The first of an eventual 1,500 patients needed worldwide was enrolled last month in the U.S. The drug, daclizumab, is being developed for monthly injection under the patient’s skin by North Chicago-based Abbott and Cambridge-based Biogen Idec.

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REDWOOD CITY, CA–(Marketwire – August 3, 2009) – Facet Biotech Corporation today announced its decision, along with its partner Biogen Idec, to continue planning for the phase 3 trial of daclizumab high-yield process (DAC HYP) in multiple sclerosis (MS). The company plans to request a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) prior to the initiation of this study. The companies expect to start the phase 3 trial during the first half of 2010.

“We look forward to working with Biogen Idec to advance the DAC HYP program,” said Faheem Hasnain, president and CEO of Facet Biotech. “We believe that DAC HYP could be an important treatment option for MS. Despite advances in MS treatment, there remains a significant need for additional therapies in this patient population.”

The companies continue to enroll patients in the SELECT phase 2b monotherapy study of DAC HYP in MS as they plan for the phase 3 study. The independent Safety Monitoring Committee (SMC) for the SELECT study conducted a planned interim futility analysis of a subset of the data and, based on that analysis, the SMC recommended the continuation of the SELECT trial. SELECT remains a blinded study.

Additional details about the phase 3 study will be available prior to the start of the trial. Upon enrollment of the first patient into the phase 3 study, Facet would receive a $30 million milestone payment from Biogen Idec.

SELECT is a phase 2b, randomized, placebo-controlled, dose-ranging study of DAC HYP as a monotherapy treatment in patients with relapsing-remitting MS. Approximately 600 patients will be randomized to receive 150 mg DAC HYP, 300 mg DAC HYP or placebo every four weeks as a subcutaneous injection. The primary endpoint is reduction in the annualized relapse rate. Secondary endpoints include reductions of new or enlarged gadolinium-enhanced magnetic resonance imaging lesions. SELECT is considered to be the first of two registration-enabling trials required by regulatory authorities.

Under the terms of the collaboration agreement between Facet and Biogen Idec, in the U.S. and Europe, the two companies equally share the costs of all development activities and, if any of the products are commercialized, all operating profits. Each party will have co-promotion rights in the U.S. and Europe, based upon sales capabilities of each party at the time. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to Facet. Facet also is eligible for future development and regulatory milestones based on the further successful development of daclizumab.

Conference Call and Webcast

Facet Biotech is holding its Q2 2009 financial results call tomorrow, August 4, 2009, at 4:30 p.m., Eastern Time, and will discuss today’s announcement regarding the DAC HYP trial during that call. The webcast is accessible at the Company’s website at www.facetbiotech.com.

About Daclizumab

Daclizumab is a humanized monoclonal antibody that binds to the high affinity IL-2 receptor and selectively inhibits this receptor on activated T cells. Hoffmann-La Roche, Inc. currently markets daclizumab under the name Zenapax® under a license from Facet Biotech. Zenapax is indicated for intravenous use for the prophylaxis of acute organ rejection in patients receiving renal transplants. For clinical development in chronic diseases, Facet has developed a high-yield manufacturing process for daclizumab (DAC HYP), which includes a high concentration, liquid formulation for subcutaneous delivery. DAC HYP is an investigational agent in clinical development for the treatment of MS under a collaboration between Facet and Biogen Idec. Daclizumab is not approved for the treatment of MS.

About Multiple Sclerosis

MS is a chronic disease of the central nervous system that affects approximately two million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About Facet Biotech

Facet Biotech is a biotechnology company dedicated to advancing its pipeline of four clinical-stage products, leveraging its research and development capabilities to identify and develop new oncology drugs and applying its proprietary next-generation protein engineering technologies to potentially improve the clinical performance of protein therapeutics. Facet Biotech Corporation launched in December 2008 as a spin-off from PDL BioPharma, Inc.

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Phase 2 Data Show Daclizumab Significantly Reduced Multiple Sclerosis Lesions in Patients Receiving Interferon Beta Therapy
Biogen Idec Inc. and PDL BioPharma, Inc. (PDL) announced today that Phase 2 data demonstrated a significant reduction in new or enlarged gadolinium-enhancing lesions when daclizumab is added to interferon beta therapy in patients with active relapsing multiple sclerosis (MS). These data will be presented tomorrow at the 23rd Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

The ongoing Phase 2, randomized, double blind, placebo-controlled clinical study, known as the CHOICE trial, studies MS patients who continue to have active MS disease while receiving interferon beta therapy. The study patients who received daclizumab 2 mg/kg subcutaneously every two weeks showed a statistically significant 72% reduction in the number of new or enlarged gadolinium-enhancing lesions (Gd+) at week 24, compared to patients on interferon beta therapy alone. Patients from the CHOICE study were followed for an additional 48 weeks after the daclizumab treatment period to further assess safety and efficacy.

