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.
Sat, Sep. 17, 5:13 PM
- A Phase 3 clinical trial, REFLECTIONS B537-02, assessing Pfizer's (NYSE:PFE) Remicade (infliximab) biosimilar candidate, PF-06438179 (infliximab-Pfizer) in patients with rheumatoid arthritis (RA) met its primary endpoint demonstrating equivalent efficacy with Remicade as measured by the number of participants achieving ACR20 (20% improvement in RA symptoms) at Week 14 of treatment. According to ClinicalTrials.gov, the estimated study completion date is May 2017.
- PF-06438179 is in development for all approved indications of Remicade, Janssen's (NYSE:JNJ) top seller at almost $6.9B (most recent four quarters).
- Novartis' (NYSE:NVS) Sandoz unit has commercialization rights to PF-06438179 in the European Economic Area (28 countries) while Pfizer retains the rights elsewhere.
Fri, Sep. 16, 3:48 PM
- Johnson & Johnson (JNJ -0.1%) inks an agreement with Abbott Laboratories (ABT +1.5%) to acquire its Medical Optics unit for $4.325B in cash. The business generated $1.1B in revenues last year in three business segments: cataract surgery, laser refractive surgery and consumer eye health.
- The deal, expected to close in Q1 2017, will be modestly accretive to JNJ's non-GAAP 2017 earnings.
Fri, Sep. 16, 10:08 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Janssen's (JNJ -0.2%) STELARA (ustekinumab) for the treatment of adult patients with moderately-to-severely active Crohn's disease who have not responded to or are intolerant of conventional therapy or a tumor necrosis factor alpha antagonist [e.g., AbbVie's Humira (adalimumab) or Janssen's Remicade (infliximab)].
- A final decision by the European Commission usually takes ~60 days.
- STELARA is currently approved in the EU and U.S. for the treatment of plaque psoriasis and psoriatic arthritis.
Mon, Sep. 12, 4:18 PM
- Johnson & Johnson's (NYSE:JNJ) Janssen Vaccines & Prevention B.V. completes its application to the World Health Organization (WHO) for an Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen.
- EUAL is procedure that can be implemented when there is a disease outbreak that carries a high risk of morbidity/mortality and there is a lack of available treatment or prevention options. It helps UN Member states and procurement agencies determine if the use of a specific vaccine is appropriate in a public health emergency.
- A prime boost vaccine regimen involves an initial dose to prime the immune system followed by a booster dose at a later date that strengthens and extends the durability of immunity.
- Janssen's Ebola vaccine candidate consists of two components based on its AdVac technology (adenovirus-based) and MVA-BN technology from Bavarian Nordic A/S.
Mon, Sep. 12, 12:18 PM
- Janssen's (JNJ -0.3%) European unit, Janssen-Cilag International NV, submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of a once-daily single-tablet regimen for the treatment of HIV-1 infection in patients at least 12 years old with a minimum body weight of 40 kg.
- The therapy consists of darunavir 800 mg, cobicistat 150, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg in a single tablet. Darunavir is a protease inhibitor, cobicistat a pharmacokinetic enhancer, emtricitabine a nucleoside reverse transcriptase inhibitor and TAF. Janssen licensed the latter three from Gilead Sciences (GILD +0.5%) in December 2014 for a single-tablet regimen.
- Darunavir is currently marketed by Janssen under the brand name PREZISTA. It markets a combo of darunavir and cobicistat in Europe under the brand name REZOLSTA.
Mon, Sep. 12, 9:23 AM
- Geron (NASDAQ:GERN) is down 27% premarket on robust volume in response to its update on two clinical trials being conducted by collaboration partner and licensee Janssen Research & Development, LLC, (NYSE:JNJ) assessing imetelstat in certain blood disorders. Investors were apparently expecting good news but will have to wait since both studies will continue in order to generate more data. In other words, proof of efficacy ain't there yet.
