Merck & Co., Inc (NYSE:MRK)’s famous five falter
Merck & Co., Inc (NYSE:MRK) investors had been holding onto faith in the company but that too seems to be on shaky ground now. The FDA has cancelled an advisory meeting that had been planned for sugammadex, the company’s post-surgery drug. It’s the fifth major blow to GMX and there’s no saying for how long investors are going to hold onto their horses (read shares).
The 5 that haven’t seen the light of day
Last February the company had spotlighted its top-5 late stage projects during the entire-year 2011 conference call. Sugammadex, HPV vaccine V503, suvorexant the insomnia treatment, Tredaptive the cholesterol drug and odanacatib the osteoporosis drug were the company’s famous five. Since then, all these 5 drugs have hit rough weather and investors are getting shaky. The company has poured $8B annually for R&D but doesn’t really have much to show for it, at the moment.
Sugammadex encounters trouble
Muscle relaxants are used post surgery. Sugammadex was developed to reverse after-effects of these relaxants. If it does receive approval, the drug will become a 1st in class selective relaxant-binding agent. Its 1st new drug application had been filed in 2008. Since then, the drug has faced one issue after the other with the FDA. The drug had received recommendation by an early advisory committee, but the FDA cited allergic reaction concerns and ended up issuing a “not-approvable” action letter.
Critical for the company’s health
Earlier this year, the company resubmitted the NDA which had received approval. However, this too was cancelled by the panel this week. Investors should know that a panel cancellation is not equivalent to a failure, but it is a definite setback. Especially at this moment, Sugammadex was important for the company with reference to the fact that the previous four drugs mate a similar fate and got sidelined into the shadows.
Merck & Co., Inc (NYSE:MRK) has said that it is in talks with the FDA to identify what steps need to be taken to complete the sugammadex review. MRK strongly believes that this drug offers distinct advantages in comparison to its competitors.