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Eli Lilly and Co (LLY.N)

LLY.N on New York Stock Exchange

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21 Apr 2017
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Latest Key Developments (Source: Significant Developments)

U.S. FDA issues CRL for baricitinib
Friday, 14 Apr 2017 09:00am EDT 

Incyte Corp : U.S. FDA issues complete response letter for baricitinib . Letter indicates that FDA is unable to approve application in its current form . Specifically, FDA indicated that additional clinical data are needed to determine most appropriate doses . FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms . "Companies disagree with agency's conclusions" . Incyte is evaluating impact of complete response on its previously-issued milestone and research and development expense guidance for 2017 .Lilly is reaffirming both its financial guidance for 2017 and its mid-term guidance for remainder of this decade.  Full Article

Eli Lilly says Lilly Endowment Inc reports open market sale of 210,000 of stock
Friday, 31 Mar 2017 12:16pm EDT 

Eli Lilly And Co :Lilly Endowment Inc reports open market sale of 210,000 of co's common stock on march 30 at $84.674 per share - SEC filing.  Full Article

Intelgenx Technologies says Eli Lilly granted Versafilm exclusive license for tadalafil film product under erectile dysfunction dosing patent
Tuesday, 28 Mar 2017 08:10am EDT 

Intelgenx Technologies Corp : Intelgenx Technologies- Eli Lilly granted Intelgenx' Versafilm exclusive license for tadalafil film product under erectile dysfunction dosing patent . Intelgenx Technologies Corp - any exclusivity associated with tadalafil compound patent expiring is not affected by this agreement - SEC filing . Intelgenx Technologies- exclusive license allows co to commercialize tadalafil ed versafilm product in U.S. prior to expiration of '166 dosing patent Source: (http://bit.ly/2nvYskj) Further company coverage: [IGX.V] ((bangalore.newsroom@thomsonreuters.com;)).  Full Article

Eli Lilly announces $850 mln investment in U.S. capital projects in 2017
Friday, 24 Mar 2017 08:00am EDT 

Eli Lilly And Co : Lilly announces $850 million investment in U.S. capital projects in 2017 . During 2012-2016, had increased U.S manufacturing workforce by more than 1,000 employees-from 5,000 to 6,000 roles-with about 400 added in Indianapolis . Company's investments span facilities across its U.S. Enterprise . Expansion is part of five-year investment by company to expand its diabetes products manufacturing operations in U.S. . Plans for a new $85 million expansion of its Trulicity (Dulaglutide) device assembly operations in U.S. . "On a path to launch 20 new products in a 10-year time frame" . Significant investment in manufacturing diabetes medicines continues with new $85 million commitment in indianapolis . Eli Lilly and Co says more favorable tax climate could lead to additional U.S. investments .Expansion also includes a $140 million insulin cartridge production facility.  Full Article

Ignyta to explore strategic options for Taladegib through amendment of Taladegib license agreement with Lilly
Thursday, 23 Mar 2017 04:00pm EDT 

Ignyta Inc : Ignyta announces exploration of strategic options for Taladegib, enabled by amendment of Taladegib license agreement with Lilly . Ignyta - agreement amends and restates prior license, development and commercialization agreement, dated November 6, 2015, by and between Ignyta, Lilly .Ignyta Inc - entered into amended , restated license, development, commercialization agreement with Eli Lilly and company for Taladegib Oncology program.  Full Article

Lilly says phase 3 breast cancer study meets primary endpoint
Monday, 20 Mar 2017 06:45am EDT 

Eli Lilly And Co : Lilly announces phase 3 monarch 2 breast cancer study of abemaciclib met primary endpoint of progression-free survival . Eli Lilly And Co - its monarch 2 trial of abemaciclib met primary endpoint of progression-free survival (pfs) . Eli Lilly And Co- intends to submit a new drug application (nda) for single-agent abemaciclib in q2 of 2017 .Plans to submit an additional application for monarch 2 in q3 of this year.  Full Article

Eli Lilly says senior VP of corporate affairs and communications to leave
Thursday, 2 Mar 2017 06:45am EST 

Eli Lilly And Co : Lilly announces changes in senior management . Eli Lilly and Co - Johna Norton will be promoted to senior vice president of global quality April 1, replacing Fionnuala Walsh . Eli Lilly And Co - Bart Peterson, senior vice president of corporate affairs and communications, will leave Lilly March 31 .Eli Lilly And Co - search currently is under way for Peterson's replacement.  Full Article

Perrigo announces FDA final approval for the generic version of Axiron topical solution
Wednesday, 1 Mar 2017 08:55am EST 

Perrigo Company Plc :Perrigo announces FDA final approval for the generic version of Axiron topical solution, 30 mg/1.5 ml.  Full Article

Lilly says provisions included in legislation to repeal Affordable Care Act could adversely affect results
Tuesday, 21 Feb 2017 03:44pm EST 

Eli Lilly And Co :Provisions included in legislation repealing, replacing affordable care act could have material adverse effect on consolidated results, cash flows.  Full Article

Lilly announces label update for its diabetes drug Trulicity
Wednesday, 8 Feb 2017 06:45am EST 

Eli Lilly And Co - : Lilly's Trulicity (dulaglutide) label updated to include use in combination with basal insulin for adults with type 2 diabetes .Label for once-weekly trulicity is now updated to include use in combination with basal insulin for adults with type 2 diabetes.  Full Article

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