Wed, Mar. 9, 3:58 PM
- Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY) earns a $5M milestone from Johnson & Johnson's (JNJ +0.3%) Janssen Biotech triggered by progress in the ongoing Phase 2 clinical trial assessing Orphan Drug-tagged daratumumab as monotherapy in three different types of non-Hodgkin lymphoma (NHL): diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL). The milestone was specific to progress in the FL arm. Genmab earned the first milestone, also $5M, in December.
- Daratumumab, branded as DARZALEX, 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. The FDA approved DARZALEX in mid-November 2015 for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.
- The companies inked a global license and development deal for daratumumab in August 2012.
- Previously: Genmab earns $5M milestone from Janssen for progress in mid-stage study of daratumumab (Dec. 9, 2015)
Tue, Mar. 8, 9:13 AM
- Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
- The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
- Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
- BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
- Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
- HBV-related tickers: (NASDAQ:GILD)(OTCQB:COCP)(NYSE:GSK)(NASDAQ:IONS)(NASDAQ:DVAX)(NYSE:JNJ)(NASDAQ:ARWR)(NYSE:MRK)(NASDAQ:CTRV)(NASDAQ:ABUS)(NYSE:SNY)(NASDAQ:ALNY)(NYSE:BMY)
- Update: Shares up 26% in early trading.
Mon, Mar. 7, 9:10 AM
- AbbVie (NYSE:ABBV) and Boehringer Ingelheim enter into a global collaboration to develop and commercialize the latter's BI 655066, a Phase 3-stage monoclonal antibody that binds to interleukin-23 (IL-23), for the treatment of psoriasis. The firms will also assess the potential of BI 655066 in Crohn's disease, psoriatic arthritis and asthma.
- BI 655066 demonstrated greater efficacy than Janssen Biotech's (NYSE:JNJ) Stelara (ustekinumab) in a recent Phase 2 study. At Week 12, the proportion of patients achieving PASI 90 (90% improvement in psoriasis symptoms) scores after receiving BI 655066 (180 mg) and Stelara were 81.0% and 40.0%, respectively. The proportions achieving PASI 100 (complete resolution of psoriasis) were 50.0% and 17.5%, respectively.
- The partnership also grants AbbVie the rights to Phase 1-stage BI 655064, an anti-CD-40 antibody. Boehringer will continue its development of BI 655064 and AbbVie has the option to advance the program after the completion of certain clinical milestones.
- Under the terms of the agreement, Boehringer will receive an upfront payment of $595M, development and regulatory milestones and royalties on net sales. In the initial period, the companies will share responsibility for future development of BI 655066, while AbbVie will be solely responsible for commercialization. Boehringer retains an option to co-promote BI 655066 for asthma.
Fri, Mar. 4, 1:27 PM
- The FDA approves the use of IMBRUVICA (ibrutinib) for treatment-naive patients with chronic lymphocytic leukemia. The data supporting clearance was generated in the Phase 3 RESONATE-2 study which showed treatment with IMBRUVICA extended progression-free survival and increased overall response rate compared to the chemo agent chlorambucil.
- IMBRUVICA, jointly developed and commercialized by Janssen Biotech (JNJ -0.4%) and AbbVie's (ABBV +1%) Pharmacyclics LLC, was originally cleared by the FDA in November 2013 for mantle cell lymphoma. Its label was expanded in July 2014 to include a certain type of chronic lymphocytic leukemia and in January 2015 to include Waldenstrom's macroglobulinemia.
Wed, Mar. 2, 6:30 AM| Wed, Mar. 2, 6:30 AM | 1 Comment
- February monthly performance was: +1.21%
- 52-week performance vs. the S&P 500 is: 0%
- $0.16 in dividends were paid in February
- Top 10 Holdings as of 1/29/2016: Exxon Mobil Corporation (XOM): 3.46%, AT&T Inc (T): 3.42%, Microsoft Corp (MSFT): 3.2%, Verizon Communications Inc (VZ): 2.8%, Apple Inc (AAPL): 2.72%, Johnson & Johnson (JNJ): 2.33%, General Electric Co (GE): 2.28%, Chevron Corp (CVX): 2.19%, Procter & Gamble Co (PG): 2.06%, Wells Fargo & Co (WFC): 1.97%
Tue, Mar. 1, 4:29 PM
- Johnson & Johnson (NYSE:JNJ) commences a $7.5B aggregate principal amount debt offering underwritten by Goldman Sachs, J.P. Morgan and Merrill Lynch. The tranches are:
- $300M Floating Rate Notes due 2019
- $700M 1.125% Notes due 2019
- $1B 1.650% Notes due 2021
- $500M 2.050% Notes due 2023
- $2B 2.450% Notes due 2026
- $1B 3.550% Notes due 2036
- $2B 3.700% Notes due 2046
- The transactions should close today.
