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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

COX-2 INHIBITOR CLASS OF DRUGS SHOULD BE REVIEWED FOR CARDIAC SAFETY, RESEARCHERS SUGGEST; DRUG COMPANY SHARES FALL ___________________________________________________________________________ Shares of several drug companies fell Thursday following an article released on Wednesday calling for a review of other members of the COX-2 inhibitor class of drugs beyond Merck & Co. Inc.'s Vioxx (rofecoxib) to evaluate whether they, too, pose an increased risk of cardiac problems. Also criticized in a related article was the lack of earlier appropriate action by the Food and Drug Administration with respect to the Vioxx situation.

The reports, which were published Oct. 6 on the Web site of The New England Journal of Medicine ahead of the Oct. 21 print edition, draw attention to the notion that the increased risk of cardiac events among Vioxx users, which led Merck to voluntarily withdraw the drug last week, may extend to the entire COX-2 inhibitor class of drugs.

"[I]t is essential to determine whether the cardiovascular risk is or is not a class effect," wrote Dr. Garrett Fitzgerald, a cardiologist with the University of Pennsylvania School of Medicine.

In another article, cardiologist Dr. Eric Topol suggested the FDA's "passive position" of waiting for data to accrue is not acceptable "given the strong signals that there was a problem and the vast number of patients who were being exposed."

The only other Food and Drug Administration-approved drugs in this class that are currently available are Pfizer Inc.'s Celebrex (celecoxib) and Bextra (valdecoxib). Novartis AG's Prexige (lumiracoxib) is awaiting FDA approval.

Also on Wednesday, the European Medicines Agency said it would review all drugs in this class in the wake of Merck's withdrawal of Vioxx.

However, Pfizer's medical director, Dr. Gail Cawkwell, said there is no evidence of increased risk of heart problems among the 75 million Americans who have taken Celebrex, according to The Associated Press.

Shares of Merck closed at $30.98, down $0.69, or 2.2 percent. Pfizer was down 3.8 percent, or $1.19, to close at $29.99. Novartis also fell to close at $45.49, a decrease of $1.19, or 2.6 percent. All the shares were heavily traded on the New York Stock Exchange.



FDA REQUESTS CLINICAL HOLD ON GENVEC TRIALS OF TNFERADE ___________________________________________________________________________ Shares of GenVec Inc. fell 46.9 percent after the Food and Drug Administration said clinical trials of the company's TNFerade should be placed on clinical hold.

The agency indicated the hold is pending review of information pertaining to a potential increase in the incidence of blood clots in patients with esophageal cancer who received the highest doses of the agent in a Phase II clinical trial, GenVec said.

TNFerade currently is in Phase II clinical trials for locally advanced pancreatic, esophageal and rectal cancers.

The company will be providing additional data to the FDA during the next several days and expects to receive a letter from the agency that provides details on follow-up actions necessary to resume the clinical trials.

"We are responding quickly to the FDA and look forward to addressing their questions, and will provide an update on the status of our discussions as soon as more substantive information is available," GenVec President and Chief Executive Officer Paul Fischer said in a press release.

Genvec shares closed at $1.20, down $1.06, in heavy trading on the Nasdaq.



CENTOCOR WARNS OF INCREASED RISK OF LYMPHOMA FOR PATIENTS TAKING REMICADE ___________________________________________________________________________ Centocor Inc. sent a letter to health care professionals warning that patients taking Remicade (infliximab) for rheumatoid arthritis were approximately three times as likely to develop lymphoma than the general public, according to the Associated Press.

Data from completed clinical trials for all patients taking the drug revealed a six-fold increased risk of developing lymphoma.

The company has updated its label for Remicade, which is indicated to treat rheumatoid arthritis and Crohn's disease, to reflect this lymphoma risk. Centocor noted the label change is in line with warnings recently added to other drugs in its class that act by blocking overproduction of tumor necrosis factor, according to the AP.

Centocor also revised the Remicade label in August. At that time, the company said some patients receiving Remicade have reported cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia.

Last week, the Food and Drug Administration approved a Remicade (infliximab) regimen--a combination of Remicade and methotrexate--as a first-line treatment for patients with rheumatoid arthritis. The expanded label eliminates the requirement that patients must fail on methotrexate treatment before they can start receiving the Remicade regimen.



JUDGE DOES NOT RULE ON PFIZER'S MOTION TO BLOCK GENERIC NEURONTIN CAPSULE ___________________________________________________________________________ A federal judge made no ruling on Pfizer Inc.'s request to block the release of a generic version of the company's epilepsy drug Neurontin (gabapentin) in capsule form, even though analysts had expected a negative decision, Reuters reported.

While the timing of a final ruling is uncertain, a negative ruling would allow Alpharma Inc. to launch its generic capsule form of Neurontin.

