CHEMEX PHASE I CLINICALS FOR AMLEXANOX, SPECTINOMYCIN to start "immediately," the firm said in a recent second quarter sales and earnings release. Licensed from Takeda, amlexanox (CHX-3673) will be studied for psoriasis and dermatitis. Spectinomycin will be studied for acne. The compound (CHX-3101) is licensed from Upjohn. Chemex will fund the studies with $ 2.25 mil. in proceeds from a recent private placement of common stock and warrants ("The Pink Sheet" July 31, "In Brief"). The firm noted that funds from the private placement, in conjunction with $ 2.4 mil. received from a rights offering to shareholders in April, "will enable us to immediately commence clinical studies on amlexanox and spectinomycin. These are our number one and two priorities behind Actinex." Clinical development also will be supported by a recently announced public offering of 1.2 mil. units of stock and warrants. The offering by Denver-based Chemex is intended to raise $ 9.6-$ 12 mil. The price of the units, each consisting of two shares of common stock and one common stock purchase warrant, is expected to be $ 8 to $ 10 per unit. In an Aug. 23 filing with the Securities and Exchange Commission, Chemex said that "the net proceeds of this offering will be used to pay approximately $ 500,000 of existing current indebtedness." Proceeds will also go toward "future research and development activities including funding the continuing development and commercialization of therapies for actinic keratoses . . . such as Actinex, ]for[ psoriasis, . . . acne, warts, reversal of photoaging and dermatitis." Chemex devoted the majority of its internal R&D efforts in the first half of 1989 to Actinex. "Because the company received less than anticipated funding in 1988," the filing explains, "the company limited budget expenditures in 1989 to approximately $ 415,000 per month and revised the 1989 budget to focus narrowly on Actinex in an effort to realize revenue as soon as possible." R&D expenses during the period, totaling $ 2.2 mil., include costs incurred by the NDA and the initiation of supplemental clinical trials on the compound. The additional studies are small-scale trials initiated in response to FDA requests for data and are ongoing, the firm said. Chemex filed an NDA for the topical treatment in December 1988. The firm is developing a topical antiviral, cytarabine, for the treatment of common and genital warts and expects to file an IND for the compound (CHX-331) by the end of 1990. The drug is also licensed from Upjohn. In the first half of the year, Chemex acquired a patent from Cooper Life Sciences for a "method which may be effective in retarding aging of the skin in humans," the filing states. In addition, Chemex recently acquired from Senju Pharmaceuticals of Osaka, Japan a license for dermatological applications of an anti-inflammatory product designated CHX-3107. The firm will investigate the drug for "prevention and/or reversal of sun-induced skin aging, psoriasis and other inflammatory skin conditions." Proceeds from the offering may additionally be used for the acquisition of "technologies, products or one or more businesses" involving the diagnosis or treatment of skin disorders, the filing notes. Chemex is considering branching out into OTC dermatologicals. The firm "has recently made a preliminary inquiry concerning one company which is developing nonprescription skin care products," the filing states. Chemex had a net loss of $ 3.8 mil. in the first six months of 1989 (ended June 30) and an $ 8.3 mil. deficit for 1988. The firm is "actively pursuing additional short-and-long term financing sources, such as debt or equity offerings, product licensing arrangements and corporate partnership alliances," the filing says. "However, if Chemex is "unable to complete its financing efforts," the filing points out, "the company may be required to curtail its activities significantly and may be unable to continue as a going concern."
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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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