To: Vector1 who wrote (668 ) 2/26/2000 3:17:00 AM From: JF Quinnelly Read Replies (1) | Respond to of 752
Tarrytown, NY, and Framingham, MA, February 25, 2000 -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Genzyme Transgenics Corporation (Nasdaq: GZTC) announced today that the companies have signed an agreement to continue the development of a transgenic source of supply for Progenics' PRO 542. Under the terms of the agreement, Genzyme Transgenics will develop transgenic goats that produce PRO 542 in their milk in exchange for undisclosed fees and milestone payments. Genzyme Transgenics will supply product from the transgenic animals which Progenics will use in clinical trials. The contract also contemplates the eventual commercial supply of PRO 542. The expanded agreement was entered into based upon the successful outcome of transgenic feasibility studies conducted by Genzyme Transgenics. "Our extended alliance with Progenics reinforces the role of transgenic production in the development and the commercialization of protein therapeutics," said Sandra Nusinoff Lehrman, M.D., President and Chief Executive Officer of Genzyme Transgenics. "This partnership represents our continuing commitment to apply our transgenic technology to the development of innovative new therapies for unmet medical needs." Progenics' most advanced HIV product, PRO 542, demonstrated reductions in HIV levels in adults and children who continued to have high levels of the virus, despite the use of approved antiretroviral therapies. PRO 542 has been tested in two Phase I/II clinical trials. In single dose studies in HIV-infected adults, dose-dependent reductions in plasma HIV-1 RNA were seen, a measure of HIV viral "load." In patients receiving the highest dose, statistically significant decreases in HIV-1 RNA were observed, and infectious virus in plasma was reduced to undetectable levels for prolonged periods following treatment. In February 2000 at the 7th Conference on Retroviruses and Opportunistic Infections, Progenics reported the results of a multi-dose trial conducted in HIV-infected children. In the trial, all six children treated with weekly doses of PRO 542 showed decreases in HIV-1 RNA ranging up to 1.5 log10. Three of six patients showed sustained reductions in viral loads that persisted for as long as 14 days post-treatment. There have been no serious drug-related adverse events reported in any of the trials. "We have been encouraged by the preliminary safety and antiviral activity observed with PRO 542 in the recently completed Phase I/II trials and are pleased to continue development of a transgenic manufacturing process for PRO 542 with Genzyme Transgenics," said Ronald J. Prentki, President of Progenics. "Given the increasing worldwide prevalence of HIV and the potential demand which would be expected for PRO 542, we consider transgenics to be the most appropriate manufacturing approach to meet the bulk volume and cost of goods requirements for a commercial product." PRO 542 is a novel fusion protein that incorporates the HIV-binding region of the human cell surface receptor into a human antibody molecule. PRO 542 is designed to neutralize HIV by binding to the HIV surface glycoprotein (gp120) and preventing the virus from attaching itself to host cells. This mechanism of action is unique amongst antiretrovirals that are either approved or in late stage clinical development. PRO 542 has been shown in preclinical studies to potently neutralize a wide range of HIV strains from all geographic regions. In an animal model of HIV infection, PRO 542 prevented infection by virus strains isolated from HIV-infected individuals. Progenics Pharmaceuticals, Inc. is a biopharmaceutical company focusing on the development and commercialization of products for the treatment and prevention of cancer and viral diseases. The Company's most advanced product, GMK, is a cancer vaccine in pivotal Phase III clinical trials for the treatment of malignant melanoma. A second cancer vaccine, MGV, with broad application to a variety of cancers, is entering Phase II trials. GMK and MGV are being developed in collaboration with Bristol-Myers Squibb Company. The Company, with CYTOGEN Corporation, has formed a joint venture focusing on the development of cancer immunotherapies based on PSMA (Prostate Specific Membrane Antigen) technology. In addition to PRO 542, Progenics has a follow-on HIV product, PRO 367, which is preparing to commence Phase I/II trials. Progenics also has collaborations with F. Hoffmann-La Roche Ltd in the area of HIV fusion co-receptors, and with American Home Products focusing on small-molecules targeting the CD4 receptor. Genzyme Transgenics Corporation has successfully produced over 60 human proteins in animals milk, including monoclonal antibodies, immunoglobulin fusion proteins, hard-to-express and plasma proteins. Genzyme Transgenics is currently working with recognized leaders in the biotechnology and pharmaceutical industries to produce transgenic proteins as potential treatments for a variety of diseases, such as autoimmune and inflammatory disorders, cancer and HIV/AIDS. Genzyme Transgenics applies transgenic technology to enable the development and production of recombinant proteins and monoclonal antibodies for medical uses. Primedica Corporation, Genzyme Transgenics' contract research organization, provides preclinical development and testing services to pharmaceutical, biotechnology, medical device and other companies.