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Apr-29-2008Rituxan Fails as Lupus Treatment,(topic overview)
CONTENTS:
- Shares of Genentech (nyse: DNA - news - people ) tumbled 5.8% to $68.96 in recent trading, while Biogen slumped 4.6% to $61.65. (More...)
- Rituxan received FDA approval in February 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy and in September 2006, also was approved for the treatment of non-progressing low-grade, CD20-positive, B cell NHL as a single agent, in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy, and for previously untreated diffuse large B cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemotherapy regimens. (More...)
- Biotechnology companies' Rituxan drug fails late-stage lupus study; 4.3%-plus declines in share prices. (More...)
- Genentech chief medical officer Hal Barron said the company "understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus." (More...)
- The Phase II/III study also did not meet any of the six secondary endpoints, the companies said. (More...)
- The companies said the study also did not meet any of the six secondary endpoints. (More...)
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Shares of Genentech (nyse: DNA - news - people ) tumbled 5.8% to $68.96 in recent trading, while Biogen slumped 4.6% to $61.65. 'We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus,' said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer, in a statement. The companies said the study did not meet its primary endpoint and also failed to meet any of the six secondary endpoints. [1] The drug, which is already approved to treat non-Hodgkins lymphoma and rheumatoid arthritis, failed to prompt a response in patients when compared with placebo in the 52-week study. The drug also failed to meet any of its six secondary goals. "We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus," said Dr. Hal Barron, Genentech's senior vice president of development and chief medical officer, in a statement.[2]
Genentech, Inc. (NYSE:DNA) and Biogen Idec, Inc. (Nasdaq:BIIB) came out this morning with some disappointing news. The biotech giants have announced that a Phase II/III study of Rituxan for lupus has failed to meet its primary endpoint defined as the proportion of Rituxan treated patients who achieved a major clinical response or partial clinical response. Unfortunately, this study results also failed to meet any of the six secondary endpoints. Genentech and Biogen Idec said they will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting. Based on the reaction, they can analyze all they want and it doesn't look like it will matter.[3] SOUTH SAN FRANCISCO, Calif. & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Genentech, Inc. (NYSE:DNA) and Biogen Idec, Inc. (Nasdaq:BIIB) announced today that a Phase II/III study of Rituxan (rituximab) for systemic lupus erythematosus (SLE, commonly called lupus) did not meet its primary endpoint defined as the proportion of Rituxan treated patients who achieved a major clinical response (MCR) or partial clinical response (PCR) measured by BILAG, a lupus activity response index, compared to placebo at 52 weeks.[4] BOSTON (Thomson Financial) - Genentech Inc. and Biogen Idec Inc. Tuesday said a Phase II/III study of Rituxan for systemic lupus erythematosus did not meet its primary endpoint.[5]
CHICAGO - ' Genentech Inc. and Biogen Idec Inc. said Tuesday a key study of Rituxan did not meet its main goal of a response in patients with systemic lupus erythematosus, commonly called lupus.[6] CHICAGO (Reuters) - Genentech Inc (DNA.N: Quote, Profile, Research ) and Biogen Idec Inc (BIIB.O: Quote, Profile, Research ) said on Tuesday a key study of Rituxan did not meet its main goal of a response in patients with systemic lupus erythematosus, commonly called lupus.[7]
BIIB has been generally higher for the past year. Biogen Idec shares have been plunging after the company announced this morning that a key study of its Rituxan did not meet its main goal of a response in patients with systemic lupus erythematosus, commonly called lupus.[8]
