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US FDA approval of RAPLIXA(TM) (fibrin sealant)

1st May 2015 10:17

RNS Number : 0033M
Vectura Group plc
01 May 2015
 

 

 

Vectura Group plc

 

US FDA approval of RAPLIXA™ (fibrin sealant)

 

 

Chippenham, UK - 1 May 2015:Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), confirms the information released today by The Medicines Company (NASDAQ:MDCO) announcing that the U.S. Food and Drug Administration (FDA) has approved RAPLIXA™ (fibrin sealant) and the RaplixaSpray™ device to provide adjunctive haemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.

The approval triggers a milestone payment to Vectura as part-of the consideration related to the acquisition by The Medicines Company of ProFibrix B.V. in 2013. The final amount of the milestone payment will be determined under the shareholder agreement. In addition, Vectura will potentially receive payments based on certain sales milestones in the US and Europe, plus a single digit royalty on sales of RAPLIXA™.

The patents licensed by Vectura to Profibrix B.V. in relation to Raplixa™ (previously known as FibrocapsTM) were acquired by Vectura as part of its acquisition of Innovata plc.

 

 

-Ends-

Enquiries

 

Vectura Group plc

+44 (0)1249 667700

Andrew Oakley, Chief Financial Officer

 

Karl Keegan, Chief Corporate Development Officer

 

 

 

Citigate Dewe Rogerson

+44 (0)20 7638 9571

David Dible / Malcolm Robertson

 

 

 

 

About RAPLIXA™ (fibrin sealant)

RAPLIXA is a fibrin sealant comprised of human-plasma derived fibrinogen and thrombin that is indicated to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.

 

About The Medicines Company

The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.

 

 

About Vectura

Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases (airways diseases). This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth $44 billion worldwide.

 

Vectura now has eight products marketed by partners with growing global royalty streams and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura currently has disclosed development collaborations and licence agreements with several global pharmaceutical and biotechnology companies, including Novartis, Sandoz, Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols, Janssen Biotech and Tianjin KingYork Group Company.

 

Vectura develops products for airways diseases and owns formulation and inhalation technologies that are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura's business strategy.

 

For further information, please visit Vectura's website at www.vectura.com.

 

 

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

 

 

 

[1] Decision Resources 2014

This information is provided by RNS
The company news service from the London Stock Exchange
 
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