Oct. 17, 2014, 8:34 AM
- The U.S. District Court for the District of Connecticut grants a preliminary injunction against Ethicon Endo-Surgery (NYSE:JNJ) preventing it from manufacturing, marketing and selling its Harmonic ACE +7 ultrasonic energy device. The injunction is the result of Covidien's (NYSE:COV) lawsuit that alleges the product infringes on three of its patents.
- Ethicon's Harmonic devices were found to infringe the same patents in a prior suit in the same court. Ethicon is currently appealing the court's damages award of $175M.
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 16, 2014, 7:46 AM
Oct. 15, 2014, 1:11 PM
- Janssen-Cilag International NV (JNJ +0.3%) files a Type II Variation with the European Medicines Agency seeking clearance to expand the label of Stelara (ustekinumab) to include treatment of moderate-to-severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies.
- In the EU, Stelara is currently approved for the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to or who have a contraindication to or are intolerant to other systemic therapies including ciclosporin, methotrexate or PUVA. It also is cleared for the treatment of active psoriatic arthritis, alone or in combination with methotrexate, in adults who responded inadequately to DMARD therapy.
Oct. 14, 2014, 8:37 AM
- Johnson & Johnson (NYSE:JNJ) Q3 results by selected line item:
- Consumer: Leaders: OTC Intl: +6.2%; OTC WW: +4.5%; Oral Care - U.S.: +4.2%; Oral Care Intl: +3.2%. Laggards: Women's Health - U.S.: -89.6%; Women's Health WW: -20.3%; Women's Health Intl: -4.2%; Wound Care/Other Intl: -3.2%.
- Pharmaceuticals: Leaders: Infectious Diseases WW: +90.1%; Edurant U.S.: +75.0%; Xarelto U.S.: +68.3%; Edurant Intl: +58.3%; Stelara U.S.: +52.8%; Oncology U.S.: +34.4%. Laggards: Incivo Intl: -50.0%; Other Infectious Diseases Intl: -41.5%; Risperdal Consta Intl: -16.5%; Other Neuroscience U.S.: -13.9%; Concerta/Methylphenidate U.S.: -10.5%.
- Medical Devices and Diagnostics: Leaders: Cardiovascular Care U.S.: +12.8%; Cardiovascular Care Intl: +5.2%; Orthopaedics U.S.: +3.2%; Diabetes Care: +3.0%. Laggards: Diagnostics WW: -90.4%; Diagnostics Intl: -81.4%; Vision Care U.S.: -12.5%; Vision Care WW: -5.9%; Surgical Care U.S.: -3.9%.
Oct. 14, 2014, 8:14 AM
- Johnson & Johnson (NYSE:JNJ) Q3 results: Total Revenues: $18,467M (+5.1%); Consumer: $3,589M (-0.6%); Pharmaceutical: $8,307M (+18.1%); Med Device & Diagnostics: $6,571M (-5.2%).
- Revenue by geographic segment: U.S.: $8,842M (+11.6%); Europe: $4,446M (-0.7%); Western Hemisphere ex-U.S.: $1,820M (-1.2%); Asia-Pacific/Africa: $3,359M (+0.9%); International: $9,625M (-0.3%); Worldwide: $18,467 (+5.1%).
- COGS: $5,399M (+1.0%); R&D Expense: $2,023M (-0.9%); SG&A Expense: $5,468M (+2.9%); Net Income: $4,749M (+59.3%); EPS: $1.66 (+59.6%).
- Gross Profit: $13,068M (+6.8%); COGS: 29.2% (-3.9%); Gross Margin: 70.8% (+1.7%); Operating Profit: $5,577M (+14.4%); Operating Earnings Yield: 30.2% (+8.9%); Net Earnings Yield: 25.7% (+51.6%).
- 2014 EPS guidance raised to $5.92 - 5.97 from $5.85 - 5.92.
Oct. 14, 2014, 7:48 AM
Oct. 13, 2014, 5:30 PM
Oct. 13, 2014, 9:07 AM
- Bristol-Myers Squibb (NYSE:BMY), Pharmacyclics (NASDAQ:PCYC) and Janssen Research & Development (NYSE:JNJ) enter into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of BMY's Opdivo (nivolumab) in combination with Imbruvica (ibrutinib) as treatment for patients with non-Hodgkin lymphoma, diffuse larger B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia.
- The clinical study will be conducted by Janssen.
- No additional details about the collaboration are disclosed.
Oct. 10, 2014, 1:43 PM
- The FDA approves Gilead Sciences' (GILD -0.3%) Harvoni for the treatment of chronic hepatitis C genotype 1 infection.
