Monday, medical device company Vascular Solutions, Inc. (VASC:News ) said that the First Circuit of the U.S. Court of Appeals has affirmed the earlier judgment in its favor in its product disparagement litigation with Marine Polymer Technologies and $2.7 million in damages to be paid to Vascular.
In the two-week trial in April 2008, the jury has issued a permanent injunction prohibiting Marine Polymer from making disparaging statements concerning the safety of Vascular Solutions' D-Stat hemostat products. The jury had also awarded $4.5 million in damages to Vascular Solutions and found five statements made by Marine Polymer regarding Vascular Solutions' D-Stat products false.
The Appeals Court,however, has determined that due to differences in opinion among the judges Vascular may either accept a $2.7 million award of damages, plus interest, or insist upon a new trial limited to the issue of determining the reasonable amount of damages.
Adding interest at the statutory rate, Vascular said that it calculates the $2.7 million award to currently total approximately $3.2 million. Today's appellate decision is subject to Marine Polymer Technologies' ability to petition for rehearing by the First Circuit and appeal to the U.S. Supreme Court. The permanent injunction issued against Marine Polymer at the conclusion of the earlier trial will remain in effect.
Independently, the Appeals Court found that the evidence "provides ample proof of malice. And the most inflammatory of the five statements, and the most glaringly unsupported, are the two that associated D-Stat Dry with specific and serious outcomes in percentages that would be remarkable for a relatively straightforward medical task -- to stop bleeding at a modest-size doctor-created incision."
Howard Root, CEO, Vascular Solutions, said, "In order to conclude this litigation, we intend to accept the $2.7 million award of damages, plus interest, and to forgo the cost and distraction of an additional trial on damages. We expect the final steps in this litigation to be concluded during the first half of 2010, and the approximately $3.2 million in damages and interest to be collected by Vascular Solutions without substantial additional expense."
VASC is currently trading at $8.40, down $0.05 or 0.59, on the Nasdaq.
Monday, December 28, 2009
Saturday, December 19, 2009
ZymoGenetics shares fall on regulatory delay
Shares of ZymoGenetics Inc. dipped Tuesday after the company said additional studies are likely needed to gain European regulatory approval of its only marketed product, Recothrom.
Sales of the drug, which is used to control bleeding during surgical procedures, climbed to $8.5 million from $1.8 million during the third quarter. While approved in the U.S., it is not yet approved in Europe. Seattle-based ZymoGenetics licensed all rights outside of the U.S. to Germany-based Bayer in 2007.
In a Securities and Exchange Commission filing Monday, ZymoGenetics said Bayer pulled its application with European regulators as a response to indications that the drug candidate would take an additional study to gain approval.
The Committee for Medicinal Products for Human Use said Bayer's submission did not meet the necessary standards.
The stock fell 13 cents, or just under 2 percent, to $6.61 in afternoon trading. ZymoGenetics shares have traded between $2.55 and $7.31 over the last 52 weeks.
Sales of the drug, which is used to control bleeding during surgical procedures, climbed to $8.5 million from $1.8 million during the third quarter. While approved in the U.S., it is not yet approved in Europe. Seattle-based ZymoGenetics licensed all rights outside of the U.S. to Germany-based Bayer in 2007.
In a Securities and Exchange Commission filing Monday, ZymoGenetics said Bayer pulled its application with European regulators as a response to indications that the drug candidate would take an additional study to gain approval.
The Committee for Medicinal Products for Human Use said Bayer's submission did not meet the necessary standards.
The stock fell 13 cents, or just under 2 percent, to $6.61 in afternoon trading. ZymoGenetics shares have traded between $2.55 and $7.31 over the last 52 weeks.
Synthetic Blood Platelets Are Twice As Effective
Scientists working with small particles at the nanoscale have recently revealed that they have developed a new type of synthetic blood platelets, which have twice the clotting capabilities of the standard variety. In the experiments they conducted on lab mice, the science group, which are based at the Case Western University (CWU), in Cleveland, managed to obtain an increased efficiency using their innovation than they could squeeze out of traditional clotting methods.