- The first trial, IMbark, is a Phase 2 study assessing two dosages of imetelstat (4.7 mg/kg and 9.4 mg/kg) in ~200 patients with intermediate/high risk myelofibrosis (MF) who have relapsed or did not respond to prior treatment with a JAK inhibitor. To date, over 90 subjects have been enrolled in the two arms. The 4.7 mg/kg dose has not demonstrated an acceptable amount of activity so the arm will be closed to further enrollment. Enrollment in the 9.4 mg/kg arm will continue. The minimum number of patients needed for the Week 12 analysis was not met so the analysis will be done on 24-week data instead. Janssen will conduct an additional internal data review in Q2 2017.
- The second trial, IMerge, evaluating imetelstat in patients with low/intermediate risk myelodysplastic syndromes who have relapsed or failed to respond to an erythropoiesis stimulating agent, will continue unmodified. Janssen will conduct another assessment in Q2 2017.
- 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.
Fri, Sep. 9, 7:45 AM
- Interim results from Janssen's (NYSE:JNJ) Phase 2a clinical assessing a triple combination therapy for the treatment of HCV showed a 100% cure rate in as little as six weeks. The data will be presented at the European Association for the Study of the Liver Special Conference in Paris, September 23 - 24.
- The aim of the ongoing study is to confirm the required dose and treatment duration for an all-oral combination regimen of odalasvir and AL-335 with or without simeprevir for six or eight weeks in treatment-naive HCV genotype 1 patients.
- The 20 subjects in cohort 1 received a daily dose of the combination of odalasvir (50 mg), AL-335 (400 mg) and simeprevir (100 mg) for eight weeks. All achieved clinical cure 24 weeks after completed therapy (SVR24).
- The 20 patients in cohort 2 received 800 mg of AL-335 every day and 50 mg of odalasvir every other day for eight weeks. The cure rate at 12 weeks post treatment (SVR12) was 90%.
- The 20 subjects in cohort 3 received 800 mg of AL-335 and 75 mg of simeprevir every day and 50 mg of odalasvir every other day for eight weeks. All achieved clinical cure four weeks after the end of therapy (SVR4).
- The 20 subjects in cohort 4 received the same regimen as cohort 3 but for only six weeks. HCV RNA was negative in 90% (n=18/20) and the other two were below the limit of quantitation at the end of treatment.
- The triple combination (odalasvir 25 mg, AL-335 800 mg, simeprevir 75 mg) once daily will now be assessed in a Phase 2b study in 400 patients with chronic HCV 1-6 infection. According to ClinicalTrials.gov, the estimated study completion date is July 2017. The Phase 2a will be expanded to include HCV-2 and -3 and those with or without compensated cirrhosis.
- AL-335 is a uridine-based nucleoside NS5B polymerase inhibitor being developed by Janssen unit Alios BioPharma. Odalasvir (formerly ACH-3102) is an NS5A inhibitor discovered by Achillion Pharmaceuticals (NASDAQ:ACHN). Simeprevir, a NS3/4A protease inhibitor, is currently marketed by Janssen as Olysio.
Tue, Sep. 6, 8:33 AM
- Karyopharm Therapeutics (NASDAQ:KPTI) is down 6% premarket on increased volume in response to its announcement of results from a Phase 2b clinical trial, STORM, assessing lead product candidate selinexor for the treatment of multiple myeloma (MM). The primary endpoint was overall response rate (ORR) over five-to-seven months.
- The single-arm open-label study evaluated selinexor, in combination with low-dose dexamethasone, in heavily pretreated (not responding to other therapies) MM patients. The overall response rate (ORR) in 78 evaluable subjects (median of seven prior treatment regimens) was 20.5% (very good partial responders + partial responders). For comparison, the ORR for Janssen's (NYSE:JNJ) DARZALEX (daratumumab) in these types of patients was 20 - 21% while Sanofi's (NYSE:SNY) isatuximab showed 20%.
- The safety profile was similar to earlier trials. Additional data will be presented later this year.
- The company intends to expand STORM to include an additional 120 patients with penta-refractory (they basically haven't responded to anything) MM. Top-line data from the expanded cohort should be available in early 2018. The company plans to request accelerated approval by the FDA based on the results.
