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How to name a product

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

Guidant accepts J&J's new $24.2 billion offer Guidant Corp. said late Friday it accepted a higher takeover offer of $24.2 billion from Johnson & Johnson.

The new offer is worth $71 per share to Guidant shareholders, an increase from a previous J&J offer of $23 billion, or approximately $68 per share. Under the agreement, J&J will pay $40.52 in cash and 0.493 shares of J&J common stock for each outstanding share of Guidant common stock.

"Together with J&J, we will have the resources to continue to build upon the existing Guidant businesses in our pursuit of meaningful innovations to address cardiovascular disease," said James Cornelius, Guidant's chief executive officer.

Boston Scientific Corp. had made attempts to outbid J&J for Guidant. Its latest offer stated that it would acquire all of the outstanding shares of Guidant for $73 per share--$36.50 in cash and $36.50 in Boston Scientific stock, subject to a collar. However, that offer expired Friday at 4pm EST. Boston Scientific made the new offer after Guidant's board of directors unanimously voted to accept an increased takeover bid from J&J earlier in the week.

In a press release, Guidant said it and J&J will promptly file updated materials with the Securities and Exchange Commission. J&J said it will further discuss the transaction at its scheduled analyst meeting on Jan. 24.

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Pfizer acquires worldwide rights to investigational diabetes agent Exubera from sanofi-aventis for $1.3 billion Sanofi-aventis Group agreed to transfer full rights to inhaled insulin powder Exubera (rDNA origin) as well as control of German production facilities for Exubera to Pfizer Inc.

Pfizer and sanofi-aventis have been in a worldwide alliance to co-develop, co-promote and co-manufacture Exubera since 1998. These collaboration contracts contained "change of control clauses," which Pfizer exercised during Aventis SA and Sanofi-Synthelabo SA's merger. According to The Wall Street Journal, sanofi-aventis disputed Pfizer's interpretation of the contracts, but after court hearings, the two firms reached the current agreement.

Pfizer will pay $1.3 billion for transferred assets and rights to Exubera. The sale includes sanofi-aventis' share of Exubera's manufacturing facility based in Frankfurt, Germany. The transaction is expected to close during the first quarter of 2006.

The Food and Drug Administration is currently considering approval of Exubera, a fast-acting dry powder formulation of human insulin that is inhaled into the lungs via the mouth before meals, for the treatment of type 1 and type 2 diabetes. As reported in October, the regulatory agency extended its review of the product by three months due to concerns regarding Exubera's pulmonary safety. Clinical studies have shown that some individuals experience a slight decline in lung function and are more likely to experience coughing when taking the drug. Sales forecasts for Exubera vary, The Journal reported.

Nektar Therapeutics, which developed the technology to produce powdered insulin, was also part of the initial developmental collaboration and said it will remain in partnership with Pfizer.

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FDA approves Cipher's Lipofen The Food and Drug Administration approved Cipher Pharmaceuticals Inc.'s Lipofen (fenofibrate) for the treatment of hyperlipidemia.

Lipofen, which was previously known as CIP-Fenofibrate, is Cipher's novel formulation of fenofibrate. It was approved for three dosages, 50 mg, 100 mg and 150 mg. Cipher said the 150 mg version is equivalent to Abbott's Tricor (fenofibrate) 160 mg under fed conditions.

In addition to the treatment of adult patients with hyperlipidemia, the approval specifically provides for the use of Lipofen as an adjunctive therapy to diet to reduce LDL cholesterol, total cholesterol, triglycerides and apolipoprotein B and to increase HDL cholesterol in adults with primary hypercholesterolemia or mixed dyslipidemia.

The company said that the market for the three existing fenofibrate formulations is expected to top $1 billion in annual U.S. sales.

Cipher, which specializes in applying proven technology platforms to currently marketed drugs, has two other late-stage products. CIP-Isoretinoin, an acne treatment, is currently under review by the FDA, and the company is preparing to file an application for CIP-Tramadol, a pain reliever, in the first half of this year.

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FDA needs additional trial data in order to approve Genelabs' experimental lupus treatment Prestara Genelabs Technologies Inc.'s Prestara (prasterone) will require additional Phase III data in order to obtain U.S. approval to treat the signs and symptoms of systemic lupus erythematosus and to prevent the loss of bone mineral density associated with lupus in women.

The Food and Drug Administration said "an additional, adequate, well-controlled Phase III clinical trial would be necessary" for the approval of Prestara's New Drug Application for the treatment of the signs and symptoms of lupus in women. Genelabs is currently designing such a trial using the FDA's draft guidance released in March 2005 for developing lupus drugs and plans to work with the agency to develop the trial protocol. In 2002, the biopharmaceutical firm received an approvable letter for Prestara.

Genelabs is also studying Prestara for the prevention of BMD loss in women with lupus, but again the FDA advised that additional positive prospective Phase III data would be necessary before considering approval. Based on this recommendation, Genelabs believes the former indication would be "a more viable route" for Prestara's development.

The firm noted that it currently does not have enough funds to pursue another clinical trial of Prestara alone, so either it would seek a new or existing collaborator to conduct such a trial or delay or discontinue future development of Prestara.

"I believe the FDA recognizes the need for new drugs for lupus, but at the same time, they also must adhere to their established standards for approval," Chief Executive Officer James Smith said.

"Genelabs is potentially only one positive clinical trial from approval for a difficult and debilitating disease that has very limited and inadequate treatment options," he added.

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Levitra improves erectile function, reduces symptoms of depression among patients with ED, major depressive disorder, data suggest Patients treated with GlaxoSmithKline Plc and Bayer AG's Levitra (vardenafil hydrochloride) demonstrated significant improvement in erectile function and depression compared with patients who received placebo, according to a study published in the January issue of the American Journal of Psychiatry.

The 12-week, flexible-dose, parallel-group, double-blind study included 280 men with ED for at least six months and untreated mild major depression. Patients were randomized to receive Levitra 10 mg/day or placebo, with an option to titrate to 5 mg/d or 20 mg/d after each of two consecutive four-week intervals.

The study's endpoints included changes in the International Index of Erectile Function erectile function domain and in the 17-item Hamilton Depression (HAM-D) Rating Scale.

According to the authors, Levitra "produced statistically significant and clinically meaningful improvement in all erectile function parameters." Specifically, patients in the Levitra group achieved an International Index of Erectile Function erectile function domain score of 22.9 compared with 14.9 for patients in the placebo group.

In addition, the HAM-D score for patients treated with Levitra was 7.9 compared with 10.1 for patients in the placebo group, with improvement in erectile function scores being "the most important predictor of remission in depressive symptoms."

"ED treatment should be considered a component of therapy for men with depression and erectile dysfunction," the authors concluded.

In the United States, Levitra is co-marketed by GSK and Bayer through its distributor, Schering-Plough Corp.

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Risk of hyponatremia appears greater with Trileptal than carbamazepine Patients treated with Novartis Pharmaceuticals Corp.'s Trileptal (oxcarbazepine) may have a greater risk of developing hyponatremia than do patients treated with carbamazepine, according to new research.

Using both cross-sectional and follow-up study designs, investigators evaluated sodium concentrations in 548 patients with epilepsy (Trileptal, n=97; carbamazepine, n=451). Data for all patients were extracted from the MINCEP Epilepsy Care Database in Minnesota.

For the cross-sectional analysis, the primary outcome variable was the patient's first sodium level after antiepileptic drug initiation. For the follow-up analysis, which included all patients with at least one sodium level measurement, the initial sodium level was used to characterize patients as initially eunatremic or hyponatremic; the primary outcome variable was the mean sodium level at subsequent measurements.

Sodium levels were categorized as normal (135 mEq/L or more), hyponatremic (134 mEq/L or less) or severely hyponatremic (128 mEq/L or less).

Findings from the cross-sectional analysis revealed that 29.9 percent of Trileptal-treated patients had hyponatremia compared with 13.5 percent of carbamazepine-treated patients.

Similarly, severe hyponatremia occurred in 12.4 percent and 2.8 percent of patients, respectively. Severe hyponatremia, the authors added, constituted 40 percent of all hyponatremia cases in the Trileptal group compared with 21.3 percent of cases in the carbamazepine group.

