Wed, Sep. 23, 7:27 AM
- An open-label 551-subject Phase 3b/4 clinical trial, called STRIIVING, assessing the safely, efficacy and tolerability of switching from an antiretroviral therapy (ART) to ViiV Healthcare's (NYSE:PFE) (NYSE:GSK) once-daily fixed dose Triumeq (abacavir/dolutegravir/lamivudine) in virologically suppressed adults with HIV-1 infection showed that viral suppression was non-inferior (no worse than) in patients who switched to Triumeq.
- The study recruited HIV-1-positive patients from a broad range of protease inhibitor (n=234), integrase strand transfer inhibitor (n=146) and non-nuclease reverse transcriptase inhibitor (n=171)-based regimens who had similar clinical profiles. The treatment satisfaction score improved significantly for those patients who switched to Triumeq (p<0.001) although there was an increase in adverse events (AEs) (4% versus 0%). The most common AEs were nausea (10%), diarrhea (7%), fatigue (7%), upper respiratory infection (7%), cough (5%) and headache (5%).
- ViiV Healthcare Chief Scientific and Medical Officer John Pottage, M.D., says, "For clinicians, choosing among antiretroviral therapies now involves balancing efficacy with factors such as tolerability, dosing, ability to use with other medications and resistance profile. These data support the use of once-daily abacavir/dolutegravir/lamivudine as a treatment option in the switch setting for appropriate patients."
- Related tickers: (NASDAQ:GILD) (NYSE:JNJ) (NYSE:MRK) (NYSE:ABBV) (NYSE:BMY) (OTCQX:RHHBY)
Thu, Sep. 17, 7:59 AM
- Interim results from a Phase 2 clinical trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) NS5A inhibitor odalasvir (ACH-3102), in combination with Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir), without ribavirin, in HCV-1 patients showed a 100% cure rate (SVR12) in HCV-1 patients (n=6/6) after six or eight weeks of treatment.
- The Phase 2 trial was an open-label, randomized, partial-crossover study to assess the safety, tolerability and efficacy of six or eight weeks of odalasvir and sofosbuvir, without ribavirin, in patients with HCV-1 infection. Eighteen patients were initially enrolled, including six as observational (group 1). Twelve patients completed eight weeks of treatment (50 mg odalasvir/400 mg sofosbuvir) while the observational group received nothing. All twelve subjects achieved SVR24. Following this phase, the six observational patients plus six additional patients (group 2) received six weeks of treatment with the same combo regimen. All achieved SVR24. Six additional rollover patients (group 3) were treated for six weeks with the combo regimen and all achieved SVR12.
- In a summary that is a bit confusing, the company states that 18 subjects (groups two and three) achieved SVR12 after six weeks of therapy, although it states that only group 3 (n=6) achieved this. Also, the total number of patients in groups 2 and 3 is 12 (6 + 6). Group 1 (n=6) is apparently included as well?
- In May, the company inked a global license and commercialization deal with Janssen Pharmaceuticals (NYSE:JNJ) for HCV products containing one or more of Achillion's HCV assets, including odalasvir, ACH-3422 and sovaprevir.
- Previously: Achillion inks collaboration deal with J&J's Janssen Pharmaceuticals in hep C (May 19)
- ACHN is up 5% premarket on light volume.
- Related tickers: (NYSE:MRK) (NYSE:BMY) (NYSE:ABBV)
Wed, Sep. 16, 8:32 AM
- The first patient has been dosed in a Phase 2 clinical trial, called IMbark, evaluating imetelstat in patients with myelofibrosis, a bone marrow disorder characterized by scarring (fibrosis) in the bone marrow which leads to severe anemia, weakness, fatigue and an enlarged spleen and liver. The study is being conducted by Janssen Biotech (NYSE:JNJ) under the terms of its November 2014 exclusive global imetelstat license from discoverer Geron (NASDAQ:GERN).
- The mid-stage trial will assess two doses (9.4 mg/kg every three weeks or 4.7 mg/kg every three weeks) of imetelstat as monotherapy in ~200 high risk MF patients who have relapsed or failed to adequately respond to Janus Kinase (JAK) inhibitor treatment [Novartis' (NYSE:NVS) Jakafi (ruxolitinib)]. An interim review of the data will be done after ~20 subjects in each arm have been dosed and followed for at least 12 weeks. The review will be the basis for any modifications going forward.
- The co-primary endpoints are spleen response rate, determined by the percentage of patients who achieve at least a 35% reduction in spleen volume from baseline at week 24, and symptom response rate, determined by the percentage of patients who experience at least a 50% reduction in Total Symptom Scores from baseline at week 24.
- According to clinicaltrials.gov, the final data collection date for the primary endpoints is March 2017. The estimated study completion date is March 2018.
- Imetelstat inhibits an enzyme called telomerase by binding to its RNA template. Most cancers have a high level of telomerase activity and relatively short telemeres (caps at the end of each strand of DNA) compared to normal cells. Inhibiting telomerase inhibits the proliferation of malignant progenitor cells.
