Johnson & JohnsonNYSE
Sat, Oct. 22, 6:37 PM
- Mallinckrodt (NYSE:MNK) and Lannett Company (NYSEMKT:LCI) are tussling with the FDA over its withdrawal of previously approved abbreviated New Drug Applications (ANDAs) for generic versions of Janssen Pharmaceuticals' (NYSE:JNJ) CONCERTA (methylphenidate HCl) for the treatment of attention deficit hyperactivity disorder (ADHD).
- The agency pulled the approvals due to the lack of bioequivalence. Although bioequivalence was the basis for the original approvals, field reports of insufficient therapeutic effect surfaced after the products were launched. In an analysis of reports from the FDA's adverse event reporting system, FAERS, the reported therapeutic failures of the generics in question were almost 10x higher than Actavis' (NASDAQ:TEVA) generic version, the reference drug. Further analyses showed differences in the rates of drug release and absorption. Specifically, the companies' products delivered the active ingredient at a slower rate 7 - 12 hours after dosing.
- Lannett has requested a hearing with the FDA on the matter. Mallinckrodt will have to do the same after an appeals court removed its pending litigation with the agency from its oral argument calendar. It has filed a Motion to Reconsider in an attempt to be put back on the docket. Both firms insist that their generic versions are safe and effective.
Thu, Oct. 20, 4:16 PM
Tue, Oct. 18, 7:20 AM
- Johnson & Johnson (NYSE:JNJ) Q3 results ($M): Total Revenues: 17,820 (+4.2%); Consumer: 3,261 (-1.6%); Pharmaceutical: 8,400 (+9.2%); Medical Devices & Diagnostics: 6,159 (+1.1%).
- Sales By Region: U.S.: 9,381 (+6.7%); Europe: 3,832 (+0.8%); W. Hemisphere ex-U.S.: 1,396 (-4.6%); Asia Pacific & Africa: 3,211 (+5.4%).
- Sales By Business: OTC: 964 (+0.1%); Immunology: 3,084 (+18.0%); Infectious Diseases: 842 (-0.7%); Neuroscience: 1,464 (-0.8%); Cardiovascular/Metabolism/Other: 1,493 (-5.9%); Medical Devices & Diagnostics: 6,159 (+1.1%).
- Key Product Sales: Remicade: 1,783 (+10.5%); Stelara: 814 (+32.8%); Zytiga: 582 (+6.2%); Xarelto: 529 (+14.8%).
- 2016 Guidance: Total Revenues: $71.5B - 72.2B (unch); Non-GAAP EPS: $6.68 - 6.73 from $6.63 - 6.73.
- Shares are up a fraction premarket.
Tue, Oct. 18, 6:41 AM
Mon, Oct. 17, 5:30 PM
Tue, Oct. 11, 12:35 PM
- In a statement, the FDA reports that it has concluded that Johnson & Johnson's (JNJ -1.6%) blood thinner XARELTO (rivaroxaban) is a safe and effective alternative to warfarin in patients with atrial fibrillation. The agency conducted a variety of analyses on a Phase 3 study, ROCKET-AF, that supported the company's marketing application and 2011 approval.
- The FDA reexamined the data because Alere's (ALR -1.6%) INRatio device was used to monitor warfarin therapy in the control group. Alere recalled the device in July of this year due to the risk of inaccurate results.
Fri, Oct. 7, 10:18 AM
- AstraZeneca (AZN -0.4%) inks an agreement with Johnson & Johnson (JNJ +0.3%) affiliate Cilag GmbH International divesting the ex-U.S. rights to Rhinocort Aqua, an OTC nasal spray for the treatment of allergic and non-allergic rhinitis and nasal polyps, for $330M in cash.
- The transaction, expected to close this quarter, does not include the transfer of any AZN employees or facilities and does not impact the company's 2016 financial guidance.
Mon, Oct. 3, 9:47 AM
- September monthly performance was: -0.52%
- 52-week performance vs. the S&P 500 is: -11%
- $0.16 in dividends were paid in September
- Top 10 Holdings as of 8/31/2016: Apple Inc (AAPL): 5.01757%, Microsoft Corp (MSFT): 4.59213%, Exxon Mobil Corp (XOM): 3.65506%, Johnson & Johnson (JNJ): 3.32616%, General Electric Co (GE): 2.90192%, Procter & Gamble Co (PG): 2.3854%, Wells Fargo & Co (WFC): 2.34646%, Pfizer Inc (PFE): 2.17377%, JPMorgan Chase & Co (JPM): 2.08563%, Amazon.com Inc (AMZN): 2.02582%
Mon, Oct. 3, 9:13 AM
- Results from a Phase 3 clinical trial, VOYAGE 1, assessing Janssen's (NYSE:JNJ) guselkumab compared to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) in adult patients with moderate-to-severe plaque psoriasis showed guselkumab to be superior. The data were presented over the weekend at the 25th European Academy of Dermatology and Venereology Congress in Vienna, Austria.
