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Rituxan approved for rheumatoid arthritis indication Genentech Inc. and Biogen Idec Inc.'s Rituxan (rituximab) in combination with methotrexate was approved by the Food and Drug Administration to reduce the signs and symptoms in adults who have moderately to severely active rheumatoid arthritis, but who have had an inadequate response to at least one tumor necrosis factor (TNF) antagonist therapy.

The companies said Rituxan is the first RA therapy that selectively targets CD20-positive B-cells, a mechanism of action that allows Rituxan to affect the pathways by which B-cells are believed to contribute to the initiation and development of RA.

The approval was based on the results of three randomized, double-blind, placebo-controlled trials in patients with active RA, including the Phase III REFLEX trial, which included patients who showed an inadequate response to or were intolerant of TNF antagonists.

A significantly greater proportion of patients who received a single treatment course of Rituxan plus methotrexate demonstrated American College of Rheumatology (ACR) 20, ACR 50 and ACR 70 response rates as compared with the patients who received placebo plus methotrexate. Specifically, 51 percent of the Rituxan-treated patients versus 18 percent of the placebo-treated patients achieved ACR 20, the study's primary endpoint, at 24 weeks.

"In clinical trials, Rituxan demonstrated significant improvement in joint pain, inflammation and physical function from a single course of therapy in this difficult-to-treat patient population," explained Dr. Stephen Paget, physician-in-chief at the Hospital for Special Surgery in New York.

Analysts at Goldman Sachs estimate that Rituxan will achieve sales of $50 million in 2006 and $100 million in 2007 for the arthritis indication, The Wall Street Journal reported. But the analysts predicted that label indication expansions could lead to sales that exceed $1 billion.

However, Reuters quoted Geoff Porges, a Sanford Bernstein analyst, as saying he expects the RA indication will add approximately $400 million to Rituxan's annual U.S. sales. He added, though, that rheumatologists may be reluctant to prescribe the therapy because it suppresses the immune system for a long period.

"I think Rituxan is going to have a slow start and face some challenges in RA," he said.

Also, Rituxan requires fewer infusions than Bristol-Myers Squibb Co.'s Orencia (abatacept), which means less revenue, Reuters added.

Rituxan is already approved for the treatment of relapsed or refractory, low-grade or follicular CD20-positive, B-cell non-Hodgkin's lymphoma. Rituxan is marketed as MabThera by Roche outside of the United States, except in Japan, where it is co-marketed by Chugai Pharmaceutical Co. Ltd. and Zenyaku Kogyo Co. Ltd.

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Erbitux receives approval for head, neck cancer indications Erbitux (cetuximab), in combination with radiation, was approved by the Food and Drug Administration to treat squamous cell cancer of the head and neck when the cancer cannot be removed by surgery. It was also approved as monotherapy in patients whose head and neck cancer has spread even after standard chemotherapy.

The regulatory agency said this is the first head-and-neck cancer drug approved in 45 years and the first such therapy that can extend survival in these patients. ImClone Systems Inc. manufactures the drug, while Bristol-Myers Squibb Co. distributes and markets it.

"We consider this approval an important advance in the treatment of head and neck cancer, because it has been shown to help some patients live longer," said Dr. Steven Galson, director of the agency's Center for Drug Evaluation and Research. "The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important."

The Erbitux/radiation combination approval was based on a study that showed it prolonged survival by 20 months when compared with radiation alone. The monotherapy indication was supported by a tumor shrinkage rate in 13 percent of patients that lasted for an average of six months.

Methotrexate, which is also used in head and neck cancer, first became available in the 1950s.

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Genentech's Lucentis receives priority review as treatment for neovascular wet AMD The Food and Drug Administration granted priority review to Genentech Inc.'s Biologics License Application for Lucentis (ranibizumab), an investigational treatment for neovascular wet age-related macular degeneration.

The FDA plans to review the drug by the end of June, six months after the BLA was submitted.

Lucentis is a humanized therapeutic antibody fragment developed by Genentech and the Novartis Ophthalmics Business Unit. The drug is designed to block new blood vessel growth and leakiness, which lead to wet AMD disease progression and vision loss. Genentech has commercial rights for Lucentis in the United States and Canada, and Novartis has exclusive commercial rights for the rest of the world.

Preliminary two-year data from a Phase III study called MARINA showed that 90 percent of Lucentis-treated patients experienced maintained or improved vision at year two compared with 53 percent of patients in the control group. Genentech said it will submit this data to the FDA.

