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Muscle contractility for potential application in the treatment of heart failure. In addition, we obtained an option to participate in future developments and commercialization of Cytokinetics' lead drug candidate arising from this program, CK-1827452, which recently entered two phase 1 clinical trials. The collaboration is worldwide, excluding Japan. There are many economic and industry-wide factors that affect our business generally and uniquely, including, among others, those relating to increased complexity and cost of R&D due, in part, to greater scrutiny of clinical trials with respect to safety which may lead to fewer treatments being approved by the FDA; increasingly intense competition for marketed products and product candidates; broad reimbursement changes; complex and expanding regulatory requirements; and intellectual property protection. See "Item 1. Business" and "Item 1A. Risk Factors" for further information on these economic and industry-wide factors and their impact and potential impact on our business. ; In addition to these economic and industry-wide factors, we, as a company, face certain additional challenges and have a number of opportunities as well. Our principal products have established leadership positions attaining significant sales levels over the last few years and have experienced strong year-over-year sales growth. However, the rate of growth has declined in each of the past several years and, in the near term, we expect this trend to continue. We believe that future sales growth for certain of our principal products should benefit from segment growth, including increased penetration through new areas of treatment and or greater awareness. At the same time in 2007, however, they will be subject to increasing competition, which includes the expected introduction of biosimilars in Europe. In addition, future sales growth may be impacted by healthcare provider prescribing behavior or use of our products, or regulatory or private healthcare organization medical guidelines and reimbursement of our products. Also, with the promise of our growing pipeline comes the challenge of delivering on the pipeline, including executing on large and complex clinical trials. To execute on these clinical trial programs we will need to increase the growth of our R&D organization, open clinical sites and enroll patients in new geographic locations and continue reliance on third-party contractors. Further, the growth of our clinical and commercial operations will require increased manufacturing capacity, which is a lengthy and costly process. In the near term, our 2007 objectives to assist in meeting these challenges and to be successful in taking advantage of our opportunities are to: i ; balance short term financial performance with increased R&D investment to allow us to execute key clinical trials for our late-stage product candidates and advance a number of additional molecules further along the development process; ii ; grow our markets and hold or increase share; iii ; vigorously defend our intellectual property and increase our leadership in anemia management; and iv ; proactively expand production capacity as we grow. Results of Operations Product sales For the years ended December 31, 2006, 2005 and 2004, worldwide product sales and total product sales by geographic region were as follows amounts in millions.
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Start Date 1981 Number NMCSD-059 Title Comparative study of cefadroxil vs. cephalexin in treatment of bacterial pneumonia in ambulatory patients Use of noninvasive bone structural measurements to evaluate stress fracture susceptibility among selected Marine Corps and Navy populations and duricef.
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Isabelle Dubus 1 , Batrice L'Azou2 , Cline Ohayon-Courts 3 , Ludivine Juvet2 , Jean-Pierre Labouyerie1 , Marie-Pierre Barrouillet3 , Christelle Bisson2 and Philippe Derache1 1 ; Laboratoire de Biochimie, 2 ; Laboratoire de Biologie Cellulaire, 3 ; Laboratoire d'Hydrologie Environement - Universit Victor Segalen Bordeaux 2. Facult de Pharmacie. 146, rue Lo-Saignat. 