Omrix, a Johnson & Johnson unit, obtains FDA approval for fibrin sealant

Johnson & Johnson (NYSE: JNJ) unit Omrix Biopharmaceuticals Ltd. has obtained US Food and Drug Administration (FDA) approval for its fibrin human sealant patch, one of Omrix's most interest products and the reason why Johnson and Johnson acquired it for $438 million in 2007.

The product, now called Evarrest, is based on Omrix's biological sealant for stopping problematic bleeding during surgery. "Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons, and in some surgical procedures can raise the patient's mortality rate to 20%," says Ethicon Biosurgery (the J&J division which includes Omrix) in its press release.

Omrix's biological sealant is currently used to stop bleeding during surgery or from wounds, but the Evarrest patch Evarrest is easier to use. To stop bleeding, the surgeon places the sealant over the wound and manually compresses it in place for three minutes. The sealant becomes part of the body, gradually degrading over several days or weeks.

The sealant is based on the production of clotting substances in human blood plasma. Ethicon Biosurgery says, "Clinical studies demonstrate that Evarrest is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard of care at 53%, potentially minimizing disruption to the surgical procedure."

The FDA approval is good news for Johnson & Johnson and for Israel's life sciences industry, and the company will produce Evarrest in Israel, at least over the next few years.

Johnson & Johnson unit Ethicon Inc., which is responsible for hemostasis and sealing solutions to which Omrix belongs, is also considering other options for producing Evarrest and other products later on. It is in talks with Swiss's Octapharma AG, founded by Omrix founder Robert Taub, for this purpose. Omrix was a spin-off of Octapharma, a producer of human plasma products.

In 2009, the State of Israel sued Omrix's founders and Johnson & Johnson for not paying royalties on the acquisition of the intellectual property of the inventor of Omrix's products, a doctor at Sheba Medical Center Tel Hashomer. Omrix and Johnson & Johnson say Omrix was responsible for most of the invention, or that which it received it from Octapharma. The case is still pending, and while it has not yet affected Ormix's thriving operations in Israel to date, it may affect them in the future.

Surgical sealant co Lifebond raises $20m

Published by Globes [online], Israel business news - Biological surgical sealant developer Lifebond Ltd. has raised $20 million.Giza Venture Capital and Aurum Ventures MKI Ltd., the venture capital arm of Morris Kahn, led the round, and were joined by current investors Pitango Venture Capital, GlenRock Israel, Zitelman Group Inc., and Robert Taub, the founder and CEO of Omrix Pharmaceuticals, which he sold to Johnson & Johnson (NYSE: JNJ) for $425 million in 2008.
Lifebond co-founder and CEO Issay Attar told "Globes", "When the current investors are excited about a company, it's a lot easier to hold another financing round."
Lifebond was named one of Israel's most promising start-ups for 2010 by "Globes".
Lifebond's flagship product is a surgical sealant for tissue after surgery to shorten the bowel. The product is undergoing a Phase I clinical trial in Brazil, and is due to begin a larger trial in Europe later this year.
"Globes": The clinical trial you're planning costs less than $20 million.
Attar: "It's always a good idea to raise a lot of money in the life sciences, if possible. This amount will be enough for us to complete an US Food and Drug Administration (FDA) trial, which we'll conduct after the European trial.
"I believe that an investment of this size by Israeli venture capital funds at this stage was made possible because the company achieved good clinical results in the Brazilian trial, and because the difference between animals and people for a product like this is not great. Therefore, the risk-reward profile is attractive."
As for raising capital only from Israeli funds, Attar said, "We also spoke with foreign funds, but it's easier to talk with someone in your own language, and we gave them preference. Obviously, foreign funds have advantages and I hope to work with them later."
Lifebond is also developing the LifePatch, a biological hemostats to stop bleeding, and a product for hernias, both of which are just beginning clinical trials.

Animal Products

Following on from the Bleeding Calf Syndrome posting available HERE and other postings available Here regarding risks of animal sourced products.

I have provided further info above provided by DEFRA. To the best of my knowledge only the UK and Scotland are acting to investigate?

