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Pfizer's Sutent approved for GI stromal tumors, advanced kidney cancer Pfizer Inc.'s Sutent (sunitinib malate) was approved by the Food and Drug Administration for treating patients with gastrointestinal stromal tumors (GISTs) and advanced kidney cancer.

Specifically, Sutent was approved to treat patients with progressed GIST or those with GIST who cannot tolerate treatment with Novartis AG's Gleevec (imatinib mesylate), the standard treatment for the disease. For the advanced renal cell carcinoma, or kidney cancer, indication, Sutent was granted accelerated approval.

This is the first time the FDA has approved a new oncology product for two indications at the same time, the agency noted.

Sutent, a tyrosine kinase inhibitor, had been granted priority review and was approved in less than six months.

The approval for treating patients with GIST was based on trials that showed the drug's ability to delay the time it takes for new lesions or tumors to grow. The FDA said that for patients treated with Sutent, the median time-to-tumor progression was 27 weeks; for patients who received placebo, the median time was six weeks.

The approval for advanced renal cell carcinoma, however, was based on the drug's ability to reduce tumor size.

"Today's approval of this drug for these indications provides compelling evidence that the use of alternative data endpoints allows us to see the benefits of novel therapies earlier in patients," said Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products.

Each year, approximately 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed, according to American Cancer Society statistics.

In separate news, Pfizer said its Exubera (rDNA origin) inhaled insulin powder was approved by the European Commission to treat adult patients with type 1 and type 2 diabetes. The drug is awaiting approval in the United States.

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BioMarin's investigational phenylketonuria treatment granted fast track status BioMarin Pharmaceutical Inc.'s Phenoptin (sapropterin dihydrochloride) was granted fast track status by the Food and Drug Administration as a potential treatment for phenylketonuria (PKU), a genetic disorder caused by a deficiency of the phenylalanine hydroxylase enzyme.

Phenoptin, an oral small molecule therapy that also received an orphan drug designation, is being studied in a Phase III trial.

"In early December of 2005, we enrolled the last patient into the ongoing Phase III clinical trial of Phenoptin, keeping us on track to announce top-line results from the double-blind, placebo-controlled portion of this trial in late March 2006," said Jean-Jacques Bienaime, chief executive officer of BioMarin.

According to BioMarin, the only current treatment for PKU, which can result in severe mental retardation and brain damage, mental illness, seizures and cognitive problems, is a restrictive medical food diet that is expensive and difficult to maintain.

Approximately 50,000 patients in the developed world have the disease, and BioMarin estimates Phenoptin could be used to treat as many as half of these patients.

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Discovery's Surfaxin granted fast track status for chronic lung disease in premature infants Discovery Laboratories Inc.'s lead product candidate, Surfaxin (lucinactant), was granted fast track status for the prevention and treatment of bronchopulmonary dysplasia, or chronic lung disease, in premature infants.

Surfaxin has previously received an orphan drug designation for treating chronic lung disease in premature infants.

Furthermore, the drug has been deemed approvable for the prevention of respiratory distress syndrome in premature infants. The FDA is expected to finish reviewing the New Drug Application for this indication by April.

Currently, no drugs are approved to treat chronic lung disease, Discovery said, adding that the condition is commonly associated with the treatment of respiratory distress syndrome in premature infants.

Discovery is conducting a Phase II trial to assess Surfaxin's safety and tolerability in treating chronic lung disease. In the trial, premature infants are receiving up to five doses of the drug within the first three to 10 days after birth, in addition to treatment with a surfactant on the first day. The intent of the trial is to investigate whether this regime can reduce the incidence of death or chronic lung disease and reduce the number of infants who need oxygen or mechanical ventilation.

For now, the only approved surfactant treatment options are animal-derived or non-protein-containing synthetic products, which Discovery said are indicated only for treating respiratory distress syndrome.

Shares of Discovery closed at $7.82, up $0.31, or 4.1 percent, in heavy trading on the Nasdaq.

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Alexion's eculizumab trial yields positive results Alexion Pharmaceuticals Inc. reported positive results from its Phase III trial of eculizumab, a drug used to treat the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).

The randomized efficacy trial called TRIUMPH included 87 patients with PNH.

The prespecified, co-primary endpoints were median transfusion rate and hemoglobin stabilization throughout a six-month period. Both endpoints were reached with statistical significance.

Furthermore, all of the secondary endpoints were achieved with statistical significance.

Eculizumab is the first drug specifically designed for the treatment of PNH. Dr. Peter Hillmen, lead investigator of the TRIUMPH steering committee, noted that many of the patients in the trial "were able to resume normal activities of daily living after having experienced years of debility."

Additionally, the company has chosen Soliris as the trade name for eculizumab, although the name has yet to be approved by the Food and Drug Administration.

Alexion shares closed at $26.40, up $4.45, or 20.3 percent, in heavy trading on the Nasdaq

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Lilly posts strong Q4, full-year results Eli Lilly and Co. posted stronger net income and sales for the fourth quarter and full year of 2005 as compared with the previous year, attributing the improvement to newer products and productivity initiatives.

Lilly earned $700.6 million, or $0.64 per diluted share, in the fourth quarter of 2005. By comparison, the firm posted a net loss of $2.4 million in the fourth quarter of 2004 and its earnings per share were break-even. For the fourth quarter of 2004, the company reported earnings, excluding charges, of $814.3 million, or $0.75 per diluted share.

The firm earned $0.80 per share for the fourth quarter of 2005, excluding certain charges, beating the average analyst forecast of $0.78 per share, according to Reuters Estimates.

Worldwide sales for the fourth quarter increased 6 percent to $3.88 billion in 2005, up from $3.64 billion in 2004.

Global sales of osteoporosis drug Forteo (teriparatide [rDNA origin]) increased 59 percent in the fourth quarter, while sales of attention-deficit/hyperactivity disorder treatment Strattera (atomoxetine hydrochloride) fell 8 percent compared with the previous fourth quarter.

Fourth-quarter sales of the firm's diabetes products, including Lilly and Amylin Pharmaceuticals Inc.'s Byetta (exenatide) injection, increased 11 percent.

For the full year of 2005, Lilly earned $1.98 billion, or $1.81 per diluted share, compared with $1.81 billion, or $1.66 per diluted share, in 2004.

Full-year sales rose 6 percent, from $13.86 billion to $14.65 billion in 2005.

In the first quarter of 2006, Lilly expects to earn $0.73 to $0.75 per share. For the entire year, the firm expects per share earnings of $3.10 to $3.20. Lilly anticipates full-year sales growth of 7 percent to 9 percent.

Lilly shares closed at $56.93, down $0.24, or 0.4 percent, in moderate trading on the New York Stock Exchange.

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Amgen posts strong earnings, revenue on higher product sales Amgen Inc. posted higher earnings and revenue in the fourth quarter and full year of 2005 as the biotech firm continued to benefit from strong drug sales.

Amgen earned $824 million, or $0.66 per diluted share, in the fourth quarter of 2005 compared with $689 million, or $0.53 per diluted share, earned in the same period of 2004.

Excluding charges, the firm earned $0.75 per share; Reuters Estimates said this figure met the expectations of analysts.

The firm posted fourth-quarter revenue of $3.27 billion, up from $2.91 billion in 2004.

Fourth-quarter product sales increased 14 percent, from $2.78 billion in 2004 to $3.17 billion in 2005. Specifically, worldwide sales of anemia treatment Aranesp (darbepoetin alfa) increased 24 percent to $873 million in the most recent quarter, up from $705 million in the fourth quarter of 2004.

For the full year, Amgen earned $3.67 billion, or $2.93 per diluted share, in 2005 compared with $2.36 billion, or $1.81 per diluted share, in 2004.

Full-year revenue also increased, from $10.55 billion in 2004 to $12.43 billion in 2005.

For 2006, Amgen expects to earn from $3.55 to $3.70 per share, on an adjusted basis. Revenue for the year is projected to range from $13.9 billion to $14.4 billion.

Amgen shares closed at $71.90, down $3.57, or 4.7 percent, in heavy trading on the Nasdaq.

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Merck KGaA Merck KGaA and Biomira Inc. will amend their licensing agreement for the liposome vaccine known as L-BLP25, which is intended to treat non-small cell lung cancer. Under the new agreement, Merck will be responsible for the administrative and financial aspects of the vaccine's development and commercialization, including a Phase III trial set to begin enrollment by midyear. In exchange, Biomira's co-promotion interest in U.S. sales of the vaccine will be converted to royalties, which are to be paid at a higher rate than royalties for other markets. According to Biomira, Merck intends to investigate the vaccine as a treatment for other types of cancer.

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Abbott Abbott's investigational acute decompensated heart failure treatment, levosimendan, licensed from Orion Corp., is advancing through the regulatory approval process in the United States. Levosimendan is currently marketed outside the United States as Simdax. Abbott is finalizing the data analysis, communicating with the Food and Drug Administration and considering what is next for the drug, Orion said.

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Genentech Inc. Genentech Inc. entered into a licensing agreement with Amgen Inc. giving each of the companies access to multiple patents associated with the manufacturing and use of antibodies and related technology. Financial terms of the agreement were not disclosed.

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Cephalon Inc. Cephalon Inc. said its attention-deficit/hyperactivity disorder drug, Sparlon (modafinil), most likely will not be launched until the second quarter of this year. The Food and Drug Administration will make its decision regarding Sparlon's New Drug Application after advisory committee meetings scheduled for February and March. In these meetings, the FDA panel members will discuss safety issues associated with ADHD therapies that are already approved. Because Sparlon has not yet been approved, it will be reviewed in a separate, subsequent meeting in March. The agency issued an approvable letter for Sparlon's NDA in October. Cephalon shares closed at $71.88, up $5.05, or 7.6 percent, in heavy trading on the Nasdaq.