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Pharma NameBrand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management FDA official proposes user fees for generic drug approvals The Food and Drug Administration hopes to charge generic drug companies user fees to review generic drug applications, according to a draft of the speech Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, was scheduled to give to the Generic Pharmaceutical Association (GPhA) Friday in Florida. The draft of Gottlieb's remarks was posted ahead of schedule on the FDA's Web site.In the draft, Gottlieb said, "From our perspective at the FDA, we have seen user fee programs applied to our medical device and new drug programs with great success, enabling not only resources that underwrote scientific and process improvements in how we evaluate applications, but also enabling more collaborative opportunities to get insight into how we can make additional process improvements by working with sponsors." He went on to say in the draft that money raised from these user fees would allow the agency to review applications faster, to have better methods for showing the bioequivalence of complex and novel small molecule products and to enhance its post-market monitoring of adverse events involving generic drugs. The Washington Post recently reported that the FDA has a backlog of more than 800 applications for generic drugs but has no plans to hire additional reviewers to help process these applications. Critics of the user fee program contend that the FDA has a long-standing policy of underfunding the Office of Generic Drugs and allows the brand-name drug manufacturers to block final approval of generics, according to The Post. Kathleen Jaeger, president of the GPhA, said, "Our problem with user fees is that they currently would not guarantee that generic drugs would be reviewed and approved any faster." In a press release issued by the GPhA on Friday, Jaeger softened her stance somewhat by saying, "the generic pharmaceutical industry would consider paying user fees if the FDA and the Bush administration would endorse legislative and other changes that the industry believes would speed its products to market." Gottlieb's speech anticipated the charge that the FDA underfunds generic approvals by noting that the budget of the Office of Generic Drugs has doubled since fiscal year 2001 and the number of full-time personnel increased from 143 to 201. The Post noted that the Office of Generic Drug's budget of approximately $28 million a year is dwarfed by the more than $400 million given to the Office of New Drugs. Currently, user fees support approximately 50 percent of the FDA staff that reviews New Drug applications. The final decision as to whether user fees for generic drug applications will be enacted rests with Congress. According to The Post, Senate Budget Committee Chairman Judd Gregg, R-N.H., said he supports the generic user fees. Pharma Name FDA accepts GSK's sNDA to expand use of Hycamtin The Food and Drug Administration accepted GlaxoSmithKline Plc's supplemental New Drug Application for Hycamtin (topotecan hydrochloride) for injection seeking approval for use of Hycamtin in combination with cisplatin to treat stage IVb recurrent or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. According to GSK, the agency also agreed to a priority review of the sNDA, which is based on results from a Phase III trial conducted by the Gynecologic Oncology Group. In the trial, which included women with measurable histologically proven stage IVb recurrent or persistent cervix cancer, patients were randomized into three arms: cisplatin, cisplatin plus Hycamtin or MVAC (methotrexate, vinblastine sulfate, doxorubicin and cisplatin). The Data Safety Monitoring Board closed the MVAC arm early because of excessive toxicity, including four treatment-related deaths among 63 patients. The results showed a statistically significant survival advantage for Hycamtin plus cisplatin as compared with cisplatin alone. Median overall survival was 9.4 months in the combination arm compared with 6.5 months in the cisplatin arm; median progression-free survival was 4.6 months in the combination arm compared with 2.9 months in the cisplatin arm. Overall response rate was also superior in the Hycamtin plus cisplatin group (27 percent for the combination vs. 13 percent for cisplatin). The study was published in the July 20 issue of the Journal of Clinical Oncology. Hycamtin is currently approved to treat metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy and to treat small cell lung carcinoma sensitive disease after failure of first-line therapy. Pharma Name Two studies provide safety data regarding Ortho-McNeil's birth control patch Ortho Women's Health & Urology, a