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."

Preoperative Fibrinogen Plasma Concentration Is Associated With Perioperative Bleeding and Transfusion Requirements in Scoliosis Surgery

Study Design. Prospective observational study.

Objective. To investigate the potential association between fibrinogen, bleeding, and transfusion requirements after scoliosis surgery.

Summary of Background Data. Bleeding complications during and after orthopedic surgery are associated with increased morbidity and mortality. Early identification of patients with increased risk of excessive bleeding offers the possibility to initiate countermeasures. Fibrinogen is a key protein in the coagulation cascade, and thus a potential biomarker for bleeding risk.

Methods. A total of 82 otherwise healthy patients (mean age: 15 ± 3 years, 85% girls) undergoing surgery for adolescent idiopathic scoliosis were included in the study. Patient variables (age, gender, operation time, and thrombosis prophylaxis), preoperative laboratory variables (hemoglobin, platelet count, activated partial thromboplastin time [aPTT], prothrombin time [PT], and fibrinogen), peroperative and postoperative bleeding volume, and transfusions were registered. Correlations between laboratory variables and bleeding volume were calculated with Pearson test. Patient variables and laboratory variables were compared with Student t test between patients with bleeding volume in the upper quartile (“bleeders”) and the remaining patients, and between patients with extensive transfusion (defined as >2 U of packed red cells) and no or limited transfusions (≤2 U).

Results. Mean fibrinogen concentration was 3.0 ± 0.7 g/L (range, 1.3– 4.9). Mean total perioperative bleeding volume was 1552 ± 1019 mL (range, 100–5800 mL). Total bleeding volume correlated significantly with preoperative fibrinogen concentration (r = −0.31, P = 0.005) but neither with platelet count, aPTT, nor PT (P = 0.61, 0.46, and 0.57, respectively). Bleeders had significantly lower preoperative fibrinogen plasma concentration (2.6 ± 0.6 vs. 3.1 ± 0.6 g/L, P = 0.002). Of total, 16% (13/82) of the patients were transfused with >2 U of packed red cells. Patients with extensive transfusions had significantly lower preoperative fibrinogen plasma concentration (2.5 ± 0.7 vs. 3.1 ± 0.6 g/L, P = 0.002), while preoperative platelet count, aPTT, and PT did not differ.

Conclusion. The results indicate that preoperative fibrinogen concentration is a limiting factor for postoperative hemostasis during and after scoliosis surgery. Preoperative measurement of fibrinogen concentration provides more information about bleeding volume and transfusion requirements than standard screening tests.

FDA "increasingly concerned with the number of imported medical devices"...Made in the USA ???

Please see our Poll results HERE
Important new recommendations have been issued by the US Food and Drug Administration (FDA) pertaining to medical device import entry review processes.
The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of their products into the US market. The letter and other detailed information about the FDA import review process is available on the FDA website.
"These recommendations will directly impact your company's ability to import medical devices, electronic product components, parts and finished products into the US," states the letter.
Specifically, the FDA recommends better adherence by importers to correct Affirmation of Compliance (AofC) data in order to avoid significant entry delays. An appendix of medical device AofC codes has been included with the FDA's Letter to Industry.
When a product enters the United States, medical device importers should make sure to include AofC codes for the following information:

• Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
• Device Listing (LST)
• Device Initial Importer (DII)
• Premarket Notification (PMN) 510(k) number, if relevant
• Investigational Device Exemption (IDE)

The agency emphasizes that although use of AofC codes remains voluntary, firms that do make use of them greatly increase their chances of having their devices cleared for import entry faster.
A separate Letter to Industry focusing on the import entry filing process for medical devices that also qualify as electronic radiation products is forthcoming, according to the CDRH.
Any questions regarding the FDA’s import entry review process should be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov.

Blog Archives related to China

BioCer Introduce Latest Plant-based Hemostasis and Coated Hernia Repair Technologies to China

BAYREUTH, Germany, March 21, 2011 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germanybased medical device manufacturer, are pleased to announce their attendance at the China Medical Equipment Fair (CMEF) Shenzhen, China 15th-19th April 2011. HaemoCer(TM) an Absorbable Polysaccharide Hemostat (APH) and Ti0(2)Mesh(TM) Hernia repair system will be on exhibit at the BioCer booth.

HaemoCer(TM) APH technology is delivered in a powder format developed to meet the challenges of problematic bleeding in surgery. Utilizing Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process modifies plant-based polymers to create a highly absorptive, biocompatible agent which enhances and accelerates the natural clotting cascade. The PURE technology format of HaemoCer(TM) APH contains no thrombin, collagen, or other human or animal components, and is resorbed within days.

