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GRAHAM SAYS FDA INCAPABLE OF PROTECTING U.S. FROM SAFETY ISSUES; LISTS FIVE DRUGS WITH SAFETY CONCERNS ___________________________________________________________________________ At a hearing before the U.S. Senate Finance Committee, Dr. David Graham testified that the Food and Drug Administration pressured him to alter findings of a study regarding Merck & Co. Inc.'s recently withdrawn Vioxx (rofecoxib) and is incapable of protecting the country against a similar safety issue. Graham also listed five currently marketed drugs that he believes may present safety problems.

Graham, a medical officer at the federal agency, presented a study in August that showed Vioxx poses a greater cardiovascular risk than Pfizer Inc.'s similar arthritis drug Celebrex (celecoxib). Prior to the study being presented in Bordeaux, France, at a meeting of the International Society for Pharmacoepidemiology, however, Graham was pressured by senior FDA management to alter his conclusions, the medical officer testified.

The FDA issued a statement that contradicts Graham's account, saying, "Some FDA scientists questioned some of the conclusions in the abstract and, as a result, [Graham] voluntarily chose to revise his conclusions, and he did so, in his own words, 'without compromising my deeply held convictions.'"

The FDA release further stated that Graham was asked to submit a draft report of his findings upon his return from France, but he failed to do so until after the COX-2 inhibitor had already been withdrawn from the market.

Graham also testified before the Committee that the FDA is "incapable of protecting America against another Vioxx" because of bureaucratic torpor and calcified policies, TheStreet.com reported. He further stated that the FDA has a bureaucratic culture in which "post-marketing safety is an afterthought."

He specifically called into question the safety of five currently marketed drugs: Abbott Laboratories obesity drug Meridia (sibutramine), AstraZeneca Plc's cholesterol drug Crestor (rosuvastatin), GlaxoSmithKline Plc's asthma drug Serevent (salmeterol), Pfizer Inc.'s COX-2 inhibitor Bextra (valdecoxib) and F. Hoffmann-La Roche Ltd.'s acne drug Accutane (isotretinoin).

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, disagreed. "I do not have reason to believe that set of five drugs is specifically more concerning [than other drugs]," she said, according to The Associated Press.

Kweder's reassurance, however, may not comfort investors, according to Friedman, Billings, Ramsey & Co. analyst David Moskowitz. "David Graham was the FDA researcher who had questioned Vioxx's safety before it was recalled, so a list of drugs he's also concerned about is going to be taken quite seriously," Moskowitz speculated, according to TheStreet.com.

Investors Thursday most sharply reacted to the concerns regarding Crestor and Serevent. Crestor has been associated with rhabdomyolysis--a muscle-wasting disease that prompted the recall of Bayer AG's statin Baycol (cerivastatin)--while Serevent has been linked with an increased risk of asthma-related death.

Shares of AstraZeneca closed at $40.34, down $3.80, or 8.6 percent, while GSK shares closed at $43.59, down $1.45, or 3.2 percent, both in heavy trading on Wall Street.

BERLEX RECEIVES APPROVABLE LETTER FROM FDA FOR YAZ ORAL CONTRACEPTIVE ___________________________________________________________________________ Berlex Inc., the U.S. subsidiary of Schering AG, received an approvable letter from the Food and Drug Administration for its investigational Yaz (ethinyl estradiol 20 mcg/drospirenone 2 mg) oral contraceptive.

In the letter, the FDA requested additional data to support the therapy's unique dosing regimen, composed of 24 days of active treatment followed by four days of placebo. Typical oral contraceptive regimens include 21 days of treatment followed by seven days of placebo, according to a Berlex press release.

Berlex said it will submit data to support the clinical benefits of the additional three days of active treatment in each cycle. The submission will include data from two recently completed placebo-controlled trials of Yaz among patients with premenstrual dysphoric disorder (PMDD).

In addition to seeking an indication as an oral contraceptive, Berlex expects to seek approval for the therapy as a treatment option for women with symptoms of PMDD who desire pregnancy intervention.

