摘要:

ObjectiveTo investigate the effect of the red vine leaf extract AS 195 on cutaneous microvascular blood flow, transcutaneous oxygen pressure (tcpO2), and leg oedema in patients with chronic venous insufficiency (CVI).Design and patientsThe study was a randomised, double-blind, placebo-controlled, crossover trial for which 129 men and women, aged ≥18 years, with CVI stage I or II were screened. Seventy-one fulfilled the inclusion criteria and were randomised.InterventionsA total of 71 patients were divided into two groups. The first group (n = 36) received AS 195 360mg once daily during a first 6-week treatment period, followed by a 4-week placebo washout period and then placebo during the second 6-week treatment period. The second group (n = 35) started with placebo and received AS 195 360mg after the placebo washout. The cutaneous microvascular blood flow in the malleolar region was measured using a newly developed laser Doppler device. TcpO2was measured using a solid-state electrode.ResultsAfter 6 weeks, patients in the AS 195 group had increased microvascular blood flow values (+241.8 ± 18.7 arbitrary units [AU] versus a decrease of –41.0 ± 18.7AU in the placebo group; p < 0.0001). Oxygen increased to 1.35 ± 0.97mm Hg (placebo: decrease of –7.27 ± 0.97mm Hg; p < 0.0001). After 6 weeks of treatment the leg circumference was decreased (ankle level: by –0.39 ± 0.09cm versus +0.29 ± 0.09cm; p < 0.0001; calf level: by –0.54 ± 0.05cm versus +0.14 ± 0.05cm; p < 0.0001).ConclusionThe administration of AS 195 improved objective symptoms of CVI and may prevent CVI deterioration.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

ObjectiveSolifenacin succinate (YM905; Vesicare®) is a promising new bladder selective muscarinic receptor antagonist under investigation for the treatment of overactive bladder. This study was designed to assess the absolute bioavailability of a single oral dose of solifenacin 10mg, which is twice the suggested starting dose.Study designSingle-centre, open-label, randomised, two-period, crossover, single-dose study.MethodsSolifenacin was administered orally as a 10mg dose and intravenously as a 5mg dose. Oral and intravenous (IV) doses were divided by a washout period of ≥14 days.Study participantsThe study group consisted of 12 healthy young men, aged 20−45 years, nine of whom completed the study.ResultsThe pharmacokinetic analysis comprised nine subjects. A single oral dose of solifenacin 10mg had a high absolute bioavailability of 88.0% (95% confidence interval 75.8, 102.1), low clearance (9.39 L/h [SD 2.68]), and an extensive mean volume of distribution at steady state (599L [SD 86]). Only 7% of solifenacin was excreted intact in the urine. Single oral and IV administration of solifenacin was well tolerated in this study. The most common adverse events related to drug treatment were headache and somnolence.ConclusionsPharmacokinetic analyses of single oral and IV doses of solifenacin demonstrated that the drug has a high absolute oral availability of 88%. This finding suggests that solifenacin may have a higher and less variable bioavailability than other antimuscarinic agents.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

AE 941 [Arthrovas™, Neoretna™, Psovascar™] is shark cartilage extract that inhibits angiogenesis. AE 941 acts by blocking the two main pathways that contribute to the process of angiogenesis, matrix metalloproteases and the vascular endothelial growth factor signalling pathway.When initial development of AE 941 was being conducted, AEterna assigned the various indications different trademarks. Neovastat™ was used for oncology, Psovascar™ was used for dermatology, Neoretna™ was used for ophthalmology and Arthrovas™ was used for rheumatology. However, it is unclear if these trademarks will be used in the future and AEterna appears to only be using the Neovastat™ trademark in its current publications regardless of the indication.AEterna Laboratories signed commercialisation agreements with Grupo Ferrer Internacional SA of Spain and Medac GmbH of Germany in February 2001. Under the terms of the agreement, AEterna has granted exclusive commercialisation and distribution rights to AE 941 in oncology to Grupo Ferrer Internacional for the Southern European countries of France, Belgium, Spain, Greece, Portugal and Italy. It also has rights in Central and South America. Medac GmbH will have marketing rights in Germany, the UK, Scandinavia, Switzerland, Austria, Ireland, the Netherlands and Eastern Europe.In October 2002, AEterna Laboratories announced that it had signed an agreement with Australian healthcare products and services company Mayne Group for marketing AE 941 (as Neovastat™) in Australia, New Zealand, Canada and Mexico.In March 2003, AEterna Laboratories announced it has signed an agreement with Korean based LG Life Sciences Ltd for marketing AE 941 (as Neovastat™) in South Korea. The agreement provides AEterna with upfront and milestone payments, as well as a return on manufacturing and sales of AE 941.