Grifols to Acquire Talecris Biotherapeutics Creating a World Leading Provider of Life-Saving Plasma Protein Therapies

BARCELONA, Spain and RESEARCH TRIANGLE PARK, N.C., June 7, 2010 /PRNewswire via COMTEX/ -- Grifols (GRF.MC) a global healthcare company and leading producer of plasma protein therapies, and Talecris(TLCR 19.97, +4.06, +25.48%) a U.S.-based biotherapeutics products company, today announced that they have signed a definitive agreement through which Grifols will acquire Talecris for a combination of cash and newly-issued Grifols non-voting shares having an aggregate value today of approximately $3.4 billion (euro 2.8 billion), creating a global leader of life-saving and life enhancing plasma protein therapeutics.

The combination of Grifols and Talecris will create a vertically integrated and diversified international plasma protein therapies company, bringing together complementary geographic footprints and products, as well as increased manufacturing scale. Grifols' leading global footprint will benefit from Talecris' strong presence in the United States and Canada. Grifols' available manufacturing capacity will enable Talecris to increase production in the near term. As a result, the combined company will be better able to meet the needs of more patients with under-diagnosed disease states around the world.

In addition, upon completion of the transaction, the combined company will have:

• the ability to derive more protein therapies from every liter of plasma, enhancing access and availability for patients, and optimizing use of collected plasma;
• an established plasma collection operation capable of meeting the combined company's needs to address increasing patient demand and an accelerated path to improving the cost efficiency of the Talecris plasma platform;
• a broad range of key products addressing a variety of therapeutic areas such as neurology, immunology, pulmonology and hematology, among others;
• an enhanced R&D pipeline of complementary products and new recombinant projects that will drive sustainable growth;
• a well established clinical research program in the U.S.

Grifols Chairman and CEO Victor Grifols commented, "The acquisition of Talecris furthers our vision to better serve patients and health care professionals with innovative products, a strong clinical research capability and new research into recombinant therapies. We look forward to combining the strengths of both companies to improve the quality of the lives of patients around the world, while positioning the enlarged group for long term profitable growth."

Talecris Chairman and CEO Lawrence D. Stern commented, "We believe that Grifols' well-established reputation, know-how and expertise will enable the combined entity to meet the needs of more patients. Our employees will benefit from the opportunities available to them as part of a larger, global organization committed to the expansion of Talecris' existing business, the development of our pipeline products, and the maintenance of our culture of compliance and quality. Importantly, our stockholders will realize a compelling premium and benefit from the ability of the combined business to accelerate key gross margin improvement opportunities within Talecris."

CryoLife purchases recombinant human serum albumin and gluteraldehyde formula

ATLANTA, June 7 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company whose products include BioGlue Surgical Adhesive, announced today that it has completed the purchase of U.S. patent # 6,329,337. The patent involves the formulation and use of recombinant human serum albumin and gluteraldehyde, and now becomes part of CryoLife's protein hydrogel patent portfolio, which includes BioGlue.

"CryoLife will continue to invest in emerging and adjacent intellectual property and tools that will complement our portfolio of surgical adhesives and glues for surgeons," said CryoLife president and CEO Steven G. Anderson. "With our acquisition of this technology, we have an additional opportunity to expand and strengthen our surgical adhesive portfolio," Anderson added.

CryoLife's BioGlue Surgical Adhesive is the leading surgical adhesive used in cardiovascular surgery around the world and is used in a wide range of reconstruction procedures. Composed of purified bovine serum albumin (BSA) and gluteraldehyde, BioGlue has been used in more than 550,000 surgical procedures and has been published in more than 250 preclinical and clinical papers discussing safety, efficacy, and application techniques since its launch in 1998.

"The strength of BioGlue assures the surgeon that delicate tissues are well reinforced and assists in controlling bleeding in complex surgery. We believe that these and other properties of BioGlue Surgical Adhesive make it a leading sealant used in complex cardiac and vascular surgery," Anderson said.

Surgical Complications of bleeding, infection dehiscence and necrosis are interelated

Miami — Keeping good closures from going bad requires not only thorough patient education and surgical planning by the physician, but also patient adherence to pre- and post-surgical instructions, according to an expert who spoke at the 68th annual meeting of the American Academy of Dermatology.

