Company Branding

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FDA APPROVES BIDIL HEART DRUG FOR BLACK PATIENTS ------------------------------------------------------------------------------- The Food and Drug Administration approved NitroMed Inc.'s chronic heart-failure treatment, BiDil (isosorbide dinitrate/hydralazine hydrochloride), for self-identified black patients.

"The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition," said Dr. Robert Temple, associate director of medical policy for the FDA. "In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil."

The approval of BiDil, which was recommended by an FDA advisory committee earlier this month, was partly based on the results of a study that involved 1,050 self-identified black patients who had severe heart failure and had already received the best treatment available.

Patients treated with BiDil experienced a 43 percent reduction in death and a 39 percent decrease in hospitalization for heart failure as compared with placebo-treated patients. Symptoms of heart failure also decreased among the patients receiving BiDil.

BiDil is the first drug to focus on treating one specific race of patients, according to Reuters. -=-

FDA GRANTS BOEHRINGER'S APTIVUS ACCELERATED APPROVAL ------------------------------------------------------------------------------- The Food and Drug Administration granted Boehringer Ingelheim Pharmaceuticals Inc.'s Aptivus (tipranavir) accelerated approval as a combination antiretroviral treatment for adults with HIV-1 who show evidence of viral replication and who are highly treatment-experienced or have HIV-1 strains resistant to other protease inhibitors.

The approval is based on 24 weeks of data from ongoing studies; traditional approval will not be considered until longer-term data are available, the company said. Study results have not yet demonstrated the drug's effect on clinical progression of HIV-1.

Aptivus 500 mg was approved to be taken twice daily in combination with Abbott's Norvir (ritonavir) 200 mg. This combination must be taken along with other HIV drugs, Boehringer said.

Aptivus 250 mg soft gel capsules will be available in pharmacies within two weeks of approval, the company added.

Aptivus, a nonpeptidic protease inhibitor, enters infected immune cells and inhibits HIV replication for many HIV strains that are resistant to other protease inhibitors.

"The prevalence of drug-resistant HIV underscores the need for new treatments," said Dr. Daniel Kuritzkes of Harvard Medical School. "Aptivus offers an important new treatment option to highly treatment-experienced patients or those with multiple protease inhibitor resistant virus."

In May, an FDA advisory committee recommended approval of Aptivus. The committee also asked that additional long-term safety trials be conducted on the drug. -=-

VIVUS' AVANAFIL FOUND SAFE, EFFECTIVE IN PHASE II TESTING FOR ERECTILE DYSFUNCTION, SHARES JUMP ------------------------------------------------------------------------------- Vivus Inc. said Phase II testing of avanafil--its next-generation, fast-acting, highly selective oral phosphodiesterase type 5 (PDE-5) inhibitor--in men with erectile dysfunction (ED) has yielded positive results.

In the double-blind, randomized, parallel-design study, 284 patients received various doses of avanafil or placebo during a 12-week period. Patients were instructed to attempt sexual intercourse 30 minutes after taking their allotted dose. No restrictions were placed on food or alcohol consumption.

Depending on the strength of the dose, avanafil resulted in erections sufficient for vaginal penetration in up to 84 percent of the attempts, according to Vivus. In addition, the company noted there were no reports of serious adverse events.

"The study demonstrated that avanafil, if approved, could be a safe, effective and convenient treatment for ED," said Dr. Joel Kaufman, an investigator in the study. "The ability to initiate intercourse in 30 minutes, which is half the time as compared to the recommended initiation time of two of the currently approved PDE-5 inhibitors, while maintaining a high degree of efficacy should help differentiate avanafil and give men a meaningful option to treat their ED."

Dr. John Dietrich, vice president of research and development at Vivus, said other studies have suggested that avanafil could have less impact than Pfizer Inc.'s Viagra (sildenafil citrate) on decreasing blood pressure when taken with nitrates, due to avanfil's high selectivity for PDE-5.

Shares of Vivus closed at $3.95, up $0.61, or 18.3 percent, in heavy trading on the Nasdaq. -=-

ABBOTT TO OFFER EXPANDED ACCESS TO UNAPPROVED CANCER AGENT XINLAY ------------------------------------------------------------------------------- Abbott received permission from the Food and Drug Administration to initiate an expanded access program in the United States for investigational agent Xinlay (atrasentan), a treatment intended for patients with late-stage, hormone-refractory prostate cancer.

Xinlay is an oral, once-daily, nonchemotherapy cancer agent belonging to the selective endothelin-A receptor antagonist class. The FDA is reviewing a New Drug Application for Xinlay based on Phase II and Phase III clinical trials in men with metastatic hormone-refractory prostate cancer.

Glenn Novarro, an analyst with Banc of America Securities, said, "We believe that today's news is a signal that the FDA considers Xinlay to be safe and effective enough to be used on patients," according to a Reuters report. "This gives us more confidence that the drug will receive approval by year-end," he added.

Expanded access programs are intended to give patients with serious diseases for which there are no other satisfactory treatments access to investigational therapies as early as possible. Abbott's program for Xinlay is scheduled to begin later this summer.

According to Novarro, if Xinlay is approved in late 2005, sales of the drug could reach $300 million in 2006 and ultimately achieve annual sales of $1.5 billion to $2 billion. -=-

GILEAD SEEKS TERMINATION OF TAMIFLU AGREEMENT WITH ROCHE ------------------------------------------------------------------------------- Gilead Sciences Inc. is seeking to terminate an agreement made in 1996 with F. Hoffmann-La Roche Ltd. for the development and licensing of Tamiflu (oseltamivir phosphate), an antiviral drug developed by Gilead that is approved to treat and prevent influenza.

"Despite our repeated communication of concerns over the last several years, Roche has not adequately demonstrated the requisite commitment to Tamiflu since its launch in the United States nearly six years ago, nor has it allocated the necessary resources to realize the potential of the product as a treatment and preventive for influenza," said John Martin, chief executive officer of Gilead. "Gilead is taking this action in the interest of our shareholders and, importantly, because it is essential for public health that health care professionals and consumers have improved access to information about Tamiflu, as well as to the product itself."

Gilead's termination notice cites Roche's failure to launch Tamiflu in some markets for which it has been approved, manufacturing problems that have led to product shortages and royalties due Gilead that have not been paid. -=-

SALIX TO ACQUIRE INKINE FOR APPROXIMATELY $190 MILLION ------------------------------------------------------------------------------- Salix Pharmaceuticals Ltd. agreed to acquire InKine Pharmaceutical Co. Inc. for $3.55 per share, or approximately $190 million, in a tax-free, stock-for-stock transaction.

The acquisition is expected to be neutral to Salix's 2006 earnings per share and "significantly accretive" after that.

InKine shareholders will receive Salix common stock in exchange for their InKine common stock. The final exchange ratio will be determined based on Salix's stock price prior to the closing of the transaction, which is anticipated for the fourth quarter.

The companies said the merger will form "the largest specialty pharmaceutical company focused exclusively on gastroenterology." Products leading the newly formed company's marketing list will include Salix's Colazal (balsalazide disodium) and Xifaxan (rifaximin), drugs for ulcerative colitis and travelers' diarrhea, respectively, and InKine's Visicol (sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous USP), a purgative preparation indicated for bowel cleansing prior to colonoscopy.

"The combination of Salix and InKine provides an unparalleled opportunity for each company to capitalize on their assets in the short-term and strengthen their prospects for continued growth over the long-term," said Carolyn Logan, chief executive officer of Salix. "The combined company should benefit from the expanded reach and penetration of a sales force totaling approximately 100 specialty sales representatives focused on gastroenterologists," she added.

The combined company will operate out of Salix's headquarters in Raleigh, N.C. -=-

Company Branding
MERCK & CO. INC. ------------------------------------------------------------------------------- Merck & Co. Inc. researchers considered reformulating Vioxx (rofecoxib) in 2000 to reduce the drug's cardiovascular risks, according to a copy of an internal company document obtained by The Associated Press. The document, which Merck unintentionally gave to plaintiff attorneys in a Vioxx lawsuit, included communication between the company's researchers and its patent department. It suggested that a patent be sought for a combination drug-- one that added another agent to Vioxx "to lessen the [cardiovascular] risk," The Wall Street Journal reported. -=-

Company Branding
SANOFI-AVENTIS GROUP ------------------------------------------------------------------------------- Sanofi-aventis Group's New Drug Application for Acomplia (rimonabant), the first selective cannabinoid type 1 blocker, was accepted by the Food and Drug Administration. Sanofi did not say for which indications the NDA was filed but said the drug "is thought to represent a new approach for the comprehensive management of cardiovascular risk factors." Acomplia has been studied as a smoking cessation aid and as a treatment for metabolic disorders among overweight and obese patients. FDA approval of the drug's brand name has not yet been granted. -=-

Company Branding
GUIDANT CORP. ------------------------------------------------------------------------------- Guidant Corp. said it will establish an independent expert panel to suggest guidelines for communicating with patients and physicians regarding their implantable heart devices. "Recent issues with some of our devices have highlighted the need for clear guidelines for communication about infrequently occurring events," said Ronald Dollens, chief executive officer of Guidant. Separately, The Wall Street Journal reported that the Heart Rhythm Society is working with the FDA to draft guidelines for manufacturers of defibrillators, advising them of what to do if they detect a pattern of malfunctions. -=-

Company Branding
DYNAVAX TECHNOLOGIES CORP. ------------------------------------------------------------------------------- Dynavax Technologies Corp. initiated Phase III testing to compare the effectiveness of its hepatitis B vaccine with GlaxoSmithKline Plc's Engerix-B HBV vaccine in an older adult population. Dynavax's vaccine combines the company's proprietary immunostimulatory sequence with HBV surface antigen and is designed to "enhance the level, speed and longevity of protection," according to the company. The vaccine is also to be tested in a younger adult population in a second Phase III trial tentatively slated for early next year. -=-