CAMBRIDGE, Mass. and LEIDEN, the Netherlands-Genzyme Corp. and Pharming Group N.V. (Euronext: PHAR / Nasdaq Europe: PHAR) announced today [10 December-ish 2001 KJO] that they have entered into an agreement that serves the interests of patients and resolves all issues remaining between the companies. The agreement enables Pharming to continue operations, move forward with its clinical development programs, and implement its plans for the future.
Under the agreement, Genzyme will obtain all of Pharming’s remaining assets related to the diagnosis and treatment of Pompe disease, including licenses to intellectual property and pre-clinical and clinical data. The acquisition of these assets will help Genzyme assure uninterrupted production of transgenic human alpha-Glucosidase for nine patients with Pompe disease participating in the extension of a clinical trial previously conducted through a joint venture with Pharming. It also improves the company’s ability to develop and commercialize a therapy for Pompe disease, where it has a broad clinical development program in place.
The agreement also calls for Genzyme to produce clinical supplies of human C1 Inhibitor for Pharming on a contract basis until June 2003. Pharming is completing a Phase 1 clinical trial evaluating the use of human C1 Inhibitor in the treatment of patients with hereditary angioedema, a serious genetic disease that may cause life-threatening complications. The protein is produced at the manufacturing facility in Geel, Belgium, that was formerly owned by Pharming N.V., the Belgian subsidiary of the Pharming Group.
Additional terms of the agreement call for Genzyme to purchase all shares of Pharming N.V.; to release Pharming Group from claims for capital contributions to joint ventures formed to develop a treatment for Pompe disease; and to forgive repayment of the promissory note due from Pharming Group under certain conditions. Both companies also agreed to terminate all legal actions between them.
In addition, Genzyme voted in favor of extending the period of Pharming’s receivership. An extension of the receivership until July 1, 2002, was approved by the majority of Pharming’s creditors and authorized on December 6 by the District Court in The Hague.
“This agreement allows both companies to move forward, and it resolves matters in a way that is in the best interests of patients,” said Jan van Heek, executive vice president of Genzyme Corp. “For Genzyme, the agreement strengthens our ability to develop and commercialize a therapy for Pompe disease. We will aggressively move forward with our expansion plans for the protein manufacturing facility in Geel, Belgium.”
From the perspective of Pharming Group, the agreement importantly keeps the company’s C1 Inhibitor program on schedule by guaranteeing the supply of recombinant C1 Inhibitor for the upcoming Phase 2/3 clinical trials in patients suffering from acute attacks of angioedema. The medical need for this product, which has been granted Orphan Drug designation in the United States and Europe, strongly motivates Pharming to develop recombinant human C1 inhibitor in an expeditious way. In addition, the agreement is structured such that Pharming is now in a position to rebuild the company based on its strong technology platform and its lead products: human C1 Inhibitor, and human Fibrinogen as a component of tissue sealant applications.