What's latest news? Do we keep studying?
You should never count your chicks before they've hatched, right Stacy.
Has the launch team layed an egg? Things are looking scrambled and that's no yoke. Maybe they can still pullet out.
Rare for a press release with any significance to be given while the market is open. I look for it after the market closes. (if today)
So for now, no news is good news.
Given the Zohydro backlash, approving any opioid is a third rail topic with the FDA. Looks like they'll drag it out and move cautiously.
For Ventiv employees, don't be surprised to receive a revised offer letter with yet another pushed back employment contingency date that hinges on XXR product approval.
3 month extended review due to new data submitted by company.
They knew this was going to be the outcome when they submitted the data, they just "hoped" for a Hail Mary!
Good Luck!
The above statement seems to be with respect to the previous delay announced on 11/25. Thus far, I've seen no concrete public news about this latest delay. Not here, not on the corp site, not on the FDA press site, nor anywhere else. Would expect to see something today.
Relax people. It's gonna be ok.
I am a bit confused. I found the pasted article below a with a simple Google search for Xartemis...
http://processandproduction.pharmac...ives-us-patent-for-xartemis-xr-260214-4184953
As the DEA asked us to hold our launch? I don't get it...
*******
Mallinckrodt receives US patent for Xartemis XR
Published 26 February 2014
Mallinckrodt has announced that it was granted a patent from the US Patent and Trademark Office which contains composition claims directed to unique design, formulation, pharmacokinetic, and release characteristics of Xartemis XR.
Xartemis XR (formerly known as MNK-795) is an investigational extended-release oral formulation of oxycodone and acetaminophen that has been studied with twice daily dosing for the management of acute pain in a post-surgical model.
If approved, Xartemis XR will be the first oxycodone and acetaminophen combination medication specifically designed with immediate- and extended-release components. The patent, US Patent Number 8,658,631, was issued on 25 February 2014.
The release profile of Xartemis XR combines Mallinckrodt-proprietary technology and Depomed's advanced Acuform drug delivery technology. Between the Mallinckrodt and Depomed patent families, Mallinckrodt believes Xartemis XR will have strong patent protection for its novel features.
Mallinckrodt president and CEO Mark Trudeau noted Xartemis XR, a key driver in the company's near-term pipeline, represents an important component of its strategy to unlock continued potential and grow its branded specialty pharmaceutical portfolio.
"Mallinckrodt's patent, which includes the product's release profile, underscores our ability to effectively leverage our core formulation capabilities and partnerships," Trudeau added.
I am a bit confused. I found the pasted article below a with a simple Google search for Xartemis...
http://processandproduction.pharmac...ives-us-patent-for-xartemis-xr-260214-4184953
As the DEA asked us to hold our launch? I don't get it...
*******
Mallinckrodt receives US patent for Xartemis XR
Published 26 February 2014
Mallinckrodt has announced that it was granted a patent from the US Patent and Trademark Office which contains composition claims directed to unique design, formulation, pharmacokinetic, and release characteristics of Xartemis XR.
Xartemis XR (formerly known as MNK-795) is an investigational extended-release oral formulation of oxycodone and acetaminophen that has been studied with twice daily dosing for the management of acute pain in a post-surgical model.
If approved, Xartemis XR will be the first oxycodone and acetaminophen combination medication specifically designed with immediate- and extended-release components. The patent, US Patent Number 8,658,631, was issued on 25 February 2014.
The release profile of Xartemis XR combines Mallinckrodt-proprietary technology and Depomed's advanced Acuform drug delivery technology. Between the Mallinckrodt and Depomed patent families, Mallinckrodt believes Xartemis XR will have strong patent protection for its novel features.
Mallinckrodt president and CEO Mark Trudeau noted Xartemis XR, a key driver in the company's near-term pipeline, represents an important component of its strategy to unlock continued potential and grow its branded specialty pharmaceutical portfolio.
"Mallinckrodt's patent, which includes the product's release profile, underscores our ability to effectively leverage our core formulation capabilities and partnerships," Trudeau added.
