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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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British drugmaker AstraZeneca and US biotechnology company FibroGen have formed a strategic partnership to develop and commercialize FG-4592 to treat anemia in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
cas no 808118-40-3 FG 4592
FG-4592 oral presentation at ASN 2012
FG-4592 is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity.
As part of the agreement, the deal will focus on US, China and all major markets except the Commonwealth of Independent States, the Middle East, South Africa, Japan and Europe, while both companies can exercise the option to extend their collaboration to other anemia indications.
AstraZeneca will pay FibroGen at least $350 million as part of a strategic collaboration to develop and commercialize FG-4592, a first-in-class oral compound in late stage development for the treatment of anaemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
This broad collaboration focuses on the US, China and all major markets excluding Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa, which are covered by an existing agreement between FibroGen and Astellas Pharma. The AstraZeneca-FibroGen joint effort will be focused on the development of FG-4592 to treat anaemia in CKD and ESRD, and may be extended to other anaemia indications. The companies plan to undertake an extensive FG-4592 Phase III development program for the US, and to initiate Phase III trials in China, with anticipated regulatory filings in China in 2015 and in the US in 2017.
In addition to $350 million in up front and non-contingent payments, AstraZeneca could pay FibroGen potential future development related milestone payments of up to $465 million, and potential future sales related milestone payments in addition to tiered royalty payments on future sales on FG-4592 in the low 20% range. Additional development milestones will be payable for any subsequent indications which the companies choose to pursue. AstraZeneca will be responsible for the US commercialization of FG-4592, with FibroGen undertaking specified promotional activities in the ESRD segment in this market. The companies will also co-commercialize FG-4592 in China where FibroGen will be responsible for clinical trials, regulatory matters, manufacturing and medical affairs, and AstraZeneca will oversee promotional activities and commercial distribution.
FG-4592 is a small molecule inhibitor of hypoxia-inducible factor (HIF), a protein that responds to oxygen changes in the cellular environment and meets the body’s demands for oxygen by inducing erythropoiesis, the process by which red blood cells are produced. The firms claim FG-4592 has the potential to address the considerable unmet medical need for an effective treatment for anaemia that offers the convenience of oral administration and an improved safety profile when compard with current standards of care. At present, treatment options involve a combination of injectable erythropoiesis-stimulating agents (ESAs) and iron supplements.
“Our collaboration with FibroGen on FG-4592 is an important addition to AstraZeneca’s growing late-stage portfolio in cardiovascular and metabolic disease, one of our core therapy areas,” comments Pascal Soriot, AstraZeneca CEO. “We know from our research into complications of renal disease that anaemia continues to be a challenge for patients with chronic kidney disease, due in part to the inconvenience and complexity of existing injectable and intravenous therapies and the safety concerns associated with them. The science behind this compound is compelling. Through our collaboration with FibroGen we aim to offer a first-in-class, convenient treatment option for doctors and patients.”
“FG-4592 has the potential to offer anaemia patients an oral therapy that provides coordinated erythropoiesis, that increases natural erythropoietin within the normal physiological range, and that is effective without intravenous iron supplementation and without an increased risk for hypertension,” adds Thomas B. Neff, FibroGen CEO. “We are especially pleased that AstraZeneca will share our commitment to making China the first-to-launch country for FG-4592 and join our effort to bring important innovation in anaemia therapy to CKD and ESRD patients in the US and other countries. This agreement secures proper development and commercialization resources for FG-4592, and ensures US clinical trial efforts are fully funded.”
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Novavax announces positive preclinical data for vaccine against influenza
Novavax announces positive preclinical data for vaccine against influenza
Novavax has announced positive preclinical results for its virus-like particle (VLP) vaccine candidate against A (H7N9) influenza.
The study examined the immunogenicity, the ability to provoke an immune response, and efficacy of two doses of its A(H7N9) VLP vaccine candidate against a lethal wild-type challenge mouse model.
