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Celgene's Thalomid fails in clinical trial as treatment for multiple myeloma Celgene Corp.'s leprosy drug, Thalomid (thalidomide), failed to prolong the lives of patients with multiple myeloma in a study co-sponsored by the National Cancer Institute.

Thalidomide had previously been prescribed to treat morning sickness and insomnia but was taken off the market in 1962 for causing serious birth defects. In recent years, the drug has been reassessed as a potential cancer treatment.

The Celgene study, which was published in the March 9 issue of The New England Journal of Medicine, included 668 patients with newly diagnosed multiple myeloma. The patients were treated with seven rounds of multiple cancer drugs and some received transplantation of their own bone marrow stem cells. In addition, approximately half of the patients (n=323) were randomized to daily treatment with Thalomid along with the chemotherapy. This group continued to receive the drug during years of maintenance therapy.

The primary endpoint of the trial was the five-year, event-free survival rate. Secondary endpoints included complete response and overall survival.

After an average follow-up period of 42 months, 478 of the study patients were still alive. Of these patients, 62 percent of the Thalomid-treated patients experienced a complete response (in which cancer cells dropped to undetectable levels) compared with 43 percent of the control group. The five-year, event-free survival rates for the Thalomid and control groups were 56 percent and 44 percent, respectively.

However, patients treated with Thalomid eventually stopped responding to the drug, at which point they deteriorated rapidly and died more quickly than did patients in the control group. As a result, the five-year overall survival rate was the same for both groups (65 percent). Patients in the Thalomid group survived a median of 1.1 years after relapse compared with a 2.7-year survival rate after relapse among the control patients.

Further, the Thalomid group experienced a higher rate of serious side effects, including blood clots, bowel obstructions, abnormal heart rhythms that led to fainting, low white blood cell count, and tremors and tingling.

Approximately 30 percent of the patients stopped taking Thalomid within two years, and by four years, more than 60 percent had stopped.

Although Thalomid is approved for treating leprosy complications, physicians can prescribe it to treat cancer and other diseases. The drug is only available through a restricted distribution program.

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Myogen's investigational PAH treatment granted fast track designation Myogen Inc.'s ambrisentan, a type-A selective endothelin receptor antagonist, was granted fast track status by the Food and Drug Administration for treating pulmonary arterial hypertension.

The drug, which has also been granted orphan drug status, is being studied in Phase III trials for this indication.

In December, Myogen released results from the Phase III ARIES-2 trial, which assessed the drug's ability to improve exercise capacity. The trial's primary endpoint was measured by the placebo-corrected mean change in six-minute walk distance (6MWD) at 12 weeks compared with baseline.

Researchers found that a daily 5 mg dose of ambrisentan improved the placebo-corrected mean 6MWD by 59.4 meters and that a daily 2.5 mg dose improved it by 32.3 meters. In contrast, patients in the placebo group experienced a decrease of 10.1 meters.

"We are pleased to receive fast track designation for ambrisentan," said Dr. Michael Gerber, Myogen's senior vice president of clinical development and regulatory affairs. "Based on clinical trial results to date and the properties of ambrisentan, Myogen believes that, if ambrisentan is ultimately approved, it may offer significant clinical benefit to PAH patients."

Earlier this week, Myogen licensed non-U.S. commercialization rights for ambrisentan to GlaxoSmithKline Plc.

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FDA grants fast track designation to Nabi's nicotine addiction vaccine Nabi Biopharmaceuticals' NicVAX (nicotine conjugate vaccine), an investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse, received fast track designation from the Food and Drug Administration.

NicVAX triggers the immune system to produce antibodies that bind to nicotine, soaking it up as it circulates in the bloodstream and preventing it from reaching the brain. As a result, the nicotine cannot produce a positive stimulus, and the addictive properties of smoking are eliminated.

Nabi said that because the antibodies are expected to be long-lasting, NicVAX may also help prevent smoking relapse.

"[C]urrent smoking cessation therapies do not effectively treat the root cause of the addiction," said Dr. Henrik Rasmussen, senior vice president of Nabi's clinical, medical and regulatory affairs. "We believe the vaccine approach inherent to NicVAX will provide clear patient advantages and a strong differentiation from currently marketed and development-stage products." NicVAX has been studied in four Phase I/II studies of nearly 200 patients and was found to be well tolerated, highly immunogenic and effective. Of those who received 200 mcg of NicVAX, the rate of cessation was 33 percent to 40 percent compared with 9 percent in the placebo group, according to Nabi.

