July 7, 2015
By Riley McDermid and Krystle Vermes, BioSpace.com Breaking News Staff
The founder and former chief executive of beleaguered East Bay pharmaceutical company IMPAX Laboratories, Inc. has stepped down, as the firm tries to regroup from a scandal-ridden spring and rocky time of it on the capital markets.
IMPAX said in a statement this week that Larry Hsu has resigned “in order to pursue other business opportunities.” Hsu served as the company’s president and CEO from October 2006 until April 2014.
“On behalf of my fellow members of the board, I want to thank Larry for his valuable service and leadership,” said Bob Burr, chairman of the Board of Directors of Impax. “He was instrumental in every step of Impax’ development and led the Company through a period of substantial growth. We wish him well in his future endeavors.”
Two weeks ago IMPAX raised a $500 million in convertible notes to pay down its debt and said Hsu will receive $2.7 million in severance pay and contract perks. He will be replaced by IMPAX exec Fred Wilkinson.
In February, Alaska Attorney General Craig Richards has asked IMPAX Laboratories, Inc. (IPKL), for more information on agreements made with makers of the brand name drugs, Adderall, Effexor and Opana. This news came on Feb. 12 after Impax was implicated in a “pay-to-delay” deal, according to the San Francisco Business Times.
In “pay-to-delay” deals, brand-name drug companies agree not to defend their patents against generic companies. In turn, they allow the generic drug on the market sooner than if a patent challenge were to go to court.
However, regulators say that generic drug companies debut on the market later than if they were to win a patent challenges. “Pay-to-delay” deals have cost consumers approximately $35 billion, according to the Federal Trade Commission. Impax is one of the many generic drug makers that have been thought to build their business off of “pay-to-delay” deals.
Adderall, a drug designed to treat attention deficit and hyperactivity disorder, was initially created by Shire plc, while Pfizer Inc. designed Effexor for the treatment of anxiety. Endo International was the original marketer of Opana, a medication for severe pain.
In December 2014, AstraZeneca PLC and Ranbaxy Laboratories landed themselves in court over the launch of a generic version of Nexium. This was the first time a lawsuit over an alleged “pay-for-delay” deal went to trial, according to the Wall Street Journal. In the end, both companies were cleared of violating anti-trust laws.
The verdict came after the jury determined that AstraZeneca’s payment to Ranbaxy Laboratories would not have been unreasonably anticompetitive.
In 2013, the U.S. Supreme Court ruled that consumers can sue over deals that ask generic drug makers to drop patent challenges and hold off on marketing their products in exchange for money, according to Bloomberg. The Supreme Court claimed that it would be “large and unjustified” for these types of payouts to be made.
A total of 40 “pay-to-delay” deals were made in fiscal 2012, and they cost drug consumers about $3.5 billion each year, according to the Federal Trade Commission.
AstraZeneca made approximately $3.9 billion from Nexium sales in 2013. The company has been preparing for the patent to expire on the drug, which is designed for the treatment of heartburn.
After Bristol-Myers Squibb Wonder Drug Meets Endpoints, Will FDA Process Be Up to Snuff?
Our most popular story last week was about a new wonder drug that wowed the FDA. An experimental anticoagulant drug under joint development between Portola Pharmaceuticals, Inc., Bristol-Myers Squibb Company and Pfizer Inc. met all primary and secondary endpoints in a Phase III study determining safety and efficacy—and our readers responded. The hope now is it will be sped to patients as fast as possible.
That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas.