"Our studies showed that treatment with Yaz results in a highly statistically significant reduction of the symptoms of PMDD as compared to placebo," said Dr. Marie Foegh, vice president of medical affairs at Berlex. "We believe this effect is due to the shortened pill-free interval of its dosing regimen combined with drospirenone, which, unlike other progestins, exhibits anti-mineralocorticoid and anti-androgenic activity."

MEDTRONIC POSTS STRONG Q2 RESULTS AIDED BY GROWTH IN CARDIAC RHYTHM MANAGEMENT, SPINAL PRODUCTS ___________________________________________________________________________ Medtronic Inc. recognized gains in earnings and revenue in its fiscal second quarter driven by growth in its cardiac rhythm management and spinal products.

For the period, Medtronic's net earnings totaled $535.7 million, or $0.44 per diluted share, compared with $476.1 million, or $0.39 per share, in the comparable period last year, representing a 13 percent increase.

Analysts polled by Thomson First Call expected earnings of $0.45 per share, according to CBS MarketWatch.

Overall revenue in the second quarter reached $2.4 billion, up 11 percent from $2.16 billion generated in the comparable period of 2003. Specifically, sales of its cardiac rhythm management products increased 8 percent to $1.1 billion in the period, including a 17 percent increase in sales of implantable cardiac defibrillators (ICD).

Art Collins, Medtronic's chief executive, noted certain milestones were achieved in the quarter, including completion of enrollment in several clinical trials, Food and Drug Administration approval of the Intrinsic and the InSync Sentry ICD systems and the generation of favorable cost-effectiveness data for several Medtronic products, which supported key reimbursement decisions.

Medtronic shares closed at $48.65, down $3.67, or 7 percent, in heavy trading on Wall Street.

PHASE II EFFICACY RESULTS INCONCLUSIVE FOR NABI'S ALTASTAPH; PHASE III PROGRAM DELAYED ___________________________________________________________________________ Nabi Biopharmaceuticals' Altastaph (Staphylococcus aureus immune globulin [human]) showed good safety and pharmacokinetic profiles in a Phase II trial involving premature low-birth-weight infants, but did not reduce the incidence of S. aureus infection.

The double-blind, placebo-controlled study included 200 infants with very low birth weight who were assigned to receive two doses of Altastaph or placebo 14 days apart, starting three to seven days after birth. The primary objectives of the study were to evaluate the product's safety and pharmacokinetics.

Following administration of Altastaph, antibody levels were well above the targeted level of 80 mcg/mL to 100 mcg/mL, which is believed to be protective against infections in neonates, the company said.

The incidence of S. aureus infection, however, was only 3 percent in the study, with three infections each in the Altastaph and placebo arms. Nabi had been expecting an incidence rate of 5 to 7 percent, based on published literature and recent clinical studies.

"As a result, the company is unable to make any inference about Altastaph's effect on infections in neonates ... the firm said in a press release.

Nabi said it will now focus its efforts on developing a next-generation Altastaph product designed to prevent infections caused by S. aureus Types 5, 8 and 336 as well as those caused by S. epidermidis. The company is targeting clinical studies of the next-generation Altastaph product in 2006.

"While our initial plan to begin Phase III clinical testing of Altastaph in 2005 will be delayed, we believe this next-generation product will provide important advantages for physicians when compared to other similar products under development," said Nabi Chief Executive Officer Thomas McLain. "By developing a product that can prevent both S. aureus and S. epidermidis infections, we will be in a unique position to help reduce illness, complications and death in at-risk patients."

Altastaph has been granted a fast track designation by the Food and Drug Administration.

Shares of Nabi closed at $14.48, down $0.79, or 5.2 percent, in heavy trading on the Nasdaq.

CARDIMA SURGICAL ABLATION SYSTEM SUCCESSFUL IN CERTAIN AF PATIENTS ___________________________________________________________________________ Cardima Inc. shares jumped 36.1 percent Thursday after the firm said 70 percent of subjects in a 22-patient study of its Surgical Ablation System (SAS) retained normal sinus rhythm six months after the procedure.

SAS was used during open chest procedures to treat chronic atrial fibrillation in patients who also required mitral and multiple valve replacement and/or repairs as well as coronary procedures.

