Wed, Apr. 20, 11:18 AM
- According to Leerink's Geoff Porges, drug makers appear to be taking little heed to politicians' outcries over high prices. In a research note, he says, "The price increases for established brands across our coverage have been substantial indeed. To the surprise of many investors, it now appears these price increases are likely to flow through to actual sales growth, with such growth more than offsetting any volume weakness in Q1 and resulting in significant positive revenue surprises for those companies when they report Q1 results."
- He cites Johnson & Johnson's (JNJ +0.8%) Q1 results released yesterday. Its total business was flat (+0.6%) but its pharmaceuticals unit was up 12.9%. His analysis showed as much as 90% of the list price increases are flowing through to reported sales, some as high as 100%.
- Over the past year, Amgen (AMGN +0.7%) increased its drug prices 8 - 28%, Gilead Sciences (GILD +0.9%) 10 - 18% for its HIV drugs and Biogen (BIIB -1.6%) 10 - 18%, according to Mr. Porges.
- Biogen reports tomorrow. Eli Lilly (LLY -0.3%), Baxalta (BXLT -1.4%), AbbVie (ABBV +0.9%), Celgene (CELG +0.4%), Bristol-Myers Sqibb (BMY +0.3%) and Shire (SHPG -1.6%) report next week. Pfizer (PFE +1%) and Merck (MRK -0.2%) report the week after. Amgen (AMGN +0.7%) is due to report shortly as is Gilead.
Tue, Apr. 19, 7:45 AM
- Johnson & Johnson (NYSE:JNJ) Q1 results ($M): Total Revenues: 17,482 (+0.6%); Consumer: 3,195 (-5.8%); Pharmaceutical: 8,178 (+5.9%); Medical Devices & Diagnostics: 6,109 (-2.4%).
- Revenues by region: U.S.: 9,321 (+7.2%); Europe: 3,847 (-4.8%); W. Hemisphere ex-U.S.: 1,331 (-18.8%); Asia Pacific & Africa: 2,983 (-0.7%).
- Strong growers: Oncology: 1,354 (+22.2%); Immunology: 2,910 (+18.1%).
- Key product sales: Imbruvica: 261 (+125.0%); Stelara: 735 (+33.9%); Simponi/Simponi Aria: 390 (+30.0%); Xarelto: 567 (+28.6%).
- Weak areas: Infectious Diseases: 776 (-20.4%); Consumer: 3,195 (-5.8%); Neuroscience: 1,549 (-4.3%).
- Pre-Tax Earnings: 5,294 (-5.0%); Non-GAAP Pre-Tax Earnings: 5,801 (+3.0%); Net Income: 4,292 (-0.6%); Non-GAAP Net Income: 4,689 (+6.1%); EPS: 1.54 (+0.7%); Non-GAAP EPS: 1.68 (+7.7%).
- 2016 Guidance: Total Revenues: $71.2B - 71.9B; Non-GAAP EPS: $6.53 - 6.68.
- Read now Johnson & Johnson In A Quandary
Tue, Apr. 19, 6:43 AM
Mon, Apr. 18, 5:30 PM
Mon, Apr. 18, 8:08 AM
- Results from a study, called REVISIT-US, that analyzed almost 23,000 real-world American patients with non-valvular atrial fibrillation (AF) showed that treatment with Bayer's (OTCPK:BAYRY) Xarelto (rivaroxaban) reduced the rate of ischemic stroke and intracranial hemorrhage (ICH) compared to the anticoagulant warfarin. The data were presented at the 12th Annual Congress of the European Cardiac Arrhythmia Society.
- REVISIT-US, a retrospective claims analysis, showed treatment with Xarelto was associated with a 29% decrease in ischemic stroke accompanied by a 47% reduction in in ICH compared to warfarin. The data confirm the efficacy of Xarelto that was shown in the pivotal ROCKET AF study.
- Xarelto, discovered by Bayer and marketed ex-U.S. by the company, is being jointly developed with Johnson & Johnson's (NYSE:JNJ) Janssen Research & Development, LLC. Janssen markets the product in the U.S.
- Rivaroxaban, a non-vitamin K oral anticoagulant, is currently approved for the prevention of stroke and systemic embolism in AF patients with one or more risk factors, the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), the prevention of recurrent DVT and PE, the prevention of venous thromboembolism (VTE) in adults undergoing elective hip replacement surgery and the prevention of VTE in adults undergoing elective knee replacement surgery.
Fri, Apr. 15, 9:03 AM
- Regulus Therapeutics (NASDAQ:RGLS) is up 11% premarket on higher-than-normal volume in response to its announcement of additional interim results from its ongoing Phase 2 development of RG-101 for the treatment of chronic hepatitis C virus (HCV) infection. The data were presented at The International Liver Congress 2016 in Barcelona, Spain.