Common surgical complications include bleeding, infection, dehiscence and necrosis, all of which are usually interrelated, says Emily J. Fisher, M.D., chief of cosmetic and laser dermatology, Lahey Clinic, Burlington, Mass. "It's very unlikely to have one of these without a second, third or fourth complication occurring," she says.

Typical examples include lower-leg complications, where lack of skin laxity and excess wound tension can lead to tissue ischemia and necrosis, as well as infection and dehiscence.
Bleeding risks

Bleeding and infections represent the most common types of postsurgical complications, Dr. Fisher says. "Minor hemorrhagic complications include increased intraoperative bleeding, which can be a challenge. But if you get it under control, it doesn't usually cause long-term problems," she says.

However, intraoperative bleeding also can increase the length of procedures and drive surgeons to choose less-than-optimal closures. "If the patient is having significant bleeding, performing a complicated flap or graft can be challenging and poses an increased risk of bleeding due to the amount of undermining necessary," Dr. Fisher says. "As a result, a surgeon may opt to perform a simpler closure to decrease this risk, but that may not be the best from a cosmetic standpoint.

"More worrisome complications include postoperative bleeding," she says. "That may require flap takedown and additional hemostasis." Often, Dr. Fisher's patients who experience postoperative bleeding will seek treatment at emergency rooms — even though she warns them not to — where ER physicians may make unwise or unnecessary alterations to the flap or graft. Fortunately, she says, although studies show postoperative bleeding is the most common dermatosurgical complication, it only impacts about 2 percent of patients (Cook JL, Perone JB.Arch Dermatol. 2003 Feb;139(2):143-152).

Full Article HERE

J&J comment on EU market and the US release of Fibrin Pad

Johnson & Johnson's (JNJ) big medical devices and diagnostics unit anticipates that pressure on product prices in Europe will rise over the long term but not immediately, the unit's top official said Thursday.
J&J also said it expects the portion of the $350 billion devices and diagnostics market it competes in to grow at a faster rate than the overall market.
Additionally, the company anticipates that unit will make about 80 "significant" regulatory filings between 2010 and 2010.
J&J, which is dealing with fallout from the recent recall of children's medicines, is holding an all-day review Thursday for the devices and diagnostics unit. That unit grew sales by 2% to $23.6 billion last year and became J&J's largest segment, eclipsing a pharmaceutical business that has been pressured by competition from generic drugs.
The segment derived more than half of its sales last year from outside the U.S. A big question for device and drug companies these days is how the European debt crisis will affect product prices as governments try to rein in health spending.
"I think longer term we clearly see there being increased pricing pressure," Alex Gorsky, worldwide chairman for J&J's devices and diagnostics unit, said during the meeting. But there are reasons to believe it won't be an "immediate" issue, and doesn't mirror the situation with drug prices, he said.
These reasons include the tendering systems used to purchase devices and the dynamics between hospitals and governments, he said.
Pricing in Europe remained a top issue when analysts asked questions. Gorsky told them the pricing issue is difficult to forecast. He also said J&J hasn't seen a slowdown in procedure volumes that could also impact sales, but added "we'll have to watch closely."

Healthcare company Johnson & Johnson (JNJ), Thursday revealed growth strategies and product pipeline information for its Medical Devices & Diagnostics Segment. The company said the segment was its largest, and that new products and acquisitions would help sustain its market-leading position in the $350 billion, worldwide medical device and diagnostics market.
The New Brunswick, New Jersey-based company provided information on products that have been launched already or are on the anvil for the current fiscal, from its seven global franchises.
Ethicon Endo-Surgery, a maker of surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products is rolling out a host of new products, J&J said. They include new energy instruments as part of its HARMONIC family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency.
Further, Ethicon continued to focus on patient comfort and surgeon ease-of-use as it built its portfolio of hernia repair products with ETHICON PHYSIOMESH Flexible Composite Mesh and its first entry into the hernia mesh fixation market with ETHICON SECURESTRAP 5mm Strap Fixation Device.
Ethicon Endo-Surgery would make a BLA filing in the U.S for its Fibrin Pad in the fourth quarter. The product combines two biomaterials and two biologics to stop bleeding during surgical procedures.