- Guselkumab was administered via subcutaneous injection at Weeks 0 and 4 and then every eight weeks thereafter.
- The study met both co-primary endpoints of a statistically valid proportion of subjects achieving PASI 90 (90% improvement in symptoms or almost complete skin clearance) and an Investigator's Global Assessment (IGA) of cleared disease (score: 0) or minimal disease (score: 1) at Week 16 versus placebo. 73.3% of subjects met PASI 90 compared to 2.9% for control (p<0.001) while 85.1% achieved IGA 0 or 1 versus 6.9% for control (p<0.001).
- VOYAGE 1 also included an active comparator arm assessing guselkumab versus adalimumab, which was administered subcutaneously at Weeks 0 and 1, then every other week thereafter. At Week 16, more subjects who received three injections of guselkumab achieved PASI 90 than those who received 10 injections of adalimumab (73.3% versus 49.7%) and a higher proportion achieved IGA 0/1 (85.1% versus 65.9%).
- At Week 24, the proportions achieved PASI 90 also favored guselkumab, 80.2% versus 53.0%. In addition, guselkumab maintained its superiority to adalimumab from Week 24 through Week 48.
- Through Week 48, the proportions of patients treated with guselkumab and adalimumab who reported at least one adverse event were 73.9% and 74.5%, respectively. Serious adverse events were similar as well, 4.9% and 4.5%, respectively.
- Further analyses from VOYAGE 1 and results from two other Phase 3s, VOYAGE 2 and NAVIGATE, will be submitted for presentation at future scientific conferences.
- Guselkumab is a human monoclonal antibody that binds to interleukin 23 (IL-23), a pro-inflammatory cytokine. J&J expects it to be a blockbuster and one of its major growth drivers.
Mon, Oct. 3, 9:10 AM
- September monthly performance was: +0.58%
- 52-week performance vs. the S&P 500 is: -9%
- $0.23 in dividends were paid in September
- Top 10 Holdings as of 8/31/2016: Apple Inc (AAPL): 3.96271%, Microsoft Corp (MSFT): 3.09853%, Johnson & Johnson (JNJ): 2.24259%, General Electric Co (GE): 1.95493%, Exxon Mobil Corp (XOM): 1.64204%, Procter & Gamble Co (PG): 1.33805%, Wells Fargo & Co (WFC): 1.31607%, Pfizer Inc (PFE): 1.21901%, Nestle SA (OTCPK:NSRGF): 1.15897%, Intel Corp (INTC): 1.14963%
Wed, Sep. 28, 9:29 AM
- TRACON Pharmaceuticals (TCON) announces a strategic licensing collaboration with Janssen Pharmaceutica N.V. (NYSE:JNJ) for two of its novel oncology assets. The deal also includes a $5M equity investment in TRACON by Johnson & Johnson Innovation via the purchase of common stock at $5.95 per share.
- The transaction grants TRACON the rights to develop two Janssen oncology programs: TRC253 (formerly JNJ-63576253), a small molecule high-affinity competitive inhibitor of wild type androgen receptor (AR) and multiple AR mutations that confer drug resistance, for the potential treatment of prostate cancer, and TRC694 (formerly JNJ-64290694), an orally available inhibitor of NF-kB inducing kinase (NIK), for the potential treatment of hematologic malignancies, including myeloma.
- TRC253 has completed IND-enabling studies and TRACON expects to initiate a Phase 1/2 proof-of-concept (POC) clinical trial in H1 2017. Following its completion, Janssen will have an exclusive option to reacquire full rights from TRACON for an upfront payment of $45M, up to $137.5M in milestones and a low single-digit royalty on net sales.
- TRC694 is currently in preclinical development. TRACON expects to file an Investigational New Drug (IND) Application in 2018. Upon completion of an initial clinical POC study, Janssen will have a right of first negotiation to reacquire the program on terms to be negotiated between the parties. If Janssen does not exercise its negotiation right and TRACON continues development, it will pay Janssen a $60M milestone payment.
- The deal provides development funding for TRACON's lead product candidate TRC105 (carotuximab), a novel clinical-stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis. It has Orphan Drug status for the treatment of soft tissue sarcoma and Fast Track status for kidney cancer.