division of Ortho-McNeil Pharmaceutical Inc., released preliminary data from two studies of the Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system that demonstrated conflicting results on the risk of venous thromboembolic events (VTE) linked to the birth control patch. The first epidemiological study evaluated the combined risk of myocardial infarction and stroke in first-time users of Ortho Evra compared with first-time users of a norgestimate-containing oral contraceptive with estrogen 35 mcg. The researchers also examined the risk of MI, stroke and VTE in the same cohorts. The first paper from this study, which evaluated the risk of nonfatal VTE and was published on the Web site of the journal Contraception, concluded that the risk of nonfatal VTE for Ortho Evra is similar to the risk for the oral contraceptives. Although the evaluation of the primary objective is ongoing, the data to this point do not demonstrate an increased risk in the combined endpoint of MI and stroke, the company said. The primary endpoint of the second study, which has not been published, was to compare the combined risk of MI and stroke in users of the patch with the same risk in users of a norgestimate-containing oral contraceptive with 35 mcg of estrogen. The study was also designed to examine the risk of MI, stroke and VTE. As with the first study, the evaluation of the data is ongoing, but the currently available data do not demonstrate an increased risk of the combined endpoint of MI and stroke. The risk of VTE, however, increased approximately two-fold in users of Ortho Evra compared with users of the oral contraceptive. According to Ortho Women's Health & Urology, "VTE is a relatively rare event but has been reported as a potential risk of all hormonal contraceptive therapy." The company said it was sharing the data with the Food and Drug Administration and other health authorities. The Wall Street Journal reported that the FDA is reviewing data. According to The Journal, the agency warned last November that the patch could increase the risk of VTE because it contains more estrogen than a typical oral contraceptive. Pharma Name Barrier's Vusion receives FDA approval for candidiasis-related diaper dermatitis Barrier Therapeutics Inc.'s Vusion (0.25% miconazole nitrate/15% zinc oxide/81.35% white petrolatum) ointment, a treatment for diaper dermatitis complicated by candidiasis (DDCC), received approval from the Food and Drug Administration. According to Barrier, Vusion is the only treatment specifically formulated for DDCC in infants aged 4 weeks or older. Barrier said 40 percent of all diaper dermatitis cases treated by physicians are complicated by the yeast candida, the cause of candidiasis. In clinical trials, researchers observed statistically significant improvement in infants with DDCC within three days of applying Vusion. In a Phase III study of 236 children aged 3 years or younger with DDCC, more than twice the percentage of patients treated with Vusion experienced the elimination of the yeast and complete clearing of all signs and symptoms of the disease at day 14 as compared with patients treated with the control (zinc oxide and petrolatum). The company expects to ship Vusion in the second quarter of this year. Pharma Name Savient explores development strategies for wholly owned Rosemont Savient Pharmaceuticals Inc. hired Citigroup Corporate and Investment Banking to explore strategic alternatives for its wholly owned subsidiary, Rosemont Pharmaceuticals, including a possible spin off or sale of the business. Rosemont is a developer, manufacturer and marketer of oral liquid medicines in the United Kingdom. Savient expects that a significant portion of the net proceeds of any spin off or sale of the subsidiary will be earmarked for a stock repurchase plan this year. The board of directors has not yet approved the transaction and will not disclose information regarding the developments until a course of action has been approved. Additionally, Savient will continue to focus on the completion of the current clinical development program for Puricase (PEG-uricase), an investigational symptomatic gout treatment in Phase III trials. Savient seeks to develop the commercialization plan, which includes identifying potential Phase IV studies and strengthening long-term manufacturing activities. The company will also begin to examine other potential indications for the drug. Savient said it wants to focus on completing a transaction with a partner for the clinical development and commercialization of Puricase outside of the United States. Pharma Name Formulary status appears to affect patient adherence to chronic drugs, new evidence finds Patients enrolled in a three-tier pharmacy benefit plan who receive generic or preferred