TiO(2)Mesh(TM) is an implant utilizing a biocompatible coating for surgical Hernia repair. Ti0(2)Mesh(TM) combines multiple requirements, specifically addressing the needs of the laparoscopic surgeon. TiO(2)Mesh(TM) offers a complete solution to the laparoscopic surgeon and coincides with the advance and rapid growth of minimally invasive surgery in China.

Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "The introduction at the CMEF of HaemoCer(TM) APH and its proprietary, integrated PURE technology offers Asian-Pacific medical professionals an opportunity to examine directly the latest advance in polysaccharide hemostats. TiO(2)Mesh(TM) which encompasses a cutting edge coating technology combined with all the requirements of the ideal Hernia repair mesh offers a complete solution to unmet needs. We anticipate surgeons and patients in China and Asia-Pacific will benefit from these advanced technological innovations in Hernia repair and Hemostasis."

BioCer Entwicklungs GmbH is a privately-held medical device company and welcomes CMEF visitors to their booth H26, hall 2. For further information, distribution inquiries, and licensing options, please visithttp://www.biocer-gmbh.de/en/.

ProFibrix Initiates Phase II With Lead Hemostasis Product Fibrocaps(TM) in US and Europe

LEIDEN, The Netherlands and SEATTLE, March 8, 2011 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that it has initiated a prospective, multi-center Phase II study with its lead product Fibrocaps at up to 20 sites, including major U.S. and Dutch academic medical centers.
Jaap Koopman, CEO of ProFibrix said: "The start of this large Phase II study in multiple surgical indications is a major milestone in the rapid development of our lead product Fibrocaps. If, as we expect, this study confirms the positive results of our first Phase II trial, we anticipate initiating a pivotal Phase III trial in early 2012, which puts us on track for a BLA filing early 2013."

About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.

About the Study
The second Phase II clinical trial of Fibrocaps (FC002) in the U.S. and Europe builds on the success of ProFibrix's first Phase II study at a number of European centers, which demonstrated a compelling safety and efficacy profile for Fibrocaps. The current Phase II trial is a prospective, randomized, single-blind, controlled study. The study sites include up to 20 major academic and leading private medical centers in the U.S. and Europe. Apart from measuring overall safety , the primary efficacy endpoint of the study is the mean time to hemostasis (TTH) of Fibrocaps versus control. Approximately 130 patients will be randomized across four different surgical indications: peripheral vascular surgery, spinal surgery, liver resection surgery and soft tissue dissection. Completion of the study is expected in the third quarter of 2011.
To allow ProFibrix to conduct the Fibrocaps Phase II clinical trial in the U.S., the company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration. Following review by the Agency in December 2010, the IND is now open and ProFibrix has started enrolling patients at the participating centers in the U.S. and EU. For more details on the study, please go to http://www.clinicaltrials.gov.

Nycomed sees 60% of sales in emerging markets by 2015

Nycomed has posted a 1.8% dip in turnover for 2010 to 3.17 billion euros, a reasonable result given the effects of generic competition to its gastrointestinal drug pantoprazole.


The Swiss privately-held drugmaker’s adjusted earnings before interest, taxes, depreciation and amortisation reached 850.5 million euros, down 20.9%. Pantoprazole sales fell 27.8% to 908.0 million euros, due principally to the loss of its patent in key European markets, Australia and Switzerland.
Sales of the drug in the USA, where it is sold as Protonix by partner Pfizer, are also falling as a result of 'at risk' launches by Teva and Sun in 2007; US exclusivity did not expire until last month. A lengthy legal battle is ongoing but recent judgments have sided with Nycomed which could pocket damages of up to $2 billion, some analysts have argued.
Much of Nycomed's future success is dependent on its recently-launched chronic obstructive pulmonary disease treatment Daxas (roflumilast). The drug, which hit the market in Denmark, Germany and the UK in September and is now available in several other European Union countries, brought in 3.8 million euros and earlier this week partner Forest Laboratories bagged US approval for the treatment, which will be sold as Daliresp.
Chief executive Hakan Bjorklund noted that a number of other products performed well, particularly from the bovine blood derivative Actovegin,  the haemostatic agent TachoSil (fibrinogen/thrombin), the nasal spray Instanyl (fentanyl) for breakthrough cancer pain and Alvesco (ciclesonide) for asthma. He is particularly pleased with the Zurich-headquartered group's performance in emerging markets where it showed above industry average growth in 2010.
Mr Bjorklund noted that Russia/CIS is Nycomed's largest market and Brazil has moved into second. Emerging markets accounted for 39% of turnover in 2010 and by 2015, "we expect them to make up around 60% of our sales".
He concluded by saying that 2011 results will be impacted by "continuing strong marketing and sales efforts around launches of Daxas and focus on our operations in the emerging markets".