You can follow this link for further details also 'This intriguing disease captures the imagination. The VLA will be working with others to help discover the cause.'

I expect manufacturers will focus efforts on recombinant, plant-based technologies.

While our industry battles achieving financial success in the market with the ideal of creating an agent that is:

• of minimized risk
• efficaious
• cost effective,
• easily deliverable
• and applicable to multiple surgeries

The removal of King Pharmaceuticals crown as leader in the multi- $million Thrombin market by Zymogenetics is

a sure indicator as to market preference and acceptance of these benefits. J&J have a human sourced Thrombin following theirpurchase of Omrix.

Certainly reconstituted animal based technologies are facing severe threats currently as the link between zoonotic diseases (animal/human transfer) become more widely known. While BNP (Bleeding Calf Syndrome) transmission is far from clear it should be of concern. The lack of reporting and individual Government action highlight the inadequacies of public protection even with a cursory investigation.

While Bleeding Calf Syndrome may not pose infection risks via medical devices it exemplifies the public vulnerabilities to weak protection measures from their Governments. This is weak response and is exactly the response delivered that saw vCJD, and Prion borne infections escalate. Harvesting Bovine Materials HERE

J 'n J Q3 - Edited

Ethicon worldwide sales grew operationally by 9.4% with US up 18% and sales outside the US up 3.8% operationally. The acquisitions of Mentor and Omrix partially offset by the divestiture of the professional wound care business added approximately 3.5 points to the worldwide operational growth. Sales for our newly acquired aesthetics products for Mentor were in line with 2008. On a worldwide basis double digit operational growth was achieved in biosurgicals and meshes.
Johnson & Johnson leads the industry in developing and next generation of advanced hemostats to address the persistent clinical problems associated with bleeding in surgical settings. A truly unique example of convergence three Johnson & Johnson companies; Ethicon, [Senacore], and the recently acquired Omrix Biopharmaceuticals have been working together to develop one such hemostat that we call the Fibrin pad.
With our heman plasma based biologics embedded directly into proprietary matrix the fibrin pad has the potential to uniquely and effectively dress bleeding challenges that are currently unmet by traditional hemostats. It’s designed to combine the functions of mechanical sealing and biological hemostatis. Upon contact with blood the biodegradable device causes a clot to form rapidly and stop bleeding without any other action. A BLA for the fibron pad is targeted for submission by the end of 2009.

Omrix founder Taub in LifeBond $8m funding round

Biosurgical products developer LifeBond Ltd. has raised $8 million in its second financing round. Pitango Venture Capital and Robert Taub led the round. 

Taub founded Omrix Biopharmaceuticals Ltd. and led the company until it was sold to Johnson & Johnson (NYSE: JNJ) for $438 million in 2008. Following the sale, Taub said that he would seek new investment opportunities, and the investment in LifeBond is the first. 

About Lifebond.

LifeBond is developing a series of next-generation biosurgical products which incorporate a proprietary adhesive platform that mimics the biochemical cross-linking cascade of late stage blood coagulation.  The adhesive formulation forms a network similar to the fibrin network of blood clots but has demonstrated adhesive strength even greater than that of blood-derived fibrin sealants.  LifeBond’s technology functions through the rapid and biocompatible in situ cross-linking of structural proteins.  As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix.  The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.

FDA approves Evicel Fibrin surgical sealant

TheU.S. Food and Drug Administration (FDA) has approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgical procedures.

"Evicel provides an effective means to stop oozing from small vessels during vascular surgery when suturing, compression or other standard techniques are not effective or practical," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

This product is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances used to promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission in manufacturing, however, the potential risk for the transmission of blood-borne viruses cannot be totally eliminated.

In a pivotal study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique of applying pressure to a plastic covering (graft) placed over the open blood vessel. Eighty-three percent of those who received Evicel stopped bleeding within four minutes, compared with 39.7 percent in the control group.

Adverse events, such as anemia and graft site infection, were generally mild and occurred at about the same frequencies in the Evicel-treated group and the control group.

FDA originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery. Evicel is manufactured by OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel.

JnJ release Q1 results - edited

We completed our acquisition of Mentor Corporation at the end of January and we are moving full speed ahead on integration of Mentor and Omrix Biopharmaceuticals within our Ethicon Surgical business. We are making progress with the integration of health media and human performance institute as we advance our new wellness and prevention platform. This business is now being reported as part of the Consumer segments financial results. These and our other acquisitions like Dabao Cosmetics and SurgRX are adding important sales and growth opportunities to our business but I would remind you that this quarter and the years results will also reflect the divestiture of our professional wound care business which was sold in the fourth quarter of 2008. Ethicon worldwide sales grew operationally by 9.1% with the US up 18.8% and sales outside the US up 3.7% operationally. The acquisitions of Mentor and Omrix offset by the divestiture of the professional wound care business added approximately two points to the worldwide growth. Sales in the US on a pro-forma basis for our newly acquired aesthetics products from Mentor although lower then 2008 performed better then the estimated market. Strong double digit growth was achieved in meshes and bio-surgical.

Surgical sealant developer sues Omrix

Prof. Uri Martinovich has filed a NIS 3.43 million lawsuit with the Tel Aviv District Court against Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) and its president and CEO Robert Taub for allegedly deprived him of his patent rights to the biological sealant that the company produces. Martinovich is the director of the National Hemophilia Center at Sheba Medical Center Tel Hashomer.
In November, Johnson & Johnson (NYSE: JNJ) acquired Omrix for $438 million. On Friday, Antitrust Authority director general Ronit Kan approved the acquisition, under the Restrictive Trade Practices Law (5748-1988). Taub founded Omrix in 1994.
Martinovich claims that he developed the compound for the biological sealant, but was deprived of his patent rights. He also claims that he was not paid for his invention or for the thousands of hours he spent developing it over ten years. He claims that Omrix violated agreements under which it promised to pay him $1.4 million for the rights to the invention.
Martinovich claims that Omrix paid him only $750,000, but that it refused to pay the $650,000 balance or to give him agreed-upon stock options. He is demanding payment of the amounts he claims he is owed, and to be sold 20,000 shares at $6 per share.
Omrix and Taub have not yet filed a statement of response.
Omrix closed at $24.90 yesterday, giving a market cap of $426 million.
There have been several cases in Israel in recent years in which inventors sued companies for allegedly depriving them of their rights. Cases include collagen-based matrices developer ColBar LifeSceiences Ltd. (which was acquired by Johnson & Johnson unit Ortho-McNeil Pharmaceutical, Inc. in 2006) and miniature implants developer Remon Medical Technologies Ltd.

Israeli regulators approve Johnson & Johnson-Omrix deal

Healthcare company Johnson & Johnson said Thursday that it has received antitrust approval from the Israeli General Director of the Antitrust Authority for its proposed acquisition of Omrix Biopharmaceuticals Inc.
Last month, Johnson & Johnson agreed to buy Omrix, which develops and markets biosurgical and immunotherapy products, for about $438 million in a cash tender offer.
Under the deal, Johnson & Johnson commenced a tender offer to buy all outstanding shares of Omrix at $25 per share, which is expected to close by the end of December 2008.
The acquisition, which has the approval of the boards of directors of both companies, is expected to be breakeven to slightly dilutive to Johnson & Johnson's earnings per share in 2009.
Following the acquisition, New York-based Omrix will operate as a stand-alone entity reporting through Ethicon, Inc., a Johnson & Johnson company that provides suture, mesh, hemostats and other products for surgical procedures.