- The study was designed to assess a shortened four-week regimen of RG-101, 2 mg/kg administered via subcutaneous injection at day 1 and day 29, in combination with four weeks of a once/daily antiviral: Gilead Sciences' (NASDAQ:GILD) Harvoni (ledipasvir/sofosbuvir), J&J's (NYSE:JNJ) Olysio (simeprevir) or Bristol-Myers Squibb's (NYSE:BMY) Daklinza (daclatasvir). 79 treatment-naive HCV-1 and HCV-4 patients were enrolled in three arms: Harvoni: n=27; Olysio: n=27; Daklinza: n-25.
- Cure rates at week 8 for RG-101 + Harvoni, RG-101 + Olysio and RG-101 + Daklinza were 100%, 100% and 90.9%, respectively. Cure rates at week 12 were 100%, 93.3%, and 100%, respectively (one relapse in Olysio arm).
- RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
- Previously: Regulus Therapeutics' HCV candidate shows 97% cure rate after eight weeks in mid-stage study; shares up 43% premarket (Feb. 17)
- Read now Regulus Add-On Could Help Regulate Hep C Drug Costs
Fri, Apr. 8, 11:05 AM
- MacroGenics (MGNX +3.1%) initiated with Buy rating and $35 price target by BTIG Research.
- Viking Therapeutics (VKTX -39.4%) initiated with Buy rating and $6 price target by H.C. Wainwright.
- Pfizer (PFE -0.3%) initiated with an Overweight rating and $38 price target by JP Morgan.
- Medivation (MDVN -0.1%) initiated with Buy rating and $56 price target by SunTrust Robinson Humphrey.
- Eyegate Pharmaceuticals (EYEG +6.5%) initiated with Buy rating and $10 price target by Noble Financial.
- Eiger Biopharmaceuticals (EIGR +0.5%) initiated with Buy rating and $35 price target by Jefferies.
- Vertex Pharmaceuticals (VRTX +0.3%) initiated with Market Perform rating and a $90 price target by BMO Capital.
- SocGen has been busy with initiations on six large cap pharmas: Buy: Merck (MRK +0.1%); Hold: Johnson & Johnson (JNJ -0.4%), Eli Lilly (LLY -0.3%) and Pfizer; Sell: Bristol-Myers Squibb (BMY -0.4%) and AbbVie (ABBV -0.9%).
- Tokai Pharmaceuticals (TKAI -6.7%) initiated with Buy rating and $16 price target by Bank of America. Initiated with Buy rating by Janney Capital.
- Cellectis (CLLS -0.1%) initiated with Buy rating and $45 price target by Ladenburg Thalmann.
- Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
- TherapeuticsMD (TXMD) initiated with Buy rating and $10 price target by Goldman Sachs.
- Protalix (PLX -4.2%) initiated with Buy rating and $3.50 price target by Rodman & Renshaw.
- Raptor Pharmaceuticals (RPTP -0.4%) upgraded to Outperform from Market Perform by JMP Securities.
- Ironwood Pharmaceuticals (IRWD -0.6%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $16 from $12.
- Intercept Pharmaceuticals (ICPT -6%) upgraded to Outperform from Market Perform by Wells Fargo.
- Edwards Lifesciences (EW -0.1%) upgraded to Buy from Neutral with $115 price target by BTIG Research.
- Express Scripts (ESRX +0.7%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $80 from $76.
- BIND Therapeutics (BIND -7%) downgraded to Market Perform from Outperform by Cowen & Company.
- Allergan (AGN -0.5%) downgraded to Neutral from Buy by Mizuho Securities. Downgraded to Neutral from Positive by Susquehanna. Price target lowered to $275 from $345.
- Bruker (BRKR +0.2%) downgraded to Market Perform from Outperform by Leerink Swann. Price target is $27.
Wed, Apr. 6, 7:50 AM
- Johnson & Johnson's (NYSE:JNJ) Janssen Biotech inks a license and collaboration deal with TESARO (NASDAQ:TSRO) for exclusive global rights, except Japan, to develop and commercialize poly polymerase (PARP) inhibitor niraparib for the treatment of prostate cancer.
- Under the terms of the agreement, TESARO will receive an upfront payment, milestones and royalties on net sales. Specific financial terms are not disclosed.
- Separately, Johnson & Johnson Innovation, J&J's venture capital arm, will make an equity investment in TESARO.
- PARP proteins play a key role in DNA repair in cancer cells. Inhibiting PARP prevents certain defective cancer cells from repairing themselves which leads to cell death. A portion of men will prostate cancer have these defective cancer cells and may benefit from treatment with a PARP inhibitor.
- Niraparib is an orally administered PARP inhibitor also under development for the treatment of metastatic breast cancer and ovarian cancer.
Tue, Apr. 5, 4:10 PM
- The FDA approves a biosimilar to Janssen Biotech's (NYSE:JNJ) Remicade (infliximab) made by Incheon, Korea-based Celltrion for Hospira. Pfizer (NYSE:PFE), through its acquisition of Hospira in September 2015, will commercialize under the brand name Inflectra (infliximab-dyyb).
