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At least 19 recordsLinked to original sources
PubMed2001

SB-271046 (SmithKline Beecham).

SmithKline Beecham is developing the 5-HT6 antagonist, SB-271046, as a potential cognition enhancer. By December 1999, phase I trials had commenced [360354]. This drug was originally being developed primarily for the treatment of shizophrenia [284490], however, cognitive disorders, including but not limited to Alzheimer's disease, have been the main target since 1998 [394309]. SB-271046 is a potent, selective 5-HT6 antagonist with a pKi value of 8.9 [333710]. SB-258585, also known as 4-iodo-N-[4-methoxy-3-(4-methylpiperazin-1-yl)phenyl]benzenesulfonamide is an analog of SB-271046 [322488]. Data recently presented at the Society for Neuroscience annual meeting in November 2000 demonstrated that administration of SB-271046 resulted in a signficant increase in glutamate and aspartate levels in the frontal cortex, without affecting noradrenaline, dopamine or 5-HT levels. This was stated to suggest that 5-HT6 antagonists might therefore be useful for treating cognitive dysfunction [390469]. The drug has also been radiolabeled in order to provide an assay for estimating in vivo 5-HT6 receptor occupancy [390470].

Animals↗
PubMed1999

Ariflo (SmithKline Beecham plc).

Ariflo (SB-207499) is a phosphodiesterase (PDE)4 inhibitor under development by SmithKline Beecham and in phase III and II clinical trials as a potential treatment for chronic obstructive pulmonary disease (COPD) and asthma, respectively [284490]. It has commenced phase II trials as a treatment for bronchial asthma in Japan [248285,300145]. In February 1999, Merrill Lynch predicted that Ariflo would be launched by the end of 2000 or early 2001 with first year sales of UK pounds sterling 25 million rising to UK pounds sterling 175 million in 2003 [300257,314372]. In February 1999 ABN Amro predicted sales of UK pounds sterling 52 million in 2001 rising to UK pounds sterling 254 million in 2005 [317577,328676].

Journal Article↗
PubMedDate not supplied

How SmithKline Beecham makes better resource-allocation decisions.

Major resource-allocation decisions are never easy. For a pharmaceuticals company like SmithKline Beecham, the problem is this: How do you make good decisions in a high-risk, technically complex business when the information you need to make those decisions comes largely from the project champions who are competing against one another for resources? In 1993, the company experimented with ways of depoliticizing the process and improving the quality of decision making. In most resource-allocation processes, project advocates develop a single plan of action and present it as the only viable approach. In SB's new process, the company found an effective way to get around the all-or-nothing thinking that only reinforces the project-champion culture. Project teams were required--and helped--to create meaningful alternatives to current development plans. What would they do with more money? With less? With none at all? In another important departure from common practice, SB separated the discussion of project alternatives from their financial evaluations. In doing so, SB was able to avoid the premature evaluations that kill both creativity and the opportunity to improve decision making. The new process at SB has allowed the organization to spend less time arguing about how to value its R&D projects and more time figuring out how to make them more valuable. In the end, the company learned that by tackling the soft issues around resource allocation--such as information quality, credibility, and trust--it had also addressed the hard ones: how much to invest and where to invest it.

Decision Making, Organizational↗
PubMed1996

Use of a reformulated Oka strain varicella vaccine (SmithKline Beecham Biologicals/Oka) in healthy children.

UNLABELLED: The first live-attenuated Oka strain varicella vaccines needed to be stored at -20 degrees C. Reformulation of this vaccine by SmithKline Beecham Biologicals has provided a vaccine shelf life of up to 2 years when stored at +4 degrees C to +8 degrees C. In this study the immunogenicity and reactogenicity of two different production lots of this reformulated vaccine at two different titres each, which corresponded to the release and expected expiry titres, were evaluated. A double-blind randomised clinical trial was conducted in healthy children aged from 9 to 24 months. Immunogenicity was assessed by the measurement of varicella specific antibodies in paired serum samples taken before and from 35 to 63 days post vaccination. Reactogenicity was assessed by the evaluation of any untoward reactions occurring up to 42 days post vaccination. In order to assess protective efficacy, parents of these subjects were contacted approximately 6 months after completion of the trial. One hundred and ninety-one subjects were recruited into the study. Of the 181 initially seronegative subjects who completed the trial according to the protocol, 179 showed seroconversion (98.9%). Reactions to the vaccine were minor and observed in 46/191 (24%) of subjects. Rashes were present in 19, fever in 22, and both fever and rash in 5. Rashes were mainly maculo-papular in nature but were vesicular in 6. Febrile reactions were shortlived. After a 6-month follow up period, attenuated varicella with minor clinical symptoms was diagnosed in 6/52 vaccinees who had close contact with natural varicella (attack rate = 11.5%). CONCLUSION: This reformulated vaccine was well tolerated, highly immunogenic and provided protection against varicella. In increased stability allowing refrigerator storage makes it a good candidate for mass vaccination programmes.

Antibodies, Viral↗
PubMed1992

The SmithKline Beecham 'quality of life' scale: a validation and reliability study in patients with affective disorder.

