The US Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 than it did last year, as the industry faces a number of ongoing operational risks, according to a new report.

The total of 30 new primary care and specialty medicines approved for marketing in the US in 2011 will be hard to beat this year, warns the study, from Fitch Ratings. Despite a strong first quarter, with eight New Molecular Entities (NMEs) approved, the total of 14 new approvals in first-half 2012 lags behind the 18 new approvals in the same period of 2011.

While the research success of branded drugmakers in 2011 will be difficult to repeat, their more modest goal of filing 12 new medicines for marketing authorisation this year is "obtainable," says the ratings agency. "Last year, branded drug manufacturers reached three-fourths of their target for regulatory registration, submitting 18 of 24 over therapies for review with drug authorities," the report notes.

2011’s unusually high number of registrations is now nearing fruition, with 13 NMEs currently under review at the US FDA or the European Medicines Agency (EMA), with expectations of full marketing approval over the next few quarters.

Filings with the FDA and/or EMA are planned this year for the following 12 NMEs: 
- Bayer's alpharadin for bone metastases in prostate cancer and regorafenib for metastatic colorectal cancer; 
- GlaxoSmithKline's IPX066 for Parkinson's disease and Revolair for chronic obstructive pulmonary disease; 
- Johnson & Johnson's canagliflozin for type 1 diabetes;
- Merck & Co's Bridion for reversal of neuromuscular blockade and suvorexant for insomnia;
- Pfizer's Aprela for relief of menopausal symptoms;
- Roche's trastuzumab-DMI for metastatic breast cancer; and
- Sanofi's Kynamro (mipomersen) for familial hypercholesterolemia, iniparib for breast cancer and Lyxumia (lixisenatide) for diabetes.

The slowdown in new late-stage projects that started at the end of last year has continued into 2012, the study also finds. Fitch-rated branded drug developers added four novel drug projects to their research programmes during the first quarter, plus another four thereafter, compared to the five NMEs which were added during fourth-quarter 2011 and 11 in the third quarter. Seven of this year's eight investigational drugs arose as a result of business development activities during recent years, it notes.

Fitch-rated firms also saw fewer stumbles in their late-stage drug projects during first-quarter 2012, when four problems arose with Phase III research assets compared to seven issues in fourth-quarter 2011. However, this low number of major obstacles did not hold steady into second-quarter 2012, when the developers experienced six more problems.  To date, delays in 2012 "are almost evenly split between outright project cancellations and regulatory hiccups," says the report.

Fitch also reports that the pharmaceutical patent wave is now cresting, with three of the industry's 10 once best-selling medicine having lost market exclusivity. Specifically, the world's top-selling drug, Pfizer's Lipitor (atorvastatin), lost its exclusivity in November 2011, while Eli Lilly's Zyprexa (olanzapine) and Sanofi's Plavix (clopidogrel) both did in so in May 2012. Another former top 10 drug, Merck & Co's Singulair (montelukast), will face generic competition from August.