IRVINGTON, N.Y., Feb. 17, 2011 /PRNewswire/ -- ORTHOCON, Inc., a developer of implantable products designed to stop the bleeding from and to deliver drugs to bone, today announced the U.S. launch of its first commercial product, the HEMASORB Absorbable Bone Hemostat Matrix.
The HEMASORB Absorbable Bone Hemostat Matrix is a ready to use, biocompatible, water resistant, and absorbable putty that is designed to rapidly stop bleeding when applied to damaged or cut bone. HEMASORB was cleared for market introduction by the U.S. Food and Drug Administration (FDA) via the 510(k) premarket notification process. In 2010, ORTHOCON conducted a limited market introduction of this product under its development name, ORTHOstat.
"We believe that HEMASORB is an innovative product that addresses a substantial market opportunity and has the potential to become a standard of care," said John J. Pacifico, President and Chief Executive Officer of ORTHOCON. "It is easy to use; it satisfies unmet needs and it is cost-effective."
Bleeding from cut bone is a common occurrence in many operative procedures. Excessive bleeding from bone 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 U.S. and Europe each year could benefit from the intra-operative use of HEMASORB.
"HEMASORB is the first commercial product that employs our proprietary Syntinate Technology Platform," commented Richard L. Kronenthal, Ph.D., ORTHOCON's Scientific Founder. "We are currently developing a pipeline of follow-on products that will complement Syntinate's utility as a bone hemostat by exploiting its unique potential to deliver drugs directly to bone."
The Syntinate Technology Platform incorporates biocompatible and absorbable solids and liquids to create a synthetic matrix that, when applied to bone, mechanically blocks bleeding. In addition, these constituents may act as drug reservoirs allowing for site specific and extended delivery of local anesthetics, anti-infective agents, and other drugs.
"We believe that our pipeline of products, beginning with HEMASORB, is very compelling and has the potential to create significant clinical and commercial value," concluded Mr. Pacifico. "We expect that the successful market launch of our HEMASORB Absorbable Bone Hemostat Matrix will prime the market for the future introduction of an array of innovative products."
Friday, February 18, 2011
Thursday, February 17, 2011
CSL Behring Marks World Hemophilia Day with Coagulation Factor Donation to World Federation of Hemophilia
KING OF PRUSSIA, Pa. and MONTREAL, Feb. 16, 2011 /CNW/ -- As a means of aiding the World Federation of Hemophilia's (WFH) progress in improving the diagnosis and treatment of hemophilia in developing countries through its Global Alliance for Progress (GAP) program, CSL Behring has committed to donating more factor VIII concentrate (FVIII) to WFH. The donated product will be used in South America, Thailand, thePhilippines, parts of eastern Europe, parts of the Middle East, and in Tunisia. The donation, the total market value of which is approximately $500,000, will be made using coagulation factor concentrate with a minimum shelf-life of one year.
CSL Behring has pledged to support the WFH with separate financial contributions totaling nearly $1 million over a period of three years. This most recent donation is part of that commitment.
"As a long-standing contributor to GAP, CSL Behring is pleased to once again be in a position to assist hemophilia patients who have a critical need for safe, effective medical therapies," said Peter Turner, President and Chief Executive Officer of CSL Behring. "We are also gratified to be a partner with WFH in this effort, an organization that continues to make a large and positive difference in the world. Our commitment to their progress remains strong."
"The WFH relies on product donations to help introduce clotting factor concentrates in developing countries and these donations serve as a catalyst for improving care," said Claudia Black, Chief Executive Officer of the WFH. "We are grateful to our industry partners such as CSL Behring, who provide, among other resources, valuable and life-saving medicine, including this most recent donation of coagulation factor. "
Factor VIII is an essential blood clotting factor that can be given to hemophiliacs to restore hemostasis.
CSL Behring has pledged to support the WFH with separate financial contributions totaling nearly $1 million over a period of three years. This most recent donation is part of that commitment.
"As a long-standing contributor to GAP, CSL Behring is pleased to once again be in a position to assist hemophilia patients who have a critical need for safe, effective medical therapies," said Peter Turner, President and Chief Executive Officer of CSL Behring. "We are also gratified to be a partner with WFH in this effort, an organization that continues to make a large and positive difference in the world. Our commitment to their progress remains strong."
