By Vicki Brower
Special To BioWorld Today
Vimrx Pharmaceuticals Inc. and Baxter Healthcare Co. named their new joint venture in cell therapies for cancer and other serious diseases Nexell Therapeutics Inc., and appointed L. William McIntosh president and CEO.
McIntosh was formerly executive vice president of business development and chief financial officer of Vimrx, in Wilmington, Del. The agreement to form Nexell, which will be located in Irvine, Calif., was reported in June 1997 and was completed in October that year. (See BioWorld Today, June 16, 1997, p. 1, and Oct. 14, 1997, p. 1.)
Nexell, which will be 80 percent-owned by Vimrx and 20 percent by Baxter, is composed of Baxter's former immunotherapy division and will utilize Baxter's ex vivo cell separation and storage platform and Vimrx's expertise in gene therapy and genomics.
Both companies contributed a total of about $40 million — $30 million from Baxter and $10 million from Vimrx — to fund Nexell, which they say represents about two years of cash at its expected burn rate. In return for technology and other assets of its immunotherapy division, Baxter received 11 million shares of Vimrx common stock and 66,000 shares of convertible preferred stock worth $90 million, bringing the total value of the transaction to $130 million.
Baxter will be responsible for manufacturing, sales and marketing, and distribution of the cancer-related cell therapy products, and Nexell will focus on research and development, partnerships and market development.
The new company's goal is to expand cell therapies beyond cancer treatments to infectious diseases, blood disorders, genetic diseases, autoimmune and inflammatory disorders, transplantation, metabolic and central nervous system disorders, bone and cartilage repair and burns.
"The whole concept of using cells as therapy has been around for decades," said McIntosh. "We are now fortunately in the position to bring this to the patient," he added.
A number of recent Phase I trials demonstrate future applications for the cell sorting technology, the company said. In one trial, a large number of precursors to infection-fighting cells were infused into patients with breast cancer who had undergone a bone marrow transplant and chemotherapy. Patients showed a reduction in neutropenia with no increase in toxicity.
A second trial, conducted at the National Institutes of Health, evaluated a gene therapy for treating chronic granulomatous disease, a hereditary defect involving an inability of some white blood cells to kill bacteria using Nexell cell selection and expansion devices and products. The results showed genetic correction of selected stem cells lead to the generation of functionally active mature neutrophils in the patient.
Lead Product Under FDA Review
Nexell's lead product, the Isolex 300 Cell Selection System, which uses magnetism and antibodies to select cells, is currently under FDA review. In November, the FDA requested additional information from the company concerning the product, which is actually a device (magnetic beads) and a drug (antibodies). The company responded in December with additional data and information, and believes its application is on track for approval around mid-year.
The product already is approved in Europe. The device can be used for either positive selection of a desired target cell population, or negative selection and removal of cells that are potentially harmful to the patient, such as tumor or T cells.
The company also plans to file for approval in the near future for its fully automatic Isolex 300i device. In 1999, Nexell will file for a different use of both devices — both positive and negative cell selection.
The latest chapter in Nexell's patent battle with CellPro Inc., of Bothell, Wash., was written in early February, when CellPro got permission to keep selling its cell-sorting device, the Ceprate SC Stem Cell Concentration System, in Europe, but was instructed to put the money made from those sales in escrow.
Formerly, CellPro had been told to stop its European sales, McIntosh said. The patent battle concerns the CD34 antibody, which both companies use. CellPro has been accused of violating patents issued to Johns Hopkins University, in Baltimore, and licensed to Becton Dickinson & Co., of Franklin Lakes, N.J., for diagnostic use and to Baxter for therapeutic use. *