" There is a critical need to discover new therapeutic pathways in lupus as no new therapy has been approved in more than 30 years. We will analyze the full set of data from this trial in the coming months, share the findings with regulatory authorities, and apply the key insights to our continued research in lupus, " said Evan Beckman, M.D., Senior Vice President, Immunology Research and Development, Biogen Idec. This Phase II/III randomized, double-blind, placebo-controlled, multi-center study was designed to evaluate the efficacy and safety profile of Rituxan in patients with moderate-to-severe SLE on a background immunosuppressant. This study excluded patients with lupus nephritis (LN).[4] A separate phase III study of Rituxan in patients with lupus nephritis, a different form of the disease, is ongoing. Lupus has proven to be a stubborn disease to overcome, leaving in its wake a long list of clinical trial failures. With that said, most analysts did not include Rituxan-lupus revenue in their financial models for either Genentech or Biogen Idec.[9] About 400,000 people in the U.S. are believed to have the disease, Biogen and Genentech say. Of those, 70 percent have SLE, the type of lupus the companies were trying to treat in their failed trial. Another phase III trial is under way to see whether Rituxan might be helpful in treating lupus nephritis, a complication of SLE affecting the kidneys. Earlier this month, Biogen and Genentech released data from clinical trials of Rituxan, showing that the drug had failed to slow the progression of a severe form of multiple sclerosis.[10]
Following is a statement about the study results from Sandra C. Raymond, President & CEO of the Lupus Foundation of America: "Demonstrating the impact of a treatment in a lupus clinical trial can be difficult, as lupus manifests itself differently in different people, and can increase and decrease in severity from one day to another. While these new results are disappointing, they are not necessarily surprising. "People with lupus have been waiting for a new treatment for nearly 45 years while suffering from this disabling and sometimes life-threatening disease. It's important to remember that there are a variety of promising therapies in the near-term pipeline - including an ongoing study of Rituxan for the treatment of lupus nephritis (kidney disease). That study assesses Rituxan's potential in a focused subset of lupus patients with a highly objective outcome.[11] WASHINGTON, April 29 /PRNewswire-USNewswire/ -- Preliminary results were released today from a late-stage clinical trial of Rituxan (rituximab) for the treatment of lupus. The study did not meet its primary or secondary endpoints of clinically reducing the severity of SLE (systemic lupus erythematosus) in people with moderate disease.[11]
The clinical database was locked, the study unblinded and results for the primary and secondary endpoints initially reviewed on April 25, 2008. This is the first of two studies evaluating the safety and efficacy of Rituxan in patients with lupus. The second, an ongoing Phase III trial (LUNAR) is evaluating Rituxan in patients with active lupus nephritis with results expected in Q1- 2009.[4]
Rituxan, an antibody that is approved to treat rheumatoid arthritis and non-Hodgkin's lymphoma, is also being studied in a Phase III trial in a different set of patients who have lupus nephritis.[7] Lupus, a nasty and mysterious disease, has proved impervious to yet another drug. This time it's Rituxan, co-marketed by Genentech and Biogen Idec and already approved for cancer and rheumatoid arthritis, which is, like lupus, an autoimmune disease. The companies said this morning that Lupus patients in a large trial of the drug fared no better than those who received placebo.[12] Lupus has proved tougher. Genentech and Biogen Idec said this morning that a different study in a somewhat different group of Lupus patients is continuing. Bristol-Myers Squibb is studying its rheumatoid arthritis drug Orencia in patients with Lupus.[12]
NEW YORK (AP) -- Biotechnology companies Genentech Inc. and Biogen Idec Inc. said Tuesday their drug Rituxan failed a late-stage study involving lupus patients.[2] NEW YORK (Reuters) - Shares of Genentech Inc (DNA.N: Quote, Profile, Research ) and Biogen Idec Inc (BIIB.O: Quote, Profile, Research ) opened lowered on Tuesday after the drug developers said a its joint lupus treatment Rituxan did not meet its main goal in a study.[13] NEW YORK (Thomson Financial) - The biotechnology sector came under heavy pressure Tuesday after Genentech Inc. and Biogen Idec Inc. said a later-stage study of Rituxan for the treatment of lupus failed.[1]
Genentech Inc. and Biogen Idec Inc. said a later-stage trial for using Rituxan as a treatment for lupus failed by every count, in another unsuccessful effort to see what other ailments the drug could help.[14]
The drug Rituxan failed to benefit patients with lupus, according to negative results from a late-stage study announced Tuesday by the drug's partners, Genentech DNA and Biogen Idec BIIB. This is the second clinical setback for Rituxan in the last two weeks.[9] Biogen Idec's efforts to expand the possible uses for its drug Rituxan had another setback Tuesday, as the company said the treatment failed to improve the condition of patients with lupus.[10]
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received Food and Drug Administration (FDA) approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin's lymphoma (NHL). It was also approved in the European Union under the trade name MabThera in June 1998.[4] Rituxan is approved by the U.S. Food and Drug Administration for the treatment of non-Hodgkin's lymphoma, and was more recently approved, in combination with methotrexate, to treat rheumatoid arthritis. More detailed findings from the trial are expected to be presented at a medical conference this fall.[11] Biogen (Nasdaq: BIIB) co-markets Rituxan, approved to treat rheumatoid arthritis and non-Hodgkins lymphoma, with California company Genentech (NYSE: DNA).[10]
Souh San Francisco-based Genentech (NYSE:DNA) and Canbridge, Mass. -based Biogen Idec (NASDAQ:BIIB) have been struggling to find other uses for the drug, which is now marketed for non-Hodgkin's lymphoma and rheumatoid arthritis.[15] Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis.[4]
The drug has been used off-label for lupus patients who have failed other drugs. Several biotech drugs have been approved for autoimmune diseases (in which the body is attacked by its own immune system) in the past few years, and many of the drugs work for more than one disease. JJ's Remicade and Abbott's Humira, for example, have both been approved for Crohn's and rheumatoid arthritis, among other maladies.[12]
On April 15, the companies announced that a late-stage study in primary progressive multiple sclerosis also failed. In this most recent study, patients with systemic lupus erythematosus (SLE), commonly called lupus, failed to respond any better to Rituxan vs. placebo after one year of treatment, the companies said.[9] " We believe the ongoing Phase III trial in lupus nephritis (LUNAR) remains an important study as it evaluates the potential of Rituxan in a different patient population[4] Biogen Idec and Genentech, meanwhile, are continuing a clinical trial to use the drug to treat a different form of lupus known as lupus nephritis.[16] The Cambridge, Mass. -based company (Nasdaq: BIIB) announced on Tuesday that its drug Rituxan did not meet minimum goals in a late-stage clinical trial to treat a form of lupus, an autoimmune disease that can lead to inflammation in the joints, skin, organs and the central nervous system.[16]
Genentech and collaborators are leading research in the field of immunology by developing a pipeline of potential agents for various immune-mediated diseases, with ongoing clinical trials in lupus, RA, MS and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.[4]
EXPLORER is the first pivotal trial to use BILAG. Unlike other lupus activity indices in which a global score is calculated, the BILAG index reports disease activity in each organ system separately.[4]
GlaxoSmithKline and Human Genome Sciences are running a trial of a drug called LymphoStat-B in more than 1,600 lupus patients.[12] The course of disease in SLE is highly variable among patients and like other autoimmune diseases, most lupus patients experience periods of illness called flares, and periods of wellness, or remission.[4] Lupus nephritis is a common and serious complication of SLE that occurs when the disease affects kidneys; approximately one-third of SLE patients will develop lupus nephritis.[4] The company has another ongoing late-stage study on lupus nephritis patients and said that will continue.[2]
