Biotech's Future Could Reside in the Home
The enormous potential of biotechnology won't be realized by large corporations making new crops, but by companies aiming at homes and small farms, says physicist Freeman Dyson.
Biotechnology will enter into individuals' daily lives in the 21st century much in the same way that electronic devices like personal computers and digital cameras brought the advances in physics and chemistry into the homes of the late 20th century, Dr. Dyson says.
In the early computer era, pioneers like John von Neumann wrongly assumed computers would develop into "large centralized facilities." Similarly, people today generally think of genetic engineering as the exclusive domain of large corporations. Instead, Dr. Dyson says, biotechnology will make its largest advances by becoming "small and domesticated." For centuries, people have been effectively genetically engineering plants and animals through selective breeding. As individuals gain access to the tools of biotechnology, they will expand the diversity of pets and plants for recreational purposes, even creating games that allow children to tinker with genes, competing to make the prickliest cactus or scariest lizard. Genetically modified tropical fish with new colors already are appearing in pet stores.
Beyond household fun, Dr. Dyson, the father of information-technology guru Esther Dyson, anticipates that the domesticated form of biotechnology will allow rural communities to challenge the economic power of cities, by transforming themselves into biotechnology research centers. He notes that Dolly, the first cloned sheep, came from an animal-breeding center in Scotland, rather than Silicon Valley. With their expertise in biotechnology, rural communities might even come up with technologies for heavy industry, such as developing earthworms that could wring aluminum from clay or seaweed that could extract magnesium from sea water.
Dr. Dyson, known for making bold predictions in many scientific fields and a favorite source for science-fiction writers, says biotechnology still poses many dangers. He leaves it to future generations to resolve how his futuristic vision can be safely adopted.
Thursday, July 12, 2007
Radiate Study Meets Primary End Point
Swiss drugmaker Roche Holding AG (RHHBY) said Tuesday that RADIATE, the third study in Actemra's (tocilizumab) extensive multinational phase III development programme, successfully met its primary endpoint.
The study examined Actemra in combination with methotrexate in rheumatoid arthritis (RA) patients who had an inadequate response to anti-tumour necrosis factor therapy (anti-TNFs).
The study conducted in 498 patients with difficult-to-treat RA disease, showed that a greater proportion of patients treated with Actemra plus methotrexate, achieved a significant improvement in disease signs and symptoms (ACR scores3) following 24 weeks of treatment, compared to patients treated with placebo plus methotrexate.
"RADIATE's positive outcome further confirms the critical role of IL-6 in the pathophysiology of rheumatoid arthritis," said Urs Schleuniger, Business Director, Inflammation and Autoimmune Disease, Roche Pharmaceuticals. "These results add to the wealth of data being compiled ahead of the anticipated regulatory filing later this year," he added.
The study examined Actemra in combination with methotrexate in rheumatoid arthritis (RA) patients who had an inadequate response to anti-tumour necrosis factor therapy (anti-TNFs).
The study conducted in 498 patients with difficult-to-treat RA disease, showed that a greater proportion of patients treated with Actemra plus methotrexate, achieved a significant improvement in disease signs and symptoms (ACR scores3) following 24 weeks of treatment, compared to patients treated with placebo plus methotrexate.
"RADIATE's positive outcome further confirms the critical role of IL-6 in the pathophysiology of rheumatoid arthritis," said Urs Schleuniger, Business Director, Inflammation and Autoimmune Disease, Roche Pharmaceuticals. "These results add to the wealth of data being compiled ahead of the anticipated regulatory filing later this year," he added.
Roche In $1B Alliance With Alnylam On RNAi
Roche Holding AG (RHHBY) Monday entered an alliance worth up to $1 billion with Alnylam Pharmaceuticals Inc. (ALNY) of the U.S. in which the Swiss drugmaker obtains access to the U.S. biopharmaceutical company's technology platform for developing treatments based on RNA interference.
Roche, based in Basel, said it will pay Alnylam $331 million upfront, including a cash payment and an equity investment of $42.5 million, which represents a stake of just under 5% of Alnylam's outstanding shares.
The close of the agreements, including Roche's purchase of Alnylam shares and purchase of Alnylam's site in Germany, is subject to certain regulatory approvals and is expected within around 30 days.