Cytomedix to Present at Sixth Annual Noble Financial Equity Conference

ROCKVILLE, Md., June 1, 2010 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex:GTF) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will participate in the Sixth Annual Noble Financial Equity Conference taking place June 7-8, 2010 at the Seminole Hard Rock Hotel in Hollywood, Florida.

Martin Rosendale, President and CEO of Cytomedix, will present a corporate update on Tuesday, June 8, 2010 at 1:30 p.m. ET in which he will provide an overview of Cytomedix, including an update on the integration of its recent acquisition of the Angel® Whole Blood Separation System and the activAT® Autologous Thrombin Processing Kit from the Sorin Group.

Company management will be available for one-on-one meetings with investors participating in the Noble Financial Equity Conference. For those who would like to schedule an appointment with Cytomedix's management, please contact Anne Marie Fields, Lippert/Heilshorn & Associates, Inc., at 212-838-3777 or at afields@lhai.com or contact your Noble Financial representative.

The presentation will be video webcast live at www.cytomedix.com where it will also be archived for 90 days.

About Cytomedix

Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, to primarily address the areas of wound care, inflammation, and angiogenesis. The Company currently markets the AutoloGel™ System, a device for the production of platelet rich plasma ("PRP") gel derived from the patient's own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP") in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from platelet poor plasma. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its products. Cytomedix is also pursuing opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics, as well as actively seeking complementary products for the wound care market. The Company also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing, or sale. Most notably is its anti-inflammatory peptide (designated "CT-112") that has shown promise in pre-clinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.

Minimallly invasive option to partial nephrectomy and the 5 % to 10 % risk of bleeding and need for transfusion

DALLAS – June 4, 2010 – A minimally invasive technique used to destroy kidney tumors with an electrically controlled heating probe showed similar effectiveness as surgical removal of tumors in curbing cancer recurrence rates for up to five years after treatment.
In an article available online in the journal Cancer, Dr. Jeffrey Cadeddu, professor of urology and radiology at UT Southwestern Medical Center, reported the outcomes of more than 200 patients who were treated with radiofrequency ablation (RFA).
Once the diagnosis of tumor is confirmed and the RFA technique is agreed upon, a needle-like probe is placed inside the tumor. The radiofrequency electricity waves passing through the probe heat up tumor tissue and destroy it. Surgeons view the RFA procedure with the aid of imaging devices such as computed tomography (CT scan).
Of the 208 patients who underwent the RFA procedure, 160 were diagnosed with renal cell carcinoma, a type of kidney cancer that is slow-growing but malignant and able to spread easily to other organs. Those patients had three- and five-year survival rates of more than 95 percent.
"These types of cancers aren't typically fast-growing, but there are between 40,000 and 50,000 cases of kidney cancers diagnosed each year in the United States," Dr. Cadeddu said. "The fact that cancer survival rates were comparable to surgical interventions is very encouraging."
Currently, many patients who are diagnosed with primary tumors that originate inside the kidney are treated surgically.
"The standard treatment is usually a partial nephrectomy, where the surgeon removes the tumor and some surrounding tissue via open or laparascopic surgery," said Dr. Cadeddu. "With surgery, there is a 5 percent to 10 percent risk of bleeding and an associated need for transfusion, as well as an increased chance of readmission for the patient. Of course, the recovery time is longer as well."
With open surgery, surgeons go in through a patient's abdomen or flank to remove the kidney tumor. A laparascopic partial nephrectomy involves doctors accessing the organ through several small incisions in a patient's abdomen. The recovery time for open surgery is about six to eight weeks and three to four weeks for laparascopic procedures.
With RFA, 90 percent of the patients are able to go home the same day, said Dr. Cadeddu, but the real advantage to RFA is its superior preservation of kidney tissue.
"Preserving kidney function has been clearly demonstrated to maximize quality of life and length of life for patients with kidney tumors," Dr. Cadeddu said. "Whenever possible, we try to save as much of the kidney as we can."

Devices, Drug Cut Bleeding Risk in PCI

Combining the direct thrombin inhibitor bivalirudin (Angiomax) with vascular closure devices was associated with the lowest rate of bleeding complications in patients undergoing percutaneous coronary intervention (PCI), a large database analysis showed.

Among more than 1.5 million PCI patients in the National Cardiovascular Data Registry (NCDR), 0.9% suffered bleeding complications when both bivalirudin and vascular closure devices were used, according to Steven P. Marso, MD, of the University of Missouri in Kansas City, and colleagues.

