Changes for page Egalet Corporation
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... ... @@ -2,24 +2,31 @@ 2 2 {{toc/}} 3 3 {{/box}} 4 4 5 -= = 5 += Paragraph 1 = 6 6 7 - Egalet Corporationisa fullyintegrated specialtypharmaceuticalcompany developing, manufacturingandcommercializing innovativetreatmentsforpain andotherconditions.Giventheneedfor acute andchronicpainproductsandtheissueof prescription abuse,the company focusednbringing non-narcoticand abuse-deterrent(“AD”) opioidformulationstopatientsandphysicians.Egaletis currentlymarketingARYMO® ER (morphinesulfate)extended-release(“ER”) tablets, fororaluseCII (“ARYMOER”), SPRIX® (ketorolactromethamine) NasalSpray (“SPRIX NasalSpray”),andOXAYDO®(oxycodoneHCI,USP) tabletsfor oraluseonly—CII (“OXAYDO”).7 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 8 8 9 - ARYMOER, an ER morphine product formulated with abuse-deterrentpropertiesand approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whichalternative treatment options are inadequate, is its first product developed using its proprietary Guardian™ Technology. Egalet acquired, and became obligated to pay royalty payments under a preexisting license of, SPRIX Nasal Spray, the first and only approved nasal spray formulation of a nonsteroidal anti-inflammatory drug (“NSAID”), used for short‑term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Egalet also licensed OXAYDO, an immediate-release (“IR”) oral formulation of oxycodone designed to discourage intranasal abuse, which is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.9 +== Sub-paragraph == 10 10 11 - InJune2017,Egalet securedaontractwithone ofthelargestpayersin theUnitedStates(“U.S.”)thatwillprovidecoverageofARYMO ER tomorethan24 millionofitsmember lives.Egaletbelievethatthiscontractwillenable itto removebarrierstoaccesstoARYMO ER forthe applicablehealthcareproviders andthepatientstheytreat.11 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 12 12 13 - Alsoin June 2017, Egalet entered into a two-year agreement with Ascend Therapeutics ("Ascend") to co-promoteSPRIX Nasal Spray to more than 9,000 women's healthcare practitioners. The agreement, set to begin in the third quarter 2017, will enable it to avail itselves of the 37-person Ascend sales team to promote SPRIX Nasal Spray to healthcarepractitioners in women'shealth.13 +== Sub-paragraph == 14 14 15 - Itssupplementalnew drugapplication(“sNDA”)forOXAYDO tosupportanabuse-deterrent labelclaimfortheintravenousroute ofabuse hasbeen acceptedbytheFood andDrug Administration(“FDA”) and had a goaldateofMarch 30, 2017. The FDAis stillreviewingthefilendan actionispending.The sNDA includesdatafrom a batteryof Category1invitro abuse-deterrent studies that was presentedat thePAINWeek conferencein September2016. OnJune 20, 2017, Egaletreceived a completeresponse letter (“CRL”) fromtheFDA regardinga priorapprovalsupplement(“PAS”) for OXAYDO® 10 mgand15 mgdosage strengths. The FDA has requestedmore information regardingtheeffectof food onOXAYDO 15 mgandtheintranasalabuse-deterrentpropertiesof OXAYDO 10 mgand 15mg.Egaletintendto work with theFDAtodetermine the path forward.15 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 16 16 17 - Beyondits commercial programs, Egalet has a pipeline of products developed using its Guardian Technology. Egalet-002, an AD, ER, oral oxycodone formulation, iscurrentlyin Phase 3 studies and in development for the same indication as ARYMO ER. Egalet has determined to delay indefinitely its previously-announced anticipated 2019 filingdate forthe Egalet-002 New Drug Application. Egalet alsohaveEgalet-003, an AD stimulant, and Egalet-004, an AD, ER hydrocodone, which were developed using its Guardian Technology. Egalet is seeking partners for all of its product candidates.17 +=== Sub-sub paragraph === 18 18 19 - Egalet continueo focusitsbusinessdevelopment onaugmentingitsproductportfoliothroughpotentialin-licensesandproductcquisitions;enhancing theopportunitiesfortsexistingproductsthrough partnershipsthataccessphysiciansnd patientsoutsideofitscommercialfocusintheU.S. ormarketsoutsidetheU.S.; and developing partnershipstoleverageitsGuardianTechnology by collaboratingon itscurrentproduct candidatesor exploringnewproductopportunities.FinancialOperations19 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 20 20 21 -Its net losses for the three months ended June 30, 2016 and 2017 were $23.8 million and $26.5 million, respectively, and $42.3 million and $51.9 million for the six months ended June 30, 2016 and 2017, respectively. Egalet recognized revenues in the three months ended June 30, 2016 and 2017 of $3.5 million and $6.3 million, respectively, and $6.1 million and $11.7 million for the six months ended June 30, 2016 and 2017, respectively. As of June 30, 2017, Egalet had an accumulated deficit of $277.8 million. Egalet expect to incur significant expenses and operating losses for the foreseeable future as Egalet incur significant commercialization expenses as Egalet continue to grow its sales, marketing and distribution infrastructure to sell its commercial products in the U.S. 22 22 23 - UntilEgalet become profitable, if ever, Egalet will seek to fund its operationsprimarily throughpublicor private equity or debt financings or other sources. Other additional financing may not be available to it on acceptable terms, or at all. Its failure to raise capital as and when needed could have a material adverse effect on its financial condition and its ability to pursue its business strategy. If Egalet is unable to raise capital when needed or on attractive terms, Egalet could be forced to delay, reduce or eliminate its research and development programs or any future commercialization efforts.22 += Paragraph 2 = 24 24 25 -= References = 24 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 25 + 26 +== Sub-paragraph == 27 + 28 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 29 + 30 +== Sub-paragraph == 31 + 32 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.