LONDON, Dec. 18, 2008-On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product TachoSil. The Marketing Authorisation Holder for this medicinal product is Nycomed Austria Gmbh.
The CHMP adopted new indications as follows: “to promote tissue sealing and for suture support in vascular surgery”.
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication for TachoSil will be as follows***: TachoSil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient (see SPC section 5.1)”.
* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.
** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.
Saturday, December 20, 2008
Friday, December 19, 2008
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.
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.
Thursday, December 18, 2008
Avigen Sells Early Stage Research Program in Hemophilia to Baxter
ALAMEDA, Calif., Dec 18, 2008 (GlobeNewswire via COMTEX) -- Avigen, Inc., a biopharmaceutical company, announced today that the company has sold the rights to its early stage blood coagulation compound, AV513, to Baxter Healthcare Corporation, a global leader in hemophilia therapy, for $7 million. Baxter acquired all rights to AV513, a compound poised for clinical research that has been shown to improve blood coagulation in preclinical models for hemophilia. Avigen has been developing AV513 as an oral therapy to treat patients with bleeding disorders, including hemophilia A.
"The sale of AV513 is an example of building value in a product that is differentiated from current therapies, and bringing it to a valuation point that generated a positive return on investment," said Kenneth Chahine, Ph.D., J.D., Avigen's president and chief executive officer. "Our team identified AV513 as a drug candidate with a novel approach for treating hemophilia and other bleeding disorders, and which offered strong IP potential in a target patient population with an unmet need. Because it was outside our neurology focus, it was our goal to follow a reasonable budget to establish AV513's value, and then move it to a better-resourced company with the expertise to develop a safe and effective therapy."
"This technology acquisition supports Baxter's efforts to research the application of novel technologies that will pioneer the next generation of hemophilia therapies," said Hartmut Ehrlich, M.D., vice president of global BioScience research and development for Baxter.
"The sale of AV513 is an example of building value in a product that is differentiated from current therapies, and bringing it to a valuation point that generated a positive return on investment," said Kenneth Chahine, Ph.D., J.D., Avigen's president and chief executive officer. "Our team identified AV513 as a drug candidate with a novel approach for treating hemophilia and other bleeding disorders, and which offered strong IP potential in a target patient population with an unmet need. Because it was outside our neurology focus, it was our goal to follow a reasonable budget to establish AV513's value, and then move it to a better-resourced company with the expertise to develop a safe and effective therapy."
"This technology acquisition supports Baxter's efforts to research the application of novel technologies that will pioneer the next generation of hemophilia therapies," said Hartmut Ehrlich, M.D., vice president of global BioScience research and development for Baxter.
Thursday, December 11, 2008
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.
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.
Monday, December 8, 2008
ZymoGenetics Presents Favorable RECOTHROM® Phase 3b Results
ZymoGenetics, Inc. (NASDAQ: ZGEN) presented positive results today from a Phase 3b clinical trial with RECOTHROM® Thrombin, topical (Recombinant). The study provided additional information about the immunologic safety of RECOTHROM and demonstrated that RECOTHROM was well tolerated when applied as an aid to hemostasis in patients, including those with pre-existing antibodies to bovine thrombin.
"In the Phase 3b study, 16% of patients entered surgery with pre-existing antibodies to bovine thrombin,” said Douglas E. Williams, Ph.D., President of ZymoGenetics. "The product label for bovine thrombin states that patients with antibodies to bovine thrombin preparations should not be re-exposed. This study indicates that RECOTHROM can be safely applied regardless of baseline anti-bovine thrombin product antibody status.”
The Phase 3b open-label, single-group, multisite study evaluated the immunogenicity and safety of RECOTHROM among 205 subjects who were at increased risk for having anti-bovine thrombin product antibodies as a result of prior surgery with a high likelihood of bovine thrombin exposure. Topical RECOTHROM was applied during a single spinal or vascular surgical procedure. Immunogenicity was evaluated by enzyme-linked immunosorbent assay at baseline and Day 29. At baseline, 173 subjects (84%) were seronegative and 32 (16%) were seropositive for anti-bovine thrombin product antibodies.
