As it endures a painful $635 million federal penalty for its marketing of OxyContin, Purdue Pharma Inc. is quietly reformulating a pain medication that hit a regulatory roadblock in 2004.
As its OxyContin woes deepened, the Stamford company pinned its hopes on Palladone, a pain reliever purported to be twice as powerful as OxyContin. Palladone was developed for use by patients who had built a tolerance to OxyContin and other opioid drugs.
Palladone debuted in February 2005; by July, the U.S. Food and Drug Administration asked Purdue Pharma to yank it from pharmacy shelves, on concerns alcohol could impair Palladone”™s time-release formula, prompting patients to take a fatal overdose.
Endo Pharmaceuticals Holdings Inc., a Pennsylvania company that settled an OxyContin-related patent suit with Purdue Pharma last year, is already selling a rival drug that it says does not provide an adverse reaction when taken with alcohol. Opana ER generated $29 million in first-quarter sales for Endo.
Palladone remains under development by Purdue Pharma, according to James Heins. He did not provide a timeline for when the company might resubmit Palladone to the FDA.
Heins declined to answer most questions regarding Purdue Pharma”™s product pipeline and financial data, saying the company considers the information proprietary.
If a shell of its OxyContin glory days, Purdue Pharma is hardly a shell company today, with 1,240 full- or part-time employees, 445 of them in Fairfield County.
“We are making substantial payments as part of this resolution,” Heins said in a written response to questions. “Nevertheless, we have budgeted for these obligations and there will be no reductions in our current work force and budgeted programs as a result of the settlement. In 2007, we will continue to fund budgeted development programs to support our future growth.”
While the company had reserved an undisclosed amount of money to address an eventual OxyContin settlement, it remains the target of numerous lawsuits, and is also exposed to agreements to indemnify co-defendants in the event of adverse jury verdicts.
It is unclear what impact the legal reserves have had on Purdue Pharma”™s research budget for future drugs. What is clear is that since OxyContin began capturing headlines for its abuse, Purdue Pharma has struggled to develop a follow-up blockbuster.
On its Web site, Purdue Pharma markets three other prescription drugs today, none of them bestsellers:
Â
Â
? MS Contin, a controlled-release morphine sulfate tablet to relieve pain;
? OxyIR, an immediate-release oxycodone capsule; and
? Uniphyl, a tablet to ease breathing.
Â
Besides Palladone, the company is developing a patch called Norspan to deliver pain medication through the skin.
Blockbuster drugs like OxyContin come few and far between ”“ in 2006, just nine of the top 200 brand-name drugs boasted triple-digit growth rates, according to Drug Topics, a trade publication for pharmacists.
Between 2000 and 2006, Purdue Pharma generated sales of $9.6 billion for OxyContin, Drug Topics estimates, peaking in 2003 as 11th best-selling prescription drug in the country.
By 2006, however, 50 drugs were ranked ahead of OxyContin, which that year produced pharmacy revenue of $683 million, down 47 percent from 2005. The only drugs to suffer a sharper drop in sales were the allergy treatment Flonase and anti-cholesterol drug Prevachol, which both saw generic drugs encroach on sales following the expiration of patents.
Oxycodone, the generic version of OxyContin, is the fourth best-selling generic drug today with sales of $1.2 billion in 2006.
Sepracor Inc., the maker of the insomnia drug Lunesta, whose current growth rate parallels that of Purdue Pharma early in the decade, had $1.2 billion in sales last year, triple its revenue in 2004. Last year, the Massachusetts company devoted $160 million to development of new drugs, or 13.7 percent of its revenue.
Purdue Pharma inexplicably branched out away from its traditional core focus on pain relief in 2002, spending $72 million to acquire the rights to four nonprescription digestive system remedies. In 2006, only one of those products appeared on Information Resources Inc.”™s list of the top 200 over-the-counter brands in 2006: Colace, a laxative that generated $25 million in revenue according to IRI, up a modest 13 percent from 2005.
Purdue Pharma is one of several companies developing antagonists to mute a body mechanism involved in the transmission of pain signals the brain. In the meantime, the company appears to be spending as much time and energy behind the legal bar as at the lab bench. In early May, Purdue Pharma and Biovail Corp. sued Par Pharmaceutical Companies Inc. after Par sought permission to sell a generic version of its Ultram-ER medication for chronic pain, which had $30 million in sales in the first quarter, double the level a year ago.
Â
Â
