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Antibody deal struck for possible $500M-plus and neuromuscular deal for up to $271M
The last weekday of June saw a pair of high-value deals, with Inhibrx LLC announcing a worldwide option and license agreement with Celgene Corp. for an antibody program against an undisclosed target, while Biogen Idec Inc. and Isis Pharmaceuticals Inc. revealed that they have entered into collaboration under which they will develop and commercialize a novel antisense drug for the treatment of myotonic dystrophy type 1 (DM1), which is also known as Steinert disease.
The total deal value for the Inhibrx-Celgene deal potential could eventually exceed $500 million after all the upfront, clinical and regulatory milestone payments are tallied, with Inhibrx also eligible to receive royalties on commercial sales.
However, the companies have been very mum on other details. Dr. Tom Daniel, president of research and early development for Celgene, says simply, "Inhibrx has developed an antibody with strong preclinical study results on a highly validated target with very promising therapeutic potential."
From the Inhibrx side, the company's president, Mark Lappe, says only, "We are pleased to have a company of Celgene's caliber as the licensee of this program. On a global basis, Celgene has the science, clinical, regulatory and commercial expertise as well as the commitment to patients that continue to deliver disease-altering solutions to patients in need as quickly as possible."
Meanwhile, with a potential deal value of as much as $271 million, Biogen Idec and Isis said they have signed an exclusive, worldwide option and collaboration agreement to come up with a treatment for DM1, the most common form of muscular dystrophy in adults.
The genetic neuromuscular disease characterized by progressive muscle atrophy, weakness and disabling muscle spasms. It is caused by a genetic defect in the dystrophia myotonica-protein kinase (DMPK) gene in which a sequence of three nucleotides repeats extensively, creating an abnormally long toxic RNA, which accumulates in the cell and prevents the production of proteins needed for normal cellular function. Isis' DM1 antisense program is being developed to correct the underlying genetic defect that causes DM1.
Isis will receive an upfront payment of $12 million and is responsible for the discovery of a lead antisense drug candidate targeting DMPK for the treatment of DM1. Isis is eligible to receive up to $59 million in milestone payments associated with the clinical development of the DMPK-targeting drug prior to licensing. Biogen Idec has the option to license the drug from Isis up through the completion of the Phase II trial. Isis could receive up to another $200 million in a license fee and regulatory milestone payments. In addition, Isis will receive double-digit royalties on sales of the drug.
Isis will be responsible for global development of the drug through the completion of Phase II clinical trials, with Biogen Idec providing advice on the clinical trial design and regulatory strategy. If Biogen Idec exercises its option, it will assume global development, regulatory and commercialization responsibilities.
"Myotonic dystrophy is a debilitating neuromuscular disease that often affects entire families," said Steven H. Holtzman, executive vice president of corporate development at Biogen Idec. "The unmet need is great, and there are currently no therapies to slow or stop progression of the disease. Myotonic dystrophy has an identifiable genetic cause, the program fits with our mission to bring innovative therapies to patients with serious neurologic diseases, and Isis' antisense compound has the potential to make a real difference. This collaboration, which is our second with Isis, reflects the tremendous respect we have for their scientific leadership and expertise in antisense technology."
"Biogen Idec is a world leader in neurodegenerative diseases," added B. Lynne Parshall, chief operating officer, chief financial officer and secretary for Isis. "This collaboration allows us to expand our pipeline of drugs for rare and severe diseases with Biogen Idec's additional resources and support. It also complements our new alliance with Biogen Idec for our Phase 1 program in spinal muscular atrophy, or SMA. As with SMA, we are using our antisense technology in a unique manner to treat another devastating disease. Biogen Idec is an ideal partner for these programs with its expertise in neurodegenerative disease and global reach to help bring these therapies successfully to patients who have no treatment options."