At the end of the study, no patients had developed antibodies against RECOTHROM. The immunogenicity profile of RECOTHROM did not differ among patients who entered the study with or without pre-existing antibodies to the bovine thrombin product.
RECOTHROM was well tolerated and observed adverse events (AEs) were consistent with those commonly seen in post-surgical settings. The most common AEs (reported by 10% or more of subjects) included incision site pain, procedural pain, nausea, constipation, anemia, muscle spasms, hypotension, and pyrexia. The safety results in this study were consistent with those observed in previously reported clinical trials with RECOTHROM.
RECOTHROM is being commercialized by ZymoGenetics and Bayer HealthCare. ZymoGenetics retains U.S. market rights, and Bayer provides its trained surgical sales force to support the first three years of the US market launch that began in early 2008. Bayer acquired rights to RECOTHROM in all markets outside the U.S. and is responsible for commercializing RECOTHROM in global markets.
"In the Phase 3b study, 16% of patients entered surgery with pre-existing antibodies to bovine thrombin,” said Douglas E. Williams, Ph.D., President of ZymoGenetics. "The product label for bovine thrombin states that patients with antibodies to bovine thrombin preparations should not be re-exposed. This study indicates that RECOTHROM can be safely applied regardless of baseline anti-bovine thrombin product antibody status.”The Phase 3b open-label, single-group, multisite study evaluated the immunogenicity and safety of RECOTHROM among 205 subjects who were at increased risk for having anti-bovine thrombin product antibodies as a result of prior surgery with a high likelihood of bovine thrombin exposure. Topical RECOTHROM was applied during a single spinal or vascular surgical procedure. Immunogenicity was evaluated by enzyme-linked immunosorbent assay at baseline and Day 29. At baseline, 173 subjects (84%) were seronegative and 32 (16%) were seropositive for anti-bovine thrombin product antibodies.
At the end of the study, no patients had developed antibodies against RECOTHROM. The immunogenicity profile of RECOTHROM did not differ among patients who entered the study with or without pre-existing antibodies to the bovine thrombin product.
RECOTHROM was well tolerated and observed adverse events (AEs) were consistent with those commonly seen in post-surgical settings. The most common AEs (reported by 10% or more of subjects) included incision site pain, procedural pain, nausea, constipation, anemia, muscle spasms, hypotension, and pyrexia. The safety results in this study were consistent with those observed in previously reported clinical trials with RECOTHROM.
RECOTHROM is being commercialized by ZymoGenetics and Bayer HealthCare. ZymoGenetics retains U.S. market rights, and Bayer provides its trained surgical sales force to support the first three years of the US market launch that began in early 2008. Bayer acquired rights to RECOTHROM in all markets outside the U.S. and is responsible for commercializing RECOTHROM in global markets.
Sunday, December 7, 2008
50th Annual Meeting of the American Society of Hematology
SAN FRANCISCO, Dec 03, 2008 /PRNewswire-USNewswire via COMTEX/ -- The American Society of Hematology (ASH), the world's largest professional association of blood specialists, expects more than 20,000 attendees at the 50th ASH Annual Meeting from December 6-9, 2008, at the Moscone Center in San Francisco, CA. The meeting will showcase the latest research and treatments for blood disorders. In honor of the Society's golden anniversary, there will also be several special programs including a unique video project featuring influential figures in hematology.
"It is my distinct honor to serve as President during this celebratory year in the Society's history. The ASH annual meeting continues to be the premier forum for physicians and researchers from around the world to hear the most up-to-date developments in hematology, and this year will be no exception," said Kenneth Kaushansky, MD, 2008 ASH President, and Helen M. Ranney Professor and Chair of the Department of Medicine at the University of California, San Diego School of Medicine. "In addition to presenting research that affects hematologists in every area of the discipline, this year's meeting underscores 50 years of unprecedented growth and advancement in the field."
Highlights of the meeting include special symposia, education programs, special interest seminars, and scientific sessions. As part of the 50th anniversary celebration, the meeting will also feature historical displays showcasing major scientific discoveries and clinical advances in the specialty. Several world-renowned scientists will share their life stories and speak about groundbreaking medical discoveries during the Pioneers in Hematology sessions.