There were three control groups, including Novavax’ non-homologous A(H7N3) VLP vaccine candidate, its A(H5N1) VLP vaccine candidate, and a placebo. All vaccine candidates were administered with or without Iscomatrix, a saponin-based adjuvant.
read all at
http://www.pharmaceutical-technology.com/news/newsnovavax-announces-positive-preclinical-data-for-vaccine-against-influenza?WT.mc_id=DN_News
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Animal testing failures put drug trial volunteers in danger
© Shutterstock
Poor pre-clinical data and an absence of negative results are pushing candidate molecules into the clinic too soon
The reporting of animal studies is biased, inflating the efficacy of drug candidates and pushing them into the clinic before they are ready. This is the verdict of new research, which finds that more treatments go from pre-clinical to human trials than ought to, wasting valuable resources and potentially putting trial participants in danger.1 It adds to a growing body of evidence pointing to problems in the way animal testing is reported and managed.
READ AT
http://www.rsc.org/chemistryworld/2013/07/failures-animal-testing-put-drug-trial-volunteers-danger
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Gene Therapy for Melanoma: Progress and Perspectives
FIGURE 1.
Schematic representation of the wild type counterpart of the typically used recombinant viral vectors. (A) Gammaretroviruses and (B) lentiviruses share similar structures, but differ greatly in their genomes and their impact on cellular function. Gag, pro, pol and env genes encode structural proteins of the capsid, protease, reverse transcriptase and envelope proteins, respectively. The additional lentiviral genes perform regulatory functions as well as alter cellular function. (C) The serotype 5 adenovirus has a protein capsid (non-enveloped) and a large, complex genome that encodes critical genes for viral replication (E1a, E1b) as well as structural and functional genes that regulate both viral and cellular activities.
Introduction
Gene therapy, the therapeutic transfer of genetic information to a target cell, continues to be a promising alternative in the fight against cancer. In the case of melanoma, the use of an experimental treatment is justified since this disease is incurable in its advanced stages. Is gene therapy a viable option for the treatment of melanoma patients? In this chapter, we will attempt to answer this question by exploring the intersection between the technology of gene therapy and the biology of melanoma, a point at which opportunities for intervention are revealed.
Gene Therapy for Melanoma: Progress and Perspectives
[1] Cancer Institute of Sao Paulo, University of Sao Paulo School of Medicine, Brazil
[2] University of Sao Paulo, Biomedical Sciences Institute, Brazil
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Analysis Of Vical’s Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial
check this video
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Vical’s (VICL) Allovectin-7 is a pure immune therapy.(1) Which means it does not directly kill cancer cells, but activates the immune system to do so. Vical will soon announce A-7 phase 3 results in Melanoma, but the mechanism of action is not specific to Melanoma, and can be used in any solid tumor cancer.(2) For this reason, I expect that Allovectin-7 will become one of the best selling cancer drugs of all time.
Allovectin-7 is a substance that is being studied as a gene therapy agent in the treatment of cancer, such as malignant melanoma. It is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin – two components of major histocompatibility complex (MHC, class I). It increases the ability of the immune system to recognize cancer cells and kill them.
In 1999, FDA granted Allovectin-7 orphan drug designation for the treatment of invasive and metastatic melanoma.
- Allovectin-7 entry in the public domain NCI Dictionary of Cancer Terms
This article incorporates public domain material from the U.S. National Cancer Institute document “Dictionary of Cancer Terms”.
Vical’s Allovectin-7
Allovectin is a first-class DNA-based immunotherapeutic designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases. The goal is to become a first-line treatment for Stage III and IV melanoma, where it is intended to provide improved efficacy, a better safety profile, and simple outpatient administration.
As last reported, the company is approaching completion of a Phase III registration trial versus chemotherapy in patients with metastatic melanoma. The reporting of end results has had numerous delays, but the results are now expected by Q3.
Outside of Allovectin, Vical has ten clinical trials ongoing, three of those independent and the rest in collaboration. Clearly, Vical is not totally dependent on this immunotherapy though it is the most advanced independent program in the company’s pipeline.
Vical has a market cap of $257M, so clearly a homerun therapy could send the stock soaring.