The rationale for the development of Repertory-Grid based quality of life assessment (QOL) is described. The emergent scale, the SmithKline Beecham Quality of Life Scale (SBQOL) utilizes 23 predetermined constructs and three fixed elements: self now, ideal self and sick self. Inclusion of the latter two elements provides a personal frame of reference for the individual and recognizes the highly idiosyncratic and subjective nature of the experience which constitutes quality of life. A study of the validity and reliability of the SBQOL was conducted in 129 patients presenting to their GP with either major depression or generalized anxiety disorder, as defined by DSM III R. Patients were treated at the discretion of their GP and followed over a period of 12 weeks with assessments of treatment efficacy being performed at 6 weeks and 12 weeks in parallel with administration of the SBQOL. The results from co-administration of standard efficacy measures such as the Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Scale (HAMA) with the SBQOL, provided good evidence of construct validity. Evidence in support of the concurrent validity of the SBQOL was provided by co-administration of the Sickness Impact Profile and General Health Questionnaire (external criteria) with the SBQOL scale. Test-retest reliability and internal consistency were high. No obvious advantage was conferred by the use of principal components analysis from the Flexigrid software package in contrast to a simple arithmetical procedure for computing interelement distances. It is concluded that the SBQOL provides a valid, reliable and practicable approach to the assessment of quality of life in patients with affective disorder.

Adolescent↗
PubMed2001

Studies on the Biosynthesis of Paraherquamide: Synthesis and Incorporation of a Hexacyclic Indole Derivative as an Advanced Metabolite This work was supported by the National Institutes of Health (Grant no. CA70375 to R.M.W.). We wish to acknowledge the American Chemical Society Division of Organic Chemistry Fellowship (sponsored by SmithKline Beecham) and the Pharmacia-Upjohn Company for financial support (to E.M.S.). Mass spectra were obtained on instruments supported by the National Institutes of Health Shared Instrumentation Grant (No. GM49631). We also wish to thank Professor Dean Crick of the Department of Microbiology at Colorado State University for helpful discussions. J.F.S.-C. thanks the DGICYT of Spain for a research grant (project no. PB98-1438).

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Journal Article↗
PubMed1999

Availability of hepatitis B vaccine that does not contain thimerosal as a preservative.

On August 27, 1999, Merck Vaccine Division (Merck & Co., Inc., West Point, Pennsylvania) received approval from the Food and Drug Administration (FDA) of a supplement to Merck's license application to include the manufacture of single-antigen preservative-free hepatitis B vaccine (Recombivax HB, Pediatric); distribution is expected to begin September 13, 1999. In addition, SmithKline Beecham Biologicals (SmithKline Beecham, Philadelphia, Pennsylvania), expects to make single-antigen preservative-free hepatitis B vaccine (Engerix-B, Pediatric) available in the near future. Further product information will be provided when it becomes available. Product packaging and labels will indicate that these vaccines do not contain preservative.

Hepatitis B Vaccines↗
PubMed1996

Comparative safety and immunogenicity of two recombinant hepatitis B vaccines given to infants at two, four and six months of age.

OBJECTIVES: To evaluate the relative safety and immunogenicity of the two recombinant hepatitis B vaccines licensed in the United States with doses recommended for routine immunization of low risk infants and a schedule that corresponds with routine pediatric visits. METHODS: Healthy infants were immunized at 2, 4 and 6 months of age with hepatitis B vaccine manufactured by either SmithKline Beecham (Engerix-B, 10 micrograms/dose, n = 228) or Merck and Co. (Recombivax HB, 2.5 micrograms/dose, n = 200). Adverse reactions were ascertained by parental reports and interviews and by review of medical records. Antibody concentrations to hepatitis B surface antigen (anti-HBs) were measured in sequential serum specimens by enzyme immunoassay. RESULTS: Adverse reactions were mild and the rates were not significantly different between the two groups. After the first and second doses the rates of seropositivity (> or = 10 mIU/ml) and seroprotection (> or = 10 mIU/ml) were significantly higher in infants given SmithKline Beecham vaccine (P < 0.01). After the second and third doses infants given SmithKline Beecham vaccine also had significantly higher geometric mean anti-HBs concentrations compared with those given Merck vaccine (348.0 mIU/ml vs. 66.9 and 1914.8 mIU/ml vs. 514.8 mIU/ml, respectively, P < 0.001). Nevertheless after the third dose 99% of infants in both vaccine groups achieved seroprotective antibody concentrations. CONCLUSIONS: Both recombinant hepatitis B vaccines were safe and immunogenic when administered concurrently with other pediatric vaccines at 2, 4 and 6 months of age, but earlier protective responses were observed with the SmithKline Beecham vaccine than with the Merck vaccine.

Consumer Product Safety↗
PubMed1999

Reactogenicity and immunogenicity of reduced antigen content diphtheria-tetanus-acellular pertussis vaccines as a booster in 4-7-year-old children primed with diphtheria-tetanus-whole cell pertussis vaccine before 2 years of age.

