Key Developments: Eli Lilly and Co (LLY.N)

LLY.N on New York Stock Exchange

30 Jan 2015
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Latest Key Developments (Source: Significant Developments)

Eli Lilly and Co and Acrux file lawsuit against Amneal Pharmaceuticals LLC for infringement of patents
Wednesday, 10 Dec 2014 05:24pm EST 

Eli Lilly and Co, Eli Lilly Export S.A. and Acrux DDS Pty Ltd:Files a lawsuit against Amneal Pharmaceuticals LLC.For infringement of four issued US patents that cover Axiron.Patents are owned by Acrux DDS Pty Ltd, a wholly-owned subsidiary of Acrux Limited, and are exclusively licensed to Lilly.Lawsuit was filed in the United States District Court for the Southern District of Indiana in response to a notice letter sent by Amneal regarding its filing with the FDA of an Abbreviated New Drug Application (ANDA) for a Testosterone Metered Dose Transdermal Solution.  Full Article

Eli Lilly and Co and Incyte announce positive top-line results from phase 3 trial of Baricitinib in moderate to severe rheumatoid arthritis
Tuesday, 9 Dec 2014 07:00am EST 

Eli Lilly and Co and Incyte Corp:Says that the Phase 3 RA-BEACON study of investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment.Says study included patients with moderately-to-severely active rheumatoid arthritis (RA) who previously failed one or more tumor necrosis factor (TNF) inhibitors and who were taking stable doses of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy.Says companies will share results of several ongoing Phase 3 studies in various disclosures in 2015.RA-BEACON study enrolled 527 patients who had previously failed at least one anti-TNF therapy, and included high percentage who had also received prior treatment with one or several non-anti-TNF biologic agents.Says patients received either 1 of 2 doses of once daily baricitinib or placebo in addition to their background conventional disease-modifying anti-rheumatic drug therapy (cDMARDs).  Full Article

Eli Lilly and Company CYRAMZA (ramucirumab) in Combination with Paclitaxel GRANTED FDA approval for Advanced Gastric Cancer after prior chemotherapy
Wednesday, 5 Nov 2014 02:49pm EST 

Eli Lilly and Company:Says that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA(ramucirumab) in combination with paclitaxel (a type of chemotherapy).As a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.This FDA approval for CYRAMZA is based on the Phase III RAINBOW trial, which compared CYRAMZA plus paclitaxel to placebo plus paclitaxel.Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate.  Full Article

Eli Lilly and Company announces dividend payment
Tuesday, 4 Nov 2014 07:00pm EST 

Eli Lilly and Company:Decided to proceed with the cash dividend distribution on the ordinary shares.Says the ex-date is Nov. 12.Says the record date is Nov. 11.Says the payment date is Dec. 12.Says the gross dividend is $0.49.  Full Article

Virbac to acquire United States veterinary assets from Eli Lilly
Monday, 27 Oct 2014 02:33am EDT 

Virbac SA:Agrees to acquire veterinary assets from Eli Lilly in United States.Says deal is for veterinary products marketed by Novartis Animal Health.Says assets to be acquired are related to two parasiticides for dogs, namely Sentinel Flavor Tabs and Sentinel Spectrum.Says deal is subject to approval by Federal Trade Commission and conditioned on closing of acquisition of Novartis Animal Health by Eli Lilly.  Full Article

Eli Lilly and Co reaffirms FY 2014 earnings outlook; lowers high end of prior FY 2014 revenue outlook to a range in line with analysts' estimates
Thursday, 23 Oct 2014 06:31am EDT 

Eli Lilly and Co:Expects FY 2014 earnings per share to be in the range of $2.34 to $2.42 on a reported basis, as compared to previous range of $2.67-$2.75.Expects FY 2014 earnings per share to be in the range of $2.72 to $2.80 on a non-GAAP basis, as compared to previous range of $2.72-$2.80.Expects FY 2014 net income to be at least $2.6 bln on a reported basis, as compared to previous range of $2.9 bln.Says it still FY 2014 net income to be at least $2.9 bln on a non-GAAP basis.Expects FY 2014 revenue in the range of $19.4 to $19.8 bln, as compared to previous range of $19.4 to $20.0 bln.FY 2014 EPS of $2.75, net income of $2.9 bln, revenue of $19.7 bln - Thomson Reuters I/B/E/S.  Full Article

CANDA NK-2 files motion to dismiss patent infringement suit originally filed by Eli Lilly and Company
Wednesday, 22 Oct 2014 05:45pm EDT 

CANDA NK-2, LLC, subsidiary of CANDA Pharma, LLC:Says the company has moved to dismiss a patent infringement lawsuit, based on lack of personal jurisdictions over the defendants.Says the claim was originally filed on Oct. 8, by Eli Lilly and Company in the United States District Court for the Southern District of Indiana.Says the motion to dismiss was filed in partnership with Nang Kuang Pharmaceutical Co., LTD., by Farney Daniels, PC, counsel for the defendants.Says lawsuit alleges that Nang Kuang infringed U.S. Patent Nos. 5,344,932 and 7,772,209 by submitting an Abbreviated New Drug Application to the U.S. Food & Drug Administration (FDA) requesting approval of a generic pemetrexed disodium, 100 mg base/vial and 500 mg base/vial for intravenous infusion.Says the pharmaceuticals are chemotherapy agents used for the treatment of various types of cancer.Case is Eli Lilly and Company v. Nang Kuang Pharmaceutical and CANDA NK-2, No. 1:14-cv-1647.  Full Article

Eli Lilly and co and Zymeworks Inc announces expansion of strategic licensing and collaboration agreement
Wednesday, 22 Oct 2014 04:15pm EDT 

Eli Lilly and co and Zymeworks Inc:Says the expansion of their existing licensing and collaboration agreement.Says on Oct. 22, Lilly is opting to expand the collaboration by up to potentially $375 mln in milestones and other payments.Plus tiered sales royalties based on country-by-country intellectual property, and sales to include development of several immuno-modulatory bi-specific antibodies against multiple targets.Zymeworks will receive an initial up-front payment in the form of an equity investment, which will strengthen the strategic relationship between the two companies.Further financial terms were not disclosed.  Full Article

Eli Lilly and Co declares fourth-quarter 2014 dividend
Monday, 20 Oct 2014 04:10pm EDT 

Eli Lilly and Co:Declares dividend for the fourth quarter of 2014 of $0.49 per share on outstanding common stock.Payable Dec. 10 to shareholders of record at the close of business on Nov. 14.  Full Article

Eli Lilly and Company announces plan to realign Puerto Rico manufacturing operations
Thursday, 16 Oct 2014 02:29pm EDT 

Eli Lilly and Company:Plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico.Says manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015.All of the about 100 full-time non-contracted employees currently working in Guayama will be offered employment at Lilly's Carolina (Puerto Rico) location.  Full Article

Drugmaker Lilly's Q4 profit falls on strong dollar, charge

Jan 30 - U.S. drugmaker Eli Lilly and Co reported a 41 percent fall in quarterly profit, hurt by a stronger dollar and a one-time charge related to a restructuring program.

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