Jul. 28, 2014, 5:35 PM
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Jul. 25, 2014, 4:03 PM
Jul. 25, 2014, 11:48 AM
- Bayer HealthCare Pharmaceuticals (OTCPK:BAYRY -2.4%) (OTCPK:BAYZF -1.7%) and development partner Onyx Pharmaceuticals (AMGN -0.3%) report that the 537-patient Phase 3 clinical trial evaluating the safety and efficacy of Nexavar (sorafenib) plus capecitabine for the treatment of advanced breast cancer failed to achieve its primary endpoint of improving progression-free survival (PFS). Nexavar is currently approved in over 100 countries for other cancers.
- The companies are evaluating Nexavar in a variety of different cancers. Bayer has exclusive marketing rights to the product ex. U.S. and Japan. They co-promote it in America and share profits globally.
Jul. 24, 2014, 2:15 PM| 3 Comments
Jul. 17, 2014, 4:17 PM
- A Phase 3 clinical trial evaluating the safety and efficacy of Amgen's (AMGN -2%) AMG 416 (formerly velcalcetide) as a treatment of secondary hyperthyroidism achieves its primary endpoint and all secondary endpoints. The primary endpoint was the proportion of patients with a 30% reduction from baseline in parathyroid hormone (PTH) levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. In the study, 75.3% of patients achieved at least a 30% reduction compared to 9.6% in the control arm.
- AMG 416 is a calcimimetic agent that is administered intravenously in patients with chronic kidney disease who are receiving hemodialysis. AMG 416 binds to and activates the calcium-sensing receptor on the parathyroid gland which causes a decrease in PTH.
Jul. 2, 2014, 4:24 PM
- Citing results that were not compelling enough to proceed, Bind Therapeutics (BIND -3.4%) and Amgen (AMGN +0.6%) notify each other that they will not be exercising their options to develop an Accurin incorporating the Amgen therapeutic payload.
- The collaboration began in January 2013 with the goal of developing a nanomedicine for treating solid cancer tumors based on Bind's platform for targeted and programmable nanomedicines and Amgen's undisclosed proprietary cancer compound.
- Bind CEO Scott Minick says that his company will proceed undeterred with its collaborations with AstraZeneca (AZN +2%), Roche (RHHBY -0.6%) and Pfizer (PFE +1%).
Jul. 1, 2014, 8:57 AM
- The FDA designates Amgen's (AMGN) investigational bispecific T cell engager (BiTE) antibody blinatumomab a Breakthrough Therapy for adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
- The designation is based on the results of a 189-patient Phase 2 clinical trial of blinatumomab in ALL patients. BTD status coveys all of the Fast Track advantages plus more intensive FDA guidance on the drug's development, the involvement of more senior agency managers and eligibility for rolling/priority review.
Jun. 12, 2014, 12:27 PM
- Amgen (AMGN +0.2%) and collaboration partner AstraZeneca (AZN -0.2%) announce the results of a 168-patient Phase 2 clinical trial evaluating the safety and efficacy of their human mAb brodalumab as a treatment for psoriatic arthritis. At 12 weeks, the therapeutic significantly improved signs and clinical symptoms of the disease as measured by a 20% improvement in the American College of Rheumatology response criteria (ACR20). In addition, many patients continued to improve and sustained their improvements through 52 weeks.
- The study achieved its primary endpoint of demonstrating superiority vs placebo in ACR20 responses at week 12. 37% of patients treated with 140 mg of brodalumab and 39% treated with 280 mg of brodalumab achieved ACR20 compared to 18% in the placebo group. 14% of patients in both test groups achieved ACR50 (50% improvement) vs 4% in the control group. Patients achieving ACR70 were not significantly higher in the test groups vs placebo.
- Brodalumab blocks the binding of IL-17 to its receptor and thus inhibits inflammatory signalling.
- The firms have initiated two Phase 3 studies evaluating brodalumab for psoriatic arthritis.
Jun. 9, 2014, 4:34 PM| Comment!
