Merck wins FDA approval for Gardasil follow-up

Merck's ($MRK) Gardasil follow-up is here, meaning blockbuster sales figures are likely on the way. But the bad news is that they'll come at the expense of the world's second-best-selling shot.

Merck's Gardasil HPV vaccine--FierceBiotech file photo
Merck's Gardasil

On Wednesday, the FDA approved Gardasil 9, which prevents cervical, vulvar, vaginal and anal cancers caused by the four HPV types its predecessor protects against, as well as an additional 5 types--31, 33, 45, 52 and 58--that cause approximately one-fifth of cervical cancers, according to the FDA.

In a study of approximately 14,000 females ages 16 through 26, Gardasil 9 proved as effective as Gardasil at blocking the four shared HPV types, and researchers determined it was 97% effective in preventing cancers caused by the 5 additional types.

While analysts estimate the new vaccine could rake in $1.9 billion a year at its peak, much of its potential market share will come at Gardasil's expense. Leerink has estimated the old vaccine will sink to just $525 million in 2018 sales for the New Jersey pharma giant--a far cry from last year's $1.83 billion tally.

But Merck may be able to amp up Gardasil 9's haul if it can overcome some of the uptake issues that have been plaguing the original shot since it hit the market. A variety of factors, including sex-related stigma, have weighed on sales, leading analysts to revise Gardasil sales predictions that once reached as high as $10 billion.

On that front, however, the company got some good news earlier this week: In a study of teen girls, HPV vaccination didn't lead to an increase in risky sexual activity, a new study showed.

- read the FDA's release
- get more from Reuters on the HPV study

Special Reports: The top 5 vaccine makers by 2013 revenue - Merck | Top 10 best-selling vaccines of 2013

Suggested Articles

The FDA is evaluating the possibility of prosecuting those involved in rogue herpes vaccine research led by a Southern Illinois University professor.

New legal complaints focus on eight Sanofi executives, most of them with local management titles, and 15 managers at distributor Zuellig Pharma.

Experts say technology is advancing to develop vaccines faster at a time of increasing emerging disease outbreaks.