The Special Symposium on the Basic Science of Hemostasis and Thrombosis will provide an opportunity for communication among scientists in the field and focus on the most important basic science contributions from 2008 to each of the three major areas of the field: thrombosis, blood coagulation and fibrinolysis, and platelet biology. In September, the Surgeon General's Call to Action to Prevent and Reduce Deep-Vein Thrombosis and Pulmonary Embolism encouraged public awareness of this blood condition that affects nearly 1 million Americans each year. The symposium will take place on Tuesday, December 9, from 7:30 - 9:00 a.m. PST.
This year's Practice Forum, "The Patient, the Hematologist, and the Unexpected," will focus on two areas of unexpected results encountered commonly enough to raise the interest of the hematology community. Additionally, this session will look at the public policy environment that will shape the practice of hematology and the Society as it enters its 51st year. This event will take place Saturday, December 6, from 6:00 - 7:30 p.m.
Another highlight of the meeting is the Presidential Symposium, which will focus on hematopoietic stem cells (HSCs). These cells are known for their role in the cure of a variety of diseases as well as for providing an understanding of stem cell development in all mammalian biology. During the symposium on Tuesday, December 9, from 9:45 - 11:45 a.m., three eminent investigators who have made significant contributions to our understanding of HSC biology will discuss the properties of these cells and their role in the human body.
Neal S. Young, MD, of the National Heart, Lung, and Blood Institute, National Institutes of Health, will discuss the pathophysiology of bone marrow failure and how clinical observations of patients with this disease have provided insights into the biology of autoimmunity, viral pathogenesis, and cancer at this year's E. Donnall Thomas Lecture on Monday, December 8, from 9:30 - 10:30 a.m. Bob Lowenberg, MD, Ph.D., of the Erasmus University Medical Center in the Netherlands, will give the Ham-Wasserman Lecture on Saturday, December 6, from 12:30 - 1:30 p.m. Dr. Lowenberg's lecture will focus on the numerous genetic abnormalities found in acute myeloid leukemia patients and ways to use this information to develop individualized therapies. Both the E. Donnall Thomas Lecture and the Ham-Wasserman Lecture represent areas of medicine that have evolved immensely over the last 50 years.
This year's plenary policy forum, "50 Years of Progress in Hematology," which is co-sponsored by ASH and the European Hematology Association, will feature Nobel Prize winner Peter Agre, MD, who will discuss how his research on water channels in red blood cells, as well as the research of others that originated in hematology, grew to have profound and catalytic influences on numerous areas of science.
For the complete annual meeting program and abstracts, visit www.hematology.org.
"It is my distinct honor to serve as President during this celebratory year in the Society's history. The ASH annual meeting continues to be the premier forum for physicians and researchers from around the world to hear the most up-to-date developments in hematology, and this year will be no exception," said Kenneth Kaushansky, MD, 2008 ASH President, and Helen M. Ranney Professor and Chair of the Department of Medicine at the University of California, San Diego School of Medicine. "In addition to presenting research that affects hematologists in every area of the discipline, this year's meeting underscores 50 years of unprecedented growth and advancement in the field."
Highlights of the meeting include special symposia, education programs, special interest seminars, and scientific sessions. As part of the 50th anniversary celebration, the meeting will also feature historical displays showcasing major scientific discoveries and clinical advances in the specialty. Several world-renowned scientists will share their life stories and speak about groundbreaking medical discoveries during the Pioneers in Hematology sessions.
The Special Symposium on the Basic Science of Hemostasis and Thrombosis will provide an opportunity for communication among scientists in the field and focus on the most important basic science contributions from 2008 to each of the three major areas of the field: thrombosis, blood coagulation and fibrinolysis, and platelet biology. In September, the Surgeon General's Call to Action to Prevent and Reduce Deep-Vein Thrombosis and Pulmonary Embolism encouraged public awareness of this blood condition that affects nearly 1 million Americans each year. The symposium will take place on Tuesday, December 9, from 7:30 - 9:00 a.m. PST.
