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			Online Market Research 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 FDA removes clinical hold on Tysabri for treating MS The Food and Drug Administration lifted its clinical hold on Tysabri (natalizumab) for treating multiple sclerosis, allowing Biogen Idec Inc. and Elan Corp. Plc to resume administration of the drug to patients who received Tysabri in an Investigational New Drug application study before the drug was suspended from the market last February. The companies expect to initiate an open-label safety IND extension study of Tysabri monotherapy soon and have specific plans to closely monitor the patients. Patients will need to decide whether to participate in the trial after discussing the potential benefits and risks of Tysabri resumption with their study physician. After completing a comprehensive safety evaluation of more than 3,000 Tysabri-treated patients, the firms identified no new confirmed cases of progressive multifocal leukoencephalopathy (PML) beyond the three original cases. "The better understanding of the actual occurrence of PML in these patients permitted better estimation of the potential risk of PML occurring in the future," the FDA explained in a question and answer sheet posted to its Web site. The regulatory agency is still "very concerned" about the potential for Tysabri-associated PML, but the currently available information is not adequate enough to clearly define the level of risk or the exact circumstances in which this risk occurs, it said. Plus, existing data demonstrate that Tysabri is a very effective product, the FDA stated. "Therefore, if a study is done in a manner that provides as much safety monitoring as feasible, it is reasonable to resume studying this product under IND to obtain more safety-related information that may permit us to begin to better understand how large or small the true risks associated with [Tysabri] are," the FDA concluded. Biogen Idec and Elan are also waiting for the FDA's decision, expected by late March under a priority review, regarding their supplemental Biologics License Application for Tysabri's use in MS. Online Market Research Genentech completes filing of sBLA for Herceptin; requests priority review Genentech Inc. completed its submission of a supplemental Biologics License Application for use of Herceptin (trastuzumab) to treat early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The company is also requesting a priority review designation for the application from the Food and Drug Administration. The sBLA is supported by joint interim data from two Phase III trials that were halted early. A joint analysis was conducted in 3,351 of the 5,635 total enrollees whose HER2-positive breast cancer had been surgically removed. They received chemotherapy with or without Herceptin. Those who received Herceptin showed a 52 percent reduction in the risk of breast cancer recurrence relative to the patients who received only standard adjuvant therapy. Three years into the study, there was a 12 percent absolute difference in disease-free survival; Herceptin was associated with a 33 percent reduction in the risk of death. Also, the benefit of Herceptin on disease-free survival was consistently evident in all clinically important patient subgroups. Herceptin is currently approved in the United States as first-line therapy with paclitaxel and as second- or third-line monotherapy in women with metastatic breast cancer whose tumors overexpress the HER2 protein. It is marketed in the United States by Genentech, in Japan by Chugai Pharmaceutical Co. Ltd. and internationally by Roche. Online Market Research FDA to begin reviewing NDA for Merck's Januvia diabetes treatment Merck & Co. Inc. said the Food and Drug Administration has accepted for standard review the company's New Drug Application for Januvia (sitagliptin phosphate), an experimental therapy for type 2 diabetes. The firm expects the FDA to act on the application by mid-October. Also, Merck is progressing on planned filings in countries outside of the United States. As a once-daily treatment, Januvia could be the first in a new class of oral drugs called dipeptidyl peptidase-4 inhibitors, which enhance the body's ability to lower blood sugar through the incretin system. Results from clinical studies have shown that Januvia is not associated with weight gain and leads to an incidence of hypoglycemia (blood sugar that becomes too low) similar to that of placebo. Online Market Research Amicus' Gaucher disease treatment receives orphan drug designation The Food and Drug Administration granted orphan drug designation to Amicus Therapeutics Inc.'s AT2101, an experimental, oral therapy for the treatment of Gaucher disease. The disease is a lysosomal storage disorder caused by a glucocerebrosidase enzyme deficiency that can damage the liver, spleen, bone marrow and, in some cases, the central nervous system. Gaucher disease affects an estimated 10,000 people in the developed world, according to Amicus. In most instances of Gaucher disease, the deficiency in glucocerebrosidase is caused by a missense mutation, which results in the misfolding and degradation of the protein. AT2101 binds specifically to the misfolded protein, which restores proper structure, trafficking and biological activity. Amicus expects AT2101 clinical studies to begin in the first half of this year. Online Market Research Genta's Genasense demonstrates positive results in Phase III trial Genta Inc.'s Genasense (oblimersen sodium) injection in addition to chemotherapy appears to significantly increase complete or nodular partial remission (CR/nPR) in patients with relapsed or refractory chronic lymphocytic leukemia as compared with chemotherapy alone. The Phase III trial included 241 patients with relapsed or refractory