Tue, Mar. 1, 3:16 PM
- The FDA approves Gilead Sciences' (GILD +2.2%) Odefsey (emtricitabine 200mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg)(R/F/TAF) for the treatment of HIV-1 infection in certain patients. Rilpivirine is from Janssen Sciences Ireland UC (JNJ +1.8%).
- Odefsey, the company's second TAF-based regimen cleared in the U.S., is indicated for antiretroviral treatment-naive patients at least 12 years old with HIV-1 RNA levels no greater than 100K copies/mL. It is also indicated as replacement for a stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
- The company is transitioning its HIV product line to TAF because it is shows antiviral efficacy at one tenth the dose of TDF (tenofovir disoproxil fumarate) while being less stressful on the bones and kidneys.
- The FDA approved TAF-based Genvoya (E/C/F/TAF) in November 2015.
- Previously: Gilead submits NDA for single tablet HIV med (July 1, 2015)
- Previously: FDA clears Gilead's Genvoya for HIV-1 infection (Nov. 5, 2015)
Wed, Feb. 24, 1:40 PM
- ViiV Healthcare, the HIV-focused joint venture between GlaxoSmithKline (GSK -1.1%), Pfizer (PFE -0.5%) and Shionogi Limited (OTC:SGIOF)(OTCPK:SGIOY), announces the results from a 41-week Phase 2a study, ECLAIR, assessing the safety, tolerability, dosing and satisfaction with long-acting, injectable cabotegravir as monotherapy for the prevention of HIV infection in adult males not at high risk of acquiring HIV. The data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
- ECLAIR randomized 127 HIV-negative subjects 5:1 to cabotegravir or placebo beginning with a safety assessment on oral cabotegravir 30 mg or placebo tablet for four weeks followed by an intramuscular injection of 800 mg cabotegravir or placebo (sterile saline) every 12 weeks for three cycles.
- The proportions of participants who completed three injections for cabotegravir and placebo were 93% (n=87/94) and 95% (n=20/21), respectively. The incidences of Grade 2 (moderate) to Grade 4 (life-threatening or disabling) adverse events during the injection phase were 80% (n=75/94) and 48% (n=10/21), respectively. The most common Grade 2-4 AE was injection site pain (59% and 5%, respectively). The incidences of all grades of adverse events during the injection phase were 98% (n=92/94) and 90% (n=19/21), respectively.
- Following repeat injections, 74% (n=67/91) favored long-acting cabotegravir over the oral version.
- ViiV intends to advance cabotegravir to Phase 3 development later this year.
- Related tickers: (NASDAQ:GILD)(NYSE:ABT)(NYSE:BMY)(NYSE:JNJ)(NYSE:MRK)(OTCQX:RHHBY)
Wed, Feb. 24, 10:15 AM
- The circuit court in St. Louis orders Johnson & Johnson (JNJ -0.9%) to pay $72M to the family of a woman who died from ovarian cancer linked to her long-term use of the company's Baby Powder and Shower to Shower products. The award consists of $10M in actual damages and $62M in punitive damages.
- The monetary award is the first by a U.S. jury over such claims, now numbering in the hundreds. The lawsuits accuse the company of failing to warn consumers that its talc-based products could cause cancer.
- Company spokesperson Carol Goodrich says, "We have no higher responsibility than the health and safety of consumers and we are disappointed with the outcome of the trial. We sympathize with the plaintiff's family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence."
- In October 2013, a federal jury in South Dakota agreed with the plaintiff that J&J's body powder products contributed to her ovarian cancer, but awarded no damages.
Mon, Feb. 22, 1:53 PM
- Results from a 159-subject Phase 3 clinical trial assessing Bristol-Myers Squibb's (BMY) all-oral HCV regimen, daclatasvir (Daklinza) combined with asunaprevir, in Asian patients positive for genotype 1b showed cure rates as high as 99%. The data were presented today at the Asian Pacific Association for the Study of the Liver Conference in Tokyo.
- The trial was an open-label design that evaluated daclatasvir 60 mg once daily and asunaprevir 100 mg twice daily for 24 weeks. 80% of patients (n=127) were from mainland China, 11% (n=17) from Korea and 9% (n=14) from Taiwan.
- Cure rates, defined as sustained virologic response at week 24 (SVR24), were 91% among all Chinese patients and 98% in those without NS5A resistance-associated variants (RAVs) at baseline. SVR24 rates were high among HCV-1b subgroups including those with cirrhosis (90%), Koreans (94%) and Taiwanese (87%). Japanese patients were not part of the study.
- In all patients, the SVR24 rate was 99% (n=137/139) in those without NS5A RAVs, regardless of the presence (98%) or absence (99%) of cirrhosis, and 42% (n=8/19) in those with baseline NS5A RAVs.
- The daclatasvir/asunaprevir regimen is currently cleared in Japan, Korea, Taiwan and certain countries in Latin America and Eastern Europe. More than 13M Chinese are HCV-positive so approval there is a priority for the company.
