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FIGURE 3. Effects of T cells transferred before sensitization on cell numbers in the bronchoalveolar lavage after challenge. T cells were transferred to mice and then the mice were sensitized and challenged as described in Fig. 2. Three days after aerosol challenge, the mice were sacrificed and their lungs were flushed four times with 0.8 ml of saline containing 2% FCS. Nucleated cells in the recovered lavage were counted after lysis of RBC. Data represent the average number of BAL cells SD, n 4 mice per group.

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Finnish National Public Health Institute. The laboratory personnel were not aware of the vaccination status or the age of the child at the time of sampling Board Members Present for the Executive Committee portion of the meeting: Garry Lean, Brian Magaro, Jack Reams, Marina Sexty Buchan and Margaret Scoles staff ; . Agenda Item #1 Approve Agenda Agenda Item #2 Secretary's Report a.Approval of Minutes from February 17 and 22 of 2005 b. Approval of minutes of March 20, 21 Agenda Item # 3 Committees a. Membership Committee Chair Discussion: It was noted that Chris Kidwell recommended accepting David Dahmen as the new membership Committee Chair. Endorsement by the BOD was unanimous. b. Canadian Committee Garry reported that in 2004 2005 the Canadian Food Inspection Agency CFIA ; and Agriculture Canada sent a task force across Canada to gather information and inform stakeholders of the progress of the proposed Canadian Organic regulatory program. Garry said the new regime would have an emphasis on consistency in inspections and certification. The CFIA hopes to be ready with a Canadian regulatory program by the Fall of 2005. Dag emailed the BOD a list of his priorities for the emerging Canadian system. Action Points: Garry will continue the conversation with the task force members and update the BOD during the next meeting. Agenda Item #4 Executive Director Report Brian closes the pre-Board portion of the meeting at 9: 15 p.m. Board and Staff Members Present, Date April 14, 2005: Ann Baier, Luis Brenes, Garry Lean, Ann Lameka Alternate ; Brian Magaro, Jack Reams, Marina S. Buchan, Margaret Scoles staff ; , Dag Falck facilitator ; Agenda Item #5 - At 9: 15 Brian welcomed the BOD members and facilitator, Dag Falck, to the meeting and then handed the meeting over to Dag to facilitate the Planning of the Strategic Plan. Dag reviewed his plan and suggested that there be three BOD phone meetings, one face to face meeting and at least one follow up phone meeting. Dag noted that he as the facilitator was in charge of the process and the participants were responsible for the content. Action Points: The BOD agreed that Margaret and Ann Lameka are invited to fully participate in the planning sessions. The next meeting is scheduled for April 28, 8: 30 p.m. Eastern Daylight Savings Time Agenda Item #6 Adjournment Minutes from the April 28 meeting have not yet been approved they will appear in our next issue and eletriptan.

N-CAM species in an extract of Xenopus developing leg muscle. The material examined in lane C is from tadpole brain and shows that only the 180X103 species appears to be expressed by this tissue. This observation is in good agreement with Sunshine et al. 1987 ; . No other bands above background were evident on Western blots. These data suggest that our polyclonal antibody recognized authentic N-CAM in sectioned material. Myotomal cells in culture The results described above show that the myotomes of Xenopus do not express N-CAM except at regions of innervation. To determine whether or not this was a presynaptic or postsynaptic labelling, we examined the appearance of N-CAM on primary cultures of myotomal muscle cells. These cells do not undergo fusion in tissue culture and remain mononucleated. As shown in Fig. 5A and B, these muscle cells did not demonstrate detectable levels of N-CAM on their surfaces. N-CAM was likewise absent from the spontaneously formed, acetylcholine receptor clusters 'hot spots' ; as shown by R-BTX labelling Fig. 5C, D ; . This is in sharp contrast to the bright staining of neurones and neuronal processes in explant cultures of Xenopus spinal cord Fig. 5E ; . To further assess the localization of N-CAM at the neuromuscular junction, we examined myotomal cells dissociated from the tail musculature of stage-50 tadpoles. The muscle cells at this stage are multinucleated, as determined by DAPI fluorescence not shown ; . At the ends of these isolated cells are patches of acetylcholine receptors, which mark the sites of the postsynaptic membrane Fig. 5F ; . Double staining and eligard. Part by cellular internalization. This was tested in vitro using purified mouse and human T-cells as a model to study the cellular uptake and clearance of anti-CD11a antibodies. Data from these studies suggest that anti-CD11a antibodies are internalized by purified T-cells. Upon internalization, the antibodies appeared to be targeted to lysosomes and were cleared from within the cells in a time-dependent manner. CD11amediated internalization and lysosomal targeting of efalizumab may constitute one pathway by which this antibody is cleared in vivo.

