King Pharma

Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain. Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain. Remoxy ER is a new formulation of oral oxycodone designed to deter abuse but still provide 12 hours of pain relief. The formulation has a thick, sticky, high viscosity, hydrophobic, gel formulation that prevents possible drug abusers from cutting, grating or dividing the drug into smaller particle sizes. It is also resistant to being modified to be injected. A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14 to 3 against approval. The company filed its first new drug application (NDA) for Remoxy ER in June 2008, and received its first complete response letter (CRL) from the FDA in December of that year. Then, a few months later, Pain Therapeutics signed a deal related to Remoxy ER with King Pharmaceutical , which resubmitted the NDA in December 2010. The following February 2011, Pfizer acquired King Pharma, picking up Remoxy ER in the process. In June 2011, the FDA rejected Remoxy again, and Pfizer indicated it planned to resolve the issues outlined in the CRL. Instead, it abandoned the drug in 2014, giving the rights back to Pain Therapeutics. In 2016, the FDA rejected it again, indicating the “NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.” Pain Therapeutics at the time stated that the CRL’s focus was on abuse deterrence and had proposed drug labeling. There was no mention of safety, efficacy, manufacturing or any biopharmacological issues. The vote is a bit of a surprise given the current emphasis on coming up with solutions to fight the opioid epidemic, but the drug’s history also suggests the problems are extensive. The PDUFA target action date for the drug is August 7. The FDA does not have to follow the recommendations of the Advisory Committee, but it usually does. Pain Therapeutics licensed the rights to Remoxy ER from Durect Corporation, based in Cupertino, California. Pain Therapeutics is located in Austin, Texas. In its first-quarter financial report, Pain Therapeutics reported a new loss of $2.2 million or $0.33 per share. It ended the quarter with cash and cash equivalents of $10.7 million compared to $10.5 million in the previous quarter. The company has other early-stage candidates in its pipeline, including PTI-125, an oral, small molecule candidate designed in-house. It is designed to treat Alzheimer’s disease. It is in a Phase I clinical stage program, funded in large part by a grant from the National Institutes of Health (NIH). It has Fenrock (transdermal fentanyl patch system), also in an early-stage program, funded by grants from the National Institute on Drug Abuse (NID). PTI-125DX is a proprietary blood-based test to detect Alzheimer’s disease.

August 12, 2016 By Alex Keown , BioSpace.com Breaking News Staff NEW YORK – An investment adviser and an attorney have been indicted on charges the duo engaged in insider trading after gaining information about Pfizer ’s 2010 $3.6 billion acquisition of King Pharmaceuticals , federal prosecutors announced this week. According to the indictment , investment adviser Tibor Klein of New York learned about Pfizer’s acquisition through his association with attorney Robert Schulman of Richmond, Va., who represented Tennessee-based King Pharmaceuticals. Klein learned of the acquisition after meeting with King at his home in Virginia and began acquiring shares of King Pharmaceutical stock for himself, Shulman and other clients he represented, in total more than $585,000 worth of stock, the government said. Additionally, the government said Klein shared the information with other brokers who snapped up more than $400,000 worth of stock. According to reports, Klein sold all the shares of King following the merger for his clients and earned a total profit of $328,000, including $8,000 for himself and more than $15,000 for Schulman, Bloomberg reported this morning. The indictment follows a 2013 civil lawsuit against Klein and Schulman filed by the U.S. Securities and Exchange Commission. Klein pleaded not guilty earlier this week and Schulman is scheduled to appear in court in Virginia next week, Bloomberg reported. Although prosecutors did not name the others brokers, Reuters noted an earlier U.S. Securities and Exchange Commission lawsuit identified one of the brokers as Michael Shechtman , a former Ameriprise Financial Inc. stockbroker and friend of Klein’s. Reuters noted that Shechtman pleaded guilty in 2014 to conspiracy to commit securities fraud in connection with the case. If convicted, the two men face up to 20 years of prison time. The charges against Klein and Schulman are the latest in a number of securities violations regarding pharma deals. Earlier this month, a cardiologist running a clinical trial for Bay Area’s Regado Biosciences has been indicted by a grand jury on two charges of alleged securities fraud. Edward Kosinski pleaded not guilty to the charges. If he is found guilty during a trial, he could spend up to 20 years in prison. Not only does Kosinski face criminal charges, the U.S. Securities and Exchange Commission has also filed civil charges against the doctor. In June, two hedge fund managers , Sanjay Valvani of Visium Asset Management and Steffan Lumiere , a former Visium portfolio manager, were charged by the U.S. attorney with conspiring with a former U.S. Food and Drug Administration official who had access to generic drug approval information, to commit securities fraud. Perhaps most notoriously, former pharma CEO and hedge fund manager Martin Shkreli was charged with seven counts of securities fraud last year. The seven count indictment included multiple charges of securities fraud, securities fraud conspiracy and wire fraud conspiracy. According to the indictment, Shkreli and his partners, including attorney Evan Greebel , orchestrated three interrelated fraudulent schemes—a scheme to defraud investors and potential investors in MSMB Capital ; a scheme to defraud investors and potential investors in MSMB Healthcare ; and a scheme to defraud Retrophin , the company Shkreli founded. The indictment said Shkreli’s scheme, which caused his investors to suffer a loss of more than $11 million, was carried out over a five-year period, from 2009 to 2014.