Mon, Sep. 26, 10:15 AM
- The FDA approves the use of Janssen''s (JNJ -0.7%) STELARA (ustekinumab) for the treatment of adults moderately to severely active Crohn's disease who have have not responded to or are intolerant of immunomodulators or corticosteroids, but have never failed treatment with a tumor necrosis factor (TNF) blocker or who failed or were intolerant of treatment with one or more TNF blockers.
- STELARA is the first approval biologic therapy for Crohn's that targets interleukin-12 and interleukin-23, proteins that play roles in inflammatory and immune responses.
- In clinical studies, between 34 - 56% of targeted Crohn's patients who received a one-time IV infusion of STELARA experienced relief from their symptoms in six weeks, some as early as three weeks. The majority of responders to initial induction dosing who continued treatment with subcutaneous injections of STELARA every eight weeks as maintenance therapy were in remission at the end of 44 weeks (one year after the initiation of the IV induction dose).
- STELARA was previously approved for the treatment of plaque psoriasis and psoriatic arthritis.
Fri, Sep. 23, 12:38 PM
- Updated interim data from a Phase 2a clinical trial evaluating a triple combination regimen in treatment-naive patients with hepatitis C virus (HCV) genotype 1 infection demonstrated a cure rate (SVR12) of 100% after only six weeks of treatment. The results were presented today at the European Association for the Study of the Liver Special Conference in Paris.
- The study is designed to assess the safety, pharmacokinetics and efficacy of different dosing regimens of odalasvir (ODV) and AL-335, with or without simeprevir (SMV). All patients (n=60) receiving a once-daily dose of AL-335 and SMV and ODV every other day achieved clinical cure (sustained virologic response 12 weeks post treatment or SVR12) after six weeks of therapy.
- All patients in cohort 1 (n=20) achieved SVR24 (sustained virologic response 24 weeks post treatment) with an eight-week regimen of AL-335 400 mg/ODV 50 mg/SMV 100 mg. Cohorts 3 & 4 (n=20 each) assessed the triple combination of AL-335 800 mg/ODV 50 mg/SMV 75 mg for six and eight weeks, respectively. All achieved SVR12.
- In cohort 2, 90% (n=18/20) of patients achieved SVR12 based on an eight-week dual regimen of AL-335 800 mg and ODV 50 mg.
- The triple combination regimen will be further investigated in Phase 3 studies.
- AL-335 is a uridine-based nucleoside NS5B polymerase inhibitor being developed by Janssen (JNJ -0.4%) unit Alios BioPharma. Odalasvir (formerly ACH-3102) is an NS5A inhibitor discovered by Achillion Pharmaceuticals (ACHN +4.7%). Simeprevir, a NS3/4A protease inhibitor, is currently marketed by Janssen as Olysio.
Fri, Sep. 23, 9:03 AM
- Janssen Biotech (NYSE:JNJ) submits its Biologics License Application (BLA) to the FDA seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), a chronic systemic inflammatory condition affecting ~1.5M Americans.
- The data supporting the filing was generated in five late-stage studies in its SIRROUND program.
- Sirukumab is being co-developed by GlaxoSmithKline (NYSE:GSK) and Janssen Biologics in a partnership that began in late 2011. It is a human monoclonal IgG kappa antibody that binds to interleukin-6 (IL-6), a cytokine that plays a key role in autoimmune conditions. The companies expect it to be a blockbuster generating peak sales of $1B+. It is also being investigated for the treatment of major depressive disorder, lupus nephritis, systemic lupus erythematosus, asthma and polymyalgia rheumatica.
Wed, Sep. 21, 8:49 AM
- The FDA approves Janssen Pharmaceuticals' (NYSE:JNJ) INVOKAMET XR (canagliflozin/metformin hydrochloride extended release) as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes (T2D). The once-daily pill combines INVOKANA (canagliflozin) with an extended-release formulation of metformin.
- Previously: Janssen submits NDA for extended release formulation of INVOKAMET for type 2 diabetics (Nov. 20, 2015)
Mon, Sep. 19, 10:41 AM
- Geron (GERN +6.4%) heads north on increased volume in response to its announcement of a license deal with Janssen Pharmaceuticals (JNJ +0.2%). The company has granted Janssen exclusive global rights to develop and commercialize products based on Geron's specialized oligonucleotide backbone chemistry in addition to RNA interference candidates for the treatment of all human disorders except blood and bone marrow cancers and exclusive of telomerase inhibitors.
- Geron has also granted Janssen a non-exclusive global license to develop and commercialize oligonucleotides based on Geron's patents covering the synthesis of monomers (building blocks of oligonucleotides). Janssen Biotech has non-exclusive rights to the same intellectual property under their November 2014 imetelstat agreement.
- Under the terms of the deal, Geron will receive an upfront payment of $5M, up to $75M in milestones and low-single-digit royalties on global net sales of each licensed product.