‘Things Must Be Bad’: Mylan’s Stumbles Over Generic Drugs Indicative Of Larger Industry Trouble

Bloomberg: Generic Drug Price Slump's Latest Victim: Mylan Profit Goal 
For the last five years, Mylan NV executives have gotten up in front of investors every year and said they could bet on one thing -- that the maker of generic drugs would hit at least $6 in earnings per share in 2018. That’s not gonna happen. On Wednesday, Mylan cut its adjusted earnings forecast for next year to $5.40 a share. It’s the latest stumble in the generic-drugs industry during a period of falling drug prices, political scrutiny and takeovers by Mylan and its competitors that either couldn’t be consummated or turned out not to work as well as hoped. (Hopkins and Melin, 8/9)

Bloomberg: Mylan Pares Losses As Path To Generic Advair Approval Smoothed 
Mylan shares briefly pulled out of an early-morning swoon after executives tempered concern about regulatory roadblocks for some of its new drugs. Approval of a highly anticipated generic version of the asthma treatment Advair, which was delayed, won’t require additional clinical or device approvals, Mylan President Rajiv Malik said on a conference call. That helped placate investors who had driven Mylan down as much as 7 percent early Wednesday after the company cut its forecast for this year and the next. The shares rose as much as 2.8 percent during the call and were down 2 percent to $31.16 at 12:05 p.m. in New York. (Hopkins, 8/9)

In other pharmaceutical news —

The Washington Post: Md. Drug Company Sues Federal Government To Fend Off Competition From Generics
One of Maryland’s largest drug manufacturers is suing the federal government to fend off competition on one of its key drugs, saying its right to exclusively sell the medication should continue an additinoal three years. The suit comes as the company, United Therapeutics, faces new competition from other firms trying to sell similar treatments on the generic market. Silver Spring-based United Therapeutics filed suit Aug. 4 in U.S. District Court for the District of Columbia, alleging the firm is entitled to a seven-year period of exclusive sale of the drug’s oral formulation. (Gregg, 8/9)

Kaiser Health News: Hospitals Slashed Use Of Two Heart Drugs After Huge Price Hikes
Even before media reports and a congressional hearing vilified Valeant Pharmaceuticals International for raising prices on a pair of lifesaving heart drugs, Dr. Umesh Khot knew something was very wrong. Khot is a cardiologist at the Cleveland Clinic, which prides itself on outstanding heart care. The health system’s pharmacists had alerted doctors about the skyrocketing cost of the drugs, nitroprusside and isoproterenol. But these two older drugs, frequently used in emergency and intensive care situations, have no direct alternatives. (Tribble, 8/9)

Bloomberg: Teva Ramps Up Sales With Medis, Respiratory Units 
Teva Pharmaceutical Industries Ltd. is ramping up asset sales as the troubled Israeli drug maker works to preserve its credit rating and cut debt, people familiar with the matter said. The company is considering a disposal of Medis, an Icelandic unit that develops generics for other companies, a representative for Teva said, confirming Bloomberg’s earlier report. The company is also weighing a sale of some of its respiratory treatment assets, the people said, asking not to be identified because deliberations are private. Teva hasn’t made a final decision about the assets and considerations are at an early stage, they said. (Baigorri, David and Bemeleh, 8/9)