Myriad Genetics’ Phase III compound, on the other hand, is a selective amyloid (amyloid beta 42) lowering agent that acts through a gamma-secretase pathway. A recent report by Decision Resources regarding Flurizan’s effect in delaying progression from mild cognitive impairment to AD, touted the drug’s potential to become the gold standard of treatment.
The launch of Flurizan is expected in 2010 with a 23% market share by 2016. Ian Sanderson of Cowen and Co. forecasts sales of $600 million by 2012 and he expects it to be the first next-generation drug to be approved by the FDA. Annabel Samimy of UBS has a Buy on the stock after considering the firm’s pipeline as well as its diagnostic business. Geoffrey Meacham, Ph.D., of JPMorgan has an Overweight rating on the stock.
Targacept is focused on a class of molecular targets called neuronal nicotinic receptors (NNR) that are involved in neurotransmitter activity potentially strengthening the nerve signal. Six analysts currently have a Buy rating on the company: CIBC, Deutsche Securities, Leerink Swann, Lazard, Nataxis, and Pacific Growth.
Targacept’s lead compound, which is partnered with AstraZeneca, is in a Phase IIb study. AZD-3480 is a small molecule drug being investigated as a treatment for cognitive impairment in both AD and schizophrenia. Results are expected by the end of 2008.
AZD-3480 has already been tested in 12 trials involving 540 subjects, it was well tolerated and had positive effects in cognition. The company has extensive IP for NNR and is also partnered with GlaxoSmithKline for other NNR drug targets. Additional IND’s are expected in Q2.
Other companies with Phase II drugs are Prana Biotechnology and Medivation. Recently, Prana reported a successful Phase IIa trial for PBT2 that showed reduced Abeta 42, a biomarker associated with AD. PBT2 is an MPAC (metal protein-attenuating compound) 8-hydroxyquinoline that reduces the impact of naturally occurring metals such as copper, thus attenuating the damaging effects of amyloid beta.
Medivation plans to initiate a pivotal confirmatory Phase III trial with Dimebon in Q2. The successful Phase II study was done in Russia, but the late-stage evaluation will be in the U.S. Dimebon appears to block a new target that involves mitochondrial pores, which are believed to play a role in cell death. Dimebon was previously approved and is used in Russia as an antihistamine.
Alzheimer’s disease is a huge market, with drugs in development that can be very cost effective. Phase II results from the aforementioned companies are encouraging, and winners should emerge as early as the first quarter of 2009. Review company websites, analysts’ reports, and technicals before investing.
Rod Raynovich is a principal at Raygent Associates. Web: www.raygent.com. Phone: (310) 379-5533. E-mail: [email protected]