Synergy Pharma's Chief Strategist Discusses Recent Results And Coming Catalysts

Last Friday, shares of Synergy Pharmaceuticals Inc SGYP traded down 5.78 percent, even though the company made public positive data from its first of two Phase III trials for its clinical constipation-predominant irritable bowel syndrome (IBS-C) drug, plecanatide.

On Monday, research firm Rodman & Renshaw issued a Buy rating on the stock, while raising its 12-month price target from $15.00 to $16.00, “In the wake of this favorable data, and in anticipation of positive results from the second trial of plecanatide in IBS-C,” which are expected before the end of the year. However, the stock continued to tumble, losing more than 5.3 percent.

Stock moves aside, Benzinga wanted to know more about Synergy Pharma and plecanatide’s potential, so we reached out to the company’s Executive Vice President and Chief Strategy Officer, Marino Garcia.

About Plecanatide

“We feel very comfortable about plecanatide and the role it can play in the market, if approved by the FDA, for both CIC [chronic idiopathic constipation] and IBS-C, just because it’s clearly shown that it works, its efficacious, and [it's] dealing with the symptoms of these patients. So, in a way, it’s ideally suited for this market, with an excellent tolerability and safety profile,” he said when asked about the recent results.

“It’s a very easy-to-use medication that can deal with the primary complaints these patients have, which is their constipation and/or the abdominal pain that comes with IBS-C, with a very favorable tolerability and safety profile, based on the Phase III data and what we are seeing,” he added.

The study addressed the two aforementioned complaints, the chief strategy officer went on. “By showing efficacy on that dual endpoint, [the study] clearly shows that [our drug] is reducing abdominal pain.”

Going into the two Phase III studies conducted by Synergy Pharma, he voiced, “[This] is ideal for a regulatory submission, where the FDA is looking for two replicate studies. They are currently reviewing two studies in CIC; we have a target approval date of January 29, 2017 [and] feel good about the interactions we’ve had with the FDA [...] With IBS-C, we expect the second trial will also be positive, which will read out by the end of the year, and then we will submit a supplementary NDA, as soon as possible, in 2017.”

“So, we hope to start the year with an approval in CIC, and the drug launched soon thereafter, and potentially end the year with another approval for the second indication, IBS-C,” he concluded.

The Size Of The Market

Benzinga moved on to ask about the size of the market for CIC and IBS-C.

According to Garcia, it has been estimated that about 45 million adults in the United States suffer from these conditions, with data suggesting that the CIC market is twice as large as the IBS-C market in terms of prevalence.

“The question really becomes, ‘how many of these patients go to see their physicians?’” he explained.

Financials

Finally, Benzinga questioned Garcia about the company’s financial stance. “At the end of the third quarter, we had $109 million on our balance sheet. So, we feel we are in a strong position [despite recent market moves].”

At last check, Synergy Pharma shares were down 5.62 percent at $4.93.

Liked this interview? Now check out our chat with Immune Pharmaceuticals Inc IMNP’s CEO, who talked about the company and its recent market rally.