ProFibrix Steps up Recombinant Fibrinogen Program With PER.C6(R) License From Crucell

ProFibrix B.V., today announced that it has concluded a commercial license agreement with Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) for PER.C6(R), a unique human protein production platform. The PER.C6(R) platform allows ProFibrix to manufacture recombinant human fibrinogen at levels that support the development and commercial roll-out of new products. Fibrinogen is at the heart of all ProFibrix products and is an essential part of nature's own injury-repair mechanism. The company's lead product Fibrocaps(TM) is based on fibrinogen derived from human blood plasma and is a unique dry powder topical hemostat that stops acute and severe bleeding during surgery or after trauma injury. Initially recombinant fibrinogen will be developed for systemic applications in hemostasis and later on for the development of tissue repair products.
Jaap Koopman, Ph.D., Chief Executive Officer, said: "The PER.C6(R) license gives us access to a manufacturing platform that has already been successfully tested by ProFibrix for high expression of biologically active recombinant fibrinogen. Our Chief Technology Officer Dr. Bram Bout was one of the inventors of PER.C6(R) while at Crucell. His intimate knowledge of the platform in combination with our substantial in-house expertise on the biology of fibrinogen provides us with a strong competitive position in the hemostasis market."
Jan Ohrstrom, MD, Chief Operational Officer, said: "We believe recombinant fibrinogen has the potential to become a breakthrough product in hemostasis and tissue repair. We intend to develop a systemic hemostat product based on recombinant fibrinogen to treat or prevent bleeding in patients with low fibrinogen levels."

Vivostat

The Danish medical device company Vivostat A/S (formerly known as Vivolution) announced the formation of a new management team to support the aggresive growth plans for the company’s Vivostat product lines.
During the last year the Alleroed-based company has completed a range of cross-organisational projects in order to prepare the company for the future. The outsourcing of the disposable production to a low-cost country, the re-branding of the Vivostat product lines and the establishment of direct sales organisations in major European markets, just to mention a few of the projects.
“The formation of the new management team is an important step in the process of preparing our company for the exciting challenges that lie ahead”, explains Tom Bjerg Laurizen, CEO at Vivostat.
Tom Bjerg Lauritzen continues: “During the last five years Vivostat has expanded from being a R&D focussed company into a significant commercial player in the surgical sealant and wound care markets. The establishment of the new management team reflects this change and lays a strong foundation for the company’s aggressive growth plans in the future”.
Together the new management team represents many years of medical device experience within sales, marketing and regulatory/medical affairs. Besides Tom Bjerg Lauritzen, the group consists of Anne Klitgård, VP of Regulatory and Medical Affairs, Henrik Vester-Andersen, VP of Sales, and Martin Poulsen, VP of Marketing.
Vivostat is already a well-established player in the European surgical sealant and wound care markets with sales of its products in 19 countries. To continue the expansion the company recently initiated the US approval process for the newest member of the Vivostat product family, Vivostat PRF - a second generation growth factor product used for the treatment of chronic wounds.
Chronic wounds are a serious problem for many diabetic patients and there is currently very little success with conventional treatment methods.

The Vivostat® System is an automated system for the on-site preparation and application of patient-derived fibrin sealant or platelet rich fibrin (PRF®). It incorporates a unique and patented biochemical process that produces an autologous sealant from 120 ml of the patient’s own blood in only 23 minutes. The sealant has biophysical properties that outperform most sealants on the market today and a delivery system that enables unparalleled control in the application during surgery.The system comprises three components: A Processor Unit for the preparation of fibrin sealant or PRF®, an Applicator Unit to control the delivery of fibrin sealant/PRF® and a disposable kit comprising all components required to collect blood and apply the sealant to the surgical site.

Fibrin glue deal talks stalled / Plaintiffs claiming substance caused hepatitis infections uncompensated

