Nabi Sells Biologics Business To German Plasma Protein Firm Biotest
This article was originally published in The Pink Sheet Daily
Executive Summary
Nabi met with FDA Sept. 11 concerning components and a timeline for completion of its Nabi-HB IV BLA, pending at the agency since 2002.
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Nabi Biopharmaceuticals will continue as a pharmaceutical development company after it divests Nabi Biologics, a business unit it formed in June, to Biotest AG for $185 million, Nabi interim President and CEO Leslie Hudson told analysts during a Sept. 11 call to announce the sale. Dreieich, Germany-based Biotest has agreed to buy the biologics business in an all-cash deal expected to close in the fourth quarter. Included in the agreement is Nabi-HB Intravenous (hepatitis B immune globulin [human]), pending at FDA since 2002 for the prevention of recurrence of hepatitis B after a liver transplant in HBV-positive transplant patients. Nabi has said it was compiling additional data the agency requested to support the BLA for the polyclonal antibody product; Nabi-HB received a positive opinion from the Blood Products Advisory Committee in July 2006 (1 (Also see "Nabi-HB Decision Anticipated “Shortly” Following FDA Advisory Committee Review" - Pink Sheet, 14 Jul, 2006.)). Also under the agreement, Biotest picks up Nabi's plasma protein production plant and nine FDA-certified plasma collection centers in the U.S., as well as the company's Boca Raton, Florida, headquarters and other facilities and assets. Nabi Biologics and certain other Nabi shared services employees "will have the prospect of a promising future with Biotest," according to Nabi. Nabi is continuing with efforts to partner both its anti-smoking vaccine NicVAX (nicotine conjugate vaccine) and StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine). Nabi reported positive Phase IIb results for the smoking vaccine in May (2 (Also see "Nabi Reports Positive Phase IIb Results For Anti-Smoking Vaccine NicVAX" - Pink Sheet, 3 May, 2007.)). During the call, Hudson noted that final results of the trial would be reported at the American Heart Association Scientific Sessions in Orlando, Florida, Nov. 7. As part of their agreement, Nabi will grant Biotest a right of first refusal on a license for StaphVAX and StaphVAX components "to be able to produce a StaphVAX-enabled product," Hudson said during the call. Nabi put development of StaphVAX on hold pending a partnering agreement after the vaccine failed a confirmatory Phase III trial in kidney dialysis patients. An external review of the trial data revealed promise for a second-generation product, but Nabi lacked funding for the program (3 (Also see "Nabi’s StaphVAX Development Back On Track" - Pink Sheet, 22 Mar, 2006.)). Nabi is moving its headquarters from Florida into its Rockville, Md., facility with "about 60-65 people" it has retained in its Nabi Pharmaceuticals unit, Hudson said. The firm entered into a strategic alternatives process when Hudson took the helm in February after pressure from activist shareholder Daniel Loeb, CEO of New York-based hedge fund Third Point, forced the resignation of CEO Thomas H. McLain. In June, Nabi announced it had isolated the biologics business and in the process eliminated 32 jobs, or about 5 percent of its workforce. "It was clear to me that there were two businesses here that had become hopelessly intermingled," Hudson said. "The plasma business is actually a viable business in its own right, and our people and ... the business will do very well ... in Biotest's hands." Third Point also was instrumental in the reorganization of Fremont, Calif.-based PDL BioPharma, announced last month (4 (Also see "PDL BioPharma Plans To Divest Assets, Emerge As Pure Play Biotech" - Pink Sheet, 29 Aug, 2007.)). -Shirley Haley ([email protected]) |