BiDil on the block for $24.5M
Man, I knew BiDil wasn't worth much, due to its absurdly high cost relative to its ingredients, but I had no idea that it was worth so little:
Targeted drug maker NitroMed Inc. plans to sell its BiDil drug business to JHP Pharmaceuticals LLC for a possible $26.3 million. New Jersey-based JHP, a privately held specialty pharmaceutical company, will buy the assets related to BiDil for $24.5 million in cash, plus up to an additional $1.8 million for inventory at the closing date.
[...]
NitroMed also reported its financial results for the third quarter which ended Sept. 30. The company's total revenues climbed slightly to $4 million, compared to $3.8 million for the same period in 2007. All of that revenue came from sales of BiDil, officials said. NitroMed's net loss dropped to $400,000 for the quarter, compared to a net loss of $8.4 million last year.
Yeah, sounds like it's time to off-load that to a company that has other winners in its lineup and doesn't need to maintain the marketing and manufacturing overhead required to keep BiDil on the market. Of course, they should have done that in the first place. You can't really build an entire company around an uninteresting drug priced too high to be relevant when its components are already available in generic form for pennies per tablet. It's not a bad drug; it's just too expensive for what it is.
If JHP is smart, they'll cut the price to about a third of its current cost, and let volume take care of the rest. Not that BiDil will ever be a huge winner, but it could certainly be bigger than it currently is if priced and marketed appropriately. Monopoly pricing only works when you have something people want, and are willing to pay for.
What does $5,256.08 look like?
It looks a little something like this:
Goodbye, generic Plavix (for real)
So it looks like at the end of next week, we're going to run out of generic Plavix. I've not followed the business drama of Big Pharma in a little while because I find it dull, so I have no commentary on the outcome of the lawsuit, which I presume has been settled in S-A and BMS's favor. Apotex had a good run while it lasted. I mentioned in September that we were warned that this might happen.
In any event, it looks like it's for real. As far as I know, this is the only time in recent history where a generic has been withdrawn. I think I recall similar things happening for Lanoxin (digoxin) and Synthroid (levothyroxine), but generics for those drugs were withdrawn because of problems with bioequivalence rather than as a result of litigation.
It's going to suck explaining the reasons why clopidogrel is temporarily going the way of the Dodo. People don't take too kindly to the idea of their copayments doubling (or more). I'm thinking I should write a little handout for people explaining what happened so we don't have to have the same conversation 500 times. After telling something a dozen or so times, you've heard all the wisecracks and complaints that such a topic engenders, and it just gets redundant and tiresome.
I also think the idea of jerking patients/consumers around like this is ethically wrong, patents and the justice system be damned. But then morality is entirely dependent on one's point of view, now isn't it?
[tags]Medicine, pharmacy, big pharma, plavix, clopidogrel, ethics[/tags]
Tykerb: GSK's rising star?
ASCO's annual meeting is going on right now, which means lots of news from the world of oncology. Much of the material is revolutionary — real breakthroughs that offer real hope to cancer patients everywhere. Clinical findings are announced, the results of drug trials are presented, and anything new and exciting that deals with cancer is pored over at ASCO.
One of the exciting results announced at ASCO has been the affect of Tykerb on patients who have failed Herceptin therapy. The trial compared breast cancer patients on chemotherapy to those on chemotherapy + Tykerb. The results were that the 320 women who took Tykerb alongside their chemo went 4 months longer than those on just chemo without their cancer progressing. As a bonus, Tykerb is administered orally rather than intravenously.
GSK is expected to submit the findings to the FDA this year, and Tykerb could hit the market as early as 2007. Hopefully Tykerb will not get tripped up like Avastin did under further review. If it remains a success, Tykerb could be a very big seller, and benefit thousands of women in the US alone. In the future, Tykerb could compete against Herceptin more directly.
[tags]Medicine, pharmacy, ASCO, Tykerb, GSK, cancer, oncology[/tags]
"Pill Pushers" — science for salesmanship?
Or sensationalist journalism to sell more magazines? Maybe both?
Probably both. Yep. It's both.
In the May 8 issue of Forbes magazine, the feature article is about Big Pharma and their marketing efforts. Stories like this are nothing new, nor do they really have anything contructive to say on the topic except to shine a bright light on a problem that has popular appeal. Big Pharma does spend a lot of money on marketing, but is it too much? I don't think so, and consequently I can't resist going through the article and picking out bits and pieces that're off the mark, and the ones that are right on. Yes, this is my idea of fun while being stuck in the lounge of a car dealership, waiting to get my car back…
This article is about 2000 words short, so you may wish to get a coffee before you start reading. Or, you know, go to the bathroom or something.
- The balogna
- Contradictions and lifestyle drugs
- Science or marketing?
- "Me-too" drugs
- Marketing and the game of deception
- Short term profits, long term value and calculated risk
- HMOs to the rescue?
- The problem of medical journals
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]