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			branding Experts 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 Celebrex-treated patients show higher odds than do other patients of experiencing MI, according to analysis of six trials A new systematic review and meta-analysis indicates that Pfizer Inc.'s Celebrex (celecoxib) may increase the risk of myocardial infarction to a similar extent as do other members of the COX-2 specific inhibitor drug class. Researchers in New Zealand culled data from bibliographic databases, Food and Drug Administration files and pharmaceutical company Web sites. All six trials included in the analysis were randomized, placebo-controlled, double-blind trials that studied Celebrex for at least six weeks and presented data on serious cardiovascular thromboembolic events. The primary study analysis compared Celebrex with placebo among 4,422 patients involved in four of the placebo-controlled trials. Three of the studies reported that 29 MIs occurred in 2,574 of the Celebrex-treated patients, while only six occurred in the 1,447 placebo-treated subjects. Thus, the odds that patients treated with Celebrex experienced MI was 2.26 times the odds in the placebo group. However, the odds of experiencing cerebrovascular events, cardiovascular death or composite cardiovascular events were not significantly higher in the Celebrex arms of the four trials. Results were similar in the secondary meta-analysis, which compared Celebrex with placebo, diclofenac, ibuprofen and paracetamol in all six trials of 12,780 patients. The odds of MI with Celebrex were 1.88 times higher than were the odds with any of the comparator drugs. Celebrex was not associated with a significant increase in any of the other outcome measures. The investigators noted, however, that the six studies were neither powered nor specifically designed to determine Celebrex-associated risk of cardiovascular thromboembolic events. Still, they concluded, "This finding would suggest that the preferential risk/benefit assessment afforded [Celebrex] over other COX-2 inhibitors by the FDA may not be supported by the currently available evidence." This study was published in the March issue of the Journal of the Royal Society of Medicine. According to Professor Richard Beasley, who spoke to Dow Jones Newswires, "These findings are critical, as the risk is similar in magnitude to the 2.24-fold increased risk of heart attack with [Merck & Co. Inc.'s] Vioxx [(rofecoxib)]." Mark Crotty, general manager at Pfizer New Zealand Ltd., told Dow Jones the results were "extremely misleading" because the study is "very much an incomplete review of the data--selecting six studies out of 48 available." He went on to say, "We very much dispute and are concerned with the nature of these findings. It's concerning for people who have been through a lot of uncertainty on the use of this medication ... ." branding Experts Avastin may be linked to cases of leukoencephalopathy syndrome Roche will brief the Food and Drug Administration regarding rare cases of a brain condition seen in some patients taking Avastin (bevacizumab), a blockbuster cancer drug the company developed with Genentech Inc., Reuters reported. The New England Journal of Medicine released correspondence received from physicians at Stanford University Medical Center and the Medical College of Wisconsin speculating that Avastin was directly associated with the development of reversible posterior leukoencephalopathy syndrome (RPLS) in two women taking the drug. RPLS can result in blindness. In the first case, a woman aged 59 years who received seven injections of Avastin for the treatment of metastatic renal cancer presented to the emergency department with severe lethargy and was subsequently admitted after experiencing a tonic-clonic seizure. The physicians noted that the patient's blood pressure fluctuated and that a neurological examination of the patient revealed cortical blindness and extensor plantar responses. Magnetic resonance imaging showed extensive leukoencephalopathy in the subcortical (distal vasculature) distribution. The patient made a rapid recovery, and the follow-up MRI six weeks later showed complete resolution of the leukoencephalopathy. In the second case, a woman aged 52 years who received three cycles of chemotherapy with fluorouracil, leucovorin calcium and Sanofi-Aventis Group's Eloxatin (oxaliplatin) presented with acute bilateral loss of vision, headache and confusion 16 hours after the first dose of Avastin was administered. A physical examination of the patient showed that she had high blood pressure, enlargement of the liver and bilateral cortical visual loss with normal optic fundi. The physicians said this clinical presentation and the patient's imaging results were characteristic of RPLS. After stringent blood-pressure control, the patient's vision improved rapidly to a full recovery by the third day. The physicians involved in this case said Avastin may have induced vasospasm, which, along with the patient's hypertension, led to RPLS. In a response to the physicians' letters, Genentech's Dr. Hal Barron wrote, "We agree that the two patients reported meet the clinical criteria for RPLS. At this time, we are reviewing the global safety database to look for cases with clinical signs and symptoms associated with RPLS and are investigating one additional case." title="branding company" Roche spokesman Alexander Klauser said in a Reuters article that "[t]his is a very rare syndrome and it is reversible as well. We will be updating regulators with these findings so prescribers can change treatment as required. We are not aware of any additional cases." According to Reuters, Genentech will work with the FDA to add information about the potential risk for RPLS to the drug's label. branding Experts New hepatotoxicity information added to Tracleer label Actelion Pharmaceuticals U.S. Inc. and the Food and Drug Administration notified health care providers that new hepatotoxicity information has been added to the prescribing information for Tracleer (bosentan), a treatment for pulmonary arterial hypertension. In a letter to health care professionals, Actelion said it received reports of rare cases of hepatotoxicity in patients taking the drug. In one case, a female patient with PAH and multiple comorbidities was treated with the recommended dose of Tracleer for 21 months. At this time, Tracleer treatment was discontinued due to marked elevations in her aminotransferase and bilirubin levels. After treatment was ended, her levels remained