"The WFH relies on product donations to help introduce clotting factor concentrates in developing countries and these donations serve as a catalyst for improving care," said Claudia Black, Chief Executive Officer of the WFH. "We are grateful to our industry partners such as CSL Behring, who provide, among other resources, valuable and life-saving medicine, including this most recent donation of coagulation factor. "
Factor VIII is an essential blood clotting factor that can be given to hemophiliacs to restore hemostasis.
Tuesday, February 1, 2011
Pfizer acquisition of King Pharmaceuticals
It will likely be a few more weeks before King Pharmaceuticals employees learn how a pending acquisition by the world's largest drugmaker will affect their jobs.
Pfizer Inc. officials announced Monday the completion of a tender offer to purchase shares of the Bristol-based drug manufacturer and intentions to finish the acquisition by the end of February. Pfizer received federal antitrust approval to proceed with the $3.6 billion deal late last week.
"At this point, it's too early to determine any [job] impacts," Pfizer spokeswoman Joan Campion said in a phone interview with the Bristol Herald Courier. "We don't fully own the company, but we're expecting that to close in the first quarter -- in the next month or so. It's just too early to determine."
King has 435 administrative and manufacturing employees at its 5th Street corporate headquarters and 2,600 companywide. In addition to the Twin City, King operates drug manufacturing facilities in Florida, Illinois, Michigan, Missouri and Wisconsin, a research and development center in North Carolina and a commercial operations center in New Jersey. It also manufactures animal health products at plants in five states and China.
Pfizer employs more than 110,000 worldwide.
"We will conduct an evaluation of our work force and our real-estate holdings and make decisions based on serving our customers best, while still remaining competitive," Campion said.
Bristol, Tenn., City Manager Jeff Broughton said city officials are also awaiting word on what the purchase will mean for the company and the city.
"We have no information as to what will happen with King's manufacturing and office facility," Broughton said. "We've been waiting to try and approach Pfizer and stress to them the importance of that facility in Bristol, but we've only had preliminary conversations because they haven't completed the purchase."
New York-based Pfizer said Monday that about 93 percent -- or 230.7 million -- of King's outstanding shares were validly tendered and not withdrawn prior to a Jan. 28 deadline. Pfizer had offered to purchase the shares for $14.25 each in cash.
After agreeing to buy King in October, Pfizer extended its tender offer twice before last week's deadline.
For its money, Pfizer will acquire a group of branded prescription pharmaceuticals, including neuroscience products Skelaxin, Flector Patch, Avinza and painkiller Embeda; hospital products, including Thrombin-JMI; the EpiPen auto injector devices and nerve gas antidotes; and Remoxyl, an oxycodone capsule designed to be tamper-resistant that is awaiting approval from the Food and Drug Administration.
Pfizer, which is reporting its quarterly results today, said it will complete the deal through a short-form merger without a vote from remaining King shareholders.
In November, a number of King shareholders filed a series of class-action lawsuits attempting to block the merger. Each claims King's board of directors undervalued the company when it agreed to Pfizer's proposed purchase price and violated a fiduciary duty to make sure the company's shareholders got the best price for their stock.
Once the merger is completed, King's common stock will cease to be traded.
After announcing the tender, a share of Pfizer stock rose 7 cents on the New York Stock Exchange Monday, closing at $18.22. King's stock rose 2 cents and closed at $14.24.
Pfizer Inc. officials announced Monday the completion of a tender offer to purchase shares of the Bristol-based drug manufacturer and intentions to finish the acquisition by the end of February. Pfizer received federal antitrust approval to proceed with the $3.6 billion deal late last week.
"At this point, it's too early to determine any [job] impacts," Pfizer spokeswoman Joan Campion said in a phone interview with the Bristol Herald Courier. "We don't fully own the company, but we're expecting that to close in the first quarter -- in the next month or so. It's just too early to determine."
