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			Package Designs Brand 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 CDC advisory panel advises pediatric use of Merck's RotaTeq rotavirus vaccine An advisory committee of the Centers for Disease Control and Prevention voted unanimously to recommend Merck & Co. Inc.'s RotaTeq (rotavirus vaccine, live, oral pentavalent) as a protectant against rotavirus gastroenteritis in pediatric patients. Infants should receive the oral vaccine at 2, 4 and 6 months of age, the Advisory Committee on Immunization Practices recommended, so that all three doses are completed by 32 weeks of age. The vaccine can prevent infants and young children from acquiring diarrhea, vomiting, fever and dehydration caused by rotavirus. If the CDC director accepts the recommendations and they are published in the Morbidity and Mortality Weekly Report, they will become official recommendations of the CDC. "Nearly every child in the United States is infected with rotavirus by age 5 and most will develop gastroenteritis, leading to a large number of physician visits, emergency room visits and hospitalizations, with a few deaths," said Dr. Anne Schuchat, director of the CDC's National Immunization Program. "Therefore, this vaccine will help reduce one of our most common and potentially severe childhood illnesses." In Phase III trials, RotaTeq prevented 74 percent of rotavirus gastroenteritis cases caused by the four serotypes targeted by the vaccine (G1, G2, G3 and G4). It also prevented 98 percent of severe cases, including 96 percent of those that required hospitalization. A trial that included more than 70,000 children also demonstrated no association between RotaTeq and a higher risk of intussusception, or bowel obstruction. Wyeth's RotaShield (live attenuated rotavirus, quadrivalent), a different rotavirus vaccine, was taken off the market in 1999 because it was associated with intussusception. "[RotaTeq] is made differently and was not associated with intussusception in a large clinical trial," Schuchat explained. "Nevertheless, we will continue to very closely monitor this vaccine to ensure there are no problems. At the same time, it's important to remember that the known benefits of the vaccine far outweigh any known risks." Both the CDC and the Food and Drug Administration will monitor reports of intussusception and other serious adverse events through their Vaccine Adverse Event Reporting System and the CDC's Vaccine Safety Datalink Program. Merck has also agreed to conduct a post-licensure study of approximately 44,000 children and to report cases of intussusception to the FDA within 15 days of receipt. Package Designs Progenics' PRO 140 granted fast track status for HIV Progenics Pharmaceuticals Inc.'s PRO 140 received fast track designation from the Food and Drug Administration as an experimental treatment for HIV infection. PRO 140, a humanized monoclonal antibody, is currently being evaluated in Phase Ib trials among patients with HIV. The drug is designed to be a viral entry inhibitor; it is directed against the CCR5 molecular portal, which allows HIV to enter healthy cells, without disrupting the normal function of CCR5. "PRO 140 may represent a new treatment paradigm for HIV patients, because it has the potential to address the limitations of currently available therapies, including the emergence of multi-drug-resistant virus, significant side effects, drug-drug or drug-food interactions, and often complex daily treatment regimens," the company explained in a press release. During one completed Phase I trial, PRO 140 showed dose-dependent binding to CCR5-expressing cells. Also, at a single 5 mg/kg of body weight dose, PRO 140 significantly coated--and thus potentially protected from HIV infection--CCR5 cells for up to 60 days. Package Designs Schering-Plough's Noxafil receives FDA priority review for treatment of invasive fungal infections in high-risk patients The Food and Drug Administration granted a six-month priority review to Schering-Plough Corp.'s New Drug Application for Noxafil (posaconazole) oral suspension, an investigational broad-spectrum triazole antifungal agent, for the prevention of serious invasive fungal infections (IFIs) in high-risk patients. Schering-Plough is seeking an indication for the prophylaxis of IFIs, including both molds and yeasts, in patients with compromised immune systems who have a high risk of developing these infections, such as patients who have undergone hematopoietic stem cell transplants or patients with prolonged neutropenia. The company is also seeking marketing approval of the drug to treat oropharyngeal candidiasis (OPC), including refractory infections. The company was granted a 10-month review from the FDA for this indication. OPC, often referred to as thrush, is a fungal infection of the mouth and throat caused by the yeast Candida. Schering-Plough filed a similar application for Noxafil to be approved for these indications in the European Union, where the product is currently approved for the treatment of certain IFIs in adult patients who are intolerant of or refractory to commonly used antifungal agents. Package Designs Axcan's Itax does not meet primary endpoint in Phase III trial Results from a Phase III trial demonstrated that Axcan Pharma Inc.'s Itax (itopride hydrochloride), a drug developed for the treatment of functional dyspepsia, did not meet its primary endpoint. The company said it is surprised by the results of the trial, particularly because it did not confirm the efficacy observed in other studies. Axcan intends to examine all potential factors relating to the trial results and conduct additional analysis of the subgroup populations. This data, together with the results of the North American Phase III study, which are expected to be announced by the end of the first half of 2006, should help clarify the outcome and help the company decide on the continuation of the drug for functional dyspepsia. "While we complete our assessment of the [Itax] program's future, we will focus on other opportunities to accelerate growth of the company by leveraging our solid business base and executing on our growth strategy," Dr. Frank Verwiel, the company's chief executive officer, stated. Axcan will continue development of Itax in other areas such as diabetic gastropathy. Shares of Axcan closed at $11.76, down $4.57, or 28 percent, in heavy trading on the Nasdaq. Package Designs CombinatoRx's CRx-140 fails to meet endpoints in Phase II trial; company discontinues development as oral psoriasis treatment CombinatoRx Inc. is discontinuing the development of CRx-140 as an oral psoriasis treatment after the drug did not meet the primary or secondary efficacy endpoints in a recent Phase II trial. In the trial of CRx-140--a syncretic drug designed to treat immuno-inflammatory diseases--103 patients with psoriasis were randomized to receive CRx-140 or cyclosporine for 12 weeks. Both treatments decreased the severity of psoriasis, according to the Physician Global Assessment and the Psoriasis Area Severity Index, but the difference between the two arms was not statistically significant. CombinatoRx plans to focus its resources on other candidates in its portfolio. CRx-140, which contains a low dose of cyclosporine and loratadine, is one of seven product candidates the company is testing in Phase II trials. Data from the trials of the other candidates are expected to be released this year. Shares of CombinatoRx closed at $12.54, down $0.66, or 5 percent, in heavy trading on the Nasdaq. Package Designs U.S. drug sales grew in 2005; trend expected to continue Data from IMS Health Inc. show that U.S. prescription drug sales grew 5.4 percent to $251.8 billion in 2005 from $238.9 billion in 2004, although fewer drugs were introduced into the market last year. After adjusting for long-term mail-order prescriptions, the volume of U.S. dispensed prescriptions increased 4.7 percent from 2004. IMS Health cited several factors that influenced the 2005 pharmaceutical market, including fewer approved new chemical entities, fewer and lower-performing product launches, decreased use of COX-2 drugs and more aggressive generic launches. For example, the generics market, which is usually a volatile segment, experienced a 20.6 percent growth in sales last year. Biologic product sales grew 17.2 percent to $32.8 billion, spurred by Amgen Inc.'s Aranesp (darbepoetin alfa) anemia therapy, arthritis drug Enbrel (etanercept) and Neulasta (pegfilgrastim) neutropenia treatment as well as Genentech Inc. and Biogen Idec Inc.'s non-Hodgkin's lymphoma drug, Rituxan (rituximab). Enbrel is co-promoted by Wyeth. Pfizer Inc.'s cholesterol-lowering drug Lipitor (atorvastatin calcium) remained the highest selling product with U.S. sales of $8.4 billion in 2005, an increase of 8 percent from 2004. AstraZeneca Plc's proton pump inhibitor Nexium (esomeprazole), Sanofi-Aventis Group and Bristol-Myers Squibb Co.'s thrombosis treatment, Plavix (clopidogrel bisulfate), Enbrel and Aranesp all had double-digit growth in sales. However, only 20 new molecular entity approvals occurred in 2005 compared with 36 in 2004. Last year also saw the approval of Eli Lilly and Co.'s diabetes therapy Byetta (exenatide), Pfizer's neurology drug Lyrica (pregabalin) and Sepracor Inc.'s Lunesta (eszopiclone) insomnia treatment; these treatments are considered to be potential blockbusters. Byetta is co-marketed by Amylin Pharmaceuticals Inc. Throughout the next five years, IMS Health expects annual growth to increase by between 5 and 8 percent, "sustained by new product launches, recovery from COX-2 [inhibitor] withdrawals and increased utilization through Medicare Part D." Anticipated launches in 2006 consist of Sanofi-Aventis' Acomplia (rimonabant) for obesity, Pfizer's Sutent (sunitinib malate) for cancer and Exubera (insulin human [rDNA origin]) inhalation powder for diabetes as well as Pfizer and Neurocrine Biosciences Inc.'s indiplon for insomnia. Their market introduction could help offset the nearly $18 billion in sales that are at risk from patent expiration this year. "The U.S. market's continued success this year will depend largely on enrollment in the new Medicare benefit, the ability to overcome safety concerns and new product launches to make up for the higher level of patent expirations. New strategies will be needed by pharmaceutical manufacturers to meet the challenges of this environment," explained Diana Conmy, corporate director of IMS Health's market insights division. Package Designs Package Designs Takeda Pharmaceutical Co. Ltd. Takeda Pharmaceutical Co. Ltd. won a patent infringement case regarding diabetes treatment Actos (pioglitazone hydrochloride), which is co-marketed with Eli Lilly and Co. in the United States. A U.S. district court judge ruled that the patent covering the drug's active ingredient was valid and enforceable, a ruling that prevents Alphapharm and Mylan Pharmaceuticals Inc. from selling generic versions of the product until the 2011 patent expiration. Other patents related to Actos expire in 2016. Package Designs Package Designs Valeant Pharmaceuticals International Valeant Pharmaceuticals International said the Food and Drug Administration approved less-restrictive labeling for Tasmar (tolcapone), an adjunctive catechol-O-methyltransferase inhibitor used in combination with levodopa/carbidopa, for the treatment of Parkinson's disease. Laboratory monitoring may now be less frequent, and patients may remain on the drug at higher alanine aminotransferase (ALT) levels than previously required. A data analysis revealed only rare elevations of certain ALT levels in patients treated with Tasmar. Package Designs Package Designs Chugai Pharmaceutical Co. Ltd. Chugai Pharmaceutical Co. Ltd. completed its assessment of Cambrex Bio Science Walkersville Inc.'s Clonetics conditionally immortalized cell lines, and the firms signed a renewable one-year license agreement. Under the terms of the agreement, Chugai will use one of the cell lines in its drug discovery program for metabolic diseases. Cambrex created the cell lines using a clone of a specially modified large T antigen and licensed telomerase technology. Financial details of the agreement were not disclosed. Package Designs Package Designs Roxane Laboratories Inc. Roxane Laboratories Inc. received approval from the Food and Drug Administration for fluticasone propionate nasal spray, a generic version of GlaxoSmithKline Plc's Flonase. The spray is intended to treat nasal symptoms of seasonal and chronic allergic and nonallergic rhinitis. The product is approved for use in adults and children aged 4 years or older. Package Designs


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