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- Citing its new draft guidance for determining bioequivalence of methylphenidate hydrochloride products, the FDA reclassifies Mallinckrodt's (NYSE:MNK) generic version of Janssen's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- The draft guidance, published on November 6, has an open comment period through January 5, 2015.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%)
Nov. 11, 2014, 10:07 AM
- At The Liver Meeting in Boston, AbbVie (ABBV -0.1%) presented results from studies in HCV patients co-infected with HIV and liver transplant recipients who received its all-oral, interferon-free investigational treatment combining three antivirals (ombitasvir/ABT-450/ritonavir and dasabuvir)
- SVR12 rates for patients co-infected with HCV/HIV that received the company's investigational treatment plus ribavirin were 93.5% for the 12-week regimen and 90.6% for the 24-week regimen.
- In non-cirrhotic liver transplant recipients with recurrent HCV-1 new to treatment, SVR12 and SVR24 rates were each 97.1%.
- HCV-related tickers: (GILD +0.5%)(MRK +1%)(JNJ -0.1%)(BMY -0.2%)(ENTA +0.2%)(RGLS +0.2%)(CNAT -0.5%)(ACHN -1.7%)
Nov. 11, 2014, 9:37 AM
- At The Liver Meeting in Boston, Merck (NYSE:MRK) presented data from a Phase 2 clinical trial evaluating the combination of the company's investigational NS3/4A inhibitor, grazoprevir, and its investigational NS5A inhibitor, elbasvir, with and without ribavirin, in treatment-naive and treatment-experienced HCV-1 patients. The length of treatment was either eight,12 or 18 weeks.
- SVR12 rates in treatment-naive non-cirrhotic patients were: 8-week regimen with RBV: 80%; 12-week regiment with and without RBV: 93% and 98%.
- SVR12 rates in treatment-naive patients with cirrhosis were: 12-week regimen with and without RBV: 90% and 97%; 18-week regimen with and without RBV: 97% and 94%.
- SVR12 rates for treatment-experienced patients with and without cirrhosis: 12-week regimen with and without RBV: 94% and 91%; 18-week regimen with and without RBV: 100% and 97%.
- SVR12 rates for HCV-1 patients co-infected with HIV: 12-week regimen with and without RBV: 97% and 87%.
- Results from a Phase 3 trial are expected in 1H 2015.
- Previously: Merck triple therapy HCV candidate fails as a four-week regimen
- HCV-related tickers: (GILD +0.4%)(JNJ -0.2%)(BMY -0.1%)(ABBV +0.3%)(ACHN +3%)(ENTA +0.4%)(CNAT)(LGND +0.5%)(RGLS)
Nov. 11, 2014, 9:05 AM
- At The Liver Meeting in Boston, Gilead Sciences (NASDAQ:GILD) presented data from three Phase 2 studies evaluating an all-oral pan-genotypic regimen, Sovaldi (sofosbuvir) + the company's investigational NS5A inhibitor GS-5816, for the treatment of HCV infection. The specific regimens were Sovaldi 400 mg plus GS-5816 25 mg or 100 mg, with and without ribavirin, for eight or 12 weeks.
- The first study, GS-US-342-0109, evaluated Sovaldi + GS5816 with and without ribavirin for 12 weeks in treatment-experienced HCV-1 and HCV-3 patients with and without cirrhosis. SVR12 rates: SOF + GS-5816 100 mg: 100% for GT1 with and without cirrhosis; 100% for GT3 without cirrhosis and 88% for GT3 with cirrhosis. SVR12 rates: SOF + GS-5816 + RBV: 100% for GT1 without cirrhosis and GT3 without cirrhosis; 90% in GT1 with cirrhosis and 96% in GT3 with cirrhosis.
- The second study, ELECTRON 2, evaluated the same regimen as the first study for eight weeks in non-cirrhotic treatment-naive genotype 3 patients. The SVR12 rate inclusive of ribavirin was 100% and 96% for the ribavirin-free approach.