King has 435 administrative and manufacturing employees at its 5th Street corporate headquarters and 2,600 companywide. In addition to the Twin City, King operates drug manufacturing facilities in Florida, Illinois, Michigan, Missouri and Wisconsin, a research and development center in North Carolina and a commercial operations center in New Jersey. It also manufactures animal health products at plants in five states and China.
Pfizer employs more than 110,000 worldwide.
"We will conduct an evaluation of our work force and our real-estate holdings and make decisions based on serving our customers best, while still remaining competitive," Campion said.
Bristol, Tenn., City Manager Jeff Broughton said city officials are also awaiting word on what the purchase will mean for the company and the city.
"We have no information as to what will happen with King's manufacturing and office facility," Broughton said. "We've been waiting to try and approach Pfizer and stress to them the importance of that facility in Bristol, but we've only had preliminary conversations because they haven't completed the purchase."
New York-based Pfizer said Monday that about 93 percent -- or 230.7 million -- of King's outstanding shares were validly tendered and not withdrawn prior to a Jan. 28 deadline. Pfizer had offered to purchase the shares for $14.25 each in cash.
After agreeing to buy King in October, Pfizer extended its tender offer twice before last week's deadline.
For its money, Pfizer will acquire a group of branded prescription pharmaceuticals, including neuroscience products Skelaxin, Flector Patch, Avinza and painkiller Embeda; hospital products, including Thrombin-JMI; the EpiPen auto injector devices and nerve gas antidotes; and Remoxyl, an oxycodone capsule designed to be tamper-resistant that is awaiting approval from the Food and Drug Administration.
Pfizer, which is reporting its quarterly results today, said it will complete the deal through a short-form merger without a vote from remaining King shareholders.
In November, a number of King shareholders filed a series of class-action lawsuits attempting to block the merger. Each claims King's board of directors undervalued the company when it agreed to Pfizer's proposed purchase price and violated a fiduciary duty to make sure the company's shareholders got the best price for their stock.
Once the merger is completed, King's common stock will cease to be traded.
After announcing the tender, a share of Pfizer stock rose 7 cents on the New York Stock Exchange Monday, closing at $18.22. King's stock rose 2 cents and closed at $14.24.
Friday, January 28, 2011
Baxter Q4 Edited
In our Regenerative Medicine business, we completed a Phase III study evaluating TISSEEL Fibrin Sealant as a hemostatic agent in vascular surgery, and filed for regulatory approval of our TISSEEL Fibrin Sealant for use in facial surgery in the U.S.....
And as you know, there were a number of factors negatively affecting sales in the quarter, which collectively totaled $80 million, or two percentage points of growth. These items include the impact of healthcare reform, the U.K. recombinant Factor VIII tender loss and a difficult comparison in vaccines related to pandemic revenues reported in the fourth quarter of 2009.
For the full year, sales increased 4% to $13.1 billion. And excluding foreign currency, sales growth was 3%, in line with our guidance. In terms of the individual businesses and beginning with BioScience, in the fourth quarter, global BioScience sales of $1.5 billion increased 1%. Excluding foreign currency, BioScience sales increased 4%, reflecting accelerated growth versus the prior three quarters.
As previously mentioned, BioScience sales were adversely impacted by five percentage points due to the impact of healthcare reform, the U.K. tender loss and the difficult vaccine comparison. Excluding these items, BioScience sales advanced 9% on a constant-currency basis. For the full year, global BioScience sales exceeded $5.6 billion and increased 1% on both a reported basis and after adjusting for foreign currency.
Within the product categories, recombinant sales of $534 million declined 5% as expected. Excluding foreign currency, sales declined 3%, primarily due to the U.K. tender and a reduction of inventory levels in the U.S. channel.....
Matthew Miksic - Piper Jaffray Companies
And then finally, this TISSEEL product that you mentioned for hemostasis, anything you can tell us about -- just the size of that opportunity, what that could mean, whether it comes this year or late this year would be helpful?
Robert Parkinson
We have quantified that and communicated, I know we've quantified and communicated that.
Mary Ladone
We have. But we have several indications that are already approving. Clearly, the competition in this area, Matt, has the broad hemostasis indication. So we are a little bit put at a compromised position. So it would help in terms of share gains to have this particular indication.
