Merck & Co Inc.NYSE
Cubist Pharmaceuticals: An Extraordinary Arbitrage Opportunity
Tue, Oct. 25, 8:04 AM
- Merck (NYSE:MRK) Q3 results ($M): Total Revenues: 10,536 (+4.6%): Pharmaceutical: 9,443 (+5.8%); Animal Health: 865 (+4.8%).
- Net Income: 2,184 (+19.6%); Non-GAAP Net Income: 2,989 (+9.9%); EPS: 0.78 (+21.9%); Non-GAAP EPS: 1.07 (+11.5%).
- Key Product Sales: Januvia: 1,006 (-0.8%); Gardasil/Gardasil 9: 860 (+37.6%); Zetia: 671 (+6.0%); Janumet: 548 (-2.5%); Proguad, MMRII & Varivax: 496 (+27.2%); Isentress: 372 (-1.3%); Keytruda: 356 (+1.1%); Cubicin: 320 (-1.5%); Remicade: 311 (-29.6%); Vytorin: 273 (-9.6%); Singulair: 239 (+18.9%); Zostavax: 190 (+6.1%); Zapatier: 164.
- 2016 Guidance: Revenues: $39.7B - 40.2B from $39.1B - 40.1B; EPS: $2.02 - 2.09 from $1.98 - 2.08; Non-GAAP EPS: $3.71 - 3.78 from $3.67 - 3.77.
Tue, Oct. 25, 6:47 AM
Mon, Oct. 24, 6:38 PM
- The FDA approves the use of Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high (at least 50%) PD-L1 expression and no EGFR or ALK mutations. KEYTRUDA is the first PD-1 inhibitor approved for these patients in a first-line setting.
- The data supporting the approval was generated in the open-label Phase 3 KEYNOTE-024 study that showed the superiority of KEYTRUDA over chemotherapy as measured by progression-free survival, overall survival and objective response rate while providing a 50% lower risk of death or cancer progression (hazard ratio: 0.50).
- KEYTRUDA's original NSCLC indication was in a second-line setting after platinum-based chemo.
Mon, Oct. 24, 5:30 PM
- ABG, AGR, AKS, ASTE, ATI, AXE, BAX, BHI, BPOP, CAT, CIT, CNC, CPLA, CTG, CVLT, CYNO, DD, EAT, EDU, ETR, FBC, FBP, FCAU, FCX, FELE, GBX, GLW, GM, GPK, HUBB, IIVI, JBLU, JNS, KEY, KKR, LLY, LMT, LPT, MAS, MDSO, MINI, MMC, MMM, MRK, NCI, NLSN, NVS, PCAR, PG, PII, PNR, R, RTIX, S, SAVE, SCHN, SERV, SHW, SIR, ST, STAY, TNC, UA, USG, UTX, VLO, WAB, WAT, WDR, WHR, WSO
Mon, Oct. 24, 7:01 AM
- GlaxoSmithKline (NYSE:GSK) files a Biologics License Application (BLA) with the FDA seeking approval of its shingles vaccine, branded as Shingrix, for the prevention of herpes zoster in people aged 50 years and older.
- In clinical studies, a two-dose regimen of Shingrix showed 90% efficacy in participants at least 70 years old and was maintained in those aged 80 and above, significantly better than Merck's (NYSE:MRK) ZOSTAVAX which is only 18% effective in people aged 80+.
- Shingles is characterized by a painful, itchy rash caused by the reactivation of latent chicken pox virus, varicella zoster. The risk of developing shingles increases with age and altered immune system status.
- Shingrix is a non-live, adjuvanted subunit (HZ/su) vaccine that combines gE, a protein found on the herpes zoster virus, with the adjuvant ASO1B which boosts the immune response to gE.
- Regulatory submissions in Europe and Canada will be made this year followed by Japan in 2017.
Sat, Oct. 22, 5:51 PM
- The FDA approves Merck's (NYSE:MRK) bezlotoxumab, branded as ZINPLAVA, to reduce the recurrence of Clostridium difficile (C. diff) infection (CDI) in adult patients who are receiving antibacterial treatment and are at high risk of CDI recurrence. ZINPLAVA should only be used in conjunction with antibacterial therapy since it is not indicated for the treatment of CDI.
- In June, the FDA's Advisory Committee voted 10-5 backing approval. Commercial launch will commence in Q1.
- Bezlotoxumab is a monoclonal antibody that specifically binds to C. diff toxin B, neutralizing its activity by preventing it from binding to host cells. Merck licensed it from Medarex in 2009.
