The total agreement Meda will cease paying royalties on sales of Acnatac, Aldara and Zyclara
Zyclara (imiquimod 3.75%) has been tested in seven clinical trials in more than 1,400 patients.
Meda acquired the exclusive European rights to Zyclara, a new formulation of imiquimod, from US-based Graceway Pharmaceuticals LLC in May 2010.
In conjunction with the agreement related to Actavis' generic version of Zyclara, it may launch its generic product on 1 January 2019, or earlier under certain circumstances.
Zyclara is a prescription medicine for skin use only to treat actinic keratosis on the full face or balding scalp in adults with a normal immune function.
M2 EQUITYBITES-August 27, 2012-Meda announces approval of Zyclara in EU(C)2012 M2 COMMUNICATIONS http://www.m2.com
Speciality pharmaceutical company Meda AB (STO:MEDAA.ST) announced today that the European Commission (EC) has granted marketing authorisation for Zyclara in the European Union.
M2 PHARMA-August 27, 2012-Meda announces approval of Zyclara
in EU(C)2012 M2 COMMUNICATIONS
M2 PHARMA-July 19, 2011-FDA okays Zyclara Cream 2.5% for actinic keratoses treatment(C)2011 M2 COMMUNICATIONS
19 July 2011 - US-based Graceway Pharmaceuticals LLC announced yesterday that the US Food and Drug Administration (FDA) has approved Zyclara Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK).
M2 EQUITYBITES-June 23, 2011-MEDA files marketing authorisation for Zyclara
in Europe(C)2011 M2 COMMUNICATIONS http://www.m2.com
29 March 2010 - US Graceway Pharmaceuticals LLC said on Friday that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zyclara
, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK).