Baxter Q1 Edited

Robert Parkinson

.......I'd like to take a moment just to update you on a few key programs and some recent highlights. First, during the quarter, we submitted a Biologics License Application or BLA to the FDA [Food and Drug Administration] for the U.S. approval of TISSEEL Fibrin Sealant as a hemostatic agent in vascular surgery. This is an expansion beyond the current marketed indications and completes the necessary clinical requirements for a broad hemostasis label, which represents a very significant opportunity for our Regenerative Medicine business.

Robert Hombach

.....Sales in Regenerative Medicine, which includes our BioSurgery products totaled $140 million and increased 18% on both the reported basis and after adjusting for foreign currency. These results reflect solid growth, particularly for FLOSEAL, and a benefit of just over $10 million in incremental sales related to the Apatech [ApaTech Inc.] acquisition, which was completed at the end of the first quarter last year. Excluding ApaTech, sales gross for the category was in high single digits.

Entegrion Licenses Stasilon Bleeding Control Dressing to Beeken BioMedical

Research Triangle Park, NC-based life sciences development company focused on expanding the therapeutic potential of the human vascular system signs agreement with new Chicago-based medical device company to continue development and commercialization of FDA-cleared hemostatic dressing.
Research Triangle Park, NC (PRWEB) April 20, 2011
Entegrion, the life sciences development company focused on expanding the therapeutic potential of the human vascular system, announces it has licensed Stasilon® to the Chicago-based medical device company Beeken BioMedical. Stasilon® is an FDA-cleared, single-use hemostatic dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
“Beeken BioMedical is committed to continue the development and commercialization of Stasilon®,” said Richard A. Kendall, President and CEO of newly formed Beeken BioMedical. “This novel medical device that extends across all of healthcare gives our company an immediate presence in the healthcare industry with opportunities to expand our sales and distribution model.”
“We selected Stasilon® as the company's initial investment for many reasons, including technology innovation and the fact that it is a low cost but effective alternative to current hemostatic devices in the market and a strategic fit to our global distribution model,” said Peter Beemsterboer, Chairman of Beeken BioMedical. “We look forward to having Entegrion as a strategic partner to further develop our product portfolio.”
Entegrion, which developed the hemostatic woven dressing in collaboration with researchers at the University of North Carolina, commented on the agreement. “We are pleased to partner with Beeken BioMedical in the introduction of Stasilon® to the surgical and wound care community. We are confident they have the experience, drive and imagination to successfully represent the technology, and, as importantly, identify additional unmet medical needs that can be addressed by future generations of products,” said Joseph DaCorta, Entegrion's Vice President and Chief Technology Officer. “They are the ideal partners for us.”
Beemsterboer and Kendall are the co-founders of Beeken BioMedical. The entrepreneurs have diverse and extensive backgrounds in developing multi-million-dollar businesses that introduce new technologies and services into healthcare and non-healthcare-related industries. The company has selected an experienced management team to continue the development and growth of the company.
Regulated as a medical device, Stasilon® addresses the immediate need to control bleeding surfaces by treating wounds caused by trauma with a novel dual-fiber hemostatic dressing. Beeken BioMedical will focus on the unique features of Stasilon® to continue to be among the first choice of hemostasis devices selected in surgery, wound care, emergency medicine, industrial and consumer care. Potential market opportunities range from hospitals, clinics, physician offices, long term and emergency care facilities, municipalities, veterinary clinics, and athletics to over-the-counter use by consumers

Recombinant Human Albumin for Use in Unique Sealant Technology

Novozymes Biopharma is pleased to announce that its recombinant human albumin, albucult®, is being used by Neomend in its ProGEL® PLATINUM surgical sealant.
This product will be commercially available in Europe beginning in the second quarter of 2011. Neomend is an innovator in sealant and adhesion prevention products for the surgical marketplace. The company utilises albucult as a key component in ProGEL PLATINUM, the only sealant of its kind developed to treat pleural air leaks following lung resection surgery. Neomend’s ProGEL is a hydrogel polymer consisting of Novozymes’ albucult and a cross-linking component of polyethylene glycol (PEG). When they are combined, a rapid cross-linking reaction creates a hydrogel matrix that results in the formation of a strong, adherent and flexible seal. The technology, which has received a European CE Mark, enables surgeons to more effectively treat lung air leaks during surgery and has already been used in more than 8,000 procedures in the US since April of last year.
David Renzi, Neomend’s President and CEO, commented: “Novozymes’ extensive experience in manufacturing, regulatory and global supply, combined with its commitment to innovation, makes the company the ideal partner for Neomend to work with on its unique sealant technology. We will launch ProGEL PLATINUM in Europe in the second quarter of this year, while also continuing the development of this platform technology into other clinical areas such as spine, general surgery and gynecology.”
“Novozymes is delighted that Neomend has selected albucult for use in its unique sealant technology”, said Dermot Pearson, Marketing Director, Novozymes Biopharma. “The partnership demonstrates Novozymes’ commitment to providing quality materials for use in the healthcare, pharmaceutical and biotechnology industries and allows the company to position itself as a reliable partner in the wound sealant and medical device markets.” The use of albucult in ProGEL PLATINUM and other medical devices confers a range of unique advantages not possible with animal-derived ingredients such as sustainability of supply, GMP compliance and improved biocompatibility. Albucult also delivers unprecedented performance and quality benefits to medical applications including sealants, device coating and cell therapy applications while ensuring batch-to-batch consistency, which can significantly reduce lot testing burdens for customers.

ORTHOCON Receives CE Mark and Health Canada Medical Device License for HEMASORB

IRVINGTON, New York, April 21, 2011 /PRNewswire/ - Absorbable Bone Hemostat Matrix Cleared For Clinical Use and Sale in Europe and Canada

ORTHOCON, Inc., a privately-held therapeutic device company, today announced that DEKRA and Health Canada have cleared its HEMASORB Absorbable Bone Hemostat Matrix for clinical use and sale in Europe and Canada.
HEMASORB is a ready-to-use, biocompatible, water resistant, and absorbable putty designed to rapidly stop bleeding when applied to damaged or cut bone. Control of bleeding from cut bone is a problem in many operative procedures including spine, orthopedic, cardiac, and craniomaxillofacial surgeries. Excessive bleeding during surgery may impair the surgeon's view of the operative field, may result in the need for blood transfusions, and may be associated with post-operative complications. ORTHOCON estimates that over 3.5 million patients undergoing surgeries in the United States, Europe, and Canada each year could benefit from the intra-operative use of HEMASORB.
"We are pleased that HEMASORB has been cleared for clinical use and sale in Europe and Canada," said John J. Pacifico, President and Chief Executive Officer of ORTHOCON. "We are confident HEMASORB will provide surgeons in Europe and Canada with an innovative and cost-effective tool to assist in their management of intra-operative bone bleeding, and we fully expect HEMASORB to become the standard of care for bone hemostasis."
HEMASORB, previously cleared by the Food and Drug Administration (FDA) via the 510(k) premarket notification process, was first introduced in the U.S. in 2010. The product has been approved for sale at leading hospitals throughout the United States and is used successfully by hundreds of surgeons. ORTHOCON will continue to focus its efforts on increasing adoption of HEMASORB in the U.S. and is actively pursuing product distribution partnerships in Europe and Canada to ensure HEMASORB becomes widely available to surgical patients in these markets.

About ORTHOCON
Founded in 2005, ORTHOCON develops, manufactures, markets, and sells implantable products that stop bone bleeding. ORTHOCON's technology platform is also being developed to enable controlled, local drug delivery to the treatment site.
ORTHOCON is funded by leading international venture capital investment firms. The company occupies 8,000 square feet at its state-of-the-art facility in Irvington, New York. For more information, please visit http://www.orthocon.com.

Unethical Device Sales Activities Exposed - Corporate Goals 1, Patient Safety 0

The healthcare giant was charged by the US Securities and Exchange Commission with violating the Foreign Corrupt Practices Act by bribing public doctors in several European countries - and paying kickbacks to Iraq - to illegally obtain business. The FCPA forbids US companies from bribing foreign government officials (read here).

Specifically, various Johnson & Johnson (JNJ) units paid bribes to public doctors in Greece who chose J&J surgical implants; public doctors and hospital administrators in Poland who awarded contracts to J&J, and public doctors in Romania to prescribe J&J meds. The subsidiaries - including DePuy and Janssen Pharmaceutica - also paid kickbacks to Iraq to obtain 19 contracts under the United Nations Oil for Food Program, according to the SEC complaint (pdf).

To settle charges, J&J agreed to pay $48.6 million in disgorgement and prejudgment interest, and another $21.4 to settle parallel criminal charges that were announced by the US Department of Justice. Meanwhile, J&J is also paying $8 million to resolve an investigation by the United Kingdom Serious Fraud Office into its DePuy unit (see this).

Why did the docs agree? The doctors and administrators working for public entities in Greece, Poland, and Romania, who ordered or prescribed J&J products, were rewarded with cash and inappropriate travel, among other goodies. And J&J subsidiaries, employees and agents used slush funds, sham civil contracts with doctors, and off-shore companies in the Isle of Man to carry out the bribery.

The charges are not a huge surprise, however. Last summer, the feds announced they have begun paying closer attention to interactions between the pharmaceutical industry and foreign governments (background). And several months ago, at least five big drugmakers received letters as the federal government seeks to uncover any violations of the FCPA.

Four years ago, by the way, the healthcare giant made a “voluntary disclosure” to US authorities about improper payments, which were made by unspecified foreign subsidiaries in connection with the sale of medical devices in a pair of unnamed countries. And the worldwide chairman of medical devices and diagnostics retired (read this). In this disclosure, the SEC noted that J&J also conducted an internal probe, according to an SEC statement.

"The Justice Department “will be intensely focused on rooting out foreign bribery in your industry. That will mean investigation and, if warranted, prosecution of corporations, to be sure, but also it will involve investigation and prosecution of senior executives,” Breuer told the crowd, adding that individuals will be held accountable, according to The Legal Times.

“I don’t care if you’re a physician and I don’t care if you’re the clerical worker. It has to do with what you do. But if you do it, your MD degree is not going to be a shield,” Breuer said. Overall, he said, the Justice Department is pursuing more than 120 FCPA investigations in cooperation with the FBI and the Securities and Exchange Commission.

And Tony West, an assistant attorney general and chief of the department’s Civil Division, noted that he recently told the Senate Judiciary Committee that enforcement will not be limited to companies."