Fri, Oct. 21, 7:16 AM
- A Phase 3 clinical trial, KEYNOTE-045, assessing Merck's (NYSE:MRK) PD-1 inhibitor KEYTRUDA (pembrolizumab) in treatment-experienced patients with advance urothelial cancer has been stopped early after the independent Data Monitoring Committee determined that the study met its primary endpoint of overall survival (OS).
- KEYNOTE-045 is a 542-subject, randomized study evaluating KEYTRUDA as monotherapy compared to investigator choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with metastatic or locally advanced/unresectable urothelial cancer that has progressed following platinum-based chemo. The co-primary endpoints are OS and progression-free survival (PFS). Secondary endpoints are overall response rate (ORR), duration of response (DOR) and safety. Participants were randomized to receive either 200 mg of KEYTRUDA every three weeks or investigator-choice chemo every three weeks.
- Detailed results will be submitted for presentation at a future medical conference.
- KEYTRUDA is Merck's fastest growing drug. It is currently approved for the treatment of melanoma, head and neck cancer and lung cancer. It is in clinical development for the treatment of more than 30 tumor types in more than 360 clinical trials.
Wed, Oct. 19, 7:25 AM
- A Phase 3 clinical trial assessing Merck's (NYSE:MRK) letermovir (MK-8228) for preventing clinically significant cytomegalovirus (CMV) infection in CMV-seropositive adults who have undergone an allogeneic hematopoietic stem cell transplant (HSCT) met its primary endpoint of a statistically valid percentage of patients with clinically significant CMV infection up to 24 weeks after HSCT. Full results will be submitted for presentation at a future scientific conference.
- The study enrolled 540 subjects who received letermovir once daily either in an oral tablet or intravenously. Therapy was begun as early as the same day as the HSCT and no later than 28 days post-transplant and continued for ~100 days.
- Letermovir is a 3,4 dihydro-quinazoline which is a new class of non-nucleoside CMV inhibitors. It inhibits viral replication by targeting the viral terminase complex. It has Orphan Drug status in the U.S., Europe and Japan and Fast Track status in the U.S.
- Merck acquired global rights to letermovir in 2012 in a deal with AiCuris GmbH & Co. KG.
Tue, Oct. 18, 9:30 AM
- Merck's (NYSE:MRK) Keytruda may get used more broadly than expected, with uptake in first-line lung cancer likely being “very rapid,” Bernstein says.
- Firm cites post-ESMO survey of 130 U.S./EU oncologists.
- Says Keytruda should gain market share in second-line lung cancer due to “halo effect.”
- Bernstein adds that the market perception of Bristol-Myers's (NYSE:BMY) Opdivo is “substantially diminished.”
- Price target on MRK is $74. Implied upside 19.4%.
Fri, Oct. 14, 6:49 AM
- Merck (NYSE:MRK) upgraded to Buy from Neutral by Bank of America. Price target raised to $70 (12% upside) from $57.
- HCA Holdings (NYSE:HCA) upgraded to Overweight from Sector Weight by KeyBanc.
- Momenta Pharmaceuticals (NASDAQ:MNTA) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $19 (54% upside) from $13.
- TESARO (NASDAQ:TSRO) upgraded to Buy from Neutral with a $123 (6% upside) price target by Bank of America.
- Pfizer (NYSE:PFE) downgraded to Hold from Buy with a $36 (10% upside) price target by Jefferies.
- Theravance Biopharma (NASDAQ:TBPH) downgraded to Underperform from Neutral by Baird. Price target raised to $24 (25% downside risk) from $19.
- Ilumina (NASDAQ:ILMN) downgraded to Sell from Neutral by Janney Montgomery Scott. Price target lowered to $125 (9% downside risk) from $155. Downgraded to Neutral from Buy by Citigroup. Price target lowered to $140 (2% upside) from $190.
- Myriad Genetics (NASDAQ:MYGN) downgraded to Sell from Neutral with a $16 (14% downside risk) price target by Ladenburg Thalmann.
Fri, Oct. 7, 8:37 AM
- Incyte (NASDAQ:INCY) is up 3% premarket, albeit on only 530 shares, in response to its announcement of updated results from the Phase 1 portion of a Phase 1/2 clinical trial, ECHO-202, assessing the combination of epacadostat and Merck's (NYSE:MRK) Keytruda (pembrolizumab) in treatment-naive advanced/metastatic melanoma patients. The data are being presented at the European Society for Medical Oncology 2016 Congress in Copenhagen.
