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Pharmaceutical BrandingBrand 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 ISSUES APPROVABLE LETTER FOR SCHERING'S BONEFOS, REQUESTS ADDITIONAL DATAThe Food and Drug Administration issued an approvable letter for Schering AG's Bonefos (clodronate), a drug designed to reduce the occurrence of bone metastases in the post-surgical treatment of patients with breast cancer. In a press release, Schering said its U.S. affiliate Berlex Inc. will request a meeting with the FDA to determine what additional information will be required to obtain approval for Bonefos. "As everybody expected straightforward approval today, the approvable letter is more than disappointing," Dr. Martin Possienke, an analyst for German broker Equinet, told CBS MarketWatch. "If [the FDA wants] additional clinical data, it would be catastrophic for Schering as most likely [Schering] cannot provide supporting data before 2007." Karl-Heinz Scheunemann, an analyst at Bankhaus Metzler & Co. KGaA, told Bloomberg.com that the delay in approval is probably due to "technical issues, rather than concern about the drug's safety." Scheunemann also estimated that, if approved, Bonefos might have sales of $264 million in the United States. In September 2004, the FDA granted priority review for Bonefos. The drug is already approved in 79 countries to treat tumor-related breakdown of bones and excessive calcium in the blood, Bloomberg.com reported. Shares of Schering closed at $70.10, down $4.31, or 5.8 percent, in heavy trading on the New York Stock Exchange. CMS INITIATES DEMONSTRATION PROJECT FOR FLU DRUGS Under a new demonstration project, the Centers for Medicare & Medicaid Services will help senior patients pay for two influenza drug prescriptions until May 31. The project is designed to help determine whether coverage for these drugs could reduce the flu's effects on Medicare beneficiaries, especially those without drug coverage. "This demonstration program will provide useful evidence on how prescription drug coverage affects the health and costs for Medicare beneficiaries ahead of the drug benefit in 2006," said Dr. Mark McClellan, administrator of CMS. GlaxoSmithKline Plc's Relenza (zanamivir), F. Hoffman-La Roche Ltd.'s Tamiflu (oseltamivir phosphate), amantadine and rimantadine are approved to treat influenza in the United States. Roche has licensed Tamiflu from Gilead Sciences Inc. For patients with Medicare Part B and no drug coverage, Medicare will pay 80 percent of the drug cost up to the Medicare allowed payment if the patients have met their Part B deductible. For beneficiaries in the Medicare-Approved Drug Discount Program, 20 percent of the card sponsor's negotiated drug cost or the Medicare allowed payment--whichever is lower--will be paid. Patients under the Transitional Assistance, Medicare Advantage and Part A hospital stay coverage will also have the antiviral drugs covered. McClellan emphasized that influenza vaccination is still the best protection for Medicare beneficiaries. However, flu drugs may alleviate complications from the virus or reduce the likelihood of contracting the flu. AAN PUBLISHES PRACTICE PARAMETER FOR PHARMACOLOGICAL TREATMENT OF PEDIATRIC MIGRAINE In a recent report outlining pharmacological recommendations for the treatment of migraine in children and adolescents, the American Academy of Neurology (AAN) Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society recommended ibuprofen and acetaminophen as safe and effective treatments for acute migraine in children, and GlaxoSmithKline Plc's Imitrex (sumatriptan) nasal spray as safe and effective in adolescents. The AAN, in conjunction with the Child Neurology Society and the American Headache Society, identified and reviewed 166 articles reporting on the pharmacologic treatment of migraine in these patient populations. Five acute treatment options and 12 preventive treatment options were evaluated. Researchers developed a four-tiered classification system to determine whether or not a recommendation should be made and, if so, the strength of that recommendation. Ratings were based on the type of trial from which the data were extracted as well as on the strength and consistency of the conclusions drawn. Investigators cited two double-blind, placebo-controlled trials demonstrating the safety and efficacy of ibuprofen 7.5 to 10 mg/kg of body weight in children with migraine. The first of these trials also included a group of patients treated with acetaminophen 15 mg/kg of body weight, in which acetaminophen was determined to be both well tolerated and significantly more effective than placebo in providing pain relief. As a result of these findings, ibuprofen was recommended as effective while acetaminophen was recommended as "probably effective." The investigators also reviewed three controlled trials demonstrating the efficacy and tolerability of Imitrex 5 mg and 20 mg nasal spray in adolescents. However, they found no data to support or refute the safety and efficacy of the oral formulations and inadequate data pertaining to subcutaneous formulations. Therefore, only Imitrex nasal