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THE NOCTURNAL FLIP-FLOP DURING SLEEP: IS IT DIFFERENT IN PEDIATRIC SLEEP APNEA? Dayyat E, 1 Maarafiya MM, 1, 2 Sans Capdevila O, 1 Montgomery-Downs HE, 1 Gozal D1 1 ; Division of Pediatric Sleep Medicine, Department of Pediatrics, University of Louisville, Louisville, KY, USA, 2 ; Pediatrics, Hamad Medical Corporation, Doha, Qatar Introduction : In adults with OSA, the supine position is consistently associated with increased severity of the respiratory disturbance during sleep. Although data on this issue in children are currently conflictive, preferential selection of body positions during sleep that reduce the risk for upper airway obstruction could skew polysomnographic findings Methods : Consecutive children referred for evaluation of snoring in the absence of craniofacial or genetic abnormalities and with polysomnographically-demonstrated OSAS were identified in the database, and the sleep time spent in the supine, prone, and side position was extracted, and compared to the sleep position characteristics of healthy children. Results : 430 children with OSA 40.3% female; 56% Caucasian and 37% African American ; , with a mean age of 6.50.2 years were included. In addition, 185 age-, gender-, and ethnically-matched children were also studied CO ; . For OSA children, mean total sleep time was 453.766.4 min and 465.243.3 min in CO p-NS ; . OSA children spent more time in the supine position 42.039.0%TST ; vs. 33.425.6%TST in CO p 0.01 ; . In contrast, OSA patients sleep less on their side 53.124.4%TST vs. 42.535.4%TST; P 0.005 ; , with no differences in the percentage of time spent in the prone position. Interestingly, obese children with OSA were more likely to adopt the prone position 20.429.1%TST ; compared to non-obese children with OSA.
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WE HAVE NOT COMPLETED PRODUCT DEVELOPMENT. We have not completed the development of our product candidates and we will be required to devote considerable effort and expenditures to complete such development. In addition to obtaining adequate financing, satisfactory completion of development, testing, government approval and sufficient production levels of such product candidates must be obtained before the product candidates will become available for commercial sale. We do not anticipate generating material revenue from product sales until perhaps the second half of calendar 2007 at the earliest. On November 3, 2006, we announced that we received an approval letter from the FDA regarding our NDA for NitroMistTM. Previously, this product was partnered with Par Pharmaceutical, or Par; however, on August 1, 2007, we announced that Par returned the rights to NitroMistTM to us as part of Par's strategy to concentrate its resources on supportive care in AIDS and oncology markets. We are currently investigating strategic partners for this product. Other potential products remain in the conceptual or very early development stage and remain subject to all the risks inherent in the development of pharmaceutical products, including unanticipated development problems and possible lack of funds to undertake or continue development. These factors could result in abandonment or substantial change in the development of a specific formulated product. We may not be able to successfully develop any one or more of our product candidates or develop such product candidates on a timely basis. Further, such product candidates may not be commercially accepted if developed. The inability to successfully complete development, or a determination by us, for financial or other reasons, not to undertake to complete development of any product candidates, particularly in instances in which we have made significant capital expenditures, could have a material adverse effect on our business and operations. WE DO NOT HAVE DIRECT CONSUMER MARKETING EXPERIENCE. We have no experience in marketing or distribution at the consumer level of our product candidates. Moreover, we do not have the financial or other resources to undertake extensive marketing and advertising activities. Accordingly, we intend generally to rely on marketing arrangements, including possible joint ventures or license or distribution arrangements with third-parties. Except for our agreements with Par, Manhattan Pharmaceuticals, Velcera and Hana Biosciences, we have not entered into any significant agreements or arrangements with respect to the marketing of our product candidates. We may not be able to enter into any such agreements or similar arrangements in the future and we may not be able to successfully market our products. If we fail to enter into these agreements or if we the third parties do not perform under such agreements, it could impair our ability to commercialize our products. We have stated our intention to possibly market our own products in the future, although we have no such experience to date. Substantial investment will be required in order to build infrastructure and provide resources in support of marketing our own products, particularly the establishment of a marketing force. If we do not develop a marketing force of our own, then we will depend on arrangements with corporate partners or other entities for the marketing and sale of our remaining products. The establishment of our own marketing force, or a strategy to rely on third party marketing arrangements, could adversely affect our profit margins. WE MUST COMPLY WITH GOOD MANUFACTURING PRACTICES. The manufacture of our pharmaceutical products under development will be subject to current Good Manufacturing Practices, or cGMP, prescribed by the FDA, pre-approval inspections by the FDA or comparable foreign authorities, or both, before commercial manufacture of any such products and periodic cGMP compliance inspections thereafter by the FDA. We, or any of our third party manufacturers, may not be able to comply with cGMP or satisfy pre- or post-approval inspections by the FDA or comparable foreign authorities in connection with the manufacture of our product candidates. Failure or delay by us or any such manufacturer to comply with cGMP or satisfy pre- or postapproval inspections would have a material adverse effect on our business and operations.