It's official: J&J to pay $438m for Omrix

Biological sealant maker Omrix Biopharmaceuticals today officially announced that Johnson & Johnson (NYSE: JNJ) will acquire the company for $438 million - $25 per share. Omrix rose 16.3% in early trading today to $24.60, giving a market cap of $421 million, after rising 30% on Friday, when reports of the acquisition first emerged.
Johnson & Johnson (JNJ) and Omrix Biopharmaceuticals (OMRI), a biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced a definitive agreement whereby Omrix will be acquired for approximately $438 million in a cash tender offer. Omrix is expected to operate as a stand-alone entity reporting through ETHICON, a J&J company and leading provider of suture, mesh, hemostats and other products for a wide range of surgical procedures.
The acquisition of Omrix would strengthen its presence in active, biologic-based hemostats and convergent products for various surgical applications. ETHICON currently has exclusive distribution rights in the U.S. and the European Union for EVITHROM(TM) Thrombin Topical (Human) and EVICEL(TM) Fibrin Sealant (Human), two active, biologic-based hemostats manufactured by Omrix. ETHICON and Omrix are also partnering on a Fibrin Pad product candidate, currently in Phase II clinical trials, as an adjunct to control mild to moderate soft tissue bleeding.
Terms
-J&J to purchase all outstanding shares through a tender for $25/share
- 18% premium over last close and ~51% over last months average trading price
- $358M total net of estimated cash on hand
Assuming this transaction closes in 2008, Johnson & Johnson is expected to incur an estimated one-time, after-tax charge of approximately $120 million reflecting the write-off of in-process research and development charges (IPR&D). The acquisition is expected to be breakeven to slightly dilutive to Johnson & Johnson’s earnings per share in 2009.
Omrix has taken a big hit this year dropping from their 52 week high of 38.18 to a low of just 8.99 after a disappointing update regarding their phase 2 fibrin coagulant patch. I think JnJ got a pretty good bargain here.

