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Oplosbaar 'supercondoom' voor vrouwen in de maak

Door: redactie
11-12-12 - 13:54 bron: Huffington post

Aan de universiteit van Washington wordt momenteel gewerkt aan een revolutionair nieuw condoom voor vrouwen. Na gebruik lost het gewoon op in het lichaam terwijl het preventieve stoffen loslaat die zwangerschap en overdracht van soa's voorkomen.

Deze nieuwe vorm van anticonceptie kreeg de naam 'hypercondoom' met zich mee. Het komt tot stand door electrospinning, een proces waarbij vezels worden gemaakt uit vloeistof binnen een elektrisch veld. Dit condoom zou niet alleen sperma blokkeren, maar ook een krachtige cocktail van anti-hiv-medicatie en hormonale stoffen loslaten, vergelijkbaar met de pil.

'Onze droom is een product te creëren waarmee vrouwen zich kunnen beschermen tegen hiv en ongewenste zwangerschappen. Eentje dat ze ook echt gaan willen gebruiken', stelt Kim Woodrow, assistent-professor bio-ingenieurwetenschappen. Dit 'supercondoom' is tot slot ook groener, aangezien het niet eindigt in de vuilbak.


www.ad.nl/ad/nl/1003/You/article/deta...

Zie link naar de term electrospinning
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Inspiration Biopharmaceuticals Highlights Positive Interim Data on its Two Lead Investigational Product Candidates: Recombinant Porcine FVIII (OBI-1) and Recombinant Factor IX (IB1001)

Source News
Company Inspiration Biopharmaceuticals, Celtic Pharma, Emory University, Ipsen
Tags Trial Results, Phase II, Protein Therapeutic, Blood, Phase III
Date December 13, 2012
Interim results suggest that OBI-1 was well tolerated and effective in the treatment of serious bleeding episodes in study patients with Acquired Hemophilia A.

The PK results with IB1001 represent the first data on the use of IB1001 in children less than 12 years of age with hemophilia B.

CAMBRIDGE, Mass., Dec. 13, 2012 -- (BUSINESS WIRE) -- Inspiration Biopharmaceuticals, Inc. (Inspiration) announced interim clinical results for the company’s two lead product candidates, an intravenous recombinant porcine FVIII (OBI-1) in the treatment of serious bleeds in acquired hemophilia A (AHA) and an intravenous recombinant FIX (IB1001) for the treatment and prevention of bleeding in children less than 12 years of age with hemophilia B. The data were presented in posters at the 54th American Society of Hematology Annual Meeting in Atlanta, Georgia.

Inspiration’s OBI-1 investigational drug met the primary endpoint of providing effective or partially effective treatment of serious bleeding in 16 subjects with acquired hemophilia A based on the investigator’s assessment of response to treatment.

The poster titled, “Recombinant B-domain deleted porcine FVIII (OBI-1) safety and efficacy in acquired hemophilia A: interim results”, described interim results from the prospective Phase 2/3 trial of the administration of OBI-1 in the treatment of serious bleeds. Sixteen AHA subjects and 1 compassionate use subject with AHA all had successful control (either effective or partially effective) of serious hemorrhage at 24 hours post the initial dose of OBI-1 and subsequent resolution of their bleed. Therapeutic FVIII levels were achieved with peak levels above 100% and maintained with intermittent OBI-1 administration determined by the peak FVIII and fall-off blood levels. In three subjects who developed anti-OBI-1 titers there was no correlation to the anti-hFVIII titers or clinical response as evaluated by FVIII levels and the resolution of bleeding. The mean immediate (20 minute) post-infusion factor VIII level was 230% and, given an initial dose of 200 U/kg, indicated an incremental recovery of about 1.15 IU/dL per IU/kg. There were 11 serious adverse events through September 2012 and 5 deaths were reported. None of the deaths were attributed by the investigator to OBI-1 treatment. One serious adverse event (pneumonia and atrial fibrillation) was deemed by the investigator to be probably not/remotely related to OBI-1. Antibodies to OBI-1 developed in 3 subjects, but all responded favorably to treatment. No specific treatment was given for the anti-OBI-1 antibodies. These interim results suggest that in this study OBI-1 was well-tolerated and effective in the treatment of serious bleeding episodes in AHA. Authors of the study included Jean St.-Louis MD, Rebecca Kruse-Jarres MD, Anne Greist MD, Amy Shapiro MD, Hedy Smith MD, Pratima Chowdary MD, Anja Drebes MD, Jay Lozier MD, and Edward Gomperts MD.

