The Top 10 Pharma Drug Recalls: Time for Innovation



Niamh Madigan
08/08/2012

Pfizer and Johnson & Johnson recently  announced that they were going to stop the development of the Alzheimer’s drug, Bapineuzumab, which was designed to halt build-up of plaque in the brain of patients, because it failed in two late-stage clinical trials. It also failed to improve cognitive or functional performance compared with a placebo in certain patients.

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With high profile late stage development failures occurring right across the industry, there now seems to be an increased pressure to make the right decisions as early as possible in development. But, the elephant in the room remains; why aren’t problems spotted during early development? Shouldn't more money, time and resources be put into Phase 1 clinical development to ensure there are less failures when drugs reach a later stage of development?

The third and final stage of clinical testing is designed to confirm the efficacy and safety of new drugs under development. Yet research indicates that, as many as four drugs in ten fail during this phase, according to research conducted by  McKinsey Quarterly.

‘Some of the key time saving strategies and information sources to make these decisions are trial design approaches, imaging techniques, biomarkers, strategic outsourcing and patient recruitment,’ says Nicola Ambler, Senior Conference Director, Pharma IQ,  who is directing the upcoming ' Innovation in Phase 1 Clinical Development’ in Milan this September.

Pharma IQ had a quick look back over the last few years to see a timeline of drug failures and recalls at the late stages of development.

August 2012: Pfizer and J&J announced  they were going to stop the development of the  Alzheimer’s drug, Bapineuzumab.

May 2012: Roche take a bashing after the Swiss major has pulled the plug on dalcetrapib, a drug which raises 'good' cholesterol, after suffering a late-stage, Phase III study failure. No safety signals were reported but Roche decided to terminate the study and the six-trial dal-HEART programme, two of which have been completed. Over 35,000 patients were involved in the studies.

March 2012: AstraZeneca and Targacept announced that their partnered depression drug--TC-5214 failed at Phase III. The last two of four late-stage studies failed to meet their primary endpoints, eliminating plans for a comeback after the first two Phase III studies also ended in failure.

March 2011: GlaxoSmithKline and partner Tolerx were dealt a blow as their drug otelixizumab failed a late-stage, Phase III trial. The drug, a humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune Type 1 diabetes.

March 2011: Sanofi-Aventis’ lung cancer drug aflibercept failed to meet its primary endpoint in a phase III trial.

December 2010: Roche’s Avastin, with $6.2 billion in 2010 sales, was withdrawn for mestastatic breast cancer as there was little proof that it extend lives and it also triggered side effects including high blood pressure and bleeding when used for the disease. The drug remains approved for colon, lung, kidney and brain cancer.

May & October 2010Roche and Biogen Idec had to pull a Phase II and Phase III study when volunteers died after taking their new drug Ocrelizumab (being tested for 2 different indications).

September 2010: GSK was hit hard when the European Medicines Agency (EMA) announced Avandia (rosiglitazone) and all diabetes medications containing rosiglitazone, used to treat diabetes Type 2, were to  be taken off the market. This included the following brands:  Avandia, Avandamet and Avaglim.

October 2007: Eli Lilly and Company announced the company was voluntarily withdrawing the sepsis drug Xigris from the market after disappointing study results..
So while Pharmaceutical companies are under more pressure to build their pipeline and get more drugs approved, particularly with impending patent cliff, perhaps they need to return to the drawing board and develop a more innovative approach.

Craig Lipset, Head of Innovation at Pfizer explains, ‘today there is a much greater sense of urgency than ever before. We really need to work together to push boundaries to ensure that we're able to fulfil our moral, ethical and legal obligations to patients. But at the same time we need to find creative new ways to work with patients, investigators and other stakeholders to understand efficacy and safety.’

While every pharmaceutical company is looking for the next blockbuster drug, high through put screening may be the best approach big pharma can take. As Jade Barker, former Chemist and blogger surmises, ‘Big pharma know most of the drugs are dead ends - but it only takes one winner to cover the cost of all the losers and then some.’

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