Pharma jaw-dropping cases and open innovation !!!

Big Pharma Failures Light the Way to Change 8/16/2012 @ 8:09AM Chris Bowe wrote this message.This is a guest post by Christopher Bowe, the US Healthcare Analyst at Informa Scrip. Informa is the leading global provider of specialist information to the scientific & academic, professional and commercial markets. First, bapineuzumab – Pfizer, Johnson & Johnson and Elan’s high-profile monoclonal antibody for Alzheimer’s disease – is all but dead. The infused drug failed again to show it could change the disease’s progression in patients. Anticipated and watched for nearly 10 years, the drug came to Pfizer in its $68 billion acquisition of Wyeth. Second, Bristol-Myers Squibb stopped a Phase II study of its BMS-094 for hepatitis C because of a serious safety issue. This is widely seen as a bad sign for this drug’s future and maybe other drugs like it. The really bad news: In February, Bristol-Myers Squibb paid $2.5 billion to acquire biopharma company Inhibitex, the developer of the drug.To save itself – and save more patients – the industry should take two vital steps: develop a more flexible approach to drug approval and patent exclusivity and change its business model to encourage more scientific collaboration among companies. The first change is relatively closer to our grasp; the second requires a sea change in the industry. The failure of bapineuzumab is the latest in a long line of disappointing compounds for Alzheimer’s. Possibly, no other disease – from patient suffering through public health to healthcare budget implications – needs breakthroughs more desperately. And the challenges and money required to achieve them are clearly enormous. It’s a perfect opportunity to develop a pilot program that could alter the current regulatory model of the industry. Broadly, pharma companies would open a new era with key regulators (FDA, EMA) and national payers to allow a vastly more flexible and adaptive approach to developing disease-modifying therapies – with agreed-upon biomarkers, and new tools to measure both real and surrogate endpoints. They could set new rules to allow companies to adapt trials to advance the approval of promising answers more quickly – for example, when it’s clear that a subset of patients is benefiting significantly. It could also agree on biomarkers and measurements to determine possible approval for promising drugs – and ways to predict and see patient response.In exchange, companies would agree to a stringent provisional approval scheme, whereby the comparative effectiveness and relative value of the drug’s outcomes would be continuously measured. Drugs that proved comparatively effective would be awarded pricing premiums and sliding patent exclusivity. It could work like this: a drug would be provisionally approved for its effects on biomarkers or patients reactions. Payers, led by the government, would allow the provisionally approved drug to be used at a very low price. Meanwhile, the provisionally approved drugs would be continually studied for their effect in patients, and comparatively to see which is better. Drugs that increasingly showed real value would be allowed price increases accordingly and could be awarded extra patent life. Provisional approvals could change, and protections for patients would be part of the continual process. Moreover, this process could result in a pool of real-world data that could help in future research or treatment. If not now with Alzheimer’s, then when for these kinds of concepts? The trouble with BMS-094 points the way toward the second, and far more difficult, change the industry needs to make. The trouble lies in the gamesmanship in large dealmaking and disease target selection in the pharmaceutical industry – gamesmanship that so often diverts or siloes vital capital and resources from solving patient health issues. During the past year, there was a frenzy to acquire drug assets aimed at the hepatitis C virus (HCV). In the wake of Gilead’s $11 billion buy of Pharmasset, another clinical stage development company working on HCV, this frenzy resulted in Bristol-Myers Squibb’s acquisition of Inhibitex. But what if the industry, instead of continuing to waste all that money in mega-deals and duplicated effort, decided to revamp its intellectual property (IP) structure? Companies could develop mutually beneficial ways to collaborate scientifically before possible therapeutic pathways hardened into fiercely protected IP. First, they could increasingly use a consortium of companies and scientists, including academic institutions, to participate in research and find new ways to assign economic benefit to the collaborators. To some degree, this is already beginning to happen. Second, rights could be configured, purchased or set in the collaboration to take a drug into expensive late-stage clinical trials aimed at gaining approval. It’s possible that we would get crucial answers to health challenges much faster than we do now with companies grinding away at similar therapeutic mechanisms. And I’m confident that under this new system entrepreneurial business people would find a way to produce products, sell them with structured patent exclusivity and make significant profits. The money invested in failure these days is jaw-dropping; and people are counting on this industry. Instead of repeating the same mistakes year after year, the industry must learn from its past failures and find the innovative way forward.