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June 13 – June 19th

June 13th: Given Imaging's RAPID(R) Access RT Device and Software Receives US Marketing Clearance

Given Imaging Ltd today announced that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for RAPID® Access RT, a handheld device that enables real-time viewing during a PillCam endoscopy procedure and RAPID® Access, the software installed on the device. RAPID Access also allows physicians to remotely initialize a DataRecorder to administer the Company's PillCam® video capsules to patients at satellite sites. Data can then be sent to a central location for processing and interpretation.

Several physicians in Europe were selected as beta-sites to test RAPID Access. According to Professor Guido Costamagna, Head of the Division of Digestive Endoscopy, Gemelli Hospital of the Catholic University, Rome, “Real-time viewing will improve physician reading times for esophageal procedures and validate the completion of small bowel procedures”.

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract.

June 14th: Merck Offers Bayer Its Stake in Schering

Germany, Bayer AG is to acquire all the shares of Schering held by Merck. In the course of joint talks, Bayer and Merck have agreed on the need to end the uncertainty regarding the Berlin Company’s future to avoid damaging. Merck has therefore decided to sell its 21.8 percent (according to SEC) stake to Bayer, thereby clearing the way for Bayer's acquisition of Schering. The purchase price is EUR 89 per share.

All other Schering stockholders who have tendered their shares under the public takeover offer, or who decide to do so before the acceptance period expires at midnight CEST on Wednesday, will benefit from this price, which is EUR 3 above the original offer.

"We're very pleased about Merck's decision, because a lengthy competitive bidding process would have greatly affected Schering's future," said Bayer Management Board Chairman Werner Wenning. "All three companies concerned will benefit from this step. We are very optimistic that we can now secure at least the three-quarters of Schering's capital stock that we were aiming for, enabling us to quickly begin the integration process. Today we have taken a major step toward creating a world-class German pharmaceutical company."

The future company "Bayer Schering Pharma" will strengthen Germany's role as a pharmaceutical industry location. This is in the interests of the entire sector. Bayer andMerck therefore agreed during their talks to look into further possible opportunities for cooperation between the two companies.

Bayer will withdraw the suit filed against Merck in New York on Tuesday.

June 19th: Exactech Announces FDA Clearance for U.S. Distribution of InterSpace(TM) Shoulder Pre-formed Antibiotic Bone Cement Spacer

Exactech, Inc, a developer and producer of bone and joint restoration products including Orthopaedic implants and biologic materials, announced today that the U.S. Food and Drug Administration (FDA) has cleared for distribution the only pre-formed cement shoulder spacer containing antibiotic available in the United States.

The InterSpace(TM) Shoulder is a major advancement in treating patients suffering from the complication of infected total shoulder arthroplasty. Like the InterSpace Hip and InterSpace Knee, which Exactech introduced in 2004, the InterSpace Shoulder provides for consistent and uniform antibiotic release into the local infected area, confers mechanical advantages by maintaining the joint space, and offers patients mobility during the interval of spacer management and the opportunity for improved function following the definitive second-stage operation.
InterSpace is manufactured by Tecres S.p.A., Verona, Italy and distributed in the U.S. exclusively by Exactech.

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