spray was recommended as effective in adolescent patients. Preventive treatment options included an antihistamine (cyproheptadine), antihypertensive agents (propranolol, clonidine), antidepressants (amitriptyline, trazodone, pizotifen), anticonvulsants (Abbott Laboratories' Depakote [divalproex sodium], topiramate, UCB Pharma Inc.'s Keppra [levetiracetam]) and calcium channel blockers (Bayer AG's Nimotop [nimodipine], flunarizine). Of these agents, cyproheptadine, amitriptyline, Depakote, topiramate, Keppra, propranolol and trazodone were not recommended due to insufficient or conflicting data. Pizotifen, Nimotop and clonidine were classified as probably ineffective and, therefore, were not recommended for use. Flunarizine was the only agent that received a rating of "probably effective" in this patient population. However, like pizotifen, flunarizine is not available in the United States. "[T]here is a clear and urgent need for methodologically sound randomized controlled trials for the use of prophylactic drugs in pediatric migraine," the authors commented. The complete report was published in the Dec. 28 issue of the journal Neurology. ZOMIG NASAL SPRAY EFFECTIVE IN ACUTE TREATMENT OF MIGRAINE, ACCORDING TO NEW DATA The results of a large, multicenter trial, REALIZE, suggest that AstraZeneca Plc's Zomig (zolmitriptan) 5 mg nasal spray is effective in treating acute migraine pain. During the first phase of the two-phase study, researchers conducted a double-blind comparison of Zomig and placebo in the treatment of a single migraine attack. A total of 1,044 migraine patients were randomized to receive Zomig 5 mg nasal spray (n=527) or placebo (n=517); 461 Zomig-treated patients and 451 placebo-treated patients were included in the intent-to-treat analysis. Of these patients, 91.4 percent usually experienced photophobia during migraines, 87.1 percent usually experienced phonophobia, 87.8 percent usually experienced nausea and 46.8 percent usually experienced vomiting. Participants were each given two doses of the study drug and were allowed to treat migraines of any intensity and at any time during the headache with the first dose. Patients were permitted to take the second dose of the study drug, or another approved escape medication, if pain relief remained insufficient after two hours. Diary cards were used to document efficacy, with headache intensity characterized both before and after treatment as none, mild, moderate or severe. The primary efficacy endpoint was total symptom relief, defined as freedom from pain, nausea, photophobia and phonophobia after one hour, regardless of baseline pain intensity. The primary efficacy endpoint was achieved by a significantly larger percentage of patients randomized to Zomig (14.5 percent) compared with placebo (5.1 percent). The authors noted that the difference between the two groups was statistically significant after 30 minutes (6.1 percent vs. 2.1 percent, respectively). Additionally, more patients receiving Zomig achieved total symptom relief after two hours, regardless of baseline pain intensity (mild, 61.3 percent vs. 15.8 percent; moderate, 33.2 percent vs. 9.0 percent; severe, 23.9 percent vs. 4.8 percent). A larger percentage of Zomig-treated patients also achieved a headache response (reduction from severe or moderate pain to mild or none), a difference that was statistically significant at 10 minutes post-dose, the authors noted. Furthermore, significantly more Zomig-treated patients were pain free after 30 minutes, had sustained pain-free status after 24 hours and reported a reduced impact of migraine on normal activities after two hours. The study appeared in the January issue of Headache. STUDY SHOWS ACCESS TO EMERGENCY CONTRACEPTION MAY NOT ALTER SEXUAL RISK BEHAVIOR, USE OF CONTRACEPTION Newly published research suggests it may be "unreasonable" to restrict patient access to emergency contraception (EC) to the clinic setting given that such access does not appear to alter contraceptive use or sexual risk behavior. Researchers conducted a single-blind, controlled trial involving 2,117 women aged 15 to 24 years who were attending four California clinics that provide family planning services. The women were not using long-term hormonal contraception, not desiring pregnancy and not requesting EC. Patients were randomized to one of three groups: those with pharmacy access to EC, those provided with three packs of levonorgestrel EC and those with access to EC through a clinic setting (control group). Women who were given three packs of levonorgestrel EC were nearly twice as likely to use EC than those in the control group (37.4 percent vs. 21.0 percent, respectively), but the frequency of unprotected intercourse was similar for these two groups (39.8 percent vs. 41.0 percent, respectively). Women in the pharmacy access group were no more likely to use EC (24.2 percent) than those in the control group. Of all the subjects, 37.5 percent reported having unprotected intercourse during the study period. When researchers compared results from each of the groups, there were no significant differences in patterns of contraceptive use or sexual