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FDA expands indication for Ortho-McNeil's Topamax

The Food and Drug Administration approved Ortho-McNeil Neurologics Inc.'s Topamax (topiramate) tablets and sprinkle capsules as initial monotherapy for patients aged 10 years or older with partial-onset or primary generalized tonic-clonic seizures.

Topamax was also indicated as add-on therapy for patients aged 2 years or older with primary generalized tonic-clonic seizures, partial-onset seizures or seizures associated with Lennox-Gastaut syndrome. Effectiveness for the new indication was demonstrated in a double-blind trial of 470 patients with partial-onset or primary generalized tonic-clonic seizures; all patients included in the trial had no more than two seizures during the three-month period prior to enrollment.

Participants were randomized to receive 50 mg/day or 400 mg/d of Topamax. The trial's primary efficacy assessment was a comparison between the groups in the time to first seizure.

Based on Kaplan-Meier survival curves, the 400 mg/d dose was favored over the lower dose.

The recommended monotherapy dose of Topamax in patients aged 10 years or older is 400 mg/d, divided into two doses, Ortho-McNeil said, noting that approximately 58 percent of patients who were randomized to the higher dosage actually achieved this level during the trial. The mean dose achieved was 275 mg/d.

The safety and effectiveness of Topamax as monotherapy have not yet been established in controlled trials of patients who switch from a regimen of other anticonvulsants, according to Ortho-McNeil.

"Antiepilepsy medications . . . are selected based on seizure type; however, the specific seizure type may not always be obvious at the time of diagnosis," said Dr. Tracy Glauser, director of the Comprehensive Epilepsy Center at the Cincinnati Children's Hospital. "A treatment like Topamax, which provides coverage for both partial-onset and primarily generalized tonic-clonic seizures, offers doctors an option in situations where differentiating between these seizure types is difficult."

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Schering-Plough's Avelox approved for fifth indication

Schering-Plough Corp. said Avelox (moxifloxacin hydrochloride), a once-daily antibiotic, was approved by the Food and Drug Administration to treat adults with complicated skin and skin structure infections (cSSSIs) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae.

This approval marks the fifth indication for Avelox, which has also been approved for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia and uncomplicated skin and skin structure infections.

Two cSSSI trials were conducted comparing Avelox with a beta-lactam/beta-lactamase inhibitor as a control. Pooled clinical success rates for Avelox versus the comparator were, respectively, 81.6 percent versus 84.8 percent for E. coli, 91.7 percent versus 70 percent for K. pneumoniae and 81.8 percent versus 57.1 percent for E. cloacae.

Schering-Plough acquired exclusive U.S. rights to Avelox from Bayer Pharmaceuticals Corp. in October of 2004. Schering-Plough explained that since Bayer developed the drug and holds the associated New Drug Application and patents, Bayer completed the research and FDA submission for this new indication.

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J&JPRD's Zarnestra deemed not approvable

The Food and Drug Administration sent a not approvable letter to Johnson & Johnson Pharmaceutical Research & Development LLC for Zarnestra (tipifarnib), an oral drug intended to treat acute myeloid leukemia in patients aged 65 years or older who are not candidates for standard chemotherapy.

The letter said the drug cannot be approved based on the data submitted. Zarnestra's New Drug Application was supported by the results of a single Phase II trial.

J&JPRD completed submission of the NDA last December under the Continuous Marketing Application Pilot-1 Program. In May, an FDA advisory committee voted against recommending accelerated approval of the drug, which had previously been granted fast track and orphan drug status.

J&JPRD said the company is still committed to developing the drug.

"Recognizing the unmet medical need in this area, the company is reviewing the FDA's letter and will determine appropriate next steps," the firm stated.

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Penwest's beta blocker deemed not approvable by FDA

Penwest Pharmaceuticals Co. received a non-approvable letter for its New Drug Application for PW2101, a beta blocker intended to treat hypertension and angina.

Reasons cited by the Food and Drug Administration in the non-approvable letter included the drug's kinetic variability among individuals and that "beta blockade as a surrogate for efficacy was not demonstrated across the entire interdosing interval on an individual subject basis," according to Penwest.

The company has decided to forgo further attempts to gain approval for the drug because of the time and resources such efforts would require.

"We are very disappointed by the FDA's decision," said Robert Hennessey, chief executive officer of Penwest. "We have concluded that given these circumstances, it is not in the best interests of our company and our shareholders to continue with the additional activities we believe would be required for this product."

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Takeda submits NDA for combination type 2 diabetes drug

Takeda Pharmaceuticals North America Inc. submitted a New Drug Application for an oral drug that combines Takeda's Actos (pioglitazone hydrochloride) with sanofi-aventis Group's Amaryl (glimepiride) to treat type 2 diabetes.

Actos, which Takeda co-promotes with Eli Lilly and Co., directly targets insulin resistance, while Amaryl, a sulfonylurea, increases the amount of insulin the pancreas produces.

The combination of these drugs helps patients with type 2 diabetes manage their blood glucose levels, Takeda said.