EXCLUSIONS Coverage of efalizumab is not recommended in the following circumstances: 1. Psoriatic arthritis without plaque psoriasis ; . 2. Rheumatoid arthritis. 3. Asthma.17 4. Children aged 18 years. 5. Coverage is not recommended for circumstances not listed in Recommended Authorization Criteria. Criteria will be updated as new published data are available.

Advantan topical glucocorticosteroid for the treatment of endogenous and exogenous eczema. Androcur anti-androgen for the treatment of prostate cancer; also used in combination with an estrogen, such as in our product Diane for the treatment of hypertrichosis, acne and seborrhea in women, when these complaints are caused by excessive androgen levels. Angeliq continuous combined oral preparation for the treatment of climacteric complaints. We received marketing authorization in the Netherlands as the European Reference Member State in 2002. Avaden sequentially combined oral hormone replacement therapy that relieves climacteric complaints and offers protection against osteoporosis. Betaferon Betaseron the first beta interferon developed for the treatment of multiple sclerosis MS ; . In 2001, Betaferon was also approved in Europe, Canada and Australia for the treatment of the secondary progressive form of multiple sclerosis SPMS ; . In addition, we have filed an NDA for SPMS in the United States. Betaferon is also approved for the treatment of multiple sclerosis in Japan. Since 2002, Betaferon is offered as a room-temperature stable formulation. Betaject and Betaject light two new autoinjectors to make the application of Betaferon easier. Use of these injectomats can reduce infection side-effects such as skin irritation and swelling. Betapace anti-arrhythmic drug which we market solely in the United States. This preparation is used for the treatment of ventricular arrhythmias irregular heart rhythm ; , such as sustained ventricular tachycardia. Bonefos product used in particular in the prevention of the sequels of metastatic bone lesions. Campath MabCampathTM humanized monoclonal anti-CD52antibody used in the treatment of chronic lymphocytic leukemia CLL ; . It represents the first antibody-based therapy indicated for refractory CLL patients, i.e. patients whose previous treatment has not worked or no longer works and eloxatin.

In the toxicology studies, overall, efalizumab and muM17 were generally well tolerated up to 26 weeks at the highest doses tested, 40 mg kg week IV ; in a non-human primate and 30 mg kg week SC ; in mice, respectively. The main effects seen in the toxicology studies were those related to the pharmacology of the antibody. The primary pharmacological effect on receptor level, i.e. downmodulation of the CD11a receptor was seen in all studies. In all pivotal studies, there was a full pharmacologic effect already at the low dose. Higher dosages did not result in stronger effects. Besides impairment of transendothelial trafficking, reduced adhesion of lymphocytes and other pharmacological effects leading to the therapeutic effect resulting from the down-modulation of CD11a, other immunological responses were noted that are likely related to the down-modulation of CD11a, but may be considered adverse. Notably, antibody response to artificial antigens tetanus toxoid or sheep red blood cells was severely diminished, indicating an impaired immune function. A potential exacerbation of infection by efalizumab cannot be ruled out. In pups of mice treated with an antibody analogue of efalizumab, a decrease in T-cell dependent immunity was observed up to at least 11 weeks of age. Only at 25 weeks of age this decrease was no longer significant. No safety margin exists and warning referring to this effect should be included in section 5.3 of the SPC. Pregnant women should not be treated with Raptiva. Discussion on the non-clinical aspects Efalizumab binds specifically to the CD11a subunit of LFA-1. By preventing LFA-1 ICAM binding, efalizumab may alleviate signs and symptoms of psoriasis.Efalizumab does not cross-react with CD11a from species other than humans and a non-human primate. Therefore, conventional nonclinical safety data with the medicinal product are limited and do not allow for a comprehensive safety assessment.Efalizumab inhibits both the humoral response to some antigens and the cell-mediated response. In mice treated with the murine surrogate antibody muM17, an inhibition of the delayed type hypersensitivity DTH ; was observed.The 6-month repeated dose study in a non-human primate is of limited value due to a number of constraints. Nevertheless, animals appear to have been sufficiently exposed to cause long-term down-modulation of CD11a and the potential effects of this long-term change were evaluated in the study to some extent. In addition the lack of histopathological data is partly compensated by p53 + + wild-typea 26-week study in mice with the surrogate antibody muM17. Studies did not produce results that would prevent use of efalizumab in humans. No evidence of carcinogenicity was seen. Yet, the results should be seen with some reservation, because the duration of the study was only 6 months. Immunological effects observed in this study were similar to those in the repeat-dose toxicity studies of shorter duration. In addition, platelet counts and efalizumab.

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