The Nordic Group Acquires Rights to Trasylol® From Bayer HealthCare

The Nordic Group Acquires Rights to Trasylol® From Bayer HealthCare

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The Nordic Group Acquires Rights to Trasylol® From Bayer HealthCare PR Newswire HOOFDDORP, Netherlands, July 13, 2012 HOOFDDORP, Netherlands, July 13, 2012 /PRNewswire/ -- Nordic Group announced today that it has reached an agreement with Bayer HealthCare in which Nordic will acquire Trasylol® (aprotinin

Publié par

nordic-group-bv

Langue

English

The Nordic Group Acquires Rights to Trasylol®

From Bayer HealthCare

PR Newswire

HOOFDDORP, Netherlands, July 13, 2012

HOOFDDORP,

Netherlands

,

July 13, 2012

/PRNewswire/ --

Nordic Group announced today that it has reached an agreement with Bayer

HealthCare in which Nordic will acquire Trasylol® (aprotinin injection)

worldwide excluding

the United States

. Under this agreement, Nordic will

become the Marketing Authorization Holder for aprotinin in the relevant

Territories. This follows the opinion of the Committee for Medicinal Products for

Human Use (CHMP) of the European Medicines Agency (EMA) from

February

2012

, recommending that the marketing authorisation for aprotinin should be

reinstated in the European Union. The recommendation took into account a full

review of the benefits and risks of all antifibrinolytic medicines, which found

that the results of the study on which the suspension of aprotinin was based

were unreliable. This positive opinion is expected to be ratified by the

European Commission later in 2012. Nordic will be managing global supplies of

aprotinin in the relevant Territories.

About Aprotinin

The CHMP has recommended lifting the suspension for aprotinin in the

following indication:

Aprotinin is indicated for prophylactic use to reduce blood loss and blood

transfusion in adult patients who are at high risk of major blood loss undergoing

isolated cardiopulmonary bypass graft surgery (i.e., coronary artery bypass

graft surgery that is not combined with other cardiovascular surgery). Aprotinin

should only be used after careful consideration of the benefits and risks, and

the consideration that alternative treatments are available. Since 2007 both

Nordic (which was already marketing an aprotinin product) and Bayer have

maintained compassionate limited access programmes in some 16 countries. In

September 2011

, the marketing authorisation for aprotinin was reinstated in

Canada

.

About Nordic Group BV

The Nordic Group is a privately owned, fast growing, fully integrated, pan-

European pharmaceutical company, with a strong focus on the development

and commercialization of niche hospital and orphan products and services that

cater to the specific needs of clients and patients. In addition to its sales and

marketing companies in 14 European countries, operating under the name of

Nordic Pharma and Nordic Drugs, the Nordic Group operates as well a number

of specialized Pharmaceutical Services companies, specialized in product

development, manufacturing, supply logistics, clinical studies and regulatory

activities. These companies are operating under the name of Prague Clinical

Services, QPharma, Disphar and Indeus. Since its creation, Nordic has enjoyed

an average growth of 20% in revenues, and it pursues its expansion through

organic growth and strategic collaborations. Additional information can be

obtained by visiting Nordic Group's website at

http://www.nordicpharmagroup.com.

Contacts at Nordic

Hans Schram, CEO, info@nordicpharma.com

Stéphane Altaba, Corporate Business Development Director,

busdev@nordicpharma.com , +33(0)1-53-63-88-77