- The third study, GS-US-342-0102, evaluated the same regimen as first study in non-cirrhotic treatment-naive patients. Results from Part A evaluating 12 weeks of treatment were presented at The International Liver Congress in April 2014. The results from Part B, presented this week, evaluated eight weeks of treatment in HCV-1 and HCV-2 patients. SVR12 rates were: G1: 81% and 90% with and without RBV; G2: 88% with and without RBV.
- HCV-related tickers: (NASDAQ:ACHN) (NYSE:BMY) (NYSE:JNJ) (NYSE:ABBV) (NASDAQ:ENTA) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Nov. 10, 2014, 7:49 AM
- At The Liver Meeting in Boston, Merck (NYSE:MRK) presented interim data on its triple-therapy regimen for HCV-1 infection. The investigational product combines the company's NS3/4A protease inhibitor, grazoprevir and its NS5A inhibitor, elbasvir, with Sovaldi (sofosbuvir).
- SVR4/8 for the 8-week regimen in treatment-naive cirrhotic patients was 94.7% (18 of 19). SVR4/8 values for other treatment groups, however, appear low. For the six-week regimen in treatment-naive cirrhotic patients, SVR4/8 was only 80% (16 of 20) with four relapses. For treatment-naive non-cirrhotic patients, the six-week regimen SVR4/8 was 86.7% (26/30) with four relapses while the four-week regimen failed to come anywhere close to efficacy at 38.7% (12/31) with 19 relapses.
- Of the 28 total relapses, 25 were genotype 1a and three were genotype 1b.
- The company plans to initiate Phase 2 clinical trials to assess the safety and efficacy of two short-duration triple therapy regimens: MK-3682 in combination with grazoprevir/elbasvir and MK-3682 in combination with grazoprevir and MK-8408 in non-cirrhotic HCV patients. MK-3682 is an investigational oral prodrug HCV nucleotide analogue NS5B polymerase inhibitor. MK-8408 is an investigational early-stage NS5A inhibitor.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:BMY) (NYSE:JNJ) (NYSE:ABBV) (NASDAQ:ENTA) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Nov. 10, 2014, 4:43 AM
- Johnson & Johnson (NYSE:JNJ) is aiming to expand in China despite facing a variety of challenges there, including a slowdown in the country’s economy.
- Chief Executive Alex Gorsky says he wants to boost the company's Chinese pharmaceutical sales, but is "concerned about the drug lag you see." It takes an average of eight years for drug approval in China, compared with four years in other markets.
- J&J is also eyeing Chinese companies to add to its portfolio of baby and beauty products, medical devices and drugs.
Nov. 9, 2014, 6:04 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its Phase 3 UNITY program investigating a 12-week all-oral TRIO regimen of daclatasvir (DCV) with asunaprevir and beclabuvir for the treatment of HCV-1 infection.
- In the UNITY-1 trial, a 12-week regimen of DCV-TRIO without ribavirin was evaluated in treatment-naive and treatment-experienced non-cirrhotic HCV patients. SVR12 was 91% overall, 92% for the treatment-naive group and 89% for the treatment-experienced group.
- In UNITY-2, a 12-week regimen of DCV-TRIO was evaluated in cirrhotic patients. SVR12 was 98% in the treatment-naive group and 93% in the treatment-experienced group with ribavirin and 93% and 87%, respectively, without ribavirin.
- In October, the company announced it would not pursue FDA approval for the dual regimen of asunaprevir and daclatasvir for the treatment of HCV-1b infection.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Nov. 9, 2014, 5:37 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its ALLY Phase 3 clinical trial investigating a 12-week ribavirin-free regimen of daclatasvir in combination with Sovaldi (sofosbuvir) in HCV genotype 3 patients, a population that has emerged as one of the most difficult to treat. The SVR12 in treatment-naive patients was 90% and 86% in treatment-experienced patients. SVR12, sustained viral response 12 weeks after the completion of therapy, is considered cured.
- The results compare favorably with SVR12 in 89% of patients with HCV-1,2 and 3 in an open-label randomized study of a 24-week regimen of the two drugs.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Nov. 9, 2014, 5:06 PM
- At this week's Annual Meeting for the Study of Liver Diseases in Boston, Achillion Pharmaceuticals (NASDAQ:ACHN) gave poster presentations on two of its HCV product candidates.
