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PubMed2004

A front-end automation tool supporting design, verification and reuse of SOC.

This paper describes an in-house developed language tool called VPerl used in developing a 250 MHz 32-bit high-performance low power embedded CPU core. The authors showed that use of this tool can compress the Verilog code by more than a factor of 5, increase the efficiency of the front-end design, reduce the bug rate significantly. This tool can be used to enhance the reusability of an intellectual property model, and facilitate porting design for different platforms.

Algorithms↗
PubMed2006

A comparison of NIH-approved human ESC lines.

In October 2003, the NIH established three extramural "Exploratory Centers for Human Embryonic Stem Cell Research." Our center acquired 15 of the 22 NIH-approved cell lines. Lines were tested for: (a) freedom from mycoplasma contamination; (b) appropriate pattern of gene expression during self-renewal and differentiation; (c) ability to adapt to uniform culture conditions; (d) ability to grow at clonal densities; (e) karyotype; (f) growth efficiency; and (g) efficiency of stable transfection following electroporation. One line harbored mycoplasma. Ten lines were converted to uniform conditions. Nine lines were fully characterized. Human ESC (hESC) lines varied markedly with respect to growth efficiency as measured by the amount of time it took to plate and double (31-57 hours), cloning efficiency (0.8%-9.2%), and stable transfection rates following electroporation (0%-53% relative to a standard mouse ESC line). One hESC line had an unstable karyotype at an early passage. Modifications of the proposed Material Transfer Agreements with hESC suppliers were required to improve accessibility to hESC lines by local researchers. The NIH-approved hESC lines vary in their behavior in culture. Many hESC lines can be maintained using culture conditions less onerous than those recommended by their suppliers. Intellectual property issues pose a significant obstacle to research using NIH-approved hESC lines.

Animals↗
PubMed2006

Deoxynucleotides can replace dideoxynucleotides in minisequencing by arrayed primer extension.

Scientific literature describing arrayed primer extension and other array-based minisequencing technologies consistently cite the requirement for four fluorescent dideoxynucleotides (with concomitant absence/inactivation of deoxynucleotides) to ensure single-base extension and thus sequence-specific intensity data that can be interpreted as a base call or genotype. We present compelling evidence that fluorescent deoxynucleotides can reliably be used in microarray minisequencing experiments, generating fluorescent sequence extension intensity profiles that are homologous to the single-base extensions obtained with terminator dideoxynucleotides. Due to the almost 10-fold higher costs (and limited fluorophore choice) of many commercially available fluorescent dideoxynucleotides, compared to fluorescent deoxynucleotides, as well as other potentially constraining intellectual property and licensing issues, this hitherto dismissed microarray chemistry represents an important reevaluation in the field of array-based genotyping and related enzymology.

Chromosome Mapping↗
PubMed2003

Pharmacological treatment of severe psychiatric disorders in the developing world : lessons from India.

Severe psychiatric disorders (schizophrenia, bipolar disorder and major depressive disorder) cause much morbidity and disability in developing countries. Most of the evidence on the efficacy and effectiveness of drug treatments for these disorders is based on trials conducted in Western countries. Cultural, biological and health system factors may profoundly influence the applicability of such evidence in developing countries. Attitudes towards, and concepts about, psychiatric disorders vary across cultures, and these may influence the acceptability of drug treatments. Genetic and environmental factors may lead to variations in the pharmacodynamics and pharmacokinetics of psychotropic drugs across ethnic groups. This may explain why lower doses of psychotropic drugs tend to be used for non-Caucasian patients. There is a dearth of mental health professionals and care facilities in developing countries, especially in rural areas. Epidemiological studies show that, despite this lack of services, the outcome of schizophrenia is favourable in developing countries. This suggests that cultural, genetic or environmental factors may play as much of a role in influencing outcome as access to antipsychotic treatment. Regional drug policies may influence the availability and cost of psychotropic drugs. In particular, the Indian experience, where drugs are manufactured by several local pharmaceutical firms, thus bringing their cost down, may represent a unique deregulated drug industry. However, the impending impact of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, with the strict enforcement of patent laws, will almost certainly lead to a rise in drug costs in the coming years. This may influence the choice and cost effectiveness of various drugs. The implications of these cross-cultural variations for policy and practice are the need to ensure a reliable supply of affordable psychotropic drugs in developing countries, trained healthcare professionals to use these drugs rationally, a concerted advocacy campaign to exclude drugs for severe psychiatric disorders from patent protection, and the development of psychosocial programmes to improve global outcomes.

Central Nervous System Agents↗
PubMed2002

Virulizin.

Virulizin, a biological response modifier, is a mixture of proteins and peptides that have been extracted from bovine reticuloendothelial tissue that activates macrophages. It is being developed by Lorus Therapeutics (formerly Imutec Pharma) for the treatment of various cancers and had completed phase II clinical trials in Canada for the treatment of pancreatic cancer and advanced malignant melanoma. The commencement of phase III clinical trials in Canada, for the treatment of pancreatic cancer, was delayed due to quality control problems with batches of virulizin and all clinical trials of virulizin were suspended as Lorus underwent a major restructuring programme. However, phase I/II clinical trials are now underway again in Canada in HIV-positive patients with Kaposi's sarcoma and for the treatment of pancreatic cancer. A phase I/II clinical trial is also underway in patients with pancreatic cancer in the USA. Lorus announced in June 2000 that it had completed a meta analysis of three phase I/II studies of virulizin that showed the drug increased survival and improved quality of life for pancreatic cancer patients. Based on these positive results, Lorus initiated a phase III trial to be conducted at 40 sites in North America in November 2001. The study aims to enrol 350 patients with advanced pancreatic cancer and will test the effectiveness of virulizin as first- and second-line treatment of pancreatic cancer. The study will compare virulizin + gemcitabine with gemcitabine alone as first-line therapy, while second-line treatment will involve patients who have failed to respond to gemcitabine. Some of these patients will receive virulizin + fluorouracil while another group will receive only fluorouracil. The study is scheduled to complete in 2004 or early 2005. Virulizin received orphan drug status for this indication from the US FDA in February 2001. Lorus received fast track designation from the FDA in June 2002 for virulizin for the treatment of pancreatic cancer. Virulizin is registered for the treatment of malignant melanoma in Mexico and is due to be launched there in 2002. Lorus has entered into an exclusive 7-year distribution agreement with Faulding Canada Inc., giving Faulding (now part of Mayne Group) the right to market and sell virulizin in Mexico for the treatment of melanoma. Lorus will receive royalties from sales of the product and will be responsible for its manufacture. In April 2002, Mayne exercised its option to acquire the distribution rights for virulizin in Brazil. Lorus Therapeutics has signed a collaborative agreement with NaPro BioTherapeutics, USA, to study the efficacy of virulizin in combination with paclitaxel for the treatment of lung adenocarcinoma. Lorus is conducting preclinical studies of virulizin in human breast cancer, lung, ovarian and prostate cancer, and has reported successful activity of the agent in these indications. Lorus was awarded a patent by the US Patent and Trademark Office to protect the only known process used to create virulizin. This patent, in conjunction with the patents issued in Australia, South Africa, New Zealand, Korea and Singapore, broadens and strengthens the protection of Lorus' intellectual property rights regarding the process, composition and use of virulizin.

Adjuvants, Immunologic↗
PubMed2002

Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride.

Celgene has developed a chirally pure form of methylphenidate (Ritalin), called dexmethylphenidate [d-methylphenidate, d-methylphenidate hydrochloride, d-MPH; Focalin]. The drug has been launched in the USA and is undergoing registration in Canada for the treatment of children with attention-deficit hyperactivity disorder (ADHD). Dexmethylphenidate is the single isomer version of racemic methylphenidate (Ritalin), which contains the active d isomer of Ritalin. Dexmethylphenidate acts via the inhibition of reuptake of norepinephrine and dopamine. Research is ongoing to further clarify the mode of therapeutic action in ADHD. Dexmethylphenidate was developed with the aim of reducing drug load, adverse events and drug interactions. Dexmethylphenidate provides effective management of attention-deficit hyperactivity disorder at half the dose of Ritalin. In April 2000, worldwide rights (excluding Canada) to dexmethylphenidate were granted to Novartis. Celgene has also granted Novartis rights to all related intellectual properties and patents. Novartis will fund all remaining development and marketing expenses required for regulatory approval and commercialisation of dexmethylphenidate. Crystaal Corporation, the marketing division of Biovail Corporation International, has exclusive Canadian marketing rights for all formulations of dexmethylphenidate. Novartis launched dexmethylphenidate (Focalin) in the USA during Q1 2002. It is available as a D-shaped tablet (2.5, 5 and 10 mg doses). Novartis had planned to use the tradename Ritadex, however the FDA recommended an alternative name due to potential prescribing errors with Ritalin. The finalized tradename to be used is Focalin. In July 2001, a new drug submission was filed with Canada's Therapeutic Products Programme for dexmethylphenidate in the treatment of attention-deficit disorder and attention-deficit hyperactivity disorder. Novartis is also developing an extended-release version of chirally pure dexmethylphenidate. Dexmethylphenidate has been found to be effective and well tolerated in clinical trials, involving a total of 684 children with ADHD and in 15 healthy adult volunteers. Dexmethylphenidate is a schedule II drug.

Attention Deficit Disorder with Hyperactivity↗
PubMed2003

Xemilofiban: SC 54684A, xemlofiban.

Xemilofiban [SC 54684, SC 54684A (HCl), xemlofiban], a glycoprotein IIb/IIIa antagonist, is an orally available prodrug of a non-peptide mimetic of the tetrapeptide RGDF. It is converted to the active metabolite, SC 54701 (the free base form of SC 54701A). Development was initiated by Searle (Monsanto). Searle became part of Pharmacia Corporation, which was acquired by, and merged into, Pfizer in April 2003. Searle had co-development and co-marketing agreements with Sankyo in Japan; these have been discontinued. In January 2003, Pharmacia donated the intellectual property for xemilofiban to Western Michigan University. In February 2003, Western Michigan University granted an exclusive worldwide licence of xemilofiban to VDDI Pharmaceuticals (formerly Virtual Drug Development Inc.). Xemilofiban was in a phase III clinical trial, the Evaluation of Xemilofiban in Controlling Thrombotic Events (EXCITE) trial, with Searle (Monsanto) in the US and Europe for the treatment of thrombosis in patients with unstable angina pectoris and acute myocardial infarction undergoing angioplasty. However, as xemilofiban demonstrated no significant clinical benefit, Searle discontinued its development. In Japan, Sankyo discontinued the development of xemilofiban for thrombosis at phase II following Searle's decision to drop the project. VDDI Pharmaceuticals plans to develop xemilofiban in cardiovascular disorders following on from the phase III studies completed by Pharmacia; a restructured dosing schedule and narrowed patient selection will be used. VDDI has research facilities worldwide and will utilise facilities in Ireland for the European clinical development programme; research facilities in the Southwest Michigan Innovation Center are planned while the head office of VDDI is based in Tennessee. Xemilofiban is in phase III development for the treatment of cardiovascular disease in conjunction with percutaneous coronary intervention.

Angina Pectoris↗
PubMed2004

Fozivudine: BM 211290, fozivudine tidoxil, FZT, HDP 990002, W 09726867.

Fozivudine [BM 211290, fozivudine tidoxil, FZT, HDP 990002, W 09726867] is a thioether lipid conjugate of zidovudine (AZT) in clinical development with Heidelberg Pharma Holdings for the potential treatment of HIV infection. Heidelberg Pharma's proprietary Linker-Cleavag-Enzyme Technology (LCE_Technology) is used to conjugate specific carriers to parent compounds, significantly improving their pharmacological, toxicological and/or clinical profile. LCE_Technology was originated at Boehringer Mannheim, which was acquired by, and integrated into, Roche. In 1999, when Heidelberg Pharma was founded, following a management buy-out from Roche Diagnostics GmbH, the new company acquired full ownership of the intellectual property and documentation related to various proprietary compounds, the LCE_Technology and its applications. According to Heidelberg Pharma's pipeline, published in August 2003, the product candidate, HDP 99.0002 (the company-specific code for fozivudine) will be in phase III development until early 2006, at which time the company hopes to file an NDA. A phase II study of fozivudine in 72 antiretroviral-naive patients with HIV infection was completed in the US and France by Roche.

Animals↗
PubMed2004

Safinamide: FCE 26743, NW 1015, PNU 151774, PNU 151774E.

Safinamide [NW 1015, PNU 151774E; FCE 26743] is a potent anticonvulsant and antiparkinsonian compound that is being developed by Newron Pharmaceuticals in Europe. It has been shown to antagonise the calcium and sodium channels, as well as inhibit monoamine oxidase type-B (MAO-B). Phase III trials for the treatment of Parkinson's disease are underway in Germany and Europe, while phase II trials in patients with epilepsy are ongoing in Italy. Newron Pharmaceuticals was founded at the end of 1998 after Pharmacia & Upjohn announced its worldwide restructuring programme. Newron obtained the rights to safinamide, which Pharmacia Corporation (now Pfizer) had been developing as PNU 151774E. Safinamide was originated by Farmitalia-CarloErba in Italy. Newron now owns all intellectual property associated with the drug.A multinational phase II trial for Parkinson's disease in Europe has shown positive results in slowing the progression of the disease; however, due to the placebo-effect seen in this study, a longer (6-month) phase IIb study is planned for the second quarter of 2003. In July 2003, Newron received an IND from the US FDA authorising a phase I trial to confirm that no dietary restrictions are needed in patients while being treated with safinamide. This study is be conducted in 12 healthy volunteers at the University of Vienna, Austria, and will be followed by efficacy studies in Parkinson's disease in the US. Five phase I trials were completed in April 2001 in Switzerland. Safinamide combines sodium and calcium channel modulatory activity with monoamine oxidase B inhibition.

Alanine↗
PubMed2005

Efaproxiral: GSJ 61, JP 4, KDD 86, RS 4, RSR 13.

Efaproxiral [RSR 13, GSJ 61, JP 4, KDD 86, RS 4] is a synthetic, small-molecule, radiation-sensitising agent being developed by Allos Therapeutics primarily for the treatment of cancer. It works by binding and allosterically stabilising deoxyhaemoglobin in hypoxic regions of tumour tissue. This increases oxygen uptake of the tumour tissue and restores its sensitivity to radiation therapy, making therapy potentially more successful. This first-of-its-class compound is particularly applicable for the treatment of certain tumour types that lack oxygen, such as brain metastases. In contrast to conventional chemotherapeutic agents or radiation sensitisers, there is no requirement for efaproxiral to be administered directly into tumours or to cross the blood-brain barrier for it to display efficacy. Efaproxiral is under review for approval in the US and EU as an adjunct to whole-brain radiation therapy (WBRT) for the treatment of brain metastases originating from breast cancer. It is also under clinical evaluation for a variety of other cancers, including glioblastoma, non-small cell lung cancer (NSCLC) and cervical cancer. Allos is seeking partnership opportunities for efaproxiral's development and marketing. The company has indicated that the development of efaproxiral would be in cooperation with a corporate partner, according to its 2003 Annual Report. In 1994, Allos Therapeutics acquired exclusive worldwide rights to intellectual property relating to efaproxiral from the Center for Innovative Technology (CIT). Allos has entered into arrangements with two contract manufacturers for the supply of efaproxiral, and a third manufacturer for the supply of the formulated drug product. Hovione FarmaCiencia is the primary supplier of efaproxiral, and is contracted to manufacture sufficient quantities on a commercial scale. In addition, a second manufacturer, Raylo Chemicals, is also producing quantities of efaproxiral. In December 2003, Allos entered into a long-term development and supply agreement with Baxter Healthcare who will formulate the efaproxiral into an injection. Allos is also seeking to establish an alternate supplier of efaproxiral injection. Allos submitted a rolling NDA to the US FDA consisting of three data components. Submission began in the third quarter of 2003 and was completed by the fourth quarter of 2003. The first part of the application containing non-clinical information was submitted on 5 August 2003. The second part of the NDA containing information about efaproxiral's chemistry, manufacture and controls (CMC) was submitted in October 2003. Allos submitted its final component of the rolling NDA in December 2003. In February 2004, Allos announced that the FDA had accepted the company's NDA under priority review status. The FDA granted efaproxiral orphan drug status in August 2004 as an adjunct to WBRT for the treatment of brain metastases among breast cancer patients. Efaproxiral also received fast-track status in November 2000 for the same indication in the US. In February 2004, Allos initiated a phase III trial, called ENRICH (Enhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases) to investigate efaproxiral as an adjunct to WBRT for the treatment of brain metastases. Median survival time is the primary endpoint of the study. The National Breast Cancer Coalition (NBCC) is collaborating with the company to support trial enrolment and to gain additional insight about ways to improve radiation treatment in this patient population. The ENRICH trial protocol was approved by the FDA under a Special Protocol Assessment process; as part of the protocol, two interim analyses for safety and efficacy will be performed.This multicentre, randomised, open-label study has a target enrolment of approximately 360 patients at >100 medical centres across the US, Canada, Europe and South America. Allos announced in September 2004 that recruitment of clinical sites for the trial is ongoing across the US and Canada. Completion of trial enrolment in North America is anticipated in December 2005. Subsequently, Allos announced in January 2005 that recruitment into the ENRICH trial has commenced and is ongoing in Europe; enrolment at European sites is expected to conclude by the third quarter of 2006. Allos Therapeutics announced in June 2004 that it had filed an MAA with the EMEA for marketing of exaproxiral as an adjunct to WBRT for treatment of patients with brain metastases originating from breast cancer. The application is based on positive data from a pivotal phase III (REACH, RT-009) trial in this indication. The completed REACH trial investigated efaproxiral among patients with brain metastases undergoing WBRT. The trial was conducted at multiple sites in 11 countries, including the US, Canada, Europe and Australia. In August 2002 Allos completed the enrolment of 538 patients in the study. Initially only 408 patients were to be enrolled, but the company increased the size of the trial to conduct an appropriately powered subgroup analysis in patients with brain metastases from breast and NSCLC. The study was designed to demonstrate a 35% increase in median survival in the subgroup of patients compared with standard WBRT alone. The primary endpoint was survival. Allos began screening US patients for a phase III trial in NSCLC in early 2003. However, in May 2003, the company announced that as part of its revised operating plan it had suspended the screening of patients for this trial. The trial, which was known as ELITE (Enhanced Lung cancer treatment with Induction chemotherapy and Thoracic radiation and Efaproxiral), was comparing induction chemotherapy followed by thoracic radiation therapy with supplemental oxygen, with or without efaproxiral. The trial was enrolling patients with locally advanced, unresectable NSCLC. ELITE was planned to enrol up to 600 patients across North America and Western and Eastern Europe. Phase II trials in patients with inoperable NSCLC have been conducted in the US and Canada. Patient enrolment in one of these studies was completed in August 2000, with a total of 52 patients enrolled. This was an open-label, multicentre study of induction therapy with paclitaxel plus carboplatin followed by chest irradiation and efaproxiral in patients with locally advanced NSCLC. Positive results from this study were reported at the annual meeting of the European Society for Therapeutics Radiology and Oncology in September 2002. Efaproxiral has completed phase I trials as a treatment of surgical hypoxia in elective surgery patients receiving general anaesthesia. However, no recent development has been reported for these indications. In 1994, Allos signed an agreement with CIT for the exclusive worldwide rights to 17 US patents, a European patent covering the UK, France, Italy and Germany plus two pending patents in these territories, two issued patents in Japan, and a pending patent in Canada. These patents cover methods of allosterically modifying haemoglobin with efaproxiral and other compounds, the binding site of efaproxiral and therapy in certain indications including cancer, ischaemia and hypoxia. In addition to the licensed patents from CIT, Allos exclusively owns two patent families with pending applications directed to a formulation of efaproxiral and to methods of its use in BLOD MRI (blood oxygenation level-dependent magnetic resonance imaging) applications. These patents are pending in the US, Canada and Europe, and include an international patent application. In a May 2002 interview with the Wall Street Transcript, the CEO of Allos estimated the overall market for radiation therapy to be approximately 750 000 patients/year. Of this, brain metastases, NSCLC and glioblastoma therapy accounts for about 170 000, 140 000 and 6000 patients, respectively. Allos intend to use a speciality sales force to market efaproxiral directly to radiation therapists in North America. To penetrate the non-oncology market in the US, the company will seek partnership with one or more pharmaceutical companies with direct sales forces and with established distribution systems. Allos is also hoping to secure an oncology marketing partner for non-North American territories. At the time, the company had been issued 21 patents in the US, Canada, Europe and Japan.

Aniline Compounds↗
PubMed2006

Oregovomab: anti-CA-125 monoclonal antibody B43.13--AltaRex, B43.13, MAb B43.13, monoclonal antibody B43.13.

ViRexx Medical Corp is developing the murine monoclonal antibody oregovomab [OvaRex, MAb B43.13] for the treatment of ovarian cancer. Oregovomab targets the circulating tumour-associated antigen CA 125, which is shed from the surface of human ovarian cancer cells; the antibodies induce broad cellular and humoral immune responses against CA 125 via complex formation. Unlike free CA 125, CA 125-oregovomab complexes can prime dendritic cells, leading to downstream activation of T cells. The antibody is undergoing advanced clinical development. AltaRex, the originator of oregovomab, was acquired by, and merged into, ViRexx Medical Corp in December 2004. AltaRex (now ViRexx Medical Corp) has established several strategic corporate alliances for the development and/or commercialisation of oregovomab. Unither Pharmaceuticals, a subsidiary of United Therapeutics Corporation, entered into a licensing agreement with ViRexx in April 2002. The agreement covers most territories worldwide, except Europe and the Middle East, which are covered by other agreements (see below); ViRexx did retain the rights to most member nations of the EU and certain other countries. In August 2003, the agreement was extended, granting United Therapeutics Corporation development rights for Germany. AltaRex and Dompe entered into a distribution agreement for oregovomab in July 2004. Territories included in the agreement are Italy, Spain, Portugal, Hungary, Poland, Czech Republic, Switzerland, Austria and certain other Eastern European countries. Under the terms of the agreement, ViRexx retains responsibility for product development and registration of the antibody, upon commercialisation in the agreed territory. The two companies will work closely to achieve product registration throughout Europe. In June 2001, Dompe entered into a sublicensing agreement with FAES for the commercialisation of oregovomab in Spain and Portugal. ViRexx is also seeking collaboration partners for Northern European markets. Medison Pharma and AltaRex entered into an agreement in April 2002. Under the terms of the agreement, the two companies will establish a joint venture to market oregovomab in Israel and the Middle East. ViRexx also has an agreement with Genesis Pharma covering the commercialisation of the antibody in Greece, Turkey, Cyprus and the Balkans. Unither Pharmaceuticals has completed trial enrollment for its two pivotal phase III trials investigating oregovomab for the treatment of advanced ovarian cancer. In June 2006, Unither reached its enrollment goal of 177 patients for the IMPACT II study, the second of two identical double-blind, placebo-controlled trials. The IMPACT I study achieved its enrollment target in December 2005. Both IMPACT studies are designed to assess the effect of oregovomab on time to disease relapse in patients with advanced ovarian cancer (stage III/IV) who have achieved an optimal response with front-line chemotherapy, and are being conducted at over 60 sites across the US. Data from the studies are intended to support registration of the antibody in the US. ViRexx also plans to utilise results from the IMPACT studies to support regulatory filings in Europe and in other countries. In addition, a phase II trial is being conducted to evaluate two dosing regimens of adjunctive oregovomab plus platinum-based first-line chemotherapy in patients with advanced ovarian cancer. The enrollment target of 40 patients has been achieved; primary study analysis is anticipated to be completed by the end of 2006. Several phase II trials with oregovomab as monotherapy or in combination with other chemotherapeutics have been completed across the US and Canada. Clinical trials have also been conducted in the EU, but ViRexx has suspended such EU studies on the basis of commercial considerations. Oregovomab has orphan drug status for the treatment of ovarian cancer; designation was granted by the US and the EU in 1996 and 2002, respectively. In addition, the US FDA granted fast-track status to the antibody in 1998. AltaRex (now ViRexx Medical Corp) has been awarded the US patent covering the company's technology for administering a low dose of foreign antibody to patients expressing the CA 125 antigen. A second US patent has also been issued for oregovomab covering the technique of photoactivation using ultraviolet light to modify antibodies and enhance specific beneficial immune responses. Furthermore, AltaRex was granted a 'multi-epitopic' patent application covering oregovomab by the European Patent Office (EPO) in October 2003. The patent covers the company's technology of IV administration of a low-dose foreign antibody, such as oregovomab, to patients expressing the target tumour-associated antigen CA 125. The EPO's grant of the patent for the European Union enables intellectual property protection of oregovomab in the great majority of worldwide markets.