Technology Review reports that the nanoparticles could be the next major innovation in this field, considering that the regular drugs were so significantly exceeded in terms of performance. “We're helping to form the clot,” CWU bioengineer Erin Lavik, who has also been the leader of the new investigation, explains briefly. The scientist reveals that plans are to create blood clotting particles that are so effective that they could be used by paramedics right at an accident site, or by doctors working on injured soldiers in battlefields around the globe.
Early safety tests turned out to be very promising, but the CWU team admits that there is still a lot of work to be done until the new nanoparticles are ready to be mass-produced, and administered to patients. Speaking about the challenges associated with the development of a good blood clotting method, University of Pennsylvania Medical School physician Mortimer Poncz said, “There's a balance between the two edges of the sword--bleeding too much and clotting too much. You don't want to stop bleeding in the leg but die of a heart attack or have stroke.” He has not been involved in the new study.
The new nanoparticles are about one third the size of normal platelets. They can run through the bloodstream without experiencing obstacles, but also have the same stickiness that makes their natural counterparts so effective at stopping bleeding. While existing drugs can indeed boost the immune system's proprietary response to injury, they can also be terribly expensive, so a cheaper, more effective method was very high up on researchers' priority lists.
Technology Review reports that the nanoparticles could be the next major innovation in this field, considering that the regular drugs were so significantly exceeded in terms of performance. “We're helping to form the clot,” CWU bioengineer Erin Lavik, who has also been the leader of the new investigation, explains briefly. The scientist reveals that plans are to create blood clotting particles that are so effective that they could be used by paramedics right at an accident site, or by doctors working on injured soldiers in battlefields around the globe.
Early safety tests turned out to be very promising, but the CWU team admits that there is still a lot of work to be done until the new nanoparticles are ready to be mass-produced, and administered to patients. Speaking about the challenges associated with the development of a good blood clotting method, University of Pennsylvania Medical School physician Mortimer Poncz said, “There's a balance between the two edges of the sword--bleeding too much and clotting too much. You don't want to stop bleeding in the leg but die of a heart attack or have stroke.” He has not been involved in the new study.
The new nanoparticles are about one third the size of normal platelets. They can run through the bloodstream without experiencing obstacles, but also have the same stickiness that makes their natural counterparts so effective at stopping bleeding. While existing drugs can indeed boost the immune system's proprietary response to injury, they can also be terribly expensive, so a cheaper, more effective method was very high up on researchers' priority lists.
Friday, December 4, 2009
Medafor publish commentary of Cryolife battle
Medafor have published a pdf document on their website detailing their current view of the on-going battle with Cryolife. In the document they accuse Cryolife (amongst a host of contractual and legal issues) of attempting to initiate a lawsuit to force a sale after the Board rejected a second offer by Cryolife to purchase Medafor. Medafor have also engaged in a lawsuit charging their previous CEO and Chairman, Dick Zerban and Cryolife CEO, Steven Anderson alleging the wrongful transfer of shares. The full document is available on the first page of the Medafor website.
Zymogenetics cuts back staff to focus on Recothrom
ZymoGenetics is cutting all of its immunology work along with 15 percent of its jobs, or 52 positions. That's in addition to the 161 jobs the developer cut in April when it decided to bow out of the cancer research business. All ongoing immunology discovery research programs will be discontinued; however, the company will keep the research capabilities necessary to support the ongoing development programs for current product candidates.
According to the regulatory filing, cutting new immunology research will allow the developer to focus on its sole marketed product, Recothrom Thrombin, a treatment for surgical bleeding. It will also give ZymoGenetics more resources for developing and commercializing its pipeline of clinical and preclinical product candidates. In a statement emailed to Xconomy, a spokesperson said that the company has abandoned the strategy of discovering and licensing out many early-stage candidates. Now it will focus on fewer programs that it will advance to later stages. The spokesperson added that the company is focusing on drug candidates that have the most potential over the next three to four years.
ZymoGenetics's reductions will result in an annual expense savings of $8 million to $10 million, in addition to the estimated $30 million in savings generated by the April restructuring. This round of layoffs leaves the developer with about 300 employees, according to Xconomy.
