Protein Design Labs Inc. (PDL) announced Wednesday that ithas acquired four human anti-viral antibodiesHas well as ahumanized anti-tumor antibody and its murine progenitorHfrom Sandoz Pharma Ltd. and Sandoz Pharmaceuticals Corp., ofEast Hanover, N.J., PDL of Mountain View, Calif., also acquiredexclusive rights to Sandoz's technology for producing humanmonoclonal antibodies as well as the patents andmanufacturing equipment.
PDL is paying Sandoz $5 million for the antibody package. Themajority, $4.5 million, goes for the rights to the four humananti-viral MAbs; $500,000 is for the other, anti-tumor MAbs,ABL364 (the murine version) and Smart ABL364 (the 90percent-humanized version), which PDL had previouslyhumanized under a collaboration with Sandoz.
Sandoz could receive up to an additional $5 million in milestonepayments from PDL (NASDAQ:PDLI). PDL retained the right tomanufacture and market the antibodies worldwide. Sandoz hascertain co-promotion and co-marketing rights under theagreement.
The Swiss company's decision to sell the antibodies and thetechnology rather than take them through to commercialdevelopment stems from the fact that they are "not part of ourcore business at this point," explained Bill O'Donnell, SandozPharmaceuticals' associate director of communications.
The human MAbs target cytomegalovirus (CMV), hepatitis Bvirus, herpes simplex virus and varicella zoster. Sandoz hasalready conducted Phase I/II clinical trials on two of thoseHfortreating CMV and hepatitis B.
In U.S.-based Phase I/II trials on liver transplant patients withend-stage chronic active hepatitis, the anti-hepatitis B antibodyproved effective in the long-term elimination of viral infectionin three of the five patients, explained Paul Nadler, PDL's vicepresident of medical and regulatory affairs. The second U.S.clinical study on this antibodyHto inhibit viral replication ininfected patients who don't require liver transplantsHis inPhase I trials, Nadler said.
Sandoz conducted two Phase I trials on the anti-CMV antibody,which binds to the virus' gH glycoprotein antigen. In Europeanand U.S. trials on bone marrow transplant recipients, theantibody was safe and well tolerated. It also exhibited a longserum half-life of 2-3 weeks, Nadler told BioWorld. And inPhase I/II trials in the U.S. on AIDS patients with CMV retinitis(an infection that can lead to blindness), there is preliminaryevidence that the antibody can retard retinitis progression.Other ongoing trials on the anti-CMV antibody are in newbornswith congenital CMV and in AIDS patients with CMV excretion.
PDL expects to take the anti-CMV antibody into Phase II/IIIsfor treating CMV retinitis in late 1993 or early 1994; and theanti-hepatitis B antibody into Phase II/IIIs in 1994.
While PDL makes its humanized antibodies by using computermodeling and genetic engineering to combine the binding siteof a mouse antibody with a binding-site-less human antibody,Sandoz derives its fully human antibodies from triomasHafusion of human splenocytes or peripheral blood lymphocyteswith a human-mouse hybridoma. The B cells for the anti-hepatitis B antibody, for instance, came from the blood of anindividual who had been vaccinated against the virus. Whenthese cells were fused with Sandoz's patented hybridoma cellline, the result was an anti-hepatitis B antibody-producingtrioma.Importantly, "none of the approximately 100 patients treatedso far with Sandoz's human MAbs have developed an immuneresponse to them," Nadler told BioWorld. Some of those patientshave received antibody every three weeks for up to two years.
Cary Queen, PDL's vice president of research, added that "PDLwill continue to produce human-like Smart antibodies whenhuman monoclonal antibodies cannot be made. We also hope tocombine the human antibody technology acquired from Sandozwith genetic technology currently under development at PDL tobroaden the range of targets against which fully humanantibodies can be produced."
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.