Inspiration intends to file a biologics license application (BLA) for OBI-1 in the first half of 2013. OBI-1 has received orphan drug designation in the US and EU, and was recently granted fast track designation by the United States Food and Drug Administration (FDA).

In addition, Inspiration’s IB1001 demonstrated an average in vivo recovery of 0.69±0.21 (mean±SD) in the 7 subjects < 12 years of age with hemophilia B versus that seen in adults (age 12 years and older) of 0.98±0.22 (mean±SD) previously reported by Martinowitz U, et al. (ref. Haemophilia, 18, 2012).

The poster titled, “IB1001, an investigational recombinant factor IX, pharmacokinetics in pediatric patients with hemophilia B”, reports preliminary pharmacokinetic (PK) data from 7 subjects (4 between 6 and 12 years of age and 3 less than 6 years of age) who underwent a 72-hour PK assessment followed by treatment with IB1001. Compared to the findings previously reported with IB1001 by Martinowitz U, et al. in adult subjects 12 years of age and older, these pediatric subjects demonstrated a more rapid metabolism of factor IX with a shorter terminal half-life (mean±SD of 19.3±7.8 h vs. 29.6±18.2 h in adults), a smaller AUC 0-8 (mean±SD of 1059±264 vs. 1668±598 in adults), and a lower in vivo recovery (mean±SD 0.69±0.21 vs. 0.98±0.22 in adults). These results are similar to those reported by Berntorp, et al (Haemophilia, 7, 2001) with nonacog alfa. Authors of the study were Shashikant J. Apte, M.D.; Uptal Chowdari, MD; M Joseph John, MD; Ri Liesner, MD; Vijay Ramanan, M.D.; Amy Shapiro, MD; Bonnie Mills, PhD; Edward Gomperts, MD; and Martin Lee, PhD.

Inspiration filed a marketing authorization application in Europe for IB1001 late 2011 and the regulatory review is ongoing. Subsequently, Inspiration filed a biologics license application in the United States for IB1001 in the first half of 2012 and the regulatory review is ongoing. The FDA placed a clinical hold on IB1001 in July 2012 when a number of study subjects developed antibodies to the host cell protein, Chinese Hamster Ovary cell proteins (CHOP), of IB1001. No clinical sequelae were associated with these antibodies and they did not impact the clinical effectiveness of the investigational product. Inspiration has made significant progress in addressing the situation, and intends to submit data to the FDA in the first part of 2013 to respond to the clinical hold.

About Inspiration’s Recombinant Porcine FVIII (OBI-1)

In the fourth quarter of 2010, OBI-1 entered late-stage clinical testing in individuals with acquired hemophilia, a rare, potentially life-threatening bleeding disorder, which, unlike congenital hemophilia, typically affects older adults and occurs equally in both males and females. Further, Inspiration has initiated a second pivotal clinical trial in individuals with congenital hemophilia A who have developed inhibitors against human FVIII.

About Inspiration’s Recombinant Factor IX (IB1001)

Inspiration's lead product candidate is an intravenous recombinant FIX product (IB1001) being developed for the treatment and prevention of bleeding in individuals with hemophilia B. IB1001 has completed pivotal Phase 3 clinical testing in the U.S., Europe, Israel and India. Pharmacokinetic results in the clinical study have demonstrated non-inferiority to the one approved recombinant FIX product currently marketed for the treatment of hemophilia B.

About Inspiration Biopharmaceuticals

Inspiration Biopharmaceuticals is exclusively dedicated to developing treatments for hemophilia, with a primary mission to broaden access to care, by providing safe and effective recombinant therapies and advancing innovation for people living with hemophilia. Inspiration has a broad portfolio of recombinant hemophilia products, which includes two products in late-stage clinical development and two preclinical programs. For further information on Inspiration, please visit www.inspirationbio.com.
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ViroPharma Launches Novel Campaign to Illustrate the Emotional Burden of Hereditary Angioedema

EXTON, Pa., Dec. 12, 2012 /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced the launch of a new unbranded campaign focusing on moments lost to hereditary angioedema (HAE) attacks to raise awareness among physicians of the emotional and psychological burden of HAE on patients' lives.

HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of a human plasma protein called C1 inhibitor. People living with HAE experience physical manifestations of attacks including, swelling and pain, but much of the true burden lies in the emotional and psychological implications for patients that greatly impact the quality of their life.

Visit www.momentsmissed.com to find out more about the emotional burden of HAE.

HAE can have a tremendous impact on a patients' mental health, daily life, and future plans. HAE attacks are highly variable and unpredictable, and many people living with HAE experience multiple attacks per month. Many patients struggle with fear of the next attack, causing a devastating psychological impact including anxiety, depression, and isolation. Approximately 50 percent of patients experience a laryngeal attack, and nearly all live in fear of having such an attack.

"Through this campaign we hope to illustrate that HAE is not just an acute clinical condition, but can also be an emotional and psychological burden to patients," said Frank Nazzario, ViroPharma's associate director, marketing.

"HAE is a life altering disease that interferes with work, school, travel and social life. ViroPharma created this campaign to give a voice to patients who bear the emotional burden of HAE and to raise awareness of the moments that are missed as a result of this disease."

emotional marketing....r*tten zijn het....bij Viropharma...
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Dr. Reddy's lanceert bod op Octoplus

Gepubliceerd op 14 dec 2012 om 05:59 | Views: 443

OctoPlus 15:22

EUR 0,52+0,02(+3,17%)

LEIDEN (AFN) - Farmaciebedrijf Dr. Reddy's Laboratories heeft zijn bod op biotechbedrijf Octoplus vrijdag officieel gelanceerd. Het bedrijf uit India biedt 0,52 euro per aandeel.

Aandeelhouders met een belang van 62,4 procent hebben al aangegeven hun stukken aan te melden, evenals individuele leden van de raad van bestuur van Octoplus, met een gezamenlijke deelneming van 1,1 procent.

De biedingstermijn loopt van 14 december tot en met 18 februari. Wanneer het bod gestand wordt gedaan of meer dan 95 procent van de stukken is aangemeld, verdwijnt Octoplus van de beurs.

Het bod van Dr. Reddy's op OctoPlus geeft het bedrijf een waardering van 27,4 miljoen euro.
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Dr. Reddy's heeft 7,5 mln aandelen Octopus gekocht, breidt belang uit tot 77,7%


AMSTERDAM (Dow Jones)--De Indiase farmaceut Dr. Reddy's Laboratories Ltd. (RDY) heeft vrijdag 7,5 miljoen aandelen Octoplus nv (OCTO.AE) gekocht voor EUR0,52 per aandeel, goed voor 14,2% van het uitstaand aandelenkapitaal.

Dr. Reddy's vergroot daarmee zijn belang in het Nederlandse concern tot 77,7%.

Donderdag lanceerde de Indiase farmaceut zijn officiele bod op Octoplus voor EUR0,52 per aandeel. De biedingsperiode eindigt op 8 februari 2013 om 18.00 uur.

De aandeelhouders van Octoplus krijgen 15 januari de kans zich uit te spreken over het bod. Op die datum vindt er in Leiden een buitengewone algemene vergadering van aandeelhouders (BAVA) waarbij het overnamebod centraal zal staan.


- Door Patrick Buis; Dow Jones Nieuwsdienst; +31 20 571 52 00; patrick.buis@dowjones.com
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PERSBERICHT: TiGenix reageert op geruchten


Leuven, Belgie - 14 december 2012 - TiGenix NV (Euronext Brussels: TIG) kondigt
aan dat, blijkbaar ten gevolge van een onrechtmatige toegang tot bepaalde niet-
publieke gedeeltes van de website van TiGenix, ontwerpen van aankondigingen
betreffende een mogelijke kapitaalverhoging middels een private plaatsing
vandaag zijn verschenen op bepaalde internetfora. De vennootschap onderzoekt de
bron en oorzaak van deze onrechtmatige toegang nog maar heeft de FSMA
onmiddellijk op de hoogte gebracht van deze feiten. De FSMA heeft vervolgens de
verhandeling van de aandelen van de vennootschap geschorst in afwachting van dit
bericht.

Zoals gebruikelijk in de biotech sector, worden opportuniteiten om bijkomende
financiering te bekomen regelmatig onderzocht en voorbereid door de
vennootschap, met inbegrip van de mogelijkheid van een kapitaalverhoging.
Momenteel heeft TiGenix echter geen beslissing genomen over een dergelijke
transactie. Indien en wanneer er over een dergelijke transactie een beslissing
zou worden genomen, zal de vennootschap de markt ten gepaste tijde informeren.

