eli lilly & co (LLY) Key Developments
Eli Lilly And Merck Reportedly Eye Novartis
Dec 4 13
Eli Lilly and Company (NYSE:LLY) and Merck Ltd. (BSE:500126) are planning to acquire Novartis AG (SWX:NOVN) animal-health business, people with knowledge of the matter said. Novartis hasn't yet invited bids for the business and none of the potential bidders has made an offer, said sources. The company is working with Goldman Sachs Group on a review of its portfolio that may lead to a sale of the veterinary business, according to sources. Spokesmen for Eli Lilly and Merck declined to comment. Speaking at a conference in London, Dekkers and Novartis chairman Joerg Reinhardt declined to comment on the animal-health business sale. Reuters reported earlier in the day that Bayer is a potential bidder for the unit. Novartis is weighing the sale of several units, including the over-the-counter medicines unit and vaccines operation. The drugmaker wants its businesses to be among industry leaders or it will consider divesting them, Chief Executive Joe Jimenez said in November.
Boehringer Ingelheim and Eli Lilly and Company Announces New Data from Phase IV Study
Dec 3 13
Boehringer Ingelheim and Eli Lilly and Company announced new data from a Phase IV study evaluating linagliptin (5 mg) as monotherapy and in combination with metformin (1,500 or 2,000 mg) in treatment-naive adults with newly diagnosed (<12 months) uncontrolled Type 2 Diabetes (T2D). The result showed that linagliptin as monotherapy or in initial combination with metformin achieved clinically significant improvements in glucose control in patients with newly diagnosed T2D and marked hyperglycaemia. Results also showed both treatments provided statistically significant reductions in blood glucose levels, with the combination therapy having greater glucose reduction compared to monotherapy. The results were presented during the 2013 World Diabetes Congress, which is being held 2 to 6 December in Melbourne, Australia. The results showed: Linagliptin monotherapy and linagliptin + metformin initial combination therapy demonstrated statistically significant reductions in HbA1c of 2.0% and 2.8%, respectively; HbA1c reduction with the initial combination of linagliptin + metformin was statistically superior to linagliptin alone; A proportion of patients achieved a target HbA1c of <7% at week 24 with linagliptin + metformin and linagliptin monotherapy (61% and 39%, respectively); Both treatments were well tolerated overall with few drug-related or serious adverse events; Hypoglycaemia occurred in 3.2% and 1.9% with linagliptin monotherapy and linagliptin + metformin initial combination therapy, respectively; Body weight was stable with linagliptin and decreased in the combination arm (1.3 kg between group difference).
Eli Lilly and Company Announces to Invest More Than $700 Million to Enhance its Global Insulin Manufacturing Capacity in Puerto Rico, France, China and Indianapolis
Nov 14 13
Eli Lilly and Company announced that it will invest more than $700 million to enhance its global insulin manufacturing capacity in Puerto Rico, France and China, as well as in Indianapolis, home to its global headquarters. Lilly's manufacturing commitment in the past year to more than $1 billion in planned investments in response to the growing diabetes epidemic and increasing demand for insulin around the world. Nearly half of the $1 billion investment will improve Indianapolis sites, where Lilly has been manufacturing insulin since it introduced the first commercially available insulin product in 1923. According to the International Diabetes Federation (IDF)--which released the latest diabetes prevalence numbers--diabetes is a significant and growing global problem, with high and increasing costs to society and to individuals. The IDF also noted that all types of diabetes are on the rise, with the number of people with type 2 diabetes increasing most dramatically. In addition to committing to investments in manufacturing, the company is investing heavily in diabetes research. Lilly currently has 14 new molecular entities in clinical development, including three under regulatory review and another in Phase III, for the treatment of diabetes and related complications. The new manufacturing investments will support both existing and future insulin-based medicines and are as follows France -- $120 million to enhance insulin cartridge manufacturing capacity; Indianapolis and Puerto Rico -- $245 million to expand insulin-active-ingredient and delivery device manufacturing capacity; China -- $350 million to expand insulin cartridge manufacturing capacity. The commitment to expand insulin production in China is the latest in a series of diabetes-related investments in this part of the world, such as the opening of the Lilly China Research and Development Center in Shanghai last year. According to the IDF, there are almost 100 million people in China with diabetes, with as many as three-quarters of them not having adequate control of their disease. Prior to this announcement, Lilly recently communicated insulin-related commitments in Indianapolis totaling $320 million to expand insulin-active-ingredient and drug product manufacturing capacity, as well as an additional $80 million in ancillary projects. Together, these announcements bring the total commitment over the past year to more than $1 billion, which will be invested over the next several years.
Eli Lilly and Company Presents at Southeast BIO Investor & Partnering Forum, Nov-07-2013 12:00 PM
Nov 1 13
Eli Lilly and Company Presents at Southeast BIO Investor & Partnering Forum, Nov-07-2013 12:00 PM. Venue: Jefferson Hotel, Richmond, Virginia, United States. Speakers: Darren Carroll.
Eli Lilly and Company Announces FDA Approval for Addition to CIALIS Product Label
Oct 25 13
Eli Lilly and Company announced the U.S. Food and Drug Administration approved a product label addition for CIALIS to include data from a 26-week study that showed CIALIS 5 mg for once daily use started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks, compared to placebo with finasteride, in men with BPH and an enlarged prostate. The combination of CIALIS and finasteride initiated for BPH therapy is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown. CIALIS is approved by the FDA to treat erectile dysfunction (ED), the signs and symptoms of BPH, and both ED and the signs and symptoms of BPH (ED+BPH). Finasteride is a type II 5 alpha-reductase inhibitor (5-ARI) approved by the FDA for the treatment of BPH in men with an enlarged prostate. The primary endpoint of the study - changes in total International Prostate Symptom Score (IPSS) at 12 weeks - demonstrated that symptom improvement in patients starting BPH treatment with CIALIS 5 mg for once daily use and finasteride was greater than those starting with placebo and finasteride (-5.2 vs. -3.8; P = 0.001). Key secondary endpoints demonstrated that improvements in IPSS occurred at the first scheduled observation at week 4 (-4.0 vs. -2.3; P< 0.001) and continued through week 26.