Dec. 4, 2014, 8:23 AM
- In a Phase 1 trial sponsored by the University of Oxford, 30 healthy volunteers will receive Bavarian Nordic's MVA-BN Filo booster vaccine in combination with the monovalent cAd3-EBO Z Ebola vaccine co-developed by GlaxoSmithKline (NYSE:GSK) and the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). Recent preclinical research suggests that employing an MVA-based booster dose may deliver a more robust and durable immune response to the primary vaccine.
- The study involves 60 healthy adults divided into three cohorts each receiving different doses of the cAd3-EBO Z vaccine. Half of each cohort will also receive the booster dose of MVA-BN Filo.
- The primary endpoint is safety and tolerability. The secondary endpoint is the cellular and humoral immune response. Preliminary results should be available in 1H 2015.
- Both cAd3-EBO Z and MVA-BN Filo have been developed in collaboration with NIAID, which also investigated the prime boost regimen of MVA-BN Filo and Crucell Holland B.V.'s AdVac technology. Crucell is part of J & J (NYSE:JNJ) unit Janssen Pharmaceuticals. Bavarian Nordic and Janssen are collaborating on the development and manufacture of large quantities of their vaccine regimen and intend to start clinical trials shortly.
- Related tickers: (NYSE:MRK) (NASDAQ:NLNK)
Dec. 3, 2014, 10:01 AM
Dec. 2, 2014, 8:30 AM
- The European Medicines Agency accepts for review a Type II variation application for Imbruvica (ibrutinib) filed by Pharmacyclics (NASDAQ:PCYC) strategic partner Janssen-Cilag International NV (NYSE:JNJ) for a potential label expansion covering the treatment of adult patients with Waldenstrom's macroglobulinemia (WM), a rare type of B-cell lymphoma.
- The acceptance of the filing triggers a $20M milestone payment to Pharmacyclics from collaboration partner Janssen Biotech.
- A supplemental NDA was filed with the FDA for WM in October.
- Imbruvica is currently approved for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma.
Nov. 25, 2014, 4:47 PM
- Amgen (AMGN -1.2%) and development partner AstraZeneca (AZN -0.6%) announce that the Amagine-2 Phase 3 trial evaluating two doses (210 mg and 140 mg every two weeks) of brodalumab in patients with moderate-to-severe plaque psoriasis met its primary endpoints compared to J&J's (JNJ -0.1%) Stelara (ustekinumab) and placebo at week 12. The 210 mg arm and the weight-based analysis group both demonstrated superiority to Stelara on achieving total skin clearance as measured by the Psoriasis Area Severity Index (PASI 100 or 100% reduction in score).
- 44.4% of patients in the brodalumab 210 mg group, 33.6% in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140 mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved PASI 100. PASI 75 (75% reduction in score) scores for the same groups were: 86.3%, 77.0%, 66.6%, 70.0% and 8.1%, respectively.
- All secondary endpoints comparing brodalumab to placebo were also met. The first major secondary endpoint comparing PASI 100 for brodalumab 140 mg against Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints for the 140 mg group versus Stelara were also numerically greater (all p values<0.05) but could not be considered statistically significant due to the sequential testing method.
- Previously: Positive Phase 3 results for brodalumab
- Previously: Amgen's brodalumab beats Stelara in Phase 3 trial
Nov. 25, 2014, 11:10 AM
- Johnson & Johnson's (JNJ +0.1%) Janssen Research & Development, LLC submits a New Drug Application (NDA) with the FDA for Yondelis (trabectedin) for the treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
- Soft tissue sarcomas are cancers of the soft tissues that connect, support and surround other body structures such as muscle, fat, blood vessels and nerves.
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 24, 2014, 3:43 PM
- Twenty-two spinoffs have been completed in 2014, the most in a decade, and another 28 have been announced. Among the catalysts are activist investors, so Credit Suisse screened for companies with multiple business segments, slow growth, and stocks trading for lower multiples than peers, in other words, "good, quality companies that are struggling to grow."
- The list is heavy on big media names like Time Warner (NYSE:TWX) and Twenty-First Century Fox (NASDAQ:FOXA), big tech like Oracle (NYSE:ORCL), Symantec (NASDAQ:SYMC), and IBM, and big industry like Lockheed Martin (NYSE:LMT), Ingersoll-Rand (NYSE:IR), and Raytheon (NYSE:RTN), but just two financial names - Travelers (NYSE:TRV) and Torchmark (NYSE:TMK).
- The rest: MO, CA, WU, DPS, PBI, SJM, HRS, SWK, EMR, WLP, MAT, GE, SNA, LLL, ITW, STJ, PDCO, HPQ, DLPH, HAS, NAVI, GME, CBS, JNJ, SLB.
Nov. 24, 2014, 12:52 PM
- Privately-held Transposagen Biopharmaceuticals enters into a research collaboration and worldwide license agreement with J&J's (JNJ -0.9%) Janssen Biotech to develop allogeneic Chimeric Antigen Receptor T-cells (CAR-T).
- CAR-T therapies have shown promise in early clinical trials for the treatment of blood cancers. They have the potential to be used "off the shelf" without the need to match donor with recipient.
- Under the terms of the agreement, Janssen will pay Transposagen up to $292M which includes an undisclosed upfront fee and development-, regulatory- and commercial-related milestones. It will also pay tiered royalties on net sales of any allogeneic CAR-T products commercialized by Janssen.