This year's Practice Forum, "The Patient, the Hematologist, and the Unexpected," will focus on two areas of unexpected results encountered commonly enough to raise the interest of the hematology community. Additionally, this session will look at the public policy environment that will shape the practice of hematology and the Society as it enters its 51st year. This event will take place Saturday, December 6, from 6:00 - 7:30 p.m.
Another highlight of the meeting is the Presidential Symposium, which will focus on hematopoietic stem cells (HSCs). These cells are known for their role in the cure of a variety of diseases as well as for providing an understanding of stem cell development in all mammalian biology. During the symposium on Tuesday, December 9, from 9:45 - 11:45 a.m., three eminent investigators who have made significant contributions to our understanding of HSC biology will discuss the properties of these cells and their role in the human body.
Neal S. Young, MD, of the National Heart, Lung, and Blood Institute, National Institutes of Health, will discuss the pathophysiology of bone marrow failure and how clinical observations of patients with this disease have provided insights into the biology of autoimmunity, viral pathogenesis, and cancer at this year's E. Donnall Thomas Lecture on Monday, December 8, from 9:30 - 10:30 a.m. Bob Lowenberg, MD, Ph.D., of the Erasmus University Medical Center in the Netherlands, will give the Ham-Wasserman Lecture on Saturday, December 6, from 12:30 - 1:30 p.m. Dr. Lowenberg's lecture will focus on the numerous genetic abnormalities found in acute myeloid leukemia patients and ways to use this information to develop individualized therapies. Both the E. Donnall Thomas Lecture and the Ham-Wasserman Lecture represent areas of medicine that have evolved immensely over the last 50 years.
This year's plenary policy forum, "50 Years of Progress in Hematology," which is co-sponsored by ASH and the European Hematology Association, will feature Nobel Prize winner Peter Agre, MD, who will discuss how his research on water channels in red blood cells, as well as the research of others that originated in hematology, grew to have profound and catalytic influences on numerous areas of science.
For the complete annual meeting program and abstracts, visit www.hematology.org.
Study: Terumo TR Band™ Hemostasis Device Reduces Radial Artery Occlusion by 56%
A new study, conducted by Dr. Samir B. Pancholy of Mercy Hospital in Scranton, Pennsylvania, shows that the concept of "guided compression" in transradial procedures can reduce radial artery occlusion by 56%, especially when facilitated by the use of the TR Band™ Hemostasis Device.
While infrequent (in the single digits), radial artery occlusion is a discouraging complication of radial artery access.
Although it is usually benign for the patient, it precludes future radial access. For example, if the radial artery occludes after a diagnostic catheterization, any subsequent PCI procedures must be done via the femoral artery.
But there are a number of methods for achieving hemostasis in a radial procedure. Pancholy looked at data from his own lab and saw that patients on whom he had used the TR Band, as opposed to the commonly-used HemoBand, had significantly lower rates of radial artery occlusion. So Dr. Pancholy devised a randomized clinical study to test the efficacy of the TR Band in preventing radial artery occlusion.
500 consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. 250 consecutive patients received hemostasis by application of HemoBand (Group I) and the next 250 patients received hemostasis using the inflatable TR band (Group II). Radial artery patency was studied the time of application of the hemostasis device, at 30 minutes, 60 minutes and at 24 hour and 30 days using Barbeau’s test.
The results were that 28 patients in Group I (11.2%), developed evidence of early occlusion (at 24 h), compared to 11 patients (4.4%) in Group II (P<0.005).>
While infrequent (in the single digits), radial artery occlusion is a discouraging complication of radial artery access.
Although it is usually benign for the patient, it precludes future radial access. For example, if the radial artery occludes after a diagnostic catheterization, any subsequent PCI procedures must be done via the femoral artery.