- Approval was expected. The Ad Comm vote in early February was 21-3 backing clearance.
Mon, Apr. 4, 7:23 AM
- March monthly performance was: +6.82%
- 52-week performance vs. the S&P 500 is: 0%
- $0.18 in dividends were paid in March
- Top 10 Holdings as of 2/29/2016: Exxon Mobil Corporation (XOM): 3.58%, AT&T Inc (T): 3.52%, Microsoft Corp (MSFT): 2.95%, Verizon Communications Inc (VZ): 2.84%, Apple Inc (AAPL): 2.7%, Johnson & Johnson (JNJ): 2.34%, General Electric Co (GE): 2.28%, Chevron Corp (CVX): 2.12%, Procter & Gamble Co (PG): 2.03%, Wal-Mart Stores Inc (WMT): 1.92%
Fri, Apr. 1, 3:45 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of FLIXABI (infliximab), a biosimilar to Johnson & Johnson's (JNJ +0.9%) Remicade (infliximab), developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen (BIIB).
- If approved, it will be the second biosimilar developed by Samsung Bioepis to be cleared in the EU. BENEPALI, a biosimilar to Amgen's (AMGN +2.8%) Enbrel (etanercept), was approved in January.
- A final decision from the European Commission usually takes ~60 days.
- Previously: First Enbrel biosimilar cleared in Europe (Jan. 17)
- Read now Samsung Bioepis And Biogen: A Profitable Case For SB2 and Enbrel
- Update: On May 30, Biogen announced that FLIXABI was approved by the European Commission.
Fri, Apr. 1, 1:31 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Janssen-Cilag International NV's (JNJ +0.4%) TREVICTA (paliperidone palmitate), a maintenance treatment of schizophrenia administered only once every three months via injection. A once-per-month formulation of paliperidone palmitate is currently marketed in Europe by Janssen under the brand name XEPLION.
- A final decision from the European Commission (EC) usually takes ~60 days.
- Update: On May 31, Janssen-Cilag announced that the EC issued its approval.
Fri, Apr. 1, 1:22 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending conditional approval of Janssen Biotech's (JNJ +0.3%) DARZALEX (daratumumab) for the treatment of adult patients with relapsed/refractory multiple myeloma whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and whose disease has progressed on the last therapy.
- Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
- Janssen licensed daratumumab from Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY) in August 2012. The FDA approved it in November 2015.
- A final decision from the European Commission usually takes ~60 days.
Thu, Mar. 31, 4:27 PM
- The prioritization of its strategic portfolio prompts Johnson & Johnson (NYSE:JNJ) Janssen Research & Development, LLC, to terminate its development of fulranumab for the treatment of osteoarthritis pain and return the rights to Amgen (NASDAQ:AMGN).
- Amgen licensed fulranumab, an anti-nerve growth factor (NGF) monoclonal antibody, to Ortho-McNeil-Janssen Pharmaceuticals (now Janssen Pharmaceuticals) in 2008. The neuroscience therapeutic area of Janssen Research & Development continues its discovery and development programs in Alzheimer's and serious mental illness.
- The FDA placed a hold on the development of anti-NGFs in April 2011 due to safety concerns, specifically a heightened risk of joint damage. The hold was subsequently lifted. The company said its decision was based on strategic priorities and not safety concerns from its ongoing Phase 3 study.
Wed, Mar. 30, 1:06 PM
- Johnson & Johnson (JNJ) unit Janssen Research & Development, LLC, announces that its Phase 3 clinical trial, MMY3004 (CASTOR), evaluating the combination of DARZALEX (daratumumab), Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE (bortezomib) and dexamethasone compared to bortezomib and dexamethasone alone in patients with relapsed/refractory multiple myeloma met its primary efficacy endpoint and will be stopped early.
- The interim analysis, performed by the independent Data Monitoring Committee, found that the daratumumab regimen showed a statistically significant improvement in progression-free survival compared to bortezomib and dexamethasone alone (p<0.0001).
- The company intends to submit the results for presentation at a future medical conference and for publication. It will also initiate discussions with regulators regarding marketing applications.
- DARZALEX was approved by the FDA in November 2015 for the treatment multiple myeloma patients who have received at least three prior lines of therapy.
- Previously: FDA clears J&J's Darzalex for treatment-resistant multiple myeloma (Nov. 16, 2015)
Wed, Mar. 23, 3:09 AM
- The U.S. Supreme Court today will consider appeals by Christian groups demanding full exemption on religious grounds from a requirement under the Affordable Care Act to provide health insurance covering contraceptives.
- Arguments on seven related cases will focus on whether nonprofit entities can object to a compromise measure offered by the Obama administration, which allowed groups to comply with the law without actually paying for the required coverage, under the 1993 Religious Freedom Restoration Act.
- Related tickers: PFE, MRK, JNJ, TEVA, CHD, OTCPK:BAYRY
Johnson & Johnson operates as an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company, through its subsidiaries operates in three... More
Industry: Drug Manufacturers - Major
Country: United States
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