Acino's position on the CHMP-recommendation on Glochem-Clopidogrel
The EMA-Committee CHMP recommends the precautionary recall of certain clopidogrel-containing medicines, for which the active ingredient was manufactured at Glochem Industries, due to GMP-failings.
In contrast, the responsible inspectors, who audited the manufacturing site of Glochem Industries, explicitly stated that there is no necessity for a recall recommendation.
No quality deficiencies relating to clopidogrel-products from Acino were recorded; therefore medicines already in the hands of patients can be used as prescribed.
Acino possesses alternative active ingredient sources and will start deliveries again shortly.
Basle, March 25, 2010, 19.00 hrs - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) published today, as a precautionary measure, a recall recommendation for certain Acino clopidogrel generics (original product: Plavix® / Iscover® by Sanofi-Aventis / Bristol-Myers Squibb). The recommendation is limited to product packs, which are in the supply chain starting at the level of pharmacists, for which the active substance was manufactured by Glochem Industries Ltd. and which are marketed based on a central authorization in the name of Acino Pharma GmbH.
GMP-failings at Glochem - no quality deficiencies of Acino products
The CMPH recommendation was preceded by a regulatory inspection of one of the production sites of the Indian active ingredient supplier on behalf of the European Medicines Agency (EMA). This inspection observed deviations from GMP (Good Manufacturing Practice) standards; however, it detected no deficiencies of product quality. Based on a comprehensive risk assessment and analysis of the active ingredient, the inspecting authorities explicitly stated that a recall of the delivered batches is not considered to be necessary. Since the GMP-failings found at the manufacturing site do not represent a health hazard, medicine already in the hands of patients can continue to be used.
Acino and its marketing partners consider recall inadequate
Patient safety comes first for Acino. Additional quality controls by Acino confirmed the impeccable quality of the clopidogrel-containing medicines from Acino. For this reason, Acino and its marketing partners follow the conclusion of the inspecting authorities and Acino Holding Ltd. Erlenstrasse 1 CH-4058 Basle
consider a withdrawal of the clopidogrel products in question neither necessary nor purposeful. Clopidogrel from Acino is launched to date in 18 countries by marketing partners. Owing to existing alternative suppliers of active ingredient, Acino expects to restore delivery readiness shortly.
Impact on the financial result of Acino
Acino's outlook for 2010 is, barring unforeseen events, cautiously optimistic. Should individual country authorities, which are free in their decision, request a recall of the clopidogrel products concerned based on the CHMP or EU commission decision, the temporary supply shortage and the possible write-down of existing and returned goods could result in a negative extraordinary item in the current financial year. This would in all likelihood have a significant negative impact on the annual result 2010.
Acino - a focused pharma group
Acino specializes in the development, registration and manufacture of generic and innovative pharmaceuticals using advanced drug delivery technologies, for which it also holds patents. With a focus on solid oral do-sage forms with modified release of the active ingredient, transdermal therapeutic patches and biodegradable, subcutaneous implants, Acino supplies leading pharmaceutical companies throughout Europe. Acino offers the pharmaceutical industry a comprehensive range of services from product development and registration to sourcing, contract manufacturing, packaging and logistics. The Acino Group is headquartered in Basle (Switzerland), currently employs approximately 420 staff and generated annual revenues of about CHF 240 million in 2009. Acino Holding Ltd., the Group's parent, is listed on the SIX Swiss Exchange (SIX: ACIN).
Contact Calendar
Luzi Andreas von Bidder
Chairman of the Board
Phone +41 61 338 60 00
[email protected]
www.acino-pharma.com 30.3.10 General Meeting of Shareholders
6.5.10 Quarterly Figures as of 30.3.10
29.7.10 Half-year Report as of 30.6.10
28.10.10 Nine-month Figures as of 30.9.10
3.3.11 Annual Report 2010