[1]AEterna Laboratories had granted Alcon Laboratories an exclusive worldwide licence for AE 941 for ophthalmic products. However, this licence has been terminated.In 1999, AEterna secured funding for AE 941, part of which is from Technology Partnerships Canada (TPC), a research support programme run by Canada's federal government. Industry Canada will contribute $Can1 for every $Can3 spent by AEterna on the development of AE 941, up to a total figure of $Can29.4 million. AEterna will reimburse TPC upon commercialisation of AE 941-derived products as a royalty on income generated.In January 2004 AEterna announced that development of AE 941 would be focusing on non-small cell lung cancer and that development for renal cell carcinoma would be discontinued.[2]AEterna had previously announced in January 2003, following its acquisition of Zentaris, that development of AE 941 would be "strictly focused" on renal and non-small cell lung cancer, suggesting that development for all other indications has been discontinued, at least for the foreseeable future.In May 2002, in its Annual Information Form, AEterna announced that resources or collaborations would be required before further development of indications other than cancer could take place. The company also announced the discontinuation of development in the area of arthritis at that time.Initiated in May 2000, this phase III trial is being led by researchers from the MD Anderson Cancer Center in Houston, Texas, USA. In addition, enrolment at approximately 70 other sites in the US and Canada was scheduled to begin in 2001. This randomised, controlled study will evaluate the efficacy of AE 941 as adjunctive treatment to standard chemotherapy and radiotherapy. The study is expected to enrol 760 patients, with trial completion targeted for 2005. The Radiation Therapy Oncology Group (RTOG) has joined the Community Clinical Oncology Programme (CCOP) in recruiting patients and in the execution of the phase III trial in NSCLC. The commitment of these two groups in the trial will complement the support provided by the MD Anderson Cancer Center and the NCI.AEterna signed a Clinical Trials Agreement (CTA) with the NCI for the realisation of another pivotal phase III clinical trial of AE 941 for the treatment of NSCLC in combination with chemo- and/or radiotherapy. The trial was initiated in early 1999 and will enrol up to 550 patients in the US and Canada.Phase I/II Canadian and US trials of AE 941 have been completed for the treatment of refractory lung cancer (n = 80).Previously, AEterna had reported results of an open-label, phase I/II study in patients with NSCLC at the 10th European Cancer Conference in Vienna (ECCO-1999) in September 1999. The results were published in early 2003 inClinical Lung Cancer.In October 2003, AEterna reported that AE 941 did not meet its primary endpoint of improving survival time in its phase III trial of AE 941 in patients with renal cell carcinoma. However, significant survival advantage was observed in a subgroup of healthier patients with clear cell histology and only a single metastatic site. This 38-patient subgroup showed a median survival time of 26.3 months for those treated with AE 941 compared with 12.6 months for patients receiving a placebo. In June 2003, AEterna reported that the number of deceased patients was 218.[3]Enrolment of patients into this pivotal phase III was completed in December 2001 at approximately 50 sites in the US, Canada, Belgium, France, Germany, the UK, Czech Republic, Poland and Argentina. AEterna has completed a planned safety analysis of the renal cancer trial (conducted by the Data Safety Monitoring Board), with positive results reported. AEterna announced in June 2002 that it expected the study to be completed in <12 months.The US FDA granted orphan drug status to AE 941 for the treatment of renal cell carcinoma in October 2002. AEterna had hoped to launch the drug for renal cancer in 2004.AEterna has been issued with four key patents (nos. 6 168 807, 5 618 925, 5 985 839 and 6 025 334) from the US Patent and Trademark Office, protecting AE 941, the process by which it is manufactured and the medical uses of the product in several therapeutic areas.AEterna has isolated a series of potent anti-angiogenic molecules from AE 941 and has filed a patent application with the US Patent and Trademark Office related to this finding.In a report published by BLC Securities (Laurentian Bank) on AEterna Laboratories (9 March 2000) it was stated that the US market launch of Neo-vastat™, as a second-line therapy for renal cell cancer, is expected to occur in the second quarter of 2002, while launch as an adjunctive therapy for non-small cell lung cancer is expected to happen in the first quarter of 2004. Sales in Europe are forecast to begin 1 year after the US launch, with a launch in the rest of the world 2 years after the initial launch.The worldwide market for adjuvant/supportive care therapies is expected to reach $US5.1 billion in 2002, and is an important market for AEterna, according to BLC Securities, since Neovastat™ is being developed as an adjunctive therapy to standard non-small cell lung cancer therapy. BLC Securities expects AEterna to sign a licensing agreement for Neovastat™ during 2000 for the marketing and distribution of the product in North America. If a strategic partner is found, it could bring AEterna $US35 million in licensing fees and milestone payments. In the report, royalty rates on worldwide sales are set at 15% (oncology) and 8% (dermatology).AEterna reported a net loss of $US1.9 million during the first quarter of 1999, which it attributed to the cost of setting up the phase III trial for the treatment of non-small cell lung cancer in combination with chemo- and/or radiotherapy.In the same report published by BLC Securities (Laurentian Bank) on AEterna Laboratories on 9 March 2000, it was stated that the US market launch of AE 941 – Psovascar is expected to occur in the fourth quarter of 2004, followed by a launch in Europe and the rest of the world 1 and 2 years, respectively, after the initial launch. BLC Securities is forecasting a maximum market penetration for the product of 4%, based on a highly competitive psoriasis market. The report also stated that the annual therapy price had been set to $US2500, reflecting the facts that AE 941 – Psovascar is seen as an adjunct to existing therapies and “given the likelihood that the treatment will be a rotating therapy”. More than 6.4 million people are estimated to suffer from psoriasis in the US, according to the report quoting the US National Psoriasis Foundation (NPF), with more than 200 000 new cases every year; over 100 million people are affected by the disease worldwide.In addition, the report published by BLC Securities (Laurentian Bank) on AEterna Laboratories on 9 March 2000 stated that the wet age-related macular degeneration (AMD) market is estimated to be worth $US1.5 billion, based on patients paying $US9000–$US12 000 per year on a lifetime basis. The report states that 1.7 million Americans >65 years of age were estimated to have AMD in 1997, with 200 000 new cases being diagnosed every year. For this forecast, BLC Securities is quoting sources such as QLT Phototherapeutics, Miravant, The US National Eye Institute, NIH and The American Macular Degeneration Foundation. QLT Phototherapeutics and Miravant expects AMD phototherapy to cost $US3000 per treatment, with at least three or four treatments necessary to maintain the results of treatment with Visudyne™.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

An intranasal spray formulation of recombinant salmon calcitonin [salcatonin] is in development with Unigene Laboratories as therapy for postmenopausal osteoporosis.Calcitonin is an endogenous polypeptide hormone that regulates calcium and bone metabolism. It is produced by the parafollicular cells of the thyroid gland in humans and other species. Calcitonin inhibits bone loss through the suppression of osteoclast activity. Salmon calcitonin is approximately 40–50 times more potent than natural human calcitonin at inhibiting osteoclast function. It can be obtained naturally from salmon or can be synthesised with the same chemical structure. Calcitonin was originally available only as an injectable formulation, but in recent years more convenient formulations have become available.Unigene is actively seeking to license its intranasal calcitonin product in Europe and other territories outside the US.nigene licensed its intranasal calcitonin product to Upsher-Smith Laboratories in December 2002, under a $US10 million exclusive US licensing agreement. Under the terms of the agreement, Unigene received an upfront payment of $US3 million from Upsher-Smith and will be eligible to receive milestone payments and royalty payments on product sales. Unigene will be responsible for manufacturing the product at its Boonton facility in New Jersey, USA, and will sell finished calcitonin product to Upsher-Smith. Upsher-Smith will package, market and distribute the product nationwide.[1,2]Unigene granted an exclusive license to Faran Laboratories in September 2003 for its intranasal calcitonin osteoporosis product in Greece. Unigene will sell the finished product to Faran, who will promote and market it throughout the country after Unigene obtains European regulatory approval and local pricing approval. Unigene will receive an upfront payment and is eligible to receive milestone payments prior to product launch. Faran will pay Unigene a fixed price for each unit of product received.[3]Qingdao General Pharmaceutical Company was a licensee for Unigene's injectable and intranasal calcitonin products in the People's Republic of China, and Unigene had received initial payments from Qingdao General Pharmaceutical in 1996. However, in June 2000, Unigene announced that it has entered into a joint venture with Shijiazhuang Pharmaceutical Group Company for the manufacture and distribution of injectable and intranasal calcitonin for the treatment of osteoporosis in China. Unigene initially will be responsible for supplying bulk calcitonin manufactured in its production facility in New Jersey and the joint venture will be responsible for filling, packaging, promoting and marketing the products. Unigene owns 45% of the contractual joint venture.Unigene is also developing oral and injectable formulations of calcitonin.In January 2004, Unigene announced it had received an approvable letter from the US FDA to market its calcitonin intranasal spray for the treatment of osteoporosis. The letter indicates that the FDA will approve the NDA upon finalisation of the labelling and resolution of specific remaining issues, including the submission of additional information and clinical data.