Eli Lilly & Co. (NYSE:LLY) Files New Drug Application


Dallas, Texas 12/26/2013 (FINANCIALSTRENDS) – Eli Lilly & Co. (NYSE:LLY) is a major drug maker which is into development and manufacture of pharma products for both animals and humans. It has manufacturing operations spread across 17 countries of the world and its products are sold across 130 countries. Its product buckets include “neuroscience products, endocrinology products, oncology products, cardiovascular products, animal health products.” Over the trailing 12 months, it has managed to post net sales of $23.26 billion and gather net income of $4.78 billion.

Strong Pipeline Of New Drugs

More importantly, its line up of target drugs is impressive with many drugs like “Dulaglutide, Edivoxetine, Ixekizumab, Necitumumab, New insulin glargine product, Novel basal insulin analog, Pomaglumetad Methionil, Ramucirumab, Solanezumab and Tabaluma” being made to go through various stages of clinical trials with the aim of getting them through FDA approval process.

New Drug Application

Earlier this month Eli Lilly & Co. (NYSE:LLY) announced that it has filed a new drug application in collaboration with Boehringer Ingelheim for getting FDA go ahead for target drug insulin glargine product. This application by the drug maker in U.S follows its application with European Medicines Agency with its “Marketing Authorisation Application”. It is also been announced that the U.S. Food and Drug Administration (FDA) has indeed accepted their combined application for target drug codenamed LY2963016 which is expected to work on the lines of insulin.


New Diabetic Drug

The application describes the target drug LY2963016 in its application as a unique “insulin glargine” based solution which when fully developed is expected to cure type 1 and type 2 diabetes. As part of the NDA, the tag team of Eli Lilly & Co. (NYSE:LLY) and Boehringer Ingelheim will test out the relative performance of the target drug in relation to “pharmacokinetic and pharmacodynamic studies”. To secure the NDA acceptance the drug makers were based on positive results from its Phase III studies and tests conducted on type 1 and type 2 diabetes patients.

Commenting about the NDA submission,Gwen Krivi, Ph.D, who is the vice president of Eli Lilly & Co. (NYSE:LLY) diabetes product development team has been quoted as saying, “The U.S. regulatory submission for our new insulin glargine product demonstrates our progress in bringing another option to the millions of Americans with diabetes who require long-acting insulin as an integral part of their treatment plan. This submission of the NDA for this product helps us realize the goal of the Lilly-Boehringer Ingelheim Diabetes alliance, which is to leverage our combined expertise to develop important treatments for people with diabetes.”

Stock Market Performance

Eli Lilly & Co. (NYSE:LLY) stock has scripted a good 3.09 percent increase in its market value in the past week. This S&P 500 index tracked stock has been under pressure to perform at the markets over the past one quarter. It has managed to post net loss of 0.96 percent in the past one month and has shed more than 3.5 percent in the past quarter. In the past one year, the stock has been range bound between $47.09 and $57.37 and over all its share holders have gained by 6.3 percent in the same one year period. At current price point of $50.74 per share, the stock has managed to gain momentum to levels which have taken it to just 11.5 percent below its 52 week high price mark.