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 News & Investment InfoPress ReleaseProFibrix and CSL Behring Enter into Fibrinogen and Thrombin Supply Agreement
Leiden, The Netherlands and Seattle, WA, June 17, 2010 - ProFibrix B.V., a leader in the development of
innovative products for hemostasis and regenerative medicine, today
announced
that it has entered into an agreement with CSL
Behring for the clinical and commercial supply of plasma-based fibrinogen and
thrombin, for the manufacturing of its lead product Fibrocaps™
. Read More >Press ReleaseProFibrix Reports Phase II Results of Hemostasis Product Fibrocaps™ and Appoints New Chief Medical OfficerLeiden, The Netherlands and Seattle, WA, March 11, 2010 - ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the conclusion of the first Phase II trial testing its unique new hemostat FibrocapsTM. Promising preliminary data from the European multicenter, open-label trial show compelling safety and efficacy (time to hemostasis) profiles for Fibrocaps, and good performance of the delivery device. Read More>Press ReleaseProFibrix obtains government loan of up to EUR 5 million (~ US$7.4 million) to support clinical development of its lead hemostasis product Fibrocaps™ Leiden, The Netherlands and Seattle, WA, January 7, 2010 - ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that SenterNovem, an agency of the Dutch Ministry of Economic Affairs, has granted the company a loan under its new Innovation Credit scheme of potentially up to EUR 5 million to finance the further clinical development of its unique new hemostat Fibrocaps™. Read More >Press ReleaseProFibrix raises US $11 million (EUR 8 million) in series B financing Leiden, The Netherlands and Seattle, Wa,August 24, 2009 - ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the successful closing of a US $11 million series B investment. The financing round was led by new investor Gilde Healthcare Partners, a leading European life sciences investor, who joins existing investor Index Ventures. Dirk Kersten from Gilde will join the company’s Supervisory Board. Read More >ProFibrix initiates Phase II clinical trial of its lead topical hemostat product Fibrocaps™Seattle,Wa,and Leiden, the Netherlands, June 18, 2009- June 18, 2009 - ProFibrix B.V. today announced the start of the company’s Phase II clinical trial for FibrocapsTM, 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 ProFibrixProFibrix 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.ProFibrix B.V. Jaap Koopman, PhD, CEO Tel: + 31 (0) 6 21628475 E-mail: j.koopman@profibrix.com ProFibrix Inc. Jan Ohrstrom MD, COO Tel: + 1 (0) 2069105404 E-mail: j.ohrstrom@profibrix.com Press ReleaseProFibrix Steps Up Recombinant Fibrinogen Program with PER.C6® License from CrucellCommercial License to Accelerate Development of New Hemostasis Breakthrough ProductsLeiden, The Netherlands, January 13 2009 - ProFibrix B.V., today announced that it has concluded a commercial license agreement with Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) for PER.C6®, a unique human protein production platform. The PER.C6® platform allows ProFibrix to manufacture recombinant human fibrinogen at levels that support the development and commercial roll-out of new products. Fibrinogen is at the heart of all ProFibrix products and is an essential part of nature’s own injury–repair mechanism. The company’s lead product FibrocapsTM is based on fibrinogen derived from human blood plasma and is a unique dry powder topical hemostat that stops acute and severe bleeding during surgery or after trauma injury. Initially recombinant fibrinogen will be developed for systemic applications in hemostasis and later on for the development of tissue repair products. Read More > Press ReleaseProFibrix expands Management team and opens US subsidiaryNew COO brings financing and product development experience in the US Leiden, The Netherlands,September 17 2008: ProFibrix B.V., a Dutch biotech company focused on products to stop bleeding and initiate tissue repair, today announced that it has added Jan Ohrstrom, MD as COO to its Executive Management team. Dr. Ohrstrom was previously part of the Senior Management team that took ZymoGenetics Inc public, and played a key role in bringing Recombinant Human Thrombin to the US market. Dr. Ohrstrom will be based in Seattle, WA, where ProFibrix has established a wholly owned subsidiary. ProFibrix Inc. will facilitate the preparations of a global pivotal Phase II/III trial for the lead product FibrocapsTM., to be conducted in 2009/2010. Additionally, the subsidiary will allow ProFibrix significantly greater access to US pool of investors. Read More > Press ReleaseProFibrix raises up to $ 11 million (€ 8.5 million) Series A financing led by Index Ventures
Datum :19-10 BioCenturyHemostatic SprinklesBioCentury - march 2007 (volume 15, number 14) ProFibrix thinks its Fibrocaps dry powder fibrin sealant may have a competetive advantage because it can be used off the shelf without rehydrating. <read more on page A15 ... > Datum :21-10 |
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