risk behaviors. As for EC use, 46.7 percent of all women who had unprotected sex reported using EC one or more times. The study authors suggested that these results support the findings of others studies, which have shown that "among young sexually active women, unprotected intercourse leads to EC use, not the converse." "[T]here is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior," the authors concluded, suggesting that restricting access to EC may be unwarranted. The study results appeared in the Jan. 5 issue of JAMA. SCHERING-PLOUGH'S PEG-INTRON EFFECTIVE AS MONOTHERAPY FOR CHRONIC HEPATITIS B, ACCORDING TO NEW STUDY Combination therapy with Schering-Plough Corp.'s Peg-Intron (peginterferon alfa-2b) and GlaxoSmithKline Plc's Epivir (lamivudine) does not appear to be superior to Peg-Intron monotherapy when they are administered for 52 weeks to patients who are Hepatitis B e antigen (HBeAg)-positive and have chronic hepatitis B (HBV), data from a new study show. GSK manufactures Epivir under an agreement with Shire Pharmaceuticals Group Plc. During the study, 307 patients were randomized to 100 mcg of Peg-Intron weekly plus placebo or plus 100 mg/day of Epivir. At 32 weeks, the Peg-Intron dose was lowered to 50 mcg per week for both treatment groups. Dosages were also adjusted for patients who weighed 55 kg or less. At 52 weeks, 242 patients remained on treatment; follow-up continued until week 78. In the final modified intent-to-treat analysis of 266 patients, a higher proportion of patients in the combination therapy group rather than the monotherapy group showed a response as assessed by the loss of serum HBeAg (44 percent vs. 29 percent). However, this difference was not sustained to week 78, when 35 percent of the combination therapy arm and 36 percent of the monotherapy group sustained the response. Similarly, 74 percent of the combination therapy-treated patients showed HBV DNA that was suppressed to below 200,000 copies/mL at treatment end as compared with 29 percent of patients who received Peg-Intron plus placebo. Again, the greater HBV DNA suppression in the combination therapy group was not sustained during follow-up. The pattern was similar for the other secondary outcome measures of HBV DNA concentrations below the level of detection and normalized alanine amino-transferase concentration. "Lack of durability could be due to the mechanism of action of [Epivir], which suppresses viral replication without inducing the HBV-specific immune response necessary for sustained viral eradication," the researchers said. They also found HBV genotype to be an independent predictor of response to Peg-Intron for the treatment of chronic hepatitis B. This study was published in the Jan. 8 issue of The Lancet. Pharmaceutical Branding WYETH PHARMACEUTICALS Wyeth Pharmaceuticals submitted an Investigational New Drug application to the Food and Drug Administration for the evaluation of ViroPharma Inc.'s HCV-796 compound. Preclinical studies have shown the polymerase inhibitor may be more potent than other compounds previously developed by the companies to treat the hepatitis C virus. The companies are collaborating to develop and commercialize antiviral compounds for hepatitis C. ViroPharma hopes to begin proof-of-concept studies with HCV-796 during the second quarter of 2005. Pharmaceutical Branding BARR LABORATORIES INC. Barr Laboratories Inc. received tentative approval from the Food and Drug Administration for mirtazapine orally disintegrating tablets 45 mg, a generic equivalent to Organon Inc.'s depression treatment Remeron Soltab 45 mg. Barr said it anticipates final approval for the drug following the expiration of exclusivities surrounding this product. Based on IMS data, Barr said Organon's sales of Remeron Soltab 45 mg were approximately $17 million for the 12-month period ending November 2004. Pharmaceutical Branding THE CENTERS FOR MEDICARE & MEDICAID SERVICES The Centers for Medicare & Medicaid Services is proposing to cover Merck & Co. Inc.'s Emend (aprepitant) when used in combination with two other anti-emetic drugs to treat chemotherapy-induced nausea and vomiting. According to CMS, trial results have shown that Emend is more effective for this indication when it is used along with other anti-emetic drugs. CMS plans to cover the drug if it is used with a 5-HT3 antagonist and dexamethasone in patients who do not respond to standard drugs intended for these nausea and vomiting symptoms. Pharmaceutical Branding GEMIN X BIOTECHNOLOGIES INC. Gemin X Biotechnologies Inc. initiated a Phase I/II trial of its investigational drug GX15-070 as a treatment for chronic lymphocytic leukemia (CLL), according to a press release. GX15-070 is a small-molecule inhibitor of Bcl-2 proteins designed to restore the natural process of cell death often inhibited in cancer cells. The open-label, dose-escalation study will involve patients with CLL who have been treated previously with an alkylating agent and fludarabine phosphate. Gemin X also said the Food and Drug Administration granted orphan drug status to GX15-070. Pharmaceutical Branding
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