Omrix Q3

Robert Taub
Thank you, Asaf. As Asaf mentioned, this quarter was another record quarter for biosurgery product sales – $9.5 million. Evicel is continuing to be a strong performer. The number of total accounts continues to increase steadily, and in quarter three, end user sales by our partner, Ethicon, once again included a very significant amount of repeat business. By year-end, we believe that total sales of Evicel will be approximately the same as our competitor.
Additionally, as mentioned in a recent press release, we announced that the EMEA approved Evicel in Europe. Evicel is now licensed for marketing in 27 plus three countries – the 27 countries of the European Union plus another three in Europe, and Ethicon will begin to sell Evicel on a country-by-country basis as Quixil is gradually phased out.
Next, Evithrom, our human-based thrombin standalone product continues to experience moderate dollar sales growth in this market. In quarter three, the total number of accounts purchasing Evithrom, however, increased by 50%, with new customers comprising 52%. As you're probably aware, however, there is currently fierce price competition in the thrombin standalone market, and as we have predicted, the market is moving toward thrombin enhanced hemostats, and we are currently developing two such products.
I would now like to update you on our Fibrin Pad. As you may recall, we have two trials, one in the U.S. in mild-to-moderate bleeding and a second one in Israel in severe bleeding.
With respect to the U.S. trial, we completed enrollment of the 90 patients needed to conduct interim analysis. We were pleased to report that the analysis showed superiority of the Fibrin Pad over Surgicel. Having demonstrated superiority, we are now able to continue with open-label enrollment. The trial will continue to enroll patients only to the Fibrin Pad arm, and according to the study design, we are required to treat at least 100 total patients for safety, which means another additional 40 patients with the Fibrin Pad.
Shortly after we announced that we had achieved superiority we were informed that the U.S. Phase II study had been suspended after a patient had experienced postoperative bleeding. This patient was not among the first 90 enrolled, but part of the subsequent 40 already. Many of you have asked why the trial was suspended if rebleeding is an expected event in surgery and in this protocol. The reason is simple. The protocol is written so that if there is a case of postoperative bleeding the trial must be suspended and an investigation must be conducted. Therefore, the decision to suspend the trial was an administrative one.
A Data Safety Monitoring Board, or DSMB, conducts the investigation and then provides a recommendation on how the trial is to proceed or if it is to be modified or even discontinued. We have now reported that the DSMB concluded their investigation and recommended that the clinical trial resume without any modifications, which it did.
I want to clarify that the DSMB's role is not to determine the relationship between the adverse event and the product. We, however, conducted a thorough product investigation and concluded that there is no issue with the clinical material.
I would still like to emphasize that a trial continuation with no modification is the absolute best case outcome. Therefore, we remain on target to complete enrollment of the 130 patients by the end of '08 or early '09. Although we still expect to be within the window of prior timeline guidance, due to the two-week investigation we are now more comfortable with an early '09 time frame. Once we complete the two-month follow-up and finish analyzing the data, we expect to file the BLA with the FDA in the first half of '09 and then assuming a standard 10-month review, we expect the approval in the first half of 2010.
Now, regarding the severe bleeding indication, I am pleased to inform you that we now have the approval from the British MHRA on behalf of the European Union to conduct a study in soft tissue severe bleeding.
I draw your attention to the fact that the indication and protocol are quite similar to the mild-to-moderate study which is ongoing in the United States. This EU severe bleeding study will be a pivotal study leading to an indication for the use of the Fibrin Pad in severe bleeding in soft tissue surgery. This kind of bleeding is different from the target bleeding in the exploratory Phase II study which we started some time ago in Israel.
Indeed, the Israeli study was purposefully designed to be the most challenging as it addresses the control of severe bleeding when the product is applied directly onto the resected solid organ, such as a kidney, a prostate, a liver or highly vascularized organs, and these organs are not soft tissues.
As you know, we reported a postoperative bleeding event in the Israeli trial. We are conducting an investigation, and pending the conclusion of the investigation of the rebleeding case we have decided to discontinue enrollment of additional patients in that Israeli trial and are focusing on initiating the European trial. But you should understand that the clinical development plan of the Fibrin Pad is proceeding well with a mild-to-moderate study in the United States and a severe bleeding study which will be initiated in Europe in the first half of '09.
Let me give you some details on the European study design. As I mentioned, it is a pivotal clinical study evaluating the safety and efficacy of our Fibrin Pad in soft tissue severe bleeding in abdominal, pelvic, retroperitoneal and noncardiac thoracic surgery. The study is a randomized multicenter clinical study evaluating the superiority of Fibrin Pad versus the standard treatment in controlling challenging severe bleeding in soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.
Alright. Now, moving on to our passive immunotherapy business. Immunotherapy product and byproduct sales amounted to $10.1 million in the third quarter of 2008. And regarding our Phase III clinical trial in the United States for IVIG, the trial is proceeding according to expectations, and we are on track to file the BLA in the third quarter of 2009.
Erik Schneider – UBS
Okay. Great. Evithrom in the U.S., you previously said that it was – had higher sales than Zymo's Recothrom. Both are now in IMS. What is it – what's different about that channel that the IMS data show Evithrom with smaller dollars, but you're confident that they're actually larger?
Robert Taub
No, we don't know what ZymoGenetics sales are other than what we read in a press release from analysts or from their own public statement, so all I can say is that we definitely are way ahead of ZymoGenetics in terms of sales.
Erik Schneider – UBS
Okay. And what we've heard from them is that they're having trouble selling the product and in fact they're seeing pricing pressure in that market, particularly, with hospitals focused on saving money where they can. Have you seen anything like that with either Evithrom or that could be affecting Evicel going forward?
Robert Taub
No, I think that I mentioned in my script that there is a fierce price competition in the thrombin area, and I think ZymoGenetics itself is triggering that. So yes, there's tremendous competition in pricing currently ongoing, but we haven't seen anything in Evicel or in the (inaudible) area. So I don't think it's an overall statement here that has to be made about the Zymo stats in the United States, but rather a very specific thrombin related situation with Kings, ZymoGenetics, Ethicon and Omrix.
Source - seekingalpha