33076 Bordeaux cedex, France. [Email : Beatrice.Lazou biocell-geppr.u-bordeaux2 ] Most of the data available related to cadmium exposure and cadmium nephropathy have been obtained from workers with occupational exposure, but now, there is some evidence that people in the general population may also have cadmium-related renal dysfunction. In this study, we investigated the effects of cadmium exposure, quantitated by atomic emission spectrometry method, on the viability and contractility of isolated glomeruli and mesangial cells. These two in vitro models are useful for the assessment of impaired glomerular filtration process. Dose-dependent cytotoxicity was measured in cultured rat mesangial cells using neutral red assay. The cytotoxicity index CL50 ; of cadmium chloride was 5-10 M. This was confirmed by a 50 % decreased in protein content in mesangial cells treated for 24 hours with 10 M CdCl2 . Thus, we used a non-lethal dose 1M ; for further investigations. In these conditions the uptake was evaluated by 25, 95 3, % per well compared to the cadmium introduced in the medium. Cadmium induced a direct contractile effect on isolated glomeruli and mesangial cell culture. The cross sectional areas, as measured with an image analysis system, were respectively decreased by 6, 04 and 8, 4 % after 30 minutes cadmium exposure. These structural changes were correlated with immunofluorescence microscope examination that shows -actin cytoskeleton disorganisation. As a consequence, the expression level of -smooth actin, one of the main mesangial sarcomeric proteins, was measured by westernblot analysis in presence of 1M CdCl2 , and compared to non treated cells. No significant change in mesangial actin content was observed after 4, 6, 24, hours of cadmium exposure. Taken together, our results suggested that a non-cytotoxic dose of cadmium can be internalized by mesangial cells, and stimulates mesangial cell contractility without affecting the protein expression level of sarcomeric actin. Further studies are undertaken in order to understand cellular mechanisms which link cadmium internalization to the regulation of mesangial contraction. Since the clinical introduction of cephalexin in current study reevaluated the appropriateness of 1971, determination of bacterial susceptibility to the cephalosporin class susceptibility testing this oral cephalosporin has been made on the concept with cephalothin and the two most basis of the zones of inhibition produced by commonly used oral agents, cefaclor and cephadisks containing 30 pig of cephalothin. This lexin. Additional studies were performed to conpractice was encouraged by a U.S. Food and firm the need to test the susceptibility of cefaDrug Administration decision endorsing the con- mandole and third-generation cefotaxime-like cept of testing only one antibacterial agent from drugs ; cephalosporins separately. each class of closely related drugs 2, 3 ; . The 30Recent clinical isolates were accumulated for pLg cephalothin disk was recommended for test- testing by the microdilution procedure from rouing bacterial susceptibility to all cephalosporins tine cultures submitted to the Kaiser Foundation that were clinically available at that time, i.e., Laboratory Oregon Region, Clackamas, Oreg. ; . cephalothin, cephaloridine, cephaloglycin, and Others were contributed by A. L. Barry Unicephalexin 3, 6 ; . In more recent years, a variety versity of California, Davis Medical Center, of other cephalosporins with essentially the Sacramento, Calif. ; , P. C. Fuchs St. Vincent same antimicrobial spectrum have become avail- Hospital and Medical Center, Portland, Oreg. ; , able, e.g., cefazolin, cephapirin, cephradine, T. L. Gavan The Cleveland Clinic Foundation, cefaclor, and cefadroxil. These also are repre- Cleveland, Ohio ; , E. H. Gerlach St. Francis sented in the disk test by cephalothin 4-6 ; . Hospital, Wichita, Kans. ; , and H. M. Sommers Since the oral and parental cephalosporin anti- Northwestern Memorial Hospital, Chicago, biotics are used in distinctly different patient Ill. ; . The 528 organisms included: Acinetobacter populations and different clinical infections, spp. 15 ; , Citrobacter diversus 10 ; , Citrobacter there may be an opportunity for differential freundii 10 ; , Enterobacter aerogenes 19 ; , Endevelopment of resistance of organisms to one terobacter agglomerans 9 ; , Enterobacter clogroup of agents, but not to the other. If this acae 19 ; , Enterobacter gergoviae 2 ; , enteroshould happen, the class susceptibility testing cocci 25 ; , Escherichia coli 25 ; , Haemophilus concept would no longer be legitimate. The influenzae 1 2 1-lactamase positive ; 40 ; , Klebsiella pneumoniae 25 ; , Morganella morganii 10 ; , Neisseria gonorrhoeae , B-lactamase posit Present address: The Clinical Microbiology Institute, Tualatin, OR 97062. tive ; 23 ; , N. gonorrhoeae P-lactamase nega1156 and cefepime.