“Patients who received daclizumab every two weeks experienced far fewer new or enlarged gadolinium-enhancing lesions than the control group, which indicates that the antibody may be a promising option for patients with MS,” said Dr. Xavier Montalban, Director of the Unit of Clinical Neuroimmunology at the Hospital Val D’Hebron in Barcelona, Spain. “In addition, we were encouraged to see a trend in the reduction of the number of relapses, or exacerbations, that these MS patients experienced. Further study is warranted.”

Daclizumab is a humanized monoclonal antibody that targets the IL-2 receptor on activated T cells. Biogen Idec and PDL plan to initiate the SELECT study, a Phase 2 trial of daclizumab alone in the same relapsing patient population, by the end of 2007.

“We are very pleased to see positive results from the CHOICE study, the first randomized trial of daclizumab in patients with relapsing MS,” said Mark A. McCamish, M.D., Ph.D., chief medical officer, PDL BioPharma. “We recognize how monoclonal antibodies have changed modern medicine and see great potential in their ability to treat serious diseases, including cancer and select immunological diseases such as MS. We’re very excited to move development of daclizumab forward with our partner Biogen Idec, the acknowledged leader in the MS field.”

“Daclizumab represents an exciting opportunity within our growing MS portfolio,” said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec. “MS is a complex disease that requires an arsenal of treatment options for patients. We look forward to advancing the daclizumab development program and initiating the SELECT trial by the end of the year.”

Study Results

The CHOICE trial is evaluating the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active MS who were enrolled at study centers in the U.S. and Europe. Patients were randomized to receive daclizumab 2 mg/kg every two weeks, daclizumab 1 mg/kg every four weeks, or placebo added to ongoing interferon beta treatment.

The primary efficacy analysis showed that at 24 weeks, the 75 patients in the 2 mg/kg group experienced 72% fewer new or enlarged Gd+ on average compared to the 77 patients who received a placebo (p=0.004). The 78 patients in the 1 mg/kg group experienced a 25% reduction in new or enlarged lesions compared with placebo but that measurement did not achieve statistical significance.

Based on data up to week 24, analysis of the relapse rate, which was a secondary endpoint, indicates that both daclizumab regimens revealed a trend in reducing the annualized relapse rate compared to placebo (an approximately 35% reduction), but these observations did not reach statistical significance.

Preliminary safety data showed similar rates of infection across all treatment groups with an overall greater incidence of serious infections in the daclizumab treated groups. (4.6% versus 1.3% placebo). Urinary tract infections were slightly higher with the 2 mg/kg dose (17% vs 13% placebo). The incidence of cutaneous events was higher in the combined daclizumab groups (34% daclizumab vs. 27% placebo) but was mild to moderate and most resolved with little or no treatment.

PDL and Biogen Idec entered into a collaboration agreement in 2005 to co- develop and commercialize daclizumab in MS and indications other than transplant and respiratory diseases. Under the collaboration, the companies are also co-developing volociximab (also known as M200), an antibody in Phase 2 development for the treatment of various solid tumors. PDL and Biogen Idec share equally the costs of all development activities and all operating profits for both products within the U.S. and Europe. The companies jointly oversee development, manufacturing and commercialization plans for collaboration products and divide implementation responsibilities to leverage each company’s capabilities and expertise. Each party will have co-promotion rights in the U.S. and Europe. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to PDL on sales of collaboration products.

Source: Biogen Idec Inc. and PDL BioPharma, Inc. (12/10/07)
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Just over a year ago, PDL Pharmaceuticals partnered with MS giant Biogen (Avonex, Tysabri) to bring a drug known as daclizumab through trials for MS. Daclizumab is today used for the prevention of kidney transplant rejection, under the marketing name Zenapax (r). The partnership seems to be bearing fruit, as the companies announced that Daclizumab hit its targets in its first Phase II multiple sclerosis trial.

230 relapsing-remitting MS’ers with “active” disease were in the trial. They were broken off into 3 groups: 1 received 1mg of daclizumab per kg of body weight, the next received 2mgs per kg, and the third received no daclizumab. However, it is very important to note that *all* groups did receive interferon-beta treatment. In other words, there was no trial arm that was monotherapy testing daclizumab alone. We will pick this thread up in a moment.

The trial results showed that the 2mg per kg daclizumab group did significantly better in terms of reduced enhancing lesions– inflammations of the brain generally indicating active disease. Details were not provided, as the full data will be released at a conference later this year.

While positive results in any clinical, double-blind setting are good news for the MS community, the ghost of the Tysabri-Avonex combination trial looms large over this combination. This is probably the last time we will ever witness two immunomodulators/suppressants being administered at the same time, given when Tysabri+Avonex came together, the deadly brain disease PML seemed to be encouraged. What this means is that even if the combination of daclizumab and interferon shows benefit, the FDA would likely never approve it without extensive, tedious but critical safety studies.

The bottomline is that a new trial where daclizumab is trialled by itself will provide the critical insight into whether this will one day be a viable therapy for MS.

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