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Dyax Corp. and Cubist Pharmaceuticals, Inc. today announced that they have signed an exclusive license and collaboration agreement for the development and commercialization of the intravenous formulation of DX-88 for the prevention of blood loss during surgery in North America and Europe
CAMBRIDGE, Mass. & LEXINGTON, Mass., USA |April 24, 2008 | Dyax Corp. (NASDAQ: DYAX) and Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that they have signed an exclusive license and collaboration agreement for the development and commercialization of the intravenous formulation of DX-88 for the prevention of blood loss during surgery in North America and Europe.
Dyax will receive a $15 million upfront payment, an additional $2.5 million milestone payment in 2008 and is eligible to receive up to an additional $214 million in clinical, regulatory and sales-based milestone payments. Dyax is also entitled to receive tiered, double-digit royalties based on sales of DX-88 by Cubist. The agreement provides an option for Dyax to retain certain US co-promotion rights. Going forward, Cubist will be responsible for costs associated with the ongoing DX-88 on-pump cardiothoracic surgery (CTS) Phase 2 trial, known as Kalahari 1, as well as all further development costs associated with DX-88 in the licensed indications in the Cubist territory.
Dyax retains exclusive rights to DX-88 in all other indications, including its hereditary angioedema program, currently in its second Phase 3 trial, as well as for the manufacturing of DX-88. Dyax also plans to develop DX-88 in other angioedemas.
"Cubist brings a wealth of clinical resources and commercial expertise in the development of a hospital-based therapy, which will serve to maximize the potential of DX-88 in the prevention of blood loss during surgery," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "Furthermore, this partnership validates DX-88's potential as a multi-indication franchise and underlines the tremendous possibilities of this valuable asset."
"DX-88 immediately leverages our strong acute care clinical development and regulatory capabilities. Assuming approval, it will be an excellent fit with our proven acute care commercial infrastructure as well," commented Mike Bonney, President and CEO of Cubist. "As a potent plasma kallikrein inhibitor, DX-88 has the potential to be a breakthrough therapy in reducing blood loss and inflammation in multiple surgical indications. There is a serious unmet medical need and a large market opportunity for a successful therapy here."
About DX-88 in Surgery
DX-88, a Dyax-discovered potent inhibitor of plasma kallikrein, is being tested in an ongoing Phase 2 clinical trial (Kalahari 1) evaluating DX-88 in the prevention of blood loss during on-pump CTS, which includes coronary artery bypass graft (CABG) and heart valve and replacement procedures. The trial followed the completion of a Phase 1/2 proof-of-concept trial for the prevention of blood loss during high risk CABG surgery.
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.
Dyax's lead product candidate is DX-88, a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications. Dyax has completed three Phase 2 trials and a Phase 3 trial of DX-88 for the treatment of hereditary angioedema (HAE). A second Phase 3 trial, known as EDEMA4, is currently being conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S. for the treatment of acute attacks of HAE.
Dyax identified DX-88 and other compounds in its pipeline using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.
Dyax is headquartered in Cambridge, Massachusetts, and has antibody discovery facilities in Liege, Belgium. For online information about Dyax Corp., please visit www.dyax.com.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. As announced today, Cubist is developing DX-88, a clinical stage compound in-licensed from Dyax Corp., as an IV therapy for use in reducing blood loss and inflammation in CTS. The Cubist product pipeline also includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections.) Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
SOURCE: Dyax Corp. and Cubist Pharmaceuticals, Inc. |