[4]Unigene filed the NDA in March 2003.[5]Using the results from a pilot study completed in the UK, Unigene filed an IND with the FDA and began clinical testing of this intranasal calcitonin in the US. Clinical studies were successfully completed by year end 2001, demonstrating significant bone marker activity and similar serum concentrations between this product and that of an existing nasal calcitonin product.The European Union's regulatory authority, the Committee for Proprietary Medicinal Products (CPMP), has confirmed the efficacy of calcitonin formulations for the treatment of postmenopausal osteoporosis and other bone disorders. The CPMP has recommended revisions to and harmonisation within the European Union of the authorised indications for calcitonin formulations. The CPMP has determined that authorised indications for intranasal calcitonin will be approved for “treatment of established post-menopausal osteoporosis in order to reduce the risk of vertebral fractures”, and new prescribing information will clarify that intranasal calcitonin does not appear to reduce the number of hip fractures. These recommendations will be implemented in the near future and will eliminate discrepancies between countries and between formulations.[6]The Chinese regulatory authorities have granted Unigene an import license for calcitonin, and Unigene and Shijiazhuang have submitted an NDA in China. If this NDA is approved, the joint venture will have up to 6 years' market exclusivity for intranasal and injectable calcitonin.[7]Unigene was granted a US patent for the intranasal formulation of calcitonin in 2002.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Conivaptan [YM 087], a benzazepine derivative, belongs to a series of highly potent, orally active arginine vasopressin V1and V2receptor antagonists that are being developed by Yamanouchi.Yamanouchi licensed conivaptan to Warner-Lambert for co-development and marketing in the Americas, Europe and Africa. In return, Yamanouchi has rights to market atorvastatin in Japan. In June 2000, Warner-Lambert merged with Pfizer. The resulting company retained the Pfizer name. However, Yamanouchi and Pfizer discontinued the co-development and marketing agreement for conivaptan. Yamanouchi is continuing the independent development of conivaptan in the US and Europe.Yamanouchi is developing an oral drug delivery formulation of conivaptan for administration in patients with chronic heart failure. The company has initiated the ADVANCE (A Dose evaluation of a Vasopressin ANtagonist in CHF patients undergoing Exercise) trial, a double-blind, multicentre trial in which 345 patients with heart failure will receive placebo or one of three doses of conivaptan for 12 weeks and their functional capacity will be assessed.[1]Conivaptan demonstrated a potent diuretic effect in animal studies.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Mitiglinide [KAD 1229, S 21403], a derivative of benzylsuccinic acid, is a potassium channel antagonist undergoing development with Kissei for the treatment of type 2 diabetes mellitus. It has potent oral hypoglycaemic activity and is structurally different from the sulphonylureas, although it stimulates calcium influx by binding to the suphonylurea receptor on pancreatic β-cells and closing K+ATPchannels.Mitiglinide belongs to a family of meglitinide analogues that also includes repaglinide and nateglinide.Mitiglinide is licensed to Servier for Europe, where it is undergoing phase III development, and for Russia, the Commonwealth of Independent States, the Baltic Republics, the Middle East, Oceania, China (including Hong Kong) and Taiwan.Kissei exclusively licensed mitiglinide to Choongwae Pharma for South Korea in March 2003.In August 2002, Kissei and Takeda entered into a co-marketing agreement for mitiglinide in Japan. The companies will co-market the agent under a single brand name.[1]Mitiglinide was licensed to Purdue Pharma for the US, Canada, Mexico and Central and South America. However, Kissei and Purdue Pharma terminated their agreement in February 2001 following Purdue Pharma's decision to concentrate on core areas such as oncology and analgesics. Kissei's US subsidiary, Kissei Pharma US, is currently carrying on the ongoing phase II clinical development in the US. However, in its Annual Report 2003, Kissei announced that it is considering outlicensing mitiglinide for development in marketing in North America.Mitiglinide has been recommended for approval in Japan for the management of postprandial hyperglycaemia in patients with type 2 diabetes.