, and HPV 6 and 11, which cause 90 percent of genital warts.
Disposing of old medications
I read the Wall Street Journal just about every day. Today's Health Mailbox was concerning old medications. A reader wrote in:
What is a safe method for disposing of old pharmaceuticals? I've been told they can enter drinking-water sources if they are flushed.
-G.C.
Now, this is actually a pretty good question. I get asked probably once every week to ten days, and I've never had an answer that I've been satisfied with. Tara Parker-Pope, the Health columnist for the journal, responds explaining the research behind the claims that these old pharmaceuticals can get into drinking water — all undoubtedly true. She then goes on to suggest that patients contact their local community pharmacies for advice, because she doesn't have a surefire method of disposing them:
The best advice is to ask your local pharmacy if it has a medication disposal program. Your pharmacist could incinerate medicines along with other pharmacy waste products.
At my pharmacy, we do not have such a program, nor do we incinerate pharmacy waste on site. (We do, however, ship PHI off to the home office where I assume it gets incinerated, though for all I know it could be shredded instead.) What we normally do is simply throw old pills in the trash. I guess that makes us bad citizens. The EPA, on the other hand, recommends simply flushing the old drugs down the toilet (PDF).
[tags]Pharmacy, medication disposal, EPA, environment[/tags]