Dec. 16, 2015, 5:01 PM
- The FDA grants final approval for Eli Lilly's (NYSE:LLY) long-acting insulin analog Basaglar (insulin glargine injection) to improve glycemic control in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
- The agency issued tentative approval in August 2014 due to a then-pending patent dispute with Sanofi (NYSE:SNY). The disagreement was resolved in September.
- Previously: Lilly and Sanofi settle Basaglar patent fight (Sept. 28)
- Previously: Lilly gets tentative approval for diabetes drug (Aug. 19, 2014)
Dec. 11, 2015, 4:25 PM
- Voyager Therapeutics (NASDAQ:VYGR) initiated with Outperform rating and $36 (52% upside) price target by Wedbush.
- Perrigo (NYSE:PRGO) upgraded to Buy from Hold with $170 (15% upside) price target by Argus.
- Myriad Genetics (NASDAQ:MYGN) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $94 (123% upside) from $72.
- Abbott Laboratories (NYSE:ABT) upgraded to Buy from Hold by Jefferies. Price target raised to $55 (24% upside) from $49.
- Eli Lilly (NYSE:LLY) upgraded to Buy from Hold by Deutsche Bank. Price target raised to $99 (19% upside) from $85.
- PerkinElmer (NYSE:PKI) downgraded to Sell from Neutral. Price target lowered to $44 (12% downside risk) from $55. LabCorp (NYSE:LH) downgraded to Neutral from Buy. Price target lowered to $126 (4% upside) from $142. Danaher (NYSE:DHR) downgraded to Neutral from Buy. Price target lowered to $103 (11% upside) from $104. All by Goldman Sachs.
- Bluebird bio (NASDAQ:BLUE) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $69 (16% upside) from $143. Maintained at Outperform by Wedbush. Price target lowered to $117 (96% upside) from $165. Downgraded to Neutral from Buy by Roth Capital. Price target lowered to $62 (4% upside) from $121. Maintained at Overweight at Piper Jaffray. Price target unchanged at $204 (242% upside).
Dec. 10, 2015, 8:46 AM
- Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) plan to commence a Phase 1 clinical trial in early 2016 to evaluate the combination of Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, abemaciclib (LY2835219), and Merck's KEYTRUDA (pembrolizumab) across multiple tumor types. Based on the results in the Lilly-sponsored study, the collaboration may progress to a Phase 2 trial in patients with metastatic breast cancer or non-small cell lung cancer, which Lilly will also sponsor.
- Abemaciclib is a cell cycle inhibitor that is designed to block the growth of cancer cells by inhibiting the enzymes CDK4 and CDK6. KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
- The companies established a clinical trial collaboration in January to evaluate the combination of KEYTRUDA and various Lilly compounds across a range of cancers.
- Previously: Lilly and Merck team up in cancer trials (Jan. 13)
Dec. 8, 2015, 7:27 AM
- Eli Lilly (NYSE:LLY) declares $0.51/share quarterly dividend, 2% increase from prior dividend of $0.50.
- Forward yield 2.36%
- Payable March 10; for shareholders of record Feb. 12; ex-div Feb. 10.
Dec. 4, 2015, 9:36 AM
- After engaging with regulatory authorities and outside experts, Eli Lilly (LLY +1.3%) decides to cease development of basal insulin peglispro (BIL) for the treatment of type 1 and type 2 diabetics. Its decision was prompted by the significant investments in time and resources required to better clarify the effects of BIL on liver fat compared to insulin glargine treatment that was observed in the Phase 3 IMAGINE trials. In February, the company announced that is was delaying its regulatory submissions in order to better understand and characterize the effects.
- Enrique Conterno, President, Lilly Diabetes, says, "While we are encouraged by the efficacy data we observed for BIL, we know that moving forward wold have required a significant amount of time and investment with no assurance that we would find conclusive answers. We are disappointed in the outcome for BIL, but we have an unprecedented opportunity to build upon the industry's broadest diabetes portfolio, which includes six new treatments approved since the middle of 2014."
