Nov. 24, 2015, 12:24 PM
- As expected, the FDA approves Eli Lilly's (LLY -1.5%) Portrazza (necitumumab), in combination with chemo agents gemcitabine and cisplatin, for treatment-naive patients with metastatic squamous non-small cell lung cancer (NSCLC).
- Necitumumab is a recombinant IgG1 human monoclonal antibody that blocks the activity of epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors.
- Previously: Ad Comm approaches for Lilly's necitumumab BLA (July 7)
- Previously: Ad Comm opinion looks positive for Lilly's necitumumab (July 9)
Nov. 20, 2015, 11:25 AM
- Eli Lilly (LLY +1.1%) will host a meeting on December 8 from 9:00 am - 4:00 pm at the Four Seasons Hotel in Boston to update investors on its strategy and growth plans for its Elanco animal health business and its Alzheimer's disease research program.
- A live webcast, along with slides, will be accessible through a link on the company's website under the "Investor" section.
Nov. 19, 2015, 7:04 AM
- Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) extend their immuno-oncology collaboration with a new Phase 3 clinical trial assessing Lilly's ALIMTA (pemetrexed) and Merck's KEYTRUDA (pembrolizumab) as first-line treatment of non-small cell lung cancer (NSCLC). The study will be sponsored by Merck and will be open to treatment-naive NSCLC patients regardless of PD-L1 status. A Phase 2 study was initiated earlier this year.
- Financial terms are not disclosed.
- ALIMTA is Lilly's number two seller, booking $2.6B in sales over the past four quarters. It is a folate analog metabolic inhibitor indicated for the treatment of NSCLC, in combination with chemo.
- KEYTRUDA , Merck's fastest growing drug (Q3 sales = $352M), is a humanized monoclonal antibody that increases the ability of the body's immune system to fight tumor cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2.
- Previously: Lilly and Merck team up in cancer trials (Jan. 13)
Nov. 13, 2015, 8:33 AM
- Based on its analysis of unblinded trial data, the independent Data Monitoring Committee (DMC) recommends Merck's (NYSE:MRK) REVEAL outcomes study of anacetrapib continue with no changes. According to clinicaltrials.gov, the estimated completion date for the 30,000-subject trial is January 2017.
- Anacetrapib inhibits a protein called cholesterol ester transfer protein (CETP), which is designed to elevate HDL cholesterol (the "good" cholesterol). CETP inhibitors were all the rage a few years ago over their potential to provide more cardioprotective benefits than lowering LDL cholesterol (the "bad" cholesterol). Big Pharma's efforts to push CETP inhibitors over the finish line hit fell flat due to toxicity and less-than-expected efficacy. Eli Lilly (NYSE:LLY), Roche (OTCQX:RHHBY), and Pfizer (NYSE:PFE) all abandoned their programs.
- Merck has not given up, however. It ran a 1,623-subject study, DEFINE, which showed that anacetrapib was both safe and effective and raised HDL by 150%. REVEAL, initiated in 2011, is designed to settle the issue once and for all. The trial will cost upwards of $500M to complete so the company is banking on a positive outcome.
Nov. 11, 2015, 6:31 AM
- WuXi PharmaTech (NYSE:WX) and Eli Lilly (NYSE:LLY) enter into a strategic collaboration to develop, manufacture and commercialize a novel small molecule drug, discovered by Lilly, in China that is targeted to reduce cardiovascular events in patients with high cholesterol and/or triglycerides, a condition affecting more than 275M Chinese.
- WuXi, through its Product Development Service and Partnership Business Unit, will be responsible for regulatory, development and manufacturing activities in China, including filing the Investigational New Drug (IND) application. Lilly will be responsible for commercial activities. Both firms will invest in the initiative.
- Financial terms are not disclosed.
Nov. 8, 2015, 9:39 PM
- Results from a Phase 3 clinical trial, SPIRIT-P1, showed treatment with Eli Lilly's (NYSE:LLY) ixekizumab significantly improved signs and symptoms of psoriatic arthritis in patients who had not been previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). The data were presented today at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Francisco.
- The 417-subject, randomized, active- and placebo-controlled study assessed ixekizumab 80mg dosed via subcutaneous injection every two or four weeks following a 160 mg starting dose. AbbVie's (NYSE:ABBV) Humira (adalimumab) 40 mg subcutaneous injection dosed every other week served as the active control for comparison to placebo. It was not powered to compare ixekizumab to adalimumab.
- At week 24, 62% of the ixekizumab two week cohort and 58% of the four week cohort achieved ACR20 (20% improvement in symptoms) compared to 30% for placebo. The proportions achieving ACR50 (50% improvement in symptoms) were 47%, 40% and 15%, respectively. The proportions achieving ACR70 were 34%, 23% and 6%, respectively.