Jun. 2, 2014, 10:00 AM
- In a Phase 3 clinical trial evaluating Amgen's (AMGN +0.1%) AMG-145 (evolocumab) in patients with homozygous familial hypercholesterolemia (HoFH), adding a monthly subcutaneous dose of 420 mg to a stable dose of statin therapy and other lipid-lowering medications significantly reduced LDL-C by 31% from baseline at 12 weeks versus placebo.
- Evolocumab is a human mAb that inhibits convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.
May. 30, 2014, 5:36 PM
May. 23, 2014, 5:54 PM
- Amgen (AMGN) says the FDA has approved its Vectibix drug as an initial treatment in patients with a type of advanced colorectal cancer who first undergo genetic screening.
- AMGN says the drug was cleared as an initial treatment in conjunction with chemotherapy for patients whose tumors have a gene mutation that renders their cancer susceptible to the medicine.
- The FDA agency also cleared Qiagen’s (QGEN) test that can show whether Vectibix will be effective in patients.
May. 22, 2014, 7:44 AM
- Roman Abramovich's investment company, Millhouse LLC and OAO Pharmstandard buy a majority share of Russian biosimilar manufacturer Biocad. Millhouse will own 50%, Pharmstandard 20% and Biocad founder and CEO Dmitry Morozov will own 30%. The purchase price is undisclosed but the firm is valued at ~$1B according to a source close to the matter.
- Pfizer (PFE) and Amgen (AMGN) reportedly had interest in the firm.
- Biocad is currently recruiting patients for clinical studies of copies of Roche's (RHHBY) Rituxan, Herceptin and Avastin. The firm also cancer chemotherapies, a drug for genital infections and three drugs for viral infections.
May. 20, 2014, 4:46 PM
- The New England Journal of Medicine publishes the results from a 31-patient 12-week Phase 1 proof-of-concept study of Amgen's (AMGN +0.1%) AMG-157 mAb for asthma. The study's conclusion is that AMG-157 reduced allergen-induced bronchoconstriction and indexes of airway inflammation before and after allergen challenge. The results are statistically significant.
- AMG-157 is a monoclonal immunoglobulin IgG2 that is a thymic stromal lymphopoietin (TSLP) inhibitor. TSLP is a cytokine thought to have a major role in allergic inflammation.
- The product candidate is one of five mAbs from Amgen's inflammation portfolio that it is developing with AstraZeneca (AZN +2.2%).
May. 12, 2014, 12:10 PM
- The South Korean colossus is investing $2B in the biotech arena in an effort to drive growth from its $347B revenue base. Its main initial focus will be biosimilars with a planned 2016 launch in Europe of an Enbrel biosimilar and a 2017 launch of a Remicade biosimilar.
- The global market for biosimilars, while lagging in the U.S. due to regulatory uncertainty, is expected to grow to $24B by 2019.
- According to unit chief Christopher Hansung Ko, "Our mandate is to become No. 1 in everything we enter into, so our long-term goal is to become a leading pharmaceutical company in the world."
- Related tickers: (IBB) (JNJ) (AMGN) (BIIB) (XBI) (SSNLF) (SSNGY)
May. 9, 2014, 4:33 PM
- The AMAGINE-1 Phase 3 clinical trial evaluating brodalumab for the treatment of moderate-to-severe plaque psoriasis meets all primary and secondary endpoints for both doses. Brodalumab is a human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammation by blocking the binding of several IL-17 ligands to the receptor.
- The primary endpoints were patients achieving at least a 75% improvement from baseline in disease severity at week 12 measured by PASI 75 and patients achieving clear or almost clear skin at week 12 according to the static Physician Global Assessment (sPGA 0 or 1).
- AMAGINE-1 is one of three clinical trails to assess the safety and efficacy of brodalumab. AMAGINE-2 and -3 are trials to evaluate brodalumab versus ustekinumab and placebo.
- Brodalumab is one of five mAbs from Amgen's (AMGN +0.6%) clinical inflammation portfolio that it is developing with AstraZeneca (AZN -1.9%) in a collaboration that began in 2012.
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