• Amarillo Biosciences Inc., of Amarillo, Texas, submitted an investigational new drug application to start a study of orally delivered interferon alpha in 60 patients with idiopathic pulmonary fibrosis. The trial is a follow-up to a positive pilot study conducted at the Texas Tech University Health Sciences Center, in which five of six IPF patients given oral IFN-alpha reported a significant reduction in chronic cough with corresponding improvement in quality of life. In separate news, the company said it is funding a study with Benchmark BioLabs, of Lincoln, Neb., to determine the effectiveness of oral interferon alpha against influenza in chickens.

• Avanir Pharmaceuticals Inc., of San Diego, signed an exclusive agreement with Healthcare Brands International to develop and market docosanol 10 percent cream for cold sores in the European Union - except Denmark, Finland, Greece, Italy and Sweden - as well as Russia and the Ukraine. Avanir will receive an up-front fee and would get milestone payments if docosanol receives certain regulatory approvals. HBI is responsible for all expenses for regulatory approval and commercialization in its territory.

• BioMarin Pharmaceutical Inc., of Novato, Calif., began a Phase II study of 6R-BH4. The trial is designed to evaluate the compound in patients with poorly controlled systemic hypertension. It will enroll about 84 patients, about half of whom will have Type II diabetes, and its primary endpoint analysis will compare the mean change in systolic blood pressure between the 6R-BH4 and placebo groups. A secondary endpoint will compare the mean change in diastolic blood pressure between both groups. The company expects results early next year.

• Cardiome Pharma Corp., of Vancouver, and its co-development partner, Deerfield, Ill.-based Astellas Pharma US, said they have met with the FDA to discuss the refusal-to-file letter received May 30 for the new drug application for RES1235 in atrial fibrillation. The companies reported that they expect to resubmit the NDA after completing a re-review and audit process and will provide further guidance in the future regarding the resubmission. (See BioWorld Today, June 1, 2006.)

• CV Therapeutics Inc., of Palo Alto, Calif., said the Data Safety Monitoring Board overseeing its Merlin TIMI-36 study of Ranexa (ranolazine extended-release tablets) recommended that the study continue to completion. No further meetings of the DSMB are planned. CV Therapeutics completed enrollment of more than 6,500 patients in May and expects top-line data in the first quarter of 2007. Under a special protocol assessment agreement, Ranexa could be approved as a first-line chronic angina therapy based on the absence of an adverse trend in death or arrhythmia compared to placebo. If the primary endpoint is met, it also could be approved to treat acute coronary syndromes and secondary prevention.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., reported data from the second of two Phase III trials of Sanctura XR, a once-daily formulation of the marketed Sanctura, in overactive bladder, which showed that the drug met its primary endpoint in reducing the frequency of urination and reducing urge incontinence episodes. The 564-patient trial also met all key secondary endpoints, including an increase in void volume and a reduction in the severity of urgency. Those results confirm data released last month from the first Phase III study, and Indevus expects to file a new drug application before the end of the year.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., received a $750,000 Phase II Small Business Innovation Research grant to advance the clinical development of PMI-150 (intranasal ketamine) for pain control. Awarded by the National Cancer Institute, part of the National Institutes of Health in Bethesda, Md., the grant will support safety and efficacy evaluations of the compound in a trial in patients suffering from episodic acute moderate to severe pain. A pilot study established proof of principle for intranasal administration of ketamine in treating episodic breakthrough pain in patients taking opioid analgesics for chronic pain.

• Nektar Therapeutics Inc., of San Carlos, Calif., agreed to a total cash payment of $25 million to the University of Alabama in Huntsville to settle UAH's litigation against Nektar and Milton Harris, the founder of Nektar Alabama and former employee of UAH. Under the terms, Nektar and Harris jointly made an up-front payment totaling $15 million, and Nektar will pay $1 million per year for 10 years. In exchange, UAH agreed to drop all claims related to the Nektar PEGylation patent portfolio. Nektar will dismiss all counterclaims.

• Theratechnologies Inc., of Montreal, said an independent Data Safety Monitoring Board recommended that its Phase III study on TH9507 to treat HIV-associated lipodystrophy continue. About 280 patients have completed 13 weeks of treatment. The company expects the first Phase III results toward the end of the year. The DSMB's recommendation is based on a review of safety data from 181 patients who have been treated for three months.

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