- In a Phase 2 pilot study evaluating eight-week treatment of its NS5A inhibitor, ACH-3102, in combination with Sovaldi (sofosbuvir) in treatment-naive HCV genotype 1 patients, the interferon-free, ribavirin-free regimen demonstrated 100% SVR12 in 12 patients. SVR12 or sustained viral response 12 weeks after the completion of therapy, is considered cured. Sovaldi's SVR12 (in combination with peg-interferon alfa and ribavirin) is 90% for HCV-1. Harvoni's (sofosbuvir + ledipasvir) is 94 - 99%.
- The company presented three posters on preclinical results for its uridine analog prodrug, ACH-3422. The data showed improved potency against HCV-3 compared to sofosbuvir. The combination of ACH-3422 with ACH-3102 or sovaprevir (Achillion's Phase 2 NS3/4A inhibitor) displayed additive synergistic activity in vitro. Also, ACH-3422, in combination with other direct-acting antiviral agents, demonstrated the ability to block the appearance of resistant colonies in vitro.
- According to recent research, the global prevalence of HCV genotypes is: type 1: 46%; type 2: 13%; type 3: 22% and type 4: 13%.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:ENTA) (NYSE:MRK) (NASDAQ:LGND) (NASDAQ:CNAT)
Nov. 7, 2014, 9:52 AM| 7 Comments
Nov. 6, 2014, 7:08 AM
- The FDA approves the combination of Janssen Pharmaceuticals' (NYSE:JNJ) Olysio (simeprivir) and Gilead Sciences' Sovaldi (sofosbuvir) for the treatment of adults with genotype 1 HCV infection. It is the second all-oral treatment option cleared for sale in the U.S. The recommended treatment duration is 12 weeks for patients without cirrhosis and 24 weeks for patients with cirrhosis.
- Previously: Janssen applies for Olysio label expansion
Nov. 4, 2014, 9:28 AM
- AstraZeneca (NYSE:AZN) establishes a clinical trial collaboration with Pharmacyclics (NASDAQ:PCYC) and Janssen Research & Development LLC (NYSE:JNJ) to evaluate the safety and efficacy of AZN's anti-PDL1 immune checkpoint inhibitor, MEDI4736, in combination with Imbruvica (ibrutinib) for the treatment of hematologic cancers including diffuse large B-cell lymphoma and follicular lymphoma.
- MEDI4736 blocks the signals that enable tumors to avoid detection by the immune system thus countering the tumor's immune-evading tactics.
- The Phase 1 clinical trial to establish a dose regimen will be conducted by Pharmacyclics. Financial terms of the collaboration are undisclosed.
- Other MEDI4736 collaborations are ongoing.
- Previously: Incyte and MedImmune collaborate on cancer immunotherapies
- Previously: Ventana and MedImmune collaborate
- Previously: Advaxis and MedImmune team up in cancer immunotherapy
Nov. 1, 2014, 8:25 AM
- Phil Davidson likes to choose solid but "boring" stocks with healthy balance sheets and strong market positions in stable industries for his American Century Equity Income Fund, which is mostly focused on wealth preservation; when volatility spiked earlier in October, his portfolio fell 2.7% vs. the market’s 4.3% decline.
- His five favorite stocks he sees as pleasantly boring in a volatile market include Johnson & Johnson (NYSE:JNJ) for its global dominance across all three of its businesses - pharmaceutical, consumer and medical devices.
- PepsiCo (NYSE:PEP) is under activist pressure to split its beverage and snack units, an added bonus to a stock that's worth owning either way; Davidson thinks fears over the decline in the U.S. carbonated soft drink market are overblown.
- At Air Products (NYSE:APD), new CEO Seifi Ghasemi is a perfect fit to squeeze more out of a company that already has good assets in a stable industry, Davidson says.
- UPS has been under pressure to keep up with growing business to consumer shipments, and has spent money to increase capacity; the spending has weighed on earnings this year, but Davidson thinks it's bound to pay off.
- Commerce Bancshares (NASDAQ:CBSH) has been a victim of the low interest rate environment, but Davidson likes its conservative business model.
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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