- Patients receiving Humira achieved ACR20, ACR50 and ACR70 scores of 57%, 39% and 26%, respectively, at week 24.
- Patients treated with ixekizumab also showed improvements versus placebo in physical function and less radiographic progression of structural joint damage.
- Ixekizumab is a monoclonal antibody that binds to interleukin-17A, a pro-inflammatory cytokine produced by the immune system's T cells. In psoriasis, IL-17A plays a major role in the excess proliferation and activation of skin cells.
- Previously: Lilly's ixekizumab successful in Phase 3 psoriatic arthritis trial (April 20)
Nov. 8, 2015, 4:02 PM
- Ignyta (NASDAQ:RXDX) secures an exclusive global license to Eli Lilly's (NYSE:LLY) taladegib (LY2940680), an orally available small molecule hedgehog/smoothened antagonist under development for the treatment of range of cancers.
- Under the terms of the agreement, Lilly will receive an upfront payment of $2.0M in cash, 1.2M shares of Ignyta common stock, up to $38M in milestones and royalties on net sales. The total value of the deal, based on RXDX's Friday closing pricing of $11.06, could potentially be $53.3M.
- Concurrently, Ignyta enters into a stock purchase agreement with Lilly under which the latter will buy 1.5M shares of Ignyta common stock at $20 per share via private placement.
- Ignyta also grants back to Lilly exclusive rights to develop and commercialize taladegib-containing products in combination with other Lilly compounds. Ignyta will be eligible to receive sales-based royalties on the combination products that Lilly launches.
- Ignyta CEO Jonathan Lim, M.D., says, "The exclusive license from Lilly of this clinical program with demonstrated compelling Phase 1 activity is well aligned with our strategic vision of developing first-in-class and/or best-in-class therapeutics that can potentially eradicate residual disease in precisely defined patient populations. This new targeted oncology program is a hedgehog/smoothened antagonist that complements our pipeline well and provides us with exciting potential monotherapy and combination therapy approaches across multiple solid tumor indications. We are grateful to Lilly for sharing Ignyta's precision oncology vision and recognizing the strong strategic fit of taladegib with our pipeline and capabilities, which led to its $30M investment in the company."
- Ignyta will host a conference call tomorrow at 8:00 am ET to discuss the deal.
Nov. 6, 2015, 11:25 AM
- Although not in Valeant's (VRX +1.5%) class, Eli Lilly (LLY -1.4%) and Merck (MRK -1.3%) disclose in their Q3 10-Qs that they have received inquiries over certain aspects of their drug pricing.
- Lilly's 10-Q (p. 48): "In September 2015, we were advised that the U.S. Attorney's office for the Eastern District of Pennsylvania and the Civil Division of the Western U.S. Department of Justice are conducting an inquiry concerning our treatment of certain distribution service agreements with wholesalers when calculating and reporting Average Manufacturer Prices in connection with the Medicaid drug rebate program. We are voluntarily responding to this request."
- Merck's 10-Q (p. 22): "The Company has received a civil investigative demand from the U.S. Attorney's Office, Eastern District of Pennsylvania which requests information relating to the Company's contracting and pricing of Dulera Inhalation Aerosol with certain pharmacy benefit managers and Medicare Part D plans. The Company is cooperating with the investigation."
Oct. 22, 2015, 7:26 AM
- Eli Lilly (NYSE:LLY) Q3 results ($M): Total Revenues: 4,959.7 (+1.7%); Animal Health: 778.8 (+33.2%).
- Net Income: 799.7 (+59.7%); EPS: 0.75 (+59.6%); Non-GAAP EPS: 0.89 (+21.9%).
- Key Product Sales: Humalog: 705.0 (-0.2%); Alimta: 628.5 (-13.1%); Cialis: 566.1 (-0.4%); Forteo: 348.9 (+5.0%); Humulin: 316.7 (-5.7%); Cymbalta: 242.9 (-34.0%); Zyprexa: 237.9 (-7.6%); Strattera: 196.9 (+2.6%).
- 2015 Guidance: Total Revenues: $19.7B - 20.0B (unch); EPS: $2.40 - 2.45 from $2.20 - 2.30; Non-GAAP EPS: $3.40 - 3.45 from $3.20 - 3.30.
- Shares are up 3% premarket on light volume.
Oct. 22, 2015, 6:26 AM
- Eli Lilly (NYSE:LLY): Q3 EPS of $0.89 beats by $0.13.
- Revenue of $4.96B (+1.6% Y/Y) misses by $30M.
- Shares -2.34% PM.
