BioWorld International Correspondent

The FDA recent approval of Shire plc's once-daily oral ulcerative colitis treatment Lialda (mesalamine) will provide Cosmo Pharmaceuticals SpA with a dual revenue stream, through royalties and production of the drug on behalf of Shire.

More importantly, however, CEO Mario Ajani told BioWorld International that the approval also validates the company's Multi Matrix (MMX) drug delivery technology, on which its own drug pipeline is based.

Specialty pharma firm Cosmo, located in Lainate, near Milan, Italy, had originally developed and out-licensed Lialda to Milan-based Giuliani SpA, which in turn out-licensed non-Italian rights to Basingstoke, UK-based Shire.

The product is a member of the aminosalicylate drug class, but offers a more convenient dosing regimen over existing formulations, which have to be administered three or four times per day. The MMX technology is designed to maximize delivery of drugs to the colon by controlling the rate of release of the drug from a matrix of hydrophobic and hydrophilic polymers.

Cosmo was founded in 1996 following the purchase of a contract manufacturing unit belonging to Parke Davis (now part of New York-based Pfizer Inc.), and developed the MMX technology internally. It now has five development projects based on that platform, all of which, apart from Lialda, are unpartnered. "We want to go it alone in the U.S.," Ajani said.

After Lialda, the next most advanced project involves Rifamycin SV MMX, a semi-synthetic rifamycin derivative currently undergoing a Phase II/III clinical trial in traveler's diarrhea. "We are now concluding the Phase II/III study. The results should be available in the next couple of months," said Chief Scientific Officer Luigi Moro.

The formulation of the antibiotic targets the large intestine and is designed to minimize any effects on the normal flora of the upper gastro-intestinal tract. "We believe our product has advantages over existing products because it is only released in the colon and it does protect a whole series of processes in the ileum," said Cosmo Chief Financial Officer Chris Tanner.

In countries where rifamycin antibiotics are approved, such as Greece, Spain, Portugal and Italy, the company aims to gain approval on the basis of the Phase II/III data, he said, but it will need to conduct additional trials before it can gain approval in other territories.

The company is about to commence two separate Phase III clinical trials, in the U.S. and Europe of Budesonide MMX, an anti-inflammatory corticosteroid in development for ulcerative colitis. It is designed to have lower side effects compared to other versions of the same compound because less is absorbed systemically through the gut wall, Moro said. "We want to complete the studies by the end of 2008," he added.

The company aims to start building its own sales force in 2009, Tanner said, with a sole focus on gastrointestinal disease. Its other pipeline projects include a low-molecular-weight version of heparin, in development for treatment of ulcerative colitis, and two preclinical proprietary compounds, an anti-TNF-alpha therapy and an androgen antagonist. The company also launched a dietary supplement for treating gastrointestinal disorders, Zacol, in Italy in 2005.