Johnson & Johnson expects to make its first NDA filing of 2008 later this week, with the submission of the opioid product tapentadol to treat moderate to severe acute and chronic pain, the firm said during its Jan. 22 fourth quarter and year end 2007 sales and earnings call.

The firm reported worldwide fourth quarter net pharmaceutical sales of $6.4 billion, up 7.5 percent over the 2006 fourth quarter. U.S. sales increased 2 percent to $3.9 billion, while sales outside the U.S. increased by 6.8 percent to $2.5 billion, on an operational basis.

Worldwide pharmaceutical sales for the year were up 4.3 percent over 2006, at $24.6 billion. The firm posted a 3.4 percent increase in U.S. pharmaceutical sales for 2007. Pharmaceuticals made up 41 percent of the firm's total sales for the year.

Nine products had 2007 sales of more than $1 billion, including Risperdal Consta (injectable risperidone), Concerta (methylphenidate transdermal system), Remicade (infliximab) and Topamax (topiramate ) . Velcade (bortezomib) exceeded the $500 million mark for the first time, according to the firm. During 2007, "We built on strong competitive positions across seven therapeutic areas, with 70 percent of our sales coming from products holding the number one or number two market positions," CEO Bill Weldon said.

The firm touted three new molecular entities it filed in 2007 and said it is on track to make between seven and 10 filings between 2008 and the end of 2010. "Many of these compounds have the potential to be first or best-in-class treatments," Weldon said.

Regarding the recent filings, Weldon noted that the firm is prepared for those launches: "We think we have the resources necessary. ...We think we are really pretty well-positioned with our sales organizations to be able to launch the products in the markets we're going into, because most of them we compete in today. We don't see that there will be any real significant needs that will have to be addressed."

J&J filed an NDA for the schizophrenia treatment paliperidone palmitate, a long-acting injectable ester of the active ingredient in Invega (paliperidone extended-release) that employs Elan's NanoCrystal technology, in October (¹ Also see "J&J Files NDA For Once-Monthly Dose Of Invega" - Pink Sheet, 29 October, 2007.).

The NDA for ustekinumab, or CNTO 1275, was filed for psoriasis in both the U.S. and Europe, positioning the plaque psoriasis treatment to become a first-in-class treatment for the disease. Centocor reported positive Phase III results for the biologic in October (² Also see "Centocor Novel Psoriasis Biologic On Track Following Positive Phase III" - Pink Sheet, 3 October, 2007.). J&J plans to market ustekinumab in all countries outside of the United States.

J&J submitted the premature ejaculation candidate dapoxetine in several countries in Europe. It received a "not approvable" letter from FDA in 2005 (³ Also see "Dapoxetine Delay: J&J’s Premature Ejaculation Drug “Not Approvable” At FDA" - Pink Sheet, 26 October, 2005.).

J&J's Tibotec subsidiary received approval for its HIV therapy Intelence (etravirine) Jan. 18 (⁴ Also see "J&J’s Intelence Approved For HIV Treatment In NNRTI-Resistant Patients" - Pink Sheet, 22 January, 2008.).

Generic competition as well as labeling and reimbursement changes for erythropoietin-stimulating agents, including J&J's Eprex (epoetin alfa), marketed in the U.S. as Procrit , had a negative impact on the firm's fourth quarter sales.

Generic competition for Duragesic (fentanyl), Ditropan (oxybutynin), Sporanox (itraconazole) and Risperdal oral in certain countries outside the U.S. reduced the fourth quarter worldwide pharmaceutical operational growth rate by approximately 1.5 percentage points, with similar impact both in and outside the U.S.

Procrit sales dropped 32.6 percent in the U.S. to $331 million year over year and 20 percent worldwide to $628 million.

Excluding both the impact of generics and declining Procrit sales, the underlying operational growth for the pharmaceutical products was approximately 9 percent.

-Jamie Hammon (j.hammon@elsevier.com)

J&amp;J Pipeline On Track; Tapentadol Filing Expected This Week

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J&J Pipeline On Track; Tapentadol Filing Expected This Week