- It also plans to initiate a pivotal 360-subject Phase 3 study, BOSTON, evaluating selinexor, in combination with Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE (bortezomib) and low-dose dexamethasone compared to VELCADE and low-dose dexamethasone alone in MM patients who have had one-to-three prior lines of therapy. The study should commence in early 2017.
- Selinexor is a SINE (Selective Inhibitor of Nuclear Export) compound. It binds to and inhibits the nuclear export protein XPO1 which leads to the accumulation of tumor suppressor proteins in the cell nucleus which amplifies tumor suppression. It is also under development for the treatment of liposarcoma, diffuse large B-cell lymphoma and acute myeloid leukemia.
- Management will host a conference call this morning at 8:30 am ET to discuss the data.
- Previously: Karyopharm up 22%; selinexor data in multiple myeloma expected in September (Aug. 30)
- Update: Slingshot Insights has an expert interview on deck to discuss the Phase 2 data.
Tue, Aug. 23, 7:35 AM
- Janssen-Cilag International NV (NYSE:JNJ) submits a Type II variation application to the European Medicines Agency (EMA) seeking approval of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) REVLIMID] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE] and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior line of therapy.
- DARZALEX is currently approved in the EU as monotherapy in adult patients with relapsed/refractory MM whose prior therapy included a proteasome inhibitor (i.e., VELCADE) and an immunomodulatory agent (i.e., REVLIMID) and experienced disease progression on the last therapy.
- In two Phase 3 studies, CASTOR and POLLUX, supporting the application MM patients who had received one or more prior lines of therapy who were treated with one of the combinations experienced greater than a 60% reduction in the risk of disease progression or death (hazard ratio less than 0.40).
Mon, Aug. 22, 4:27 PM
- Nano cap Tokai Pharmaceuticals (NASDAQ:TKAI) hits the skids again with lead product candidate galeterone. Today, the company disclosed that it has terminated enrollment in its Phase 2 expansion clinical trial, ARMOR2, assessing galeterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have become resistant to Medivation's (NASDAQ:MDVN) Xtandi (enzalutamide).
- It has also decided not to proceed with its planned study of galeterone in mCRPC patients who rapidly progress on either Xtandi or Janssen's (NYSE:JNJ) Zytiga (abiraterone acetate).
- A month ago, shares crumbled when the company announced that it terminated its Phase 3 ARMOR3-SV study of galeterone in treatment-naive mCRPC patients who tumors express the splice variant AR-V7 after the independent Data Monitoring Committee determined that the trial was unlikely to meet its efficacy endpoint.
- The company says it is continuing its analysis of the ARMOR3-SV data and is assessing its options with the galeterone program.
- Shares are down 23% after hours on robust volume.
Wed, Aug. 17, 4:08 PM
- Janssen Biotech (NYSE:JNJ) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval of the use of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) Revlimid] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE] and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- The FDA granted Breakthrough Therapy status for DARZALEX for this indication last month. Janssen has requested Priority Review of the filing.
- The FDA approved DARZALEX in November 2015 as monotherapy for MM patients who have received at least three prior lines of therapy.
Tue, Jul. 26, 8:43 AM
- Thinly traded micro cap Tokai Pharmaceuticals (NASDAQ:TKAI) craters 70% premarket on higher-than-normal volume in response to its announcement that it will stop its Phase 3 clinical trial, ARMOR3-SV, assessing lead product candidate galeterone compared to enzalutamide (XTANDI) in treatment-naive men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the androgen receptor splice variant AR-V7. The company made its decision based on the recommendation from the independent Data Monitoring Committee that the trial was unlikely to meet its primary efficacy endpoint.
- Tokai intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to enzalutamide and its planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate (ZYTIGA).
- Galeterone is an orally available small molecule that disrupts the androgen receptor (NYSE:AR) signaling pathway by degrading AR, blocking the binding of testosterone or dihydrotestosterone with AR and inhibiting CYP17, an enzyme that plays a key role in the synthesis of testosterone. Prostate cancer is stoked by androgens acting through the androgen receptor.
- Related tickers: (NASDAQ:MDVN)(OTCPK:ALPMF)(OTCPK:ALPMY)(NYSE:JNJ)