Although the Phase I through Phase III failure rate is 90-95%, the odds of success may still be improved in the next generation of drugs launched. The news website Endpoints has recently organized for us the top 10 R&D pipelines that suffered great setbacks in the second half of 2017.
No. 1: AstraZeneca—The year’s biggest failure didn’t leave the scar outside, but it still hurt inside
AstraZeneca was forced to concede in July last year that the crucial clinical trial of the combination therapy Mystic (Imfinzi and tremelilumab) had failed the test on progression-free survival (PFS) in non-small cell lung cancer (NSCLC), which gave a terrible start of second half of 2017 for it. Mystic was deemed to be an immunotherapy that could compete against Merck’s Keytruda and BMS’ Opdivo, but the failure made the company’s share price plunge 15%, remarkable for a pharmaceutical giant with 15 blockbuster pipelines. And Merck and BMS are still unshakeable in this field. Despite the setback, AstraZeneca will continue its tumor immunotherapy research. There is still no conclusion on one pivotal Phase II study of it, but market expectations have dropped considerably, as the saying goes "you bet big, you lose big".
No. 2: Roche—It will lose the income of blockbuster drugs, and the Phase III clinical failure of a new drug added to its woes
The problem the biopharmaceutical giant Roche is confronted with is the biosimilars’ threats against its three cash cows: Avastin, Herceptin, and Rituxan. Genentech’s Lampalizumab was the new blockbuster drug the company placed high hopes on, but its two Phase III clinical trials targeting patients with acute macular degeneration successively failed in September and November last year, and the project was thereafter ended. Therefore, this drug expected to reach USD 150-200 million market sales was written off. The impression Roche gives is that it well publicizes the successful drugs, such as Hemlibra approved last year, but is usually quiet about the failed projects. It is hoped that it could add transparency on the failed project results in the future.
No. 3: Celgene—Big money is no guarantee of success, but sometimes makes you more painful
Celgene paid USD 710 million to gain the right to develop the antisense RNA drug Mongersen, but the drug failed the Phase III clinical trial in autumn last year, which is considered as a cautionary case: making investment decision before having sufficient reliable information relating to a drug. Now all eyes have shifted to the clinical results of Celgene’s multiple sclerosis Ozanimod, which Celgene acquired for USD 7.1 billion from Receptos. Having yet walked out the shadows of Mongersen today, Celgene already reached another USD 9 billion deal with Juno. It was clear that Celgene was feeling pressured to add "something solid" to the product R&D pipelines. Mongersen’s failure made its pipeline R&D all the more urgent.
No. 4: Acorda—Misfortunes never come singly
Acorda conceded in November last year that the Tozadenant for Parkinson's disease had risks in clinical trial and suspended relevant Phase III study. The key patents on its franchise drug Ampyra were likely to be stripped away earlier last year. Its CEO Ron Cohen announced the acquisition of Finland’s Biotie in early 2016 for USD 363 million to add a badly needed late-stage drug to the company’s R&D pipeline, but thereafter, FDA announced that its drug CVT-301 had a safety issue, which threw a damp. The year was awful for Acorda, and the failure of the drug Tozadenant that was at late R&D stage was the most direct blow.
No. 5: Johnson& Johnson—Self-confidence is important, but there’s no arguing with data
In the first half of last year, J & J claimed that it had the late-stage R&D pipeline in place to deliver steady revenu...
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