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Divisions of Neurosurgery Neuro-Oncology, Department of Surgery, Sherbrooke University and Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada Abstract Malignant astrocytomas are aggressive neoplasms with a dismal prognosis despite optimal treatment. Maximal resective surgery is traditionally complemented by radiation therapy. Chemotherapy is now used on patients as initial therapy when their functional status is congruent with further treatment. The classic agents used are nitrosoureas, but temozolomide has taken the front seat recently, with recent data demonstrating increased survival when this agent is used concurrently with radiation therapy in newly diagnosed glioblastoma patients. A new class of agents, refered to as biological modifiers, are increasingly used in clinical trials in an effort to affect the intrinsic biologic aberrations harboured by tumor cells. These drugs comprise differentiation agents, anti-angiogenic agents, matrixmetalloproteinase inhibitors and signal transduction inhibitors, among others. This article reviews the standard cytotoxic agents that have been used to treat malignant astrocytomas, and the different combination regimens offering promise. In addition, recent advances with biological modifiers are also discussed. Three major histological types of diffuse infiltrative tumors are recognized by the World Health Organization's classification of gliomas: astrocytoma, oligodendrogliomas, and oligoastrocytomas.1 These tumors are further classified by subtypes mainly for astrocytomas ; and by histological grading. Grading usually serves the purpose of orienting treatment and predicting in the most accurate way the outcome for a given patient. Glial neoplasms represent a continuum of increasingly cellular and pleiomorphic lesions.1-3 Therefore grading systems translate a punctual assessment of this continuum, and can only approximate the biological behavior of a tumor. For astrocytic tumors, a four tier system is used.3, 4 The term malignant astrocytoma typically refers to grade III and IV fibrillary astrocytomas, respectively dubbed anaplastic astrocytoma AA ; and glioblastoma multiforme GBM ; . Malignant astrocytomas constitute about 50% to 60% of primary brain tumors, with an incidence ranging from 5 to 8 per 100, 000 inhabitants.5 Peak incidence is in the fifth or sixth decade of life, and has been increasing in recent years, an observation that may not be fully explained by aging of the population.6 In adults, malignant astrocytomas are almost exclusively supratentorial in location over 90% ; . These tumors spread by diffusely infiltrating the brain, and tumor cells are found at a distance from the enhancing anomalies on radiological studies.7 This fact accounts in part for their dismal prognosis, by preventing a complete resection and rendering local treatment modalities only partially effective. Standard treatment for astrocytic tumors has traditionally consisted of maximal surgical resection, followed by radiotherapy. The most frequently used radiation dose-schedule consists of 60 Gy given in 30 fractions over six weeks. Even with this so-called optimal treatment, a cure cannot be considered an accessible goal. The median survival produced by this approach is only 35 to 48 weeks for patients bearing a GBM.8, 9 Anaplastic astrocytoma patients fare better, with a median survival of two to three years, This review article appeared originally in Can J Neurol Sci 2006; 33: 127-40. The article is reproduced with kind permission from the Journal under the special arrangement of "Journal Article Exchange" between Canadian Journal of Neurosciences and Neurology Asia and cefixime.

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PH-Dependent Uptake of Cefadroxil. Because PEPT2mediated transport is stimulated by a proton gradient, the pH dependence of cefadrooxil uptake 1 M ; was investigated in Tris-MES cerebrospinal fluid buffers at pH 7.4 and pH 6.5. Although a proton-stimulated uptake of cefadroxul was demonstrated in PEPT2 mice at pH 6.5 versus pH 7.4 p 0.01 ; , no pH dependence was observed in PEPT2 mice Fig. 4 ; . The absence of a proton-dependent uptake in PEPT2 mice indicates that residual uptake of cefadroxil in choroid plexus is not mediated by another POT family member. Concentration-Dependent Uptake of Cefadroxil. The uptake kinetics of cefadroxil in choroid plexus was evaluated over the concentration range of 0.5 to 500 M pH 7.4, 37C ; . As shown in Fig. 5 and Table 1, PEPT2 mice demonstrated saturable transport with a Vmax of 5.4 pmol mg min, a Km of 34 M, and a Kd of 0.0069 l mg min. Thus, under linear conditions, the carrier-mediated component accounted for 96% of cefadroxil's total uptake. The nonsaturable component 0.0069 pmol mg min at 1 M ; was similar to the uptake of 1 M cefadroxil in PEPT2 mice at 4C 0.0096 pmol mg min; Fig. 2 ; . In contrast, PEPT2 mice exhibited a less efficient transport