Mon, Sep. 14, 5:22 PM
- CareDx (NASDAQ:CDNA) announces that its donor-derived cell-free DNA (dd-cfDNA) technology will be used in a major NIH-sponsored study of clinical outcomes in kidney transplantation. The study, called The Clinical Trials in Organ Transplantation (CTOT) project, is being jointly sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
- The study will assess if taking infliximab [Janssen's (NYSE:JNJ) Remicade] just prior to transplant surgery, in addition to the typical anti-rejection drugs, protects the kidney from damage caused by TNF-alpha and whether it keeps the kidney healthy for a longer period of time. Infliximab blocks TNF (tumor necrosis factor).
- Preliminary data from CareDx-sponsored studies showed that dd-cfDNA increased prior to acute rejection events in transplanted hearts and kidneys and decreased following courses of immunosuppressive treatments.
- The company's dd-cfDNA test will be performed on CTOT samples to provide new information that could positively impact the care of kidney transplant patients by improving the quality of surveillance.
Mon, Sep. 14, 4:23 PM
- Janssen Pharmaceutical (NYSE:JNJ) unit Crucell Hollland B.V. awards a subcontract valued at $9M over five years to Bavarian Nordic A/S (OTCPK:BVNRY) to improve the manufacturing process and establish long-term storage of MVA-BN Filo bulk vaccine. The subcontract is part of BARDA's (U.S. Biomedical Advanced Research and Development Authority) contract with Janssen to support the advanced development and manufacturing of the Ebola prime-boost vaccine regimen of Bavarian's MVA-BN Filo and Janssen's Ad26.ZEBOV.
- The subcontract also includes options for an additional $24M to implement process development activities for formulation of a final drug product with a longer shelf life.
- To date, Bavarian has produced and delivered the bulk equivalent of over 1M doses of its vaccine to support clinical trials in Europe and Africa.
- Bavarian will recognized the majority of the revenue from the subcontract in 2016 and 2017.
Mon, Sep. 14, 11:15 AM
- With market eyes on a Fed rate-hike decision considered to be a bit of a toss-up amid differing opinions, Goldman Sachs is banking on the (slightly) more dovish position that the agency will wait until December. The bank is still laying out how to play the hike when it invariably comes.
- Strength in balance sheets is what you need, it says, noting that those companies outperform (by an average 5%) in the three months after a rate-boosting cycle begins. In Goldman's "High Quality Stock" basket: CMG, DLTR, PEP, KMI, BLK, GOOG, AAPL, PCLN, ORCL, WFC.
- Meanwhile, it suggests avoiding companies with high floating-rate debt as they bear the brunt of a move away from near-zero interest rate policy. "When the tightening cycle finally starts, the immediate impact will be felt by firms with high proportions of variable rate borrowing."
- Included in that "avoid" list: CL, COL, JNJ, AAPL, EBAY, MET, KO, GIS, F, MCD, GM, TWX, CVX, AGN, MON.
- (Yes, cash-rich Apple made both lists, having a strong balance sheet along with floating debt.)
Mon, Sep. 14, 10:35 AM
- Janssen Biotech (JNJ +0.5%) submits a supplemental New Drug Application (sNDA) seeking clearance for the use of IMBRUVICA (ibrutinib) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL).
- The data supporting the filing was generated from the Phase 3 RESONATE-2 study which showed ibrutinib to be superior to chlorambucil as determined by progression-free survival (PFS).
- IMBRUVICA, jointly developed with AbbVie's (ABBV -0.5%) Pharmacyclics, inhibits an enzyme called Bruton's tyrosine kinase (BTK). The BTK protein transmits key signals to B cells to mature and product antibodies. Specific cancers need BTK to multiply and spread.
- IMBRUVICA is currently approved for the second line treatment of CLL, CLL with the 17p deletion, Waldenstrom's macroglobulinemia and the second line treatment of mantle cell lymphoma.
Sat, Sep. 12, 10:50 AM
- A self-proclaimed "kid in a candy store" in 2011, Lowes (NYSE:L) CIO Joe Rosenberg isn't as excited now as he was then, but he remains a long-term bull and sees a few particular pockets of value.
- Source: Barron's
- On oil, either OPEC and non-OPEC countries reach an agreement to cut production and the price spikes upward, or there isn't an agreement and the price collapses - wiping out a lot of production. Either way, the price moves higher, says Rosenberg, and energy stocks (XLE, OIH) have likely bottomed.
- Rosenberg doesn't think the dividend gets cut at Chevron (NYSE:CVX), noting board members like John Stumpf were buyers of the stock at much higher levels. "The probability of them then agreeing to a dividend cut seems somewhat remote." A similar case can be made for Shell (RDS.A, RDS.B) or ExxonMobile (NYSE:XOM).
- Catalysts for Johnson & Johnson (NYSE:JNJ) include a breakup into three companies, and better capital allocation - notably, getting far more aggressive with share repurchases. "JNJ could raise $50B in the bond market in a heartbeat and use that money to buy back stock." Don't rule out an activist investor if management doesn't get with it.
- Ford (NYSE:F) and General Motors (NYSE:GM) are "incredibly cheap," says Rosenberg. The strong sales pace is sustainable because the average age of cars on the road in the U.S. is about 11 years - they need to be replaced. "The stocks are discounting a very bearish scenario."
