PDL BioPharma will need to find a partner to collaborate on the development of daclizumab in asthma before moving forward with the indication, the company reported Aug. 30.

"We are evaluating opportunities to establish a new collaboration," PDL said. "In the meantime, we will redouble our efforts to focus daclizumab development in MS and chronic transplant."

The Fremont, Calif.-based company announced it would seek a partner for daclizumab for asthma after Roche backed out of a development deal. The two companies have been pursuing development of the humanized monoclonal antibody in asthma since 2004. At the time, the companies said they would pursue a broad moderate to severe persistent asthma indication (¹ Also see "PDL/Roche Targeting Broad Zenapax Asthma Indication Under Development Deal" - Pink Sheet, 16 September, 2004.).

As a result of Roche's decision, PDL now holds exclusive development and commercial rights to daclizumab in asthma, the company said.

Roche already markets daclizumab as Zenapax for the prevention of organ rejection in patients receiving renal transplants. PDL and Roche will continue to jointly pursue development of the drug for transplant maintenance indications, and the companies remain on track to initiate a Phase II study for transplant maintenance in 2007, PDL reported.

Roche told "The Pink Sheet" DAILY the decision to discontinue its involvement in the asthma development stemmed from a "regular portfolio review." The company noted it has another Phase II candidate, R411, in development for asthma. Roche said it continues to have a strong relationship with PDL.

Daclizumab has been part of a three-way partnership that also includes Biogen Idec. PDL (then called Protein Design Labs) licensed the rights to the drug for non-transplant indications from Roche in 2003, then in September 2004 entered the joint agreement with Roche for asthma and other related respiratory disease applications.

In 2005, PDL announced a deal with Biogen Idec to co-develop daclizumab in multiple sclerosis indications (² Also see "Biogen Idec Gains Phase II MS, Cancer Biologics Through PDL Deal" - Pink Sheet, 3 August, 2005.).

Daclizumab has shown positive results in the treatment of patients with chronic, persistent asthma with high doses of inhaled corticosteroid therapy. A Phase II trial evaluating daclizumab in 114 patients, which PDL reported results from in April 2004, met its primary endpoint of percent change in forced expiratory volume in one minute (FEV1) from baseline to 12 weeks.

Nonetheless, the asthma market is a crowded category, with plenty of new entries anticipated. AstraZeneca is expected to launch Symbicort (budesonide/formoterol), which recently cleared FDA, in mid-2007 (³ Also see "FDA Approves Symbicort Asthma Combo Therapy" - Pink Sheet, 21 July, 2006.).

In August, Schering-Plough and Novartis announced plans to develop the first once-daily, fixed-dose combination asthma treatment combining a long-acting beta2-agonist and an oral corticosteroid in a single inhalation device (⁴ Also see "Schering/Novartis To Develop Once-Daily Inhalation Combination For Asthma, COPD" - Pink Sheet, 14 August, 2006.).

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

PDL Seeks Partner For Daclizumab In Asthma After Roche Backs Out

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