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Brief Marketplace Overview

1Q, 2005

Significant landscape transition intrinsic to the forthcoming dynamics of the Age-Related Macular Degeneration (AMD) marketplace has occurred with FDA fast track approval of Macugen for wet AMD in December, 2004.  This marketed competitive threat to Visudyne requires intraocular injection repeated at 6 week intervals, with Phase III results advocating acceptable efficacy.  Development continues for Diabetic Macular Edema, for which Macugen was granted fast track status, and for Retinal Vascular Occlusion.  Macugen’s MAA was accepted by the EMEA September, 2004, and NDS priority review has been granted for the Canada market.  Positioning will include Phase II/III comparative data deficiency minimization, focusing upon the diversity of efficacy in multiple AMD subtypes, rather than relative performance as compared to Visudyne. 

Miravent's photosensitizer Rostaporfin is currently in Preregistration, designed for use in conjunction with PhotoPoint photodynamic therapy, a low power, non-thermal light produced by a solid-state diode laser, manufactured by Iridex Corporation in partnering with Miravent for compound development.  Previous licensing agreements with Pharmacia & Upjohn and subsequently Bausch & Lomb have been abandoned with rights returning to Miravent.  After granting fast track review status, the FDA issued an approvable letter in September, 2004, requesting additional clinical trial data.  The Photopoint PMA was submitted simultaneously with the March, 2004 NDA.  Following expedited review, marketing authorization is subject to the outcome of Rostaporfin approval as part of a combination drug and device product.  

Genaera’s Squalamine, a parenterally administered angiogenesis inhibitor continues in late Phase development.  Retaane, Alcon’s angiogenesis inhibitor administered by posterior juxtascleral injection, has advanced in Preregistration with a recently completed rolling NDA submission.  Comparative efficacy issues exist as compared to Visudyne for both compounds. 

Additional AMD pipeline compounds and technologies in early Phase development include VEGF Trap, Panzem, Talaporfin Sodium, AG 13958, Combrestatin A4, AdPEDF, Endovion, Sirna 027, Cand 5, BDM E, Therasight, Celebrex, and A 6.  Various marketplace partnering and acquisition opportunities remain available.

Phase III Diabetic Retinopathy trials for Lilly/Takeda’s Ruboxistaurin, a protein kinase C beta inhibitor, are ongoing, following positive Phase II results.  Additional data indicates the potential for Diabetic Macular Edema intervention, to be supported by currently initiating Phase III trials.  Development in the Japan market continues. 

ISTA is evaluating Vitrase, their marketed hyaluronidase compound, for nonproliferative Diabetic Retinopathy intervention.  Preliminary Phase IIa results obtained in a Mexico City trial suggested acceptable efficacy.

Ono’s aldose reductase inhibitor Epalrestat yielded positive results in a long-term proliferative and nonproliferative Diabetic Retinopathy trial.  Further development priority appears at issue with regard to the Ono portfolio, as well as hepatic toxicity associated with the compound.

BIM 23190, currently in Phase II EU development , is a selective somatostatin analogue, inhibiting growth hormone as well as insulin growth factor-1.  Biomeasure and Ipsen are partnering in development, based upon an agreement signed in July 2003. 

Additional compounds in preclinical development for Diabetic Retinopathy include Dexlipotam, AdPEDF, Cand5, and BDM E.  Vitamin E and ACE Inhibitors may have a role in Diabetic Retinopathy prevention.

Inspire/Allergan/Santen’s Diquafosol, a P2Y2 receptor agonist is currently in Preregistration in the US, and early development in the Asia and EU markets for Dry Eye.  It has been portrayed as a chemically stable, long term usage formulation, without the need for refrigeration.  The FDA, following fast track review, in a December, 2003 approvable letter, requested additional clinical data.  Continuation of a Phase IIIb study was insufficient in meeting the FDA’s demands.  An additional Phase III trial was newly enrolling as of June, 2004 to close in 1Q, 2005.  Additional findings will be reviewed by the FDA and regulatory decision rendered 2H, 2005.

Allergan’s suit against the FDA, in attempting antibiotic declassification for Restasis, was dismissed January 21, 2005, thereby thwarting their attempt to obtain 3 years of marketing exclusivity.  The compound is portrayed as difficult to reformulate, with minimization of the effect of the decision upon sales.

Alcon’s eicosanoid Icomucret, asserting efficacy through mucin secretion stimulation and thickening of the corneal mucin layer, is currently in late Phase development in the US  and the EU.  Otsuka America continues in Phase III with rebamipide Dry Eye development.  Tacrolimus remains in Phase II by Sucampo/Fujisawa, cevimeline in early Phase development by Daiichi, as is Duramycin by Lantibio, Ecabet by ISTA/Senju in Japan, UNIL 88 in Switzerland by Debiopharm, and Gefarnate in Japan by Santen.
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