Wed, Apr. 15, 10:14 AM
- Coherus BioSciences (CHRS -3%) and Baxter International (BAX +0.4%) amend their August 2013 collaboration agreement pertaining to the development and commercialization of CHS-0214, a biosimilar to Amgen's (AMGN +1%) Enbrel (etanercept). Certain milestones and funding obligations have been revised and the partnership has been expanded to include select pre-commercialization activities. The revised milestone payments may increase Baxter's funding obligations by ~$12M. It also has agreed to buy Coherus common stock in a private transaction.
Mon, Apr. 6, 7:20 AM
- The European Commission approves Amgen's (NASDAQ:AMGN) Vectibix (panitumumab) as first-line treatment, in combination with the chemo regimen FOLFIRI, for patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC). About half of mCRC patients are classified as WT RAS. FOLFIRI is an irinotecan-based chemotherapy frequently used as first-line treatment for CRC in Europe.
- In the EU, Vectibix is also cleared for use in patients with WT RAS mCRC as first-line therapy in combination with FOLFOX (another chem regimen), as second-line therapy in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemo excluding irinotecan and as monotherapy after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemo regimens.
- Europe has the highest incidence of CRC in the world, with ~470K new cases each year. It is the second most common cancer in Europe following lung cancer.
Mon, Mar. 30, 12:30 PM
- Last night on CBS' 60 Minutes news show, two segments were dedicated to an experimental treatment for brain cancer being developed at Duke University. The therapy, based on a genetically modified form of the polio virus, was injected directly into the brains of patients with glioblastoma, a type of brain cancer with a poor prognosis. Of the 22 patients treated in a Phase 1 study, 11 died. In the group of 11 survivors, though, all experienced a shrinkage in their tumors with three being cancer-free.
- The polio virus, engineered to render it incapable of harming normal cells, replicates in cancer cells, killing them. Other viruses under investigation as cancer killers are herpes simplex, vaccinia and respiratory viruses.
- Companies working on genetically engineered viruses include Amgen (AMGN +0.6%) and Oncolytics Biotech (ONCY -0.4%). Amgen got into the business via its acquisition of Biovex in 2011. On April 29, a joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee will review Amgen's Biologics License Application (BLA) for talimogene laherparepvec (T-VEC), based on the herpes virus, for the treatment of metastatic melanoma.
- The unique feature of engineered viruses is that they are designed as a single treatment, rather than a multi-dose regimen. Another benefit is their scalability, a potential problem with personalized CAR-T therapies.
Mon, Mar. 30, 10:18 AM
- The FDA accepts under Priority Review Amgen's (AMGN +1.2%) supplemental New Drug Application (sNDA) for Kyprolis (carfilzomib) for the treatment of patients with relapse multiple myeloma who have received at least one prior therapy. The PDUFA date is July 26.
- Kyprois is currently cleared for the treatment of patients with multiple myeloma who have received as least two prior therapies.
- Multiple myeloma is the second most common blood cancer with ~230K people living with the disorder worldwide and ~114K new cases diagnosed each year.
- Kyprolis has generated $331M in sales the past four quarters.
Mon, Mar. 30, 8:00 AM
- The European Medicines Agency (EMA) validates (accepts for review) the Marketing Authorization Application (MAA) for SB2, Biogen's (NASDAQ:BIIB) biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). The MAA was submitted by the firm's joint venture partner, Samsung Bioepis. This is the second MAA accepted for review by the European regulator. It validated the MAA for SB4, a biosimilar to Amgen's (NASDAQ:AMGN) Enbrel (etanercept), earlier this year.
- Both SB2 and SB4 will be manufactured at Biogen's Hillerod, Denmark facility, once approved.
Tue, Mar. 24, 10:30 AM
- Cancer diagnostics firm Dako expands its collaboration with Amgen (AMGN +0.4%) in the field of personalized medicine, specifically companion diagnostics. Agilent Diagnostics and Genomics Group President Jacob Thayson says, "We are proud to both continue and broaden our multi-year partnership with Amgen. Together, we will continue our work in the development of high quality companion diagnostic products to enable physicians and pathologists to identify cancer patients who are more likely to respond to a specific therapy."
- Specific terms of the collaboration are not disclosed.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Mon, Mar. 23, 12:49 PM
- Amgen (AMGN -1.8%) will host a conference call and webcast today at 1:00 pm PT to discuss the Phase 3 results for brodalumab, its candidate for the treatment of moderate-to-severe plaque psoriasis, that were presented at the American Academy of Dermatology meeting.
