HaemoCer Instrumentation Advances Plant-sourced Hemostat Applications into Minimally Invasive Surgeries

BAYREUTH, Germany, May 31, 2012 /PRNewswire/ --BioCer Entwicklungs GmbH (BCE), a German based medical device manufacturer, announces the CE approval of its advanced HaemoCer™ Universal Applicator (UA). HaemoCer™ UA is a delivery configuration for applications of the HaemoCer™ Absorbable Polysaccharide Hemostat (APH) system in minimally invasive surgical procedures.

The HaemoCer™ UA system is a unique instrumentation for laparoscopic, ENT, spinal and other MIS procedures where precise delivery of APH particles to the bleeding site is mandatory. The delivery instrument is easily attached to the HaemoCer™ bellows dispenser and enables hemostat delivery under direct vision to the wound site for the control of capillary, venous and arteriolar bleeding. The initial HaemoCer™ 5 gram product range has also expanded to include multiple size configurations meeting the strong international market demand for HaemoCer™ in multidisciplinary procedures.

Dr. Markus Heinlein, Managing Director of BioCer, commented, "The clinical introduction of HaemoCer™ UA offers surgeons a delivery option within the expanding practice of minimally invasive surgery. Collaborating with leading laparoscopic surgeons and German engineers, our system has been designed for the controlled release of hemostatic particles. HaemoCer™ UA encompasses 3 unique advances, including a press-and-release locking system facilitating UA tip placement without uncontrolled discharge. Secondly the system features a tip design which minimizes tip blockage, both common difficulties with current particle delivery devices. Finally the new instrumentation is sold separately and the push-on coupling sheath will accommodate other devices allowing medical professionals and patients to immediately benefit from this new instrumentation while converting stocks to HaemoCer™."

BioCer Entwicklungs-GmbH, HaemoCer APH particles are manufactured utilizing a Polysaccharide Ultra-hydrophilic Resorbable Engineering (PURE) process.  HaemoCer™ contains no human or animal components and is developed and manufactured in Germany. For information, distribution inquiries, and licensing options, please visit http://www.biocer-gmbh.de or email info@biocer-gmbh.de.

Baxter Announces ADVATE Approval in China for the Treatment of Hemophilia A

Baxter International Inc. announced the approval of ADVATE[Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency) in China by the State Food and Drug Administration (SFDA). It is estimated that more than 50,000 people in China are living with hemophilia A.

''The introduction of recombinant FVIII therapies in China offers new treatment options for hemophilia patients. The launch of ADVATE is another step in advancing hemophilia care in China,'' said Professor Yang Renchi, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, the leading professional hematological institution providing basic medical research with clinical services in China.

''Great strides have been made in managing hemophilia, allowing people with this serious condition to live longer, more active and fulfilling lives than ever before,'' said Guan Tao, Secretary General of Hemophilia Home, the hemophilia patient organization in China. ''The availability of ADVATE will be an important milestone for people with hemophilia in China.''

ADVATE is infused directly into the bloodstream and works by temporarily raising the level of factor VIII in the bloodstream, allowing the body's blood clotting process to properly function. Extensive global use and multiple clinical trials demonstrate clinical evidence for ADVATE. With SFDA's action, ADVATE is now approved in 54 countries worldwide.

''The approval of ADVATE in China marks an important milestone for Baxter and supports our ongoing commitment to treating individuals living with hemophilia,'' said Ludwig Hantson, Ph.D., president of Baxter's BioScience business.

Baxter continues to work closely with the Chinese hemophilia community, including both patients and treaters, to provide access to care for this life-saving, life-sustaining therapy. In 2010, Baxter cooperated with the Ministry of Health to set up a ''Hemophilia Disease Management System,'' China's first nationwide hemophilia patient registration and management system integrating diagnosis and treatment information. In recent years, Baxter has donated more than five million IUs of hemophilia products to Chinese patients and has provided a number of resources to raise awareness of the disease.

About ADVATE

ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] was initially approved by the FDA in July 2003 for control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII therapies.

ADVATE is approved in the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Hong Kong, Iceland, Iraq, Japan, Macau, Malaysia, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Uruguay and Venezuela.

In the United States, ADVATE [Antihemophilic Factor (Recombinant) Plasma/AlbuminFree Method] is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is the only antihemophilic factor approved in the United States for prophylactic use in both adults and children. ADVATE is not indicated for the treatment of von Willebrand disease.

FastSeal(R) Bioabsorbable Vascular Access Closure System

Vascular Closure Systems, Inc, First in Human (FIH) Use of the FastSeal(R) Bioabsorbable Vascular Access Closure System -- 100% Success Rate, Including Patients with Challenging Anatomy and Vessel Condition.