As reported, Alpharma entered into an agreement with Teva Pharmaceutical Industries Ltd. earlier this year under which Teva will be permitted to launch its own versions of gabapentin capsules during the exclusivity period. Teva agreed to share a portion of Alpharma's patent litigation risks as part of the transaction.

Analysts also speculated that Pfizer would enter the market with its own generic version of the drug through a unit it obtained with its acquisition of Pharmacia Corp., Reuters reported.

In August, Ivax Corp. launched generic versions of Neurontin tablets.

Sales of Neurontin exceeded $2.2 billion in the United States and $2.7 billion worldwide in 2003.

EPIVIR REDUCES DISEASE PROGRESSION IN CHRONIC HEPATITIS B PATIENTS WITH CIRRHOSIS, ADVANCED FIBROSIS, STUDY DEMONSTRATES ___________________________________________________________________________ Continuous treatment with GlaxoSmithKline Plc's HIV drug Epivir (lamivudine) reduces the risk of liver complications for patients with chronic hepatitis B who also have cirrhosis or advanced fibrosis, according to a new study. The researchers suggested that the magnitude of protection conferred by Epivir is "substantial," with a reduction of approximately 50 percent in disease progression during a median period of 32 months of treatment.

The study included 651 patients with chronic hepatitis B infection and histologically-confirmed cirrhosis or advanced fibrosis. Participants were randomized to receive either 100 mg per day of Epivir or placebo for up to five years. Time to disease progression was the study's primary endpoint.

The median treatment duration was 32.4 months. The study was halted earlier than planned because of the significant difference between the treatment and placebo groups with respect to the proportion of patients who reached the endpoints.

Among the Epivir-treated patients, 7.8 percent reached the primary endpoint. This percentage was significantly lower than the 17.7 percent observed among placebo-treated subjects. Additionally, the increase in Child-Pugh score, which is an indication of the severity of cirrhosis, was significantly greater among patients who received placebo compared with those on Epivir. The occurrence of hepatocellular carcinoma also was significantly less likely among the participants who were randomized to Epivir compared with placebo (3.9 percent vs. 7.4 percent).

Serious adverse events were reported by 12 percent of the patients in the Epivir group and by 18 percent of those in the placebo group.

The study was published in the Oct. 7 issue of The New England Journal of Medicine.

AETERNA ZENTARIS REPORTS POSITIVE PHASE II DATA FOR CETRORELIX IN PATIENTS WITH BPH ___________________________________________________________________________ AEterna Zentaris Inc. said data from a Phase II trial of a depot formulation of its drug cetrorelix demonstrated a statistically significant improvement in the clinical symptoms associated with benign prostatic hyperplasia.

The study, which is designed to evaluate different dosage regimens of the investigational compound, included 250 patients with BPH. The results revealed a dose-dependent improvement in symptoms for all but the lowest dose of the four active regimens, which ranged from 60 mg to 120 mg during a period of four weeks.

The company said these findings are consistent with earlier studies. It also reported cetrorelix exhibited an "excellent" safety and tolerability profile after the patients had been followed for up to 26 weeks.

AEterna Zentaris is developing cetrorelix in BPH through collaboration with Solvay Pharmaceuticals Inc. and Shionogi/Nippon Kayaku, the company noted in a press release.

Cetrorelix already is marketed for in vitro fertilization under the brand name Cetrotide. In addition to BPH investigations, cetrorelix also is in advanced clinical development for the treatment of uterine myoma and endometriosis.



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WYETH ___________________________________________________________________________ Wyeth and Sienabiotech SpA entered a drug discovery agreement to research and co-develop novel compounds that target the treatment of neurodegenerative diseases, particularly Alzheimer's disease. Wyeth will have worldwide marketing rights for products resulting from the collaboration, and Sienabiotech will have the option to develop compounds emerging from the joint effort for orphan disease indications. Financial terms were not disclosed.

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BIOVAIL CORP. ___________________________________________________________________________ Biovail Corp. named Douglas Squires as chief executive officer of the Toronto-based company. He replaces company founder Eugene Melnyk, who will remain chairman. Squires previously served as CEO at MDS Pharma Services, a contract research firm to the drug industry.

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SANTHERA PHARMACEUTICALS AG ___________________________________________________________________________ Santhera Pharmaceuticals AG granted a non-exclusive license to Genzyme Corp. for its cellular screening system for the discovery of treatments for a variety of muscle diseases. Genzyme will pay Santhera an undisclosed technology license fee and will have the option to obtain an exclusive worldwide license to develop and commercialize some of Santhera's small molecule compounds for neuromuscular diseases.

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ZELTIA SA ___________________________________________________________________________ Zeltia SA's Yondelis, which is being investigated for the treatment of soft tissue sarcomas, received orphan drug status by the Food and Drug Administration. Earlier this week, the Madrid, Spain-based company's Aplidin also was granted an orphan drug designation. Aplidin is being investigated for use in treating multiple myeloma, according to Reuters.

 

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