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.
Generic Famvir: Here today, gone tomorrow
That's my prediction, anyway. Teva has launched their generic Famvir amidst ongoing patent litigation, which is a pretty risky move. They risk damages if they lose their case, because there're no pesky clauses to cover their asses like Apotex had. So far as I know, anyway. As far as I can see, Teva's just using the ponderous judicial process to give them some time to sell a new drug. They'll block proceedings at every turn, that's guaranteed.
Quick review: Hatch-Waxman allows the first generic manufacturer to get its ANDA approved to have 180 days of market exclusivity, unless they sell the rights to this period of time back to the pharmaceutical company that developed the drug. This effectively results in 6 additional months being tacked onto the end of a patent. Apotex had done this with their generic Plavix, but slipped in a clause wherein they could start selling immediately if there was any question about the validity of the patent. Once BMS had inked the deal, Apotex turned around and contested the patent thereby allowing them to start selling immediately without fear of repercussion. Pretty shrewd on their part. (Apotex also has no annoying shareholders to please since they are a privately-held company, so they can get away with stuff like this.)
This was why generic Plavix was available for a while, and then disappeared.
Teva doesn't have anything like this, so they're really going out on a limb, here. I'm not sure how their move is legally defensible, and I'm 95% sure that they're going to lose. The only question will be whether the actuaries did their math right: will the revenue generated during this time will be greater than the damages awarded Novartis for stepping on their toes?
At least this won't be as bad as the Plavix debacle which really pissed a lot of people off on both sides of the counter, myself included. Famvir isn't really a maintenance drug in the same way as Plavix, and there're far fewer people taking it than Plavix. It's also not the only drug in its class, and Valtrex remains more popular. Thank God for small mercies.
Teva are a bunch of twats, though, as far as I can see.
[tags]Teva, Famvir, famciclovir[/tags]
What does $5,256.08 look like?
It looks a little something like this:
Will Lovenox eventually have an approved generic?
Sanofi Aventis had its patent overturned in a California court the other day, but the millionbillion dollar question is whether or not a generic can be approved to compete with the brand. That's thanks to the lack of a generic biologic approval pathway. Basically, the law which allows non-biologic generic drugs uses the process laid out in 505(b)(2) or 505(j) of the Food, Drug, and Cosmetic Act.
An equivalent approval route for biologic drugs hasn't been established yet, but now the question is whether or not enoxaparin can be approved under 505(b)(2) or 505(j). The door isn't completely closed through 505(b)(2), but it's not exactly black and white whether a follow-on product is possible, either. So now that the patent's been overturned, does it even matter?
[tags]Medicine, pharmacy, Lovenox, enoxaparin[/tags]
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]
More on reversing Type 1 diabetes
This past summer, I went on an article-printing spree, and one of the things I printed was this NYTimes article about the work of Dr. Denise Faustman, a diabetes researcher out of MGH in Boston. I read it early last week, and had been idly wondering what became of her research, thinking I should dig and see if anything newer had happened. Fast-forward to last night, I was cruising digg, and I came across more results involving the same protocol that she used back in 2003.
In March of this year, three other labs confirmed that Dr. Faustman's protocol could reverse Type 1 diabetes in non-obese diabetic (NOD) mice. Those results were inconclusive on the role of spleen cells in the recovery of insulin-producing pancreatic islets. The new data from the NIH provide a fourth confirming study, and more significantly, the role of spleen cells in islet regeneration.
In the 2001 and 2003 studies, Faustman and colleagues treated end-stage nonobese diabetic (NOD) mice with Freund's complete adjuvant, a substance that suppresses the activity of the immune cells that destroy islets in type 1 diabetes. They also introduced donor spleen cells to retrain the immune system not to attack islets and found that the protocol not only halted the immune destruction caused by diabetes but also allowed the insulin-producing pancreatic islet cells to regenerate. Evidence indicated that the spleen cells were the source of at least some of the regenerated islet cell and hastened the restoration of blood sugar levels.
The direct contribution of spleen cells to islet recovery, first described in the 2003 study, is confirmed in the current work. NIH researchers used cell lineage tracking in the form of Y-chromosomal fluorescence in situ hybridization (FISH), in combination with insulin staining, to follow the fate of male spleen cells transplanted into female recipients. The female mice that received male donor cells consistently showed Y-chromosome-positive insulin-producing islet cells, indicating that the introduced spleen cells contribute to islet recovery. The current study also showed that the degree of spleen cell contribution is influenced by mouse age at the start of treatment. Spleen cells appear to contribute to islet recovery more in mice who are older and with more advanced diabetes compared with younger mice with less advanced diabetes, in which regeneration of remaining islets may be the dominant mechanism.
With four studies confirming the success of the diabetic reversal, I am wondering when Phase I human trials will begin. From an economic standpoint, FCA and BCG are both good choices, since they are both orphaned drugs. FCA is incredibly old — Dr. Freund, the guy who created it, died in 1960.
While I'm glad to see the success of these studies, it's still a long way from mice to people. I have my doubts about the side effect profile of this treatment as well. FCA is a biologic made (usually) from killed M. tuberculosis, and is forbidden for use in humans. It has a high incidence of painful reaction and potential tissue damage. So that leaves BCG, a similar, but less potent biologic made from M. bovis, found in TB vaccines. The NYT article states that BCG was used in Dr. Faustman's 2003 work, but the original research paper (PDF) indicates that it was actually FCA.
This leaves me wondering two things: 1) will BCG have a similar effect and 2) if BCG is not successful, will FCA be approved for use in humans?
[tags]Medicine, diabetes, type 1 diabetes, fca, bcg, biochemistry, physiology[/tags]
Generic clopidogrel: whiplash for the masses
Saturday morning, we received a voicemail sent to all of the branches in our chain about the stopped production of generic clopidogrel. You may recall that Apotex shipped all of the generic it had on hand as soon as their deal with S-A and BMS fell through. Well a judge has just ordered Apotex to stop producing and shipping the generic, so you can see why Apotex was in a hurry to get everything they had out the door, just in case.
Fortunately, there's not going to be a recall, so Judge Stein certainly made the right decision in that case, but I'm waiting to hear what the shakeout ends up being. Will generic clopidogrel remain on the market or will it disappear? The voicemail made it sound like our company's supplies of the generic will hold for as long as it takes to resolve the matter once and for all, but that could just as well have been in response to Apotex assurances that everything would go swimmingly. The possibility that Apotex might lose wasn't even considered, which I found disingenuous. That's in stark contrast to this WaPo article which makes it sound as though Apotex has no chance of winning at all. (Which very well could mean that it was written from a press release from Sanofi-Aventis, given that there's no stock response information for BMS listed, who also has a huge stake in Plavix's fate.)
Frankly, I don't know what to think. I'm not a lawyer, and I'm not familar with the patent dispute in this particular case. The folks at Patent Baristas don't have much more, either. If the generic disappears, it's going to piss a lot of people off, both patients and providers. Myself included. No one likes being jerked around, particularly when it affects their wallet.
[tags]Medicine, pharmacy, plavix, clopidogrel, Apotex[/tags]