Falling apart over Omrix

When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment. It now turns out that while Omrix may not be of the all or nothing genre, it is a real madhouse for investors like me, who were looking for an oasis of tranquility in the biotechnology sector, a sector that has traditionally been fraught with risk.
Since the beginning of the year, Omrix has managed to issue a severe warning (in March) for the fourth quarter of 2007, plunge heavily, and replace its CFO a second time. At the beginning of this month, on the eve of Yom Kippur of all times, it issued an announcement in which it reported positive interim results in the important trial of its advanced surgical sealant, following which the share rose strongly, just as the collapse on the markets was moving into high gear. The news made the fast a bit easier to handle, but the joy was short-lived.
By the next day, Yom Kippur itself, Omrix had already updated investors with the announcement that it was halting the trial due to the occurrence of a critical fault, just a day after declaring it a success. Investors like me switched on their computers after Yom Kippur ended, only to find that the share had plummeted for the second time in six months. Later on in the month, Omrix tried to put the fiasco of the failed trial behind it with a reassuring announcement to investors about a strong third quarter. But Omrix's weary investors found little cause for cheer, and the share barely moved at all.
The denouement came last Friday when Omrix joyfully announced the resumption of the trial, as if nothing had happened at all. "We got it wrong, there was no fault," was what the announcement amounted to, and the company's share regained just a small part of the ground it lost on Yom Kippur. One can imagine how investors, who abandoned the stock on Yom Kippur after it crashed 40% following the announcement of the fault, felt last Friday when Omrix revealed it never actually happened.
The analysts covering Omrix are also finding that their patience is wearing thin. In its latest review, Citigroup describes the company's astounding u-turn as "one step forward, three steps back, one step forward." It assumes that the fault occurred for one of two reasons - either a technical failure due to human error, or bleeding in another place not treated by the sealant. Until such time as they receive further clarification, which will most likely be forthcoming on November 6, when Omrix unveils its results, Citigroup's analysts are retaining the lukewarm "Hold" recommendation they issued following the company's stiff warning in March, with a target price of just $15.
On top of all this, the Omrix roller coaster has been dogged by sporadic rumors that it could be sold for around $25 a share. The identity of the possible buyers regularly changes. Among those rumored to be in the frame are Ofer Group, Johnson & Johnson Inc. (NYSE: JNJ), Omrix's partner in the marketing and development of the aforementioned sealant and, according to "Globes", also European pharmaceutical giant Bayer AG (LSE: BYR; XETRA: BAY).

Source: Globes

Omrix Biopharmaceuticals Announces Patient Enrollment Will Resume In Fibrin Pad U.S. Phase II Clinical Trial In Mild to Moderate Bleeding

Omrix Biopharmaceuticals, Inc. ("Omrix”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that the Fibrin Pad U.S. Phase II clinical trial in mild to moderate bleeding will resume patient enrollment and continue with no modifications.
On October 9, 2008, the Company announced that the U.S. Phase II clinical trial had been suspended in order to investigate an incident of post-operative bleeding. This event met the stopping rules, as outlined in the clinical trial protocol.
Per the clinical trial protocol, upon the suspension of the study, a Data Safety Monitoring Board, or DSMB, reviewed the data related to the event. The DSMB has concluded their investigation and authorized the trial to recommence.
About the Fibrin Pad
The Fibrin Pad builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

Omrix Q3 revenue beats Wall Street view

Oct 20 (Reuters) - Biopharmaceutical company Omrix Biopharmaceuticals Inc reported a 35 percent rise in its third-quarter revenue, beating analysts' average estimate, and raised its full-year product sales outlook.
The company reported preliminary quarterly revenue of $21.3 million, compared with $15.8 million a year earlier. Analysts on average expect the company to post a revenue of $19.1 million, according to Reuters Estimates.
Omrix sees 2008 product sales of $70 million to $72 million, up from its prior forecast of $68 million to $71 million.
The company reaffirmed that it expects its biosurgery product sales in 2008 to increase about 75 percent from a year ago.
The company said its product sales guidance is partly based on the current biosurgery sales outlook provided by Ethicon Inc, a unit of Johnson & Johnson.
Ethicon has exclusive sales and marketing rights to Omrix's biosurgical products in the United States and the European Union.
Omrix shares closed at $14.48 on Friday on Nasdaq.

