Cardiome Pharma Corp. announced that its affiliate has signed an exclusive license agreement with an affiliate of Allergan plc that will result in the Cardiome Group (Cardiome) commercialising Xydalba (Dalbavancin) in France, the UK, Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada.
Cardiome will provide Allergan with a staggered upfront payment totalling US$ 13 million and will provide Allergan additional milestone payments and royalties based upon commercial achievements and sales of Xydalba. Additional terms of the agreement were not disclosed.
Xydalba was approved by the European Medicines Agency (EMA) in February 2015 as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults and by the US Food and Drug Administration (FDA) in May 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA. Dalbavancin is commercialised under the trade name Dalvance in the US and Xydalba in certain countries outside the US.
“Our license of Xydalba is a transformational moment for Cardiome,” said William Hunter, M.D., president and CEO of Cardiome. “Over the past three years we have restructured and redirected Cardiome to become a differentiated specialty pharmaceutical company focused on commercializing proprietary growth pharmaceuticals in Europe and Canada. Xydalba will fit perfectly within our current commercial footprint alongside Brinavess, Aggrastat and Esmocard. Licensing a product of this profile is a strong signal of our progress and we look forward to working with Allergan to bring this compelling medicine to patients in need across our territories.”
Xydalba is approved for sale in the following territories licensed by Cardiome: the UK, Germany, France, Denmark, Iceland, Finland, Malta, Norway, Sweden, Belgium, Netherlands, Luxemburg, and Ireland. Xydalba is not yet approved in other countries for which Cardiome has licensed rights in including Canada and Switzerland. Cardiome expects to initiate commercial sales of Xydalba in its territories as early as 2016.
Xydalba is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. Xydalba is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes, and a single dose regimen of 1500 mg also administered over 30 minutes. Xydalba demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
There were more than 4.8 million hospital admissions of adults with ABSSSI from 2005 through 2011, which included patients with cellulitis, erysipelas, wound infection and major cutaneous abscess. In fact, hospital admissions for ABSSSI significantly increased by 17.3 percent during this timeframe. The majority of all skin and soft tissue infections in hospitalized patients are caused by streptococci and Staphylococcus aureus, and approximately 59 percent of these S. aureus infections in the US are estimated to be caused by MRSA. Early and effective treatment of ABSSSI is critical to optimize patient recovery and for certain patients may also help to avoid potentially lengthy and costly hospital stays.