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NDC 00071091547 00071091548 00071091647 Label Name LOESTRIN 21 1 20 TABLET 5X21 LOESTRIN 21 1 20 TABLET LOESTRIN 21 1.5 30 TABLET 5X21 LOESTRIN 21 1.5 30 TABLET LOESTRIN FE 1.5 30 TABLET LOESTRIN FE 1.5 30 TABLET ESTROSTEP FE-28 TABLET ESTROSTEP FE-28 TABLET OMNICEF 125MG 5ML SUSP OMNICEF 125MG 5ML SUSP NEURONTIN 250MG 5ML SOLN DILANTIN 125MG 5ML SUSP ZARONTIN 250MG 5ML SYRUP CEREBYX 50MG ML VIAL CEREBYX 50MG ML INJECTION BENADRYL 50MG ML VIAL BENADRYL 50MG ML VIAL DOVONEX 0.005% CREAM DOVONEX 0.005% CREAM DOVONEX 0.005% CREAM DOVONEX 0.005% CREAM DOVONEX 0.005% SOLUTION ULTRAVATE 0.05% CREAM ULTRAVATE 0.05% CREAM ULTRAVATE 0.05% OINTMENT ULTRAVATE 0.05% OINTMENT EURAX 10% CREAM EURAX 10% LOTION EURAX 10% LOTION DOVONEX 0.005% OINTMENT DOVONEX 0.005% OINTMENT DOVONEX 0.005% OINTMENT DOVONEX 0.005% OINTMENT LAC-HYDRIN 12% LOTION LAC-HYDRIN 12% LOTION LAC-HYDRIN 12% CREAM LAC-HYDRIN 12% CREAM DESQUAM-X 5% GEL DESQUAM-X 5% GEL DESQUAM-X 10% GEL DESQUAM-X 10% GEL WESTCORT 0.2% OINTMENT WESTCORT 0.2% OINTMENT WESTCORT 0.2% OINTMENT STATICIN 1.5% SOLUTION WESTCORT 0.2% CREAM WESTCORT 0.2% CREAM WESTCORT 0.2% CREAM EXELDERM 1% CREAM EXELDERM 1% CREAM EXELDERM 1% CREAM T-STAT 2% TOPICAL SOLUTION EXELDERM 1% SOLUTION No. Claims 37 375 23 Amount Paid $1, 477.01 $17, 223.67 $1, 256.97 $13, 871.36 $13, 226.69 $60, 500.26 $855.28 $178, 800.53 $23, 272.18 $32, 889.81 $40, 261.90 $584, 682.04 $56, 511.19 $6, 285.46 $8, 762.41 $154.26 $556.15 $1, 400.77 $138, 853.09 $37, 892.03 $1, 215.27 $37, 061.61 $34, 756.64 $137, 577.35 $11, 551.49 $107, 388.64 $26, 450.97 $21, 286.23 $9, 298.81 $3, 450.55 $165, 913.69 $58, 273.79 $61, 365.71 $110, 972.31 $114, 787.48 $86, 381.12 $50, 703.61 $292.04 $339.04 $486.22 $1, 218.51 $740.93 $1, 479.07 $1, 666.52 $120.44 $8, 609.15 $12, 320.44 $11, 149.47 $6, 844.00 $12, 843.71 $9, 339.96 $43.32 $3, 423.77.