[2]Kissei is also conducting phase II/III clinical trials with a combination of mitiglinide and an α-glucosidase inhibitor (additional indication) in patients with type 2 diabetes in Japan.In the US, the agent is being evaluated in phase II clinical trials with Kissei Pharma USA.Mitiglinide is also undergoing a phase-III, 12-month, multicentre, randomised, double-blind study in a total of 710 patients in comparison with repaglinide for the treatment of type 2 diabetes. This study will be followed by a 12-month open-label treatment with mitiglinide alone or in combination therapy.Servier (Australia) conducted a randomised, double-blind, multicentre phase III study in Australia comparing mitiglinide with metformin or a combination of the two for the treatment of type 2 diabetes.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Natalizumab [AN 100226, anti-α4integrin monoclonal antibody, Antegren®] is a humanised monoclonal antibody that blocks α4β1integrin-mediated leukocyte migration. Natalizumab is in phase III trials for the treatment of multiple sclerosis in North America and the UK, and for the treatment of Crohn's disease also in the UK. It may have potential in the treatment of other immune-related inflammatory disease. Elan Corporation intends to examine the potential of natalizumab in rheumatoid arthritis and ulcerative colitis.4β1 integrin on circulating leukocytes binds to vascular cell adhesion molecule-1, which is expressed at high levels in the blood vessels in the CNS during exacerbations of multiple sclerosis. This allows leukocytes expressing α4β1 integrin (very late antigen-4) to move from the peripheral blood into the CNS. Inflammatory proteins and other factors released from lymphocytes in the brain lead to the progression of symptoms.A limitation of natalizumab is that it must be injected and cannot be administered orally. Scientists have transformed the large anti-α4 monoclonal antibody into much smaller, drug-like molecules suitable for oral administration.Protein Design Labs has granted a worldwide nonexclusive licence under its antibody humanisation patents to Elan Pharmaceuticals for natalizumab. Biogen Inc. has entered into an agreement with Elan for a worldwide exclusive collaboration to develop, manufacture and commercialise natalizumab for multiple sclerosis and Crohn's disease and rheumatoid arthritis. Development of natalizumab is also being funded, in part, by Axogen (acquired by Elan in 1999). In November 2003, Biogen and IDEC Pharmaceuticals merged to form Biogen Idec. Elan repurchased royalty rights on a package of products, including natalizumab, from Autoimmune Disease Research Company.Elan and Genzyme Transgenics Corporation signed an agreement to produce natalizumab in GTC's genetically engineered goats, which will express the compound in their milk. Genzyme Transgenics Corporation changed its name to GTC Biotherapeutics in June 2002; it is no longer a subsidiary of Genzyme Corporation.Following discussions with the US FDA, Elan completed enrolment in a second phase III trial, involving approximately 420 patients with Crohn's disease. This Evaluation of Natalizumab as Continuous Therapy-2 (ENACT-2) trial evaluated the effect of natalizumab on duration of response and remission in patients with Crohn's disease. In January 2004, Elan Corporation and Biogen Idec announced that the phase III, ENACT-2 maintenance trial of natalizumab in Crohn's disease met the primary endpoint of maintenance of response. Elan and Biogen Idec will discuss these data with regulatory authorities in both the US and Europe and determine the appropriate path forward for natalizumab in Crohn's disease.[1]An NDA for Antegren®in Crohn's disease was expected to be filed at the end of 2003; however, due to failing to meet the primary endpoint in the induction trial, Elan is unable to predict when and if a regulatory filing will be made.Earlier, on 23 January 2001, theWall Street Journalreported that the Biogen CEO expects Antegren®to become ablockbusterdrug, with sales of at least $US1 billion. He also predicted that Antegren®could be on the market as early as 2003 for the indication of Crohn's disease and in 2004 for multiple sclerosis. TheJournalstated that Biogen is under pressure to develop new drugs since its flagship product Avonex®will be losing its US Orphan Drug Act protection in 2003. Antegren®has a different mechanism to that of Avonex®and could be used either alone or as a combination therapy.