Contactgegevens
Eduardo Bravo Claudia D'Augusta Hans Herklots

Chief Executive Officer Chief Financial Officer hans.herklots@tigenix.com

eduardo.bravo@tigenix.com claudia.daugusta@tigenix.com +32 16 39 60 97


Over TiGenix
TiGenix NV (NYSE Euronext Brussels: TIG) is een toonaangevend Europees
celtherapiebedrijf met één commercieel product voor kraakbeenherstel,
ChondroCelect®, en een sterke pijplijn met klinische adulte stamcelproducten
voor de behandeling van auto-immuunaandoeningen en ontstekingsziekten. Het
hoofdkantoor van TiGenix bevindt zich in Leuven (België). Daarnaast heeft het
bedrijf vestigingen in Madrid (Spanje) en Sittard-Geleen (Nederland). Ga voor
meer informatie naar www.tigenix.com.

Toekomstgerichte informatie
Dit document kan vooruitziende verklaringen en schattingen bevatten met
betrekking tot de verwachte toekomstige prestaties van TiGenix en de markt
waarin het bedrijf actief is. Enkele van deze verklaringen, voorspellingen en
inschattingen kunnen herkend worden aan de hand van bepaalde bewoordingen zoals
'gelooft', 'verwacht', 'neemt zich voor', 'plant', 'streeft na', 'raamt', 'kan
misschien', 'zal', 'blijft', en andere gelijkaardige uitdrukkingen. Deze gaan
over zaken die geen historische feiten zijn. Zulke verklaringen, voorspellingen
en schattingen steunen op verschillende veronderstellingen en beoordelingen van
bekende en onbekende risico's, onzekerheden en andere factoren, die redelijk
geacht werden toen ze gemaakt werden, maar die achteraf ook onjuist kunnen
blijken te zijn. Werkelijke gebeurtenissen zijn moeilijk te voorspellen en
kunnen het gevolg zijn van factoren waarop TiGenix geen vat heeft. Bijgevolg
kunnen de werkelijke resultaten, financiële toestand, prestaties of
verwezenlijkingen van TiGenix of van de sector aanzienlijk verschillen van de
toekomstige resultaten, prestaties of verwezenlijkingen waarvan in deze
verklaringen en schattingen expliciet of impliciet gewag wordt gemaakt. Vanwege
deze onzekerheden kan er geen garantie gegeven worden met betrekking tot de
nauwkeurigheid of redelijkheid van die vooruitziende verklaringen,
voorspellingen en schattingen. Daarenboven zijn toekomstgerichte verklaringen,
voorspellingen en schattingen slechts geldig vanaf de publicatiedatum van dit
document. TiGenix wijst elke verplichting af om alle vooruitziende verklaringen,
voorspellingen of schattingen te actualiseren om eventuele wijzigingen te
weerspiegelen in de verwachtingen van TiGenix of veranderingen van
gebeurtenissen of omstandigheden waarop zulke verklaringen, voorspellingen of
schattingen steunen, behalve als dat verplicht is door de Belgische wetgeving.



This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.

Source: TiGenix via Thomson Reuters ONE
[HUG#1665267]

www.tigenix.com

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Global Transfection Technologies Market worth $601 Million by 2017

DALLAS, December 14, 2012 /PRNewswire/ --

The report "Global Transfection Technologies Market- (Lipofection, Calcium Phosphate, Electroporation, Nucleofection, Magnetofection, Gene Gun, Viral) And Types (Gene Delivery, DNA Delivery, Protein Delivery, SiRNA Delivery) (2012-2017) " defines and segments the global Transfection market with analysis of forecasting of the global revenue and applications revenue for transfection products. It also identifies driving and restraining factors for the global transfection market with analysis of trends, opportunities, challenges, strengths, weakness and threats. The market segmentation and revenue forecasting has been done region wise (including North America, Europe, Asia and Rest of the World), and also on the basis of application, products and technologies.

Browse 9 market data tables and 26 figures spread through 130 slides and in-depth TOC on "Global Transfection Technologies Market - (Lipofection, Calcium Phosphate, Electroporation, Nucleofection, Magnetofection, Gene Gun, Viral) And Types (Gene Delivery, DNA Delivery, Protein Delivery, SiRNA Delivery) (2012 - 2017)."
www.marketsandmarkets.com/Market-Repo...
Early buyers will receive 10% customization on reports.

