Merck & Co's huge rise in profits was overshadowed somewhat by the news that the US Food and Drug Administration will rescind breakthrough therapy designation for its hepatitis C combo, due to the highly-effective drugs from Gilead Sciences and AbbVie already on the market.

The FDA cited the availability of other recently-approved treatments for HCV genotype 1 patients for the move. Merck recently announced that it expects to file grazoprevir/elbasvir (MK-5172/MK-8742), an oral, once-daily combination, in the first half of 2015, adding that the withdrawal of BTD will not impact its ability to file an NDA “or the timing of that filing”.

Back to the financials and fourth-quarter net income came in at $7.32 billion, up from $781 million in the like,year-earlier period, boosted by an $11.2 billion gain on the sale of its consumer care business to Bayer. Turnover declined 7% to $10.48 billion, hit by currency impact.

The asthma blockbuster Singulair (montelukast) was up 7% to $319 million, while the anti-allergy medicine Nasonex (mometasone) fell 18% to $268 million, hit by generic competition.

The company's best-selling meds are the diabetes drug Januvia (sitagliptin) and Janumet (sitagliptin plus metformin) which collectively brought in $1.65 billion, a rise of 2%. Sales of the cholesterol drugs Vytorin (ezetimibe plus simvastatin) and Zetia (ezetimibe) totalled $1.03 billion, down 10%, while the anti-inflammatory Remicade (infliximab), the Johnson & Johnson drug which Merck sells outside the USA, contributed $557 million, also down 10%.

Turnover from the HIV drug Isentress (raltegravir) reached $418 million, a fall of 5%, while sales of the cervical cancer vaccine Gardasil decreased 10% to $356 million.

Merck said it expects full-year 2015 earnings of $3.32-$3.47 per share, excluding special items but including a $0.27 impact from foreign exchange.