elevated and she developed liver failure and cirrhosis. Her liver failure eventually subsided and, approximately seven months after she stopped taking the drug, her liver function tests recovered. "This case underscores the need to continue monthly monitoring for the duration of Tracleer treatment," Actelion said, adding that it also emphasizes the need to follow the label's guidelines for dosage adjustment and monitoring. Actelion noted that patients taking Tracleer are already being called each month with a reminder to take monthly liver function tests. If patients say they have not taken the tests, the Tracleer distributor notifies the prescribing physician. branding Experts Medicis' Vanos corticosteroid cream approved for additional indication Medicis Pharmaceutical Corp.'s Vanos (fluocinonide) was approved as a primary treatment for all pruritic and inflammatory skin conditions that are responsive to corticosteroids, such as eczema and poison ivy, in patients aged 12 years or older. The drug, a Class I corticosteroid, was already approved to treat plaque-type psoriasis. Medicis noted that Vanos is a convenient, highly potent cream that can be applied one or two times per day for psoriasis and once a day for other indications. Vanos is under patent protection until 2021 and is available in 30 g and 60 g sizes. branding Experts UCB submits BLA for investigational Crohn's disease treatment Cimzia UCB Group submitted a Biologics License Application to the Food and Drug Administration for the approval of Cimzia (certolizumab pegol) as a treatment for Crohn's disease. If approved, Cimzia would be the first PEGylated Fab' fragment of a humanized anti-TNF alpha antibody. It would also be the first biologic to treat Crohn's disease via subcutaneous injection, the firm noted. The BLA included safety and efficacy data from clinical trials with a total of more than 1,500 patients with Crohn's disease. The studies, known as PRECiSE 1 and PRECiSE 2, met their primary endpoints, demonstrating that Cimzia induced and maintained a clinical response and remission in a significant percentage of the patients. The company plans to request marketing authorization from the European Agency for the Evaluation of Medicinal Products within a few weeks. In addition to trials in Crohn's disease, Cimzia is also being studied as a treatment for rheumatoid arthritis and psoriasis. branding Experts Merck ends collaboration with Nastech for investigational obesity nasal spray Merck & Co. Inc. terminated its collaboration agreement with Nastech Pharmaceutical Co. Inc. for PYY3-36 nasal spray (PYY), which is intended to treat obesity, because of a lack of efficacy. Nastech's shares fell 37.3 percent on the news. Merck concluded that Nastech's intranasal formulation of PYY3-36 is not efficacious based on the results of a preliminary proof-of-concept study. Nastech, however, said its review of the data showed the formulation to be capable of safely delivering the drug to the blood stream via nasal administration. "Based on our review, Nastech believes that clinical trial results to date support the continued development of this important investigational product for the treatment of obesity, and we remain committed to the further advancement of the PYY clinical program this year," said Dr. Steven Quay, chief executive officer of Nastech. Quay added that the firm has the financial and human resources to advance the drug's development. After it successfully completes dose optimization studies, the company will begin Phase II trials and seek a new commercialization partner for the drug. The termination is expected to add approximately $3.7 million in revenue to Nastech during the first quarter. Shares of Nastech closed at $14.43, down $8.59, in heavy trading on the Nasdaq. branding Experts branding Experts Pfizer Inc. Pfizer Inc. entered into an agreement with NicOx SA for exclusive rights to use NicOx's proprietary nitric oxide-donating technology to discover potential ophthalmology drugs. Pfizer also has the option to obtain an exclusive worldwide license to develop and commercialize any resulting compounds in the ophthalmology field. The firm will pay $27.3 million to NicOx in the first year of the collaboration, of which approximately $18 million will be an equity investment in NicOx. NicOx will also receive research funding and possible milestones payments of more than $356.2 million and royalties on any resulting marketed products. branding Experts branding Experts Abbott Abbott's legal action against Takeda Pharmaceutical Co. Ltd. was dismissed on the grounds that the shareholders' agreement between the companies requires that the lawsuit must be filed in Japan. Abbott claimed that Takeda earned excessive profits from its supply of lansoprazole, the main ingredient in Prevacid, a gastroesophageal reflux disease drug. Takeda supplies the drug to TAP Pharmaceutical Products Inc., which is jointly owned by Takeda and Abbott. Takeda was not required to make a statement regarding the allegations. branding Experts branding Experts Boston Scientific Corp. Boston Scientific Corp.'s proposed $27 billion acquisition of Guidant Corp. is expected to close approximately one week later than planned, based on an amendment the companies filed with the Securities and Exchange Commission. In a letter to shareholders, Boston Scientific said it now expects the merger to close during the week of April 3. Guidant shareholders will receive an extra $0.0132 in cash per share of Guidant stock each day beyond March 31 until the actual closing date. As a result, the delay is expected to cost Boston Scientific approximately $4.5 million in interest payments. The letter to shareholders specified that a meeting will take place on March 31 to allow shareholders to vote on the merger agreement. branding Experts branding Experts Sangamo BioSciences Inc. Sangamo BioSciences Inc. and MaxCyte Inc. entered into a license, option, development and supply agreement for MaxCyte's cell loading system to be used in Sangamo's HIV/CCR5 zinc finger DNA-binding proteins therapeutic program. Under the agreement, Sangamo may also choose to use the system in oncology. The agreement, which includes a supply contract and allows for milestone payments to be paid to MaxCyte for any resulting products, grants Sangamo the option for a commercial license to MaxCyte's technology. That license would allow Sangamo to reference MaxCyte's Food and Drug Administration Master File in regulatory submissions it makes. branding Experts


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