RNA interference, or RNAi, is considered one of the hottest new areas of drug research. It represents breakthrough in understanding how genes are turned on and off in cells. RNAi was the basis for last year's Nobel Prize in medicine, as it is seen offering a completely new approach to drug discovery and development.
Roche's deal follows on the heels of AstraZeneca's (AZN) deal with U.K.-based Silence Therapeutics Plc (SLN.LN), announced on Friday and valued at as much as GBP200 million. Last fall, Merck & Co. (MRK) agreed to pay $1.1 billion for Sirna Theruapeutics Inc. of the U.S. to get access to RNAi technology.
Roche, based in Basel, said it will pay Alnylam $331 million upfront, including a cash payment and an equity investment of $42.5 million, which represents a stake of just under 5% of Alnylam's outstanding shares.
The close of the agreements, including Roche's purchase of Alnylam shares and purchase of Alnylam's site in Germany, is subject to certain regulatory approvals and is expected within around 30 days.
RNA interference, or RNAi, is considered one of the hottest new areas of drug research. It represents breakthrough in understanding how genes are turned on and off in cells. RNAi was the basis for last year's Nobel Prize in medicine, as it is seen offering a completely new approach to drug discovery and development.
Roche's deal follows on the heels of AstraZeneca's (AZN) deal with U.K.-based Silence Therapeutics Plc (SLN.LN), announced on Friday and valued at as much as GBP200 million. Last fall, Merck & Co. (MRK) agreed to pay $1.1 billion for Sirna Theruapeutics Inc. of the U.S. to get access to RNAi technology.
Monday, July 09, 2007
Santhera And Novartis Set Licencing Deal On CMD Treatment
Switzerland-based Santhera Pharmaceuticals AG (SANN.EB) Monday said it has enetered a licensing agreement with Novartis AG (NVS) covering the compound omigapil for the treatment of Congenital Muscular Dystrophy, or CMD.
Santhera will pay Novartis an upfront fee, and a further milestone payment upon entering into the pivotal clinical trial in CMD. Santhera will have the right to use all preclinical and clinical data generated on omigapil and receives the remaining drug substance on stock at Novartis. Furthermore, Novartis will receive an additional payment if the drug receives market approval in the EU and the United States as well as royalties based on the sales of the product.
Santhera will develop omigapil as a potential treatment for this severe, genetically determined neuromuscular condition which frequently affects infants or young children with life-threatening progressive muscle weakness. Santhera expects to commence a Phase II trial in CMD patients by the end of 2008. Santhera also has the option to expand the development of omigapil into other neuromuscular indications while Novartis retains a buy-back option confirming Novartis' continuing interest in the compound and its potential as identified by Santhera.
Novartis retains the option to buy back the rights to omigapil under certain conditions. If Novartis decides to exercise this buy back option Santhera would be reimbursed a multiple of its development costs and would receive milestone payments upon market approval as well as royalties based on future product sales. In addition, Novartis is committed to use Santhera's specialized sales and marketing organization in the U.S., which is expected to be in place to support the launch and marketing of Santhera's lead compound SNT-MC17 for Friedreich's Ataxia and other indications.
Santhera will need to perform additional preclinical development work with SNT-317, given its intended use in children, before commencing a Phase II clinical trial in CMD patients. This trial is expected to start before the end of 2008.
Santhera will pay Novartis an upfront fee, and a further milestone payment upon entering into the pivotal clinical trial in CMD. Santhera will have the right to use all preclinical and clinical data generated on omigapil and receives the remaining drug substance on stock at Novartis. Furthermore, Novartis will receive an additional payment if the drug receives market approval in the EU and the United States as well as royalties based on the sales of the product.
Santhera will develop omigapil as a potential treatment for this severe, genetically determined neuromuscular condition which frequently affects infants or young children with life-threatening progressive muscle weakness. Santhera expects to commence a Phase II trial in CMD patients by the end of 2008. Santhera also has the option to expand the development of omigapil into other neuromuscular indications while Novartis retains a buy-back option confirming Novartis' continuing interest in the compound and its potential as identified by Santhera.