Animals↗
PubMed1999

Globalization, pharmaceutical pricing, and South African health policy: managing confrontation with U.S. firms and politicians.

Brewing since the advent of South African democracy in 1994 and promises of health sector transformation, an extraordinary drug war between President Nelson Mandela's African National Congress government and U.S. pharmaceutical manufacturers took on global proportions in 1998-1999. Within months of the passage of South African legislation aimed at lowering drug prices, the U.S. government quickly applied powerful pressure points to repeal a clause allowing potential importation of generic substitutes and imposition of compulsory licensing. At stake were not only local interpretations of patent law and World Trade Organization rules on Trade in Intellectual Property, but international power relations between developing countries and the pharmaceutical industry. In reviewing the ongoing debate, this article considers post-apartheid public health policy, U.S. government pressure to change the law, and pharmaceutical industry interests and links to the U.S. government, and evaluates various kinds of resistance to U.S. corporate and government behavior. The case thus raises--not for the first time--concerns about contemporary imperialism ("globalization"), the role of the profit motive as an incentive in vital pharmaceutical products, and indeed the depth of "democracy" in a country where high-bidding international drug firms have sufficient clout to embarrass Vice President Al Gore by pitting him against the life-and-death interests of millions of consumers of essential drugs in South Africa and other developing countries.

Conflict, Psychological↗
PubMed2003

Uneven health outcomes and political resistance under residual neoliberalism in Africa.

Africa has suffered two decades of policy implementation associated with the "neoliberal" macroeconomic as well as micro-development paradigm, and the health status of this continent has deteriorated markedly. Notwithstanding the discrediting of such policies since the late 1990s, they continue to be applied in Africa, especially by the World Bank and IMF, through Poverty Reduction Strategy Papers and the Highly Indebted Poor Countries debt relief initiative. Evidence can be found in the inadequate fiscal allocations to the health sector; the inadequate conceptualization of health in relation to other sectors; insufficient consultation with civil society; ongoing implementation of cost-recovery and user-fee provisions; a failed strategy to access pharmaceutical products, by respecting unnecessary Trade in Intellectual Property Rights provisos; and, most importantly, glaring insufficiencies in reducing Africa's foreign debt. One reflection of the balance of forces between Washington financial agencies and African societies is the adoption of the New Partnership for Africa's Development at the urging of the South African and Nigerian governments. While the WHO has helped to research, publicize, and criticize the problems associated with durable neoliberalism in African health care, it also continues to make serious mistakes as it remains locked within the paradigm. A human rights perspective being developed by the African Social Forum is, in contrast, consistent with broader international trends in the opposition to corporate globalization.

Africa↗
PubMed2002

Genomics, health, and society.

On June 27, 2001, the World Health Organization conducted hearings in Geneva for a Special Report on Genomics & Health. Initially intended as a document to address the ethical, legal, and social implications of the gathering genomics resolution (ELSI), the terms of reference of the report were significantly modified to give primary emphasis to a scientific and technological assessment of the implications of genomics for human health. The Citizens' Health Initiative, one of two NGOs invited to make submissions at these consultations, suggested that no less important than the scientific and technical assessment was a perspective which gave due attention to the social context and political economy of scientific/technological development and its deployment. The article below touches upon neglected health priorities of poor countries, intellectual property rights and patents, risk management, insurance and discrimination, and predictive (prenatal) testing, reproductive choice, and eugenics.