- Harvoni is a combination of ledipasvir and sofosbuvir. It is the first approved regimen that does not require administration with interferon or ribavirin.
- This is the third HCV drug approved in the last 12 months. The agency cleared Janssen's (JNJ +0.3%) Oysio (simeprevir) in November 2013 and Sovaldi in December 2013.
- Price: $94,500/12 weeks, $63,000/8 weeks.
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 6, 2014, 1:55 PM
- Privately-held Danbury, CT-based Perosphere enters into a third collaboration agreement with Daiichi Sankyo to study PER977, Perosphere's investigational anticoagulant reversal agent, in Phase 3 trials with edoxaban, Daiichi's investigational oral, once-daily factor Xa-inhibitor.
- In Phase 1 and 2 studies, PER977 showed that it directly binds to heparin as well as circulating direct factor Xa- and IIa-inhibitors reversing their anticoagulant effect. PER977 does not bind to blood coagulation factors or other blood proteins. In healthy volunteers, it reverses anticoagulant activity after a single IV dose of 100 mg - 300 mg and does not require an extended infusion in order to maintain the reversal.
- Under the terms of the agreement, Perosphere will seek FDA and EMA approval of PER977 to reverse anticoagulant activity of edoxaban and commercialize PER977 in the U.S. and EU. It retains full worldwide commercial rights to PER977. Perosphere will receive an upfront payment from Daiichi Sankyo as well as clinical development-related milestones. It plans to submit an NDA to the FDA by June 2015.
- Related tickers: (JNJ -0.4%)(OTCPK:BAYRY -0.4%)(OTCPK:BAYZF +0.1%)(PFE -0.3%)(BAX)(BMY -0.3%)(ISIS -1.9%)(PTLA)(AZN -0.1%)(MRK -0.6%)
Oct. 2, 2014, 10:35 AM
- Thinly-traded nano cap GeoVax (OTCQB:GOVX +18.5%) announces that it has initiated an Ebola vaccine development program based on its DNA/MVA (modified vaccinia Ankara) platform.
- It will develop GOVX-E301 as a single dose vaccine to the ZEBOV strain of Ebola, which is the strain responsible for the current outbreak, and two-dose GOVX-E302 for routine immunization and protection against the three Ebola strains known to be lethal to humans.
- Related tickers: (TKMR -2.8%)([[SRPT] +2.4%)(BCRX +1.2%)(HEB -7.6%)(INO +0.5%)(NNVC -0.3%)(GSK -0.4%)(JNJ)(OTC:FUJIF)(OTCPK:FUJIY -1.4%)(NLNK -3.2%)(CMRX +0.3%)
Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Oct. 1, 2014, 8:21 AM
- Yesterday, the U.S. Government released the first comprehensive disclosure of payments made by medical companies to doctors. Over the first five months of 2013, med firms paid $3.5B to doctors to fund items such as research, consulting, royalties to hospitals to help develop products and fees for speaking engagements. The monies were disbursed in two broad categories: research funding and fees to doctors for consulting and other non-research services.
- Roche's (OTCQX:RHHBY) Genentech unit led the way in the non-research category with $135M. Most of this (90%) went to a Southern California hospital network for royalties.
- Bristol-Myers Squibb (NYSE:BMY) was #1 in the research category with $329M which, according to the company, was largely the value of experimental medicines used in studies.
- Medtronic (NYSE:MDT) paid one unidentified doctor ~$3M who was among a group of six physicians paid at least $500K by the device maker. The company's total outlay for the period was $30.1M.
- Johnson & Johnson (NYSE:JNJ) paid $68M for non-research expenses.
- The disclosures, mandated by Obamacare, cover 4.4M payments to ~550K doctors and 1,360 teaching hospitals from August to December 2013.
- The disclosures are a bit controversial. Physicians complained that the government did not give them enough time to review the data to correct mistakes.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Sep. 30, 2014, 8:45 AM
- Johnson & Johnson (NYSE:JNJ) acquires privately-held clinical stage biopharmaceutical firm Alios BioPharma for $1.75B in cash.
- Alios develops therapies for viral diseases. Its lead product is AL-8176, an orally administered antiviral therapy in Phase 2 clinicals for the treatment of infants with respiratory syncytial virus (RSV).
- Janssen Pharmaceuticals R&D Chief William N Hait, M.D., Ph.D. says, "We are excited that this acquisition will enable us to explore treatment options for a number of viral infections, including RSV, the last of the major pediatric diseases with no available preventive therapy."
JNJ vs. ETF Alternatives
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale ofproducts in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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