Novartis retains the option to buy back the rights to omigapil under certain conditions. If Novartis decides to exercise this buy back option Santhera would be reimbursed a multiple of its development costs and would receive milestone payments upon market approval as well as royalties based on future product sales. In addition, Novartis is committed to use Santhera's specialized sales and marketing organization in the U.S., which is expected to be in place to support the launch and marketing of Santhera's lead compound SNT-MC17 for Friedreich's Ataxia and other indications.
Santhera will need to perform additional preclinical development work with SNT-317, given its intended use in children, before commencing a Phase II clinical trial in CMD patients. This trial is expected to start before the end of 2008.
Galapagos Extends Osteoarthritis Deal With GlaxoSmithKline
Galapagos NV (GLPG.BT) announced Monday that its existing multiyear alliance in osteoarthritis with GlaxoSmithKline (GSK) will be expanded, and that Galapagos has issued 513,281 new shares for an investment of EUR4.4 million by GSK.
GSK will bring a drug discovery program against a selected GSK target into the alliance. Within this additional program, Galapagos will progress a disease-modifying drug towards completion of clinical Phase IIa or "Proof-of-Concept", at which point GSK's global research and development organization will be responsible for the late-stage development, production and marketing of the drug. Furthermore, GSK may add a second osteoarthritis drug discovery program against a selected GSK target into the alliance.
GSK will bring a drug discovery program against a selected GSK target into the alliance. Within this additional program, Galapagos will progress a disease-modifying drug towards completion of clinical Phase IIa or "Proof-of-Concept", at which point GSK's global research and development organization will be responsible for the late-stage development, production and marketing of the drug. Furthermore, GSK may add a second osteoarthritis drug discovery program against a selected GSK target into the alliance.
Industries and Government Promote E-Prescribing
The widespread use of electronic systems to send prescriptions from doctors to pharmacies promises to prevent thousands of life-threatening medical errors, save billions of dollars in health-care costs and even drive more business to drug stores.
Most U.S. physicians, however, have yet to adopt electronic prescribing, or e-prescribing, for the estimated 4 billion prescriptions they write annually, a situation that a phalanx of corporations and the government are working to change.
E-prescriptions, at only a couple of million a month today, "are on the verge of an explosion," Walgreen Co. (WAG) Chairman David Bernauer told the National Association of Chain Drug Stores in April.
With e-prescribing, physicians can use hand-held or desktop computers or "smart" mobile phones to send patient drug prescriptions to pharmacy computers.
Beyond conveying prescriptions, systems can alert doctors to potential drug interactions or dosing problems, eliminate handwriting errors, automate the time-consuming renewal process, provide data on a patient's drug plan, and potentially cut thousands of pharmacy calls to doctors. Hospitals, insurers, technology companies, regional collaboratives and pharmacies have been working to advance adoption of e-prescribing.
The drug store industry formed an organization, SureScripts, in 2001 to develop a network that now allows doctors to electronically transmit prescriptions to almost all U.S. pharmacies. More than 120 physician and pharmacy software companies are certified or nearly certified to send or receive prescriptions over the SureScripts exchange.
The scores of physician software companies with products used in e-prescribing include large electronic health-records businesses such as General Electric Co.'s (GE) GE Healthcare and standalone e-prescribing concerns such as Zix Corp. (ZIXI).
Early this year, one of those companies, clinical software maker Allscripts Inc. (MDRX), joined computer maker Dell Inc. (DELL) to form a broad coalition - the National ePrescribing Patient Safety Initiative - in a $100 million effort to provide for free Allscripts' Web-based e-prescribing technology to every physician in the U.S.
The NEPSI coalition includes health insurers Aetna Inc. (AET) and WellPoint Inc. (WLP), technology giants Microsoft Corp. (MSFT) and Cisco Systems Inc. (CSCO), Fujitsu Ltd.'s (FJTSY) U.S. computer business, Google Inc. (GOOG), Sprint Nextel Corp. (S), SureScripts, Wolters Kluwer N.V.'s (WTKWY) health division, and several academic medical centers.
The coalition targets doctors in small group practices, aiming to address concerns about costs and difficulty, among other barriers to their adoption of e-prescribing technology.
