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Merck unveils sweeping plan to cut costs, increase efficiency Merck & Co. Inc. will expand its previous restructuring efforts by implementing companywide actions to change "virtually every aspect" of its business and attempt to reclaim a leadership position in the pharmaceutical industry.

The company intends to focus its research and development efforts in nine "priority disease areas, including Alzheimer's disease, atherosclerosis, cardiovascular disease, diabetes, novel vaccines, obesity, oncology, pain and sleep disorders."

Merck will also revamp its marketing and sales strategy, with the goal of achieving greater efficiency and effectiveness. In addition to previous efforts that have reduced the number of redundant sales representatives by approximately 50 percent, the company plans to "place more emphasis on active engagement with key opinion leaders" and "devote additional resources to utilizing technology and demonstrating product value to physicians," moves that are expected to reduce the company's spending per brand by as much as 20 percent by 2010.

Touting a robust drug pipeline, Merck said it expects to submit three filings to the Food and Drug Administration in 2006 and to have five programs in Phase III trials by the end of the first quarter of 2006.

Merck expects the restructuring to result in up to $5 billion in total savings through 2010, although previously announced plans to cut 7,000 jobs and close or sell five manufacturing facilities could cost the company up to $1 billion in 2006, Dow Jones Newswires reported.

Regarding the extensive and far-reaching changes, Merck's chief executive officer, Richard Clark, said, "Merck will remain a research-driven pharmaceutical company, but we need to change our approach to virtually every aspect of our business, and we must act with a sense of urgency."

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GTx reports positive results from interim analysis of Acapodene trial GTx Inc. said treatment with Acapodene (toremifene citrate) 80 mg for one year provides highly statistically significant increases in bone mineral density in men with prostate cancer who are receiving androgen deprivation therapy (ADT).

In the double-blind Phase III trial, 1,394 patients were randomized to receive Acapodene 80 mg or placebo for 24 months. Although the trial's primary endpoint is the occurrence of radiographic vertebral fractures, the current interim analysis focused on BMD, a secondary endpoint of the trial, in the first 200 patients to complete one year of therapy. The interim analysis was meant to "give confidence" that Acapodene would deliver a 40 percent reduction in fractures at two years.

The analysis revealed that patients treated with the drug, a selective estrogen receptor modulator, experienced increases in BMD of 2.3 percent in the lumbar spine, 2 percent in the hip and 1.5 percent in the femoral neck compared with placebo.

"Acapodene's BMD changes are of a magnitude that should deliver the desired fracture benefit, as they are consistent with BMD changes that have translated into greater than 50 percent fracture reductions in other . . . trials of postmenopausal women," said Dr. Matthew Smith, a lead researcher in the trial.

"We also remain confident that our Phase III trial of Acapodene will show benefits in the trial's other secondary endpoints, including improvements in the lipid profile of the men receiving Acapodene, as cardiovascular disease is a leading cause of death for men on ADT," added Dr. Mitchell Steiner, chief executive officer of GTx.

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Spectrum, GPC Biotech begin rolling submission of NDA for satraplatin for hormone-refractory prostate cancer Spectrum Pharmaceuticals Inc.'s co-development partner, GPC Biotech AG, began the rolling submission of a New Drug Application with the Food and Drug Administration for satraplatin plus prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer.

The rolling submission process allowed GPC to submit the chemistry, manufacturing and controls section of the application to the FDA when it became available, which in turn will allow the review process to begin before the drug's dossier is completed. Rolling submission is available only for drugs that have received fast track status.

Satraplatin, an investigational, platinum-based chemotherapy, is the first such drug to be orally bioavailable; it is administered in capsule form. Phase II trials of the drug in hormone-refractory prostate, ovarian and small cell lung cancers have been completed. In addition, the combination of satraplatin with radiation therapy has yielded promising early clinical results, leading to the initiation of a Phase I/II study of the combination therapy in patients with non-small cell lung cancer.

"In December alone, we achieved our target enrollment in the Phase III registrational trial, announced the opening of accrual of a Phase II study evaluating satraplatin in combination with [Bristol-Myers Squibb Co.'s] Taxol (paclitaxel) and reported that the independent data monitoring board reviewed the safety data from the Phase III trial and recommended that the trial continue as planned," said Dr. Rajesh Shrotriya, Spectrum's chief executive officer. "The submission of the rolling NDA is a major step forward toward the ultimate goal of making satraplatin available to patients as quickly as possible."

The FDA granted fast track designation for the drug as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer in September 2003.

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MabThera maintenance therapy improves survival of patients with non-Hodgkin s lymphoma, study suggests Patients with indolent non-Hodgkins lymphoma have an increased likelihood of survival if they receive maintenance therapy with MabThera (rituximab), according to data presented at the 47th annual meeting of the American Society of Hematology in Atlanta.

Genentech Inc. developed rituximab and co-markets it in the United States with Biogen Idec Inc. as Rituxan. F. Hoffmann-La Roche Ltd. markets the drug as MabThera in other countries except Japan.

The study included 465 patients with relapsed and refractory indolent non-Hodgkins lymphoma. The subjects were randomized to receive six cycles of MabThera plus CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone) or CHOP chemotherapy alone.

The results of this induction phase demonstrated a significantly higher rate of complete remission for patients who received MabThera plus CHOP compared with those who received CHOP alone (29 percent vs. 16 percent). Median progression-free survival also was significantly better for MabThera-plus-CHOP-treated patients (33 months vs. 20 months).

The patients who responded to therapy during this induction phase of the study were then randomized to either MabThera maintenance therapy--administered as an infusion every three months for two years--or no additional therapy.

MabThera maintenance therapy resulted in significantly increased overall survival in all of the patients regardless of whether they had received CHOP or CHOP plus MabThera as their initial therapy.

Specifically, patients initially treated with CHOP chemotherapy had an overall survival rate at three years of 71 percent with no MabThera maintenance therapy, but an overall survival rate of 82 percent if they did receive MabThera maintenance, a difference that represented a 48 percent reduction in the risk of death. For patients initially treated with CHOP plus MabThera, the overall survival rates with and without maintenance therapy were 81 percent and 88 percent, respectively, which represented a 50 percent reduction in the risk of death.

Maintenance therapy with MabThera may well become the new standard of care for these patients, Roche said.

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BiDil cost-effective treatment for heart failure in black patients, according to study data NitroMed Inc.'s BiDil (isosorbide dinitrate/hydralazine hydrochloride) reduced hospitalizations and was associated with a favorable cost-effectiveness profile in black patients in a recent study.

Researchers analyzed data from the A-HeFT trial, which included 1,050 self-identified black patients with New York Heart Association class III or class IV heart failure. Patients in the trial were randomized to receive BiDil or placebo in addition to standard treatment for heart failure.

Taking into account BiDil's current retail price, researchers found that the drug's use resulted in savings of $533 per patient for costs related specifically to heart failure and $1,730 per patient for "total direct health care costs" during a mean follow-up period of 12.8 months.

Researchers also found that patients who took BiDil incurred fewer hospitalizations for heart failure (0.33 per subject) than did those who took placebo (0.47 per subject) and, on average, had shorter hospital stays (6.7 days vs. 7.9 days, respectively). Furthermore, patients in the BiDil arm experienced a 43 percent decrease in mortality risk as compared with patients in the placebo group.

Assuming no additional benefits associated with the drug other than those demonstrated in the trial, and using costs related to heart failure, the researchers projected the cost effectiveness of BiDil to be $16,600 per life-year at two years after enrollment, $37,000 per life-year at five years and $41,800 per life-year during a lifetime.

"In summary, treatment with [BiDil], previously shown to have improved clinical outcomes in black [patients] with advanced heart failure, also reduced heart failure-related and all health care resource use and costs in A-HeFT, primarily because of a large reduction in heart failure-related hospitalizations," the study authors wrote.

The researchers added that long-term use of the drug is likely to be associated with a favorable cost-effectiveness profile, noting that "adoption of this strategy seems prudent for black [patients] with moderate to severe heart failure."

As an adjunct to standard therapy, BiDil is approved to improve survival, prolong time to hospitalization for heart failure and improve patient-reported functional status in self-identified black patients.

Results of the study appeared in the Dec. 13 issue of the journal Circulation.

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Cost may prohibit Xolair from being covered in health plans, researchers suggest Although studies indicate that use of Genentech Inc. and Novartis AG's Xolair (omalizumab) appears to be efficacious and safe among adults with allergic asthma, researchers recommend restricting the drug's inclusion in health plans because of its high cost.

A team of investigators reviewed published data, which showed that treatment with Xolair may reduce the need for inhaled corticosteroids and rescue medications and improve asthma control and quality of life among adults with moderate to severe allergic asthma. Additionally, the team performed a cost analysis.

In 2005, the average wholesale price for a single dose of 150 mg of Xolair was $568, and the annual acquisition cost ranged from $15,000 per person to $44,000 per person. These figures led the researchers to suggest that Xolair should be categorized as a "restricted use" drug and given only to patients who meet specific criteria.

As an example, they said that in patients with severe, poorly controlled asthma, the high cost of the drug may be offset by the savings that result from less frequent use of medical services for asthma exacerbations.

The study was published in the November/December issue of the Journal of Managed Care Pharmacy.

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The Food and Drug Administration The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee said Merck & Co. Inc.s investigational Zostavax (zoster vaccine live) appears safe for use in patients aged 60 years or older, but there is a lack of data for its use in patients aged 50 to 59 years, Reuters reported. Merck is proposing that the vaccine be approved as an immunization in adults aged 50 years or older to prevent herpes zoster and postherpetic neuralgia and to reduce acute and chronic zoster-associated pain.

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F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd. and Maxygen Inc. entered into an alliance to co-develop recombinant factor VIIa products for intracerebral hemorrhage, trauma and other indications. Under the agreement, Roche and Maxygen will share research and development costs related to creating the product candidates, with Maxygen leading early-stage development and Roche assuming the later stages of development. Roche will retain exclusive global rights to commercialize the next-generation recombinant factor VIIa products for acute indications; Maxygen can choose to co-fund U.S. marketing activities and receive royalties. Maxygen will retain all product rights associated with the indication of hemophilia. Excluding potential royalty payments, Maxygen could receive as much as $95 million as a result of the alliance.

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Inamed Corp. Inamed Corp.'s board unanimously approved a $3.2 billion merger offer from Allergan Inc. in a deal that would allow Allergan, which makes Botox (botulinum toxin type A), to expand its wrinkle-treatment product line. Inamed said it had not yet signed the agreement and that the transaction would not be finalized until Allergan has completed a limited due diligence investigation of Inamed's Juvederm product line and related disclosure schedules to the merger agreement. Earlier this week, Inamed paid Medicis Pharmaceutical Corp. a $90 million fee to terminate a previous merger agreement with that company.

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Xcyte Therapies Inc. Xcyte Therapies Inc. and Cyclacel Group Plc agreed to merge, thereby creating an international, publicly traded biopharmaceutical company with a "strong development pipeline." The transaction, which will be structured as an acquisition of all of subsidiary Cyclacel Ltd.'s capital stock by Xcyte, is expected to close at the end of the first quarter of 2006. The resulting company, which will be called Cyclacel Pharmaceuticals Inc., will build upon Cyclacel's existing portfolio of orally available drugs that modulate the cancer cell cycle, the companies said. Further financial terms of the agreement were not disclosed.