Robert Hombach
And TISSEEL is a meaningfully sized product for us. So returning to growth with this new indication would be helpful.
Matthew Miksic - Piper Jaffray Companies
So it's incremental, not a game changer necessarily?
Mary Ladone
Correct.
And as you know, there were a number of factors negatively affecting sales in the quarter, which collectively totaled $80 million, or two percentage points of growth. These items include the impact of healthcare reform, the U.K. recombinant Factor VIII tender loss and a difficult comparison in vaccines related to pandemic revenues reported in the fourth quarter of 2009.
For the full year, sales increased 4% to $13.1 billion. And excluding foreign currency, sales growth was 3%, in line with our guidance. In terms of the individual businesses and beginning with BioScience, in the fourth quarter, global BioScience sales of $1.5 billion increased 1%. Excluding foreign currency, BioScience sales increased 4%, reflecting accelerated growth versus the prior three quarters.
As previously mentioned, BioScience sales were adversely impacted by five percentage points due to the impact of healthcare reform, the U.K. tender loss and the difficult vaccine comparison. Excluding these items, BioScience sales advanced 9% on a constant-currency basis. For the full year, global BioScience sales exceeded $5.6 billion and increased 1% on both a reported basis and after adjusting for foreign currency.
Within the product categories, recombinant sales of $534 million declined 5% as expected. Excluding foreign currency, sales declined 3%, primarily due to the U.K. tender and a reduction of inventory levels in the U.S. channel.....
Matthew Miksic - Piper Jaffray Companies
And then finally, this TISSEEL product that you mentioned for hemostasis, anything you can tell us about -- just the size of that opportunity, what that could mean, whether it comes this year or late this year would be helpful?
Robert Parkinson
We have quantified that and communicated, I know we've quantified and communicated that.
Mary Ladone
We have. But we have several indications that are already approving. Clearly, the competition in this area, Matt, has the broad hemostasis indication. So we are a little bit put at a compromised position. So it would help in terms of share gains to have this particular indication.
Robert Hombach
And TISSEEL is a meaningfully sized product for us. So returning to growth with this new indication would be helpful.
Matthew Miksic - Piper Jaffray Companies
So it's incremental, not a game changer necessarily?
Mary Ladone
Correct.
Vascular Solutions Acquires Zerusa For US$4.3 Mln
(RTTNews) - Medical devices company Vascular Solutions, Inc. (VASC: News ) said Thursday it has acquired the assets of Zerusa Limited for 3.15 million euros or US$4.3 million. The deal allows the company to have sole control for the sale of Guardian hemostasis valves in the U.S. and abroad.
As per the terms, Vascular will pay 2.85 million euros or US$3.9 million at closing and 0.3 million euros or US$0.4 million six months after closing.
Vascular said the acquisition will be accounted for as a business combination in the first quarter of 2011. The company expects the deal to be accretive to earnings by about $0.01 per share in 2011, with insubstantial transition and integration costs incurred in the first quarter of 2011.
Zerusa is an Ireland based medical device company, which makes Guardian hemostasis valves that are are designed to maintain hemostasis during interventional catheterization procedures.
Vascular Solutions has been selling the Guardian hemostasis valves in the U.S. under an exclusive distribution relationship with Zerusa since 2007.
In 2010, worldwide sales of the Guardian hemostasis valves were $1.7 million, consisting of $1.3 million in sales
As per the terms, Vascular will pay 2.85 million euros or US$3.9 million at closing and 0.3 million euros or US$0.4 million six months after closing.
Vascular said the acquisition will be accounted for as a business combination in the first quarter of 2011. The company expects the deal to be accretive to earnings by about $0.01 per share in 2011, with insubstantial transition and integration costs incurred in the first quarter of 2011.
Zerusa is an Ireland based medical device company, which makes Guardian hemostasis valves that are are designed to maintain hemostasis during interventional catheterization procedures.
Vascular Solutions has been selling the Guardian hemostasis valves in the U.S. under an exclusive distribution relationship with Zerusa since 2007.
