Genzyme and Dyax Announce Joint Venture for DX-88 in Hereditary Angioedema
Tuesday June 24, 7:31 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 24, 2003--Genzyme General (Nasdaq:GENZ - News), a division of Genzyme Corp., and Dyax Corp. (Nasdaq: DYAX - News) announced today Genzyme's decision to exercise its option to acquire a 50 percent interest in the DX-88 program for the potential treatment of hereditary angioedema (HAE) and potentially other chronic inflammatory indications. DX-88 is in phase II clinical trials for HAE, a rare disease characterized by acute episodic attacks of subcutaneous, abdominal and/or laryngeal swelling.
The decision by Genzyme follows its review of clinical data from the first completed phase II clinical trial of DX-88 for HAE, an open-label 9-patient study conducted by Dyax in Europe. Initial results of the study demonstrated that all patients met the primary endpoint, as announced by Dyax in March.
In addition to the European phase II study, a 48-patient, double-blind placebo-controlled dose escalating phase II study (Evaluation of DX-88's Effect on Mitigating Angioedema; EDEMA1) of DX-88 is being conducted under a U.S. IND. The first of four dose cohorts in EDEMA1 is completed and the second cohort is underway. DX-88 has received orphan drug designation for the treatment of angioedema by both U.S. and European regulatory authorities.
Under the terms of the joint venture, both companies will share development costs of DX-88 for HAE going forward. In addition, Dyax will receive milestone payments from Genzyme upon dosing the first HAE patient in a pivotal clinical trial of DX-88 and upon regulatory approval for the first indication. In addition, Dyax will receive milestone payments from Genzyme if DX-88 is approved in additional chronic inflammatory indications. Contingent upon regulatory approval of DX-88 for HAE, Genzyme will market the product worldwide, and Genzyme and Dyax will equally share profits from sales of DX-88 for HAE and/or other chronic inflammatory diseases. In March 2003, Dyax exercised an option to acquire from Genzyme all rights to DX-88 in surgical indications.
"Genzyme clearly has tremendous experience and strength in orphan drug development and marketing of products for unmet medical needs. They have demonstrated that significant and sustainable markets can be built for products that treat little known conditions. We could not have a more suitable partner. We have already established a successful working relationship with Genzyme and look forward to working together on advancing DX-88 through pivotal clinical trials and potential U.S. regulatory approval," commented Henry E. Blair, Chairman and CEO of Dyax Corp.
"We are enthusiastic about joining with Dyax to pursue the further development of DX-88, which holds promise for patients who suffer from hereditary angioedema," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "This opportunity is consistent with our focus on developing innovative therapies for patients with rare genetic disorders for which an unmet medical need exists. We are encouraged by the results of early clinical studies of DX-88 and by our conversations with physicians and patients. We look forward to working with Dyax to bring this product forward."
"The human toll of HAE in terms of disability and even death is tragic. Sadly, the anabolic steroids being used in the U.S. for attack prevention are often ineffective and can produce untoward side effects such as liver toxicity and, in female patients, virilization. The HAE community is thrilled that Genzyme is joining with Dyax in testing and developing DX-88 as a treatment for our dreadful disease," noted Anthony Castaldo, Founding Board Member of the U.S. Hereditary Angioedema Association.
DX-88
DX-88 is a small protein discovered by Dyax utilizing its proprietary phage display technology. DX-88 has exquisite specificity and affinity for kallikrein, a serine protease. Unihibited, kallikrein leads to the inflammatory cascade. In addition to being studied in phase II trials for its potential to treat HAE, DX-88 is in phase I/II clinical development for the prevention of blood loss and other systemic inflammatory responses (SIRS) during cardiothoracic surgery, an indication where kallikrein is also thought to be a relevant target. |