CLL who were randomized to fludarabine plus cyclophosphamide (Flu/Cy) or Genasense plus Flu/Cy. The primary endpoint of the study was to increase the proportion of patients who achieved CR/nPR. Data showed the addition of Genasense increased the proportion of patients who achieved CR/nPR from 7 percent in the Flu/Cy-only group to 17 percent in the Genasense group. Additionally, the duration of CR/nPR was significantly longer in the group treated with Genasense as compared with the Flu/Cy-only group. The proportion of patients who achieved durable symptom-free benefit correlated with the degree of response. The duration of complete clinical benefit was higher in the Genasense group (383 or more patient-months) as compared with the Flu/Cy-only group (136 or more patient-months). "We look forward to improving on these results when we extend the use of Genasense into studies of patients with less advanced disease," said Dr. Loretta Itri, Genta's chief medical officer. These data were presented at the 10th annual International Congress on Hematologic Malignancies in Whistler, B.C. Genta shares closed at $2.82, up $0.23, or 8.9 percent, in heavy trading on the Nasdaq. Online Market Research Progenics' methylnaltrexone yields positive results in Phase III study Progenics Pharmaceuticals Inc.'s methylnaltrexone (MNTX), an investigational treatment for opioid-induced constipation in patients with advanced medical illness, demonstrated positive results in a second Phase III clinical study. MNTX is a peripheral opioid receptor antagonist designed to rapidly treat the side effects of opioids without interfering with pain relief. The double-blind, placebo-controlled study included 133 patients with advanced medical illness and opioid-induced constipation despite the use of laxatives. Patients were randomized to receive MNTX 0.15 mg/kg of body weight or placebo every other day for one week. Those who received MNTX and did not have at least three bowel movements by day eight were eligible to escalate to MNTX 0.3 mg/kg for week two. Results showed that 51.2 percent of patients who received subcutaneous administration of MNTX experienced induced bowel movement within four hours compared with 15.5 percent of patients in the placebo group. Furthermore, median time to bowel movement was thirty minutes for those who responded to MNTX 0.15 mg/kg. All primary and secondary efficacy endpoints of the study were positive and statistically significant. There were no serious adverse events, and the drug was generally well tolerated. Most patients with advanced medical illness require opioid treatment for pain and can experience debilitating constipation, a side effect that is not adequately treated by current therapies, Progenics noted. In December, Progenics and Wyeth Pharmaceuticals entered into an agreement to co-develop and co-commercialize MNTX. The agreement is worth up to $416.5 million, according to Reuters. Progenics shares closed at $27.99, up $1.38, or 5.2 percent, in heavy trading on the Nasdaq. Online Market Research Online Market Research Abbott Abbott selected two antigen targets from Celera Genomics Group for further investigation and potential therapeutic development. Abbott now has six targets under investigation from the strategic collaboration established between the two companies. Under the terms of the agreement, Abbott is screening a number of protein antigens identified and validated by Celera Genomics to discover, develop and commercialize therapies for the treatment of cancer. Online Market Research Online Market Research Eli Lilly and Co. Eli Lilly and Co. and Boehringer Ingelheim GmbH changed their contractual agreements for Yentreve/AriClaim (duloxetine hydrochloride), which is marketed outside the United States to treat stress urinary incontinence (SUI). Lilly will repurchase sole global commercialization rights to duloxetine for SUI and any future urinary incontinence indications and will continue marketing it for this indication outside the United States. The firms have also decided not to pursue marketing approval for the product in this country. Lilly also owns U.S. rights to duloxetine when it is sold to treat major depressive disorder and diabetic peripheral neuropathic pain as Cymbalta. Both firms will continue to market duloxetine as Cymbalta or Xeristar in foreign countries for these indications; they also plan to continue developing potential new indications in generalized anxiety disorder and fibromyalgia. Online Market Research Online Market Research KV Pharmaceutical Co. KV Pharmaceutical Co. acquired exclusive rights from Gedeon Richter Ltd. to market a group of generic drugs throughout the United States. KV's generic marketing division, Ethex Corp., is expected to sell the generic drugs in the cardiovascular, diabetes and central nervous system markets through 2017. KV expects some of these products to enter the U.S. market during the next few years after approval from the Food and Drug Administration and patent expirations. In exchange for a share of the revenue, Gedeon Richter will be responsible for developing, manufacturing and meeting regulatory requirements for the products. Online Market Research Online Market Research Keryx Biopharmaceuticals Inc. Keryx Biopharmaceuticals Inc. licensed the worldwide rights to Zerenex from Taiwan-based Panion & BF Biotech Inc. In a Phase II trial, researchers are studying the effects of Zerenex, an oral, inorganic, iron-based compound designed to decrease phosphate levels, as a treatment for hyperphosphatemia in patients with end-stage renal disease. Under the terms of the agreement, Keryx will make up-front and milestone payments, and pay royalties on product sales. The worldwide rights exclude certain Asian-Pacific countries. Online Market Research


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