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Biotech / Medical : Cohesion Technologies, Inc (CSON) -- Ignore unavailable to you. Want to Upgrade?


To: RockyBalboa who wrote (13)5/22/1999 9:25:00 PM
From: Mad2  Respond to of 28
 
MEDICAL MATERIALS UPDATE

March, 1999

SECTION: BIOLOGICALS; Vol. 6, No. 2

LENGTH: 438 words

HEADLINE: Cohesion Technologies Begins Coseal Study

BODY:
According to an article in the Palo Alto, California BW HealthWire (March 1, 1999) Cohesion Technologies (2500 Faber Place, Palo Alto, CA 94303; Tel: 650/354-4300, Fax: 650/354-4675) has begun its feasibility study for its trademarked CoSeal surgical sealant, designed to seal anastomotic sites in vascular and cardiovascular surgery. The feasibility study is being conducted at three sites in Europe, and will include up to 15 patients undergoing peripheral vascular surgery, such as grafting procedures. The clinical endpoint of the feasibility study will be to time the cessation of leakage.

Based on proprietary hydrogel technology, CoSeal surgical sealant is designed to bond strongly and rapidly to tissue, forming a seal that prevents blood leakage in cardiovascular and vascular surgeries. CoSeal surgical sealant is a self-polymerizing gel that does not require additional equipment such as light sources or heat for activation. The delivery system is easily prepared in less than five minutes. The product is totally synthetic and is completely resorbed within 30 days. Patient enrollment is expected to be completed within four to six weeks. With favorable results, the company will begin a larger, pivotal clinical trial in Europe.

"This product, even in its early concept phase, received very favorable responses from surgeons who observed product demonstrations," said David Foster, CEO. "Surgical repair necessitates the opening or puncturing of body cavities, organs and vessels, and compromises barriers that normally prevent leakage in the body. The consequences of this leakage can range from minor inconvenience to life-threatening events, and can be especially serious in vascular and cardiovascular surgical procedures. We believe CoSeal surgical sealant may offer surgeons significant competitive advantages including that (it) is completely synthetic, takes about five minutes to prepare, and self-polymerizes at the surgical site in seconds."

Cohesion Technologies is developing products for the estimated $ 1.3 billion worldwide surgical hemostasis and sealant markets. CoSeal surgical sealant is the second product developed by Cohesion. The first, its trademarked CoStasis surgical hemostat designed to treat diffuse bleeding, was recently commercialized in selected European countries. A U.S. pivotal clinical trial with CoStasis surgical hemostat for the treatment of diffuse bleeding in cardiothoracic, hepatic, general, and orthopedic surgical procedures was recently completed, and the company expects to file a pre-market approval application with the FDA in the spring of 1999.

LANGUAGE: ENGLISH

LOAD-DATE: March 26, 1999



To: RockyBalboa who wrote (13)5/22/1999 9:28:00 PM
From: Mad2  Respond to of 28
 
Copyright 1999 Medical Data International, Inc.
Medical Industry Today

February 18, 1999, Thursday

SECTION: DEVICE AND DIAGNOSTICS

LENGTH: 897 words

HEADLINE: CoStasis Launch May Lead to Better Control of Bleeding

BODY:
Surgeons in various parts of Europe soon will have access to a new resource in their efforts to control bleeding.

COHESION TECHNOLOGIES' (Palo Alto, CA) European distributors have launched commercial sales of CoStasis--a liquid hemostat designed to control diffuse surgical bleeding--in Austria, Germany and the United Kingdom. The company received the CE Mark for the product in September.

In the next several months, the company expects to finalize agreements and training programs with more distributors and to roll-out the product into Belgium, Denmark, Finland, France, Italy, the Netherlands, Norway, Portugal and Spain.

The pre-mixed, ready-to-use collagen/thrombin suspension is supplied in one syringe and is mixed with the patient's own plasma from a second syringe at the time of application to the bleeding site. CoStasis remains intact during the critical wound-healing period, and then is absorbed and eliminated by the body.

"We have begun to assemble a distributor network with proven ability to build a market for new, innovative products, and we look forward to bringing the many advantages of CoStasis to physicians and their patients across Europe. During 1998, it is estimated that Europe's 2,000 cardiovascular surgeons performed approximately 300,000 surgical procedures, in which control of bleeding was essential," said Alan Schempp, vice president of sales and marketing, in a statement.

