Drugs

Flawless Product Launch Helps Commercial Success: Consultants

L.E.K. Consulting says that FDA approval for a new drug is no guarantee of commercial success. In a report on lessons learned from the company’s Launch Monitor, L.E.K. says that to drive real value, biopharma companies must execute the launch process flawlessly. “As history shows,” the report says, “many companies fail in this process, due to a combination of factors such as limited market access, poor understanding of market needs, or misjudgment of competitive threats.”

The report lists these executive insights:

the average peak U.S. revenue of products introduced over the past 15 years is about $800 million, with only 20% reaching U.S. sales of $1 billion and over 50% failing to reach U.S. sales of $250 million;
on average, products reach about 50% of peak sales by year three and the early year sales are strongly predictive of ultimate peak sales;
about half of all products launched over the past 15 years have under-performed pre-launch consensus forecasts by more than 20%;
while performance issues cut across all therapeutic areas, infectious diseases, immunology, and cardiovascular diseases are the therapeutic areas where the most products underperform Wall Street expectations;
on average, large pharma companies’ product launches have average peak revenues 50% higher than those of smaller players;
small companies are more likely to underperform expectations than larger companies and the difference in revenue performance is magnified in diseases driven by primary care channels; and
early launch planning, effective stakeholder engagement, better forecasting, and highly disciplined execution can help address barriers and better manage Wall Street expectations.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome