Replies to post #161762 on Biotech Values

[jq1234]

Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIA

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/05/bayer-joins-the-combo-drug-nce-challenge-club-petitions-fda-for-5-year-exclusivity-for-natazia-.html?utm_source=twitterfeed&utm_medium=twitter

the company asks the Agency to effectively erase the award of 3-year new clinical investigation exclusivity for the oral contraceptive NATAZIA (estradiol valerate and estradiol valerate/dienogest) Tablets and instead award a period of NCE exclusivity. Similar requests for NCE exclusivity recognition were made in petitions submitted to FDA earlier this year concerning STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets (Docket No. FDA-2013-P-0058) and PREPOPIK (sodium picosulfate, magnesium oxide and citric acid) for Oral Solution (Docket No. FDA-2013-P-0119). Indeed, the STRIBILD petition called out NATAZIA as one example for which NCE exclusivity would be ongoing if FDA had awarded such exclusivity in the first place.

[jq1234]

NCE: In shift, FDA to give 5-year exclusivity for fixed dose combination (FDC) containing a new active moiety

[It confirmed my previous contention that FDA was trying to make general guidance on this subject by delaying exclusivity decision on AMRN's Vascepa and GILD's Stribild]

New Interpretation

"As a result, an application for a fixed-combination submitted under section 505(b) of the FD&C Act will be eligible for 5-year NCE exclusivity if it contains a drug substance, no active moiety of which has been approved in any other application under section 505(b).30," FDA explained. "For example, a fixed-combination drug product that contains a drug substance with a single, new active moiety would be eligible for 5-year NCE exclusivity, even if the fixed-combination also contains a drug substance with a previously approved active moiety."

http://www.raps.org/focus-online/news/news-article-view/article/4680/utm_source/social/utm_medium/post/utm_campaign/rfnews.aspx

Here is draft guidance which will apply from now on, not retroactively to already approved, ie GILD's Stribild and Bayer's Natazia:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386685.pdf