"A doctor can sign up within an hour," Allscripts Chief Executive Glen Tullman, co-chair of NEPSI, said in an interview. The coalition isn't providing statistics yet but Tullman said the effort is "making great progress."
NEPSI estimates that as many as 20% of the 550,000 practicing U.S. physicians had the technology to send e-prescriptions but that only 5% of the nation's doctors actually have been using it to prescribe electronically.
Allscripts' Tullman said the coalition's effort so far has added thousands of more physicians nationwide to the ranks of e-prescribers. He expects "a very strong, very high-visibility" ramping up in September, with large employers and more managed-care companies and payors joining the coalition. He also expects state governments to become active in mandating electronic prescribing.
After recent updates to state laws and regulations, e-prescribing is now legal in 49 states and soon will become so in all 50 with the addition of Alaska, according to SureScripts President and Chief Executive Kevin Hutchinson.
E-prescribing proponents, including the U.S. Department of Health and Human Services, point to a study that estimates adoption of e-prescribing technology could save $27 billion in U.S. health-care costs by reducing adverse drug events and improving work flow.
"Clean and correct scripts safeguard our patients' safety, save our pharmacists time and increase our business," Walgreens' Bernauer said in his speech. Bernauer cited a study showing that 11% more prescriptions make it to the pharmacy when a doctor switches to e-prescribing.
HHS, in a recent report to Congress, cited expert projections that e-prescribing could avoid more than 2 million adverse drug events annually, 130,000 of which are life-threatening. Even so, five government-funded e-prescribing pilot projects did not establish the effect on patient safety, the report said, noting the role of office staff members in handling e-prescribing tasks. The effect on safety requires more study, the report said.
The Allscripts-Dell coalition cites statistics from the nonprofit Institute of Medicine of the National Academies that 1.5 million patients a year are injured and more than 7,000 die as the result of preventable medication errors. The numbers actually may be higher, as Allscripts says studies indicate that doctors using the NEPSI-provided software cancel 1% of prescriptions because of improper-dosage or adverse-reaction warnings during prescribing.
Investment firm Stifel Nicolaus expects the move to e-prescriptions to accelerate in the near term, and sees its adoption as "a key on-ramp to the adoption of electronic medical records," a view that some others share.
E-prescribing is a component of insurer WellPoint's multi-million-dollar health information-technology efforts, said Charles Kennedy, WellPoint vice president for health IT. In Ohio, doctors can earn higher reimbursement from WellPoint if they fill prescriptions electronically.
WellPoint sees e-prescribing as a way to lower costs and improve safety and quality of care, including driving greater use of generic drugs, Kennedy said. The company is seeing very rapid growth in the transactions, although e-prescribing, in its early stages, remains "a drop in the bucket," he said.
Allscripts is "doing the right thing" and making health-care better in giving doctors free access to its web-based e-prescribing software, Allscripts CEO Tullman said. He acknowledged that the company also aims to build its brand and sell its wider offering of electronic-health-records software to physicians. "We think of this as the on-ramp to the electronic health-care highway," he said.
The company estimates that its paying customers and those receiving the free software account for approximately half of all prescriptions filled electronically in the U.S. today.
Among other efforts in recent years, regional partnerships in Massachusetts, where Blue Cross and Blue Shield of Massachusetts is involved, and Rhode Island have made those states e-prescribing leaders. In Michigan, the big three U.S. automakers joined with insurers and others to launch an e-prescribing effort.
Researchers from the Center for Studying Health System Change noted in the journal Health Affairs this spring that physicians with e-prescribing equipment reported various problems with using it but said employment of such technology improves prescribing safety and the efficiency of their practices, "and they did not want to go back to paper."
The Medicare Modernization Act of 2003 required adoption of technical standards for processing electronic prescriptions and mandated that Medicare prescription-drug plans support e-prescribing.
The law effectively resolved industry debate over which standards to use, according to SureScripts CEO Hutchinson. He also serves as a commissioner on HHS's American Health Information Community, which develops standards to accelerate adoption of health-care technology.
E-prescribing is one process the federal government is exploring to improve health-care interoperability and keeping patients on their medications, he said. The prescription "makes it beyond the glove box of the car," Hutchinson noted.
