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BIOTECH & CREATIVITY/Biotech's promise arrives -- with a price tag
Sunday, May 1, 2005 (SF Chronicle)
David Ewing Duncan For 30 years, prognosticators have proclaimed that the future of health care belongs to biotechnology -- to the promise that miraculous and less-expensive treatments will flow from a deeper understanding of disease at the genetic and molecular level of the human body. This hoped-for bright future will affect California in two ways: One of every 10 U.S. health care dollars -- a total of more than $1.6 trillion last year -- is spent in this state, and the epicenter of the biotech industry is the Bay Area. Has the future arrived? Yes and no. Yes in the case of a few wonder drugs, and in the wealth of research that has inched us closer to teasing out the basic mechanisms of how ailments work. The drugs are expensive for patients, and cost a fortune to create and develop, but the handful of biotech home runs, such as synthetic insulin in the 1980s and the new anti-cancer drugs Avastin and Erbitux have vastly improved lives. They may very well reduce health care costs one day by keeping people out of hospitals and away from costly surgeries and other interventions. But the bright future hasn't arrived in this sense: The price tag for creating a promised proliferation of new drugs continues to soar, with the secrets of how to design molecular-based drugs proving frustratingly complex, and far more expensive than anyone imagined. Tens of billions of dollars have been spent in the past 10 years alone in research and development to produce a dozen or so major drugs and several dozen treatments for rare diseases. Those treatments are a great boon for the patients concerned, but the balance sheet for the industry remains deeply in the red. Successful drugs reflect this cost at the retail level, with some biotech drugs priced in the thousands of dollars a month. Even when new drugs contribute to reducing overall costs for the total health care system, individuals don't always see the savings. No one draws up personal budgets based on, for example, the savings they realized by avoiding an operation for colon cancer because they took South San Francisco-based Genentech's Avastin. But people do know when they have to pay thousands of dollars a year for drugs -- particularly when insurance does not cover all or part of the cost, and the cash comes out of pocket. Avastin, the first drug of its kind, works by restricting the blood vessels that supply cancerous tumors with oxygen and nutrients. It increases average survival rates by several months for 150,000 patients a year diagnosed with colon cancer. For some, it saves their lives. It is far less toxic than traditional chemotherapies. Recently, Avastin has been shown to reduce tumors in lung cancer and breast cancer. Its cost, however, is a whopping $4,000 a month during a typical colon cancer patient's treatment of about 10 months -- or $40,000 total. This is far more than traditional chemotherapies, which cost a few hundred dollars a month. Another unique cancer drug, ImClone's Erbitux, which stimulates the body's antibodies to fend off cancer, costs up to $12,000 a month, though it is taken for a shorter period of time. The wholesale cost for all drugs to treat each colon cancer patient (treatment is usually in the form of multiple drugs) has climbed to $250,000 today, says cancer doctor Leonard Saltz of Memorial Sloan-Kettering Cancer Center in New York City. Cancer in the United States requires about $64 billion a year in direct costs to treat, and $125 billion more in lost productivity, according to the National Cancer Institute. Avastin, Erbitux and other expensive wonder drugs add to this cost. "How can we afford to pile $20,000-a-year drugs on top of $20,000-a-year drugs?" asked Michael Friedman, CEO of City of Hope National Medical Center in Los Angeles in an interview last week with BusinessWeek. The pharmaceutical and biotech industries argue that in the long run, new drugs will save money. Heart drugs, such as those that lower cholesterol, do save money by preventing surgery. Twenty years ago, biotech broke into prime time by coming up with synthetic insulin and growth hormones, and with drugs, such as synthetic erythropoietin, that stimulate bone marrow to ramp up the production of red blood cells for patients suffering from anemia, particularly cancer patients and patients on dialysis. These drugs are still expensive, but they do save lives, and in some cases, they save money in the long run by keeping people healthy who would otherwise need expensive medical treatment. Biotech also has enormous potential to find cures in areas such as stem cells and nanotechnology -- although the costs likely will be high. One day soon, society will need to weigh the benefits and costs of these treatments and soberly assess whether we can afford the bill -- even with so many lives at stake. The potential of biotech as a potent weapon to fight disease is being established, and we can hope that biotech will pay for itself -- and provide the long-promised miracles for less -- but that remains to be determined. David Ewing Duncan is a science writer and author of the forthcoming book, "The Geneticist Who Played Hoops With My DNA ... and other masterminds from the frontiers of biotech." E-mail the author at his Web site, www.davidewingduncan.com. ---------------------------------------------------------------------- Copyright 2005 SF Chronicle
Comments
First generation Epoetins
by
Jorge
on Wed 05 Oct 2005 04:43 AM EDT | Profile | Permanent Link
First generation Epoetins The global market for recombinant human erythropoietin (rHu-epo) was about US$ 11 bln. in the year 2004 and is expected to continue its growth (annual rate of 18 % over the last five years). The predominant rHu-epo products are epoetin alfa from Amgen & Kirin/Sankyo and licensee Ortho-Biotech (J&J) and epoetin beta from Roche & Chugai, the latter ones only outside the USA . epoetin alfa and beta products still have market exclusivity in countries with valid patent protection and prevented marketing of epoetin omega and epoetin delta so far. epoetin omega is only marketed in several countries without valid patent protection. Amgen already launched in 2001 the first modified epoetin product. However, patents for epoetin alfa expired in Europe in 2004 and patents for epoetin beta will expire in 2006 (Schellekens H, 2004), while US patent protection for epoetin alfa lasts until 2013. La Merie Business Intelligence performed a search for publicly available information about epo biogenerics (i.e. biosimilars or follow-on biologics) and other erythropoiesis-stimulating agents competing with patent protected epo products. Main outcomes of the analysis are: E·rythropoietin (epo) biosimilars in off-patent countries More than 6 European companies are in advanced clinical development stage or close to submitting the registration file at the EMEA. One company already received marketing approval in Croatia (outside the European Union). Further four non-European companies from India , Korea and China plan to enter the European epo arena First Generation epo (generics) in off-patent countries More than 15 companies are already manufacturing rHu-epo drug substance all over the world in countries without valid patent protection. Manufacturing sites are in Cuba , Brazil , Argentina , South Africa , South Korea , Taiwan , India and China . Major international players of first generation epo biogenerics in “off-patent countries” are Dragon Pharmaceuticals (China/Canada), LG Life Sciences ( Korea ) and Wockhardt ( India ). Next generation Erythropoiesis-Stimulating Agents (ESAs) La Merie Business Intelligence identified 12 projects in the pipeline of new erythropoiesis-stimulating agents mainly aiming at improvement of pharmacokinetics or enabling oral dosing. These agents include pegylated versions of epo, epo-fusion proteins, new peptides and oral small molecules in preclinical or clinical development stages up to phase III. Re: BIOTECH & CREATIVITY/Biotech's promise arrives -- with a price tag
by
Mary-Anne
on Fri 25 Jan 2008 12:33 PM EST | Profile | Permanent Link
Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. The United Nations Convention on Biological Diversity defines biotechnology as : "Biotechnology has contributed towards the exploitation of biological organisms or biological processes through modern techniques, which could be profitably used in medicine, agriculture, animal husbandry and environmental cloning."
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