The BLA submission was based on data from the MARINA trial, as well as another Phase III trial called ANCHOR and a Phase I/II trial named FOCUS. Findings from the studies showed that Lucentis improved vision in patients with wet AMD. Additionally, in another head-to-head clinical study, Lucentis demonstrated a clinical benefit compared with Novartis AG and QLT Inc.'s Visudyne (verteporfin) photodynamic therapy.

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Lilly, Amylin file sNDA for Byetta Eli Lilly and Co. and Amylin Pharmaceuticals Inc. submitted a supplemental New Drug Application to the Food and Drug Administration seeking approval for expanded use of diabetes drug Byetta (exenatide) injection.

The companies hope to market Byetta as an add-on therapy to thiazolidinediones in patients who have type 2 diabetes but are not achieving acceptable blood sugar control.

Byetta is already approved as an add-on therapy to metformin, a sulfonylurea or a combination of the two in patients with type 2 diabetes who do not have acceptable blood-sugar control.

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Schwarz Pharma's patch for Parkinson's disease deemed approvable by FDA Schwarz Pharma AG received an approvable letter from the Food and Drug Administration regarding Neupro (rotigotine) transdermal system as a potential treatment for the signs and symptoms of early-stage idiopathic Parkinson's disease.

"We anticipate responding to the action letter within six months," said Dr. Iris Loew-Friedrich, a member of Schwarz Pharma's executive board. "The FDA requires additional analyses and summaries from the existing database."

Neupro is a non-ergoline dopamine receptor-agonist that is designed to be applied as a once-daily patch and to deliver the drug continuously into the body throughout a 24-hour period. The patch formulation allows for this once-daily dosing and a simple titration scheme, the firm said.

More than 1,500 patients with Parkinson's disease have already been treated with the product. During a Phase III study, it also showed effectiveness in treating patients with advanced Parkinson's disease.

Additionally, Neupro is being studied as a treatment for restless legs syndrome. First results from a double-blind, placebo-controlled Phase III trial in this indication are expected in the first quarter of next year.

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FDA issues non-approvable letter to BioDelivery Sciences' Emezine for treating nausea, vomiting BioDelivery Sciences International Inc. received a non-approvable letter from the Food and Drug Administration for the company's New Drug Application for Emezine (prochlorperazine maleate) buccal tablet formulation intended to treat severe nausea and vomiting.

The letter informed BDSI that additional information is required to address remaining questions. The company requested a meeting with the FDA regarding the letter and will use the outcome of this meeting to evaluate the progression of Emezine.

Emezine is an oral drug absorbed directly through the mucosa of the mouth. Currently, the only alternatives to orally administered tablets are injections and suppositories, BDSI said.

BDSI exclusively licenses Emezine in the United States from Reckitt Benckiser Healthcare Ltd. If the drug progresses, Reckitt Benckiser will manufacture the tablets for BDSI.

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Genta Inc. Genta Inc. said the Food and Drug Administration accepted the New Drug Application for Genasense (oblimersen sodium) injection. The company is seeking to market the product in combination with fludarabine and cyclophosphamide as a therapy for relapsed or refractory chronic lymphocytic leukemia. Action by the FDA will be taken on or before Oct. 28, 2006.

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DelSite Biotechnologies Inc. DelSite Biotechnologies Inc., a subsidiary of Carrington Laboratories Inc., selected Invitrogen Corp.'s PD-Direct services to develop a process for a cell-based avian H5 influenza whole virion antigen to be used in DelSite's nasal vaccine product. Last year, DelSite completed a Phase I clinical trial of its GelVac delivery system, without antigen, which showed that doses of GelVac were consistently and reproducibly delivered to the nasal cavity, and were well tolerated.

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RxKinetix Inc. RxKinetix Inc. concluded its end-of-Phase-II meeting with the Food and Drug Administration for RK-0202 as an investigational treatment for oral mucositis and is proceeding with plans for Phase III development. The double-blind, randomized placebo-controlled Phase II trial of RK-0202 included patients with head and neck cancer. Results showed that patients who received RK-0202 had a 29 percent lower incidence of grade 3 or greater oral mucositis, as determined by the World Health Organization, than did patients who received placebo. Also, fewer RK-0202-treated patients required an external feeding tube as compared with the control group.

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Medivation Inc. Medivation Inc. received a telephonic update from the Food and Drug Administration regarding the Investigational New Drug application for Dimebon, which is being developed for the treatment of Huntington's disease. The regulatory agency said that Medivation needs to conduct more toxicology studies before its IND can be approved. Dr. David Hung, the firm's chief executive officer, said the company has not yet received a written communication from the FDA or discussed the IND with FDA staff. Once it does, Medivation will consult with its own staff, but it believes the requested studies can be completed in a few months.

 

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