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Registration date : 2008-11-09

PostSubject: Suboxone News   Fri 11 Sep 2009, 7:57 pm

By Sarah Shannon
Sept. 11 (Bloomberg) --
Reckitt Benckiser Plc’s Suboxone heroin-dependency treatment will probably cope better with generic competition than the company forecasts, meaning profit estimates are too low, according to investors and analysts.
Suboxone, Reckitt’s fastest-growing product, is popular with U.S. doctors, who say it can wean addicts off opiates more effectively than methadone. Protection from generic competition runs out in October and Reckitt has repeatedly said the drug’s profit and revenue will fall as much as 80 percent next year.
Nine of 11 analysts surveyed by Bloomberg say that figure is too pessimistic, as Reckitt will probably preserve sales by throwing regulatory roadblocks at competitors and improving drug delivery by creating a Suboxone film-strip that dissolves in the mouth. Suboxone sales rose 45 percent last year to 341 million pounds ($564 million), accounting for about 5 percent of
revenue at the maker of Lysol cleaners and French’s mustard.
“Reckitt are always under-promising and over- delivering; there is an expectation they will do that with Suboxone,” said
David Keir, investment director at Scottish Widows Investment Partnership, whose funds include 1.05 percent of Reckitt shares.
Slough, England-based Reckitt has beaten analysts’ earnings estimates for seven consecutive quarters, Bloomberg data
shows. A drop of only 30 percent in Suboxone sales next year would add 6 to 7 percent to earnings per share estimates, according to Andy Smith, an analyst at ICAP Securities in London.
“Reckitt has a track record of conservatism in providing market guidance,” Smith said. He advises buying the
The stock rose 22 pence, or 0.75 percent, to 2,948 pence at 10:36 a.m. in London trading. Reckitt has climbed 14 percent this year, compared to the 8 percent gain of competitor Unilever NV.
Orphan Status
Of the 11 analysts interviewed by Bloomberg, only two agreed with Chief Executive Officer
Bart Becht’s forecast of an 80 percent sales decline, reiterated as recently as July. Becht has said Reckitt won’t produce its own generic version of the drug.
“Our guidance is based on our best estimates, given previous experience of loss of orphan drug status, and we stick to that,” spokeswoman
Andraea Dawson-Shepherd said by phone. She wouldn’t comment further, and Becht declined to be interviewed.
Until next month, Suboxone benefits from so-called orphan status, which provides an extra seven years’ exclusivity after a drug’s patent runs out. U.S. regulators grant the distinction to some medicines treating rarer conditions.
Suboxone affects the same brain receptors as morphine or heroin, without producing the same euphoric “high” or withdrawal symptoms. In 2006, 560,000 Americans aged 12 and older had abused heroin at least once in the year prior to being surveyed, according to the U.S. National Survey on Drug Use.
Patients Double
Joseph Terranova prescribes Suboxone to about 70 former heroin users at a time in Long Island, New York. He says more than 50 percent of his patients come off drug dependency after using Suboxone for around 18 months. He has more than doubled the amount of patients receiving the treatment in the last year.
With no generic competition, weaning drug users off heroin using Suboxone comes at a price. The treatment sells for $576.65 for 90 tablets of 8 milligrams on, representing a cost of about $2,339 a year to users taking one a day.
Tom Kosten, Deputy Chair of Psychiatry and Dean for Clinical Research at Texas’ Baylor College of Medicine, says he can prescribe Suboxone for about $5 a tablet. That compares with 50 cents per dose of methadone, a traditional treatment for heroin addicts that comes with more withdrawal symptoms, a greater risk of overdose and more need for doctors’ oversight.
“There are more people who want to come in for Suboxone than we have been able to handle,” Kosten said. He has 20 patients on Suboxone at Houston’s VA medical center, compared with 120 on methadone, and expects that proportion to reverse itself by next year.
FDA Approval
Suboxone’s main ingredient, buprenorphine, was discovered in the 1960s. Naloxone, the other ingredient, makes it impossible to get high if Suboxone is ground up and injected.
Suboxone in its present form was given approval by the U.S. Food and Drug Administration in 2002 to be prescribed by registered doctors. It’s the kind of drug that would typically lose most of its sales on the first day of generic competition, according to independent pharmaceutical analyst
Frances Cloud.
To delay that day, Reckitt has filed a so-called citizen petition, which calls for patient safety tests, against any generic competition that may appear. The company may also buy back the European distribution rights to the medication from
Schering-Plough Corp. to hold on to revenue, according to Chas Manso de Zuniga, an analyst at Evolution Securities in London. No talks are being held on such a transaction, Monique Mols, a Schering-Plough spokeswoman in the Netherlands, said by e-mail.
Citizen Petition
“If no one launches a generic product, then obviously Suboxone profits will be higher than currently assumed,” said
John Wilson, investment director of U.K. equities at Standard Life Investments in Edinburgh. Wilson helps manage about $200 billion of assets, including 7.26 million shares in Reckitt, or 1.02 percent of the company, Bloomberg data show.
The FDA can take up to 180 days to respond to a citizen petition. Such a petition may delay generic competition to Suboxone for a few months, “but none of the arguments are strong enough to result in a permanent ban,” according to
Andrew Wood, an analyst at Sanford C. Bernstein in New York.
Still, “management’s 80 percent loss seems very extreme,” said Wood, who forecasts a 56 percent 2010 drop for Suboxone sales. With the market for such treatments still growing, “Reckitt will be losing share, but of a bigger category.”
Reckitt has completed the second of three trials generally needed for regulatory approval of the film-strip version of Suboxone, according to Bloomberg data.
The film-strip equivalent may allow the drug to enter the body more quickly and efficiently than a tablet, according to Professor
Michael Colman of Aston University’s pharmacy department in Birmingham, England.
The FDA won’t approve any generic versions until after Suboxone loses orphan-drug protection on Oct. 8, Becht said last month. He declined to give any outlook on Suboxone sales in the fourth quarter. “The question is not if they come, the question is when and how many?” he said of generic rivals.
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