- Previously: Amgen's brodalumab beats Stelara in Phase 3 trial (Nov. 11, 2014)
- Previously: Last Phase 3 brodalumab psoriasis trial successful (Nov. 25, 2014)
Mon, Mar. 23, 7:30 AMBiogen Idec shortens name; CEO says drug candidates in neurodegenerative diseases could pay off big in five years
- With a shortened name and new logo, Biogen (NASDAQ:BIIB) is entering a high risk-high return phase of its corporate life. CEO George Scangos, on board since 2010, is leading the firm into several difficult-to-treat areas in neurodegenerative diseases like Alzheimer's (AD), ALS and spinal muscular dystrophy. It won't take but one or two successes for the payoff to be huge.
- Shares jumped on Friday after the company announced positive Phase 1b results for its Alzheimer's candidate, BIIB037 (aducanumab). If the Phase 3, due to start later this year, is successful it could be the largest selling drug in history. As many as 75M people could be living with AD by 2030.
- Mr. Scangos says, "The future looks pretty exciting for us. If the Alzheimer's thing works, then we're not just an MS (multiple sclerosis) company. We are broadly focused on neurodegenerative diseases. Five years down the road, with some luck, we'll have an Alzheimer's drug that's getting approved. I hope we can transform the treatment of MS. By that time, we will have made substantial progress on ALS and nerve degenerative diseases, spinal muscular dystrophy in kids. All that stuff is on our plate. I am sure of two things, not all it is going to work, but some of it will."
- The company is also working on biosimilars to Amgen's (NASDAQ:AMGN) Enbrel (etanercept) and J&J's (NYSE:JNJ) Remicade (infliximab).
Fri, Mar. 20, 1:39 PM
- In Phase 3 data presented at the American Academy of Dermatology meeting in San Francisco, the proportion of patients receiving Celgene's Otezla (apremilast) 30 mg twice daily that achieved a PASI-75 score (subjective 75% improvement in psoriasis) at Week 16 was 40% compared to 12% for placebo (p<0.0001).
- A post hoc (retrospective) analysis showed no significant difference in PASI-75 scores between the orally-available Otezla and Amgen's (AMGN +0.4%) injectable Enbrel (etanercept), although the study was not powered to directly compare the two.
- The FDA cleared Otezla on March 21, 2014 for the treatment of adults with active psoriatic arthritis and on September 23, 2014 for moderate-to-severe plaque psoriasis. The European Commission approved it for moderate-to-severe plaque psoriasis on January 16, 2015.
Fri, Mar. 20, 9:59 AM
- Amgen Astellas BioPharma K.K., a joint venture between Amgen (AMGN +1.1%) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY), files a regulatory application with the Japanese Ministry of Health, Labour and Welfare seeking clearance for Repatha (evolocumab) for the treatment of high cholesterol.
- Repatha is a PCSK9 inhibitor that works by freeing up more low density lipoprotein (LDL) receptors on the surface of liver cells so more LDL-C can be removed from the blood. PCSK9 inhibitors represent the next generation of cholesterol-lowering medicines after statins. Approximately 50% of Japanese patients on statin therapy fail to reach their LDL-C goal so the market opportunity is substantial.
- Previously: Japanese study shows Amgen's evolocumab lowers bad cholesterol in high risk patients (March 14)
Fri, Mar. 20, 7:56 AM
- The U.S. District Court of San Francisco denies Amgen's (NASDAQ:AMGN) preliminary injunction to block the sale of Novartis' (NYSE:NVS) Zarxio, a biosimilar of the former's $1.2B Neupogen (filgrastim) that was approved by the FDA several weeks ago, the first biosimilar to clear the regulatory hurdle in the U.S. Amgen intends to appeal the decision.
- Novartis previously agreed to delay Zarxio's U.S. launch until the court's decision or April 10, whichever came first. If it proceeds with the launch and Amgen wins its appeal, it would have to pay costly damages. In a statement, Novartis said, "Given the importance of this case for future biosimilars, we agreed with Amgen before this hearing to jointly request expedited review of any appeal to the Federal Circuit." It is unknown how long Amgen's appeal will take.
- Previously: FDA clears first biosimilar (March 6)
Mon, Mar. 16, 8:26 AM
- A Phase 3 study evaluating Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) in patients with hypercholesterolemia showed that patients receiving Praluent 150 mg every two weeks lowered their low-density lipoprotein cholesterol (LDL-C) by an additional 62% (p<0.0001) at Week 24 compared to placebo, with consistent LDL-C lowering maintained over 78 weeks (56% reduction, p<0.0001).
