While PDL BioPharma hopes to advance its lead product Nuvion (visilizumab) into a pivotal ulcerative colitis trial by mid-2007, the firm is also looking to expand its acute care portfolio through several anticipated partnerships and the acquisition of a commercial product.

The Phase II/III RESTORE-1 trial of Nuvion in patients with intravenous steroid-refractory ulcerative colitis is two-thirds enrolled, with a Data Monitoring Committee review slated for the second quarter of 2007, the Fremont, Calif.-based biotech reported during its third quarter earnings call Nov. 2.

"Around the time of the DMC review, we expect to provide more details related to our expected timing for the [pivotal] RESTORE-2 study's accrual and completion, as well as a target BLA filing of Nuvion in both the U.S. and EU," CEO Mark McDade told investors.

The exec said the firm is looking outside of irritable bowel disease at "the potential partnering of Nuvion because we think it would accelerate...the lifecycle management of a much broader array of diseases such as multiple sclerosis or diabetes that would have the potential to be treated using an anti-CD3 humanized antibody."

McDade indicated that PDL is "looking very aggressively" at potential in-licensing opportunities, with a focus on an acute care product.

"We've talked about the possibility of filling a gap for our commercial organization, which I think is proving itself quite adept in the hospital setting. And we think a product opportunity that's in the acute care hospital setting would be appropriate and can be managed along with our...promoted products [ Cardene and Retavase ]...between now and the 2008 timeframe."

After Nuvion, the heart failure drug ularitide is PDL's priority. However, the firm recently decided not to initiate the drug's Phase III program until a "cardiovascular-competent partner" is found.

Such a partner "may be global, or it may be more European-centric in nature, and we hope to conclude a partnership in the 2007 timeframe," McDade said. Ularitide is in the same natriuretic peptide class as J&J's Natrecor (nesiritide).

After ularitide is the biologic daclizumab. The firm saw disappointing news this summer when Roche backed out of an asthma development deal (¹ Also see "PDL Seeks Partner For Daclizumab In Asthma After Roche Backs Out" - Pink Sheet, 30 August, 2006.).

"It is behind ularitide as a priority, but we are optimistic about finding a partner in the 2007 timeframe," McDade reported. Daclizumab is also in studies for multiple sclerosis and chronic transplant rejection in partnership with Biogen Idec and Roche, respectively.

PDL is still waiting to meet with FDA regarding a failed Phase III trial of its type 1 hepatorenal syndrome treatment terlipressin, announced in August (² Also see "PDL’s Terlipressin Fails Phase III Trial; Company To Meet With FDA" - Pink Sheet, 7 August, 2006.). The firm continues to work with partner Orphan Therapeutics, and the meeting with FDA is anticipated "later this year."

PDL's total revenues for Q3 rose 44% to $111.4 mil. over the same period in 2005, including $18.8 mil. in deferred collaboration revenues from Roche's discontinuation of the daclizumab deal.

- Lee Szilagyi (l.szilagyi@elsevier.com)

PDL Focus Remains Nuvion, But 2007 Could Include Several Significant Deals

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