The frequency of hyponatremia increased with age, a trend that the researchers noted was more pronounced with Trileptal than carbamazepine.

Investigators also analyzed the effect of concomitant AEDs (phenytoin, valproic acid, GlaxoSmithKline Plc's Lamictal [lamotrigine], UCB Pharma Inc.'s Keppra [levetiracetam]) on the risk of hyponatremia. Of those evaluated, only Keppra was associated with an increased risk: 52.4 percent of patients treated with Keppra and Trileptal were hyponatremic compared with 23.7 percent of patients treated with Trileptal without Keppra. Similar findings were observed when Keppra users and nonusers were compared in the carbamazepine group, but the difference was not statistically significant (18.5 percent vs. 12.8 percent).

Lastly, the authors observed a weak association between carbamazepine dose and hyponatremia risk. However, there was no association observed between Trileptal dose and sodium levels.

During the follow-up analysis, researchers analyzed data for 44 Trileptal-treated patients and 204 carbamazepine-treated patients. They observed that patients with an initially eunatremic measurement had a low incidence of hyponatremia during subsequent measurements (approximately 7 percent), regardless of which treatment they received. At the same time, patients with an initially hyponatremic measurement had a high risk of recurrent hyponatremia (64.7 percent in both groups).

The authors noted that treatment choice, age, gender and the use of other AEDs seemed to have little effect on whether or not hyponatremia persisted at follow-up.

"This implies that there probably exists a subset of patients with epilepsy who are inherently susceptible to Trileptal- or carbamazepine-induced hyponatremia. A single measurement of the sodium level during early treatment course is predictive of future development of hyponatremia and can be used to identify patients at risk," title="branding company" they suggested.

The study appeared in the Dec. 27 issue of the journal Neurology.

How to name a product

How to name a product
Wyeth Wyeth announced plans to initiate clinical trials on three new treatments for Alzheimer's disease during 2006, according to Reuters. The firm is already studying three other treatments for the disease, two of which are in early-stage testing. The potential drug candidates work by blocking the body's production of beta-amyloid, the protein that has been identified as the main cause of Alzheimer's disease, or by speeding up the body's removal of the protein, Wyeth told Reuters.

How to name a product

How to name a product
Schering-Plough Corp. Schering-Plough Corp. initiated a Phase III study to compare the use of 0.5 mcg/kg of body weight of Peg-Intron (peginterferon alfa-2b) maintenance monotherapy once weekly with standard supportive care among patients with cirrhotic hepatitis C who are co-infected with HIV. Schering plans to enroll 448 patients in the randomized, open-label study. The primary endpoints include time to death, liver decompensation, liver transplant or liver cancer. The firm said patients will be treated until the end of the 36-month trial or until one of these clinical events occurs. Peg-Intron is currently approved as monotherapy and in combination with Schering's Rebetol (ribavirin) for the treatment of chronic hepatitis C in adult patients with compensated liver disease.

How to name a product

How to name a product
Novo Nordisk A/S Novo Nordisk A/S said its Norditropin NordiFlex (somatropin [rDNA origin]) injection 5 mg and 10 mg growth hormone pens can now be stored unrefrigerated after the first use. The company said the new storage flexibility, which was approved by the Food and Drug Administration, is designed to improve patient adherence, adding that the new 10 mg pen further simplifies treatment with dose increments of 0.05 mg.

How to name a product

How to name a product
Cephalon Inc. Cephalon Inc. agreed to settle its pending U.S. patent infringement dispute with Mylan Pharmaceuticals Inc. related to Provigil (modafinil) tablets, a sleep disorder treatment. As part of the settlement, Mylan will receive a non-exclusive, royalty-bearing right to market and sell a generic version of the drug in the United States, with the license becoming effective in October 2011. If Cephalon receives a pediatric extension for Provigil, Mylan's entry would be delayed until April 2012. Financial terms of the agreement, which is subject to review by the Federal Trade Commission, were not disclosed.

 

How to name a product

 

 



       

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