J&J Advances Pipeline With Yondelis, Carisbamate Filings

Company is on track to achieve goal of filing seven to 10 new products from the beginning of 2008 through end of 2010, CEO Weldon says.

Johnson & Johnson progressed its pipeline with the filing of two new drugs in the fourth quarter: trabectedin (marketed outside the U.S. as Yondelis ) for the treatment of relapsed ovarian cancer, and carisbamate for the adjunctive treatment of partial onset seizures.

The filings bring the total number of drugs filed by J&J in 2008 to four, with the others being golimumab, a next-generation anti-TNF under FDA review for rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and rivaroxaban, an oral factor Xa inhibitor for the prevention of deep vein thrombosis and pulmonary embolism.

"We said we would file seven to 10 new products for approval between the beginning of 2008 and the end of 2010, and, despite some setbacks, we remain on course with that commitment," CEO William Weldon told investors during the company's year-end financial review Jan. 20.

Trabectedin, a synthetic cytotoxic, would represent a new, non-platinum treatment option for patients with ovarian cancer. A Phase III trial showed that patients treated with trabectedin in combination with the chemotherapy Doxil (doxorubicin) had a statistically significant improvement in the primary endpoint of progression-free survival compared to those treated with Doxil alone. J&J's OrthoBiotech unit licensed the drug from PharmaMar, which maintains rights to the compound in Europe and Japan.

If approved by FDA, carisbamate, filed in October, could be marketed under the brand name Comfyde . In clinical trials, the antiepileptic has demonstrated a benefit in reducing seizure frequency in some patients with partial onset seizures with a good tolerability profile, according to the company.

Ionsys development halted

J&J also announced two pipeline setbacks. The company has halted all research and commercial activities for Ionsys (fentanyl hydrochloride), a needle-free, patient-activated analgesic system. The opioid was approved by FDA in May 2006 for the short-term management of post-operative pain in adults requiring opioid analgesia during hospitalization (¹ (Also see "J&J/Alza’s Ionsys To Launch In 2007" - Pink Sheet, 23 May, 2006.)).

The drug's proprietary E-Trans delivery system relies on a low intensity electrical current to move a 40 mcg dose of fentanyl from a reservoir into the skin over a 10-minute period. But the company ran into technical snags, perhaps related to manufacturing; a manufacturing supplement was submitted to FDA in April.

"Technical challenges with Ionsys lead to this decision," VP-Investor Relations Louise Mehrotra said. "We remain committed to exploring novel delivery technologies and believe strongly in the potential that innovative drug device combinations may offer."

J&J also said development of TMC-207 for the treatment of tuberculosis has been delayed by slower-than-expected enrollment in clinical trials. The company now projects regulatory filing for TMC-207 in 2011 instead of 2009/2010, the timeframe it had indicated last year.

In a separate regulatory update, J&J said it has submitted a response to FDA regarding its application for ustekinumab. The first-in-class monoclonal antibody for the treatment of chronic moderate to severe plaque psoriasis was the subject of a December FDA "complete response" letter requesting a proposal for a Risk Evaluation and Mitigation Strategy (² (Also see "FDA To Centocor: Show Me The REMS" - Pink Sheet, 22 Dec, 2008.)).

Pharma sales take a hit

Worldwide pharmaceutical sales were down for the quarter and year, diving 11.1 percent to $5.69 billion in the fourth quarter and 1.2 percent to $24.57 billion for the year. The introduction in June of generic versions of the antipsychotic Risperdal (risperidone) and lower sales of the anti-anemia agent Procrit (epoetin alfa) hurt overall sales.

For the year, sales of Risperdal oral fell 37.8 percent to $2.13 billion and sales of Procrit declined 14.7 percent to $2.46 billion. Excluding the impact of Risperdal and continuing declines in Procrit, pharmaceutical sales would have grown by 6 percent operationally, Weldon noted.

Declines in the pharma segment were offset by sales gains in J&J's consumer and medical devices & diagnostics units. Consumer sales were up 10.8 percent for the year to $16.05 billion, and sales in the device and diagnostics unit grew 6.4 percent to $23.13 billion.

Net earnings for the year were $12.9 billion, an increase of 22 percent, related to a one-time after-tax gain and one-time charges in the year-ago period. Excluding special items, net earnings increased 6.8 percent.

-Jessica Merrill ([email protected])