Settlement talks have reached an impasse for plaintiffs involved in lawsuits against the government over claims they were infected with the hepatitis C virus after being administered fibrin glue during surgery.
The government has cited that a causal link is unclear between the glue, a compound of fibrinogen and other substances used as a surgical adhesive for stitches made in heart and other types of surgery, and the hepatitis infections.
Since the January enactment of a special measures law to provide compensation to patients, about 600 plaintiffs have reached a settlement with the government. The plaintiffs who received state compensation were infected with the virus after being administered with a fibrinogen blood product.
However, the vast majority of plaintiffs claiming they were infected by the virus after being administered fibrin glue have yet to be compensated.
So far, only four such plaintiffs have reached a settlement with the government, according to a national group of lawyers representing hepatitis C victims that were infected by the virus through tainted blood products.
This leaves about 160 plaintiffs who have been unable to claim what the government says are blanket relief measures.
A 27-year-old man from Kanagawa Prefecture was diagnosed with acute hepatitis after a heart operation when he was 5. His condition is now chronic.
For many years, he did not know what the source of his infection was, but in light of the many media reports on the issue of hepatitis caused by tainted blood products, he made an inquiry to the hospital that operated on him at the end of last year and learned that fibrin glue was used in his surgery.
He brought a case against the government in April, but no progress has been made toward reaching a settlement.
A doctor recommended that he undergo interferon treatment, which is known to be effective for hepatitis C sufferers. But treatments costs several tens of thousands of yen a month, and the man lacks the funds to pay for it.
"The glue may have saved my life, and I bear no grudge against the hospital," the man said. "But I can't think of anything else that could have caused the infection, and I want the government to compensate me soon."
Fibrin glue is believed to have been administered to about 79,000 people in the 1980s.
But the glue is applied to incisions and wounds and differs from fibrinogen, which is used as a hemostatic agent and administered by intravenous injection.
The government has said "the infection rate is unclear because [fibrin glue] is not injected directly into blood vessels."
Settlements have only been reached so far with individuals whose infection is clearly linked to the application of the glue.
"By March, we hope to collect scientific data and establish fixed criteria for settlements," a Health, Labor and Welfare Ministry spokesman said. "Should a clear causal link be found, we'll swiftly begin settlement procedures."
The lawyers group says it has confirmed cases of infection from the use of minute quantities of the glue, and on Friday submitted a written demand to five district courts at which lawsuits are in progress--those in Tokyo, Osaka, Nagoya, Fukuoka and Sendai.
"The glue's danger is clear," the demand states. "[The government] should reach settlements as quickly as possible."

CPC Adds Key Bench Strengths to Medical and Technical Advisory Team

CPC of America, Inc. (OTCBulletinBoard: CPCF.OB) , a company focused on the development of therapeutic devices that enhance the quality of patient care in endovascular procedures, announced the addition of three medical and technical advisors to its team. Dr. Olexander Hnojewyj, Dr. James L. Rogers and Richard E. Anderson will add strategically important bench strengths to the team's expertise as they work to develop MedClose(TM), an investigational*-stage vascular closure system (VCS) that is intended to seal the femoral arterial puncture site following diagnostic or interventional catheterization procedures. Information on CPC's advisory team can be found at CPC's enhanced corporate Web site, CPCMedDevices.com.

Merry Christmas and Seasons Greetings

To All Readers I would just like to pass on my thanks for your support over the past year.

So to all Merry Christmas and a Happy New Year!!!

St Jude Medical acquires Radi Medical Systems for $250 million

US-based St Jude Medical has completed the acquisition of Sweden-based Radi Medical Systems for $250 million in cash.
With this transaction, Radi Medical Systems will become part of the St Jude Medical cardiovascular division. The transaction is expected to be neutral to St Jude Medical's consolidated earnings per share in 2009 and is expected to be positive to consolidated earnings per share beginning in 2010.
St Jude Medical funded the acquisition with cash on hand outside the US as well as with the proceeds from a new three-year term loan established recently with a syndicate of banks.
In connection with the transaction, Banc of America Securities acted as financial advisor to St Jude Medical, and Sidley Austin and Mannheimer Swartling Advokatbyra are serving as legal counsel to St Jude Medical and Katsky Korins and Advokatfirmen Lindahl are serving as legal counsel to Radi Medical.
Daniel Starks, chairman, president and CEO of St Jude Medical, said: "This acquisition will accelerate the expansion of St Jude Medical's cardiovascular growth platform and benefit the customers, employees and shareholders of both companies. We look forward to capturing strategic synergies through this acquisition and further expanding our investment in our cardiovascular division technology, products and programs."
Thomas Engstrom, CEO of Radi Medical Systems, said: "We are pleased to join with the industry leader in active vascular closure and a partner who shares our vision of developing innovative cardiovascular technologies that improve patient care. This transaction brings together complementary product lines and, through St Jude Medical's sales and distribution infrastructure, extends our reach to even more physician customers for the benefit of the patients they help everyday."

Committee For Medicinal Products For Human Use Post-Authorisation Summary Of Positive Opinion For Tachosil

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.

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.

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.

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.