The highest rate, 2.8%, was seen in patients for whom manual compression was the sole means of bleeding control, the researchers reported in the June 2 issue of the Journal of the American Medical Association.

Rates associated with vascular closure devices and bivalirudin alone were 2.1% and 1.6%, respectively (P<0.001>for differences):

6.1%, manual compression
4.6%, vascular closure devices
3.8%, bivalirudin
2.3%, vascular closure devices plus bivalirudin

But Marso and colleagues also found that the combination approach was used more often in low-risk patients. Only 14.4% of high-risk patients had both bivalirudin and closure devices for bleeding control, compared with 21.0% of low-risk patients.

By the same token, 40.3% of high-risk patients had manual compression versus 30.8% of low-risk patients.

"This apparent risk-treatment paradox highlights an opportunity for routine preprocedural risk stratification as a means to identify patients ideally suited for individualized bleeding avoidance strategies with the goal of increasing the safety of PCI," Marso and colleagues wrote.

"Targeting bleeding complications as a quality-improvement goal holds great potential for improving the safety and cost-effectiveness of PCI," they added.

The study examined outcomes in 1,522,935 patients undergoing PCI at 935 hospitals participating in the data registry from 2004 to 2008.

Among them, 30,654 had inhospital bleeding complications. These were defined in three ways: serious enough to warrant transfusion or a prolonged hospital stay for management, or leading to a decrease of more than 3 g/dL in blood hemoglobin content.

Bleeding risks were predicted on the basis of age, gender, peripheral vascular disease, renal function, previous congestive heart failure, previous PCI, and whether patients had myocardial infarction with ST-segment elevation. The risk prediction model had been developed previously from NCDR data.

Marso and colleagues suggested several potential explanations for the lower use of the drug-plus-device strategy in high-risk patients.

One is that assessing patients for bleeding risk is neither easy nor common, they indicated. Another is that familiarity with bivalirudin and/or closure devices outside the elective PCI setting may be limited.

"The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies," Marso and colleagues wrote, adding that interventions to encourage pre-PCI risk assessment should be tested.

In a statement, Ralph Brindis, MD, MPH, president of the American College of Cardiology, said the study's findings would themselves help reverse the paradox.

"Assessing a patient's risk of bleeding prior to PCI can help improve its safety by utilizing proven bleeding avoidance strategies for patients most likely to benefit from the procedure," he said. "This study identifies how we can adapt our practices to focus on individual comorbidities and provide even greater high-quality, patient-centered care."

Kirk Garratt, MD, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, commented in a statement that the data do suggest "a synergy between drug and device."

"My only concern is that we don't know how many patients were considered for a closure device but didn't get one," he said.

"We always take a picture of the artery after we put the sheath in, to see if a closure device will work. Sometimes we learn that the artery has been punctured in a way that increases bleeding and prevents use of closure devices," he observed.

The authors noted several limitations of the study. "First, this was not a randomized trial; thus, a causal relationship between bleeding avoidance and evaluated strategies cannot be concluded. Second, potential unmeasured confounding is a limitation of all observational studies."

Kuros Completes Patient Recruitment

Zurich, Switzerland, 2nd June 2010 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has completed recruitment in a 200 patient Phase IIb clinical trial designed to assess the efficacy and safety of KUR-113 (Viz.I-040202) in open tibial shaft fractures.
This study is a randomized, controlled, open-label (dose-blinded) dose finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures. The aim of the trial is to assess the safety and efficacy of KUR-113 in combination with standard of care (SOC) vs SOC alone. The use of KUR-113 is designed to improve bone healing by reducing the time needed to achieve bone healing as well as the incidence of secondary interventions.
KUR-113 utilizes Kuros’ “TG-hook” technology for binding proprietary biologics into a fibrin sealant. The product candidate is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant and is applied directly to the fracture site in the form of a paste. KUR-113 has been designed to deliver vPTH locally at the fracture site and to maintain this via the slow controlled release of vPTH over time from the fibrin matrix. The fibrin matrix also plays a further important role in the bone healing process by providing a physical scaffold for cell ingrowth. The trial will assess whether this approach is safe and efficacious.
A total of 200 patients have been randomized and treated in over 31 centers across Europe. The primary endpoint of this study is the proportion of patients healed at 6 months after surgery when compared to SOC alone. Kuros is expecting to report the outcome of this study in the first half of 2011.
Dr. Virginia Jamieson, Chief Medical Officer of Kuros, commented: “We are very pleased to have completed recruitment for this study with KUR-113 and we look forward to reporting the results of this novel approach to the treatment of open tibial shaft fractures in the first half of 2011.”
KUR-113 is licensed to Baxter International Inc. under a collaboration and license agreement which was signed in 2005. Following the successful completion of this study, Baxter will take over responsibility for the further development of KUR-113.
Didier Cowling, Chief Executive Officer of Kuros, commented: “Completion of patient recruitment in this large Phase IIb study is another significant step for Kuros. We look forward to broadening the application of this technology to additional orthopedic settings”

