Two months after submitting a new drug application for its lead oral antibiotic, Orapem, Replidyne Inc. signed a U.S. commercialization deal with Forest Laboratories Holdings Ltd.

Terms call for Replidyne to receive an up-front payment of $50 million, plus undisclosed milestone payments tied to development and commercial achievements. The company also stands to receive royalties on product sales, pending FDA approval of Orapem (faropenem medoxomil) in acute bacterial sinusitis, community-acquired pneumonia, acute exacerbations of chronic bronchitis and uncomplicated skin infections, said Kenneth Collins, president and CEO of Louisville, Colo.-based Replidyne.

"Forest has demonstrated a proven ability to launch products in the primary care market," he said, adding that, while New York-based Forest will take the lead on sales and marketing of Orapem, Replidyne will "co-promote the adult product to [ear, nose and throat doctors] and infectious disease docs."

The companies will share in the development and regulatory approval of the drug in the initial indications, as well as future programs, including a pediatric formulation.

"We’ll have an option to promote that to pediatricians when it’s approved," Collins told BioWorld Today.

The pediatric version is in a Phase II study for otitis media.

Orapem is an ester prodrug derivative of faropenem, a beta-lactam antibiotic designed to provide improved oral bioavailability and higher systemic concentrations. If approved, the drug would be the first oral penem in the U.S.

Replidyne submitted its NDA in December, based on 11 Phase III studies and safety data from more than 5,000 patients. (See BioWorld Today, Jan. 10, 2006.)

The company expects an update later this month on the status of the NDA, Collins said.

In 2004, Replidyne gained exclusive rights to develop and commercialize Orapem in the U.S. and Canada from Tokyo-based Daiichi Asubio Pharma Co. Ltd., and also retained an exclusive option for rights in the rest of the world, except for Japan.

At this time, Replidyne’s focus is on the U.S., but Collins said the company "would expect, eventually, to get a partner or partners for Europe and other parts of the world."

Beyond Orapem, Replidyne has an early stage pipeline of other anti-infectives, including REP8839, a topical antibacterial product for treating skin infections and methicillin-resistant Staphylococcus aureus infections. An investigational new drug application for that product is expected later this year.

REP8839 was selected as the lead compound from a tRNA synthetase program licensed in 2003 from London-based GlaxoSmithKline plc.

The company also has discovery programs focused on inhibiting bacterial DNA replication to treat bacteria that have become resistant to existing antibiotics.

Founded in 2000, Replidyne has raised $121.5 million in private financing. Recently, it completed a $62.5 million Series D round in one of the largest private rounds of the biotech industry in 2005. (See BioWorld Today, Sept. 9, 2005.)