Journal Article↗
PubMed2006

A case analysis of INFOMED: the Cuban national health care telecommunications network and portal.

BACKGROUND: The Internet and telecommunications technologies contribute to national health care system infrastructures and extend global health care services markets. The Cuban national health care system offers a model to show how a national information portal can contribute to system integration, including research, education, and service delivery as well as international trade in products and services. OBJECTIVE: The objectives of this paper are (1) to present the context of the Cuban national health care system since the revolution in 1959, (2) to identify virtual institutional infrastructures of the system associated with the Cuban National Health Care Telecommunications Network and Portal (INFOMED), and (3) to show how they contribute to Cuban trade in international health care service markets. METHODS: Qualitative case research methods were used to identify the integrated virtual infrastructure of INFOMED and to show how it reflects socialist ideology. Virtual institutional infrastructures include electronic medical and information services and the structure of national networks linking such services. RESULTS: Analysis of INFOMED infrastructures shows integration of health care information, research, and education as well as the interface between Cuban national information networks and the global Internet. System control mechanisms include horizontal integration and coordination through virtual institutions linked through INFOMED, and vertical control through the Ministry of Public Health and the government hierarchy. Telecommunications technology serves as a foundation for a dual market structure differentiating domestic services from international trade. CONCLUSIONS: INFOMED is a model of interest for integrating health care information, research, education, and services. The virtual infrastructures linked through INFOMED support the diffusion of Cuban health care products and services in global markets. Transferability of this model is contingent upon ideology and interpretation of values such as individual intellectual property and confidentiality of individual health information. Future research should focus on examination of these issues and their consequences for global markets in health care.

Computer Communication Networks↗
PubMed2006

A human rights approach to the WHO Model List of Essential Medicines.

Since the first WHO Model List of Essential Medicines was adopted in 1977, it has become a popular tool among health professionals and Member States. WHO's joint effort with the United Nations Committee on Economic, Social and Cultural Rights has resulted in the inclusion of access to essential medicines in the core content of the right to health. The Committee states that the right to health contains a series of elements, such as availability, accessibility, acceptability and quality of health goods, services and programmes, which are in line with the WHO statement that essential medicines are intended to be available within the context of health systems in adequate amounts at all times, in the appropriate dosage forms, with assured quality and information, and at a price that the individual and the community can afford. The author considers another perspective by looking at the obligations to respect, protect and fulfil the right to health undertaken by the states adhering to the International Covenant of Economic, Social and Cultural Rights (ICESCR) and explores the relationship between access to medicines, the protection of intellectual property, and human rights.

Drugs, Essential↗
PubMedDate not supplied

[Chiral switch: towards a better benefit-risk ratio?].

The chirality of drugs has emerged as a major theme in drug design, discovery, development and intellectual property. Single enantiomers offer some advantages and two options are available: the switch from an existing racemic drug to the single enantiomer or the development of an enantiomerically pure chiral drug. At present, the second possibility is systematically considered. The possibility of chiral switch has led to innovative drugs. However, this opportunity may be limited by several factors: the spontaneous interconversion of the two enantiomers, the pharmacokinetic profile or the selective toxicity of the most active enantiomer, and the difficulty of demonstrating the clinical superiority of one enantiomer over the racemate. Finally, the small size of the market, the policies of the drug agencies and/or the patent problem also limit the development of enantiomers. All these factors have led the pharmaceutical industry to develop new galenic forms rather than enantiomers when the patent of the racemate is expiring.

Drug Design↗
PubMed1993

Patents for genetically modified animals.

Should genetically engineered animals be patented? This issue has been one of the most contentious as lawmakers have grappled with how best to protect intellectual property. Since the 1980 case of Diamond v. Chakrabarty, in which the U.S. Supreme Court ruled that a living microorganism is patentable, the U.S. Patent and Trademark Office has determined that plants and nonhuman animals can be patented. These policy decisions have led to congressional debate on whether animals should be patentable subject matter. Patenting of living organisms is unique for three reasons: the invention itself is alive; the invention in some instances can reproduce itself; and the invention sometimes cannot be adequately described for patent specification purposes, leading to the need for deposit of the invention for patent purposes.

Animals↗