LIDAK PHARMACEUTICALS DEVELOPING LIDAKOL TOPICAL FOR HERPES, and other inflammatory skin diseases. The La Jolla, California-based development stage pharmaceutical company's first product would compete with Burroughs Wellcome's Zovirax (acyclovir). The completion of Lidakol preclinicals and the start-up of human clinicals could be accomplished in six months to a year, Lidak said in a Dec. 28 filing with the Securities and Exchange Commission. Initially, Lidak will seek approval for the patented long-chain alcohol as a treatment for both oral and genital herpes. Later, the firm will pursue other indications, "including eczema and psoriasis, wound healing and therapeutic use (i.e. burn) injuries," the company says. Once the drug is in clinicals, the company plans to seek a licensing or distribution partner to market the product in Europe and other international markets. In the U.S., however, Lidak said it anticipates entering a "joint venture or similar arrangement" with one or more large pharmaceutical firms to complete testing and regulatory approval. The start-up's other major project is the development of a technology that places a functioning human immune system in severely immunocompromised mice. Lidak sees the technology initially as an alternative to human testing of human viruses, particularly diseases affecting the immune system, like AIDS. The Human Immune System-Reconstituted Severe Combined Immunodeficiency (SCID) Mouse Technology has to date been picked by Searle, Repligen and the University of Rochester as a screening method for compounds in development. Lidak will test AIDS therapeutics for Searle and another type of potential human AIDS therapeutic for Repligen, the filing states. The Rochester contract is to screen certain compounds for infectious diseases in infants. Lidak's system would compete other SCID mouse technologies, including one developed by the one year-old Palo Alto-based firm, Systemix. The SEC filing details a plan for an initial public offering of 1 mil. units of Lidak Pharmaceuticals, consisting of 5 mil. shares of Class A common stock and 5 mil. redeemable Class A warrants. D. H. Blair is underwriting the offering, which has an anticipated price of $5 per unit. Of the net proceeds, $1.26 mil. would be directed at R&D and testing. The filing has not yet been completed. Lidak licenses the hu-PBL-SCID technology from Medical Biology Institute (MBI), a nonprofit biomedical research organization established by Lidak Chairman and CEO David Katz, MD. Katz founded Lidak in late 1988 as a vehicle for developing and commercializing research efforts at MBI. Katz was also a founder of the San Diego-based privately-held biotech firm, Quidel, in 1981. Other executives at Lidak include President Fred Espinosa -- as a biotech start-up consultant -- and VP and Chief Scientific Officer Darcy Wilson, PhD, as a research pathologist.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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