North American Vaccine Inc. has agreed to pay $25 million toCephalon Inc. for a Maryland manufacturing plant it used to produceclinical trial supplies of Myotrophin, the Lou Gehrig's disease drugdeveloped in collaboration with Chiron Corp.
Officials of Cephalon, of West Chester, Pa., said the decision to sellthe Beltsville, Md., facility followed completion of Chiron'sVacaville, Calif., plant, which will produce commercial quantities ofMyotrophin for treatment of amyotrophic lateral sclerosis, also calledLou Gehrig's disease.
Cephalon and Chiron have not filed a new drug application (NDA)with the FDA for the recombinant insulin-like growth factor, but theagency in June approved the companies' treatment investigationalnew drug application, allowing distribution of Myotrophin to patientsoutside those treated in clinical trials.
"As soon as possible" is how Cephalon spokesman Jason Rubinresponded to a question about when the Myotrophin NDA would besubmitted. Chiron and Cephalon had said they planned to file theNDA in the third quarter of this year. Two Phase III studies arecompleted.
In purchasing Cephalon's manufacturing plant, North AmericanVaccine, of Beltsville, will pay cash and assume lease obligations.The companies did not disclose the cash portion of the $25 millionsale price. Cephalon paid $14 million in 1992 to acquire the plant.
Cephalon and North American Vaccine said Friday they signed adefinitive sales agreement and a final closing is expected soon. Thedeal also is subject to review by the Federal Trade Commission.
Sharon Mates, North American Vaccine's president, said hercompany now has two production plants across the street from eachother. The newly acquired facility will manufacture vaccines, such asthose for meningitis and pneumonia, which are in clinicaldevelopment. The company makes an acellular pertussis componentfor combination with inoculations against diphtheria and tetanus inthe other plant.
North American Vaccine's diphtheria, tetanus and acellular pertussisvaccine is approved in Denmark and Sweden. It is scheduled forreview by an FDA advisory panel later this month.
Larry Kurtz, spokesman for Chiron, said the Vacaville plant, located50 miles north of the company's headquarters, is fully operationaland has produced qualifying lots of Myotrophin for the NDAsubmission. He also noted the FDA has inspected the plant for theagency's licensing review.
In addition to Myotrophin, the other major product manufactured atChiron's Vacaville plant is platelet-derived growth factor, a wound-healing product in late-stage development for diabetic ulcers incollaboration with Johnson & Johnson, of New Brunswick, N.J.
Chiron's stock (NASDAQ:CHIR) closed Friday at $19.062, anincrease of $0.187. Cephalon (NASDAQ:CEPH) ended the day up$0.437 to $24.062 North American Vaccine (AMEX:NVX) finisheddown $0.25 at $25. n
-- Charles Craig
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