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Saturday, May 28, 2022

Avanir Drug Candidate Advances to 2nd-Phase Trial

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Aliso Viejo-based Avanir Pharmaceuticals Inc. is stepping up development of one of its drug candidates.

The company recently announced a second-phase trial of Avanir’s AVP-923 compound in regard to certain symptoms of patients with Alzheimer’s disease, Chief Medical Officer Randall Kaye said in a recent conference call.

Avanir has enrolled its first patient in the trial, which is looking at whether the compound relieves agitation, irritability and other symptoms, Kaye said. The trial also will look “at exploratory end points that can provide additional information of where to explore further for AVP-923,” he added.

Kaye also touched on Avanir’s core Nuedexta drug, which combines a pair of fairly common medications—dextromethorphan and quinidine—and received Food and Drug Administration approval in 2011.

Nuedexta treats a rare neurological disorder called pseudobulbar affect, which is marked by uncontrollable crying or laughing episodes, and can be associated with multiple sclerosis, brain injuries and amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

The disorder affects an estimated 1.5 million to 2 million people in the U.S. Avanir and others have claimed it’s underdiagnosed because doctors aren’t familiar with it.

Avanir is working to increase knowledge of pseudobulbar affect in an effort to continue to grow Nuedexta sales. Such efforts include product samples and a speakers’ bureau of doctors that teaches doctors to identify, diagnose and treat people with the disorder.

“We’ve reached a very exciting milestone as a company in August with over 10,000 total (Nuedexta) prescriptions dispensed,” Kaye said.

Avanir has submitted a response to the European Medicines Agency for a marketing authorization application for Nuedexta.

Separately, industry newsletter Paragon Report highlighted Avanir in a report that suggested the biotech industry has made strong gains overall this year, thanks to patent expirations, favorable legislation and a faster FDA review process.

Dendreon Layoffs

Dendreon Corp., a Seattle-based biotechnology company with 250 workers at a plant in Seal Beach, recently said it plans to cut 145 research and development and administrative positions at its headquarters.

Dendreon filed papers on the layoffs, scheduled for Nov. 20, with the Washington state government, according to a report in the Puget Sound Business Journal.

The biotechnology company said in July it was cutting 600 of its 1,500 jobs overall in a bid to cut costs. It indicated that most of those jobs would result from its closing its Morris Plains, N.J., manufacturing operation.

It’s uncertain whether the pending layoffs in Seattle complete the layoff plan. A check of the California Employment Development Department shows no filing for layoffs in Seal Beach.

A Dendreon spokesperson said the company “has met the legal notification requirements of the states affected by the work force reductions.”

Dendreon makes Provenge, a medication used to treat advanced prostate cancer. It opened its Seal Beach plant in the Pacific Gateway business park in 2011.

Dendreon has struggled for the better part of a year, after saying that sales of Provenge were growing slower than expected.

CombiMatrix Placement

CombiMatrix Corp. has entered into a private placement deal of its stock that’s expected to net the Irvine-based molecular diagnostics provider $2.5 million in proceeds.

CombiMatrix said it would receive $1.05 million from the investors upon closing the first tranche of the deal, and that it intended to file a proxy statement seeking shareholder approval for the remaining $1.45 million.

The financing should enable CombiMatrix “to build on the momentum we are creating in the prenatal and pediatric markets with our expanded test menu,” said R. Judd Jessup, the company’s chief executive.

“We are pleased to be strengthening our balance sheet and to be moving forward on our commercial initiatives,” Jessup said.

InstaMed Accreditation

InstaMed Inc., a company that processes out-of-pocket healthcare payments from offices in Newport Beach and Philadelphia, said it received full accreditations for two programs sponsored by Farmington, Conn.-based Electronic Healthcare Network Accreditation Commission.

The company was recognized for excellence in health-data processing and transactions, as well as demonstrating that it meets a high standard of quality in handling protected health information and follows industry-established criteria for processing payments.

InstaMed processes payments for healthcare services through a network that connects providers, insurers and patients. Its clients include more than 200,000 healthcare providers across the country.

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