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Fisons licensing agreements include deal for Ciba's iralukast; RPR closing in on takeover.

Executive Summary

FISONS AND CIBA TO COLLABORATE ON IRALUKAST DEVELOPMENT FOR ASTHMA, Fisons announced Sept. 29. Under the agreement, the companies will collaborate on development and marketing of Ciba's leukotriene d4 antagonist iralukast in a powder formulation for delivery via Fisons' Ultrahaler delivery system. "The arrangements between the parties contemplate and provide for the possibility of further cooperation in relation to follow-up compounds, devices and alternative delivery systems," Fisons added. Iralukast will begin Phase III trials in 1996, Ciba said; the Swiss firm plans to introduce a formulation using its own single-dose dry powder device before completing development of the Ultrahaler formulation.

FISONS AND CIBA TO COLLABORATE ON IRALUKAST DEVELOPMENT FOR ASTHMA, Fisons announced Sept. 29. Under the agreement, the companies will collaborate on development and marketing of Ciba's leukotriene d4 antagonist iralukast in a powder formulation for delivery via Fisons' Ultrahaler delivery system. "The arrangements between the parties contemplate and provide for the possibility of further cooperation in relation to follow-up compounds, devices and alternative delivery systems," Fisons added. Iralukast will begin Phase III trials in 1996, Ciba said; the Swiss firm plans to introduce a formulation using its own single-dose dry powder device before completing development of the Ultrahaler formulation.

Fisons announced two other agreements Sept. 29: a copromotion deal with 3M for its Airomir HFA aerosol brands in several European markets and an R&D agreement with the biotech firm Magainin. The flurry of agreements came as Rhone-Poulenc Rorer stepped up the pressure in its bid for a hostile takeover of the company.

The agreement with Magainin involves the Plymouth Meeting, Penn. firm's MSI-843, which is in research as an inhalation product for treatment of pseudomonas infections in cystic fibrosis patients. The agreement in principle between the two firms is subject to completion of a final agreement by Nov. 15. Fisons will pay a nonrefundable $2 mil. licensing fee up front; a portion of the fee was paid upon signing of the agreement in principle, Magainin said.

Under the agreement, Fisons will pay 100% of the preclinical and clinical testing costs for MSI-843 through Phase IIa of development. Fisons estimated those costs at approximately $2.4 mil. Fisons and Magainin will split Phase IIb and Phase III costs evenly and will share profits from any sales of the drug equally. Magainin has held a pre-IND meeting with FDA and plans to file an IND in mid-1996, the firm said.

The announcement of the agreements appeared designed to coincide with the deadline for Rhone-Poulenc Rorer to increase its bid for Fisons. Fisons pointed out, however, that at least one of the deals was in negotiation before RPR made its offer in August: "The negotiations that led to [the iralukast] agreement started in 1994."

On Oct. 5, RPR increased its offer for Fisons from 240 pence per share ($2.7 bil.) to 265 pence per share ($2.9 bil.). Fisons again rejected the offer as undervaluing the company.

The final offer, under U.K. takeover rules, cannot be increased. Rhone-Poulenc Rorer launched its takeover bid in August, maintaining that Fisons cannot successfully pursue its strategy of focusing on in-licensing of asthma and respiratory products ("The Pink Sheet" Aug. 21, p. 5). RPR was reported to have purchased 15% of Fisons on the open market at the increased rate. The final offer closes Oct. 20.

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