Wed, Sep. 9, 10:43 AM
- Genmab A/S (OTCPK:GMXAY) announces that licensor Janssen-Cilag (JNJ -0.4%) has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval for daratumumab for the treatment of patients with multiple myeloma who have received at least three different lines of therapy.
- The submission triggers a US$10M milestone payment to Genmab from Janssen. Genmab licensed daratumumab to Janssen in August 2012.
Wed, Sep. 9, 9:33 AM
- Epirus Biopharmaceuticals (NASDAQ:EPRS) acquires privately-held Netherlands-based Bioceros for $14.1M in cash and stock payable over a one-year period.
- Bioceros develops monoclonal antibodies and GMP-ready cell lines. It has a number of biosimilar cell lines from its proprietary CHO platform.
- The deal enables Epirus to pick up three preclinical product candidates: BOW080 [biosimilar to Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab)]; BOW100 [biosimilar to J&J's (NYSE:JNJ) Simponi (golimumab)] and and BOW090 [biosimilar to J&J's Stelara (ustekinumab)].
Wed, Sep. 9, 7:56 AM
- Hamburg, Germany-based Evotec (OTCPK:EVTCY) enters into a four-year research collaboration with Pfizer (NYSE:PFE) in the field of tissue fibrosis. Under the terms of the agreement, the companies will explore potential novel mechanisms as targeted anti-fibrotics in multi-organ fibrosis. Evotec will contribute its drug discovery platform and Pfizer will contribute key technologies, industrial scope and expertise in drug development and marketing.
- Specific financial terms are not disclosed but include an upfront payment to Evotec and development- and sales-based milestones.
- Evotec inked collaboration deals with Sanofi (NYSE:SNY) a month ago in the field of cancer immunotherapies and diabetes. The firms established a five-year drug discovery collaboration in March.
- Evotech consummated a drug discovery deal in Alzheimer's disease with Johnson & Johnson (NYSE:JNJ) in November 2013.
Fri, Sep. 4, 2:49 PM
- The FDA will assess Janssen Biotech's (JNJ -2%) Biologics License Application (BLA) for daratumumab for the fourth line treatment of multiple myeloma under Priority Review. The accelerated process shortens the review clock to six months from ten. The PDUFA date is March 9, 2016.
- Daratumumab, licensed from Danish biotech Genmab A/S (OTCPK:GMXAY), is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of multiple myeloma cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
- Previously: Janssen Biotech completes rolling BLA submission for daratumumab (July 9)
Tue, Aug. 25, 1:40 PM
- Heartland Food Products is buying Johnson & Johnson's (JNJ +1.1%) Splenda low-calorie sweetener brand for an undisclosed sum. The deal is expected to close by year's end.
- J&J's consumer revenue fell 7% Y/Y in Q2 (+2.3% exc. forex) to $3.5B. On its earnings call (transcript), J&J reiterated its strategy of focusing its consumer product portfolio "around the key consumer need states in brands that are backed with strong clinical science and professional endorsements."
Fri, Aug. 21, 7:18 AM
- Janssen-Cilag (NYSE:JNJ) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for a once-every-three-months formulation of paliperidone palmitate for the treatment of schizophrenia. If approved, it will be the first such therapy with a 4x/year dosing regimen.
- Once-monthly paliperidone palmitate in currently marketed in the EU as XEPLION.
Mon, Aug. 17, 4:33 PM
- Major stock indexes rebounded from opening declines to finish modestly higher, after a solid housing report showed some strength on a lightly traded Monday.
- Homebuilding stocks paced gainers, including Toll Brothers (TOL +2.3%); Ryland (RYL +2.1%); KB Home (KBH +3.1%), Lennar (LEN +2.7%) and Taylor Morrison Home (TMHC +2.9%).
- The S&P 500 gained 0.5% to 2,102.44; for 2015, it's up 2.12%. The move up came despite a grim reading from New York manufacturing that sent bond yields lower. TLT +0.5%; TBT -0.8%.
- Volumes overall were about 20% below recent average.
- Sector gains were broadly distributed, with a flat energy sector as the laggard. Healthcare stocks performed well, paced by dollar volume leaders Gilead Sciences (GILD +0.7%), Johnson & Johnson (JNJ +1.1%) and Biogen (NASDAQ:BIIB) +1.1%.
Wed, Aug. 12, 1:56 PM
- Among the many sellers of Aquinox Pharmaceuticals (AQXP -10%) recently was Johnson & Johnson (JNJ -0.6%). According to a regulatory filing, it unloaded over 1.5M shares on August 10 and 11 at an average price of $22.41, reducing its stake to 100K shares.
- Aquinox experienced breathtaking action over several days, even by biotech standards. On Friday, August 8, in response to its announcement of positive trial results for its lead product candidate, shares closed up almost five-fold ($10.42) from Thursday's close of $1.79. On Monday, August 10, shares peaked at a mind-boggling $55.75 before easing to $18.88. On Tuesday, shares peaked at $30.00 before moderating to close at $21.01.
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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