of cefadroxil i.e., 6-fold lower value for Vmax Km ; with a Vmax of 2.7 pmol mg min, a Km of 110 M, and a Kd of 0.0084 l mg min. Under linear conditions, the carrier-mediated component accounted for 75% of cefadroxil's total uptake in PEPT2 mice. To remove the contribution of OAT-mediated uptake, cefadroxil studies were also performed in the presence of 5 mM p-aminohippurate Fig. 6; Table 1 ; . Kinetic analyses revealed that in PEPT2 mice, the Vmax was 4.1 pmol mg min, the Km was 27 M, and the Kd was 0.0064 l mg min. In the absence of OAT transport mechanisms, PEPT2 mice exhibited a strictly linear uptake in choroid plexus i.e., no saturable transport and a Kd of only 0.010 l mg min being observed ; , with uptake values significantly less than those observed for PEPT2 mice in the absence of p-aminohippurate. For ease of comparison, Fig. 7 clearly shows the impact of PEPT2 and or OAT transporters, along with nonsaturable processes, in the uptake profiles of cefadroxil in the choroid plexus of wild-type and PEPT2 null animals and cefpodoxime. Patients' experiences and their confirmation. Following state laws that allow for the medical use of cannabis, an increasing number of patients have collected experience with cannabis. Many reported benefits from its use. Some of this experience has been confirmed in reports and clinical investigations or stimulated clinical research that confirmed these patients' experience on other patients suffering from the same disease Several examples show that the attitude of people towards the medical use of cannabis is based on such personal experience. Lynn Nofziger, the former White House director of communication and chief speech writer of President Ronald Reagan, stated in a foreword to a book on the medical use of marijuana: "Strange as it may seem, here is one right-wing Republican who supports carefully controlled, medical access to marijuana. When our grown daughter was undergoing chemotherapy for lymph cancer, she was sick and vomiting constantly as a result of her treatments. No legal drugs, including the synthetic "marijuana" pill MarinolTM, helped her situation. As a result we finally turned to marijuana which, of course, we were forced to obtain illegally. With it, she kept her food down, was comfortable, and even gained weight ; A doctor should have every possible medication -- including marijuana -- in his armentarium ; " Nofziger 1999 ; . In several investigations, patients' experiences were collected by health care professionals and scientists. Among these investigations is the report "Cannabis. The scientific and medical evidence" by the British House of Lords Select Committee on Science and Technology 1998 ; and " Marijuana and medicine: Assessing the science base" by the U.S. Institute of Medicine Joy et al. 1999 ; The IOM report, "Marijuana and Medicine: Assessing the Science Base, " was ordered by the White House Office of National Drug Control Policy in January 1997 Joy et al. 1999 ; . Review of available information began in August 1997, including several public hearings, site visits to cannabis buyers' clubs and HIV AIDS clinics, and months of examining the existing scientific database. The report urges politicians to soften their hard line against the therapeutic use of cannabis and states that marijuana is potentially effective for some symptoms. It recommends rigorous clinical trials and development of a delivery system that eliminates the harmful effects of smoking. Beyond the harms of smoking, the range of problems associated with medical marijuana were within the acceptable range of problems associated with other medications. Under the headline "Who Uses Medical Marijuana?" the IOM Report of 1999 says: "There have been no comprehensive surveys of the demographics and medical conditions of medical marijuana users, but a few reports provide some indication. In each case, survey results should be understood to reflect the situation in. This information is increasingly important in presence of laws and regulations for accountability and authenticated health care information. In the version 3 model, all persons having responsibilities in a service order, performance and documentation ; are consistently and uniformly associated with the service through the Actor class. The Actor.type cd allows to precisely specify the actual responsibility of every person at different points in the service's life cycle. Note that anesthesia may be considered an integral part of a surgical procedure or a separate service that is strongly related to the surgery. If anesthesia is considered integrated with the surgery service, the anesthesiologist can be reported as an Actor of type "anesthesiologist" connected directly to the surgery service. In a more fine grained perspective were anesthesia is a service on its own, the anesthesiologist will be associated with the anesthesia service rather than the surgery service. 3.2.2.9 Anesthesia code IS ; 00399 and vantin.