"Surgeons in Europe and Japan have been using fibrin glues and sealants for years to stop bleeding, but these products suffer from a variety of clinical and usage problems that CoStasis specifically addresses."

Compared to current products, CoStasis has several advantages, according to Schempp. He said that they include:

Versatility. CoStasis is designed to be more adherent and elastic than current products, which enables it to bind strongly to various tissue surfaces, including rough and intricate areas.

Easy Preparation. CoStasis is designed as a two-part system, prepared in about 5 minutes just before it is needed.

Ease of Use. CoStasis is a self-polymerizing liquid system with no need for equipment such as light sources or heat for activation or efficacy. And the patent-pending delivery system gives the surgeon flexibility to use the same system throughout the surgical procedure.

Safety. CoStasis uses the patient's plasma, eliminating potential contamination risks inherent with products derived from pooled human sources.

Cost Effectiveness. CoStasis is designed to give the surgeon the flexibility to determine whether to use the product during the surgical procedure. In comparison, current products have lengthy preparation times and require the surgeon to commit to use before a determination of need.

"Our initial shipments of CoStasis this quarter are expected to be modest," Schempp said. "We anticipate that it will take a couple of quarters to gradually broaden our distributor coverage and our range of product configurations in Europe."

Cohesion's sales efforts in Europe are under the direction of Hubert Goossens, who joined the Company last month as director of sales for Europe, the Middle East and Africa.

The company is manufacturing CoStasis at its Palo Alto headquarters.

Meanwhile, the company is pursuing FDA approval for the product. The U.S. pivotal clinical study with CoStasis for treating diffuse bleeding in cardiothoracic, hepatic, general and orthopedic surgical procedures is completed, and the company expects to file a Premarket Approval application with the FDA this spring.

In a statement last month, the company reported preliminary findings from its 300-patient, randomized clinical study conducted at 10 major U.S. medical centers using CoStasis for treatment of bleeding in cardiovascular, hepatic, general and orthopedic surgery procedures.

Preliminary findings showed that CoStasis stopped bleeding in soft tissue applications in about 98 percent of the treated patients within 3 to 10 minutes depending on the surgical site, compared with about 70 percent in the control group treated with a collagen hemostatic sponge. Also, CoStasis stopped bleeding in one-third to one-half the time of the control group. Bleeding stopped in less than 2 minutes from application in more than 70 percent of patients treated with CoStasis, compared with almost 40 percent of the patients in the control group.

The company said that CoStasis also performed well in difficult-to-treat hard tissue bleeding (the sternal edge and iliac crest), as bleeding stopped in more than 85 percent of the treated sites within 3 to 10 minutes depending on the site, compared with about 50 percent for the control group. Furthermore, in more than 70 percent of the hard tissue sites, bleeding was stopped within 2 minutes using CoStasis, compared with about 25 percent for the control group.

CoSeal Surgical Sealant, the company's second product candidate, is being designed to prevent leakage of blood in cardiovascular and vascular surgeries. CoSeal is in preclinical development.

Cohesion Technologies develops products for the surgical hemostasis and sealant markets.
CONTACT: Lisa Morgensai, Cohesion Technologies (650/354-4300)

Copyright 1999 Medical Data International Inc. All rights reserved. Reprints may be obtained by permission. Contact MDI account representatives, (800) 826-5759.

LANGUAGE: ENGLISH

LOAD-DATE: February 17, 1999



To: RockyBalboa who wrote (13)5/22/1999 9:31:00 PM
From: Mad2  Respond to of 28
 
BIOWORLD Today

May 13, 1999

SECTION: No. No. 92, Vol. Vol. 10; Pg. NA

IAC-ACC-NO: 54631195

LENGTH: 676 words

HEADLINE: OTHER NEWS TO NOTE.

AUTHOR-ABSTRACT:
THIS IS THE FULL TEXT: COPYRIGHT 1999 American Health Consultants Inc. Subscription: $ 1,350 as of 1/97. Published daily. Contact American Health Consultants, 3525 Piedmont Road NE, Building 6, Ste. 400, Atlanta, Georgia 30305. Phone (404) 262-7759, Fax (404) 814-0759.