"We were somewhat surprised and very pleased with the outcome achieved using a limited surgical maze lesion set," said Dr. Didier Loulmet of Lenox Hill Hospital in New York, who conducted the study. "We will continue our work with this technology in a new patient group with an expanded lesion set most closely replicating the lesions in the traditional surgical maze procedure."

Cardima's SAS was approved by the Food and Drug Administration in February 2003 to ablate cardiac tissue during heart surgery using radio frequency energy. Cardima said the system is expected to be used primarily by cardiac surgeons in the treatment of atrial fibrillation. The company believes the system can significantly reduce the time required to form lesions and can sense tissue temperature interactively to ensure lesions are uniform, thin and linear.

Separately, Cardima said it received written notice that it is not in compliance with Nasdaq regulations requiring the company to have a minimum of $2.5 million in stockholders' equity, $35 million market value of listed securities or $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recent years. The company said that by Dec. 2 it will provide the Nasdaq with a plan to achieve and sustain compliance with its SmallCap Market listing requirements.

Shares of the company closed at $0.49, up $0.13, in heavy trading on the Nasdaq.

TWICE-WEEKLY ZOCOR MAY BE SAFE, COST-EFFECTIVE ALTERNATIVE TO DAILY REGIMEN, NEW TRIAL REVEALS ___________________________________________________________________________ New findings suggest that administering Merck & Co. Inc.'s Zocor (simvastatin) twice weekly instead of daily to hyperlipemic patients may be safe and cost-effective.

In the non-randomized, open-label study completed by 31 hyperlipemic patients, treatment with Zocor 10 mg or 20 mg daily was switched to a twice-weekly regimen of Zocor 40 mg or 80 mg for 12 weeks.

The percentage of patients attaining the appropriate LDL cholesterol goal was not statistically different between enrollment and week 12 (87 percent vs. 68 percent), indicating that the twice-weekly regimen safely maintained most patients' intended LDL cholesterol level. The study also showed that mean LDL cholesterol value increased from enrollment through 12 weeks.

Only three patients reported nonadherence to the twice-weekly regimen. Fifty-five percent of participants reported either equal convenience with both treatment strategies or preference for the twice-weekly regimen.

The researchers estimated the cost savings associated with the twice-weekly regimen would be $32,000 per 1,000 patients annually.

"Large outcome studies evaluating this approach are needed," the study authors suggested.

Complete details of the analysis appeared in the November issue of The Annals of Pharmacotherapy.

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BOEHRINGER INGELHEIM PHARMACEUTICALS INC. ___________________________________________________________________________ Boehringer Ingelheim Pharmaceuticals Inc. received Food and Drug Administration approval for Atrovent HFA (ipratropium bromide) Inhalation Aerosol. The product is an alternative to the company's Atrovent Inhalation Aerosol, which uses a chlorofluorocarbon (CFC) propellant. The new formulation, which uses hydrofluoroalkane as a propellant, was developed in response to the Montreal Protocol on Substances that Deplete the Ozone Layer. Boehringer said it has invested more than $500 million in the reformulation of its metered-dose inhaler products.

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ISTA PHARMACEUTICALS INC. ___________________________________________________________________________ Ista Pharmaceuticals Inc. licensed from Senju Pharmaceuticals Co. Ltd. the exclusive U.S. marketing rights for ecabet sodium, an experimental treatment for dry eye syndrome. The product is currently in Phase II testing in Japan. Ista said it expects to complete an additional Phase IIb study and initiate a Phase III study during the second half of next year.

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EMISPHERE TECHNOLOGIES INC. ___________________________________________________________________________ Emisphere Technologies Inc. entered into a licensing agreement with F. Hoffmann-La Roche Ltd. to develop oral formulations of certain small-molecule compounds that are already approved for use in bone-related diseases. The specific products were not disclosed. Emisphere will receive an upfront fee, potential milestone payments and royalties on sales.

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TAPESTRY PHARMACEUTICALS INC. ___________________________________________________________________________ Tapestry Pharmaceuticals Inc. said it will discontinue development of its gene-editing technologies in order to focus its assets on the development of its nearer-term oncology drug candidates. Tapestry will eliminate approximately 20 positions, or 25 percent of its workforce. The firm expects annualized savings of approximately $4 million per year due to the restructuring.

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