Amaryl is indicated for patients with type 2 diabetes as adjunctive therapy when diet and exercise alone do not suffice. It can be taken in combination with insulin or metformin, both of which are frequently prescribed diabetes drugs.

Actos is a once-daily adjunct to diet and exercise and is approved as monotherapy for type 2 diabetes. It can be prescribed in combination with insulin, sulfonylureas or metformin.

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Tysabri meets primary, secondary endpoints in Crohn's disease trial

Elan Corp. Plc and Biogen Idec Inc.'s Tysabri (natalizumab) met the primary endpoint of clinical response in patients with moderately to severely active Crohn's disease in Phase III testing.

Clinical response, defined as a 70-point decrease in Crohn's Disease Activity Index (CDAI) score from baseline, was evaluated at weeks eight and 12. Additionally, the trial, which included 510 patients, achieved all secondary endpoints, including clinical remission (defined as a CDAI score of less than or equal to 150) at weeks eight and 12. Moreover, researchers found no notable differences between Tysabri and placebo in the overall rates of adverse events.

The companies voluntarily suspended U.S. sales and all trials of the drug in February based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system.

Participants in this trial had already completed dosing before the suspension took place. The companies said a comprehensive safety evaluation for any possible link to PML is ongoing.

"Patient safety remains our top priority," said Dr. Lars Ekman, Elan's president of research and development. He said the companies plan to share data from this and other studies of Tysabri in Crohn's disease with the Food and Drug Administration to determine the future of the drug.

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Hyphanox shown inferior to Pfizer's Diflucan in Phase III trial

Barrier Therapeutics Inc. revealed that the company's oral antifungal candidate, Hyphanox (itraconazole), failed to reach its primary endpoint of therapeutic cure in Phase III testing.

The trial, which included 800 participants, was designed to show that a single dose of Hyphanox was not inferior to a single dose of Pfizer Inc.'s Diflucan (fluconazole) in the treatment of vaginal candidiasis, commonly known as vaginal yeast infection.

The results of the trial showed that 26 percent of patients treated with Hyphanox reached the primary endpoint compared with 37 percent of patients treated with Diflucan.

"The outcome of the study is disappointing," said Dr. Geert Cauwenbergh, Barrier's chief executive officer. "We will continue to analyze the massive amount of data to determine next steps for this indication. The results from this single-dose study for vaginal candidiasis do not affect our confidence in the potential of Hyphanox for the chronic treatment of onychomycosis [nail fungus], for which the active ingredient, itraconazole, is currently approved in the United States."

Hyphanox contains a patented formulation of itraconazole, the same active ingredient in Janssen Pharmaceutica Products LP's Sporanox, which is already approved to treat nail fungus.

Barrier's stock closed at $7.93, down 46.4 percent, or $6.85, in heavy trading on the Nasdaq.

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Novartis AG

Novartis AG signed an exclusive global license agreement with Arrow Therapeutics Ltd. for A-60444, an investigational treatment for infections resulting from the respiratory syncytial virus (RSV), the most common respiratory virus in infants. The agreement grants Novartis rights to develop, manufacture and commercialize the compound, rights for back-up compounds and a right of first negotiation on follow-up compounds. Novartis said there are no RSV-specific antivirals available at this time, adding that A-60444 is the most advanced small molecule therapy being developed for this indication. The drug is being tested in Phase I/II trials.

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Genta Inc.

Genta Inc. submitted the initial section of a New Drug Application to the Food and Drug Administration for its injectable cancer therapy, Genasense (oblimersen sodium). The NDA seeks accelerated approval for the compound's use in combination with fludarabine plus cyclophosphamide to treat patients with chronic lymphocytic leukemia (CLL) who have previously received fludarabine. Genasense was granted a fast track designation for this indication.

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OSI Pharmaceuticals Inc.

OSI Pharmaceuticals Inc.'s diabetes and obesity unit, Prosidion, granted Merck & Co. Inc. a worldwide, nonexclusive license for a combination therapy comprising a dipeptidyl peptidase IV inhibitor and an unspecified agent; the combination therapy is intended to treat type 2 diabetes and related conditions. In return, OSI will receive up-front, milestone and royalty payments. Additional financial terms of the agreement were not disclosed.

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Neurochem Inc.

Neurochem (International) Ltd. said the Food and Drug Administration will review the company's New Drug Application for Fibrillex, a treatment for amyloid A amyloidosis that was granted fast track and orphan drug status in February of 2004. The NDA includes efficacy and safety data from a single Phase II/III trial. Neurochem and Centocor Inc. entered into an exclusive collaboration and distribution agreement for Fibrillex late last year.

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Avanir Pharmaceuticals

Avanir Pharmaceuticals completed the submission of its New Drug Application to the Food and Drug Administration for Neurodex, a treatment for patients with pseudobulbar affect (PBA). Also referred to clinically as pathological laughing and crying, emotional lability and emotional incontinence, PBA is a neurological condition characterized by the disinhibition or loss of control of the motor expression of emotion. Patients with PBA laugh or cry uncontrollably, often out of context with their social environment. If approved, Neurodex would be the first drug indicated to treat PBA.

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