The company plans to initiate a Phase II proof-of-concept study in the second quarter that will include approximately 300 people. Results from this study are expected to be available in the second half of 2007.

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Vertex's potential RA treatment meets endpoints of Phase II trial Vertex Pharmaceuticals Inc.'s VX-702 met its primary objectives in a Phase II trial of patients with rheumatoid arthritis, according to a preliminary analysis.

The trial included 315 patients with moderate to severe RA, 278 of whom completed all 12 weeks of treatment. Patients were randomized to 5 mg of VX-702, 10 mg of VX-702 or placebo once each day. They could also receive certain disease-modifying antirheumatic drugs but not anti-tumor necrosis factor therapies or methotrexate, Vertex noted.

After the end of the treatment phase, patients were evaluated for improvement in clinical signs and symptoms using criteria from the American College of Rheumatology.

Researchers found that, at week 12, patients who were treated with VX-702 had a dose-dependent, statistically significant increase in ACR20 response rates, which was the study's primary endpoint. Thirty-eight percent of patients who received the 5 mg dose and 40 percent of patients who received the 10 mg dose had an ACR20 response compared with 30 percent of patients in the placebo group.

The trial also showed that 32 percent of placebo-treated patients, 41 percent of those who received 5 mg VX-702 and 44 percent of those who received 10 mg VX-702 had a moderate or good response according to European League Against Rheumatism criteria.

Based on this preliminary analysis, Vertex said it will initiate additional studies of the drug, including trials that will test it in combination with methotrexate.

According to Reuters, some analysts were not overly impressed with Vertex's preliminary data. With the release of the trial results, the company's shares fell 5.7 percent.

One analyst cited by Reuters attributed the less-than-enthusiastic response to the fact that the drug has not yet been tested with methotrexate, a standard treatment for this disease. He also remarked that only three-month trial data are available for VX-702, while six-month trial results are available for other RA drugs.

Shares of Vertex closed at $37.98, down $2.30, in heavy trading on the Nasdaq.

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ARBs as effective as ACE inhibitors in reducing atherosclerotic events after acute MI, data show Angiotensin receptor blockers may be as effective as ACE inhibitors in reducing atherosclerotic events after acute myocardial infarction, new research suggests.

The VALIANT study compared the effects of ACE inhibitor captopril, Novartis AG's ARB, Diovan (valsartan) and a combination of the two drugs in 14,703 patients enrolled between 12 hours and 10 days after the onset of acute MI. In addition, study participants had left ventricular systolic dysfunction, clinical evidence of heart failure or both.

Patients were randomized to receive captopril up to 50 mg three times per day, Diovan up to 160 mg two times per day or a combination regimen consisting of captopril up to 50 mg three times per day plus Diovan 80 mg twice daily. Mean follow-up time was 24.7 months.

The trial's primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular mortality and a number of composites of CV mortality and nonfatal CV events (including MI, hospitalization for heart failure, stroke and resuscitation after cardiac arrest).

According to the results, the overall incidence of atherosclerotic events was similar in the captopril and Diovan groups. The rates of the fatal and nonfatal CV composite endpoints were also similar among captopril- and Diovan-treated patients. A total of 587 patients (total investigator-reported events, 796) in the Diovan group were adjudicated as having a fatal or nonfatal MI compared with 559 patients (total investigator-reported events, 798) in the captopril group and 554 patients (total investigator-reported events, 756) in the combination group.

"[T]his analysis of the very large and high-risk cohort of patients with acute MI in VALIANT suggests that ARBs are as effective as ACE inhibitors in reducing atherosclerotic events, even when given in addition to other secondary preventative treatments," the authors wrote. "These data also suggest, but do not prove, that adding an ARB to an ACE inhibitor may have a small additional anti-infarction effect."

The study appeared in the Feb. 21 issue of the Journal of the American College of Cardiology.

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Health plan cost reduced when Raptiva rather than Enbrel positioned as first-line biologic Administration of Genentech Inc.'s Raptiva (efalizumab) rather than Amgen Inc. and Wyeth's Enbrel (etanercept) as first-line biologic therapy in the treatment of patients with moderate to severe chronic plaque psoriasis reduces health plan costs, according to new data.

Using data from clinical trials to determine dosing and efficacy, and average wholesale price data to determine costs, researchers modeled the effect of choosing either Enbrel or Raptiva as first-line treatment for moderate to severe chronic plaque psoriasis on health plan costs for 100 patients.

The researchers assumed that patients who did not achieve at least a 50 percent improvement in symptoms on the Psoriasis Area and Severity Index (PASI 50) would switch to the other biologic after six months. They also assumed that all Enbrel patients reduced their doses after 12 weeks of therapy, from 50 mg twice weekly to 50 mg once weekly, consistent with the dosing recommendations in the package insert. Because the cost of treating adverse events, monitoring and physician visits primarily affect the medical budget instead of the pharmacy budget, these factors were not included in the analysis.

With Enbrel positioned as the first-line therapy, drug costs for the treatment of 100 patients for 24 weeks totaled $1.35 million. PASI 50 was achieved in 77 percent of patients, who continued receiving Enbrel for another 28 weeks at an additional cost of $810,000. The remaining 23 percent of patients who failed to achieve PASI 50 were switched to Raptiva for the next 28 weeks, at an additional cost of $260,000. This resulted in a total annual cost of $2.41 million.

With Raptiva positioned as the first-line therapy, drug costs for the treatment of 100 patients for 24 weeks totaled $950,000. PASI 50 was achieved in 67 percent of patients, who continued receiving Raptiva for another 28 weeks at an additional cost of $740,000. The remaining 33 percent of patients who failed to achieve PASI 50 were switched to Enbrel for the next 28 weeks, at an additional cost of $490,000. This resulted in a total annual cost of $2.2 million.

Using Raptiva first reduced total annual costs by $210,000 ($2,210 per treated patient).

Although the authors assumed that all patients who received Enbrel were able to reduce their dose after 12 weeks, they noted that this is not always the case in actual practice. For each patient who was stepped down, the Raptiva-first strategy saved an additional $106,027 annually ($1,060 per treated patient).

"New biologic therapies have substantially improved treatment of psoriasis. This improvement comes at increased cost to health system pharmacies," the authors concluded. "Choosing a preferred first-line biologic therapy for psoriasis may help minimize pharmacy costs related to these new therapies."

These data were presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco.

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Merck & Co. Inc. Merck & Co. Inc. entered into an exclusive, worldwide agreement with Paratek Pharmaceuticals Inc. through an undisclosed affiliate for the development and licensing of PTK 0796. The broad-spectrum aminomethylcycline antibiotic is being developed in oral and intravenous formulations and is being tested in Phase I trials. It has demonstrated efficacy in treating problematic infections, such as those caused by methicillin-resistant Staphylococcus aureas. Merck, which was granted the right to market PTK 0796 globally, provided an undisclosed amount of up-front funding and will take over the primary responsibility for developing the drug. In exchange, Paratek will be eligible to receive milestone payments that could reach as much as $127 million, as well as royalties. Paratek also retains the option to co-promote the drug's IV formulation in the United States.

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Eli Lilly and Co. Eli Lilly and Co. initiated a Phase III study of enzastaurin for the treatment of relapsed glioblastoma multiform (GBM), an aggressive and malignant form of brain cancer. Enzastaurin is an oral-serine-threoninekinase designed to suppress the growth of tumors through multiple mechanisms. The randomized, open-label registration study will include 397 patients with GBM and will compare the drug's efficacy, safety and tolerability with that of Bristol-Myers Squibb Co.'s CeeNU (lomustine). Enzastaurin is also being studied as a treatment for non-Hodgkin's lymphoma, colorectal cancer, non-small cell lung cancer, pancreatic cancer and mantle cell lymphoma.

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Smith & Nephew Plc Smith & Nephew Plc received approval from the Food and Drug Administration to amend the label for Supartz, the company's joint fluid therapy. Supartz is used to treat osteoarthritic knee pain through intra-articular injections of hyaluronic acid. The previous label indicated that the drug was to be administered through five weekly injections. Amendments to the label's directions for use and precaution sections give physicians the option of administering the product as few as three times per week.

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Indevus Pharmaceuticals Inc. Indevus Pharmaceuticals Inc.'s Investigational New Drug application for Nebido, an injectable testosterone treatment intended to treat male hypogonadism, was accepted by the Food and Drug Administration. Indevus plans to start a pharmacokinetic trial of the drug by the end of the month. Indevus licensed U.S. rights to Nebido from Schering AG. The drug was recently launched in Europe and "is expected to be the first three-month testosterone preparation available in the United States in the growing market for testosterone replacement therapies," Indevus said, adding that the company plans to file a New Drug Application in the second quarter of next year.