The company is pleased to announce that after receiving Ethical Committee (EC) and Ministry of Health (MOH) approval, for the first human use of the company's FastSeal(R) Bioabsorbable Vascular Access Closure System, Phase I of the First in Human (FIH) clinical testing has been completed, with 100% successful results, and no adverse effects, including post procedural discomfort. The average Time to Hemostasis (TTH) was less than one minute. The clinical cases included vessels that were normal, diseased, severely fibrosed and with calcified plaque.

The initial series of human clinical cases were performed on Percutaneous Coronary Intervention (PCI) patients, by Prof. Alessandro Bortone of the Policlinico di Bari, University of Bari School of Medicine (IT). Phase II testing will begin within the next two weeks.

The detailed FIH test results will be presented at multiple upcoming medical conferences.

The company is planning to begin International commercialization (pending regulatory approval) during the fourth quarter of this year.

About FastSeal(R)

Our Bioabsorbable Vascular Access Closure System is packaged and used as a single piece unit, with no assembly required prior to use, and no separate deployment device is needed to be inserted into the puncture site. Simply insert the FastSeal(R) system into the hub of the procedural introducer sheath, and advance the attached plunger. The system design enables hemostasis within less than a minute after the non-collagen sealing element has been deployed. Our system doesn't require the use of a specific type or brand of vascular introducer sheath, and is compatible with any commercialized vascular introducer sheath with a useable length of between 10 to 12 cm. Once the sealing element has been deployed, no external compression is required. The inner vessel section of the sealing element is absorbed within 10 to 14 days. The remainder of the sealing element is completely absorbed within 21 days. The FastSeal(R) system has the ability to be removed after deployment (if desired), without causing trauma to the vessel or requiring a surgical intervention.

CSL Behring Data Shows 4-Factor Prothrombin Complex Concentrate Is Effective

Data presented by CSL Behring at the 2012 Thrombosis and Hemostasis Summit of North America (THSNA) showed that a balanced, human 4-factor prothrombin complex concentrate (PCC) is as effective as the current standard of treatment in stopping bleeding in patients receiving vitamin K antagonist therapy (i.e., warfarin). Currently in the United States, fresh frozen plasma is the standard treatment for warfarin reversal. The data are from the first and largest randomized clinical study to demonstrate the non-inferiority of 4-factor PCC to plasma through clinical endpoints and to show superiority through bioanalytical endpoints.

The Phase IIIb study results showed that the hemostatic efficacy of 4-factor PCC was comparable to plasma at 24 hours in patients who required urgent reversal of warfarin therapy (72.4 percent and 65.4 percent, respectively). Additionally, the co-primary efficacy endpoint analysis showed that the 4-factor PCC was superior in achieving target INR correction within 30 minutes at the end of infusion as compared to plasma (62.2 percent and 9.6 percent, respectively). Four-factor PCC was also superior to plasma in rapidly and safely raising the levels of clotting factors II, VII, IX, X, and anticoagulant Proteins C and S at the same 30 minutes post-treatment time point (p values<0.0001).

"Patients on warfarin therapy are susceptible to acute and serious bleeding. For the physician, quickly stopping that bleeding is absolutely critical," said Ravindra Sarode, M.D., Director of Transfusion Medicine and Hemostasis Reference Laboratory at the University of Texas, Southwestern Medical Center, who presented the data. "This trial demonstrates that 4-factor PCC may offer healthcare professionals an important new treatment advance over plasma in managing patient outcomes in an important critical care setting."

The study also found that PCC was well-tolerated in patients and that the incidences of severe treatment-emergent adverse events, serious adverse events and deaths were generally similar between the PCC and plasma groups. Also, PCC was shown to possibly reduce the risk of transfusion-associated circulatory overload - that is, when too much fluid is transfused or transfusion is too rapid, which can lead to cardiac events - when compared to plasma (8.7 percent compared to 19.3 percent, respectively).

"We are very encouraged by the results, as this is the first and largest randomized clinical study showing 4-factor PCC is highly effective in reducing INR and increasing factor levels to support hemostatic efficacy during warfarin-induced bleeding," said Russell Basser, M.D., Senior Vice President, Global Clinical R&D, at CSL Behring. "CSL Behring is advancing our investigational 4-factor PCC through rigorous clinical study with the goal of bringing to the United States a safe, effective new treatment option for people who are at risk of major bleeding that results from warfarin use."

About Prothrombin Complex Concentrate (PCC) (Human)

Prothrombin complex concentrates (PCC) are derived from human plasma. CSL Behring's investigational PCC contains four important pro-coagulant factors in significant quantities: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as anticoagulant Proteins C and S.

Guidelines from the American College of Chest Physicians recommend 4-factor PCC, rather than plasma, for rapid reversal of anticoagulation in patients with vitamin K antagonist associated major bleeding. The guidelines also recommend the use of vitamin K (5 to 10 mg) administered by slow intravenous (IV) infusion rather than reversal with coagulation factors alone.

