After receiving a "complete response" letter from FDA in August for paliperidone palmitate, a long-acting form of Invega (paliperidone extended release), Johnson & Johnson updated investors that a launch of the long-acting atypical antipsychotic could be pushed back until around 2010.

During the company's third-quarter sales and earnings call Oct. 14, Pharma Group Chairman-Global R&D Paul Stoffels said the firm will include data about a new dosing option when it resubmits the NDA.

"Palmitate uses a novel delivery technology, and as with a lot of novel technologies, you learn as you conduct more clinical trials about how best to use this technology," he said.

FDA did not request additional clinical trials in the "complete response" letter for the drug, but rather a re-analysis of a subset of the data (¹ Also see "Paliperidone “Complete Response” Makes Two For J&J Under Two-Week-Old FDA Policy" - Pink Sheet, 27 August, 2008.).

However, J&J already has initiated a comparative trial evaluating paliperidone palmitate to Risperdal Consta (risperidone injection), using higher initiation dosing, with results anticipated in 2009. The decision to conduct the comparative study using a higher dosing option came after an initial comparative trial yielded interesting results.

"One of the things we have learned from the first comparative trial with Consta is that we can get much more consistent efficacy with palmitate across broad populations of patients with a higher initiation dose," Stoffels told investors. Based on those findings, J&J initiated a placebo-controlled study focusing on the higher dose; those findings also demonstrated strong efficacy and excellent tolerability, according to the company.

"Given what we have learned about the higher initiation dosing providing an optimal level of patient outcome, we plan to include this new dosing option in our response to FDA," Stoffels said. J&J anticipates the data will be submitted in the first half of 2009, and be given a six-month review by the agency.

Paliperidone palmitate is a once-monthly injectable in development for the treatment of schizophrenia. J&J said it also is considering initiating a bipolar program in 2009.

J&J had intended to move paliperidone palmitate into the market sooner to help stem the impact of the loss of exclusivity of immediate-release Risperdal on its CNS franchise.

Instead, the company has focused more recently on Risperdal Consta, which is dosed every two weeks. The firm also is developing a once-monthly version of Risperdal Consta with its partner Alkermes, which has raised some questions about how J&J would differentiate the two once-monthly options should they both reach the market (² Also see "Monthly Risperdal Consta: J&J’s Paliperidone Fallback?" - Pink Sheet, 23 May, 2008.).

Generic impact results in flat pharma sales

Generic Risperdal weighed on J&J's pharma sales in the third quarter, as did softer sales of the erythropoiesis stimulating agent Procrit (epoetin alfa).

Third-quarter sales of Risperdal fell 61.5 percent to $320 million, although sales of Consta increased 15 percent to $338 million. Procrit/ Eprex sales dipped 9.2 percent to $619 million, impacted by a decline in the ESA market of about 18 percent, J&J reported.

Worldwide Pharmaceutical sales were close to flat at $6.1 billion, with an operational decline of 2.5 percent offset by a 2.7 percent gain from currency. U.S. pharma sales fell 6 percent to $3.54 billion, while international sales increased 10.3 percent to $2.58 billion.

Pharma growth drivers included Remicade (up 19.4 percent), Topamax (up 18.8 percent), Concerta (up 72.3 percent) and Velcade (up 46.2 percent).

Given recent turmoil in the financial markets, CFO Dominic Caruso assured investors that J&J has ready access to commercial paper - a money market instrument corporations use to finance operations temporarily - at "attractive" rates. At the end of September, J&J renewed an expiring 364-day credit facility for $6.3 billion and got a new five-year credit facility for $1.4 billion, both of which had AAA credit ratings affirmed, he said.

"These facilities are part of our continued efforts to maintain our financial strength and flexibility," the exec added.

The faltering economy has affected some "pockets" of the business, Caruso said, mostly in the area of elective procedures and women's health procedures.

Net earnings were $3.3 billion, up from $2.55 billion in the third quarter last year. However, the year ago period included an after-tax restructuring charge of $528 million associated with a cost improvement program. Excluding this charge, net earnings for the third quarter 2008 increased 7.6 percent.

-Jessica Merrill (j.merrill@elsevier.com)

Paliperidone Palmitate Launch Unlikely Until 2010, J&amp;J Says

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Paliperidone Palmitate Launch Unlikely Until 2010, J&J Says