The 257 patients in the study were evaluated for effectiveness every four weeks for 52 weeks using a measure of lupus disease activity known as the British Isles Lupus Assessment Group, or BILAG.[7] The primary endpoint of the study was the proportion of patients who achieved either a Major Clinical Response (MCR) or Partial Clinical Response (PCR) using the BILAG instrument at 52 weeks.[4] Additional endpoints included: time adjusted area-under-the-curve minus baseline of BILAG score over 52 weeks; proportion of patients who achieve a MCR, and proportion of patients who achieve a PCR (including MCR) at Week 52; proportion of patients who achieve BILAG C or better in all domains at Week 24; time to moderate or severe flare over 52 weeks; change in SLE Expanded Health Survey physical function score from baseline at Week 52; and proportion of subjects who achieve a MCR with < 10 mg prednisone per day from Weeks 24 to 52.[4]
Rituxan received FDA approval in February 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy and in September 2006, also was approved for the treatment of non-progressing low-grade, CD20-positive, B cell NHL as a single agent, in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy, and for previously untreated diffuse large B cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemotherapy regimens. [4] In February 2006, Rituxan also received FDA approval in combination with methotrexate to reduce signs and symptoms and, in January 2008, to slow the progression of structural damage in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF-antagonist therapies.[4] Rituxan has already had approval since 1997 to treat a form of non-Hodgkin's lymphoma and since 2006 has been used in combination with another drug to treat rheumatoid arthritis.[16] Rituxan, already on the market for non-Hodgkin's lymphoma and rheumatoid arthritis, had 2007 sales.[14]
Genentech and Biogen Idec reported 2007 Rituxan sales of $2.29 billion in the U.S., primarily as a treatment for the blood cancer non-Hodgkin's lymphoma.[9] Biogen Idec made the announcement jointly with drug development partner Genentech Inc. (NYSE: DNA) in California. Drug companies increasingly try to broaden the number of treatments for which their drugs can be used.[16]
Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.[4] Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit http://www.gene.com.[4]
Shares of Biogen Idec (nasdaq: BIIB - news - people ) fell 5.5% to $64.67 in premarket trading.[5] Genentech shares fell 4.6 percent to $69.85 on the New York Stock Exchange and Biogen stock dropped 4.5 percent to $61.75 on the Nasdaq.[13] Shares of Biogen fell 4.11% in morning trading to $62.01 while Genentech was down 6.04% at $68.74.[14] Shares of Cambridge, Mass. -based Biogen ( BIIB ) fell $2.75, or 4.3%, to $61.92 in morning trading Tuesday.[2]
Among the ETF's other heavily-weighted components, shares of Applera Corp. (nyse: ABI - news - people )-Applied Biosystems Group fell 1.3% to $31.17, Genzyme Corp. (nasdaq: GENZ - news - people ) dropped 1.3% to $71.03 and Gilead Sciences Inc. (nasdaq: GILD - news - people ) slipped 31 cents to $52.20.[1]
Biotechnology companies' Rituxan drug fails late-stage lupus study; 4.3%-plus declines in share prices. [2] Lupus and multiple sclerosis were seen as long-term growth opportunities for Rituxan, so the recent study failures take a bite out of that prospect.[9]
Genentech chief medical officer Hal Barron said the company "understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus." [15] Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science.[4]
The companies had hoped to add lupus, a serious autoimmune disorder, to the list of approved indications for the drug.[10] "Lupus patients have suffered without a new treatment for more than four decades. For this reason, we are grateful to the companies that are searching for new lupus treatments. The millions of people who battle lupus with their families every day have waited long enough."[11] While estimates vary widely regarding the number of people affected by lupus, approximately 400,000 patients in the U.S. are believed to have the disease.[4]