brand-name prescriptions for chronic therapy may achieve better adherence than those who receive nonpreferred branded drugs through the plan, new findings demonstrate. Researchers assessed pharmacy claims data from Anthem Prescription Management and Anthem Blue Cross and Blue Shield, a large managed care plan that provides coverage to Colorado and Nevada residents. Members who filled a new prescription for one of six classes of chronically used drugs (i.e., statins, oral contraceptives, orally inhaled corticosteroids, angiotensin receptor blockers, calcium channel blockers and ACE inhibitors) between Oct. 1, 2001, and Oct. 1, 2002, were included in the analysis. All members were enrolled in plans with at least three tiers. In total, 7,532 new prescriptions were filled--23.2 percent for nonpreferred brand-name drugs (third tier, highest copayments), 58.1 percent for preferred drugs (second tier, moderate copays) and 18.7 percent for generic drugs (first tier, lowest copays). Adherence, as measured by the proportion of days patients possessed a supply of their prescribed study drugs, ranged from 20.6 percent to 64.9 percent across the six drug classes. After controlling for patient sociodemographic factors and drug class, the results indicated that adherence was 12.6 percent higher among patients who were initially prescribed a generic drug as compared with patients prescribed a nonpreferred drug (58.8 percent vs. 52.2 percent). Furthermore, patients who received generic drugs had 62 percent higher odds of achieving adequate adherence as compared with those who received nonpreferred drugs. For patients initially prescribed preferred drugs versus nonpreferred drugs, the adherence rate was 8.8 percent higher. These patients had 30 percent greater odds of achieving adequate adherence as compared with those who received nonpreferred prescriptions. The study appeared in the Feb. 13 issue of Archives of Internal Medicine. Pharma Name Pharma Name King Pharmaceuticals Inc. King Pharmaceuticals Inc. entered into a collaboration with Arrow International Ltd. to commercialize certain formulations of King's Altace (ramipril), an ACE inhibitor. Specifically, Arrow has given King rights to current and future New Drug Applications involving novel formulations of the ACE inhibitor and intellectual property related to the novel formulations. Arrow will be responsible for manufacturing and supplying the new formulations of Altace for King, under certain unnamed conditions. In return, King made an up-front payment of $35 million to Arrow, which will also receive $50 million based on the timing of specific events and could receive another $25 million if certain conditions are met. Arrow will also be paid for manufacturing and supplying the new formulations. Pharma Name Pharma Name Novavax Inc. Novavax Inc. entered into a research collaboration with researchers at the University of Pittsburgh School of Medicine to study the efficacy of virus-like particle (VLP) influenza vaccines and Novasomes (paucillamellar non-phospholipid liposomes). As part of the agreement, scientists at the university will work with Novavax scientists to evaluate the full range of immunity elicited by Novavax's influenza VLP vaccines and the ability of its Novasomes to lower the dose of antigen needed to protect against influenza virus infection. Pharma Name Pharma Name Alkermes Inc. Alkermes Inc. submitted a complete response to the approvable letter issued in December by the Food and Drug Administration regarding the company's New Drug Application for Vivitrol (naltrexone), an investigational, extended-release, injectable suspension for the treatment of alcohol dependence. The company expects the FDA to classify the response as a Class I resubmission, which the FDA would likely review within 60 days of resubmission. The NDA for the drug was submitted last March, and in June the company entered into a collaborative agreement with Cephalon Inc. to develop and commercialize Vivitrol in the United States. Pharma Name Pharma Name AEterna Zentaris Inc. AEterna Zentaris Inc. said the National Cancer Institute interrupted recruitment for the company's Phase III trial of Neovastat, an investigational treatment for non-small cell lung cancer, following a recommendation by the trial's Data Safety Monitoring Board. AEterna said the DSMB's recommendation was "based solely on a slow patient recruitment rate." The NCI is awaiting interim efficacy data analysis. According to AEterna, the trial will proceed as planned. The double-blind, placebo-controlled trial includes patients with inoperable stage IIIa and IIIb NSCLC. Researchers are evaluating the effects of Neovastat combined with radiotherapy and chemotherapy. Pharma Name
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