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw
Kiran Mazumdar-Shaw, MD, BIOCON
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw, MD, BIOCON
Biocon is looking at gaining market share and improving its margins with a greater focus on its product mixes and organizational efficiencies. Biocon Chairman and Managing Director Kiran Mazumdar-Shaw tells Financial Express that the company has outpaced the market, despite various challenges and that the pharmaceutical market needs to have a more robust regulatory set-up. Edited excerpts:
READ ALL AT
http://kiranmazumdarshaw.blogspot.in/2013/07/indian-pharma-market-needs-strong.html
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Serum Institute of India acquires rights to TB vaccine
Serum Institute of India acquires rights to TB vaccine
Serum Institute of India, a Pune-based manufacturer of vaccines, is planning on taking a promising vaccine – originally developed in Germany – and introducing it into the clinic. Studies have shown that the new vaccine is more effective and better tolerated than currently available options.
By signing a contract with Hannover-based Vakzine Projekt Management (VPM), Serum has secured the licence to the various patents and technologies related to the…
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Kyowa Hakko Kirin Korea begins patient recruitment in phase I/II study of BIW-8962 in lung cancer
Kyowa Hakko Kirin Korea begins patient recruitment in phase I/II study of BIW-8962 in lung cancer
http://www.kyowa-kirin.com/news_releases/2011/pdf/e20110802_04.pdf
http://clinicaltrials.gov/ct2/show/NCT01898156
Kyowa Hakko Kirin Korea Co., Ltd
This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 and preliminary efficacy in Phase 2 in subjects with advanced/recurrent lung cancer or mesothelioma.
http://www.myeloma.org.uk/patient-information/drug-development/hcp-drug-scanner/biw-8962/
UK regulator approves access to Revolade drug after three-year process
25 July 2013
The National Institute for Health and Care Excellence (NICE) in the UK has recommended immune disorder drug Revolade for use on the NHS after a process of three and a half years.
The GSK once-daily oral treatment is now available to adult patients in England and Wales living with chronic immune (idiopathic) thrombocytopenic purpura (cITP), an immune disorder associated with low-blood platelet counts.
In patients with cITP, the immune system prematurely destroys platelets or impairs their production so that platelets are lost from the circulation faster than they can be replaced from the bone marrow, where they are made.
This results in patients developing mild bruising or serious bleeding, which affects their quality of life and, in some instances, may be fatal.
It is estimated that cITP currently affects 50 in 100,000 people in the UK.
The only other licensed TPO-RA recommended by NICE is romiplostim, which is given in the form of a weekly injection.
The Royal London Hospital’s clinical director for pathology Prof Adrian Newland said: “I was very pleased to see that NICE has recognised the clinical value and cost-effectiveness of eltrombopag in their guidance.
“We now have an important addition to the treatment options for patients with severe or refractory disease.”
Revolade is an oral thrombopoietin receptor agonist (TPO-RA) that stimulates the growth and maturation of cells in the bone marrow (megakaryocytes) that produce platelets, increasing platelet production.
When added to conventional immunosuppressive therapy, Revolade, also known as eltrombopag, increases response rates compared with placebo and in some patients.
GlaxoSmithKline UK general manager Erik Van Snippenberg said: “This has been a lengthy three and a half year long appraisal process. We are pleased that NICE has recommended eltrombopag and that the small number of cITP patients in England and Wales are granted access to an alternative treatment option offering the benefit of oral convenience.
“With eltrombopag, we hope to ultimately make a meaningful difference in the quality of life of cITP patients and contribute to potential savings for the NHS.”
Compound Suffocates Tumors
Scientists have discovered a new molecule that prevents cancer cells from responding and surviving when starved of oxygen and which could be developed into new treatments for the disease, according to new research published in the Journal of the American Chemical Society.
Cancer Research UK scientists at the University of Southampton found that this molecule targets the master switch—HIF-1—that cancer cells use to adapt to low oxygen levels, a common feature in the disease.
read all at
Find out more:
- Cancer Sciences Unit
- Is it your ambition to help cure cancer? If so, visit: www.southampton.ac.uk/medicine/undergraduate/index.page
