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ProFibrix Commercial License PER.C6(R

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aossa 18 juni 2010 10:52

CSL heeft een Per.C6 licentie voor het ontwikkelen van recombant proteins.

harrysnel 18 juni 2010 11:07

quote:
aossa schreef:
CSL heeft een Per.C6 licentie voor het ontwikkelen van recombant proteins.

Zetten ook in op "plasma replacement therapies", zie bv. dit stuk op website:

"We are committed to significantly investing in our future R&D portfolio and capabilities in the areas of plasma replacement therapies, vaccines, immunomodulators (with our proprietary ISCOMATRIX® adjuvant) and therapeutic proteins (using recombinant technology)."
www.cslbehring.com/research-development

En:
"Biotherapies differ from conventional chemical-derived pharmaceuticals in many ways. They are derived from human plasma, or produced as their recombinant equivalents, instead of from chemicals. These expensive source materials comprise a much higher portion of the therapy’s cost than the chemicals used in pills and tablets. Biotherapies also undergo rigorous safety controls and inspections throughout every step of the year-long manufacturing process, from the collection of plasma to the final packaging of the finished product.

While plasma therapeutics treat small patient populations, traditional pharmaceuticals may treat millions of patients worldwide. As a result, economies of scale in the plasma protein industry are much narrower than in the traditional pharmaceutical industry. In fact, the costs of production for plasma-derived medical therapies are typically around 70% of the selling price compared to only about 19% for chemical-based pharmaceuticals."
www.cslbehring.com/about

better-cheaper-faster met perc6?

bilbo3 18 juni 2010 11:22

Fibrocaps wordt in eerste instantie gebruikt met uit bloed gewonnen fibrinogeen.
Profibrix voorziet echter op termijn een tekort aan donorbloed en werkt derhalve aan een oplossing mbv recombinant fibrinogeen. Dit doen ze met behulp van Per.c6.
Dus Per.c6 is niet uit de picture, maar het zal nog wel even p zich laten wachten.

van de profibrix site:

Recombinant Fibrinogen
The only currently available source of human fibrinogen is plasma from human donor blood. The amount of donated human plasma considered safe is in high demand, and the potential applications of fibrinogen are increasing. Experts believe that this could lead to a shortage of safe plasma-derived fibrinogen in the future.

ProFibrix is committed to establishing a versatile and commercially feasible recombinant production platform for human fibrinogen to enable the development of new, advanced products. Recombinant fibrinogen is believed to have substantial safety advantages over fibrinogen purified from human donor blood. The ProFibrix platform is also designed to allow production to be easily scalable to meet any demand.

ProFibrix has already established that recombinant human fibrinogen production in PER.C6® cells is cost-effective. In collaboration with a large-scale cGMP manufacturer, ProFibrix is currently in the process of expanding the production of recombinant fibrinogen to industrial volumes.

The recombinant fibrinogen platform in development may provide ProFibrix with a unique position in the hemostasis and tissue repair market. The first indication for recombinant fibrinogen may be systemic therapy in patients with inadequate levels of circulating functional fibrinogen.

flosz 3 mei 2011 09:19

ProFibrix Secures Funding for Progression of Lead Product Into Late Stage Clinical Development and Announces Management and Supervisory Board Appointments

LEIDEN, The Netherlands and SEATTLE, May 3, 2011 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products that help stop bleeding (hemostasis) after surgery, today announced the successful closing of a series B follow-on financing. In conjunction with the financing and to support the company's next stage of development towards commercialization, ProFibrix also announced several management and Supervisory Board appointments.

THE SUPERVISORY BOARD WILL BE CHAIRED BY INDEPENDENT DIRECTOR LEONARD KRUIMER, Chief Financial Officer of Crucell. Over the past decade, Mr. Kruimer has been instrumental in building Crucell from an entrepreneurial start-up into a global vaccine company, taking the company public and leading a number of large and successful M&A transactions. Also joining the Supervisory Board as an independent director is Vic Schmitt. Mr. Schmitt has been a long-time senior executive at Baxter International, a key player in the hemostasis market, where he last served as President of Venture Management.
In addition to these high profile appointments to the Supervisory Board, Jan Ohrstrom, has been named Chief Executive Officer. Before joining ProFibrix, Dr. Ohrstrom was a senior executive at ZymoGenetics, where he was responsible for the development of several products, and a member of the team that took the company public. Dr. Ohrstrom started his career at Novo Nordisk. Jaap Koopman, founding CEO of ProFibrix, will become Chief Scientific Officer.
In addition to the private funding the company was awarded a government credit, bringing the total new funds available to the company for the progression of Fibrocaps(TM) to EUR 15 million (USD 22 million). New investors Vesalius Biocapital and INKEF Capital co-led the financing round, while existing investors Index Ventures and Gilde Healthcare Partners also participated. Alain Parthoens from Vesalius Biocapital, Dirk Kersten from Gilde Healthcare Partners, and Francesco De Rubertis from Index Ventures will also hold seats on the board of ProFibrix.
The proceeds of the financing will be used to progress the company's lead product Fibrocaps into late stage clinical development, as well as to support the company's other pipeline programs. Fibrocaps is currently being investigated in a prospective, multi-center Phase II study in multiple surgical indications at up to 20 sites, including major U.S. and Dutch academic medical centers. If this study confirms the positive results of the first Phase II trial, ProFibrix anticipates initiating a pivotal Phase III trial in early 2012, and file for approval by the U.S. Food and Drug Administration in early 2013.
Jan Ohrstrom, MD, said: "We are very pleased to welcome Vesalius Biocapital and INKEF Capital to our investor base. Our successful financing and strengthened Supervisory Board and leadership team should put ProFibrix in an excellent position to continue the development of Fibrocaps and prepare for its commercial launch. We would like to extend our gratitude to the parting board members for their contribution and commitment to the early development of ProFibrix."
Jaap Koopman said: "Jan Ohrstrom has played a key role in transitioning ProFibrix to a market-focused company. He has the capabilities and skills to take ProFibrix through its next stages of growth to become a leading hemostasis company. I look forward to seconding him in his new role as CEO, and to continue to contribute to the development of new products based on our fibrinogen technology platform."
tinyurl.com/65olza6

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