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Advanced Magnetics revises Phase III trials for ferumoxytol; shares fall

After meeting with the Food and Drug Administration, Advanced Magnetics Inc. said it plans to revise its Phase III program for ferumoxytol in intravenous iron replacement therapy. The company's shares fell 18.1 percent on the news.

The program will now include a primary efficacy analysis suggested by the FDA that is "consistent with the analysis upon which a recent approval of another IV iron product was based."

As a result of the changes, additional patients will be enrolled in the ferumoxytol chronic kidney disease efficacy studies and in the large-scale safety studies. The existing hemodialysis protocol will be redesigned, as well.

Advanced Magnetics estimated that it will have to add $5 million to $7 million to the budget for the Phase III program and now anticipates submitting the New Drug Application for ferumoxytol in the middle of 2007.

The company plans to continue its discussions with the FDA "to ensure a clear regulatory path for submission, review and approval of the NDA for ferumoxytol as an iron replacement therapeutic." It also noted that it has assembled a scientific advisory board to help complete the program and a data monitoring committee to provide independent oversight.

Advanced Magnetics shares closed at $10.40, down $2.30, in heavy trading on the American Stock Exchange.

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FDA grants TheraQuest Biosciences' TQ-1017 second orphan drug status

TheraQuest Biosciences' TQ-1017 received a second orphan drug designation from the Food and Drug Administration.

TQ-1017 is an abuse-deterrent, once-daily, extended-release formulation of tramadol designed to gradually release its active ingredient throughout a 24-hour period.

The most recent orphan drug designation is for the management of postherpetic neuralgia, a chronic, debilitating neuropathic pain syndrome associated with herpes zoster infection, or shingles. The drug received its first such designation in February for the treatment of HIV-associated neuropathy.

According to TheraQuest, the only drugs currently approved to treat postherpetic neuralgia are Endo Pharmaceuticals' Lidoderm (lidocaine) and Pfizer Inc.'s Neurontin (gabapentin) and Lyrica (pregabalin).

The company said several mechanisms of action contribute to tramadol's pain-relieving effects, including serotonin and norepinephrine reuptake inhibition and opioid receptor activation.

The orphan drug status makes TheraQuest eligible for seven years of market exclusivity upon approval.

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CV Therapeutics, Astellas' regadenoson meets primary endpoint in first Phase III study

New results show CV Therapeutics Inc. and Astellas Pharma US Inc.'s regadenoson, an experimental drug that is designed to help physicians monitor blood flow to the heart, was shown to be as effective as Astellas' Adenoscan (adenosine), the leading agent currently used for myocardial perfusion imaging (MPI) studies in the United States.

The first of two similar Phase III studies included 784 patients and was designed to assess the comparability of MPI studies that used regadenoson and those that used Adenoscan. MPI studies help detect coronary artery disease by identifying areas of poor blood flow.

If regadenoson meets the primary endpoint of the second Phase III trial, the two companies plan to submit a New Drug Application to the Food and Drug Administration. Under an agreement between the companies, if regadenoson is approved, Astellas will manufacture, sell and market the product in North America and CV Therapeutics will manage the drug's clinical development program.

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Bone mineral density gains made with NPS' Preos appear to be maintained with Merck's Fosamax, study shows

After one year of therapy with NPS Pharmaceuticals' Preos (parathyroid hormone [rDNA origin]), gains in bone mineral density (BMD) appear to be lost if treatment is not followed by an antiresorptive agent such as Merck & Co. Inc.'s Fosamax (alendronate sodium), according to updated trial data published in the Aug. 11 issue of The New England Journal of Medicine.

During the first year of the PaTH study, 238 postmenopausal women with low BMD were randomized to receive daily treatment with 100 mcg of subcutaneous Preos, 10 mg of oral Fosamax or a combination of the two. The Journal published the results from year one in September 2003.

In the second half of the two-year study, patients who had taken only Preos during the first year were randomized to receive placebo or Fosamax; patients who had taken Fosamax alone or in combination with Preos the first year were assigned to Fosamax therapy during year two. In addition, all participants received GlaxoSmithKline Plc's Tums (calcium carbonate) and vitamin D daily. Two hundred twenty-three patients completed the study.

After two years of treatment, those who took Fosamax after Preos therapy had significant increases in BMD as compared with the group who received placebo after Preos therapy. Specifically, patients in the placebo group lost substantial BMD during the second year.

"These results have clinical implications for therapeutic choices after the discontinuation of [Preos]," the study authors concluded.

NPS submitted a New Drug Application for Preos in May of this year.

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Extended dosing of Procrit comparable to weekly dosing in study of patients with anemia related to chronic kidney disease

Less frequent dosing of Ortho Biotech Products LP's Procrit (epoetin alfa) for maintaining hemoglobin levels in patients with anemia related to chronic kidney disease may achieve a similar response to that of weekly dosing, suggests a recent study.

A total of 519 patients with anemia related to chronic kidney disease who were not on dialysis were included in the PROMPT study, a randomized, open-label trial designed to determine whether extended Procrit dosing schedules of up to once every four weeks are comparable to weekly dosing in maintaining hemoglobin levels.

Patients were randomized to Procrit in dosages of 10,000 U once weekly, 20,000 U every two weeks, 30,000 U every three weeks or 40,000 U every four weeks. Currently, the approved dose for this indication is 50 U to 100 U/kg of body weight three times a week.

