Monday, February 18, 2008

New Drugs?

I'm writing this from the point of view of retail pharmacy because that's what I know about....

Does anyone know if there are any potential blockbuster drugs in development for the big pharmaceutical companies? I admit that I've fallen a little behind when it comes to recent developments in the pharmaceutical industry.

The other day, I was thinking about what pharmacy will be like in 10 years, and I got to thinking about how just about all the drugs out right now will be off-patent with generic versions available. Lipitor will be generic. Plavix will be generic (again!). Pretty much all the blockbuster brand name drugs will be generic.

If this is the case, what are the pharmaceutical companies developing to replace these drugs? I know in many cases, they'll just make an XR version or a single enantiomer version (i.e. Zyrtec to Xyzal), but insurance companies tend to limit the use of those drugs.

I've touch on this before when I mentioned how treatment guidelines for the major longterm diseases (hypertension, hyperlipidemia, chronic heart failure, diabetes) haven't changed all that much in quite some time. Statins are still the drug of choice for high cholesterol. Heart failure and post-MI patients still use beta-blockers and ACE Inhibitors. Type II diabetics still use mainly Metformin and/or a sulfonylurea.

I haven't heard of anything coming out in the near future that will completely change our guidelines for those diseases. Therefore, if no big advances come out in the next 10 years, we'll be looking at the majority of chronic illnesses being treated pretty much entirely with generic drugs. This will be great for the patients, great for the insurance companies, and great for pharmacies. However, the big pharmaceutical companies won't be too happy about this.

The pharmaceutical companies will have to respond to this in some way, and I don't think making products like Ambien CR or Xyzal will be sufficient. Will they be forced to drop their prices in order to compete with generics? More likely, they'll spend tons of money trying to convince doctors that their latest and greatest "me too" drug is a HUGE improvement over the less costly generic.

I think it will be interesting to see how this all plays out. I suppose we'll get a really good glimpse when we see how Pfizer responds to Lipitor coming off-patent. All I know is that if I were in charge of one of those big companies, I'd cut my enormous direct-to-consumer advertising budget and start spending a lot more cash on drug research and development. Without a revolutionary new drug, these companies could be in a lot of trouble.


Gary said...

yea i agree...once all those brands come off patent and generics will be available what in the world will these drug companies do? as for pfizer they were working on a new drug (im blanking on the name) but it was supposed to increase your HDL. however, people died during testing (so i heard) needless to say that didnt go over too well.

Eric, AKA The Pragmatic Caregiver said...

The every-two-weeks form of Byetta could be a monster drug with very little chance of meaningful generic competition - biosimilars are gonna be a mess.

Disease-modifying Alzheimers drugs will be monsters. Single-enantiomer flurbiprofen, caprospinol, etc.

Non-monitored anticoagulants could make warfarin a thing of the past.

I'd bet good money that a wildly effective NSAID would be a monster if they can address the safety issues.


Pharmacy Mike said...

To answer both posts...

Ximelagatran, the direct thrombin inhibitor that was supposed to make coumadin obselete, didn't get approved due to liver damage.

Torecetrapib (Pfizer's HDL raiser) was supposed to be a huge blockbuster, but that didn't make it either.

I wouldn't say drugs like Byetta or Januvia are really changing the ways we treat diabetes. They're basically just another option to get some additional lowering of hemoglobin A1C.

A safer NSAID would be pretty huge, but I haven't heard about any in development. We all saw how well Vioxx and Bextra worked out in that regard.

I suppose we do have a lot of room for advancement in the treatment of Alzheimer's Disease, so that could be an area too.

Eric, AKA The Pragmatic Caregiver said...

I suspect that the Byettaesque stuff won't be so much for diabetes as metabolic syndrome / obesity. Look at the hope there was for rimonabant with the relatively modest weight loss, and then look at the quartile data for Byetta. *On average*, Byetta isn't that impressive as a weight loss agent, but if you take out the 25% of people who lost the least weight, it' It's enough weight loss to take people from Obese to Merely Overweight. Add this to the FDA's reluctance to take on the biosimilars issue, and it's got monster potential. Right now, the bid sub-q dosing holds it back more than the efficacy. I agree that it isn't a revolution in diabetes control, though.

Obesity drugs in general have probably the broadest blockbuster market potential, but the pipelines are littered with failures. I think Merck's cannabanoid drug is going to have the same side f/x problems that doomed Sanofi. I'm also noting a lack of new active ingredients in the stuff that is doing well in Phase II/III trials - say, Orexigen's combo of modified-release zonisamide and bupropion. I think it's the BiDil situation - prescribers will just use generic zonisamide and bupropion XL rather than buy the clever combo. The Neuropeptide Y agents look intriguing, but the studies are too early to tell much. But given the general number of fatasses waddling through the world, I can't help but seeing even something as modestly effective as orlistat, minus the crap-your-pants part, as being a monster.

(note - I too, am a fatass)

The NSAID pipeline is admittedly Kate Moss-grade thin, given the failure of Arcoxia, Dynastat and Prexige. I can't help but think that there's some preclinical work based on the new understandings of COX activity in the platelet as reported by the group from Rochester whose name escapes me at the moment - nonetheless, with aging boomers coming onstream every day, OA drugs have such huge market potential.

I think you're basically right though - where's the next Zestril or Celebrex or Prilosec? Clearly, some of the oral oncology agents (well, maybe not Nexavar) are going to be big, and they're gonna be something you pick up at the pharmacy for $6K/bottle, but the absolute number of patients on them isn't going to be Truly Stunning.

It seems like the recipe for success is:

1) Completely New or substantially improved treatment for a problem that bothers people where existing treatments had some gaping hole of failure. Examples being lack of boner (yes, there were ED drugs prior to Viagra, but they didn't prompt guys to call their doctor and ask for it). ALso acceptable: nail fungus with Lamisil tablets, not being able to sleep but wanting to wake up without much of a hangover (insert short-half-like hypnotic here), etc.

2) Problem lasts a long time, but won't kill you instantly. Acute MI? Ear infection? You take the drug for a couple of days or weeks.

3) Affects middle-aged white people with insurance. Malaria has huge potential, but there's no money in it.

4) Doesn't require dopey delivery devices or more than 2x/daily dosing. Bonus points for once.

pharmacy chick said...

I really think if they ever came out with a workable female version of viagra/cialis/etc, they would really have something. After all 50% of people who have sex are female and there are no meds out there to help the pre or post menopausal issues of libido in women.

Chris, Pharm.D. said...

As for female libido, doesn't testosterone help?.....but the real point of my comment: Levo-atorvastatin!!!! All the great benefits of atorvastatin but less side effects! Will probably be released a few months prior to the expiration of the Lipitor patent. There will be a study that shows 0.5% absolute risk reduction for rhabdo or something.

Anonymous said...

There are probably quite a few blockbuster drugs in development, but no one knows about them yet. Metformin, for example, was a drug that was expected to play a minor role in diabetes - but it was huge because of outcome studies.

Lipitor should have been a minor addition to the statin market, but it got huge based on clinical succsss.

I work in industry on R and D on drugs, and you never know when your drug is going to take off or tank... and most of them tank - never to be seen again.

As to your point about DTC adversiting and R and D budget.... the reason you have an R and D budget is BECAUSE of DTC. DTC ads sell more drugs - and with more sales, you direct more monies to R and D. Cut pharma sales, and research will dry up. Then again.. in some ways, it looks like pouring more money in R and D doesnt guarantee success. You need a lotta luck.