Omrix shares whipsaw on Evicel nod

Omrix Biopharmaceuticals Ltd. probably wants to forget last week, when its share fell 35% after the clinical trial of its fibrin pad was suspended because of safety problems. Subsequently, however, and without any new announcement about the trial, the share recovered half the loss. Omrix closed at $15 yesterday, giving a market cap of $256 million, up from its low point of $11.60 five days after the trial suspension was announced.
Yesterday's 3.4% rise in Omrix's share can be attributed to the company obtaining European Medicines Agency (EMEA) marketing approval for Evicel liquid fibrin sealant, the company's surgical sealant and the product of its kind in the US. Johnson & Johnson (NYSE: JNJ) Ethicon Inc., which markets Evicel in the US, will also market it in Europe.

Omrix Biopharmaceuticals Receives Approval from European Medicines Agency for Evicel Liquid Fibrin Sealant (Human)

NEW YORK - (Business Wire) OMRIX Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received approval from the European Medicines Agency (EMEA) for Evicel, the Company’s liquid fibrin sealant.
The EMEA’s approval permits EVICEL to be marketed in Europe under the following indication, “As a supportive treatment in surgery where standard surgical techniques are insufficient for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery.”
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a general hemostasis in surgery indication.
With an EMEA approval, EVICEL is licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix’ and ETHICON’s supply and distribution agreement, ETHICON has the marketing rights for the EU.

About EVICEL

EVICEL™ is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL™ is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing.

Postoperative Bleeding Halts Fibrin Pad Trial; Omrix Falls

Only a day after reporting positive interim results from a Phase II study of its Fibrin Pad product in mild to moderate bleeding, Omrix Biopharmaceuticals Inc. said the study has been suspended to investigate an incident of postoperative bleeding.

Shares of the New York-based firm (NASDAQ:OMRI) plunged 34.5 percent, losing $6.14 Thursday to close at $11.67.

Interim analysis from the U.S. Phase II study, conducted after 90 patients were randomized 2-to-1 to receive Omrix's Fibrin Pad or Surgicel (Johnson & Johnson), showed that the Fibrin Pad was superior to Surgicel in controlling mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic and thoracic surgery.

The trial was designed to measure the proportion of subjects achieving hemostatic success at four minutes after randomization without requiring additional treatment during a subsequent six-minute observation period.

The trial was to continue enrolling patients until at least 100 subjects had been treated with Fibrin Pad, and prior to announcing the trial suspension, Omrix said it had expected to complete that enrollment by the end of this year or early next year.

The company has not disclosed any details of the suspension at this time, and representatives of Omrix could not be reached for comment.

The Fibrin Pad is designed to use the company's aprotinin-free fibrin sealant technology, the same technology that helped create Evicel, a liquid fibrin sealant that gained FDA approval as an adjunct to hemostasis in patients undergoing surgery when control of bleeding by standard surgical technique is neither effective nor practical.

As a next-generation, absorbable biosurgical product, the Fibrin Pad comprises a flexible biodegradable matrix that's coated with human fibrinogen and human thrombin and is designed to help form instant clots for rapid control of bleeding and for possible use on active bleeding sites.

It was not clear from the company's release when the incident of postoperative bleeding occurred in the U.S. Phase II trial, though analyst Jonathan Aschoff, of Brean Murray Carret & Co., wrote in a research note that it occurred after the 90th patient was enrolled and, therefore, was not included in the interim analysis.

Omrix also reported data from a separate ongoing Phase II trial in Israel that is designed to test Fibrin Pad in severe bleeding when the product is applied primarily on the bleeding site. And in that study, four patients have been treated to date with Fibrin Pad, one of whom experienced postoperative bleeding.

"While the detailed reason for this serious adverse event is still under investigation, the fact that it occurred in two patients treated with the Fibrin Pad so far" raises questions as to the product's safety profile, Aschoff wrote, adding that there likely would be some delay in the program, for which he previously had projected a mid-2010 market launch.

Omrix also has submitted an application to UK regulatory authorities to begin a pivotal study of Fibrin Pad in soft tissue severe bleeding when applied adjunctively to the standard of care. That application is under review.

In addition to Evicel, Omrix markets Evithrom (topical human thrombin), a blood-clotting protein - using the same thrombin component as Evicel - for controlling bleeding during surgery. Evithrom gained approval in 2007 and is distributed by a division of Somerville, N.J.-based Ethicon Inc.

