Wyeth & Elan: More Questions in Alzheimer’s Study Results (WYE, ELN)
Today was the long awaited Alzheimer’s drug data presented from Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE). The companies presented detailed results from their 18-month Phase II study of bapineuzumab in patients with mild to moderate Alzheimer’s disease.
The study was on 234 randomized with findings reported on 229 patients, and efficacy was measured from a baseline of 78 weeks. The data looked very positive on the surface with safety and efficacy results supporting the design of an ongoing global Phase III program.
Some data is mixed and shares were hit as a result. It showed statistically significant and clinically meaningful effects were observed in multiple endpoints in ApoE4 non-carriers. The company also noted that pre-specified efficacy analysis did not reach significance in the total population.
Favorable directional changes were seen in some endpoints in ApoE4 carriers, warranting further study. The post-hoc anlysis showed statistically significant and clinically meaningful benefits in important subgroups.
You can read about the full results here. There were measurements of less or slower brain shrinkage combined with better memory test results observed in the study, and if our data is correct that would be superior to any existing treatments and is probably above other study reports to date.
The problem is the pre-specified efficacy analysis as well as a few deaths in the trial (which were noted as “unbelieved to be from the drug” despite no deaths in teh placebo group.
This data was shown at the Alzheimer’s Association’s International Conference on Alzheimer’s Disease 2008 in Chicago, Illinois.
Shares are getting slapped down in after-hours. Wyeth stock is down 8.5% at $41.25 and Elan stock is down 15% at $28.49 in after-hours trading. Both stocks had been higher initially ahead of the data. This looks more and more like mixed data, and unfortunately it looks like Alzheimer’s patients have a long way to go before even any meaningful help will arrive.
Jon C. Ogg
July 29, 2008 (5:45 PM EST)
Small Alzheimer’s Play Draws Attention After Others Failed
You have probably noticed the recent failure of some once-promising Alzheimer’s Disease treatments. Mryiad Genetics (NASDAQ: MYGN) saw a huge disappointment over this recently.
A small Autralian biotech called Prana Biotechnology Ltd. (NASDAQ: PRAN) is out making the rounds showing how its Alzheimer’s treatment is showing promise.
Today it announced the publication of key research findings with its lead Alzheimer’s Disease drug, PBT2, in an article titled “Rapid restoration of cognition in Alzheimer’s transgenic mice with 8-hydroxyquinoline analogs is associated with decreased interstitial Abeta” in the current edition of the scientific journal Neuron. Its key features are:
- PBT2 profoundly and rapidly improved cognition in transgenic mice.
- PBT2 prevented the formation of soluble Abeta oligomers, the form of Abeta believed to be the most toxic.
- PBT2 substantially reduced the amount of all forms of Abeta in the transgenic mouse brain, over a nine week period.
- PBT2, within hours of oral administration, significantly lowered soluble (interstitial) Abeta in the brain, sampled using in vivo microdialysis.
- Using a well established model for memory formation, PBT2 protected neurons in living brain tissue from the toxic effects of Abeta which impairs the signaling between neurons in Alzheimer’s disease.
The company also noted yesterday that its co-founding scientist recently addressed the U.S. Senate Special Committee on Aging.
This alone isn’t really a stock event in and of itself. But it does still leave some underlying and residual value in Prana as long as its data doesn’t take a nose dive. Its shares are very thin volume in the U.S> and today’s level is $3.63.
Its 52-week trading range is $2.06 to $6.73. Its market cap is listed as $65.9 million, but we would caution that it raised $7 million via a private placement in may to fund its research programs. At that time shares were north of $4.00.
It’s going to take quite a bit longer to know just how well these ongoing research programs develop in the quest to beat or even tame Alzheimer’s. Any drug that makes it to market that can make any impact has a mega-blockbuster potential.
Jon Ogg
July 9, 2008