Oct. 21, 2015, 5:30 PM
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Oct. 21, 2015, 4:41 PM
- Eli Lilly (NYSE:LLY) will report Q3 results tomorrow before the open. Consensus view is EPS of $0.75 (+14%) on revenues of $4.98B (+2%).
Oct. 19, 2015, 2:36 PM
- Eli Lilly (NYSE:LLY) declares $0.50/share quarterly dividend, in line with previous.
- Forward yield 2.51%
- Payable Dec. 10; for shareholders of record Nov. 13; ex-div Nov. 10.
Oct. 16, 2015, 12:32 PM
- Opko Health (OPK +2.5%) initiated with Overweight rating and $14 (47% upside) price target by JP Morgan.
- Jazz Pharmaceuticals (JAZZ +1.7%) initiated with Outperform rating and $200 (44% upside) price target by Northland Capital Markets.
- Mallinckrodt (MNK) initiated with Outperform rating and $92 (37% upside) price target by Northland Capital Markets.
- Shire (SHPG +1.1%) initiated with Outperform rating and $288 (38% upside) price target by Northland Capital Markets.
- Nabriva Therapeutics (NBRV +2.2%) initiated with Outperform rating and $19 (90% upside) price target by Leerink.
- Penumbra (PEN -0.2%) initiated with Buy rating and $48 (20% upside) price target by Canaccord Genuity.
- REGENXBIO (RGNX -3.6%) initiated with Overweight rating and $36 (100% upside) price target by Piper Jaffray.
- Dyax (DYAX -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $36 (29% upside) from $25.
- Eli Lilly (LLY +1.5%) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $105 (30% upside) from $89.
- Athenahealth (ATHN -4.6%) downgraded to Underperform from Buy by Jefferies. Price target lowered to $105 (22% downside risk) from $125.
- Halyard Health (HYH -1.5%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $27 (6% downside risk) from 38.
Oct. 14, 2015, 7:49 AM
- Top-line results from a Phase 3 clinical trial, RA-BEAM, showed that Eli Lilly (NYSE:LLY) and Incyte's (NASDAQ:INCY) orally administered baricitinib was superior to AbbVie's (NYSE:ABBV) injectable Humira (adalimumab) in improving symptoms in patients with rheumatoid arthritis (RA). RA-BEAM evaluated the safety and efficacy of baricitinib in RA patients who failed to respond to methotrexate therapy compared to placebo for 24 weeks or Humira for 52 weeks. More than 1,300 participants were randomized to receive either 4 mg oral baricitinib once-daily on background methotrexate, 40 mg injectable Humira every other week on background methotrexate or placebo on background methotrexate.
- The study met its primary endpoint a statistically significant proportion of patients achieving ACR20 (20% improvement in RA symptoms) at week 12 versus placebo. In addition, at week 24, baricitinib was superior to placebo in preventing progressive structural joint damage. The treatment benefits of baricitinib observed at weeks 12 and 24 were maintained through 52 weeks of therapy.
- More patients receiving baricitinib achieved ACR20 after 12 weeks of therapy as well as improved DAS28-hsCRPscore (measurement of disease activity and coronary risk) compared to Humira.
- Serious adverse events were comparable between placebo and baricitinib. The most common were nasopharyngitis and bronchitis.
- The results will be submitted for publication and presentation at future medical conferences in 2016.
- Baricitinib is a once-daily, orally administered, selective JAK1 and JAK2 inhibitor, enzymes that play key roles in a range of inflammatory diseases. It is being co-developed by Lilly and Incyte under an exclusive global license and collaboration agreement inked in December 2009.
Oct. 13, 2015, 7:42 AM
- Eli Lilly (NYSE:LLY) enters into a preclinical research collaboration with Inglewood, CA-based ImaginAb to study potential novel T cell-based immuno-oncology therapies. Under the terms of the partnership, ImaginAb will conduct preclinical research using its immune imaging agent, IAB22M2C (an anti-human CD8 probe) to detect T cell trafficking, redirection and infiltration in response to Lilly oncology molecules. ImaginAb retains full rights to its imaging agents used in the project.
- CD8-positive T cells, known as cytotoxic T cells, are associated with positive clinical response to anti-PD-1 therapy in melanoma. IAB22M2C is a PET-based imaging agent that detects CD8-positive T cells which will provide a whole-body picture of immune response. This will potentially enable better patient selection and well as a better understanding of the mechanisms of immune-modulating treatments.
- Financial terms are not disclosed.
Eli Lilly & Co. discovers, develops, manufactures and sells pharmaceutical products. The company operates through the following business segments: Human Pharmaceutical Products and Animal Health. The Human Pharmaceutical products segment includes the discovery, development, manufacturing,... More
Industry: Drug Manufacturers - Major
Country: United States