According to the regulatory filing, cutting new immunology research will allow the developer to focus on its sole marketed product, Recothrom Thrombin, a treatment for surgical bleeding. It will also give ZymoGenetics more resources for developing and commercializing its pipeline of clinical and preclinical product candidates. In a statement emailed to Xconomy, a spokesperson said that the company has abandoned the strategy of discovering and licensing out many early-stage candidates. Now it will focus on fewer programs that it will advance to later stages. The spokesperson added that the company is focusing on drug candidates that have the most potential over the next three to four years.
ZymoGenetics's reductions will result in an annual expense savings of $8 million to $10 million, in addition to the estimated $30 million in savings generated by the April restructuring. This round of layoffs leaves the developer with about 300 employees, according to Xconomy.
Thursday, December 3, 2009
ProFibrix Initiates Phase II Clinical Trial of its Lead Topical Hemostat Product Fibrocaps(TM)
SEATTLE, Washington, and LEIDEN, The Netherlands - ProFibrix B.V. today announced the start of the company’s Phase II clinical trial for Fibrocaps(TM), the company’s lead topical Hemostat product, with the successful treatment of the first patients for mild to moderate bleeding during liver surgery. ProFibrix expects to complete the study before the end of 2009.
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.
ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and conduct a combined phase II/III pivotal study in various surgical indications.
Jaap Koopman, PhD, Chief Executive Officer, said: “The successful treatment of the first patients with our lead product Fibrocaps is an important milestone for the company. With focus and dedication we have made enormous progress over the past two years, and we are on track to bring Fibrocaps to the point of market approval.”
About ProFibrix
ProFibrix was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA. The company leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.
ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and conduct a combined phase II/III pivotal study in various surgical indications.
Jaap Koopman, PhD, Chief Executive Officer, said: “The successful treatment of the first patients with our lead product Fibrocaps is an important milestone for the company. With focus and dedication we have made enormous progress over the past two years, and we are on track to bring Fibrocaps to the point of market approval.”
About ProFibrix
ProFibrix was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA. The company leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.
Tuesday, November 24, 2009
Orthovita to Present at the Piper Jaffray 21st Annual Health Care Conference
Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the Piper Jaffray 21st Annual Health Care Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Wednesday, December 2nd, at 3:00 p.m. Eastern Time, at the New York Palace Hotel, 455 Madison Avenue, New York, New York. A live webcast of the presentation will be available, and can be accessed for 30 days following the conference, by visiting http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=***VITA&item_id=2539636.
Thursday, November 12, 2009
Covidien Introduces First FDA-Approved Spine Sealant
NORTH HAVEN, Conn.--(BUSINESS WIRE)-- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of DuraSeal(TM) spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the U.S. every year, with an estimated 10% of these surgeries requiring dural repair and sealing. Tears in the dura the outermost membrane covering the brain and the spinal cord can result in cerebral spinal fluid (CSF) leaks after surgery, leading to possible medical complications and extended hospital stays. One recent study found that CSF leaks after spinal surgery are estimated to cost an average of $6,479 in additional expense, mainly due to longer hospital and intensive care unit stays.(1)
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients' medical conditions and the nature of the complex spinal procedures performed.(2)
The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
"DuraSeal is a great example of how we develop solutions at Covidien," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien. "We observe the challenges that surgeons face in the operating room and work with the medical community to come up with innovative products that may optimize patient outcomes, can improve healthcare economics and are intuitive for surgeons and their teams to use."
The DuraSeal spine sealant system was introduced today at the North American Spine SocietyAnnual Meeting in San Francisco and last month at the Congress of Neurological Surgeons in New Orleans. For further information, please visit www.durasealspine.com.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of$10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients' medical conditions and the nature of the complex spinal procedures performed.(2)
The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
"DuraSeal is a great example of how we develop solutions at Covidien," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien. "We observe the challenges that surgeons face in the operating room and work with the medical community to come up with innovative products that may optimize patient outcomes, can improve healthcare economics and are intuitive for surgeons and their teams to use."
The DuraSeal spine sealant system was introduced today at the North American Spine SocietyAnnual Meeting in San Francisco and last month at the Congress of Neurological Surgeons in New Orleans. For further information, please visit www.durasealspine.com.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of$10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
Friday, November 6, 2009
Sometimes only the Lawyers win.......ZymoGenetics says restraining orders lifted
ZymoGenetics Inc. said Friday that a federal judge in Tennessee has removed three temporary restraining orders imposed on the company over marketing and promotion of its lead drug, Recothrom.
