Chief Executive of Gilead Sciences Inc. (NASDAQ:GILD) [Detail Analytic Report], John Milligan stated in an interview that it’s time for them to go out and do major deals, Bloomberg reported. They need some other assets that can bolster their pipeline. Milligan, who become the new Chief Executive in March, has inherited the drugmaker at a critical juncture. Sales of Harvoni and Sovaldi, Gilead’s two blockbuster hepatitis C drugs among the fastest-selling drugs of all time fell for the first time previous quarter as they face competing products, sparking concerns that the franchise will decline faster than predicted.
Milligan added he’s eager to score a significant asset in cancer, one of the three therapeutic areas he seeks to extend alongside liver diseases and inflammatory disorders. Gilead, whose only approved cancer drug, Zydelig, is limited in use because of its side effects, doesn’t have a significant compound in-house. Gilead has a nascent oncology platform, but what he doesn’t yet see is a drug that they can rally around, he added. With $21.3 billion in cash and short-term equivalents on hand, he has the firepower to spend big. The pressure is high to repeat the success his predecessor John Martin had with the $11 billion deal in 2011 that brought in hepatitis C drug Sovaldi, which helped double revenue in 2014.
While he wouldn’t identify specific targets, Geoffrey Porges, analyst at Leerink Partners LLC, estimates the Milligan needs to find a product that would add $5 to $10 billion to revenue in the coming five to ten years to move the needle. Porges added in another era he would be considered one of the most respected executives in the entire industry, but unfortunately he’s sort of stepped into the leadership position at a very challenging time and effectively has to re-prove himself.
Mast Therapeutics, Inc. (NYSEMKT:MSTX) [Detail Analytic Report] released its first quarter financial results for the three months completed on March 31, 2016. The Firm’s net loss for the period was $11.2 million, or $0.06 a share compared to a net loss of $9.6 million, or $0.06 a share for the same quarter in 2015. Brian M. Culley, Chief Executive Officer of Mast commented during first quarter earning call thet the Q1 was a productive one for the firm. Not only did they complete enrollment in their Phase III EPIC research of vepoloxamer in sickle cell disease, but also they reported positive data from a Phase IIa research of AIR001 in patients with heart failure with preserved ejection fraction conducted at Mayo Clinic, and the selection of AIR001 for a double-blind, placebo-controlled Phase II research in approximately 100 patients with HFpEF to be conducted at premier U.S. clinical centers that make up the HFN.
Culley added with 388 patients, the EPIC research was the largest placebo-controlled research in sickle cell disease ever concluded and should provide many insights into the activity of vepoloxamer in this indication. Importantly, vepoloxamer has the potential to become the first and only approved therapy for shortening the duration of a sickle cell vaso-occlusive crisis and they are working diligently toward generating top-line results, which they expect to announce this quarter.
Meanwhile, they are advancing their two heart failure programs. Their 150-patient Phase II research of vepoloxamer in chronic heart failure is ongoing, with ten research sites now open, and the HFN’s 100-patient Phase II research of AIR001 in HFpEF is anticipated to begin in the Q3 of 2016.
Synthetic Biologics Inc. (NYSEMKT:SYN) [Detail Analytic Report] declared a loss of $10.8 million in its recently competed quarter. The Maryland-situated firm disclosed that it had a loss of 12 cents a share. The results beat Wall Street estimates. The average estimate of experts polled by Zacks Investment Research was for a loss of 13 cents a share.
President and Chief Executive Officer of Synthetic Biologics, Jeffrey Riley commented during conference call that their momentum from last year carried into the first quarter of 2016, as they continued to make important clinical progress in their microbiome-focused programs. During the period, they announced positive topline results from the second Phase II clinical trial of SYN-010 in patients with IBS-C.
Riley added they are scheduled to present detailed data supporting earlier announced positive topline data from both SYN-010 Phase 2 clinical trials in a poster presentation at DDW 2016 later in May. They also look onward to holding an end of Phase II meeting with the FDA this summer to discuss late-stage clinical trials of their SYN-010 program. With this continued progress, they are well positioned to start Phase III clinical trials of SYN-010 during the second half of 2016.