›The biotech company recently turned down an offer by a Johnson & Johnson unit.
By Shiri Habib 8-Aug-2008
Sources inform ''Globes'' that Omrix Biopharmaceuticals Ltd. (Nasdaq: OMRI ) has received a buyout offer from a US hedge fund for $25 per share, amounting to $430 million, in a deal that would take Omrix private. Omrix closed at $22.13 on Friday, giving a market cap of $378.8 million. The offer represents a 14% premium on the company's market cap.
The company had no comment on the report.
Omrix's share has risen 57% in recent months on reports that something interesting was going on there, as well as the company's quite strong financial report for the second quarter, published last week.
The sources added that, a few months ago, Omrix received an acquisition offer from Johnson & Johnson (NYSE: JNJ) unit Ethicon Inc., with which Omrix has a distribution agreement. Omrix turned the offer down because it felt that the offer was too low. Omrix president and CEO Robert Taub is now examining the offer from the US hedge fund, and he will reportedly send it to Ethicon to give it an opportunity to make a better offer of its own.
Omrix had claimed in the past that Ethicon was not making a strong enough effort in marketing the company's biosurgical sealants and other products. However, the company's appear to have settled their differences and their relationship is as good as ever.
Omrix will have to make a share buyback offer in order to sell the company to a private company and delist from Nasdaq.[I do not understand what this means.] Omrix's holdings are quite dispersed. Taub owns 9.4% of the company and, together with four other private parties, owns 17%. The public and institutional investors own the rest, including 7% by Adage Capital Partners GP LLC, 5.6% by Oberweis Asset Management Inc., and 4.4% by Orbimed Advisors LLC.
US and European sales of Omrix's flagship product, the Evicel fibrin sealant, are growing. The market is now waiting for the company's next two products, which could greatly boost sales if and when they are approved in the coming years: Adhexil for the prevention of post-surgical infections in tissue, especially gynecological procedures; and a fibrin pad for the prevention of bleeding during surgery. The results of the Phase II trial for the fibrin pad are due in late 2008 or early 2009, and it should reach market by late 2010. The results of the Phase I/II trial for Adhexil are due in late 2009, and could lead to a strategic or distribution agreement.‹
Fibrin Pad Phase II (the 90 patients trial), achieving "superiority" to the control arm in the primary efficacy endpoint.
Omrix Biopharmaceuticals Announces Interim Analysis Indicating Superiority of Fibrin Pad Versus SURGICEL in Mild to Moderate Bleeding In U.S. Phase II Clinical Trial And Provides Update On Additional Fibrin Pad Clinical Trials
NEW YORK--(BUSINESS WIRE)--Omrix Biopharmaceuticals, Inc. (“Omrix”) (NASDAQ: OMRI - News), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today interim results from its U.S. Phase II clinical trial evaluating the safety and hemostatic effectiveness of the Company’s Fibrin Pad product candidate as an adjunct to control mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. The Company also provided an update on additional Fibrin Pad clinical trials, including the Phase II study being conducted in Israel in severe bleeding.
Interim Analysis From U.S. Phase II Clinical Trial in Mild to Moderate Bleeding
The prospective, randomized, and controlled study is comparing the Fibrin Pad to SURGICEL and is designed to show superiority. Interim analysis at 90 patients, which were randomized 2:1 Fibrin Pad to SURGICEL, indicated that the Fibrin Pad was superior to SURGICEL in the primary efficacy endpoint, which measured the proportion of subjects achieving hemostatic success at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. Hemostasis is defined as no detectable bleeding at the target bleeding site (TBS).
In accordance with the clinical protocol, since the study hypothesis test for superiority has been established, randomization has been stopped and additional non-randomized patients are currently being enrolled and treated with the Fibrin Pad. Enrollment in the Fibrin Pad arm will continue until a minimum of 100 subjects are enrolled. Clinical data regarding the Fibrin Pad’s safety profile will be collected for all patients and includes a 1 month follow-up as outlined in the clinical trial protocol. The Company expects to complete enrollment of the additional 40 patients required to be treated with the Fibrin Pad by the end of 2008 or early 2009.
Update On Israeli Phase II Clinical Trial in Severe Bleeding
The Company also provided an update on the Israeli Phase II exploratory clinical trial, which is being conducted outside of a U.S. Investigational New Drug (IND) application. The clinical trial, which commenced enrollment in early July 2008, is a randomized, controlled clinical study to evaluate the safety and efficacy of the Fibrin Pad in severe bleeding when the product is applied primarily on the bleeding site. The control arm consists of standard of care, defined as suture, cautery, ligature or passive hemostats.
To date, seven patients have been enrolled in the study, of which four have been treated with the Fibrin Pad. Of the four patients treated with the Fibrin Pad, one patient experienced post-operative bleeding, which was considered a serious adverse event (SAE).
Additional Fibrin Pad Clinical Trials
Lastly, the Company submitted a clinical trial application, or CTA, in the United Kingdom to conduct a pivotal study to evaluate the safety and efficacy of the Fibrin Pad in soft tissue severe bleeding when the product is applied adjunctively to the standard of care. The CTA is currently under review by The Medicines and Healthcare products Regulatory Agency, or MHRA. To date, the Company has received no comments regarding the clinical sections of the application. Omrix expects the CTA to be approved by the end of 2008 or early 2009 and will commence the study shortly thereafter.
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