Rodelis Therapeutics, Inc.

November 9, 2015 By Alex Keown , BioSpace.com Breaking News Staff WASHINGTON – More pharmaceutical companies are facing legal and political scrutiny over the prices of prescription medication, after the Merck & Co. and Eli Lilly and Co. reported they are the subject of an investigation by the U.S. Attorney’s Office in Pennsylvania over proper pricing information with Medicaid , Reuters reported this morning. In a 10-Q regulatory filing last week, Merck said it had received a civil investigative demand from the U.S. Attorney’s office over the pricing of Dulera, an asthma inhaler launched in 2010. The attorney’s office is looking at the company’s pricing in regards to “certain pharmacy-benefit managers and Medicare Part D plans,” the company said in its filing. Merck said it was cooperating with the investigation. Merck is also a defendant in approximately 20 active federal and state lawsuits alleging personal injury as a result of the use of Vioxx. Most of these cases are coordinated in a multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana, the company said in its filing with the U.S. Securities and Exchange Commission . Eli Lilly also said in its 10-Q filing the attorney’s office is conducting an inquiry “concerning our treatment of certain distribution service agreements with wholesalers when calculating and reporting Average Manufacturer Prices in connection with the Medicaid drug rebate program.” Lilly said it is voluntarily responding to the request. An Eli Lilly spokesperson told Dow Jones Business News the company believes its accounting practices related to the Medicaid drug rebate program are correct. Pfizer Inc. is also the subject of an investigation that its Wyeth unit overcharged Medicaid programs by not reporting its best prices for the heartburn drug Protonix, Dow Jones Business News said. Pfizer has said the allegations have no merit. Lilly is also the subject of a multiple lawsuits involving its blockbuster drug Cymbalta over patients claiming injuries following the discontinued use of the drug, the company said in its filing. Since the companies disclosed the investigations, for Eli Lilly is slightly down to $79.39 per share and for Merck is also slightly down to $54.22 per share. CNN reported stock prices for the pharmaceutical industry has been on the decline since former U.S. Secretary of State Hillary Clinton , now a candidate for the Democratic presidential nomination, tweeted a threat of capping the prices of prescription drugs to prevent “price gouging,” which sent biotech stock prices plummeting in September. Clinton has proposed to cap monthly out-of-pocket costs for prescription drugs at $250. Additionally, Clinton’s campaign said she would also seek to curb the amount of money drug companies can spend on advertising. Following Clinton’s tweet, the Nasdaq Biotechnology Index dropped 4.4 percent and the SPDR S&P Biotech ETF dropped by 6 percent. One company that has certainly seen its stock crashing down over the past few months is Valeant Pharmaceuticals International Inc. , which is being examined not only for drug pricing, but also for accounting practices associated with a specialty pharmacy company it worked with. Since a high of $259.98 per share price on Aug. 4, Valeant ’s has plummeted to a year-low of $81.77 per share. The stock is currently trading at $78.81 per share. Valeant is facing scrutiny from U.S. lawmakers and two U.S. attorney’s offices over pricing of drugs acquired through acquisitions. Valeant is under fire for a price increase of two recently-acquired cardiac drugs, Nitropress and Isuprel, after the company acquired Salix Pharmaceuticals, Ltd. . Valeant then increased the prices for those drugs by 212 percent and 525 percent, respectively. Valeant acquired the two drugs in April. Other companies that have been the subject of ridicule over price hikes include Turing Pharmaceuticals , which increased the price of the toxoplasmosis drug Daraprim by 5,000 percent after it acquired the drug in August. Rodelis Therapeutics acquired the tuberculosis drug Cycloserine in August and raised the cost of a 30-day treatment of $500 to $10,800. Facing the backlash, Rodelis agreed to give the drug back to the Purdue Research Foundation , which has oversight of the manufacturing operation. However, now that the foundation has regained control, the price of the drug did not return to $500. Rather, 30 tablets now cost $1,050.