In 2010, worldwide sales of the Guardian hemostasis valves were $1.7 million, consisting of $1.3 million in sales
Wednesday, January 26, 2011
Morgan out, Hart in as CEO at Portland-based HemCon Medical Technologies
John W. Morgan, the chief executive of Portland-based HemCon Medical Technologies since 2004, resigned Monday "to pursue other opportunities," the company said in a press release.
He has been replaced as CEO by Nick Hart, who has been the company's chief financial officer for the last two years.
HemCon, a privately held company that makes and sells bandages and dressings that promote coagulation and discourage infection, employs about 126 people in Portland, Ireland and the Czech Republic. The company doesn't disclose revenues.
The company's dressings are derived from chitosan, a component of shrimp shells. They have been widely used by the U.S. military and, the company says, are responsible for saving at least 100 lives. For the last several years, the company has pushed aggressively into civilian markets.
A federal jury in New Hampshire last spring awarded a $29.4 million judgment to HemCon rival Marine Polymer Technologies, which makes a biocompatible dressing made from algae and claimed HemCon had violated its patent. HemCon appealed that award and has been permitted to continue selling its products while the case proceeds.
HemCon Chairman William P. Wiesmann said Monday that the change was "a natural progression," as Morgan sought bigger challenges.
Wiesmann said annual sales had fallen off from a high of more than $72 million several years ago, but that he expects the company to be profitable again by the fourth quarter of this year.
He has been replaced as CEO by Nick Hart, who has been the company's chief financial officer for the last two years.
HemCon, a privately held company that makes and sells bandages and dressings that promote coagulation and discourage infection, employs about 126 people in Portland, Ireland and the Czech Republic. The company doesn't disclose revenues.
The company's dressings are derived from chitosan, a component of shrimp shells. They have been widely used by the U.S. military and, the company says, are responsible for saving at least 100 lives. For the last several years, the company has pushed aggressively into civilian markets.
A federal jury in New Hampshire last spring awarded a $29.4 million judgment to HemCon rival Marine Polymer Technologies, which makes a biocompatible dressing made from algae and claimed HemCon had violated its patent. HemCon appealed that award and has been permitted to continue selling its products while the case proceeds.
HemCon Chairman William P. Wiesmann said Monday that the change was "a natural progression," as Morgan sought bigger challenges.
Wiesmann said annual sales had fallen off from a high of more than $72 million several years ago, but that he expects the company to be profitable again by the fourth quarter of this year.
Monday, January 24, 2011
Wednesday, December 29, 2010
Saturday, December 25, 2010
Wednesday, December 22, 2010
Stanford's ideas generate $65.1 million in revenues
A new report card for one of the nation's most powerful innovation engines shows that Stanford-based inventions generated $65.1 million in income for the university in 2009 despite the recession -- up from $62.5 million the previous year.
Stanford's total earnings from inventions were $1.1 billion during the past four decades, with more than half coming from just two inventions: the hypertext searching used by Google and groundbreaking DNA-splicing technology, according to an annual survey by the Association of University Technology Managers.
No longer isolated "ivory towers," schools like Stanford harvest great ideas and then try to send them out in the world. There they can be turned into commercial products -- and reward the campus with royalty income from licensing rights.
The two most lucrative inventions are decades old and are no longer producing revenue. Recombinant DNA, a 1974 invention, creates artificial DNA through gene splicing and brought in $225 million; Google's "PageRank" tool, patented in 1996, brought in $336 million.
Every school dreams of the next Gatorade -- a simple mixture of water, sugar, lemon juice, sodium, potassium, and phosphate that has yielded the University of Florida more than $80 million since 1973.
But instead of bringing home the bacon, many universities throw money into the void with little hope of return.
There's a chasm between a good idea and a product, termed "the valley of death."
Patents are expensive, with fees and legal costs involved in obtaining a single patent range from $20,000 to $25,000. Because it takes so long to bring a product to market, the royalties are based on license deals done 10 to 15 years ago.
Stanford ranks 10th in annual earnings among the nation's campuses, according to the new survey. By comparison, the University of California system had 47 startup companies and $103 million in royalties.
Nationally, scientific research from about 150 universities created 555 startup companies and resulted in more than 4,500 patent optioning and licensing deals last year, earning $1.8 billion in payouts.
