Schering Deutschland GmbH

euro adhoc: Schering AG
Mergers - Acquisitions - Takeovers
Bayer offer remains unchanged despite voluntary Ultravist® Injection 370 mgI/ml recall and insufficient results of clinical Phase III trial with sargramostim (n.o.v.e.l. 4) Executive Board o

@@start.t1@@--------------------------------------------------------------------------------   Disclosure announcement transmitted by euro adhoc.   The issuer is responsible for the content of this announcement. --------------------------------------------------------------------------------@@end@@

31.07.2006

Schering AG, Germany is voluntarily recalling its X-ray contrast agent Ultravist Injection 370 mgI/mL (iopromide injection) due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of Ultravist (150 mgI/ml, 240 mgI/ml, 300mgI/ml). Production of Ultravist 370 mgI/ml in China and Korea is not affected, and domestic supply in these two countries will continue. In Japan, only Proscope® 370 mgI/ml, in Spain, also Clarograf® 370 mgI/ml is affected.

Schering is undertaking this recall of Ultravist 370 mgI/ml due to the possible presence of particulate matter in conjunction with crystallization in consideration of the potential for thromboembolic safety problems if the product is administered to patients.

Schering AG further announced today results observed in two recently completed placebo-controlled, randomized, double-blind clinical studies of sargramostim for the treatment of Crohn's disease. Results from the Phase III induction trial (n.o.v.e.l. 4) suggested a treatment benefit but failed to demonstrate superiority in the two primary endpoints of response and/or remission at eight weeks compared to placebo. However, primary and secondary endpoints were met in the n.o.v.e.l. 2 study. This Phase II trial demonstrated that sargramostim was significantly more effective than placebo for induction of corticosteroid-free clinical remission in steroid-dependent Crohn’s disease patients.

Schering AG is conducting an in-depth analysis of the data and will be in contact with regulatory agencies to discuss any potential adjustments to the development program in order to make sargramostim available for Crohn’s disease patients.

The Executive Board of Schering AG cannot exclude that both informations will slightly depress the company’s value. On the current information basis it was not possible to evaluate and quantify negative impacts resulting from sargramostim clinical trials results. With respect to the recall of Ultravist 370 mgI/ml KPMG Deutsche Treuhand-Gesellschaft Aktiengesellschaft Wirtschaftsprüfungsgesellschaft, who was instructed parallel to the evaluation process at Schering, came in a first indicative assessment to the conclusion that the recall may have a negative impact on the company’s value in the amount of EUR 0.74 per Schering share. In connection with the planned domination and profit and loss transfer agreement between Bayer subsidiary Dritte BV GmbH and Schering AG jointly instructed appraiser KPMG had informed the Executive Board of Schering AG on July 26, 2006 that the value per Schering share amounted to EUR 87.63 (equivalent to a total value of Schering AG of EUR 16.723 billion). The valuation was based on the principles of the Standard S1 of the Institute of Chartered Accountants for the implementation of company valuations (IDW S1). On the basis of the KPMG valuation Bayer AG had offered to Schering AG to agree on a compensation payment of EUR 89.00 and a guaranteed dividend in the amount of EUR 3.62 (net) per share under the domination and profit and loss transfer agreement.

The Executive Board of Bayer AG informed Schering AG today that this offer remains unchanged despite the recall of Ultravist 370 mgI/ml and the sargramostim clinical trial results. Executive Board of Schering has decided to accept the Bayer offer and, subject to approval of the Schering Supervisory Board, to enter into the domination and profit and loss transfer agreement.

Legal Instruction

After the proposed offer of cash compensation by Dritte BV GmbH, a wholly owned subsidiary of Bayer Aktiengesellschaft, in connection with the planned domination and profit and loss transfer agreement between Dritte BV GmbH and Schering Aktiengesellschaft is made available to Schering Aktiengesellschaft shareholders, Schering Aktiengesellschaft will file with the U.S. Securities and Exchange Commission a solicitation/recommendation statement on Schedule 14D-9 with respect to the offer of cash compensation. Holders of ordinary shares and American depositary shares of Schering Aktiengesellschaft are advised to read such solicitation/recommendation statement when it becomes available because it will contain important information. Holders of ordinary shares and American depositary shares of Schering Aktiengesellschaft will be able to obtain such solicitation/recommendation statement and other filed documents when they become available free of charge at the U.S. Securities and Exchange Commission's website (http://www.sec.gov) and at Schering Aktiengesellschaft's website (http://www.schering.de).

@@start.t2@@end of announcement                                                 euro adhoc 31.07.2006 13:05:25
--------------------------------------------------------------------------------@@end@@

ots Originaltext: Schering Deutschland GmbH
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:
Oliver Renner
Leiter Corporate Business Communication
Tel.:  +49 (0)30 468 12431
Fax: +49 (0)30 468 16646
E-Mail: oliver.renner@schering.de

Branche: Pharmaceuticals
ISIN:      DE0007172009
WKN:        717200
Index:    DAX, CDAX, HDAX, Prime All Share
Börsen:  Baden-Württembergische Wertpapierbörse / regulated dealing
              Niedersächsische Börse zu Hannover / regulated dealing
              New York / ADR
              Frankfurter Wertpapierbörse / official dealing/prime standard
              Börse Berlin-Bremen / official dealing
              Hamburger Wertpapierbörse / official dealing
              Börse Düsseldorf / official dealing
              Bayerische Börse / official dealing



Weitere Meldungen: Schering Deutschland GmbH

Das könnte Sie auch interessieren: