Longtime Orange County eye device executive Vicente Anido Jr.’s marching on with a new company.
Anido has been chief executive of publicly traded Aerie Pharmaceuticals Inc., which discovers, develops and commercializes treatments for glaucoma, an eye disease that’s a major cause of blindness, since July 2013. He was named chairman that year.
Aerie has an office in Newport Beach, but its legal headquarters is in Bedminster, N.J., with another office in Research Triangle Park, N.C.
The company said this month that it closed a $125 million round of financing with New York-based investor Deerfield Management Co.
Aerie said it plans to use the money to pay for development programs advancing drug candidates Rhopressa and Roclatan, along with commercializing Rhopressa in late 2017 pending a successful outcome of clinical trials and regulatory approval.
“Now that the Deerfield financing has closed, we have the financial resources to drive our lead clinical programs forward into commercialization while having the additional flexibility to execute our strategy of building a major ophthalmic pharmaceutical company,” Anido said in a news release.
Registration trials for Rhopressa started in July, according to Aerie.
The company has said it expects efficacy data for the drug candidate in mid-2015 and a new-drug application filing with the Food and Drug Administration in mid-2016.
“Enabling activities” for a third-phase clinical trial of Roclatan have also commenced.
“If approved, we believe Roclatan has the potential to be the most efficacious therapy in the market for the treatment of glaucoma,” Aerie said in an August news release that included a product development update.
Avanir Completes Offering
Aliso Viejo-based Avanir Pharmaceuticals Inc. closed a public offering of 20.9 million shares of its stock late last month, giving it gross proceeds of $230.2 million.
Money raised from the offering will be used to fund commercial activities related to its primary drug, Nuedexta, and the commercial launch of its AVP-825 drug candidate, pending Food and Drug Administration approval.
Avanir has surged on Wall Street. The drugmaker’s shares were up 264% as of early October since the start of the year, with a recent market value of $1.95 billion.
The company has had a run of good news lately, including positive second-phase results for its AVP-923 drug candidate. AVP-923 is a potential therapy for Alzheimer’s disease and works by alleviating dementia-related neuropsychiatric symptoms, such as agitation and aggression.
Direct Flow Gets European OK
Direct Flow Medical Inc., a Santa Rosa-based company with manufacturing in Lake Forest, has received European regulatory approval for an enhanced transfemoral delivery device to be used with the company’s transcatheter replacement heart valve.
The new delivery device has an ergonomic handle designed “for easy, precise and controlled delivery of the Direct Flow Medical valve,” Direct Flow said in a news release. The device also has a sheath that the company said allows for “easy access and excellent trackability through calcified and torturous anatomies.”
Doctors using the device “have been able to access vessels as small as 5.2mm with the Direct Flow Medical delivery system,” said Dr. Christoph Naber of the Contilia Heart and Vascular Center in Essen, Germany.
Clarient on Cancer Testing
Clarient, an Aliso Viejo-based unit of GE Healthcare, said this month that it would collaborate with British drugmaker GlaxoSmithKline PLC to establish a network of clinical laboratories. The partnership is aimed at improving diagnostic testing for cancer patients and is targeted at pharmaceutical and healthcare organizations.
The companies’ laboratory testing will initially cover more than 70 melanoma-, or skin cancer-related, mutations. Testing will cover other types of cancerous tumors as the network develops.
GE Healthcare said in a news release that the laboratories will offer a subscription-based service aimed at identifying genetic mutations associated with tumor types. The company said Clarient would use “its clinical laboratory, pathology and genomics expertise to certify the labs and generate diagnostic data on metastatic melanoma patients.”
U.K.-based GE Healthcare said the first labs in the partnership will open in Russia and Brazil in early 2015.