- The trial, call ODYSSEY LONG TERM, assessed Praluent 150 mg (n=1,553) compared to placebo (n=788) in patients judged at high cardiovascular (CV) risk and who were receiving the maximum tolerated dose of statin therapy with or without other lipid-lowering treatment. Patients self-administered a subcutaneous injection of Praluent every two weeks via a pre-filled syringe.
- At Week 24, 81% of patients in the Praluent cohort achieved their pre-specified LDL-C goal compared to 8.5% for placebo (p<0.0001).
- Praluent is an investigational human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibiting PCSK9 frees up more LDL receptors on the surface of liver cells which enables the more LDL-C to be removed from the blood.
- Alirocumab and Amgen's (NASDAQ:AMGN) evolocumab are the front-runners to dominate the post-statin cholesterol-lowering market. They will be competing right out the blocks in the U.S. The FDA's PDUFA dates are July 24 alirocumab and August 27 for evolocumab. Praluent is being co-developed by Sanofi (NYSE:SNY).
Sat, Mar. 14, 9:17 PM
- A Phase 3 study, called YUKAWA-2, evaluating Amgen's (NASDAQ:AMGN) Repatha (evolocumab) in Japanese patients with high cardiovascular (CV) risk and high cholesterol showed that treatment with subcutaneous injections of Repatha 140 mg every two weeks, compared to placebo, in combination with different daily doses of atorvastatin (Pfizer's Lipitor), reduced low-density lipoprotein cholesterol (LDL-C) by 67 to 76% from baseline at Week 12 and the mean of Weeks 10 and 12. The data were presented at the American College of Cardiology's 64th Annual Scientific Session.
- In Japan, almost 50% of high-CV-risk patients on statins fail to reach their LDL-C goal. The company intends to submit its application for approval in Japan as soon as feasible. The PDUFA date from the FDA is August 27.
- Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibiting PCSK9 frees up more LDL receptors on the surface of the liver cells which enables more LDL-C to be removed from the blood.
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug (Nov. 10, 2014)
Fri, Mar. 13, 9:19 AM
- Cytokinetics (NASDAQ:CYTK) reports that the enrollment of ~450 patients in the expansion phase of the Phase 2 COSMIC-HF trial evaluating omecamtiv mecarbil in heart failure patients is complete. In addition, over 200 patients have finished the protocol-specified 20-week duration of dosing with a data readout expected in H2. The trial is being run by collaboration partner Amgen (NASDAQ:AMGN).
- COSMIC-HF is a randomized, double-blind, placebo-controlled, multicenter study with two parts: a dose escalation phase and an expansion phase. The dose escalation phase, competed in 2013, assessed the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. The expansion phase will assess the safety, tolerability and pharmacokinetics of omecamtiv mecarbil during 20 weeks of treatment at an initial dose of 25 mg and increasing to 50 mg depending on the patient's plasma concentration.
- Omecamtiv mecarbil is a cardiac myosin activator. Myosin is a protein in heart muscle this is responsible for converting chemical energy into the mechanical energy that results in a heart beat. Cardiac myosin activators increase systolic ejection time which results in an increase in cardiac contractility and more oxygen-efficient cardiac function.
Tue, Mar. 10, 8:24 AM
- Akebia Therapeutics (NASDAQ:AKBA) completes patient enrollment in the third and final cohort in its Phase 2 study evaluating its lead product candidate, AKB-6548, for the treatment of patients with anemia secondary to chronic kidney disease (CKD) who are undergoing dialysis. The company expects to report top-line results in Q3.
- The multi-center, open-label trial has three cohorts of ~30 CKD dialysis patients with anemia who have been switched from injectable recombinant erythropoiesis-stimulating agent therapy to AKB-6548. Patients in the first two cohorts receive once-daily doses of AKB-6548 while patients in the third cohort receive AKB-6548 three times per week. All patients will be evaluated for 16 weeks of treatment, including an assessment of hemoglobin (HGB) response to AKB-6548 during an eight-week dosing period, followed by an assessment of HGB response to algorithm-guided dose adjustments of AKB-6548 during an additional eight weeks of treatment.
- AKB-6548's value proposition is oral administration and lower peak erythropoietin (EPO) levels compared to injectable recombinant EPO-stimulating agents like Amgen's (NASDAQ:AMGN) Epogen (epoetin alfa).
- Approximately 30M Americans have CKD with ~1.8M with anemia.
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