Change and Transformation in the Biotechnology Industry: Will Equal Biotechnology--Pharma Partnerships Become the Model of the Future? O Alan L. Crane, HBS MBA 1992 Senior VP, Global Corporate Development, Millennium Pharmaceuticals, Inc. O Thomas Honohan VP, R&D Alliances and Business Integration, Aventis Pharmaceuticals O Werner Kroll, Ph.D. VP Technology Collaborations, Head of Pharmacogenomics and Toxicogenomics, Pharmaceutical Division, Bayer Corp. O Christopher K. McLeod Executive Vice President, CuraGen Corporation O Jeffrey M. Wiesen, Esq. Chairman of the Biotechnology Practice, Mintz, Levin, Cohn, Ferris, Glowsky, and Popeo O Moderator: Juan Enriquez Director, Life Science Project, Harvard Business School NOTES and lotensin, for instance, loestrin 24 fe.
Expanding Proprietary Oral Contraceptive Franchise The successful launch of SEASONALE, while a highlight of the year, represented only one facet of our activities in proprietary oral contraceptive development.We have a strong portfolio of traditional regimen and extended-cycle oral contraceptives currently under development, and are complementing our internal development activities through select product acquisitions. During fiscal 2004, we acquired Women's Capital Corporation and its FDAapproved Plan B emergency contraceptive.We continue to market Plan B as a prescriptiononly product, while working with FDA to remove the prescription-only barrier, thus affording more timely access to this important therapy. Further expanding our proprietary oral contraceptive line, we acquired the U.S. and Canadian rights to Galen's Loestr9n and the Loeatrin Fe oral contraceptives. In addition to product acquisitions, we expanded internal development activities. As part of the commitment to build a portfolio of extended-cycle oral contraceptives, work progressed on our SEASONALE Lo oral contraceptive, a lower dosage form of SEASONALE that is in Phase IIIB clinical trials with a supplemental NDA sNDA ; submission targeted for the second half of fiscal 2005.We also expect to file a New Drug Application NDA ; in the first half of fiscal 2005 for DP-3, a 91-day extended-cycle oral contraceptive regimen that includes seven days of unopposed estrogen. Clinical trials to support the filing of a NDA for DP-3 were completed during the fiscal year.We are also developing a 28-day.
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The federal government uses its buying power to negotiate lower prices for the drugs it purchases for its beneficiaries such as veterans, government employees and retirees. Unfortunately, 46 million uninsured Americans have no one doing the same on their behalf. During the spring of 2006, researchers from the state Public Interest Research Groups PIRGs ; posed as uninsured customers and surveyed by phone hundreds of pharmacies in 35 cities from all regions of the country and conducted a statewide survey in Vermont. We compared the prices charged to uninsured consumers with the lower prices pharmaceutical companies charge the federal government, the Federal Supply Schedule prices see sidebar ; . We then compared the prices charged to uninsured consumers with drug prices in Canada and with the results of a similar survey we conducted in 2004. Our survey demonstrates that the uninsured in America pay high prices for prescription drugs when compared with the prices paid by the federal government and our neighbors to the north, for instance, 24 generic loestrin.
In addition, Alberta, Saskatchewan, Manitoba and Ontario each have dedicated representatives that will participate in the project's development, providing significant resources to ensure its success and to ensure that provincial priorities are represented in its evolution. The first stage of the project has included a series of meetings across Canada with the research community, including academia, food development centres, government and others. In addition, meetings were conducted with health organizations, such as the Heart and Stroke Foundation, Canadian Diabetes, as well as with the Dieticians of Canada, and finally with ingredient manufacturers and food processors. These meetings served as an opportunity to introduce the Pulse Innovation Project to the industry, to create an understanding of the research and mescaline.
