Synergy Pharmaceuticals Inc.’s second quarter 2013 loss (excluding the change in fair value of derivative instruments) of 13 cents per share was narrower than the year-ago loss of 15 cents and the Zacks Consensus Estimate of a loss of 23 cents per share. The share count was higher in the second quarter of 2013 than a year ago.
The biopharmaceutical company did not generate any revenues in the second quarter of 2013 as was the case a year ago. Research and development expenses at Synergy Pharma climbed 18.7% to $9.1 million in the second quarter of 2013. The increase was due to Synergy Pharma’s efforts to develop its pipeline. General and administrative costs increased to $2.8 million in the second quarter of 2013 from $1.9 million a year ago.
Synergy Pharma to Offload FV-100 Assets
In a separate development, ContraVir Pharmaceuticals, Inc. – currently a subsidiary of Synergy Pharma – filed a Form 10 Registration Statement with the U.S. Securities and Exchange Commission (SEC) for the planned spin-off of its FV-100 assets into an independent publicly traded entity.
The Form 10 includes pertinent information about ContraVir and the planned separation. This comprises an overview of the business, which ContraVir will operate apart from the company’s competitive strength and other relevant factors. Through this move, Synergy Pharma intends to focus on its core areas of strength.
Focus on plecanatide
Plecanatide is Synergy Pharma’s lead pipeline candidate. Last month, Synergy Pharma announced that the enrolment procedure of its phase IIb study on plecanatide for the treatment of patients suffering from irritable bowel syndrome with constipation (IBS-C) has reached the halfway mark.
Synergy Pharma expects to enroll a total of 350 patients suffering from IBS-C for the phase IIb study, which is being conducted around 70 sites in the US. Synergy Pharma expects to enroll the last patient for the study in the final quarter of 2013 and release top-line data from this study in the first quarter of 2014. The constipation market currently includes Ironwood Pharmaceuticals/ Forest Laboratories’ (IRWD - Analyst Report)/ Linzess.
Plecanatide is also being developed for treating patients suffering from chronic idiopathic constipation (CIC). Earlier in the month, Synergy Pharma reached an agreement with the U.S. Food and Drug Administration (FDA) on the plan of developing plecanatide further for treating CIC patients.
The FDA agreed on the design, duration, size and primary and secondary efficacy endpoints of the phase III studies. As per the agreement with the FDA, Synergy Pharma will initiate a pivotal phase III study by year end to evaluate the safety and efficacy of plecanatide in CIC patients.
Synergy Pharma currently carries a Zacks Rank #3 (Hold). Right now, Questcor Pharmaceuticals, Inc. looks attractive with a Zacks Rank #1 (Strong Buy).