The Seattle biotechnology company (NASDAQ: ZGEN) on Wednesday disclosed that it had been slapped with the restraining orders as part of a lawsuit filed by four companies, including rival King Pharmaceuticals Inc. The lawsuit accuses ZymoGenetics of unfair competition, false advertising, trademark infringement and related claims, ZymoGenetics said.
In a filing Friday with the Securities and Exchange Commission, ZymoGenetics said the judge in Tennessee had vacated the restraining orders, which "have no further force or effect." The company did not elaborate, but said it disputes the lawsuit's allegations and intends to "vigorously defend" itself at a hearing in the case scheduled for Nov. 16.
ZymoGenetics on Thursday said third-quarter revenue increased 131 percent, to $8.5 million, from the same quarter a year ago, due to sales of Recothrom, a bleeding-control drug. The company narrowed its Q3 loss to $11.4 million, or 17 cents a share, from a loss of $28.8 million, or 42 cents a share, in the year-ago quarter.
The Seattle biotechnology company (NASDAQ: ZGEN) on Wednesday disclosed that it had been slapped with the restraining orders as part of a lawsuit filed by four companies, including rival King Pharmaceuticals Inc. The lawsuit accuses ZymoGenetics of unfair competition, false advertising, trademark infringement and related claims, ZymoGenetics said.
In a filing Friday with the Securities and Exchange Commission, ZymoGenetics said the judge in Tennessee had vacated the restraining orders, which "have no further force or effect." The company did not elaborate, but said it disputes the lawsuit's allegations and intends to "vigorously defend" itself at a hearing in the case scheduled for Nov. 16.
ZymoGenetics on Thursday said third-quarter revenue increased 131 percent, to $8.5 million, from the same quarter a year ago, due to sales of Recothrom, a bleeding-control drug. The company narrowed its Q3 loss to $11.4 million, or 17 cents a share, from a loss of $28.8 million, or 42 cents a share, in the year-ago quarter.
Thursday, November 5, 2009
King Pharmaceuticals Inc has sued ZymoGenetics Inc
Nov 4 (Reuters) - King Pharmaceuticals Inc has sued ZymoGenetics Inc seeking damages and injunctive relief, alleging trademark infringement among other things, and a U.S. court has temporarily restrained Zymogenetics from marketing a product, according to a regulatory filing.
ZymoGenetics said in the filing that the three temporary restraining orders (TROs), passed on Nov. 3 without hearing its side, were prohibiting it from engaging in certain marketing or promotional conducts related to Recothrom, its hemostasis aid.
ZymoGenetics said King, in the suit filed in a federal court in Tennessee, alleged Zymogenetics of engaging in unfair competition, false advertising, trademark infringement and other related claims.
"We are seeking immediate relief from the court to vacate the TROs, and we will seek an immediate hearing on this motion," ZymoGenetics said in the filing.
A hearing on King's motions for preliminary injunctive relief is scheduled for Nov. 16, and ZymoGenetics will oppose King's request for preliminary injunctive relief, it said.
"We currently believe that this litigation will not have a material adverse effect on our financial condition, our results of operation, or our cash flows," ZymoGenetics added.
ZymoGenetics said in the filing that the three temporary restraining orders (TROs), passed on Nov. 3 without hearing its side, were prohibiting it from engaging in certain marketing or promotional conducts related to Recothrom, its hemostasis aid.
ZymoGenetics said King, in the suit filed in a federal court in Tennessee, alleged Zymogenetics of engaging in unfair competition, false advertising, trademark infringement and other related claims.
"We are seeking immediate relief from the court to vacate the TROs, and we will seek an immediate hearing on this motion," ZymoGenetics said in the filing.
A hearing on King's motions for preliminary injunctive relief is scheduled for Nov. 16, and ZymoGenetics will oppose King's request for preliminary injunctive relief, it said.
"We currently believe that this litigation will not have a material adverse effect on our financial condition, our results of operation, or our cash flows," ZymoGenetics added.
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