Stanford's royalty revenue in 2009 came from 517 different technologies, generating from $3 million to $38 million. Its current big money-maker is an antibody invention, which led to the development of many valuable drugs.
But the statistics are sobering: After Google's PageRank and recombinant DNA inventions, "the rest of it is a bunch of technologies that generated much less income," said Katharine Ku, Stanford's Director for Technology Licensing, in a rare public presentation to the school's faculty senate last year. Only 19 inventions brought in more than $5 million. About 58 earned about $1 million, she said.
Fewer than half of the 300 research universities actively seeking patents have managed to break even from technology transfer efforts. Instead, two-thirds of the revenue tracked by the association has gone to only 13 institutions, including Stanford and UC.
Stanford's other best ideas, among the 7,400 inventions total, are FM Sound Synthesis, which led to the ringing of cell phones; recombinant DNA, used to make vast amounts of proteins like insulin, among other products; MINOS, an optimization software program; functional antibodies and DSL, which provides digital data transmission over the phone wires.
Ku recalled when Stanford engineering students Larry Page and Sergey Brin took their research project, based on a new search technology, to her office in hopes of finding a company interested in licensing their invention. Stanford marketed it to every potential licensee it could think of -- without success. So Page and Brin created their own company, and licensed the PageRank tool from Stanford. In exchange, Stanford was given Google stock.
Further reading
Stanford's total earnings from inventions were $1.1 billion during the past four decades, with more than half coming from just two inventions: the hypertext searching used by Google and groundbreaking DNA-splicing technology, according to an annual survey by the Association of University Technology Managers.
No longer isolated "ivory towers," schools like Stanford harvest great ideas and then try to send them out in the world. There they can be turned into commercial products -- and reward the campus with royalty income from licensing rights.
The two most lucrative inventions are decades old and are no longer producing revenue. Recombinant DNA, a 1974 invention, creates artificial DNA through gene splicing and brought in $225 million; Google's "PageRank" tool, patented in 1996, brought in $336 million.
Every school dreams of the next Gatorade -- a simple mixture of water, sugar, lemon juice, sodium, potassium, and phosphate that has yielded the University of Florida more than $80 million since 1973.
But instead of bringing home the bacon, many universities throw money into the void with little hope of return.
There's a chasm between a good idea and a product, termed "the valley of death."
Patents are expensive, with fees and legal costs involved in obtaining a single patent range from $20,000 to $25,000. Because it takes so long to bring a product to market, the royalties are based on license deals done 10 to 15 years ago.
Stanford ranks 10th in annual earnings among the nation's campuses, according to the new survey. By comparison, the University of California system had 47 startup companies and $103 million in royalties.
Nationally, scientific research from about 150 universities created 555 startup companies and resulted in more than 4,500 patent optioning and licensing deals last year, earning $1.8 billion in payouts.
Stanford's royalty revenue in 2009 came from 517 different technologies, generating from $3 million to $38 million. Its current big money-maker is an antibody invention, which led to the development of many valuable drugs.
But the statistics are sobering: After Google's PageRank and recombinant DNA inventions, "the rest of it is a bunch of technologies that generated much less income," said Katharine Ku, Stanford's Director for Technology Licensing, in a rare public presentation to the school's faculty senate last year. Only 19 inventions brought in more than $5 million. About 58 earned about $1 million, she said.
Fewer than half of the 300 research universities actively seeking patents have managed to break even from technology transfer efforts. Instead, two-thirds of the revenue tracked by the association has gone to only 13 institutions, including Stanford and UC.
Stanford's other best ideas, among the 7,400 inventions total, are FM Sound Synthesis, which led to the ringing of cell phones; recombinant DNA, used to make vast amounts of proteins like insulin, among other products; MINOS, an optimization software program; functional antibodies and DSL, which provides digital data transmission over the phone wires.
Ku recalled when Stanford engineering students Larry Page and Sergey Brin took their research project, based on a new search technology, to her office in hopes of finding a company interested in licensing their invention. Stanford marketed it to every potential licensee it could think of -- without success. So Page and Brin created their own company, and licensed the PageRank tool from Stanford. In exchange, Stanford was given Google stock.
Further reading
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