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FDA approves strengthened isotretinoin risk management program

The Food and Drug Administration approved a strengthened distribution program for acne treatment isotretinoin intended to prevent use of the drug during pregnancy.

Isotretinoin is sold by F. Hoffman-La Roche Ltd. as Accutane, by Barr Laboratories Inc. as Claravis, by Ranbaxy Pharmaceuticals Inc. as Sotret and as a generic; the drug is also sold as Amnesteem by GenPharm Inc. and Mylan Bertek Pharmaceuticals Inc.

In order to receive authorization to prescribe or use the drug, which is tied to a significant risk of birth defects if taken during pregnancy, physicians and patients must register in the manufacturers' program, called iPledge, and accept specific responsibilities; these include "completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy testing," the FDA said.

Wholesalers and pharmacies must also abide by the program requirements in order to distribute and dispense the drug, the agency added.

Patients and physicians must register in iPledge starting Dec. 31, 2005, while wholesalers and pharmacies must register starting Oct. 31, 2005.

In addition, the FDA approved changes to the existing warnings, patient information and informed consent document so that health care providers and patients "can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin."

Furthermore, the FDA issued a public health advisory and revised patient and health care provider information sheets to inform health care providers about iPledge. Also, the agency said a reporting and collection system for serious adverse events associated with isotretinoin has been established. All pregnancy exposures to isotretinoin must also be reported to the agency.

In February 2004, the FDA's Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee called for significant improvements to isotretinoin's restricted access program. Proposed changes included "mandatory registration to ensure that patients who could become pregnant have negative pregnancy testing and birth control counseling before receiving the drug," the FDA said.

Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne.

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Axcan pushes back Itax NDA filing date; shares fall

Axcan Pharma Inc. pushed back the New Drug Application filing date for its lead product candidate, Itax (itopride hydrochloride), for the treatment of functional dyspepsia, prompting shares to fall 16 percent.

In June, Axcan said it planned to file the NDA in the first half of 2006. Now, the company expects to file the application in the summer of 2006.

Axcan does not expect data from Phase III Itax trials to be available until the first half of 2006.

"Management had previously stated that it expected to have Itax data ready for scrutiny by the end of this calendar year," Scotia Capital analyst Campbell Perry said in a note, according to Reuters. The data and NDA delay will cause an overall delay of almost one year, Perry explained.

"In biotech, the market hates product launch delays," he said.

Axcan said it has finished the clinical work on five of seven Phase I studies of the drug and this information will be included in its NDA. The results of its six-month and one-year safety studies will also be available to be included in its NDA.

Functional dyspepsia is an upper gastrointestinal system disorder that affects up to 25 percent of Americans each year, Axcan said.

Axcan also plans to study Itax as a treatment for diabetic gastroparesis and gastropathy.

The company also announced that net income for the third quarter ended June 30, 2005, was $4.1 million, or $0.09 per diluted share, compared with $12.6 million, or $0.25 per diluted share, in the third quarter of last year. Net sales were $59.4 million this quarter compared with $62 million in 2004.

Axcan shares closed at $12.26, down $2.33, in heavy trading on the Nasdaq.

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Altana's Daxas shows promise for COPD, study shows

Altana AG's investigational phosphodiesterase-4 inhibitor, Daxas (roflumilast), appears to be a promising treatment option for patients with chronic obstructive pulmonary disease, according to a Phase III study published in the Aug. 13 issue of The Lancet.

A total of 1,411 patients with moderate to severe COPD were randomized to 250 mcg of Daxas (n=576), 500 mcg of Daxas (n=555) or placebo (n=280) each day for a period of 24 weeks between April 2002 and June 2003. A total of 1,157 patients completed the study.

The study's primary outcomes were postbronchodilator forced expiratory volume in one second (FEV1) and health-related quality of life (QOL). Lung function parameters and COPD exacerbations were included as secondary outcomes.

Both Daxas-treatment groups had significant improvements in postbronchodilator FEV1 compared with the placebo group. At 24 weeks, the improvement from baseline was 74 mL for the 250 mcg group and 97 mL for the 500 mcg group compared with placebo.

While both Daxas groups also had improvements in health-related QOL, as measured by St. George's respiratory questionnaire (SGRQ), the differences were not significant compared with placebo. The improvement in SGRQ total score was 1.7 units for the 500-mcg group and 1.6 units for the 250-mcg group compared with placebo.