September 22, 2015 By Alex Keown , BioSpace.com Breaking News Staff CHICAGO -- With a threat of capping the prices of prescription drugs to prevent “price gouging,” a tweet by Democratic presidential candidate Hilary Clinton sent pharmaceutical stock prices down 10 percent on Monday. Clinton, the former U.S. Secretary of State and current front-runner in the Democratic primary, made her announcement following news reports of Turing Pharmaceuticals raising the price of a recently acquired drug by 5,000 percent. The Associated Press reported Clinton has proposed to cap monthly out-of-pocket costs for prescription drugs at $250. Additionally, Clinton’s campaign said she would also seek to curb the amount of money drug companies can spend on advertising. The campaign said part of the plan would also seek to ensure federal regulation through the U.S. Food and Drug Administration that would ensure all prescription drug advertisements would provide “clear information to consumers.” After Clinton used Twitter to denounce Turing’s new price structure for Daraprim , a drug that’s been on the market since 1953, several specialty pharmaceutical companies saw their stocks fall. The Associated Press reported Mallinckrodt Pharmaceuticals PLC , saw shares drop 10.02 percent, while the top 20 drugmakers saw their stocks fall an average of 2 percent. The Nasdaq Biotechnology Index dropped 4.4 percent, the AP said . The SPDR S&P Biotech ETF dropped by 6 percent, the Street reported . Although the presidential candidate impacted the stock market Monday, several analysts told The Street that pricing concerns are “nothing new” and “will likely continue to be a headwind for the sector.” Daraprim is used to treat toxoplasmosis, a parasite that threatens those who have compromised immune systems, such as cancer and HIV patients, as well as pregnant women. Turing, which acquired Daraprim in August for $55 million from Impax Laboratories , increased the price point of the drug from$13.50 per tablet to $750 per tablet. The drug is used by about 2,000 people in the United States annually, the Boston Globe reported . Martin Shkreli , Turing’s chief executive officer, defended the price increase multiple times within the past few days, arguing that the drug, which is taken for about six weeks, is a bargain because of its life-saving capabilities. When Turing acquired the drug, Shkreli, a former hedge fund manager, said the funds from the price increase would be used to subsidize new research into treatments for toxoplasmosis. But health care workers who primarily work with those patients with compromised immune systems, have not bought Shkreli’s reasoning. Joel Gallant , former chairman of the HIV Medicine Association , told the Boston Globe that HIV patients may remain on the drug for much longer than six weeks due to their compromised immune system, which could cost hundreds of thousands of dollars. “They are not in the game for biomedical research,” Gallant told the Globe. “They are getting exclusive rights to a cheap drug and raising the price because they can.” A letter sent to Turing by the Infectious Diseases Society of America implored Turing to reconsider the new pricing structure. Under the current pricing structure, it is estimated that the annual cost of treatment for toxoplasmosis, for the pyrimethamine component alone, will be $336,000 for patients who weigh less than 60 kilograms and $634,500 for patients who weigh more than 60 kilograms. This cost is unjustifiable for the medically vulnerable patient population in need of this medication and unsustainable for the health care system,” the IDSA said in its letter. U.S. Sen. Bernie Sanders , who is also vying for the Democratic presidential nomination, and U.S. Rep. Elijah Cummings also sent a letter to Turing demanding an explanation on the price increase. The duo said they were conducting an investigation on the price increase. Last month Sanders sent letters to Pfizer and Valeant about price increases for some of their drugs, the Street reported . According to the U.S. Centers for Disease Control , toxoplasmosis is considered to be a leading cause of death attributed to foodborne illness in the United States. More than 60 million men, women, and children in the U.S. carry the parasite, but most do not show symptoms due to a health immune system. Those with compromised immune systems, including cancer patients, HIV patients and pregnant women. If not held in check by a healthy immune system or medication, the parasite can attack the brain and lead to blindness or brain damage. Turing is not the only company to dramatically increase the cost of medication. Rodelis Therapeutics acquired the tuberculosis drug Cycloserine in August and raised the cost of a 30-day treatment of $500 to $10,800, the New York Times reported . Facing the backlash, Rodelis agreed to give the drug back to the Purdue Research Foundation , which has oversight of the manufacturing operation. However, now that the foundation has regained control, the price of the drug did not return to $500. Rather, 30 tablets now cost $1,050.