It’s been a bad few weeks for Big Pharma. First, Bristol-Myers Squibb announced that the much-hyped Opdivo drug failed to meet a clinical endpoint in a non small-cell lung cancer trial, which turns out might be good news for a rival Merck drug.
But Friday, New Jersey-based Merck had its own set of bad news to report.
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The New Jersey company announced that after an independent analysis of its Odanacatib drug to treat osteoporosis, it won’t be developing the drug. That analysis found that the drug increased the risk of stroke.
“We have learned that odanacatib treatment reduces the risk of osteoporotic fractures. At the same time, we believe that the increased risk of stroke in our Phase 3 trial does not support further development,” said Roger Perlmutter, president, Merck Research Laboratories, in a statement.
Odanacatib was meant to be a once-weekly oral drug that would inhibit the cathepsin K enzyme, that plays an important role in the cells that break down existing bone tissue —especially, the protein components of bone.
In its 2015 annual report, while acknowledging that the drug had led to more strokes in patients than the placebo, the company nonetheless concluded that it would go ahead and apply for regulatory approval in 2016 once the independent analysis was completed.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
However, the writing was already on the wall if the history of this drug’s development is followed.
Back in 2014, when the company had reported that there were safety issues it had also declared that it would seek regulatory approval that year, according to Reuters. And even that was a delay from 2013 when the company pushed back the regulatory filing citing that it needed additional data.
Pharma companies like Merck are trying to protect their revenue stream as generics come to market, and Odanacatib was supposed to be one such candidate.
Analysts had at one time pegged the market potential for the drug at its peak to be $1 billion by 2020.
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