Today is the second annual World Multiple Sclerosis (MS) Day. Seems like a good day, I think, to take a good look at the current offerings and up-and-coming treatments for the debilitating disease.
Old school
|
Drug |
Companies |
2009 Sales (in billions) |
Year-Over-Year Increase |
|---|---|---|---|
|
Copaxone |
Teva Pharmaceuticals (Nasdaq: TEVA) |
$2.8 |
25% |
|
Rebif |
Merck KGaA and Pfizer (NYSE: PFE) |
$1.9 |
15% |
|
Betaseron |
Bayer |
$1.5 |
6.1% |
|
Avonex |
Biogen Idec (Nasdaq: BIIB) |
$2.3 |
5% |
|
Tysabri |
Biogen Idec and Elan (NYSE: ELN) |
$1.1 |
30% |
Source: Company press releases.
Each and every one of them is a blockbuster and a couple -- Copaxone and Tysabri -- are still growing like gangbusters.
Top selling Copaxone got a boost from a label change that said it could be used at the earliest possible time after just one multiple sclerosis attack. Whether it can keep up that growth remains to be seen.
New patients going onto Tysabri have actually slowed down recently as the number of cases of progressive multifocal leukoencephalopathy (PML), a potentially deadly brain infection, has increased. Elan and Biogen have a three-pronged approach to reaccelerating sales:
- Develop a test for the virus that causes PML in combination with Tysabri to help patients determine their risk of getting PML.
- Develop a treatment for patients that develop PML.
- Test Tysabri against other multiple sclerosis drugs -- Rebif and Copaxone -- to show that treatment with Tysabri early in the disease progression is helpful.
All three will take awhile to develop because clinical trials are involved. That leaves Tysabri in somewhat of a holding pattern waiting for its chance to catch up to the top-selling drugs.
Newcomers
Acorda Therapeutics' (Nasdaq: ACOR) Ampyra, which was approved earlier this year, is designed to help multiple sclerosis patients walk better. The best thing about the drug, which will be sold by Biogen outside the U.S., is that it doesn't have to compete directly against the current offerings as it's used in combination with other drugs. Initial demand has been higher than Acorda was expecting, but still relatively low: during the first month on the market, Acoda shipped just $3.4 million worth of Ampyra, which included initial stocking by specialty pharmacies. It'll be a while before this one's a blockbuster.
Through a complicated manufacturing deal after Bayer and Novartis (NYSE: NVS) each bought one of the partners that originally developed Betaseron, Novartis was allowed to sell a competing drug, Extavia. The drug is really just Betaseron with a different label; Bayer even manufactures Extavia for Novartis. Extavia only registered sales of $49 million last year, but that's OK since the development of Extavia was mostly to help Novartis prepare for its upcoming offering.
In the works
Novartis has an oral multiple sclerosis drug, Gilenia, currently under review by the Food and Drug Administration; an advisory panel is scheduled for next month with a decision from the FDA expected in September. While normally an oral medication would be a clear winner over the current offerings that have to be injected or infused, how much market share Gilenia will be able to take is still up in the air.
The side effect profile for Gilenia is somewhat troublesome. The issues aren't likely to keep it from getting on the market, but they may slow down early adoption until doctors are more comfortable with prescribing it. It's also in a race with Merck KGaA, which has an oral medication that's not far behind and may take some of Gilenia's potential customers.
The oral versus needle mode of administration may be a little overblown. Because of the seriousness of multiple sclerosis, the efficacy of the drug is much more important than it is for less-severe diseases like diabetes where Amylin Pharmaceuticals' Byetta is arguably a better drug than Merck's (NYSE: MRK) Januvia, but has much lower sales because it's injected while Januvia is taken orally. That's not likely to happen in the multiple sclerosis space because patients are more willing to tolerate the needle pokes to treat the debilitating disease.
Invest in other's misery?
Whether its multiple sclerosis, lung cancer, orphan indications, or the myriad of other diseases, making money off someone else's misery is kind of a touchy subject and readers will occasionally email me asking why I'm rooting for more patients. That's certainly not what I'm doing; nothing would bring me more joy than to see multiple sclerosis eradicated.
But as that's not going to happen soon -- and certainly not without the help of drugmakers -- I see no problem with investing in drugmakers despite the potential moral pitfalls.
Your mileage may vary. If so, let us know in the comment box below.