Outside of biosurgery, the company is developing several immunotherapy products, including intravenous immunoglobulin (IVIG) for immune deficiency and autoimmune diseases, as well as other antibody-based products targeting hepatitis B, West Nile virus and smallpox vaccine-related complications.

Omrix recorded total revenue of $19.2 million for the second quarter - $18.2 million of that came from product sales - and posted a net income of $3 million, or 17 cents per share. As of June 30, the firm had a cash position of $83.1 million.

Interim Phase II Data Establishes Superiority Of Omrix Biopharma's Blood-clot Inducing Fibrin Pad Over Johnson & Johnson's SURGICEL

Wednesday, Omrix Biopharmaceuticals Inc. announced that according to the interim results of a phase II trial, its investigational Fibrin Pad, a blood-clot inducing material proved to be superior to SURGICEL, developed by Johnson and Johnson's Ethicon subsidiary. The Fibrin Pad is being evaluated as an adjunct to control mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery.According to the interim analysis, 90 patients were randomized in the ratio of 2:1 to be treated with Fibrin Pad and SURGICEL, respectively. The primary efficacy end point 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.The company noted that since the superiority of Fibrin Pad has been established, randomization has been stopped and additional non-randomized patients are currently being enrolled and treated with Fibrin Pad. Enrollment in the Fibrin Pad arm will continue until a minimum of 100 subjects are enrolled, according to Omrix.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.In addition, the company said that till date seven patients have been enrolled in the Israeli Phase II exploratory clinical trial, which is being conducted outside of a U.S. Investigational New Drug application study. Four have been treated with the Fibrin Pad, of which one patient experienced post-operative bleeding, which was considered a serious adverse event.Omrix also revealed that it has 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. Omrix expects the CTA, which is currently under review to be approved by the end of 2008 or early 2009. The company plans to commence the study shortly thereafter.

European co expresses interest in biotech co Omrix

Among the possible candidates to acquire Omrix is German giant Bayer.
Sources inform that a European company is interested in acquiring Israeli biosurgical and immunotherapy products maker Omrix Biopharmaceuticals Ltd. , and that it is offering a substantial premium on the company's $320 million market cap. The company is reportedly conducting due diligence.
Among the possible candidates to acquire Omrix is German pharmaceuticals giant Bayer AG (XETRA; BAY; LSE: BYR). Bayer markets products of Omrix competitor ZymoGenetics Inc. (Nasdaq: ZGEN) and is a partner of Omri, a company owned by Omrix CEO Robert Taub, who owns 15.7% of Omrix.

Omrix Biopharmaceuticals Completes Enrollment of Initial 90 Patients Needed to Conduct Interim Analysis in Fibrin Pad U.S.

Omrix Biopharmaceuticals, Inc. ("Omrix") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has completed enrollment of the first 90 patients in its Phase II clinical trial for the Fibrin Pad in mild to moderate bleeding. The Company expects to release 90 patient interim efficacy analysis by the end of October 2008.
The Fibrin Pad is a breakthrough convergence product being developed by Omrix in collaboration with ETHICON, INC., a Johnson & Johnson company. The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Pad when compared to SURGICEL. The primary endpoint will measure time to hemostasis at four minutes after randomization and if any re-bleeding occurs during a subsequent six minute observation period. The first 90 patients were randomized 2 to 1 so that 60 patients have been treated with the Fibrin Pad and 30 patients have been treated with SURGICEL.
The interim efficacy analysis is being conducted to assess the superiority of the Fibrin Pad when compared to SURGICEL. If the interim analysis demonstrates superiority, the study will continue as an open label study and will enroll an additional 40 patients. Of the 130 total patients enrolled in the study, 100 will be treated with the Fibrin Pad as required by the study protocol. All 130 patients are expected to be enrolled by the end of 2008 or early 2009.
About the Fibrin Pad
The Fibrin Pad is being developed in collaboration with ETHICON, Inc., a Johnson & Johnson company, and builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL* Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.