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Dec. 4, 2015, 4:54 PM
- Johnson & Johnson (JNJ +2.1%) says it has wrapped the acquisition of Novira Therapeutics, the privately held biopharma developer of hepatitis B antivirals.
- Terms weren't disclosed. The company is being integrated into Janssen's Infectious Disease & Vaccines Therapeutic Area.
- Novira's lead candidate, the orally administered NVR 3-778, is in Phase 1b clinical trials.
- Earlier, Barclays had launched coverage of JNJ with an Overweight rating and $115 price target; shares closed today up 2.1% to $102.91.
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. 1, 2015, 7:09 AM| Dec. 1, 2015, 7:09 AM
- November monthly performance was: +0.26%
- 52-week performance vs. the S&P 500 is: -4%
- $0.16 in dividends were paid in November
- Top 10 Holdings as of 10/30/2015: Apple Inc (AAPL): 3.52%, Microsoft Corp (MSFT): 3.36%, Exxon Mobil Corporation (XOM): 3.27%, General Electric Co (GE): 3.01%, AT&T Inc (T): 2.91%, Verizon Communications Inc (VZ): 2.75%, Johnson & Johnson (JNJ): 2.22%, Wells Fargo & Co (WFC): 2.15%, Chevron Corp (CVX): 2.1%, Pfizer Inc (PFE): 2.1%
Nov. 30, 2015, 11:28 AM
- Under its Priority Review process, the FDA approves elotuzumab, in combination with Celgene's (CELG -1.7%) REVLIMID (lenalidomide) and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received one to three prior lines of therapy.
- In clinical studies, patients receiving elotuzumab plus REVLIMID and dexamethasone showed a longer period of progression-free survival (19.4 months) compared to those receiving REVLIMID and dexamethasone alone (14.9 months). In addition, 78.5% of patients treated with elotuzumab plus the other two experienced complete or partial shrinkage of their tumors compared to 60.1% of patients who did not receive elotuzumab.
- Orphan Drug- and Breakthrough Therapy-tagged elotuzumab was co-developed by Bristol-Myers Squibb (BMY -0.7%) and AbbVie (ABBV -2.2%). BMY has sole commercialization rights to the product, which will be marketed under the brand name Empliciti.
- Multiple myeloma, a type of blood cancer that occurs in plasma cells, strikes ~27K Americans each year resulting in over 11K deaths.
- Elotuzumab is the second monoclonal antibody cleared by the FDA for MM. It approved Janssen's (JNJ -0.7%) Darzalex (daratumumab) several weeks ago.
- Previously: FDA accepts elotuzumab BLA under Priority Review (Sept. 1)
- Previously: FDA clears J&J's Darzalex for treatment-resistant multiple myeloma (Nov. 16)
Nov. 30, 2015, 9:58 AM
- Janssen Biotech (JNJ -0.6%) and Janssen-Cilag International NV file marketing applications with the U.S. FDA and the European Medicines Agency, respectively, seeking clearance of STELARA (ustekinumab) for the treatment of moderately-to-severely active Crohn's disease, an inflammatory condition of the GI tract that affects ~700K Americans and ~250K Europeans.
- STELARA, an interleukin-12 and interleukin-23 antagonist, is currently cleared in both areas for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Nov. 23, 2015, 11:09 AM
- The FDA approves privately held Boehringer Ingelheim's anticoagulant Pradaxa (dubigatran etexilate mesylate) for the prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery. Without preventive anticoagulant therapy, as many as 60% of hip replacement patients would be at risk for blood clots.
- The FDA initially cleared Pradaxa in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. In 2014, it approved the indications of DVT and PE in patients who have been treated with a parenteral anticoagulant for up to 10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
- Related tickers: (BMY +0.2%)(JNJ +0.4%)
Nov. 20, 2015, 7:36 AM
- Janssen Research & Development (NYSE:JNJ) submits a New Drug Application (NDA) to the FDA for INVOKAMET XR, a once-daily fixed-dose combination of canagliflozin and metformin hydrochloride extended release (XR) in two tablets for glycemic control in type 2 diabetics.
- INVOKAMET, cleared by the FDA in August 2014, is a fixed-dose combination tablet containing canagliflozin and immediate release metformin hydrochloride. The European Commission approved it in April 2014 under the brand name VOKANAMET.
- The FDA cleared single agent canagliflozin, branded as INVOKANA, in March 2013.
Nov. 18, 2015, 9:49 AM
- Aduro Biotech (ADRO -1.4%) earns an undisclosed milestone payment from licensee Janssen Biotech (JNJ +0.4%) triggered by Aduro's filing of an Investigational New Drug (IND) application with the FDA for ADU-741, a LADD (live-attenuated double-deleted)-engineered Listeria mononcytogenes bacteria in development for the treatment of patients with metastatic castration-resistant prostate cancer. The IND will enable Janssen to initiate a Phase 1 study.
- The companies inked their collaboration deal in May 2014 under which Aduro received an upfront payment and is eligible to earn up to $346M in milestones as well as royalties on commercial sales.
Nov. 17, 2015, 7:39 AM| Nov. 17, 2015, 7:39 AM | 1 Comment
Nov. 16, 2015, 1:40 PM
- The FDA approves Janssen's (JNJ +0.8%) Darzalex (daratumumab) for the treatment of multiple myeloma (MM) patients who have received at least three prior lines of therapy. Breakthrough Therapy-tagged daratumumab is the first monoclonal antibody approved for MM. The FDA's approval comes early. The PDUFA date was March 9.
- Janssen licensed the product from Genmab in August 2012.
- Daratumumab is an investigational human IgG1k monoclonal antibody that binds to the transmembrane ectoenzyme CD38, found on the surface of multiple myeloma cells. Once bound, it induces rapid tumor cell death.
- Previously: FDA grants Priority Review for Janssen's daratumumab BLA (Sept. 4)
- Previously: J&J (NYSE:JNJ) unit Janssen Biotech buys the global licensing rights to cancer agent daratumumab... (Aug. 30, 2012)
Nov. 16, 2015, 10:07 AM
- Data from two mid-stage clinical trials, SURVEYOR-I and SURVEYOR-II, show AbbVie's (ABBV +1.3%) investigational HCV regimen, ABT-493 and ABT-530, produced cure rates as high as 100% after 12 weeks of treatment. The results are being presented at The Liver Meeting in San Francisco.
- Results from the two ongoing studies include genotypes 1, 2 and 3. Data from genotypes 4 - 6 will be presented at future meetings.
- SURVEYOR-I is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adult HCV-1 patients and non-cirrhotic HCV-4,-5 and -6 treatment-naive or treatment-resistant adults. The cure rates range from 97 - 100% in HCV-1.
- SURVEYOR-II is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adults with HCV-2 or -3 who were new to therapy or had failed earlier treatment with interferon/ribavirin. The cure rates range from 96 - 100% in HCV-2 and 83 - 94% in HCV-3.
- ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, are being developed for the pan-genotypic (genotypes 1-6) treatment of HCV infection. ABT-493 was discovered under the company's collaboration with Enanta Pharmaceuticals (ENTA -1.2%). A Phase 3 trial in genotypes 1-6 was initiated this month.
- Related tickers: (MRK +0.4%)(GILD +0.1%)(BMY +0.2%)(JNJ +0.8%)
Nov. 16, 2015, 7:42 AM
- Preliminary results from a Phase 2a clinical trial, OSIRIS, showed HCV-4 patients treated with Janssen's (NYSE:JNJ) OLYSIO (simeprevir) and Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir) for 12 weeks achieved cure rates as high as 100%. The data were presented at The Liver Meeting in San Francisco.
- OSIRIS assessed the regimen of simeprevir 150 mg and sofosbuvir 400 mg in 63 HCV-4 patients, both treatment-naive and treatment-experienced, with and without cirrhosis. Patients without cirrhosis were randomized to receive either eight or 12 weeks of therapy while patients with cirrhosis received 12 weeks of treatment.
- Results showed a 100% cure rate (SVR12) in patients treated for 12 weeks (n=43) and 75% (n=20) in patients treated for eight weeks. Five patients in the eight-week group relapsed, all were genotype IL28B non-CC and non-responders to other therapies.
- HCV-4 is the most common type of HCV infection in the Middle East. As many as 10% of Egyptians are HCV-positive, almost all genotype 4.
- Related tickers: (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:MRK)
Nov. 12, 2015, 11:59 AM
- A study by not-for-profit ethics and governance watchdog Bioethics International (BI) of all clinical trials submitted to the FDA for drugs approved in 2012 showed a wide range of disclosure of results with almost all falling far short of full transparency. The lack of sharing of all trial data has been one contributor to the erosion of public trust in drug companies. According to BI President Jennifer Miller, Ph.D., only 12% of Americans believe that pharmaceutical firms are honest and ethical.