A compound found in sunless tanning spray may help to heal wounds following surgery

Results published today in the Proceedings of the National Academy of Sciences show that a sticky gel composed of polyethylene glycol and a polycarbonate of dihydroxyacetone (MPEG-pDHA) may help to seal wounds created by surgery.

Procedures to remove cancerous breast tissue, for example, often leave a hollow space that fills with seroma fluid that must typically be drained by a temporary implanted drain. "This is an unpleasant side effect of surgery that is oftenunavoidable," explains Dr. Jason Spector, co-author of the study and plastic surgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

The gel could potentially be used in all different reconstructive surgeries to prevent seroma formation. "The new substance would act to glue together the hole left behind to prevent seroma buildup," says Dr. Spector.

DHA is a compound that sticks to compounds in biological tissues, called amines. The sticky properties of DHA are what allows sunless tanner to adhere to the skin without being wiped off. However, it is biodegradable and water soluble as well, which means that the compound does not stay tacked onto the body's tissues forever. Currently used "bio-glues" are made from animal products and take a long time to degrade in the body -- both factors that raise the risk of infection.

"DHA is a compound that is naturally produced in the body," explains Dr. David Putnam, the study's senior author and a biomedical engineer from Cornell University's Department of Biomedical Engineering and School of Chemical and Biomolecular Engineering. "The glue is broken down, or metabolized, and then safely removed by the body."

Dr. Putnam's lab and his collaborators work to create safe, synthetic compounds from chemicals found in nature. DHA is an intermediary compound produced during the metabolism of glucose, a sugar used by the body for fuel.

To create the new compound, MPEG-pDHA, Dr. Putnam and his lab first bound the single molecule monomer of DHA, which is highly reactive, to a protecting group molecule, making it stable enough to manipulate. This allowed the engineers to bind the monomers together to form a polymer, or chain of molecules, along with MPEG. Doing so allows the polymer gel to be injected through a syringe.

"Making a polymer from DHA has eluded chemical engineers for about 20 years," says Dr. Putnam.

Now in gel form, the compound has the ability to stick tissues together, preventing the pocket from filling with seroma fluid, like an internal Band-Aid, explains Dr. Putnam. The researchers found that the gel prevented or significantly lowered seroma formation or fluid buildup in rats that had breast tissue removed.

"The next step would be to test the gel on larger animals and then in clinical trials in human surgical cases," says Dr. Spector.

Previous results, published by Drs. Putnam and Spector, in the August 2009 issue of the Journal of Biomedical Materials Research, showed that the gel also prevented bleeding in a rat liver.

"This is another aspect of the compound that would be greatly beneficial if proven to be applicable in humans," says Dr. Spector. "The gel could speed the healing and decrease bleeding within the body."

Talecris Biotherapeutics to Present at the 2010 Citi Investment Research Global Health Care Conference

RESEARCH TRIANGLE PARK, N.C., May 20 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics Holdings Corp. (Nasdaq:TLCR) today announced that Lawrence D. Stern, chairman and chief executive officer of Talecris, will present at the 2010 Citi Investment Research Global Health Care Conference at 11:30 a.m., Thursday, May 27, 2010, at the Hilton New York Hotel inNew York, N.Y.

A live webcast of Talecris' presentation will be accessible through the investor relations section of the Talecris Web site,www.talecris.com/investor-relations.htm. A replay of the webcast will be available until June 10, 2010, and can be accessed at the same Web address.