The mean exacerbation rate was 1.13 per patient among placebo-treated patients as compared with 1.03 in patients who received Daxas 250 mcg and 0.75 in patients treated with Daxas 500 mcg.

The researchers concluded that Daxas is a "promising candidate for anti-inflammatory COPD treatment because it improved lung function and reduced exacerbations compared with placebo. Long-term studies are needed to fully assess the effect on health-related quality of life."

Pfizer Inc. terminated its development agreement with Altana for Daxas in July based on data showing Daxas did not reduce the number of asthma attacks in a study compared with placebo. Altana plans to continue developing the drug on its own until it is ready for the market, at which time it plans to enter into a partnership.

Altana initially presented data from this study in March 2004 in Frankfurt, Germany, at the annual Congress of the German Society of Pulmonology.

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Using Rebif or Avonex at or near conception may increase miscarriage risk among women with MS, study shows

Women who take Serono Inc. and Pfizer Inc.'s Rebif (interferon beta-1a) or Biogen Idec Inc.'s Avonex (interferon beta-1a) may have an increased risk of miscarriage, according to a study published online Aug. 10, ahead of print by the journal Neurology.

The study authors wrote that although women with multiple sclerosis are advised to stop using interferon drugs before becoming pregnant, some women do become pregnant while still receiving the treatments.

To explore the role of Rebif or Avonex on miscarriage risk, researchers studied patient data from eight clinical trials of Rebif or Avonex. A total of 3,361 women were included in the trials, and 69 of these women became pregnant.

Forty-one of the pregnant women were still receiving Rebif or Avonex at the time of conception or had stopped the therapy within two weeks before conceiving, thus exposing the fetus to the drugs. Twenty-two women had discontinued Rebif or Avonex more than two weeks before conception, while six women had received placebo.

The 41 pregnancies with fetal exposure to Rebif or Avonex resulted in 20 healthy full-term infants, one healthy premature baby, nine induced abortions, eight miscarriages, one fetal death and one infant was born with hydrocephalus. Hydrocephalus is a condition that occurs when the brain is compressed by an excess of fluid and becomes damaged. No follow-up data were available for one patient.

In the group of 22 women who discontinued Rebif or Avonex more than two weeks before conception, 20 babies were healthy and full-term, one infant was premature but healthy and one infant was born with Erb's Palsy, which is a condition of paralysis in the muscles of the upper arm.

As compared with the general population, the miscarriage rate was higher in the group with fetal exposure to Rebif or Avonex. However, the investigators wrote that this difference was not "significant."

"Until more exposure data become available, patients remain advised to stop [Rebif or Avonex] therapy before becoming pregnant," the authors conclude.

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Study evaluates parathyroid hormone treatment in women with osteoporosis taking Merck's Fosamax

Study findings suggest that "a regimen of three-month cycles of parathyroid hormone alternating with three-month cycles without parathyroid hormone causes the early phase of action of parathyroid hormone (characterized by pure stimulation of bone formation) to be dissociated from the later phase (activation of bone remodeling)" among women with osteoporosis who had received long-term treatment with Merck & Co. Inc.'s Fosamax (alendronate sodium).

Researchers randomized 126 women with osteoporosis who had been taking Fosamax for at least one year to Fosamax plus parathyroid hormone subcutaneously daily, Fosamax plus parathyroid hormone subcutaneously daily for three 3-month cycles alternating with three-month periods without parathyroid hormone or Fosamax alone for 15 months.

Results indicated that bone formation indexes increased "swiftly" in both parathyroid hormone groups. Among patients who received cyclic parathyroid hormone therapy, bone formation declined during cycles without parathyroid hormone and increased again during cycles with the hormone.

Although bone resorption increased in both parathyroid hormone groups, it increased progressively more in the daily-treatment group than in the cyclic-therapy group. Researchers added that spinal bone mineral density increased 6.1 percent in the daily-treatment group and 5.4 percent in the cyclic-therapy group at 15 months.

New or worsening vertebral deformities were reported in one patient in the daily-treatment group, two in the cyclic therapy group and four in the Fosamax only group.