- Transposagen will enter into a three-year research collaboration with Janssen focused on preclinical research. Janssen will be responsible for the manufacturing and commercialization of allogeneic CAR-T therapies.
Nov. 24, 2014, 8:40 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
Nov. 20, 2014, 12:48 PM
- Johnson and Johnson (JNJ -0.8%) unit Janssen Research & Development, LLC submits its NDA for three-month atypical antipsychotic paliperidone palmitate for the treatment of schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic with a 4x/year dosing schedule.
- The FDA approved once-monthly paliperidone palmitate (Invega Sustenna) in July 2009. It is cleared for sale in over 80 countries.
Nov. 19, 2014, 2:44 AM
- Johnson & Johnson's (NYSE:JNJ) multibillion-dollar trial with Boston Scientific (NYSE:BSX) is set to begin Thursday, as a NY federal court judge decides whether Guidant, through its successor Boston Scientific, should be held liable for breaching a contract.
- J&J is seeking in excess of $5B in damages and interest from Boston Scientific, claiming that Guidant violated clauses included under their agreement to combine in 2004.
Nov. 13, 2014, 5:55 PM
- Geron (NASDAQ:GERN) +30.7% AH on news it entered into an exclusive worldwide license and collaboration agreement to develop its blood disorder drug imetelstat with Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech.
- GERN says it will receive $35M upfront and could receive as much as $900M more as the drug is tested and if it is approved by regulators and reaches certain sales targets; it also would get royalties on sales of imetelstat.
- The companies plan to start a mid-stage trial of imetelstat in 2015; they also want to study the drug as a treatment for other blood diseases.
Nov. 13, 2014, 10:53 AM
- The FDA approves Janssen Pharmaceuticals' (JNJ +0.7%) Supplemental New Drug Applications (sNDA) for its antipsychotic med Invega Sustenna for the expanded indications of the treatment of schizoaffective disorder as either monotherapy or adjunctive therapy. It is the first and only once-monthly medication to treat schizoaffective disorder as monotherapy.
- Invega Sustenna was approved for sale in the U.S. on July 31, 2009 for the acute and maintenance treatment of schizophrenia in adults. The product generated $403M in Q3 revenue.
Nov. 13, 2014, 7:33 AM
- Citing its new draft guidance for determining bioequivalence of methylphenidate hydrochloride products, the FDA reclassifies Mallinckrodt's (NYSE:MNK) generic version of Janssen's (NYSE:JNJ) Concerta (methylphenidate HCL) from AB (freely substitutable at the pharmacy level) to BX (presumed to be therapeutically inequivalent).
- The draft guidance, published on November 6, has an open comment period through January 5, 2015. Nevertheless, the agency states that the change in classification would be reflected in the November 13 update of the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- Unsurprisingly, the company strongly believes its product is safe and effective when used as indicated. President & CEO Mark Trudeau says, "We believe that the FDA's actions are not supported by sound scientific evidence and not consistent with the best interests of patients. Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA and in the 21 months since launch more than 88M doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug (Concerta) to the company's methylphenidate ER products. We believe that this very low reporting rate is in line with response rates recorded for patients switching between different formulations of existing products."
- Since the agency's action was not contemplated in the company's October 14 guidance announcement, it will update it once the potential impact is fully assessed. Mallinckrodt will report fiscal Q4 and full-year results on November 19 before the open.
- Methylphenidate ER was the company's top seller in Q3 in the Specialty Generics and API segment generating $54.7M in sales. This represented 16.6% of the segment's total revenue of $329.4M and 8.4% of the firm's total Q3 revenue of $653.1M.
Nov. 11, 2014, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
Nov. 11, 2014, 11:03 AM
- At The Liver Meeting in Boston, Gilead Sciences (GILD +1.1%) presented results from several Phase 2 and Phase 3 trials evaluating Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic HCV infection in patients with limited or no treatment options, including decompensated cirrhosis, HCV recurrence following liver transplantation and patients refractory to other direct-acting antivirals.
- In a pooled analysis of Phase 2 and Phase 3 open-label studies involving more than 500 HCV-1 patients with compensated cirrhosis who received Harvoni alone or with ribavirin (RBV) for 12 or 24 weeks, 96% achieved SVR12.
- In a Phase 2 open-label study evaluating patients with decompensated cirrhosis and those with HCV recurrence after a liver transplant, 87% of those receiving Harvoni + RBV for 12 weeks achieved SVR12 compared to 89% of the treatment arm receiving a 24-week regimen (subgroup analysis of 108 HCV genotype 1 and 4 patients).
- In another subgroup analysis from the same Phase 2 trial, response rates for patients who developed HCV (genotypes 1 and 4) recurrence following liver transplantation who were treated with Harvoni + RBV were analyzed. SVR12 rates for non-cirrhotic patients were 96% and 98%, respectively, for the 12- and 24-week regimens. For patients with compensated cirrhosis, the SVR12 rate was 96% for both regimens. For patients with decompensated cirrhosis, the SVR12 rate was 81% for both regimens.
- In two studies of HCV patients who failed prior therapy, those receiving Harvoni + RBV for 12 weeks achieved SVR12 rates of 96% and 98%. Those receiving Harvoni alone for 24 weeks (Study GS-US-337-0121) achieved an SVR12 rate of 97%.
- HCV-related tickers: (BMY -0.1%)(MRK +1.4%)(ABBV +0.3%)(JNJ +0.2%)(ACHN -0.6%)(RGLS -2.7%)(CNAT -1.1%)(ENTA -0.4%)
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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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