Contributed by: Dennis Fortier, President, Medical Care Corporation
A few weeks ago, we wrote about the glimmering ray of hope that had emanated from bad news about potential new Alzheimer's treatments.
Both Bapineuzumab and Solanezumab, the two most progressed new drugs in the development pipeline, had both failed the final stage of their respective clinical trials, and would not be approved by the FDA. However, there was some evidence, and much speculation, that both drugs had shown signs of efficacy in secondary data analyses.
Now, as presented at the American Neurological Association's 2012 annual meeting earlier this week, those secondary analyses have been verified and a newfound optimism has swept the field.
Of course, drug approvals require a massive investment of time and money, and drug companies must always weigh the costs of completing that high risk process, against the benefits they might capture during the few remaining years of the drug's patent life, once the process is completed and the drug is commercialized.
Readers might be surprised to learn that drug companies sometimes abandon effective drugs, if the approval process takes too long and the viable (patent protected) period for recouping their investment is too short. This is the decision that Eli Lilly (Solanezumab) and Pfizer (Bapineuzumab) must now face as they consider the time and cost of next steps to bring these drugs to market.
At this point, there are two encouraging signs that each company might push forward and lobby the FDA for an efficient path to near-term approval. One is that the Federal government, under the National Alzheimer's Prevention Act, is committed to identifying new treatments for this disease. The other, is that the Wall Street analysts, ever pessimistic about success of new AD drugs, have pushed Lilly's stock price upwards in the wake of this new information.