Covalent scores deal from new biotech firm
conduct a global Phase 2 clinical trial of a new antithrombotic
agent in the US, Europe, and South America.
A company spokesperson told www.Outsourcing-Pharma.com that the sponsor of the trial is a privately owned US biotechnology company and a new client of Covalent, however no further details were disclosed.
The Phase 2 trial, expected to begin immediately, will assess the efficacy and safety of the new antithrombotic agent in patients at risk of cardiovascular disease and is expected to last 1.5-2 years.
Over 13 million people in the US suffer from thrombotic diseases, including myocardial infarction, stroke, peripheral arterial occlusive disease and pulmonary embolism, each year.
Each year thrombotic diseases cause over 1 million deaths and a health care cost of over $100 bn.
Anticoagulants, a market worth over $6 bn per year, are the first line of therapy, however, the use of anticoagulants is also associated with a high risk of serious or dose limiting hemorrhage, and in the case of heparin, heparin-induced-thrombocytopenia and thrombosis syndrome.
Thus the development of a new antithrombotic agent with a lower risk of hemorrhage is highly sought after and may have blockbuster potential.
>Covalent, who has already received an upfront payment, will provide services including consulting on trial design and protocol development, project and study site management, field operations, data management, biostatistical support, and medical writing.
"If this trial is successful, it is anticipated that additional clinical research trials will be conducted by the sponsor and that Covalent will be well positioned to participate in this potentially large development program," Kenneth Borow, Covalent Group's president and CEO said.
In addition to the Phase 2 contract, Covalent also announced today that it has signed several other new contracts to provide services in the areas of cardiovascular disease, nephrology, vaccines, and ophthalmology, worth a total of $1 m.
The contracts are for consulting services as well as changes-of-scope for existing business and are expected to last 12 months.