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Samaritan Pharmaceuticals (formerly Steroidogenesis Inhibitors) is developing a high-dose oral stabilised formulation of procaine hydrochloride [Anticort™SP 01, SP001, Virucort™] as an anticortisol drug for the treatment of HIV and AIDS. Preclinical investigations for its potential in the treatment of patients with Alzheimer's disease are also underway with Samaritan.The levels of cortisol, a hormone produced by the adrenal gland, are increased in many diseases, including AIDS. Serum cortisol levels are elevated during all stages of HIV infection, particularly in AIDS patients, whereas dehydroepiandrosterone (DHEA) levels are higher in the early stages of disease rather than in the advanced stages. Anticortisol drugs have been shown to reduce both the infectivity and the production of HIVin vitro.Anticort™is available for licensing. Altachem Pharma had an exclusive licence to manufacture, use, distribute and sell oral procaine in Canada with an option to purchase the same rights for other Commonwealth countries. However, this agreement has been terminated. Cato Research in the US has been enlisted to implement a long-range clinical and business development plan to facilitate US FDA approval and manufacturing of the procaine formulation worldwide. Altachem Pharma received approval to begin a phase I trial of Anticort™in Canada in HIV-positive patients receiving anti-HIV treatment.In January 2004, Cortisol Research International-Romania filed for orphan drug designation with the US FDA for Virucort™ 50 for the treatment of depression in children with HIV.[1]A study examining the efficacy of Anticort™in children infected with HIV has been conducted in Romania. One aspect of this study will investigate the possibility of reducing the dosage of zidovudine required if it is used in combination with Anticort™. Following early indications that children treated with placebo in this trial have deteriorated while some children under the Anticort™have shown improvements, especially in the 150–200mg group, Romanian clinicians have asked the Romanian FDA Commissioner for approval to switch children receiving placebo to receive Anticort™.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

GTC Biotherapeutics (formerly Genzyme Transgenics Corporation) is developing a transgenic form of antithrombin III known as recombinant human antithrombin III [rhATIII]. It is produced by inserting human DNA into the cells of goats so that the targeted protein is excreted in the milk of the female offspring. The transgenic goats have been cloned in collaboration with the Louisiana State University Agriculture Center. GTC Biotherapeutics is conducting clinical trials of rhATIII in coagulation disorders. rhATIII is believed to be both safer and more cost-effective than the currently available plasma-derived product. rhATIII is also being investigated in cancer and acute lung injury.Genzyme Transgenics Corporation, originally a subsidiary of Genzyme Corporation, changed its name to GTC Biotherapeutics in June 2002; it is no longer a subsidiary of Genzyme Corporation. GTC Biotherapeutics is seeking partners for the commercialisation of rhATIII. Restructuring of GTC Biotherapeutics to support its commercialisation programmes was announced in February 2004.[1]Genzyme Transgenics Corporation was developing rhATIII in association with Genzyme General (Genzyme Corporation) in the ATIII LLC joint venture, but in November 2000 a letter of intent was signed for the reacquisition of the rights by Genzyme Transgenics Corporation. It was announced in February 2001 that this reacquisition was not going to be completed and that the development of rhATIII was to continue with ATIII LLC. However, in July 2001, Genzyme Transgenics Corporation reacquired all the rights in the transgenic antithrombin III programme.SMI Genzyme Ltd, a joint venture between Sumitomo Metal Industries, Japan, and Genzyme Transgenics Corporation, USA, was set up to fund development of transgenic antithrombin III in Asia. However, in October 2000, Genzyme Transgenics Corporation reacquired, from Sumitomo Metal Industries, the rights to its technology for production of medicines from milk in 18 Asian countries, including Japan. The 10-year-old joint venture, SMI Genzyme Ltd, was dissolved.In June 2002, GTC Biotherapeutics estimated the current market size for plasma ATIII products to be approximately $US250 million – of which sales in Europe amounted to $US110 million, Japan $US130 million and the US $US10 million.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

GlaxoSmithKline is developing a two-dose, oral rotavirus vaccine [Rotarix™] under a licensing agreement with AVANT Immunotherapeutics. Rotarix™ is a live attenuated human rotavirus strain, which was developed by AVANT in collaboration with the JN Gamble Institute of Medical Research in the US. Originally, the research partner for the JN Gamble Institute was the Virus Research Institute, but the latter company merged with T Cell Sciences in August 1998 to form AVANT Immunotherapeutics.In 1997, AVANT signed an agreement with SmithKline Beecham (now GSK) for collaboration in the development of Rotarix™. In December 2000 SmithKline Beecham merged with Glaxo Wellcome to form GlaxoSmithKline (GSK). The agreement grants GlaxoSmithKline exclusive worldwide marketing rights to the vaccine in exchange for royalties, licence fees and milestone payments to AVANT. Under the agreement, GlaxoSmithKline assumed all responsibilities for the development and manufacture of the vaccine following the successful completion of the US phase II study of Rotarix™, for which AVANT received a milestone payment from GlaxoSmithKline.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS