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Genentech, Biogen Idec seek additional indication for Rituxan Genentech Inc. and Biogen Idec Inc. submitted a supplemental Biologics License Application for Rituxan (rituximab).

The firms are seeking expanded approval of the drug as a first-line therapy for treatment-naïve patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with cyclophosphamide, vincristine and prednisone (CVP) chemotherapy or cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy or following CVP chemotherapy in patients who reached a response of stable disease or better.

The sBLA is largely based on data from two randomized, controlled trials of Rituxan in 644 treatment-naïve patients.

In the first study, a Phase III trial of 322 patients with follicular, CD20-positive, B-cell NHL, there was an improvement in progression-free survival when Rituxan was used along with CVP chemotherapy compared with CVP chemotherapy alone, Genentech said.

The second Phase III trial involved 322 patients who had responded to or demonstrated stable disease to first-line CVP chemotherapy. These patients were randomized to receive Rituxan infusions during a two-year period or to be observed. Again, Rituxan was associated with an improvement in progression-free survival, the primary endpoint of both studies.

Rituxan is approved as a single agent for relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL. It also has indications in diffuse large B-cell lymphoma and rheumatoid arthritis.

Rituxan is marketed as MabThera by Roche outside of the United States, except in Japan, where it is co-marketed by Chugai Pharmaceutical Co. Ltd. and Zenyaku Kogyo Co. Ltd.

FDA to review Novartis' NDA for Galvus, potential treatment for type 2 diabetes The Food and Drug Administration has accepted for review Novartis AG's New Drug Application for investigational diabetes drug Galvus (vildagliptin).

Novartis is seeking approval of the oral drug, formerly known as LAF237, as a once-daily treatment for type 2 diabetes.

Galvus is a DPP-4 inhibitor; it works by targeting the pancreatic islet dysfunction that causes patients with type 2 diabetes to have high blood sugar levels, Novartis said.

The NDA includes data from studies of more than 4,300 patients. The worldwide trials, which assessed Galvus as a monotherapy and in combination with standard diabetes treatments, found that Galvus significantly reduced blood sugar for as long as one year of treatment, according to Novartis. The firm noted that Galvus was well tolerated and was not associated with weight gain.

"Most of the treatments that we use today focus primarily on stimulating insulin secretion or lowering resistance," said Dr. Vivian Fonseca, chief of endocrinology and metabolism at Tulane University Health Sciences Center in New Orleans. "The positive clinical results we've seen to date with Galvus underscore the importance and promise of addressing the dysfunction of both the pancreatic beta- and alpha-cells."

PTC's investigational muscular dystrophy treatment receives fast track designation The Food and Drug Administration granted PTC Therapeutics Inc.'s PTC124 fast track designation as a treatment for Duchenne muscular dystrophy (DMD) resulting from a nonsense mutation in the dystrophin gene.

PTC124 is an oral drug candidate being developed as a potential treatment for a variety of genetic disorders caused by nonsense mutations, including cystic fibrosis. The company said that an estimated 10 percent of CF cases and 15 percent of DMD cases are caused by a nonsense mutation.

Researchers are evaluating the drug in Phase II clinical trials of DMD and CF. PTC expects the trials to be completed by the end of the year.

In December 2004, PTC124 was granted orphan drug status for the treatment of DMD.

Amgen, Abgenix complete BLA submission for panitumumab in treating colorectal cancer Amgen Inc. and Abgenix Inc. completed the filing of their Biologics License Application for panitumumab with the Food and Drug Administration.

The BLA seeks the drug's approval in treating metastatic colorectal cancer in patients who have not responded to standard chemotherapy.

The firms began submission of the rolling BLA in December, shortly after Amgen said it would buy Abgenix for $2.2 billion.

In November, the firms released Phase III data showing that patients who received panitumumab had a 46 percent decrease in tumor progression rate compared with patients who received supportive care alone.

The open-label trial involved 463 patients who were randomized to receive infusions of panitumumab 6 mg/kg of body weight every two weeks in addition to supportive care, or supportive care alone. Per protocol, patients were not required to receive pre-medication or a loading dose prior to the administration of the study drug.

"The pivotal Phase III study of panitumumab not only met the primary endpoint of improving progression-free survival in patients with metastatic colorectal cancer, but the results surpassed our expectations based on preset measurement criteria in the protocol," said Dr. Willard Dere, chief medical officer at Amgen.

Amgen plans to present results from this trial at a medical conference next week.

Panitumumab, a fully human monoclonal antibody, was granted fast track status by the FDA last July.

Pharmion seeks additional prescribing information for MDS treatment Vidaza Pharmion Corp. submitted a New Drug Application supplement to the Food and Drug Administration to add intravenous administration to the prescribing information for Vidaza (azacitidine), a demethylating agent for patients with myelodysplastic syndromes.

The drug is already approved for subcutaneous administration; according to Pharmion, dosing of the drug would remain the same for IV administration, at 75 mg/m2 per day for seven days, every four weeks.

Pharmion expects to receive a response from the FDA regarding the submission, which was based on existing clinical data and recently completed studies, within six to 10 months.

Vidaza is approved to treat all five MDS subtypes in low-risk and high-risk patients. The subtypes include refractory anemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, refractory anemia with ringed sideroblasts (if the patient has neutropenia or thrombocytopenia or requires transfusions) and chronic myelomonocytic leukemia.

Sanofi Pasteur's flu vaccine yields antibody response at high doses in clinical trial, does not cause severe side effects Results of a clinical study show that, in the majority of patients, two 90 mcg doses of Sanofi Pasteur's subvirion influenza A (H5N1) vaccine generate neutralizing antibody responses usually associated with protection against the flu, without causing severe side effects.

The double-blind study included 451 healthy adults aged 18 to 64 years who were randomized to receive two intramuscular doses of the vaccine or placebo. The vaccine was administered at dosages of 7.5 mcg, 15 mcg, 45 mcg and 90 mcg; the second dose was given 28 days after the first.

A "very clear" dose-response relationship was observed, with a large difference in response between the patients who received lower doses and those who received the vaccine at the 45 mcg and 90 mcg doses. The group who received the 90 mcg dose was the only group in which more than 50 percent of patients achieved the trial's endpoint, which was the development of a microneutralization titer of 1:40 or greater after two doses of the vaccine.

For the safety analysis, patients were followed for 56 days. Data showed that the vaccine was generally well tolerated at all doses, with patients grading 84 percent of all reported symptoms as mild. The frequencies of injection site pain and local tenderness after each dose were greater among vaccine recipients than among placebo recipients and were greater for patients who received the higher doses.

"Given that this is a new kind of influenza virus for the body to experience, we anticipated it would take more of a punch to elicit an immune response, and that is certainly the case," said William Schaffner, who served on the study's safety-monitoring board, in an article in The Wall Street Journal. Schaffner, chairman of the department of preventive medicine at Vanderbilt University School of Medicine, said those involved with the trial "anticipated a better response at the low dose."

Data from the study were published in the March 30 issue of The New England Journal of Medicine.

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GlaxoSmithKline Plc GlaxoSmithKline Plc and Pharmacopeia Drug Discovery Inc. entered into an agreement under which GSK's Center of Excellence for External Drug Discovery will work with Pharmacopeia to bring therapeutic candidates that have been clinically validated to GSK's research and development unit. GSK will make $15 million in cash payments to Pharmacopeia in exchange for the option to conduct Phase III trials on and globally commercialize drugs from the alliance. Each drug development program that is pursued under the agreement will be eligible for success-based milestone payments of up to $83 million along with a double-digit royalty. The agreement stipulates that GSK will receive warrants to purchase Pharmacopeia stock at a premium.

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Eisai Co. Ltd. Eisai Co. Ltd. and DNAVEC Corp. signed a drug discovery research agreement for an Alzheimer's disease vaccine therapy. Using DNAVEC's Sendai virus vector, Eisai intends to develop a gene vaccine that can selectively induce anti-beta-amyloid antibody production through mucosal immunity. Eisai will also receive priority rights to develop, manufacture and market any discoveries from the program.

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Ranbaxy Laboratories Ltd. Ranbaxy Laboratories Ltd. acquired Ethimed N.V., one of Belgium's largest generic drug companies. Financial terms of the agreement were not disclosed. According to The Associated Press, the transaction marks Ranbaxy's third acquisition this week. The company is also buying GlaxoSmithKline Plc's generic business in Italy and Terapia SA, a generic drug company in Romania. Ranbaxy agreed to pay approximately $324 million for Terapia.

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Watson Pharmaceuticals Inc. Watson Pharmaceuticals Inc. plans to divest its manufacturing facility located in Phoenix that produces sterile injectable products. The facility employs approximately 236 people and manufactures 15 products. During the next year, Watson plans to seek contract manufacturing agreements with third-party suppliers or with a potential new owner of the facility for its key products. The company said if it cannot find a "suitable purchaser," it will close the plant by the end of the second quarter in 2007. Watson acquired the Phoenix facility in 2000 when it bought Schein Pharmaceutical Inc.