In letter to Allergan, SEC says it will scrutinize industry’s use of non-GAAP accounting
When the SEC criticized Valeant Pharmaceuticals over its use of non-GAAP reporting, it seemed like a regulator barking at a company known for pushing the limits. But now the agency has fired a warning shot across the bow of the industry, saying in a letter to Allergan that it intends to examine how the industry is potentially exploiting the practice. In its Jan. 11 letter to Allergan CFO, the SEC admonished the company for using non-GAAP in reporting its earnings per share. While other companies may do the same thing, and the agency said it didn’t agree with its use that way.
Acacia Pharma’s Baremsis meets primary endpoint in pivotal phase 3 study
Acacia Pharma Group Ltd., the supportive care company developing products for US and international markets, has announced positive results from its fourth and final pivotal phase 3 study investigating Baremsis (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea & vomiting (PONV), despite having received prior antiemetic prophylaxis. Acacia Pharma has now completed four pivotal phase 3 studies of Baremsis successfully, all meeting their primary endpoint, and these will form the basis of the efficacy and safety package which the Company aims to submit to the US FDA as part of its New Drug Application (NDA) in 1H 2017.
Phase 3 test is on the way for Axovant’s dementia drug
Positive results in a first crop of patients treated with its dementia drug have encouraged Axovant to start preparing for a phase 3 study. So far 11 patients with Lewy body dementia (LBD) have been treated with nelotanserin, which is being developed to tackle the visual hallucinations and sleep disturbances that can afflict people with these diseases. The results have outpaced expectations, with nelotanserin achieving a significant improvement in extrapyramidal symptoms—Parkinson’s disease-like effects caused by the nerve degeneration in LBD—as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS). Final data are due mid-year, with the phase 3 trial due to start in the second half of the year.
Novartis expands Vivinda TV, offering docs digital access to medical conferences
Vivinda TV, a burgeoning virtual conference platform created to deliver on-demand medical content, most recently aired the full unedited content from the European Cancer Congress held in Amsterdam last month. And the platform has worked so well that Novartis is ramping it up. In June, for the American Society of Clinical Oncology conference, Vivinda TV drew 4,600 registrations from virtual delegates in 103 countries, and for the European School for Advanced Studies in Ophthalmology conference, Vivinda TV drew 1,800 virtual delegates—compared with the 500 to 600 that attend in person. Currently, the platform can be accessed by healthcare providers in any country except Canada, Japan, Norway, Sweden and the U.S.
Aurobindo responds to White House urging, plans second U.S. plant
Aurobindo Pharma, which just started on its first U.S. plant in August, said today it will build a second sterile injectables plant at its site in New Jersey. Hyderabad-based Aurobindo, which derives about half of its finished drug sales from the U.S., still produces most of those in India, where it has half a dozen plants. Today, the company reported third-quarter earnings of 3.9 billion INR ($58.4 million), up 11.5%. It said that U.S. sales of both oral and injected drugs were up 12% for the quarter but that pricing pressure on generic meds in the U.S. had dampened its earnings.