The study found that approximately 90 percent of patients who received Procrit once every two weeks and more than 75 percent of patients who received the drug once every three or four weeks maintained hemoglobin levels of at least 11 g/dL of blood. The recommended target range on Procrit's product label is between 10 g/dL and 12 g/dL.

"The results of the PROMPT study suggest that Procrit may provide sufficient hemoglobin levels in patients even when dosed less than once weekly for maintenance therapy," said Dr. Robert Provenzano, the study's principal investigator, in a press release. He noted that because Procrit injections are typically administered by medical professionals, less-frequent dosing could be more convenient for patients.

The study appeared in the August issue of the journal Clinical Nephrology.

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Combination of NSAIDs, SSRIs does not appear to substantially increase risk of GI bleeding compared with risk when drugs prescribed alone

The risk of gastrointestinal bleeding is not substantially greater when nonsteroidal anti-inflammatory drugs are prescribed with selective serotonin reuptake inhibitors than when the drugs are prescribed alone, according to a case-control analysis.

Using records from The Health Improvement Network, a database maintained for general medical practices in England and Wales, 11,261 patients were identified as having a first diagnosis of upper GI bleeding between Jan. 1, 1990, and Nov. 1, 2003. Patients with Read diagnostic codes for duodenal bleeding, hematemesis and melena were considered eligible for inclusion in the analysis. Up to six controls for each case (53,156 total) were randomly selected and matched by gender, general practice and age at the case's index date.

Patients who took nonselective NSAIDs and COX-2 inhibitors had almost a three-fold risk of GI bleeding. By comparison, patients who took aspirin had a lower risk; they were 1.54 times as likely to develop GI bleeding as were controls.

Current use of an antidepressant was also linked to a higher risk of GI bleeding, especially with SSRI use as compared with the use of tricylic antidepressants.

Patients who were prescribed an antidepressant only were 2.23 times as likely as controls to develop GI bleeding, while those who took an NSAID only were 2.19 times as likely. Those who took drugs from both classes were 2.83 times as likely to develop GI bleeding when compared with controls.

"Our findings are important as they are widely generalizable and suggest that current advice to avoid combining these drugs so as to avoid an excess risk of [GI] bleeding is over cautious," the research group concluded.

The study was published in the August issue of the journal Alimentary Pharmacology and Therapeutics.

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Pfizer Inc.

Pfizer Inc. is changing its direct-to-consumer advertising to make it consistent with the pharmaceutical industry's "Guiding Principles" on DTC advertising. The new guidelines were adopted by the Pharmaceutical Research and Manufacturers of America earlier this month. Some of Pfizer's intended changes include waiting at least six months before launching consumer ad campaigns for new drugs in order to allow time for physician education and better targeting ads to age-appropriate audiences including promoting its erectile dysfunction drug, Viagra (sildenafil citrate), on television only during programs that have more than 90 percent adult viewership. Pfizer said the changes are designed to encourage dialogue between patients and physicians, to better communicate the risks and benefits associated with prescription drugs and to help people contend with obstacles they may face in achieving healthier behaviors.

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Boston Scientific Corp.

Boston Scientific Corp.'s Wingspan Stent System with Gateway PTA Balloon Catheter was granted a Humanitarian Device Exemption approval by the Food and Drug Administration. The Wingspan Stent System, a self-expanding, nitinol stent that opens narrowed arteries in the brain, is the only device currently available in the United States to treat intracranial atherosclerotic disease (ICAD), according to Boston Scientific. The stent system is indicated to improve cerebral artery lumen diameter in patients with ICAD who do not respond to medical therapy. Milt McColl, president of Boston Scientific's neurovascular business unit, said the HDE approval is "an important first step in providing patients and physicians with new options for ischemic stroke."

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GE Healthcare

GE Healthcare entered into a collaboration with the Harvard Center for Neurodegeneration & Repair (HCNR) to improve research of the human central nervous system and neurodegenerative conditions using GE's cellular imaging system, the IN Cell Analyzer. Used to analyze a variety of cellular processes in disease definition and drug development, the proprietary system will help scientists better understand the molecular and pathological mechanisms of Parkinson's disease, Alzheimer's disease, Huntington's disease, amyotrophic lateral sclerosis and multiple sclerosis. Through the collaboration, HCNR and GE also plan to develop new software tools to accelerate disease analysis in the lab.

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Halozyme Therapeutics Inc.

Halozyme Therapeutics Inc.'s Investigational New Drug application for Chemophase was approved by the Food and Drug Administration. The company may now begin a Phase I study to determine the safety, tolerability and pharmacokinetics of a single intravesical dose of Chemophase combined with mitomycin in patients with superficial bladder cancer. Halozyme said it hopes to bring the product "into the clinic" next quarter.

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Correction:

In the Aug. 11 edition of Health Care Business Daily, we reported erroneous information in the story titled "Pfizer submits NDA for Sutent for treating gastrointestinal stromal tumors, metastatic renal cell carcinoma; receives fast track status." In a Phase III study, Pfizer Inc.'s Sutent (sunitinib malate) more than doubled survival rates and significantly reduced tumor growth and spread as compared with placebo when administered to patients with gastrointestinal stromal tumors who were resistant to Novartis AG's Gleevec (imatinib mesylate). To date, Sutent has not been compared with Onyx Pharmaceuticals Inc. and Bayer AG's sorafenib in a Phase III trial.

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