BODY:
Ariad Pharmaceuticals Inc., of Cambridge, Mass., completed a Phase I study of its small-molecule drug, AP1903, which is being developed for treating graft-vs.-host disease in transplant patients. There were no drug-related adverse events and it was well tolerated. It was the first trial of an Ariad ARGENT Dimerizer Drug.

CoCensys Inc., of Irvine, Calif., entered into an agreement to sell its position in Cytovia Inc. for $ 3.3 million. Cytovia was formed last year as a technology spin-off from CoCensys to commercialize apoptosis inhibitor and screening cell technology. Entities affiliated with the venture capital firm Domain Associates LLC purchased the stake. CoCensys also entered into an agreement to repurchase up to $ 3.18 million of its Series E preferred stock.

Cohesion Technologies, of Palo Alto, Calif., said it generated a thermally stable human Type I collagen and gelatin in yeast, in a proprietary form. The company also generated, along with partner Pharming BV, of Leiden, the Netherlands, a founder transgenic male calf named Columbus with the human procollagen genes present.

ImClone Systems Inc., of New York, will start a second Phase III trial of its lead cancer drug, C225, in patients with advanced squamous cell head-and-neck carcinoma. The news triggered a $ 3 million milestone from its corporate partner, Merck KgaA, of Darmstadt, Germany. C225, a monoclonal antibody, inhibits activity of epidermal growth factor receptor associated with cancer cell growth in a number of solid tumors. The trial's endpoints will be response and time to disease progression.

Medarex Inc., of Annandale, N.J., and Germany-based Schering AG amended their antibody development agreement. Medarex now will use its HuMAb-Mouse technology to produce fully human antibodies to three new antigens. Medarex could receive additional license fees, milestone payments and royalties.

Neurogen Corp., of Branford, Conn., and Pfizer Inc., of New York, further extended their 1995 collaboration on development of obesity drugs that work through the neuropeptide Y transmitter. The one-year extension will fund Neurogen's work through October 2000. The companies are working separately on projects involving the GABA neurotransmitter.

Onyx Pharmaceuticals Inc., of Richmond, Calif., expanded its Phase I study of ONYX-015, its lead anticancer agent, to include patients with Barrett's esophageal metaplasia, a precursor to esophageal cancer involving localized lesions in the esophagus. The test will evaluate the safety, maximum tolerated dose and biological activity of ONYX-015 when administered via intralumenal lavage. ONYX-015 is a genetically engineered adenovirus that has been shown to replicate in and kill tumor cells.

PathoGenesis Corp., of Seattle, has started selling TOBI (tobramycin solution for inhalation) in Canada. TOBI, the first aerosolized antibiotic solution approved by the Health Protection Branch of Canada, is marketed for the management of cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa infections. TOBI also is approved in the U.S.

Ribozyme Pharmaceuticals Inc. (RPI), of Boulder, Colo., reported that Eli Lilly and Co., of Indianapolis, purchased $ 7.5 million of RPI stock as part of its agreement to develop ribozymes for the treatment of hepatitis C. As part of the agreement, RPI could eventually receive up to $ 38 million in pre-product revenues.

SuperGen Inc., of San Ramon, Calif., has more than doubled the number of cancer centers participating in its Phase III trial of RFS 2000, its proprietary drug to treat pancreatic cancer. SuperGen added 75 clinics operated by Dallas-based Physician Reliance Network, bringing the total number of centers to 132.

Teva Pharmaceutical Industries Ltd., of Jerusalem, reported that the Swiss Intercantonal Medicines Control office approved Copaxone for the treatment of relapsing-remitting multiple sclerosis. Although Copaxone is licensed in 13 other countries, this is the drug's first Western European approval.

LANGUAGE: ENGLISH

IAC-CREATE-DATE: May 14, 1999

LOAD-DATE: May 15, 1999



To: RockyBalboa who wrote (13)6/5/1999 8:46:00 AM
From: RockyBalboa  Read Replies (1) | Respond to of 28
 
CSON failed 2 times to get over the 7" mark. Interesting is that the volume is much higher than in earlier trading.

Wonder whether it works the next time. But I used the weakness to buy some at 6 1/8. They may rise. It fell like a stone, but, there were some serious buyers in the low 6s.