BACKGROUND: The recent introduction of acellular pertussis vaccines (Pa) offers the possibility of booster doses in older children and adults. This can be conveniently accomplished by combining acellular pertussis antigens with diphtheria and tetanus toxoids. However the optimal dosage for the booster injection has not yet been determined. OBJECTIVE: To compare the reactogenicity and immunogenicity of diphtheria-tetanus-acellular pertussis vaccines (DTPa) with lower antigen contents to a licensed DTPa vaccine when given at 4-7 years of age as a booster to DTPw-primed children. METHODS: Two hundred and twenty-six children primed with four doses of DTPw before 2 years of age were enrolled and allocated to three groups to receive one dose of either DTPa (Infanrix, SmithKline Beecham, Biologicals), a reduced antigen formulation of this vaccine (dtpa, SmithKline Beecham Biologicals), or an experimental low dose formulation (dtpa-exp; d and t, Michigan Biologic Products Institute). Reactogenicity was assessed using diary cards for 15 days. Immunogenicity was determined as antibody responses against the vaccine components in pre- and 1 month postvaccination sera. RESULTS: Of the 225 children who completed the study, 60.0-66.7% reported symptoms, with no significant differences in rates between groups. Local, systemic and unsolicited symptoms occurred with similar frequencies in all three groups, the vast majority (> 90%) being considered as mild or moderate. No serious adverse events related to vaccination were reported. After vaccination, all subjects displayed seroprotective concentrations against diphtheria and tetanus, and 98.7-100% had antibodies against the three pertussis component antigens. The group receiving the reduced dose of the licensed vaccine showed antibody concentrations comparable to those of the full dose group. However, the group receiving the experimental low dose formulation had statistically significantly lower antibody concentrations against both diphtheria and tetanus toxoids compared with the two other groups, as well as significantly lower anti FHA antibody concentrations. CONCLUSIONS: Reducing the antigen content of dtpa had no deleterious effect on the immunogenicity of the vaccine when given as a fifth dose at 4-7 years of age in DTPw-primed children. The reactogenicity profile of both the reduced antigen dtpa vaccines and DTPa were acceptable, the vast majority of local and systemic reactions being considered as mild to moderate, with no vaccine-related serious adverse events reported. The use of lower antigen content dtpa vaccine as a booster in children aged 4-7 is safe and immunogenic.

Antibodies, Bacterial↗
PubMed2004

Rotavirus vaccine--AVANT immunotherapeutics/GlaxoSmithKline: 89-12, RIX4414.

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.

Humans↗
PubMed2001

A prophylactic hepatitis B vaccine with a novel adjuvant system.

Studies with recombinant hepatitis B vaccines show seroprotection rates varying between 91 and 100%. Thus, a limited risk may remain for non-responding populations (e.g. non-responders, haemodialysis patients, elderly) who could benefit from a more immunogenic hepatitis B vaccine. One strategy to enhance the immune response is the use of novel adjuvants. SmithKline Beecham has developed a new adjuvant system containing alum and 3-deacylated monophosphoryl lipid A: SBAS4 (SmithKline Beecham Adjuvant System 4). Pilot studies showed that SBAS4 improved in vivo humoral and in vitro cellular immune responses compared to the response to classical recombinant hepatitis B vaccines and was safe and well-tolerated. Several studies assessed the profile of the HBsAg/SBAS4 vaccine in a healthy population, non-responders or elderly. In general the HBsAg/SBAS4 vaccine was well tolerated. Compared to an established recombinant hepatitis B vaccine, we observed an increased local reactogenicity but few symptoms were reported as severe. The HBsAg/SBAS4 vaccine elicits a strong immune response: subjects are protected faster and the GMTs are usually much higher. HBsAg/SBAS4 thus has the potential to protect those subjects who fail to be protected by well established hepatitis B vaccines.

Adjuvants, Immunologic↗
PubMed1996

Preventing endoscopic retrograde cholangiopancreatography related sepsis: a randomized controlled trial comparing two antibiotic regimes.

Current antibiotic prophylaxis for endoscopic retrograde cholangiopancreatography (ERCP) is not standardized and may be inadequate. We aimed to evaluate the efficacy of 3 days of additional oral antibiotics in the prevention of ERCP-related sepsis. One hundred and fifty-six patients were randomized prospectively to receive either intravenous ticarcillin and clavulinic acid (Timentin; SmithKline Beecham, Dandenong, Victoria, Australia), pre-ERCP (group I) or Timentin and 3 days of oral amoxycillin and clavulinic acid (Augmentin; SmithKline Beecham, Dandenong, Victoria, Australia), group II). Blood cultures were taken 30 min after the procedure. The occurrence of sepsis, defined as a temperature over 38 degrees C, occurring in the first 7 days was recorded and the risk factors for the development of sepsis were evaluated. Four patients had significant positive blood cultures despite the prior administration of Timentin. Sepsis occurred in 10% of group I patients, but only 3% of group II patients (relative risk 3.30; 95% confidence intervals 0.74-14.8). The performance of sphincterotomy and the presence of common bile duct stones were significant risk factors for the development of sepsis. We would recommend 3 days of additional oral Augmentin after a single dose of intravenous antibiotics in patients at increased risk of sepsis, which would include those with bile duct stones and/or those undergoing a therapeutic procedure.

Amoxicillin↗