Eli Lilly and CompanyNYSE
Yesterday, 7:47 AM
- Undeterred by its solanezumab flop, Eli Lilly (NYSE:LLY) inks an agreement with AstraZeneca (NYSE:AZN) to co-develop MEDI1814, an antibody selective for amyloid beta 42 currently in Phase 1 development. The deal builds on the companies' existing collaboration related to BACE inhibitor AZD3293, in Phase 3 development.
- Under the terms of the agreement, Lilly will pay an upfront fee of $30M to AstraZeneca. Other financial terms are not disclosed.
- Amyloid beta is type of protein that leads to the formation of amyloid plaques in the brain, the accumulation of which is associated with Alzheimer's disease (AD) . Amyloid beta 42 is a form of amyloid beta that is particularly associated with AD.
- MEDI1814 was originally developed at MedImmune which AstraZeneca acquired for $15.6B in 2007.
Yesterday, 6:55 AM
- Eli Lilly (NYSE:LLY) presented the results from the failed Phase 3 EXPEDITION3 study yesterday at the Alzheimer's Disease (CTAD) 2016 Meeting in San Diego.
- Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to placebo (p=0.095) from baseline to week 80 as determined by a scale called ADA-Cog14 which measures cognitive functions such as memory, attention and language abilities. This was the primary endpoint.
- Since the primary endpoint was not met the p-values for the secondary efficacy analyses were not adjusted for multiple comparisons. The solanezumab cohort experienced a 13% slowing of cognitive decline versus placebo as measured by a questionnaire called MMSE (p=0.014). The difference in slowing of cognitive decline also favored solanezumab as measured by other scales called CDR-SB (15%; p=0.004) and ADCS-iADL (14%; p=0.019). Measurement by another questionnaire, FAQ, fell short of statistical significance (7%; p=0.140).
- The difference in the change in amyloid beta between the test group and control was statistically significant, but the change in amyloid deposition as measured by positron emission tomography (PET) was not.
- Drug-related adverse events included spinal osteoarthritis (1.1%); dysuria (pain while urinating)(0.9%); vitamin D deficiency (1.4%) and nasal congestion (1.2%).
- Solanezumab is a monoclonal antibody that binds to a type of protein called amyloid beta after it is produced, allowing it to be cleared from the brain before forming amyloid plaques, the accumulation of which is associated with AD. Drug candidates targeting amyloid plaques have struggled to demonstrate a statistically valid functional treatment benefit, however.
- Previously: Lilly's solanezumab flunks late-stage study in Alzheimer's-related dementia; shares down 14% premarket; Biogen down 8% in sympathy (Nov. 23)
Fri, Dec. 2, 1:26 PM
- The FDA approves Eli Lilly (LLY +2.8%) and development partner Boehringer Ingelheim's Jardiance (empagliflozin) to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes and CV disease.
- The data supporting the new claim was generated in a large-scale post-marketing study involving more than 7,000 patients.
- The approval is a big win for the companies considering the close Ad Comm vote (12 - 11 in favor) in June.
- Novo Nordisk (NVO +0.7%) is close behind. It filed marketing applications in the US. and Europe in late October seeking approval of the same claim for Victoza (liraglutide).
- Previously: FDA Ad Comm to review Boehringer Ingelheim's applications for CV risk claims for diabetes meds (June 27)
Fri, Dec. 2, 10:39 AM
Mon, Nov. 28, 2:05 PM
- BMO Capital downgrades Eli Lilly (LLY -2.2%) to Market Perform from Outperform after the Phase 3 failure of Alzheimer's candidate solanezumab. Price target lowered to $64 (5% downside risk) from $91.
- Atlantic Equities cuts its rating as well, from Overweight to Neutral.
Wed, Nov. 23, 3:43 PM
- The potential haircut to future revenue that PDL BioPharma (PDLI -15.2%) faces from Eli Lilly's (LLY -10.5%) solanezumab flop was already priced into the stock says RBC's Adnan Butt. PDL was eligible to receive royalties on solanezumab sales.
- He calls the sell-off an "overreaction" and adds that the most significant near-term catalyst is Novartis' (NVS +1%) hypertension drug Tekturna (aliskiren), which the company owns a piece of through its initial $75M equity investment in Noden Pharma DAC (Noden acquired global rights from Novartis). PDL expects to invest an additional $64M by next year.
Wed, Nov. 23, 9:16 AM| Wed, Nov. 23, 9:16 AM | 3 Comments
Wed, Nov. 23, 8:40 AM
- Merck (NYSE:MRK) slumps 3% premarket on higher-than-normal volume as the selling spreads from the disappointing Phase 3 results for Eli Lilly's (NYSE:LLY) Alzheimer's disease (AD) candidate solanezumab.
- Merck's late-stage AD candidate is verubecestat (MK-8931), an inhibitor of an enzyme called BACE which plays a key role in the production of amyloid beta peptides. Inhibiting BACE is believed to decrease the formation of amyloid plaques in the brain thereby slowing the progression of AD.
- A Phase 3 study called APECS is currently recruiting patients. The primary endpoint is the change from baseline to week 104 in a scale called CDR-SB (same scale Biogen is using in its late-stage studies of aducanumab). According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is May 2019. The estimated study completion date is March 2021.
Wed, Nov. 23, 8:30 AM
- Micro cap Anavex Life Sciences (NASDAQ:AVXL) is up 4% premarket, albeit on only ~4,500 shares, on the heels of Eli Lilly's (NYSE:LLY) failure with Alzheimer's disease (AD) candidate solanezumab.
- Anavex's lead candidate is Anavex 2-73, an orally available sigma-1 receptor (S1R) agonist in development for the treatment of AD and Parkinson's disease. S1R plays a key role in modulating neurotransmission.
Wed, Nov. 23, 8:21 AM
- The exodus from Eli Lilly (NYSE:LLY) over the failure of Alzheimer's disease (AD) candidate solanezumab is engulfing other players in the space other the Biogen (NASDAQ:BIIB).
- AC Immune (Pending:ACIU) is down 27% premarket on light volume. Its lead product candidate is crenezumab, a monoclonal antibody that is designed to bind to all forms of misfolded Abeta proteins which promotes the disaggregation of plaques.
- Axovant Sciences (NYSE:AXON) is down 9% on light volume. Its AD candidate is intepirdine, an antagonist of the 5HT6 receptor which promotes the release of acetylcholine, a neurotransmitter essential for normal cognition.
Wed, Nov. 23, 7:49 AM
- Eli Lilly's (NYSE:LLY) flop with solanezumab stokes selling in Biogen (NASDAQ:BIIB) which is down 8% premarket on average volume. The latter's candidate is Fast Track-tagged aducanumab, in Phase 3 development for the treatment of early-onset Alzheimer's disease (AD).
- The first Phase 3, EMERGE, will enroll 1350 subjects. The primary endpoint is the change from baseline to week 78 in a scale called CDR-SB (Clinical Dementia Rating - Sum of Boxes). According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is February 2020. The estimated study completion date is February 2022.
- The second Phase 3, ENGAGE, has the same enrollment target, endpoint and treatment period as EMERGE.
- Aducanumab is a human recombinant monoclonal antibody derived from a library of B cells collected from healthy elderly subjects with no signs of cognitive impairment. In a Phase 1b study, patients receiving aducanumab showed a statistically significant reduction in beta amyloid in the brain. It is being developed under a global deal with Neurimmune inked in November 2007.
Wed, Nov. 23, 7:08 AM
- A Phase 3 study, EXPEDITION3, assessing Eli Lilly's (NYSE:LLY) solanezumab in people with mild dementia due to Alzheimer's disease (AD), failed to show a significant treatment effect compared to placebo as measured by a scale called ADAS-Cog14. The results favored solanezumab but the differences were small.
- The company is evaluating its options but will not pursue regulatory submissions for the indication. Detailed results will be presented on Thursday, December 8 at the Clinical Trials on Alzheimer's Disease meeting.
- Solanezumab is a monoclonal antibody that binds to forms of type of protein called amyloid beta after it is produced, allowing it to be cleared from the brain before forming amyloid plaques, the accumulation of which is associated with AD. Drug candidates targeting amyloid plaques have struggled to demonstrate a statistically valid functional treatment benefit, however. This is yet another example.
- Lilly expects to record a Q4 charge of ~$150M ($0.09/share after-tax). It will release revised 2016 guidance and its 2017 outlook on December 15 along with a conference call at 9:00 am ET instead of the previously scheduled call on January 4.
- Shares are down 14% premarket on increased volume.
- Biogen (NASDAQ:BIIB) is down 8% premarket on light volume. It is developing another amyloid-related monoclonal antibody for AD called aducanumab.
Tue, Nov. 22, 8:44 AM
- QuintilesIMS (NYSE:Q): will lead a collaborative initiative involving Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) and Pfizer (NYSE:PFE) with the goal of providing clearer and more proactive insight into how anti-cancer treatments are used in actual practice across key European markets. Specifically, the initiative aims to bridge the information gaps and inconsistencies in knowledge related to how oncology products are used, for which types of patients and indications and in what sequences and combinations. The ultimate goal is to improve the quality of care for cancer patients and improve outcomes.
- Financial details are not disclosed.
Fri, Nov. 18, 8:33 AM
- Privately held Athenex and Eli Lilly (NYSE:LLY) will work together in a Phase 1b study assessing the combination Athenex's oral paclitaxel (Oraxol) and Lilly's CYRAMZA (ramucirumab) in patients with advanced gastric cancer and esophageal cancer. Patient enrollment will commence in 2017.
- Athenex will sponsor the study while Lilly will supply product.
Fri, Nov. 11, 7:21 AM
- Dr. Reddy's Laboratories (NYSE:RDY) announces the commercial availability of its generic version of Eli Lilly's (NYSE:LLY) Evista (raloxifene hydrochloride) tablets in the U.S.
- Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women, to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and to reduce the risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.
- According to IMS Health, the American market is ~$265M.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%