Hey anti-pharma hypocrates, why don't you throw up your hands and march down Madison Ave. demanding that there's got to be a cheap generic somewhere out there to treat this disease. Better yet, get the lawyers involved as well, as you can read "drug has been used off-label for lupus patients" Oh no, off-label use, those "snake-oil" salesmen of the pharma business at it again.[12] Physicians evaluate eight organ-based systems (general, mucocutaneous, neurological, musculoskeletal, cardiovascular and respiratory, vascular, renal, and hematological) every 4 weeks when scoring lupus activity using BILAG. Physical exam findings and lab results for each organ system are used to produce a rating that compares the level of disease severity over the past 4 weeks to the previous assessment.[4] The British Isles Lupus Assessment Group (BILAG) index is a validated clinical measure of lupus disease activity.[4] Lupus nephritis is an inflammation of the kidney caused by lupus, a chronic inflammatory disease.[2] Lupus is an autoimmune disease characterized by inflammation of the joints, skin, major organs and central nervous system as the immune system attacks healthy tissues and cells.[7] There are several types of lupus, including the most common form of the disease, SLE, which comprises 70 percent of all lupus cases.[4] Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML). There are two reports of PML in Rituxan-treated patients with SLE. These patients had longstanding disease and had received other immunosuppressants including prednisone, azathioprine and cyclophosphamide. It is important to note that patients with SLE are often profoundly immunocompromised either due to their disease or the medications they are taking.[4] Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after treatment with Rituxan in about 12 months for most patients.[4] Rituxan has more than 10 years of clinical experience across all indications and more than 1,000,000 patient exposures.[4]
JP Morgan analyst Geoffrey Meacham said Wall Street had been optimistic about Rituxan for lupus due to favorable data in smaller studies. 'That said, our model and most Street models did not include lupus sales, so we don't expect large downward revisions to estimates on the news,' Mr. Meacham said in a note.[6] We remain optimistic that we are coming ever closer to new and better treatments for lupus.[11]
The Phase II/III study also did not meet any of the six secondary endpoints, the companies said. [7] Biogen also added that the Phase II/III study also did not meet any of the six secondary endpoints.[8]
The findings are initial results from a Phase II/III study conducted by Genentech, Inc., known as the EXPLORER study.[11]
Know What You Own: Genentech has a deep cancer drug pipeline, with about 15 experimental drugs in phase I, II or III trials.[9]
The fact that the trial was unsuccessful, should not affect the current stock proformance and price. This is a good buying opportunity. It lets Carl Icahn in at lower prices. If Biogen was truly interested in stopping him from a potential proxy fight, Mr. Mullen and his crack team of BofD would authorize a buy back, a dividend or other method to increase shareholder value.[12]
Please also refer to the risk factors described in Genentech and Biogen Idec's periodic reports filed with the Securities and Exchange Commission.[4] Right before the open, Genentech shares are down almost 5% to $69.70 and Biogen-Idec shares are down almost 5% at $61.50.[3]
The companies said the study also did not meet any of the six secondary endpoints. [5]
SOURCES
1. Biotech sector ETF falls to 2-month low as Genetech/Biogen's Rituxan study fails - Forbes.com
2. Genentech, Biogen drug study setback - Apr. 29, 2008
3. 24/7 Wall St.: Genentech & Biogen-Idec Tank Rituxan Hopes on Lupus Treatment (DNA, BIIB)
4. Genentech and Biogen Idec Announce Top-Line Results from Phase II/III Clinical Study of Rituxan in Systemic Lupus Erythematosus
5. Genetech/Biogen Idec say Rituxan study for lupus failed to meet primary endpoint - Forbes.com
6. reportonbusiness.com: Genentech, Biogen say lupus study fails; shares drop
7. Genentech, Biogen shares drop after lupus study fails | Reuters
8. Biogen Idec (BIIB) NewsBite - Biogen Reports Disappointing Results from Lupus Treatment
9. Another Rituxan Setback for Biogen, Genentech | Biotech | ABT BIIB CRIS DNA EXEL IMGN - TheStreet.com
10. Biogen Idec drug fails in lupus trial - Triangle Business Journal:
11. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
12. Health Blog : Lupus Resists Biotech's Autoimmune Push
13. Genentech, Biogen shares fall on failed study | Markets | Hot Stocks | Reuters
14. Free Preview - WSJ.com
15. Genentech: Rituxan fails as lupus treatment - Sacramento Business Journal:
16. Biogen Idec faces disappointing news for Lupus treatment - Boston Business Journal:
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