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Teva leases certain of its facilities. The Kfar Sava plant, the Jerusalem pharmaceutical plant, the Netanya chemical plant and the Ramat Hovav plant are operated out of buildings owned by Teva on land leased from the Israel Lands Administration. The leases with respect to the Kfar Sava plant extend until 2032 and 2034, with an option to renew until 2081 and 2083, respectively. The leases with respect to the Netanya plant extend until 2018 and 2022, with an option to renew until 2067 and 2071, respectively. The lease with respect to the Ramat Hovav plant extends until 2043, with an option to renew until 2092. The lease with respect to the Jerusalem pharmaceutical plant extends until 2021, with an option to renew until 2070. Most of the above payments due under these leases other than the options ; have been prepaid. The corporate headquarters in Petach Tikva is leased until December 2006, with an option to renew annually until December 2012. In North America, Teva leases its facility located in North Wales, Pennsylvania, the initial term of which expires in 2011, with a five-year extension option. The leases on the two buildings in which Sicor conducts its manufacturing operations in Irvine, California expire in 2007 and 2008, respectively. Leases on the other Irvine buildings, which are used for warehouse, packaging, research and office purposes, expire at various times from September 2006 through 2010; all but one of those leases used for office purposes ; contain options to renew for various periods. Part of Novopharm's headquarters in Toronto, Ontario is leased through 2010, with an option to renew for one additional five-year period, while the other part currently is in month-to-month status. Novopharm also leases a manufacturing site on a month-to-month basis and a warehouse in Toronto under a lease that expires next year and which Novopharm may or may not renew. Teva owns or leases various other facilities worldwide. In addition through its acquisition of Ivax in January 2006, Teva acquired pharmaceutical manufacturing facilities in Buenos Aires, Argentina; Munro, Argentina; Santiago, Chile; Opava, Czech Republic; Preston Brook, England; Runcorn, England; Miami, Florida; Falkenhagen, Germany; Waterford, Ireland; Mexico City, Mexico; Ramos Arizpe, Mexico; Northvale, New Jersey; Congers, New York; Lima, Peru; Kutno, Poland; Cidra, Puerto Rico; Guayama, Puerto Rico; St. Croix, the U.S. Virgin Islands; and Guacara, Venezuela. Ivax owns the manufacturing facilities in Argentina, Chile, the Czech Republic, England Preston Brook ; , Florida, Germany, Mexico, New York, Poland, Puerto Rico and Venezuela and leases its remaining manufacturing facilities. Ivax also owns or leases various other facilities worldwide. ITEM 4A: UNRESOLVED STAFF COMMENTS None. ITEM 5: OPERATING AND FINANCIAL REVIEW AND PROSPECTS Introduction Teva is a global pharmaceutical company producing drugs in all major treatment categories. It is the world's leading generic drug company and has the leading position in the U.S. generic market. Teva has successfully utilized its production and research capabilities to establish a global pharmaceutical operation focused on supplying the growing demand for generic drugs and on opportunities for proprietary branded products for specific niche categories, with its leading branded drug being Copaxone for multiple sclerosis. Teva's active pharmaceutical ingredients "API" ; business provides both significant revenues and profits from sales to thirdparty manufacturers and strategic benefits to Teva's own pharmaceutical production through its timely delivery of significant raw materials. The generic drug industry as a whole, and therefore Teva's own operations, are affected by demographic trends and budgetary constraints of governments and health care organizations. In each of the markets in which Teva operates, governments as well as private employers are working to control growing health care costs, and there is a steadily growing recognition of the importance of generics in providing access to affordable pharmaceuticals. The generic industry is significantly affected by trends of consolidation among managed care 37.
CARDIZEM LA . 26 carisoprodol. 49 CASODEX. 40 CATAPRES-TTS . 22, 24 CEDAX. 6 CEENU . 15 cefaclor. 6 cefadroxil . 6 cefazolin inj . 6 cefoxitin inj . 6 cefpodoxime proxetil. 6 cefprozil . 6 CEFTIN susp . 6 ceftriaxone . 6 cefuroxime axetil. 6 cefuroxime inj. 6 CELEBREX .5, 13 CELLCEPT. 41 CELONTIN . 9 CENESTIN . 38 cephalexin. 6 CEREZYME . 33 chloroquine . 17 chlorpheniramine pseudoephedrine ext-rel 8 mg 120 mg. 45 chlorpromazine . 11, 19 CHLORPROMAZINE inj. 19 CHLORTHALIDONE 100 mg . 26 chlorthalidone 25 mg, 50 mg . 26 chlorzoxazone. 49 cholestyramine . 27 CIALIS . 35 ciclopirox . 30 cilostazol. 24 CILOXAN oint. 43 cimetidine . 34 cimetidine inj. 34 CIPRO HC OTIC. 45 CIPRO inj . 7 CIPRO susp . 7 CIPRO tabs 100 mg . 7 CIPRO XR. 7 CIPRODEX . 45 ciprofloxacin .8, 43 cisplatin . 16 55 and keftab and cefadroxil.

Ibid, paragraph 180. Syfait Opinion, paragraph 100. See commission Communication on the Single Market in Pharmaceuticals, COM 1998 ; 588.

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