- Related tickers: (GILD +2.2%)(ABBV +0.7%)(MRK +0.8%)(JNJ +0.5%)
Wed, Feb. 17, 8:55 AM
- Micro cap Regulus Therapeutics (NASDAQ:RGLS) is up 43% premarket on robust volume in response to its announcement of positive interim results from a Phase 2 clinical trial assessing RG-101, in combination with other antivirals, in patients with chronic hepatitis C virus (HCV) infection.
- The study was designed to evaluate a four-week treatment regimen of 2 mg/kg of RG-101 at Day 1 and Day 29, in addition to four weeks of once/daily Harvoni (ledipasvir/sofosbuvir), Olysio (simeprevir) or Daklinza (daclatasvir). Seventy-nine HCV-1 and HCV-4 patients are enrolled, while 38 have been evaluated through eight weeks of follow up. Of these, 97% (n=37/38) had HCV RNA viral loads below the limit of quantification (SVR12). For those assessed through 12 weeks of follow up, 100% (n=14/14) remained below the level of detection.
- The primary endpoint analysis (12 week follow up) for all 79 subjects should be available in late Q2.
- 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.
- Related tickers: (NASDAQ:GILD)(NYSE:JNJ)(NYSE:BMY)(NYSE:ABBV)(NYSE:MRK)
Tue, Feb. 16, 11:53 AM
- Data from a Phase 2 clinical trial assessing FibroGen's (FGEN +4.9%) oral agent roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) showed that patients on hemodialysis who were previously receiving epoetin alfa [Amgen's (AMGN +1.1%) EPOGEN or J&J's (JNJ +0.3%) PROCRIT] but switched to roxadustat maintained hemoglobin (Hb) levels regardless of iron deletion status, degree of inflammation or prior iron regimen over six or 19 weeks. The results were published in the American Journal of Kidney Disease.
- In the first part of the study, lasting six weeks, lowest dose roxadustat (1.0 mg/kg 3x/week) maintained hemoglobin levels on par with epoetin alfa. Some separation was seen at higher doses of at least 1.5 mg/kg with 79% of patients showing a hemoglobin response compared to 33% for epoetin alfa.
- In the second part of the study, 51% of the roxadustat cohort achieved a Hb level of at least 11.0 g/dL compared to 36% for epoetin alfa (normal range is 13.5 - 17.5 for men and 12.0 - 15.5 for women). In addition, maintenance dosing of roxadustat was not correlated with levels of the inflammatory biomarker C-reactive protein (CRP). Decreases in cholesterol and hepcidin (key regulator of iron) were also observed in the roxadustat group.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa.
- It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Previously: Data from mid-stage study show CKD patients with anemia respond to FibroGen's roxadustat in dose-related manner (Aug. 13, 2015)
Tue, Feb. 9, 10:08 PM
- Earlier today, the FDA's Arthritis Advisory Committee voted 21 - 3 recommending approval of Celltrion's biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab), CT-P13, for all indications.
- If approved, which is probable, Pfizer (NYSE:PFE) will commercialize it in the U.S. under the brand name Inflectra.
- Previously: Ad Comm approaches for Remicade biosimilar (Feb. 5)
Tue, Feb. 9, 8:07 AM
- EPIRUS Biopharmaceuticals (NASDAQ:EPRS) commences its pivotal Phase 3 clinical trial, called UNIFORM, to demonstrate the bioequivalence of BOW015 to J&J's (NYSE:JNJ) Remicade (infliximab) in rheumatoid arthritis (RA). The 58-week, double-blind, one-to-one randomized, comparator-controlled study will be conducted across sites in the U.S., Europe and Latin America. The primary endpoint is the proportion of patients achieving ACR20 (20% improvement in RA symptoms) at Week 16.
- The company plans to file global marketing applications in 2017 based on 30-week data.
Mon, Feb. 8, 8:17 PM
- Genco, the logistics company bought by Fedex (FDX -1.2%) for $1.4B in 2014, is taking over operations from a Johnson & Johnson (JNJ +1.5%) distribution center.
- The changeover will begin in April. J&J Health Care Systems founded its Memphis Logistics Center in 2003 at at 770,000-square-foot location. The center distributes medical device and diagnostic equipment.
- Some 450 full-time workers are employed at the center, and the move will include employee changes; "some job actions" were taken last week, a spokeswoman says, but "a vast majority of the employees at our Memphis Distribution Center received offers of employment from Genco."
Fri, Feb. 5, 9:49 AM
- The FDA's Arthritis Advisory Committee will meet on Tuesday, February 9 to discuss and review the Biologics License Application (BLA) from Incheon, Korea-based Celltrion seeking clearance of its biosimilar to Janssen's (JNJ -2.9%) Remicade (infliximab).
- Based on a quick review of the FDA's document, it appears that Celltrion's application has the necessary data proving bioequivalence.
- Remicade is J&J's top seller, generating almost $6.6B in sales over the past four quarters.
- Draft questions
- FDA briefing doc
- Celltrion briefing doc
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
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