Painkiller is topic of inquiry
The Utah-produced drug's place in illicit trade worries authorities
By Bob Mims
Actiq, a cancer-pain drug developed and produced in Utah, is the subject of inquiries by federal investigators and attorneys general in two Eastern states over its growing popularity with the illicit narcotics trade.
Cephalon Inc. spokesman Robert Grupp confirmed Wednesday that his company is cooperating with the Connecticut and Pennsylvania attorneys general, and the U.S. Attorney's Office in Philadelphia, in checking reports that Actiq, annually prescribed to more than 6 million patients, is being illegally diverted.
"While we take all such reports seriously, we believe that out of the millions of prescriptions of Actiq made a year, the reports of abuse and diversion are very small compared to other Schedule II drugs [a class of potentially addictive narcotics]," Grupp said.
Actiq, a powerful synthetic opioid, became a Cephalon product in July 2000, when the company acquired Salt Lake City's Anesta Corp. in a $444 million stock exchange deal. Also known as Fentanyl, it is typically prescribed as an anesthetic for cancer-related pain; it is delivered in berry-flavored, lollipop-type lozenges - usually used by child patients - as well as transdermal patches and by injection.
Authorities suspect the narcotic, known as "perc-a-pop" in illicit drug slang and 100 times more powerful than morphine, is being illegally diverted by some unscrupulous pharmacies and physicians' offices, or through theft and fraudulent prescriptions.
Numerous requests for comment from the Connecticut and Pennsylvania attorneys general, and the U.S. Attorney in Philadelphia went unanswered as of late Wednesday.
However, Pennsylvania Attorney General Jerry Pappert has publicly targeted Actiq in the recent past as a dangerous attraction for young narcotics abusers. In April, his office declared the drug's ease of use and sweet taste made it increasingly popular on the streets.
Pappert spokesman Kevin Harley told The Associated Press then that Actiq is "a drug that is easily administered or taken by somebody who might be afraid to either take a pill, snort, or inject a needle in their arm."
However, Grupp downplayed the reports of increasing abuse of Actiq, which along with the sleep drug Provigil and the seizure medicine Gabitril forms a lucrative product troika for the West Chester, Pa.-based Cephalon.
Indeed, the company seemed much more concerned with the Pennsylvania and Connecticut attorneys generals' requests - by subpoena, in the case of Pennsylvania, and voluntarily from Connecticut - for documents related to Cephalon's marketing and promotion of all three of its primary drug products.
"It is important to note that [the drug diversion] conversation is separate from the other conversations," Grupp stressed. "We are cooperating . . . but the requests for information are quite broad, literally 'all documents since marketing began.' " He added that Cephalon is confident it will pass muster because it strives to keep its promotions "sound and appropriate" within a corporate policy of "robust compliance [with] the spirit and letter of the law."
However, the company seemed a bit darker in its filings to the Securities and Exchange Commission, allowing that, "These [marketing] matters may involve the bringing of criminal charges and fines, and/or civil penalties" and that "an adverse outcome could have a material adverse effect on our financial position, liquidity and results of operations."
The comments came in the same statement in which the company informed regulators that it had been subpoenaed in early September by the U.S. Attorney's Office in Philadelphia for background "relating to our sales and promotional practices for Provigil, Actiq and Gabitril." A voluntary request for similar information by the Connecticut attorney general, later in September, also is being met, Cephalon stated.
Apparently, that was not what investors in the biotechnology company wanted to hear just one week after Cephalon - blaming $215 million in charges relating to its acquisition of Cima Labs and various stock deals - posted a third-quarter loss of $165.3 million, or $2.94 a share.
Since Cephalon mentioned the inquiries in a Tuesday SEC filing, its stock has lost 82 cents, or nearly 2 percent. On Wednesday, shares closed at $48.95 Wednesday, down 47 cents from Tuesday's $49.42 per share trading on the Nasdaq exchange.
What it is: Actiq is the trade name under which Cephalon Inc. has sold its version of Fentanyl, a powerful synthetic opioid for cancer-pain sufferers. The drug, in its various forms is 100 or more times more powerful than morphine.
How it is administered: The drug is delivered through berry flavored, lollipop-like oral lozenges, transdermal patches or by injection.
Illicit uses: The euphoric effects of Actiq make it and other Fentanyl derivatives mainstays on the illicit drug market. Bogus prescriptions and theft are blamed for some of the illegal trade; addicts also are said to salvage used patches, siphoning off residue for injection or freezing and cutting patches into sections for oral absorption under their tongues or inside a cheek. On the streets, Actiq lozenges typically go for $20-25 per unit or $450 per carton (containing 24 units).
Sources: IMS Health Inc., Drug Abuse Warning Network, National Forensic Laboratory Information System, U.S. Drug Enforcement Administration.
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