COPENHAGEN, Denmark—The U.S. Federal Trade Commission (FTC)has granted antitrust clearance of the Danish company Genmab's global licenseand development agreement with Janssen Biotech Inc. for daratumumab(HuMax(r)-CD38), a human CD38 monoclonal antibody.
The Sept. 21 clearance, a stipulation of theHart-Scott-Rodino Act, rendered the license agreement effective immediately,thus giving the two companies the green light to move forward in thedevelopment and commercialization of the cancer therapy.
The worldwide licensing deal, announced Aug. 30, is valuedto be worth up to $1.1 billion, including the rights to daratumumab and abackup antibody. Genmab also could receive tiered, double-digit royalties.
The agreement is actually the second signed between the twocompanies in less than two months. The licensing agreement for daratumumab isthe Danish company's potential first-in-class multiple myeloma therapy whichalso included a $55 million upfront payment by Janssen, a subsidiary of parentcompany Johnson & Johnson, and an equity investment from another J&Jcompany, thus extending the cash runway of the Danish biotech to at least fouryears. The agreement also calls for Janssen to be fully responsible for allcosts 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 withbroad-spectrum killing activity. The therapy is currently administered in anintravenous formulation.
Daratumumab targets the CD38 molecule, which is highlyexpressed on the surface of multiple myeloma cells. Daratumumab could also havepotential in other cancers on which CD38 is expressed, including diffuse largeB-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia,plasma cell leukemia, follicular lymphoma, mantle cell lymphoma and acutemyeloid leukemia.
"Janssen was one of the first companies to recognize thepower and promise of monoclonal antibodies and today is a world leader inbiologics," said Dr. William N. Hait, head of Janssen Research &Development LLC, in a press release. "We look forward to applying that sameexpertise to daratumumab to help meet the needs of patients with multiplemyeloma."
Daratumumab "is an exciting, innovative compound, and we aredelighted to add it to our portfolio," Hait said.
Genmab CEO Jan van de Winkel said in a press release, "Weare very pleased to partner with Janssen on another Genmab innovation and lookforward to working with them to accelerate the development of daratumumab andto maximize the value of this product. This agreement significantly strengthensour financial position, ensuring that Genmab can continue to developmuch-needed differentiated antibody therapeutics to help cancer patients in thefuture."
When word first leaked to the biotech community aboutGenmab's potential global licensing agreement, more than a dozen companiesstepped forward to express interest in partnering with the Danish firm. Infact, ever since preliminary clinical data on daratumumab was presented at theAmerican Society of Hematology annual meeting in December 2011 in San Diego,Genmab has been almost overwhelmed by interest from pharmaceutical and biotechcompanies, according to van de Winkel.
Rachel Curtis Gravesen, senior vice president of investorrelations and communications for Genmab, said in order to find an appropriatepartner in the venture, the company "ran a structured process where a number ofcompanies were in discussions under CDA, concerning entering a partnership withus for the development and eventual commercialization of daratumumab. Janssenwas one of the companies involved in this process."
While daratumumab "will continue to be developed formultiple myeloma, the deal also covers studies planned in three newindications," Gravesen says. "There are a variety of potential indicationswhere an anti-CD38 antibody could be used. This includes diffuse large B celllymphoma, mantle cell lymphoma, plasma cell leukemia and follicular lymphoma."
However, Janssen has "not publicly stated which three newindications will be chosen," she adds.
The cancer therapy "is thought to kill cancer cells inmultiple different ways," Gravesen says. This includes complement-dependentcytotoxicity, antibody-dependent, cell-mediated cytotoxicity, apoptosis andmodulation of the CD38 enzymatic activity.
"Daratumumab has the potential to be a first-in-classtreatment," she says. "Preclinical and early clinical data suggests there maybe 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 alsoenhance cell killing in combination with current marketed treatments such asRevlimid and Velcade."
Of the two ongoing studies with daratumumab, there is aone-dose finding study in Phase I/II, and one study in combination withRevlimid, also a Phase I/II, Gravesen says. A second combination study withVelcade—also a Phase I/II study—is expected to start soon.
The partnership with Janssen is expected to ensure a broadclinical program, which will include the launch of multiple Phase III studies,Gravesen says.