Mon, Jan. 26, 7:31 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announced that the FDA has accepted under priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.
- Priority review status shortens the review time to six months so the PDUFA date is July 24.
- The European Medicines Agency accepted the companies' Marketing Authorization Application (MAA) several weeks ago.
- Alirocumab is an investigational monoclonal antibody targeting proprotein subtilisin/kexin type 9 (PCSK9). It will be competing with Amgen's (NASDAQ:AMGN) evolocumab for supremacy in the post-statin anti-cholesterol market. The PDUFA date for the FDA's review of evolocumab is August 27.
- Previously: European regulator accepts Regeneron/Sanofi application for cholesterol-lowering med (Jan. 12)
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug (Nov. 10, 2014)
Thu, Jan. 22, 4:07 PM
Mon, Jan. 19, 5:11 PM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Cosentyx (secukinumab) as a first-line systemic treatment for adult patients with moderate-to-severe psoriasis. It is the first interleukin-17A inhibitor cleared in Europe.
- Cosentyx is also cleared for sale in Australia and Japan. FDA approval is imminent considering the unanimous positive vote by the Dermatologic and Ophthalmic Drugs Advisory Committee in October.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Wed, Jan. 14, 8:25 AM
- Ziopharm (NASDAQ:ZIOP) jumps 50% premarket on robust volume in response to its announcement of an exclusive license deal with partner Intrexon (NYSE:XON) (+12%) with The University of Texas MD Anderson Cancer Center covering technology and intellectual property related to non-viral adoptive cellular cancer immunotherapies. The technologies originate from two researchers who have pioneered the design and clinical investigation of chimeric antigen receptor (CAR) T cell therapies for the potential treatment of cancer using non-viral gene integration platforms.
- The two researchers are Laurence Cooper, M.D., Ph.D, professor of pediatrics at MD Anderson who has expertise in immunotherapies and Perry Hackett, Ph.D., professor within the College of Biological Sciences at Minnesota, who discovered and developed a system called Sleeping Beauty, a non-viral DNA plasmid-based gene transfer system.
- The deal brings the CAR-T technology together Intrexon's technology suite and Ziopharm's clinically tested RheoSwitch Therapeutic System interleukin-12 modules. Up to five CARs are expected to enter the clinic this year and off-the-shelf programming initiating in 2016.
- Under the terms of the agreement, MD Anderson will receive $100M from the companies in the form of $50M of common stock from each firm. In addition, the companies have committed $15M - 20M over each of the next three years for researching and developing the technologies.
- CAR-T therapies are the "next big thing" in cancer treatment.
- Related tickers: (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:AMGN) (NYSE:NVS) (NYSE:JNJ)
Mon, Jan. 12, 4:52 PM
- Amgen (NASDAQ:AMGN) enters into a research collaboration with MD Anderson Cancer Center focused on the company's bispecific T cell engager (BiTE) antibody constructs. The partnership will identify targets for the therapy in myelodysplastic syndrome, a bone marrow disorder in which the body does not produce enough healthy blood cells. It can cause severe anemia and lead to the development of acute myelogenous leukemia.
- The collaboration will leverage the expertise of Anderson's Moon Shots Program, which aims to accelerate the conversion of scientific discoveries into clinical advances and significantly fewer cancer deaths.
Mon, Jan. 12, 9:46 AM
- Hospira (HSP) submits its Biologics License Application (BLA) to the FDA for Retacrit, a biosimilar to Amgen's (AMGN +1.3%) Epogen (epoetin alfa) and Janssen's (JNJ +0.5%) Procrit (epoetin alfa). The submission was actually made on December 16 under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009.
- Last week, an FDA advisory committee voted in favor of the approval of Sandoz's BLA for its biosimilar to Amgen's Neupogen (filgrastim).
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
Mon, Jan. 5, 2:00 PM
- The FDA's Oncologic Drugs Advisory Committee meets Wednesday to review the Biologics License Application (BLA) submitted by Sandoz (NVS +0.1%) for a biosimilar version of Amgen's (AMGN -0.8%) Neupogen (filgrastim).
- In the briefing documents, reviewers determined that there are no clinically meaningful differences compared to Neupogen. This bodes well for the approval of the first biosimilar in the U.S.
- Briefing doc
Mon, Jan. 5, 10:01 AM
- Amgen (AMGN -2.8%) and Kite Pharma (KITE +3.4%) enter into a strategic research collaboration and license agreement to commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite's engineered autologous cell therapy (eACT) platform and Amgen's library of cancer targets.
- Under the terms of the agreement, Amgen will contribute cancer targets while Kite will employ its CAR platform, R&D and manufacturing capabilities and expertise. It will be responsible for all preclinical research, cell manufacturing and processing through the Investigational New Drug (IND) filing. Each company will be responsible for the development and commercialization of their respective CAR-T candidates including all related expenses.
