Commercialization Plecanatide

1 commercialization

1.1 manufacturer financials
1.2 intellectual property
1.3 regulatory information

commercialization

trulance manufactured synergy pharmaceuticals, inc. (nasdaq: sgyp), biopharmaceutical company focused on gastrointestinal diseases. sgyp acquired pawfect foods, inc. in july 2008. prior acquisition, synergy majority-owned subsidiary of callisto pharmaceuticals. in january 2013, callisto pharmaceuticals merged synergy pharmaceuticals (having owned 40% of synergy s stock. plecanatide synergy s drug on market.

manufacturer financials

in first quarter of 2017, synergy reported net loss of $64.6 million, compared $59.9 million net loss in first quarter of 2016. rather expected, trulance has come on market, , came substaintial costs. has resulted in slight drop in stock price in recent months. however, company has no debt. puts plecanatide 1 step above roughest competition, linaclotide (manufactured ironwood pharmaceuticals), because ironwood beholden enormous amounts of debt , unlikely turn profits many years. synergy plans reach profitability 2018. of march 2017, synergy had $16.7 million in convertible debt $139 million in cash. comparison, ironwood remains unprofitable after 5 years , has $238 million remaining in convertible debt.

plecanatide being marketed sales force of 250, , marketing targeting top 70% of brand name drug prescribers. sgyp reports 60% of adult patients cic , commercial insurance have unrestricted access trulance. however, express scripts announced not include trulance on 2018 preferred drug formulary , sgyp has since taken hit.

intellectual property

synergy pharmaceuticals inc. has been issued total of 21 patents patent , trademark office (uspto) related gc agonists, expiration dates 2022-2034. 3 new patents method of manufacturing, formulations, , methods of using plecanatide issued uspto. patents plecanatide have been issued european patent office (epo). in may 2010, manufacturer of plecanatide s main competition, ironwood pharmaceuticals, filed anonymous opposition patent. after synergy complained ironwood had filed opposition falsified , misleading information, epo chose uphold synergy s right patent. in addition, there 8 foreign patents plecanatide.

regulatory information

synergy pharmaceuticals, inc. filed investigational new drug (ind) application fda on april 2, 2008, , may 2, 2008 had received notice proposed study safe. first phase clinical trial plecanatide (formerly proprietary drug sp-304) began in june 2008. beginning in february 2010, multiple phase ii clinical trials initiated, including cic3 , national cic3 trials. latest phase ii trial cic concluded in march 2016. there have been multiple phase iii trials plecanatide in pursuit of ibs-c indication, latest of completed in june 2017.

in january 2016, nda filed fda , april pdufa action date had been assigned. noted above, plecanatide approved use in cic in january 2017. snda filed in march 2017 add additional indication of irritable bowl syndrome constipation (ibs-c) , pdufa date set january 2018.