Dr. Jan Cornell, a family practice physician in Calumet, Mich., adopted Allscripts' free software in February. "The pharmacists were really happy to see me use something that has a printout," he said. The initial loading of patient information into the system can be a chore, and his colleagues are wary of the task, he said.
Most U.S. physicians, however, have yet to adopt electronic prescribing, or e-prescribing, for the estimated 4 billion prescriptions they write annually, a situation that a phalanx of corporations and the government are working to change.
E-prescriptions, at only a couple of million a month today, "are on the verge of an explosion," Walgreen Co. (WAG) Chairman David Bernauer told the National Association of Chain Drug Stores in April.
With e-prescribing, physicians can use hand-held or desktop computers or "smart" mobile phones to send patient drug prescriptions to pharmacy computers.
Beyond conveying prescriptions, systems can alert doctors to potential drug interactions or dosing problems, eliminate handwriting errors, automate the time-consuming renewal process, provide data on a patient's drug plan, and potentially cut thousands of pharmacy calls to doctors. Hospitals, insurers, technology companies, regional collaboratives and pharmacies have been working to advance adoption of e-prescribing.
The drug store industry formed an organization, SureScripts, in 2001 to develop a network that now allows doctors to electronically transmit prescriptions to almost all U.S. pharmacies. More than 120 physician and pharmacy software companies are certified or nearly certified to send or receive prescriptions over the SureScripts exchange.
The scores of physician software companies with products used in e-prescribing include large electronic health-records businesses such as General Electric Co.'s (GE) GE Healthcare and standalone e-prescribing concerns such as Zix Corp. (ZIXI).
Early this year, one of those companies, clinical software maker Allscripts Inc. (MDRX), joined computer maker Dell Inc. (DELL) to form a broad coalition - the National ePrescribing Patient Safety Initiative - in a $100 million effort to provide for free Allscripts' Web-based e-prescribing technology to every physician in the U.S.
The NEPSI coalition includes health insurers Aetna Inc. (AET) and WellPoint Inc. (WLP), technology giants Microsoft Corp. (MSFT) and Cisco Systems Inc. (CSCO), Fujitsu Ltd.'s (FJTSY) U.S. computer business, Google Inc. (GOOG), Sprint Nextel Corp. (S), SureScripts, Wolters Kluwer N.V.'s (WTKWY) health division, and several academic medical centers.
The coalition targets doctors in small group practices, aiming to address concerns about costs and difficulty, among other barriers to their adoption of e-prescribing technology.
"A doctor can sign up within an hour," Allscripts Chief Executive Glen Tullman, co-chair of NEPSI, said in an interview. The coalition isn't providing statistics yet but Tullman said the effort is "making great progress."
NEPSI estimates that as many as 20% of the 550,000 practicing U.S. physicians had the technology to send e-prescriptions but that only 5% of the nation's doctors actually have been using it to prescribe electronically.
Allscripts' Tullman said the coalition's effort so far has added thousands of more physicians nationwide to the ranks of e-prescribers. He expects "a very strong, very high-visibility" ramping up in September, with large employers and more managed-care companies and payors joining the coalition. He also expects state governments to become active in mandating electronic prescribing.
After recent updates to state laws and regulations, e-prescribing is now legal in 49 states and soon will become so in all 50 with the addition of Alaska, according to SureScripts President and Chief Executive Kevin Hutchinson.
E-prescribing proponents, including the U.S. Department of Health and Human Services, point to a study that estimates adoption of e-prescribing technology could save $27 billion in U.S. health-care costs by reducing adverse drug events and improving work flow.
"Clean and correct scripts safeguard our patients' safety, save our pharmacists time and increase our business," Walgreens' Bernauer said in his speech. Bernauer cited a study showing that 11% more prescriptions make it to the pharmacy when a doctor switches to e-prescribing.
HHS, in a recent report to Congress, cited expert projections that e-prescribing could avoid more than 2 million adverse drug events annually, 130,000 of which are life-threatening. Even so, five government-funded e-prescribing pilot projects did not establish the effect on patient safety, the report said, noting the role of office staff members in handling e-prescribing tasks. The effect on safety requires more study, the report said.