- Companies were ranked by both legal requirements to disclose data per the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA) and the ethical standard that all human-based research should be publicly available in order to contribute to generalized knowledge.
- The cross-sectional analysis of the 2012 data showed that 39 new medicines and 48 new drug entities were cleared by the FDA, 15 by 10 large firms. Researchers identified 318 relevant clinical studies (out of a total of 342) involving 99,599 participants. A median of 57% of the trials were registered, 20% reported results in clinicaltrials.gov, 56% were published and 65% were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 study.
- Gilead Sciences (GILD -1.1%) didn't fare too well, providing only 21% of the data on its HIV combo med Stribild. Sanofi (SNY -3%) was also cited for its lack of reported data on MS drug Aubagio. Firms scoring well included GlaxoSmithKline (GSK -1.2%), Johnson & Johnson (JNJ -0.9%) and Pfizer (PFE -0.4%). All disclosed 100% of their trial data for at least one drug.
- BI is in the process of expanding its rankings to include other years.
- On a positive note, the major players have indicated a keen interest in doing a better job sharing trial data, motivated, no doubt, by the work of interested observers such as BI.
- ETFs: BIB, BIS GRX, IRY, IXJ, BME
Nov. 12, 2015, 8:47 AM
- Janssen Biotech (NYSE:JNJ) launches a new mobile app called Gut Check to help improve disease monitoring for the 1.6M Americans living with the inflammatory bowel diseases (IBD) ulcerative colitis and Crohn's disease.
- Gut Check enables patients to track their daily symptoms and lifestyle habits and share the information in real time with their healthcare providers. It leverages bi-weekly patient-reported outcome surveys to help assess progress over time. Healthcare professionals can use the dashboard on their tablet or computer to filter and compare patient data within their practice, local data or even national data.
- In addition to the bi-weekly surveys and daily symptoms tracking, Gut Check features a GPS-enabled bathroom finder with ratings and reviews, the ability to share activity and engagement via social media, information on IBD-related topics, including diet and exercise, an integrated calendar and tokens and comparative status ranking earned through engagement.
- The Gut Check app is available at no charge for IBD patients and the Gut Check dashboard (to connect with patients) is available free-of-charge to healthcare professionals. Both can be downloaded in the Apple App Store and Google Play.
Nov. 9, 2015, 7:47 AM
- Janssen Pharmaceuticals (NYSE:JNJ) enters into an exclusive global license agreement (except Korea and China) with Seoul, South Korea-based Hanmi Pharmaceuticals to develop and commercialize HM12525A, a novel biologic GLP-1/Glucagon dual receptor agonist about to enter Phase 2 development for the treatment of diabetes and obesity.
- HM12525A is an oxyntomodulin-based therapy that has shown evidence of improving multiple metabolic parameters that lead to improved blood glucose, body weight and insulin sensitivity. Oxyntomodulin is a naturally occurring hormone found in the colon that suppresses appetite.
- Under the terms of the deal, Hanmi will receive an upfront payment of $105M, up to $810M in milestones and double-digit royalties on commercial sales.
Nov. 4, 2015, 12:48 PM
- Johnson & Johnson (JNJ) acquires privately held Novira Therapeutics, a clinical stage biopharmaceutical firm developing therapies to cure chronic hepatitis B infection within one year of treatment, for an undisclosed sum. The transaction should close this quarter.
- Novira's lead product candidate is NVR 3-778, a orally available, small molecule, direct-acting antiviral that inhibits the HBV core or capsid protein. HBV core is an attractive drug target since it is plays a key role in viral replication and survival. NVR 3-778 disrupts the HBV life cycle by inducing the assembly of defective capsids. According to the company, its inhibitors, when used in combination with current standard-of-care drugs (nucleosides and interferon), should deliver greater and faster suppression of viral DNA and new virus production.
- Selected HBV-related tickers: (ARWR +2.1%)(GILD -1%)(CTRV -3.2%)(ABUS +2.6%)(DVAX -1.8%)(MRK +0.7%)(SNY -0.8%)(GSK +0.1%)(ISIS +2.1%)(ALNY +3.1%)(BMY -0.6%)
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale of products in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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