- Kite will receive an upfront payment of $60M, funding for R&D expenses through IND filing, up to $525M in milestones and high single- to double-digit royalties on product sales and the license of Kite's IP for CAR-T cell products.
- Amgen is eligible to receive up to $525M in milestones from Kite and tiered single-digit royalties on sales.
- Kite will host a conference call today at 4:00 pm ET to discuss the deal.
Dec. 18, 2014, 7:01 AM
Dec. 17, 2014, 2:06 PM
- According to Bloomberg, Amgen (AMGN +1%) intends to charge $178,000 per standard course of treatment for its blood cancer therapy, Blincyto (blinatumomab). The price assumes two cycles of treatment at $89,000 per cycle, the median duration of treatment for patients who responded to therapy in clinical trials.
- For comparison purposes, Merck's (MRK +0.7%) Keytruda (pembrolizumab) costs $150,000 per year and Bristol-Myers Squibb's (BMY +2.2%) Yervoy (ipilimumab) costs $120,000 per course.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
Dec. 10, 2014, 7:36 AM
- Bristol-Myers Squibb (NYSE:BMY), Ono Pharmaceutical Co., Ltd. and Kyowa Hakko Kirin Co., Ltd. enter into a clinical trial collaboration agreement to conduct a Phase 1 study of the combination of the PD-1 immune checkpoint inhibitor Opdivo (nivolumab) and mogamulizumab, an anti-CCR4 antibody, for the treatment of advanced or metastatic solid tumors.
- Opdivo was cleared for sale in Japan in September. Mogamulizumab was launched there in May 2012 for the treatment of certain blood cancers.
- The trial will be conducted in Japan and managed by Ono and Kyowa.
- Kyowa licensed mogamulizumab to Amgen (NASDAQ:AMGN) in 2008 for non-oncology indications but nothing came of it. The companies terminated their agreement in April.
Dec. 8, 2014, 5:04 PM
- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) initiate a collaborative study to evaluate the safety and efficacy of the former's talimogene laherparepvec and the latter's Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma.
- The study will have two phases: Phase 1 will determine the safety and tolerability of talimogene laherparepvec in combination with Keytruda in patients with previously untreated, unresected stage IIIB to IVM1c melanoma. The second phase will be randomized to evaluate the safety and efficacy of the two drugs. Approximately 110 patients will be enrolled across 35 sites in the U.S., Europe and Australia.
- Pembrolizumab is a PD-1 inhibitor. Talimogene laherparepvec is designed to promote tumor antigen release to initiate an anti-tumor immune response which may be complimentary to pembrolizumab's role in releasing PD-1 pathway-mediated inhibition of anti-tumor immune responses.
- The FDA recently accepted for review Amgen's BLA for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma. The PDUFA date is July 28, 2015. An MAA has also been submitted in Europe.
- Previously: Amgen submits MAA for cancer immunotherapeutic (Sept. 2, 2014)
Dec. 8, 2014, 1:38 PM
- The FDA approves Amgen's (AMGN +1.9%) Orphan Drug-designated Xgeva (denosumab) for the treatment of patients with hypercalcemia of malignancy (HCM) refractory to biphosphonate therapy.
- HCM is a serious complication in patients with advanced cancer. It results from cancer-driven increases in bone resorption and, if untreated, can lead to serious complications and death. Patients with the condition have poor prognoses.
- Among the benefits of the Orphan Drug tag is a seven-year period of market exclusivity for the indication following approval.
Dec. 8, 2014, 9:08 AM
- In a Phase 2 study evaluating Amgen's (NASDAQ:AMGN) Blincyto (blinatumomab) in patients with minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukemia (ALL), 78% of patients receiving Blincyto experienced a complete MRD response after one treatment cycle. Nearly all (98%) occurred within the first treatment cycle.
- The data were presented at the American Society of Hematology meeting in San Francisco.
- Blincyto is the company's most advanced bispecific T cell engager (BiTE) immunotherapy. The technology helps the body's immune system detect and attack malignant cells. The modified antibodies are designed to engage two different targets simultaneously thereby juxtaposing T cells to cancer cells and triggering apoptosis (cell death). The FDA approved it last week for use in ALL.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
Dec. 8, 2014, 7:08 AM
- In a 218-patient Phase 3 trial, Novartis (NYSE:NVS) unit Sandoz's investigational filgrastim biosimilar demonstrated similarity to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also demonstrated that repeated switching at each cycle between in the investigative biosimilar and Neupogen showed no impact on efficacy, safety or immunogenicity.
- Neutropenia is an abnormally low number of neutrophils, a type of white blood cells that are the primary defense against infections.
- The FDA accepted for review Sandoz's application for filgrastim in July. It is the first such acceptance in the U.S. under the Biologics Price Competition and Innovation Act of 2009.
- Neupogen generated ~$1.2B in sales the past four quarters.
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