Epratuzumab
Posted: Wed May 10, 2006 7:21 am
Another one that's in phase III for lupus and they are talking about testing in other autoimmune diseases, including MS.
Immunomedics licenses drug to UCB
MAY. 10 - Business Week - Shares of Immunomedics Inc. jumped Wednesday when the biotech company said it agreed to license its lead product to Belgian biotech drug maker UCB for the treatment of immune system diseases.
Immunomedics shares rose 42 cents, or almost 15 percent, to $3.28 in morning trading on the Nasdaq. Shares have traded between $1.63 and $3.50 over the past 52 weeks.
Under the agreement, UCB will pay Immunomedics $38 million upfront for worldwide development, marketing and sales rights to epratuzumab to treat autoimmune diseases like lupus or multiple sclerosis, where the immune system attacks itself by mistake.
Immunomedics also stands to receive up to $145 million in cash milestone payments and $20 million in equity investment from UCB, as well as royalties and sales bonuses for the drug.
The drug is currently in two late-stage clinical trials for the treatment of lupus, and has been given "fast track" status by the Food and Drug Administration, meaning the company can submit data to the agency as it becomes available rather than waiting to submit it all at once.
Epratuzumab is a type of biotech drug known as a monoclonal antibody, or a protein designed to attack a specific kind of cell, allowing for targeted disease treatments.
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Here's some more info on the drug from the company's website:
In order to effectively develop our extensive product pipeline, and address diseases with unmet medical needs, we have prioritized our clinical development efforts with the development of three product candidates for the therapy of cancer and autoimmune disease. Two of these products are different naked humanized antibodies, which recognize antigens on B-cells, called CD22, and CD20. Epratuzumab (anti-CD22 antibody, IMMU-103) is being evaluated in patients with moderate and severe SLE and other B-cell mediated autoimmune diseases, and in non-Hodgkin’s lymphoma (NHL), a type of blood cancer. Our humanized CD20 antibody is currently in clinical trials for the therapy of non-Hodgkin’s lymphoma. For solid tumors, we are advancing yttrium labeled PAM4 (IMMU-107) antibody for the treatment of patients with pancreatic cancer.
We have initiated the ALLEVIATE, or “alleviate lupus affliction with epratuzumab and validate its autoimmune safety and efficacy,” trials in May 2005. The Alleviate A trial is enrolling patients with severe lupus, and the Alleviate B trial is for patients with moderate lupus activity. Both trials are pivotal phase III randomized, double-blinded, placebo controlled trials using BILAG scores to measure disease activity. The U.S. Food and Drug Administration (FDA) granted its Fast Track Product designation to epratuzumab for the treatment of patients with SLE.
Epratuzumab is also being expanded into other autoimmune diseases. We have completed a phase II trial for Sjögren’s Syndrome, an autoimmune disorder affecting as many as four million Americans in which white blood cells attack the salivary glands. Initial results indicated that epratuzumab is active in this difficult to diagnose and treat disease. In NHL, two phase II studies involving epratuzumab in combination with rituximab, and one phase II study with epratuzumab plus rituximab and CHOP therapy were completed in 2004 with encouraging results.
http://www.immunomedics.com/5clinical/c ... rview.html
Immunomedics licenses drug to UCB
MAY. 10 - Business Week - Shares of Immunomedics Inc. jumped Wednesday when the biotech company said it agreed to license its lead product to Belgian biotech drug maker UCB for the treatment of immune system diseases.
Immunomedics shares rose 42 cents, or almost 15 percent, to $3.28 in morning trading on the Nasdaq. Shares have traded between $1.63 and $3.50 over the past 52 weeks.
Under the agreement, UCB will pay Immunomedics $38 million upfront for worldwide development, marketing and sales rights to epratuzumab to treat autoimmune diseases like lupus or multiple sclerosis, where the immune system attacks itself by mistake.
Immunomedics also stands to receive up to $145 million in cash milestone payments and $20 million in equity investment from UCB, as well as royalties and sales bonuses for the drug.
The drug is currently in two late-stage clinical trials for the treatment of lupus, and has been given "fast track" status by the Food and Drug Administration, meaning the company can submit data to the agency as it becomes available rather than waiting to submit it all at once.
Epratuzumab is a type of biotech drug known as a monoclonal antibody, or a protein designed to attack a specific kind of cell, allowing for targeted disease treatments.
<shortened url>
Here's some more info on the drug from the company's website:
In order to effectively develop our extensive product pipeline, and address diseases with unmet medical needs, we have prioritized our clinical development efforts with the development of three product candidates for the therapy of cancer and autoimmune disease. Two of these products are different naked humanized antibodies, which recognize antigens on B-cells, called CD22, and CD20. Epratuzumab (anti-CD22 antibody, IMMU-103) is being evaluated in patients with moderate and severe SLE and other B-cell mediated autoimmune diseases, and in non-Hodgkin’s lymphoma (NHL), a type of blood cancer. Our humanized CD20 antibody is currently in clinical trials for the therapy of non-Hodgkin’s lymphoma. For solid tumors, we are advancing yttrium labeled PAM4 (IMMU-107) antibody for the treatment of patients with pancreatic cancer.
We have initiated the ALLEVIATE, or “alleviate lupus affliction with epratuzumab and validate its autoimmune safety and efficacy,” trials in May 2005. The Alleviate A trial is enrolling patients with severe lupus, and the Alleviate B trial is for patients with moderate lupus activity. Both trials are pivotal phase III randomized, double-blinded, placebo controlled trials using BILAG scores to measure disease activity. The U.S. Food and Drug Administration (FDA) granted its Fast Track Product designation to epratuzumab for the treatment of patients with SLE.
Epratuzumab is also being expanded into other autoimmune diseases. We have completed a phase II trial for Sjögren’s Syndrome, an autoimmune disorder affecting as many as four million Americans in which white blood cells attack the salivary glands. Initial results indicated that epratuzumab is active in this difficult to diagnose and treat disease. In NHL, two phase II studies involving epratuzumab in combination with rituximab, and one phase II study with epratuzumab plus rituximab and CHOP therapy were completed in 2004 with encouraging results.
http://www.immunomedics.com/5clinical/c ... rview.html