Mad about mAbs
October 2012
by Lori Lesko  |  Email the author

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COPENHAGEN, Denmark—The U.S. Federal Trade Commission (FTC) has granted antitrust clearance of the Danish company Genmab's global license and development agreement with Janssen Biotech Inc. for daratumumab (HuMax(r)-CD38), a human CD38 monoclonal antibody.  
 
The Sept. 21 clearance, a stipulation of the Hart-Scott-Rodino Act, rendered the license agreement effective immediately, thus giving the two companies the green light to move forward in the development and commercialization of the cancer therapy.  
 
The worldwide licensing deal, announced Aug. 30, is valued to be worth up to $1.1 billion, including the rights to daratumumab and a backup antibody. Genmab also could receive tiered, double-digit royalties.  
 
The agreement is actually the second signed between the two companies in less than two months. The licensing agreement for daratumumab is the Danish company's potential first-in-class multiple myeloma therapy which also included a $55 million upfront payment by Janssen, a subsidiary of parent company Johnson & Johnson, and an equity investment from another J&J company, thus extending the cash runway of the Danish biotech to at least four years. The agreement also calls for Janssen to be fully responsible for all costs associated with developing and commercializing daratumumab going forward, including the costs of two ongoing Phase I/II studies.
 
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. The therapy is currently administered in an intravenous formulation. Daratumumab targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, follicular lymphoma, mantle cell lymphoma and acute myeloid leukemia.
 
"Janssen was one of the first companies to recognize the power and promise of monoclonal antibodies and today is a world leader in biologics," said Dr. William N. Hait, head of Janssen Research & Development LLC, in a press release. "We look forward to applying that same expertise to daratumumab to help meet the needs of patients with multiple myeloma."  
 
Daratumumab "is an exciting, innovative compound, and we are delighted to add it to our portfolio," Hait said.
 
 
Genmab CEO Jan van de Winkel said in a press release, "We are very pleased to partner with Janssen on another Genmab innovation and look forward to working with them to accelerate the development of daratumumab and to maximize the value of this product. This agreement significantly strengthens our financial position, ensuring that Genmab can continue to develop much-needed differentiated antibody therapeutics to help cancer patients in the future."  
 
When word first leaked to the biotech community about Genmab's potential global licensing agreement, more than a dozen companies stepped forward to express interest in partnering with the Danish firm. In fact, ever since preliminary clinical data on daratumumab was presented at the American Society of Hematology annual meeting in December 2011 in San Diego, Genmab has been almost overwhelmed by interest from pharmaceutical and biotech companies, according to van de Winkel.  
 
Rachel Curtis Gravesen, senior vice president of investor relations and communications for Genmab, said in order to find an appropriate partner in the venture, the company "ran a structured process where a number of companies were in discussions under CDA, concerning entering a partnership with us for the development and eventual commercialization of daratumumab. Janssen was one of the companies involved in this process."  
 
While daratumumab "will continue to be developed for multiple myeloma, the deal also covers studies planned in three new indications," Gravesen says. "There are a variety of potential indications where an anti-CD38 antibody could be used. This includes diffuse large B cell lymphoma, mantle cell lymphoma, plasma cell leukemia and follicular lymphoma."  
 
However, Janssen has "not publicly stated which three new indications will be chosen," she adds.  
 
The cancer therapy "is thought to kill cancer cells in multiple different ways," Gravesen says. This includes complement- dependent cytotoxicity, antibody-dependent, cell-mediated cytotoxicity, apoptosis and modulation of the CD38 enzymatic activity.
 
"Daratumumab has the potential to be a first-in-class treatment," she says. "Preclinical and early clinical data suggests there may be a potential for using daratumumab as a monotherapy. In preclinical studies, it was shown to inhibit tumor growth and be active at low doses and also enhance cell killing in combination with current marketed treatments such as Revlimid and Velcade."  
 
Of the two ongoing studies with daratumumab, there is a one-dose finding study in Phase I/II, and one study in combination with Revlimid, also a Phase I/II, Gravesen says. A second combination study with Velcade—also a Phase I/II study—is expected to start soon.
 
 
The partnership with Janssen is expected to ensure a broad clinical program, which will include the launch of multiple Phase III studies, Gravesen says.
Code: E101207

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