- The company will book a $55M charge in Q4 ($0.03 per share after tax). Its full-year earnings guidance will remain unchanged ($2.40 - 2.45 - GAAP; $3.40 - $3.45 - non-GAAP). Q4 results will be reported on January 28.
- Previously: Side effect of Lilly basal insulin potentially delays regulatory filings past 2016 (Feb. 23)
Dec. 4, 2015, 8:03 AM
- Horizon Pharma (NASDAQ:HZNP) resumed with Underweight rating and $23 (14% upside) price target by Morgan Stanley.
- Prima Biomed (NASDAQ:PBMD) initiated with Outperform rating and $6 (376% upside) price target by FBR Capital.
- Bluebird bio (NASDAQ:BLUE) resumed with Buy rating and $121 (54% upside) price target by Roth Capital.
- Barclays initiates coverage of six large caps: AbbVie (NYSE:ABBV) with an Equal Weight rating and $72 (28% upside) price target; Bristol-Myers Squibb (NYSE:BMY) with an Equal Weight rating and $70 (5% upside) price target; Johnson & Johnson (NYSE:JNJ) with an Overweight rating and $115 (14% upside) price target; Merck with an Overweight rating and a $66 (25% upside) price target; Eli Lilly (NYSE:LLY) with an Overweight rating and $95 (14% upside) price target and Pfizer (NYSE:PFE) with an Equal Weight rating and $34 (5% upside) price target.
- GW Pharmaceuticals (NASDAQ:GWPH) resumed with Buy rating and $130 (51% upside) price target by Roth Capital.
- ImmunoGen (NASDAQ:IMGN) resumed with Buy rating and $16 (24% upside) price target by Jefferies.
- Myokardia (NASDAQ:MYOK) initiated with an Outperform rating and $22 (75% upside) price target by Wedbush and an Outperform rating and $18 (43% upside) price target by Credit Suisse.
Dec. 3, 2015, 7:41 AM
- Thinly traded micro cap Foamix Pharmaceuticals (NASDAQ:FOMX) announces positive top-line results from a 24-subject Phase 2 clinical trial assessing FDX104 for the prevention of moderate-to-severe skin rashes in patients receiving epidermal growth factor receptor antibody inhibitors (EGFRI) [Eli Lilly's (NYSE:LLY) Erbitux (cetuximab) or Amgen's (NASDAQ:AMGN) Vectibix (panitumumab)] for the treatment of cancers such as colon and head and neck. The acne-like (acneiform) rash is the most common side effect from EGFRI drugs and, if severe enough, treatment should be withheld, reduced or discontinued.
- Each randomized patient in the study acted as their own control by treating one side of the face with FDX104 and the other with a foam vehicle (placebo) in a blinded manner.
- Results showed the side treated with FDX104 was better overall than the placebo-treated side. The mean maximal rash severity favored FDX104, 1.33 versus 1.71. 37.5% of patients (n=9/24) developed a Grade 3 rash (severe) on the placebo side compared to 16.7% (n=4/24) on the FDX104 side. The difference in the prevention of severe rash was statistically valid (p<0.05) in favor of FDX104 as measured by the Wilcoxon Signed-Rank test. Other exploratory analyses also trended positively.
- FDX104, a doxyocycline foam, appeared safe and well-tolerated with no drug-related systemic adverse events observed. Local reactions were noted in six patients with five resolved before the end of the study.
- The company will host a conference call this morning at 8:30 am ET to discuss the results. Shares are up 9% premarket on light volume.
Nov. 27, 2015, 10:43 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Tuesday, December 1, to review privately held Fabre-Kramer Pharmaceuticals' New Drug Application (NDA) for gepirone hydrochloride extended-release tablets for the treatment of major depressive disorder (MDD).
- FDA briefing doc
- Company briefing doc
- Draft questions
- MDD-related tickers: (OTCQB:VSTA)(OTCPK:OTSKY)(OTCPK:TKPYY)(NYSE:PFE)(NASDAQ:ALKS)(NASDAQ:AVNR)(NYSE:TEVA)(NASDAQ:SHPG)(NYSE:LLY)(NYSE:GSK)
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."
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
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