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For emotional support that is repeatedly expressed by people with HIV AIDS is the need for physical contact. When touch is avoided it clearly communicates fear and distance. For many, touch symbolizes acceptance and understanding. Informational support refers to the type of support associated with obtaining accurate information about health care and treatment options, social service resources, insurance coverage, strategies for coping with and adjusting to life with HIV disease, etc. Seeking information promotes a sense of control and helps people interpret, comprehend, and cope with HIV infection. Instrumental support refers to practical assistance with everyday needs e.g., transportation, shopping, housework, etc. ; The mental health provider can be of substantial assistance by helping the client in assess and develop his or her support system in terms of emotional, informational, and instrumental sources of support. It is also helpful for the mental health provider to convene meetings with the client and members of his or her support system. These meetings can be used to clarify and explain the needs of the client, identify the realistic availability and resources of various members of the support system, apportion and assign tasks among the various members of the support system, and explore potential conflicts associated with roles and responsibilities and methamphetamine.
References 1. Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. The sixth report of the Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure. Arch Intern Med. 1997; 157: 2413-2446. Weber MA, Laragh JH. Hypertension: steps forward and steps backward: the Joint National Committee fifth report. Arch Intern Med. 1993; 153: 149-152. Tobian L, Brunner HR, Cohn JN, et al. Modern strategies to prevent coronary sequelae and stroke in hypertensive patients differ from the JNC V consensus guidelines. J Hypertens. 1994; 7 pt 1 ; : 859-872. 4. Hypertension Detection and Follow-up Program Cooperative Group. The Hypertension Detection and Follow-up Program: a progress report. Circ Res. 1977; 40 suppl I ; : I-106I-109. 5. Laragh JH, Sealey JE. Renin system understanding for analysis and treatment of hypertensive patients: a means to quantify the vasoconstrictor elements, diagnose curable renal and adrenal causes, assess risk of cardiovascular morbidity, and find the best-fit drug regimen. In: Laragh JH, Brenner BM. Hypertension: Pathophysiology, Diagnosis, and Management. New York, NY: Raven Press Ltd; 1995: 1813-1836. 6. Blumenfeld JD, Mann SJ, Laragh JH. Clinical evaluation and differential diagnosis of the individual hypertensive patient. In: Laragh JH, Brenner BM. Hypertension: Pathophysiology, Diagnosis, and Management. New York, NY: Raven Press Ltd; 1995: 1897-1911.
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To normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension among ever- and never-users. 10. HEADACHE The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause see WARNINGS 1.c. ; . 11. BLEEDING IRREGULARITIES Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. If bleeding persists or recurs, nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. Absence of a withdrawal menses may also occur. In the event of amenorrhea for two cycles or more, pregnancy should be ruled out. In the clinical trial with Loetrin 24 Fe, 31-41% of the women using Lorstrin 24 Fe did not have a withdrawal menses in at least one of 6 cycles of use. Some women may experience post-pill amenorrhea or oligomenorrhea possibly with anovulation ; , especially when such a condition was preexistent. PRECAUTIONS 1. SEXUALLY TRANSMITTED DISEASES Patients should be counseled that this product does not protect against HIV infection AIDS ; and other sexually transmitted diseases. 2. PHYSICAL EXAMINATION AND FOLLOW-UP A periodic personal and family medical history and complete physical examination are appropriate for all women, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. 3. LIPID DISORDERS Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. See WARNINGS 1.d. ; . In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis and methylprednisolone.
LCMS Annual Meeting The LCMS Annual Meeting, held on Oct.18, 2005, marked the changing of presidents from John Reed, M.D., to Mark Carlson, M.D. Following a general business meeting the evening's entertainment was provided by a group of LCMS members presenting the mystery, "The Case of the Missing Oscar." Medicare Part D LCMS partnered with the Community Health Endowment of Lincoln to host six public educational forums on the new Medicare Part D. Over 1, 000 individuals attended the sessions with speakers from the Nebraska Department of Insurance and the Lincoln Area on Aging Agency LAAA ; . However, it was clear Medicare Part D has left many seniors with more questions than answers. In an effort to help the seniors in our community, LCMS staff has been asked by Congressman Fortenberry's office to join a community coalition to conduct enrollment sessions to help people without web access to enroll in a Medicare Part D plan. John Reed, M.D., presents the president's gavel to Mark Carlson, M.D. Dr. Carlson in turn, thanked Dr. Reed for his leadership and guidance of the board and the organization in the last year.
