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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

Astellas submits NDA for AF treatment Astellas Pharma US Inc. submitted a New Drug Application to the Food and Drug Administration for intravenous RSD1235, its investigational drug intended for the acute conversion of atrial fibrillation.

The NDA includes five years of clinical development data, drug co-developer Cardiome Pharma Corp. said, noting that an open-label safety study in patients with recent-onset AF and a Phase III study in patients with post-operative atrial arrhythmia are currently being conducted.

Astellas was granted an exclusive license to the intravenous form of the drug from Cardiome; the firms worked together on its development. Once RSD1235 is approved, Astellas will market it in the United States, although its trade name has not been decided.

Cardiome has the rights to the IV formulations of RSD1235 everywhere other than the United States, Canada and Mexico, and also retains global rights to the drug's oral formulation intended to prevent AF.

AF, an abnormal heart rhythm that affects the heart's upper chambers, is the most common cardiac arrhythmia and lowers the pumping capacity of the heart. The condition can lead to congestive heart failure and an increased risk of stroke, Cardiome noted.

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Astellas' Prograf receives FDA approval as immunosuppressant in recipients of heart transplants; firm sells OTC unit The Food and Drug Administration granted Astellas Pharma US Inc. approval for the use of Prograf (tacrolimus) as an immunosuppressant to prevent organ rejection in patients who receive a heart transplant.

The decision was based on two open-label, randomized clinical studies, which included a total of 645 recipients of heart transplants. Researchers evaluated the safety and efficacy of treatment with Prograf versus cyclosporine immunosuppression in primary orthotopic heart transplantation.

In one of the studies, 314 patients received a regimen of antibody induction, corticosteroids and azathioprine in combination with Prograf or cyclosporine modified for 18 months. At 18 months after transplation, 91.7 percent of patients in the Prograf group experienced patient/graft survival compared with 89.8 percent in the cyclosporine group, the FDA said.

The other study included 331 patients who received corticosteroids and Prograf plus Wyeth's Rapamune (sirolimus), Prograf plus Roche's CellCept (mycophenolate mofetil) or cyclosporine modified plus CellCept for one year. At the end of the study, patient and graft survival rates were similar between the arms with 93.5 percent survival in the Prograf plus CellCept group and 86.1 percent survival in the cyclosporine modified plus CellCept group.

Prograf is currently approved to treat patients undergoing kidney and liver transplants. The drug's active ingredient, tacrolimus, is also used to treat eczema in a cream formulation marketed by Astellas as Protopic.

Separately, Astellas agreed to sell all outstanding shares of its fully owned over-the-counter subsidiary, Zepharma Inc., to Daiichi Sankyo Co. Ltd. Daiichi will pay approximately $199.8 million in cash upon closing the deal and additional cash payments after the closing.

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Prestwick receives approvable letter from FDA for Xenazine Prestwick Pharmaceuticals Inc. received an approvable letter from the Food and Drug Administration for Xenazine (tetrabenazine), an investigational treatment of chorea associated with Huntington's disease.

Xenazine is a selective and reversible dopamine depletor that inhibits vesicular monoamine transporter 2. It is the first New Drug Application that has been filed for a product designed to treat chorea associated with Huntington's disease.

The letter states that the company must meet certain conditions prior to FDA approval. The FDA stated its intent to discuss the NDA at a public meeting of the Peripheral and Central Nervous System Advisory Committee, the date of which has not yet been set.

Results of a Phase III study published in the Feb. 14 issue of the journal Neurology showed that titrated doses of up to 100 mg/day of Xenazine reduced symptoms of chorea and improved global outcome scores among patients with Huntington's disease. The proportion of patients who achieved at least minimal global improvement on the Clinical Global Impression of severity, defined as a score of three or less, was also greater with Xenazine than with placebo (69 percent vs. 24 percent).

The trial investigators observed a trend toward an improvement on the Unified Huntington's Disease Rating Scale (UHDRS) total motor score with Xenazine, but the adjusted mean treatment effect was not statistically significant. Further, the active drug appeared to have a negative impact on UHDRS Functional Checklist and Stroop word reading scores.

The FDA designated Xenazine an orphan product and also granted fast track status for the drug.

Chorea, which causes excessive, involuntary and repetitive movements in patients, is a characteristic of many neurological diseases.

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Schwarz's lacosamide meets primary endpoint of Phase III trial in diabetic neuropathic pain Schwarz Pharma AG's oral lacosamide significantly reduces diabetic neuropathic pain at a 400 mg dose, according to the results of a recent Phase III trial.

In the double-blind trial, 469 patients with diabetic neuropathy received placebo or lacosamide at daily doses of 200 mg, 400 mg or 600 mg for up to 18 weeks. The trial's primary endpoint was the change in Likert pain score (0=no pain, 10=worst possible pain) from baseline to the last four weeks of the maintenance phase. Patients used the Likert scale to rate their perception of pain twice a day in an electronic diary.

According to Schwarz, at the target dose of 400 mg/day, lacosamide showed a clinically relevant reduction in diabetic neuropathic pain, with the primary endpoint reaching statistical significance.

For the entire treatment, maintenance and titration phases, the pain reduction with lacosamide was statistically significant versus placebo, Schwarz said.

The firm noted that secondary efficacy analyses showed statistical significance in several areas for the lacosamide 400 mg and 600 mg groups.

This is the third Phase III trial for lacosamide in this indication, and Schwarz expects the overall development program to support filing for lacosamide's approval in the United States and in Europe.