About the Study

This was an open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of human 4-factor prothrombin complex concentrate (PCC) to plasma for rapid reversal of acute major bleeding in patients receiving warfarin therapy. The study enrolled 212 patients. The primary endpoint was hemostatic efficacy with respect to the adequacy of stopping an ongoing major bleed within 24 hours from the start of infusion. The secondary endpoints evaluated plasma levels of major clotting factors (Factors II, VII, IX, X, proteins C and S); time to INR correction; number of transfusions, amount of blood products used, and hemostatic agents; and safety and tolerability (including all-cause mortality).

3 Chinese drug makers recall 13 chromium-tainted (porcine)gelatin products

Three pharmaceutical companies have recalled their chromium-contaminated drug capsules after authorities suspended sales of 13 types of problematic medicines.
Tonghua Yason Pharmaceuticals in Northeast China's Jilin province said the company decided to recall all tainted products made since 2010.
"Pharmaceutical producers do not possess the capability to examine capsules, so we just simply checked the quality report provided by capsule suppliers and then let them go," an anonymous official with the company's product quality department was quoted as saying by stcn.com, a website run by Securities Times.
But the company said the producer of the problematic capsules was a Zhejiang-based company and was not among those exposed by media.
China Central Television revealed in an investigative program on Sunday that nine pharmaceutical companies were packaging medicines with capsules made with industrial gelatin, which contains a much higher degree of chromium than edible gelatin.
The industrial gelatin was made from waste leather at plants in Jiangxi, Zhejiang and Hebei provinces, according to the report. (Pictured above:  Huge piles of substandard leather scraps at the warehouse of Xueyang Gelatin and Glair Factory in Hengshui, Hebei province, were used to make gelatin that was sold to capsule makers. Wang Min / Xinhua).
Normally, capsules are made with material from animal bones.
Excessive intake of chromium can result in chronic diseases. 

Jilin-based Huinan Tianyu Pharmaceutical posted a statement on its website saying that it is recalling the batch of products exposed by CCTV, but "those products were not problematic because they were produced in 2009 and they accorded with the standards set in related code released in 2000".
The Chinese Pharmacopoeia, amended in 2010, permits no more than 2 milligram of chromium per 1 kilogram of medicine. Before that, the cap was 5 mg per 1 kg for heavy metal, but it had no specific stipulation about chromium, said the announcement.
The company's products were found with 3.54 mg of chromium per 1 kg of medicine.
Dandong Tongyuan Pharmaceutical in Northeast China's Liaoning province also announced the recall of its chromium-contaminated products, according to China News Service.
Xiuzheng Pharmaceutical Group in Jilin said in a statement on its website that the company has suspended sales of the problematic products but said "the capsule suppliers we pick are quality firms that meet all the country's standards and we are re-examining those products".
After the chromium scandal was exposed, websites for three pharmaceutical companies involved, including Xiuzheng, were hit by hackers.
Song Xunjie, a manager with Xueyang Gelatin and Glair Factory in Hebei province, was detained on Monday by police and suspected of setting fire to his factory to eliminate evidence.
The fire did not cause any casualties. The factory had suspended production and police sealed 200 tons of products there.
The factory mainly sold products in Beijing and Zhejiang, as well as cities such as Changzhou, Jiangsu province, and Xiamen, Fujian province, according to Xinhua News Agency.
Sun Zhongshi, an expert with the National Rational Drug Use Monitoring System under the Ministry of Health, said the drug watchdog paid more attention to the quality of medicine inside the capsules rather than the capsules themselves, and should draw a lesson from this scandal.

SOURCE: China Daily

Have J&J Learnt From Baxters Chinese Pig Heparin Experience ? ?

May 03, 2012 -- Johnson & Johnson (China) Investment Ltd announced today the acquisition of Guangzhou Bioseal Biotechnology Co Ltd, a biopharmaceutical company specialising in the design, development and commercialisation of a porcine plasma-derived biologic product for controlling bleeding during surgery.

Financial terms of the transaction were not disclosed.

The company said that the acquisition was completed after obtaining all necessary Chinese Government approvals.

Bioseal manufactures a porcine-derived fibrin sealant, BIOSEAL, currently the only porcine plasma-derived fibrin sealant approved for use in China. Fibrin sealants are used by surgeons as an adjunct to haemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.

Bioseal will work closely with Ethicon Inc, a Johnson & Johnson company, which offers a complete line of absorbable haemostats with a commitment to advancing the future of biosurgery beyond haemostasis, to seal leaks, join structures and enhance healing. The acquisition of Bioseal will reportedly complement Ethicon's existing biosurgery portfolio and will allow the business to immediately enter the fibrin sealant market in China, broaden product offerings and create an opportunity to increase global reach by introducing advanced biologic solutions that meet the various needs of more physicians and patients, throughout Asia and around the world.

This is reportedly the first acquisition in the medical device industry for Johnson & Johnson (China).

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