The Allscripts-Dell coalition cites statistics from the nonprofit Institute of Medicine of the National Academies that 1.5 million patients a year are injured and more than 7,000 die as the result of preventable medication errors. The numbers actually may be higher, as Allscripts says studies indicate that doctors using the NEPSI-provided software cancel 1% of prescriptions because of improper-dosage or adverse-reaction warnings during prescribing.
Investment firm Stifel Nicolaus expects the move to e-prescriptions to accelerate in the near term, and sees its adoption as "a key on-ramp to the adoption of electronic medical records," a view that some others share.
E-prescribing is a component of insurer WellPoint's multi-million-dollar health information-technology efforts, said Charles Kennedy, WellPoint vice president for health IT. In Ohio, doctors can earn higher reimbursement from WellPoint if they fill prescriptions electronically.
WellPoint sees e-prescribing as a way to lower costs and improve safety and quality of care, including driving greater use of generic drugs, Kennedy said. The company is seeing very rapid growth in the transactions, although e-prescribing, in its early stages, remains "a drop in the bucket," he said.
Allscripts is "doing the right thing" and making health-care better in giving doctors free access to its web-based e-prescribing software, Allscripts CEO Tullman said. He acknowledged that the company also aims to build its brand and sell its wider offering of electronic-health-records software to physicians. "We think of this as the on-ramp to the electronic health-care highway," he said.
The company estimates that its paying customers and those receiving the free software account for approximately half of all prescriptions filled electronically in the U.S. today.
Among other efforts in recent years, regional partnerships in Massachusetts, where Blue Cross and Blue Shield of Massachusetts is involved, and Rhode Island have made those states e-prescribing leaders. In Michigan, the big three U.S. automakers joined with insurers and others to launch an e-prescribing effort.
Researchers from the Center for Studying Health System Change noted in the journal Health Affairs this spring that physicians with e-prescribing equipment reported various problems with using it but said employment of such technology improves prescribing safety and the efficiency of their practices, "and they did not want to go back to paper."
The Medicare Modernization Act of 2003 required adoption of technical standards for processing electronic prescriptions and mandated that Medicare prescription-drug plans support e-prescribing.
The law effectively resolved industry debate over which standards to use, according to SureScripts CEO Hutchinson. He also serves as a commissioner on HHS's American Health Information Community, which develops standards to accelerate adoption of health-care technology.
E-prescribing is one process the federal government is exploring to improve health-care interoperability and keeping patients on their medications, he said. The prescription "makes it beyond the glove box of the car," Hutchinson noted.
Dr. Jan Cornell, a family practice physician in Calumet, Mich., adopted Allscripts' free software in February. "The pharmacists were really happy to see me use something that has a printout," he said. The initial loading of patient information into the system can be a chore, and his colleagues are wary of the task, he said.
Thursday, July 05, 2007
NICE OKs Elan, Biogen MS Treatment Tysabri
Ireland-based Elan Corp. (ELN) and U.S.-based Biogen Idec (BIIB) said Tuesday they welcome the U.K. National Institute for Health and Clinical Excellence recommendation for the use of their drug Tysabri, the first NICE approval for any multiple sclerosis drug.
The companies said Tysabri represents a significant advance in MS treatment, offering hope of delaying the progression of disability and reducing the frequency of relapses.
According to the companies, treatment with Tysabri over two years leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.
As of late May, the treatment was being used in about 12,000 patients in both commercial use and clinical trials in the U.S., Germany, France, Ireland and other countries.
However, said one analyst who follows the sector, a key approval for the drug is still awaited from the U.S. Food and Drug Administration.
"This has to be seen in that context," he said, though he added that approval in the U.K. clearly bodes well for the drug.
The companies said Tysabri represents a significant advance in MS treatment, offering hope of delaying the progression of disability and reducing the frequency of relapses.
According to the companies, treatment with Tysabri over two years leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.
As of late May, the treatment was being used in about 12,000 patients in both commercial use and clinical trials in the U.S., Germany, France, Ireland and other countries.
However, said one analyst who follows the sector, a key approval for the drug is still awaited from the U.S. Food and Drug Administration.
"This has to be seen in that context," he said, though he added that approval in the U.K. clearly bodes well for the drug.
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