The US Food and Drug Administration has awarded Merck & Co’s cancer drug Keytruda (pembrolizumab) a second breakthrough therapy status, this time signalling its belief that therapy may offer patients with a specific form of lung cancer a significant improvement over existing approaches.
The anti-PD-1 immunotherapy is being developed for the treatment of Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC), in patients whose disease has progressed despite platinum-based chemotherapy.
Keytruda was also previously awarded breakthrough status for advanced or unresectable melanoma in patients no longer responding to other treatment, for which it has since bagged an FDA approval, and it is also being studied across more than 30 types of cancers, both as monotherapy and in combination with others.
Meanwhile, the drugmaker, which is known as MSD outside of the US and Canada, saw its sales for the third quarter slip 4.3% to $10.56 billion, falling shy of the $10.67 reportedly forecast by Wall Street. The decline includes $425 million of lower sales due to divestitures and the termination of the joint venture with AstraZeneca.
But the drop in sales was also driven by an 11% fall in revenues from cervical cancer jab Gardasil to $590 million, on weaker uptake by US vaccination programmes, as well as continued patent loss effects.
Diabetes and anti-inflammatories doing well
On the flip side, combined sales of diabetes drug Januvia (sitagliptin) and Janumet (sitagliptin/metformin) grew 5% to $1.4 billion in the third quarter, reflecting higher sales in the US and Europe (although these were partially offset by price reductions in Japan), while those from anti-inflammatory drugs Remicade (infliximab) and Simponi (golimumab) were up 11% at $774 million.
On paper the company earned $895 million, or $0.31 per share, compared to $1.12 billion, or $0.38 a share a year earlier. But, taking special items out of the equation, profit came in at $0.90 per share, overshooting analysts’ expectations of $0.88 a share, after a round of aggressive cost cuts that included a significant internal reshuffle.
"Last October, we launched a multi-year initiative to transform Merck and build a platform for sustained, future growth," said chief executive Kenneth Frazier, noting that “one year later, we delivered solid third-quarter results and are making steady progress in our transformation, including divesting non-core assets, reducing our expense base and investing in our promising new product launches and pipeline”.
The group trimmed its full-year 2014 earnings forecast to $3.46-$3.50 per share, from prior guidance of $3.43 to $3.53 per share.