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BRAND and GENERIC NAME LITHIUM CARBONATE ER LITHIUM CITRATE LITHIUM CITRATE LITHOBID LITHOSTAT LO OVRAL LO OVRAL 28 LOCOID LOCOID LOCOID LOCOID LIPOCREAM LODOSYN LOESTRIN 1.5 30-21 LOESTRIN 1 20-21 LOESTRIN 24 FE LOESTRIN FE 1.5 30 LOESTRIN FE 1 20 LOFENE LOFIBRA LOFIBRA LOFIBRA LOFIBRA LOFIBRA LOKARA LOMOTIL LOMOTIL LONOX LOPERAMIDE HCL LOPID LOPRESSOR LOPRESSOR LOPRESSOR LOPRESSOR HCT LOPRESSOR HCT LOPRESSOR HCT LOPROX LOPROX LOPROX LOPROX SHAMPOO LORABID LORABID LORABID LORABID LORCET 10 650 LORCET PLUS LORCET-HD LORTAB LORTAB 10 LORTAB 2.5 LORTAB 5 LORTAB 7.5 LOTEMAX LOTENSIN LOTENSIN LOTENSIN LOTENSIN LOTENSIN HCT LOTENSIN HCT LOTENSIN HCT LOTENSIN HCT LOTREL STRENGTH 450 MG 8 MEQ 5ML 8 MEQ 5ML 300 MG 250 MG 30 MCG; 0.3 MG 30 MCG; 0.3 MG 0.1 % 0.1 % 0.1 % 0.1 % 25 MG 30 MCG; 1.5 MG 20 MCG; 1 MG 20 MCG; 75 MG; 1 MG 30 MCG; 75 MG; 1.5 MG 20 MCG; 75 MG; 1 MG 0.025 MG; 2.5 MG 67 MG 134 MG 200 MG 54 MG 160 MG 0.05 % 0.025 MG 5ML; 2.5 MG 5ML 0.025 MG; 2.5 MG 0.025 MG; 2.5 MG 2 MG 600 MG 1 MG 100 MG 25 MG; 50 MG 25 MG; 100 MG 50 MG; 100 MG 0.77 % 0.77 % 0.77 % 1% 200 MG 400 MG 100 MG 5ML 200 MG 5ML 650 MG; 10 MG 650 MG; 7.5 MG 500 MG; 5 MG 500 MG 15ML; 7.5 MG 15ML 500 MG; 10 MG 500 MG; 2.5 MG 500 MG; 5 MG 500 MG; 7.5 MG 0.5 % 5 MG 10 MG; 6.25 MG 10 MG; 12.5 MG 20 MG; 12.5 MG 20 MG; 25 MG 10 MG; 20 MG Form CONTROLLED RELEASE TABLET SOLUTION SYRUP CONTROLLED RELEASE TABLET TABLETS TABLETS TABLETS CREAM OINTMENT SOLUTION CREAM TABLETS TABLETS TABLETS TABLETS TABLETS TABLETS TABLETS CAPSULES CAPSULES CAPSULES TABLETS TABLETS LOTION LIQUID TABLETS TABLETS CAPSULES TABLETS SOLUTION TABLETS TABLETS TABLETS TABLETS TABLETS CREAM GEL SUSPENSION SHAMPOO CAPSULES CAPSULES SOLUTION SOLUTION TABLETS TABLETS CAPSULES ELIXER TABLETS TABLETS TABLETS TABLETS SUSPENSION TABLETS TABLETS TABLETS TABLETS TABLETS TABLETS TABLETS TABLETS CAPSULES Tier 1 3.
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