"Based on the convincing entirety of results from the clinical development program, we plan to discuss with the authorities filing for lacosamide in diabetic neuropathic pain," said Dr. Iris Loew-Friedrich, a member of Schwarz's executive board. "At our target dose, lacosamide had a clinically relevant effect in neuropathic pain."

Lacosamide is also being developed as a treatment for epilepsy.

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EpiCept's Ceplene significantly increases leukemia-free survival in patients with AML, study finds EpiCept Corp.'s investigational acute myeloid leukemia treatment, Ceplene (histamine dihydrochloride), met the primary endpoint, an increase in leukemia-free survival, in a Phase III clinical study.

The study included 320 patients with AML in complete remission. Patients were randomized to receive subcutaneous injections of 0.5 mg of Ceplene plus 16,400 U/kg of interleukin-2 (IL-2) twice daily for 18 months or no treatment (control). The patients were observed for at least three years after enrollment.

Three years after the last patient was enrolled, it was determined that Ceplene/IL-2 significantly improved leukemia-free survival as compared with the control group in the intent-to-treat population.

"The benefit of Ceplene/IL-2 was attributable mainly to a reduction of the frequency of relapse among patients in their first complete remission (n=261)," EpiCept said.

The firm noted that, for these patients, the drug combination significantly improved leukemia-free survival; three-year leukemia-free survival estimates were 40 percent for this patient group versus 26 percent for the control group.

The company plans to file for approval of Ceplene in Europe this year as a remission maintenance therapy for patients with AML.

These data were published online in the journal Blood on March 24.

EpiCept shares closed at $4.50, up $1.19, or 36 percent, in heavy trading on the Nasdaq.



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ACC, AHA update perioperative beta blocker guidelines The American College of Cardiology and the American Heart Association updated their practice guidelines for perioperative beta blocker therapy.

"Since the publication of the previous guidelines on perioperative cardiovascular evaluation for noncardiac surgery in 2002, the issue of perioperative beta blockade for noncardiac surgery has taken on increased importance," the organizations said.

They noted that the Physicians Consortium for Performance Improvement and the Surgical Care Improvement Project have determined that perioperative beta blockade should be used as a quality measure, which made it "imperative" to update the guidelines.

Updates to the guidelines include the recommendation that patients undergoing surgery who are currently taking beta blockers to treat ACC/AHA class I guideline indications should continue with their beta blocker therapy.

The updated guidelines also say perioperative beta blocker therapy is "probably recommended" for additional patients, including those whose perioperative assessments for vascular surgery identify them to be of high cardiac risk, determined by the presence of multiple cardiac risk factors. Beta blocker treatment is also "probably recommended" for those who are undergoing intermediate- or high-risk procedures and whose assessments identify coronary heart disease and high cardiac risk.

The new recommendations also include a section on patients who may be considered for perioperative beta blocker therapy. These patients include those who are at low cardiac risk (as defined by the guidelines) and who are not currently taking beta blockers and those patients with a single risk factor.

The associations cautioned against applying these guidelines to patients with nonischemic cardiomyopathy, decompensated heart failure or severe valvular heart disease in the absence of coronary heart disease.

The guidelines were published online at Cardiosource.com on March 29.

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Food and Drug Administration The Food and Drug Administration approved Aurobindo Pharma Ltd.'s generic capsule formulation of GlaxoSmithKline Plc's HIV/AIDS treatment Retrovir (zidovudine). According to the FDA, this is the first time a generic capsule form of an HIV/AIDS drug has been approved for use in the United States. "This is a significant generic approval," said Dr. Andrew von Eschenbach, acting commissioner of the agency. "Approval of this additional dosage form of zidovudine should help reduce the cost of this therapy for American patients."

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Valeant Pharmaceuticals International Valeant Pharmaceuticals International and the Food and Drug Administration notified health care professionals of complaints the company received regarding small cracks at the base of the plastic tip of the applicator for Diastat (diazepam). The cracks result in leakage of the medication when the plunger is depressed, which prevents full dosing from being administered. Diastat, which is administered in the rectum, is used to treat selected refractory patients with epilepsy on stable regimens of antiepileptic drugs who require intermittent use of Diastat's active ingredient to control seizure activity. The FDA asked health care professionals to advise patients to return any product with a cracked tip to their pharmacy for immediate replacement.

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NitroMed Inc. NitroMed Inc. is cutting approximately 30 research and development positions as it restructures its organization. The firm said it will focus on developing an extended-release version of its heart failure drug for black patients, BiDil (isosorbide dinitrate/hydralazine hydrochloride), and on finding out-licenses and collaborations for its nitric oxide-enhancing technologies such as NMI-3377, which is being developed as a cardio-renal compound. "The restructuring is being undertaken to align the company's cost structure with revenue expectations," NitroMed said. The firm noted that it is working to develop a formulation of BiDil that can be taken once or twice a day rather than three times a day, as it is currently approved.

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Medarex Inc. Medarex Inc. initiated a clinical trial of ipilimumab (MDX-010) for use as a monotherapy in patients who were previously treated for metastatic melanoma. The trial is expected to include 150 patients with unresectable stage III or stage IV metastatic melanoma and will assess response rate (complete and partial responses) as the primary endpoint. The Food and Drug Administration reviewed the trial under a Special Protocol Assessment. Medarex is developing the drug with Bristol-Myers Squibb Co.

 

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