But there are a number of methods for achieving hemostasis in a radial procedure. Pancholy looked at data from his own lab and saw that patients on whom he had used the TR Band, as opposed to the commonly-used HemoBand, had significantly lower rates of radial artery occlusion. So Dr. Pancholy devised a randomized clinical study to test the efficacy of the TR Band in preventing radial artery occlusion.500 consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. 250 consecutive patients received hemostasis by application of HemoBand (Group I) and the next 250 patients received hemostasis using the inflatable TR band (Group II). Radial artery patency was studied the time of application of the hemostasis device, at 30 minutes, 60 minutes and at 24 hour and 30 days using Barbeau’s test.
The results were that 28 patients in Group I (11.2%), developed evidence of early occlusion (at 24 h), compared to 11 patients (4.4%) in Group II (P<0.005).>
Tuesday, December 2, 2008
Starch Medical Launches New, Bioinert Surgical Hemostats
SAN JOSE, Calif., Dec. 2 /PRNewswire/ -- Starch Medical Inc, a San Jose, CA-based medical device manufacturer, announces the CE approval of its PerClot(TM) Polysaccharide Hemostatic System (PHS) and the StarFoam(TM) Absorbable Polysaccharide Hemostat. Introduction of PerClot(TM) PHS will commence this month in the European Union and other select international markets. The StarFoam(TM) Absorbable Polysaccharide Hemostat will launch during the 2nd quarter, 2009.
PerClot(TM) PHS is an absorbable, surgical hemostat composed of Absorbable Modified Polymers (AMP(TM)). AMP(TM) technology incorporates sophisticated, plant-based polymer modification processes that yield biocompatible, polysaccharide particles. There is no thrombin, collagen, or other human or animal components in AMP(TM) particles. A family of customized, single-use application instruments will enhance the delivery of AMP(TM) to the wound site for the control of capillary, venous and arterial bleeding in both open and minimally invasive surgical procedures.The StarFoam(TM) Absorbable Polysaccharide Hemostat, also developed with AMP(TM) technology, is produced in a hemostatic foam (wafer) configuration. Application of StarFoam(TM) will feature a simple "press and release" technique.
David Lang, President of SMI, commented, "The clinical introduction of PerClot(TM) PHS and its proprietary, integrated AMP(TM) technology represents the next generation of polysaccharide hemostatic agents. The StarFoam(TM) product line will offer surgeons a choice of hemostatic formats for a range of surgical wounds. Compared to current polysaccharide based hemostats, PerClot(TM) PHS and StarFoam(TM) demonstrate superior hydrophilic action and enhanced adhesive strength. These performance features, coupled with custom delivery systems, have been favorably received in a diverse range of surgical applications in Europe, Asia and Latin America."
SMI is a privately-held medical device company engaged in the design, manufacture, marketing and licensing of breakthrough, hemostatic solutions. Starch Medical's proprietary, patent-pending technology platform (AMP(TM)), including powders, foams and films, will focus on the worldwide, multi-billion dollar biomaterial, hemostasis, and wound care marketplace. For additional information, distribution inquiries, and licensing options, visit http://www.starchmedical.com/.
Saturday, November 29, 2008
ZymoGenetics' longtime CEO is stepping down
ZymoGenetics Chief Executive Bruce Carter will step down Jan. 2, to be succeeded by current President Douglas Williams.Carter, 65, a prominent figure in local biotech circles, became president and chief executive of ZymoGenetics in 1998, when the Seattle company was a subsidiary of Novo Nordisk.
He led the spinoff that turned the Seattle-based biotech into an independent company in 2000. Eight years later, he presided over the launch of the company's first commercial product, Recothrom, a genetically engineered form of a blood protein used to control surgical bleeding.
He leaves as ZymoGenetics, which once ranked highest in market capitalization among Seattle-area biotech firms, has seen its shares plummet 77 percent in the past year because investors are disappointed at sluggish Recothrom sales.
"It has been an honor to lead ZymoGenetics and a privilege to work with so many bright and talented people. It is also satisfying to think that discoveries at ZymoGenetics have led to lives saved," said Carter in a statement.
"In many ways it is sad to leave, but all organizations are invigorated by new blood, and I am confident that in Doug we have the right person to drive this company forward and capitalize on the opportunities we have created for patients and shareholders."
Monday, November 24, 2008
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.
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.
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