"The early phase may be more important to the increase in spinal bone mineral density," the study authors added. "In patients with persistent osteoporosis after prior [Fosamax] treatment, both daily treatment and cyclic treatment with parathyroid hormone increase spinal bone mineral density."

This study was published in the Aug. 11 issue of The New England Journal of Medicine.

NPS Pharmaceuticals Inc. submitted a New Drug Application for Preos (parathyroid hormone [rDNA origin]) in May of this year.

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Boehringer's Mirapex improves pain in patients with fibromyalgia, study shows

Patients with fibromyalgia who were treated with Boehringer Ingelheim Pharmaceuticals Inc.'s Mirapex (pramipexole dihydrochloride) demonstrated improvement in measures of pain, function, fatigue and global status in a new study.

The 14-week study included 60 patients with fibromyalgia, a condition for which there is no specifically approved treatment. Patients with comorbidities, disabilities and those taking certain other drugs were not excluded from the study.

Patients were randomized to either 4.5 mg of oral Mirapex (n=39) or placebo (n=21) each night.

The study's primary outcome was improvement in the pain score, as measured by the 10-cm visual analog scale (VAS), at 14 weeks. Secondary outcomes were measured by the Fibromyalgia Impact Questionnaire, the Multidimensional Health Assessment Questionnaire (MDHAQ), the pain improvement scale, the tender point score, the 17-point Hamilton Depression Inventory and the Beck Anxiety Index.

At 14 weeks, patients who received Mirapex saw a 36 percent decrease in VAS pain score while patients who received placebo saw a 9 percent decrease. Forty-two percent of the Mirapex group had at least a 50-percent decrease in pain compared with 14 percent of the placebo group.

Though not all secondary endpoints were significantly better for the Mirapex group, none of the study's endpoints favored the placebo-treated patients.

Mirapex-treated patients improved from baseline more than placebo-treated patients with regard to function (22 percent vs. 0 percent), fatigue (29 percent vs. 7 percent) and global scores measured by the MDHAQ (38 percent vs. 3 percent).

Mirapex was generally well tolerated, though both study arms had "remarkably common" reports of nausea.

"Further investigation of this [Mirapex] treatment paradigm is warranted to determine its mechanism of action in patients with fibromyalgia, its long-term risks and benefits and to confirm these findings in patients not taking concomitant medications," the authors concluded.

Mirapex is currently approved for the treatment of idiopathic Parkinson's disease and is co-promoted in the United States for this indication by Boehringer and Pfizer Inc.

This study appeared in the August issue of Arthritis & Rheumatism.

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Novartis AG

Novartis AG and Schering AG declined to comment on rumors that Novartis is eyeing Schering as a merger target, Forbes.com reported. The rumors have come up before, Forbes said, adding that analysts are skeptical that the rumors are accurate.

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Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.'s Abbreviated New Drug Application for generic versions of 5 mg, 30 mg and 35 mg Actonel (risedronate sodium) tablets was tentatively approved by the Food and Drug Administration. Actonel, which is indicated for treating and preventing postmenopausal and glucocorticoid-induced osteoporosis and for treating Paget's disease, has annual sales of approximately $942 million, Teva said. Actonel is marketed by The Alliance for Better Bone Health, an alliance between Procter & Gamble and Aventis Pharmaceuticals Inc. Teva expects final approval when pending patent litigation is resolved.

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Genzyme Corp.

Genzyme Corp. is cutting 40 positions, or approximately half of Bone Care International Inc.'s remaining Middleton, Wis.-based staff, the Milwaukee Journal Sentinel reported. In May, Genzyme agreed to acquire Bone Care for approximately $600 million, net of Bone Care's $119 million cash. Genzyme plans to keep Bone care's quality control operations in Middleton, according to Dan Quinn, a Genzyme spokesman, the Journal Sentinel said. The firm also offered jobs to some of Bone Care's scientists and marketing staff; Genzyme plans to keep Bone Care's sales force.

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Neurologix Inc.

Neurologix Inc. plans to submit to the Food and Drug Administration a request to amend the Phase I study of NLX, a gene therapy designed to treat Parkinson's disease, during the second half of 2005, said Dr. Michael Sorell, the firm's chief executive officer. With no treatment-related adverse events observed in the 12 patients treated on a single side of the brain, the company wants to treat additional patients bilaterally (on both sides of the brain) as it prepares for a pivotal efficacy trial, Sorell said.

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