- The rates of progression-free survival (PFS) in 19 patients treated with the combination were 74% (n=14/19) at Month 6 and 57% (n=11/19) at Month 12. Median PFS has not been reached. The complete response rate (CR) was 26% (n=5/19) while the objective response rate (ORR) and disease control rate (DCR) were 58% (n=11/19) and 74% (n=14/19), respectively. Median follow-up was 56+ weeks (range: 46 - 90+).
- In the total Phase 1 population (n=62), grade 3 (severe) and above treatment-related adverse events (TRAEs) were observed in 19% (n=12/62), the most common being rash (8%) and increased lipase (5%). Five patients (8%) discontinued treatment due to TRAEs. The most common (at least 15%) all-grade TRAEs were fatigue, rash, joint pain, itchy skin, diarrhea and nausea.
- Epacadostat is a small molecule inhibitor of IDO1, an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation thereby allowing cancer cells to avoid detection by the immune system. Pembrolizumab 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.
- Enrollment in the Phase 2 portion is ongoing.
Thu, Oct. 6, 3:32 PM
- Biotech investors are sitting on the sell button today. The iShares Nasdaq Biotechnology ETF (IBB -2.4%) is down on increased volume. Shares have retraced over 5% since the recent close of 300 on September 22.
- Alnylam (ALNY -48%) is leading the rout after it announced that it was dropping development of RNAi candidate revusiran.
- Representative tickers: (AMGN -0.3%)(BIIB -1.3%)(GILD -1.9%)(CELG -1.4%)(BMY)(MRK -0.7%)(PFE -1.2%)(VRTX -3%)(ALXN -2.2%)
Wed, Oct. 5, 10:45 AM
- The FDA is now requiring a black box warning in the labels of at least nine brand name direct-acting antiviral drugs for the treatment of hepatitis C virus (HCV) infection due to the risk of reactivation of hepatitis B in patients who previously had the disease. The agency says that it has identified 24 cases of such reactivation from November 22, 2013 through July 18, 2016.
- The revised labeling applies to Gilead Sciences' (GILD +0.5%) Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), AbbVie's (ABBV +0.7%) Viekira Pak (ombitasvir/paritaprevir/ritonavir, dasabuvir) and Merck's (MRK +0.6%) Zepatier (elbasvir and grazoprevir).
- Hepatitis B reactivation was not reported as an adverse event in the clinical trials of the HCV drugs.
Tue, Oct. 4, 9:20 AM
- Samsung Bioepis announces that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar to Roche's Herceptin (trastuzumab). Herceptin is a monoclonal antibody indicated for the treatment of breast cancer and gastric cancer. The MAA was submitted in August.
- SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab). It is the company’s first oncology biosimilar candidate submitted for regulatory review in Europe.
- The marketing and distribution of SB3 in Europe will be handled by Merck (NYSE:MRK) if approved.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB).
Mon, Oct. 3, 10:47 AM
- September monthly performance was: +0.2%
- 52-week performance vs. the S&P 500 is: +7%
- $0.21 in dividends were paid in September
- Top 10 Holdings as of 8/31/2016: AT&T Inc (T): 5.38068%, Exxon Mobil Corp (XOM): 5.11766%, Verizon Communications Inc (VZ): 4.15514%, Chevron Corp (CVX): 3.62745%, General Electric Co (GE): 3.46929%, Procter & Gamble Co (PG): 3.13406%, Wal-Mart Stores Inc (WMT): 2.92688%, Pfizer Inc (PFE): 2.90452%, Philip Morris International Inc (PM): 2.83223%, Merck & Co Inc (MRK): 2.39541%
Mon, Oct. 3, 9:04 AM
- September monthly performance was: +0.5%
- 52-week performance vs. the S&P 500 is: -3%
- $0.04 in dividends were paid in September
- Top 10 Holdings as of 6/30/2016: JPMorgan Chase & Co (JPM): 3.02927%, US Treasury Note 1.125%, Citigroup Inc (C): 2.72752%, Bank of America Corporation (BAC): 1.75979%, General Electric Co (GE): 1.64495%, Apache Corp (APA): 1.43672%, Merck & Co Inc (MRK): 1.40565%, Royal Dutch Shell PLC Class A (OTCPK:RYDAF): 1.39841%, Morgan Stanley (MS): 1.39796%, US Treasury Note 0.625%