Failure of denufosol at Phase III means firm will now focus on ophthalmology franchise.
Inspire Pharmaceuticals is canning its late-stage cystic fibrosis candidate denufosol tetrasodium due to disappointing Phase III trial results, which were reported in January. The firm will now have to cut 27% of its workforce as part of a restructuring program it hopes will save $40 million in 2011. The restructuring will see 65 jobs axed, primarily in R&D, manufacturing and technology, and administration. Some $30 million of the total costs saved during the year will relate to reductions in R&D spending.
Denufosol was Inspire’s only clinical-stage candidate outside of its core field of ophthalmic drugs. The firm will now focus on its eyecare franchise, through which it receives revenues from sales of Azasite® (azithromycin ophthalmic solution) 1%, an antibiotic for the treatment of bacterial conjunctivitis. Inspire also co-markets Elestat® (epinastine HCl ophthalmic solution) 0.05%, which is indicated for the prevention of ocular itching associated with allergic conjunctivitis.
The firm’s clinical pipeline includes ProlacriaTM (diquafosol tetrasodium ophthalmic solution) 2%, which is in Phase III development for dry eye syndrome. Development of Prolacria is currently on hold, and Inspire instead receives revenues from Allergan relating to sales of the latter’s marketed cyclosporin-based dry-eye treatment, Restasis™. Under terms of the firms’ agreement, which was amended in August 2010, Inspire now has unilateral control over any future Prolacria development and commercialization. If it decides to resume clinical development of the drug and achieves regulatory approval in a particular country, it can either offer Allergan Prolacria commercializaiton rights to that territory, or commercialize the drug there itself and stop receiving revenues from net sales of Restasis in the same country.
Inspire is separately carrying out Phase II studies evaluating Azasite for the treatment of blepharitis. The firm also has an ongoing Phase I-stage glaucoma program that includes two candidates: a rho kinase inhibitor INS117548 and a latrunculin B compound INS115644.
In December Inspire confirmed that its partner Santen Pharmaceutical received Japanese pricing approval for a diquafosol tetrasodium dry-eye product, DIQUASTM Ophthalmic Solution 3%. Japanese launch of the drug by Santen triggered a $1.25 million milestone payment to Inspire. Santen has rights to develop and commercialize diquafosol tetrasodium for the treatment of ocular surface diseases, such as dry-eye disease, in Japan and nine other Asian countries. The drug is currently undergoing Phase III testing by Santen in China.
Inspire separately reported its Q4 and full-year 2010 financial results today. The firm recorded a net loss of $4.3 million during Q4 2010, compared with a net loss of $2.6 million in Q4 2009. Net loss for 2010 was $35.4 million, compared with a $40 million deficit in 2009.
The firm’s total revenues for Q4 2010 were up just $0.6 million, at $30.3 million. Revenues for sales of Azasite were $13.2 million in Q4 2010, up 9% on the equivalent 2009 quarter. Product co-promotion and royalty revenues, including royalties from net sales of Restasis, and co-promotion revenues from net sales of Elestat, were $15.9 million in Q4 2010, down from $17.5 million.
Full-year Azasite revenues were $42.7 million in 2010, up 22% compared with 2009. Co-promotion and royalty revenues for 2010 were $62.5 million, up $5.3 million on 2009.