Elan and Emisphere in joint venture for oral heparin; Elan hires ex-FDAer as compliance chief.

ELAN/EMISPHERE TECHNOLOGIES JOINT VENTURE FOR ORAL HEPARIN/HEPARINOIDS will combine Elan's drug delivery and Emisphere's membrane absorption technologies under a letter-of-intent stage agreement. The alliance would focus on development of oral heparin and heparinoid products, anticoagulants that now are administered intravenously. The joint venture, announced Oct. 18, will seek pharmaceutical partners interested in developing oral formulations of the anticoagulant products, using Emisphere's CADDSYS and PODDS transmembrane technologies and Elan's broad drug delivery technologies to develop the final formulations more rapidly.

Elan will make an up-front payment of $7.5 mil. in the joint venture and will make an equity investment through the purchase of 600,000 Emisphere shares at a price of $12.50 per share, which is a premium to the stock's trading range of 8-5/8 to 9-11/16 in the 12 days before the announcement. Athlone, Ireland-based Elan also will acquire five-year warrants to purchase 250,000 shares of Hawthorne, N.Y.-based Emisphere stock. Elan has an early-call option on the warrants under certain conditions, the companies noted.

Outside regulatory compliance consultants have conducted a further audit of the company's Athlone manufacturing facility and have certified that the plant meets current Good Manufacturing Practice standards, Elan reported. Following a review of the company's responses to a July 12 FDA warning letter, Elan said FDA has scheduled a reinspection of the plant.

The warning letter remarked that FDA has conducted four inspections of the Athlone plant in the last two years and repeatedly found "significant deviations" from cGMPs. FDA suggested bringing in outside consultants and also recommended that the company evaluate the facility on a "global basis for cGMP compliance" ("The Pink Sheet" Aug. 14, T&G-16).

After the last Athlone inspection, FDA inspected Elan's Gainesville, Ga. plant and the company received another warning letter Sept. 25 concerning manufacturing and related procedures. Elan subsequently met with FDA officials in the Atlanta district office and "addressed fully the matter raised," Elan said, adding that it is now finalizing its response to the Georgia warning letter.

Elan announced that ex-FDAer Ronald Kartzinel, MD/PhD, has joined the firm as worldwide head of regulatory compliance. Kartzinel was a division director at FDA for six years and subsequently held senior positions in the drug industry, including VP-development at Ciba-Geigy.