Transfection technologies are widely used in cell research, recombinant protein production, drug discovery, gene therapy and therapeutics. The growing market for recombinant protein boosts the development of transfection technologies; biopharmaceutical companies are looking for technologies in hard to transfect cells in order to maximize production and product efficiency. There is demand for methods in hard to transfect cells which are the key for future applications and growth.

Cost has been a major factor in the transfection market. The market is segmented based on the technologies, where Bio-chemical based methods hold the major share in the market because of its cost advantage and simplicity over other technologies. Physical based methods are growing at a healthy pace because of its ability to transfect hard to transfect cells, while the viral mediated methods are growing at a steady phase.

The key growth area of transfection products is the application in therapeutic area, where transfection is effectively used in treatment of cancer and other genetic disorders. Growth in gene therapy market is also driving the transfection market. Gene therapy promises to cure various diseases and disorders, and is one of the growing applications in therapeutic segments with four approved drugs being in market. Electrochemotherapy is another upcoming therapeutic method being tested widely in Europe and America for treating cutaneous and sub-cutaneous tumors.

The global market for transfection products was estimated to be worth US $385 million in 2012 and is expected to reach US $601 million by 2017, growing at a CAGR of 9.32% from 2012 to 2017
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Bioengineering Factor VIII B-Domain Sequences Improves Function and Efficacy in Hemophilia A Models
Program: Oral and Poster Abstracts
Session: 321. Blood Coagulation and Fibrinolytic Factors: Poster II
Sunday, December 9, 2012, 6:00 PM-8:00 PM
Hall B1-B2, Level 1, Building B (Georgia World Congress Center)
Joshua I Siner1*, Nicholas P Iacobelli1*, Lacramioara Ivanciu, Ph.D.1, Denise E. Sabatino, Ph.D.1,2, Mortimer Poncz, MD1,2, Rodney M. Camire, PhD1,2 and Valder R Arruda, MD, PhD2,3

1Division of Hematology, The Children's Hospital of Philadelphia, Philadelphia, PA
2Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
3Division of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA

We previously reported that recombinant canine B-domain deleted factor VIII (FVIII) was expressed predominantly (>75%) as a single-chain protein and, upon activation with thrombin, yielded an active cofactor species with increased stability due to delayed A2 domain dissociation. We hypothesized that this could be in part due to a unique recognition sequence (HHQR) for intracellular PACE/Furin protease present in the canine FVIII, but absent in other mammals including human, porcine and murine FVIII where the sequence is RHQR. Here, we changed position 1645 from R to H in the B-domain deleted human FVIII (hFVIII-RH) and found that much more of the protein was expressed in a single chain form (3-fold) compared to hFVIII-wild type (hFVIII-WT). Importantly, the variant hFVIII-RH was biologically active exhibiting a 2-fold higher activity measured in a 2-stage activated partial thromboplastin time (p<0.05) likely due to slower dissociation of the A2-domain upon thrombin activation compared to hFVIII-WT (t½ 3.48 vs. 1.48 minutes, respectively).
We next sought to determine the potential in vivo efficacy and safety of circulating hFVIII-RH in murine models of hemophilia A (HA) by hepatocyte-restricted transgene expression using adeno-associated viral (AAV serotype 8) vector and by exogenous administration of the recombinant protein. HA mice received varying doses (8x1012-4x1013 vg/kg) of AAV-hFVIII-WT or AAV-hFVIII-RH and exhibited a corresponding dose-dependent response of FVIII with plateau antigen levels 2-3 fold higher in hFVIII-RH than hFVIII-WT expressing mice (n = 5/group, p < 0.05 at all doses). At the low dose cohort, circulating FVIII antigen levels were 79±6.6 and 50±9 ng/ml for the FVIII-RH and FVIII-WT, respectively. In the mid dose cohort, FVIII levels were 165±54 and 84±9 ng/ml and in the high dose 274±39 and 120±35 ng/ml. We monitored the blood loss following tail-clip assay in groups of mice stratified into groups determined by expression to be low (28-60 ng/mL), mid (60-100 ng/mL), or high (above 100 ng/mL) for analysis (n= 3-9/group). Expression of either hFVIII variant was capable of decreasing the blood loss of mice in the low group compared to untreated HA mice, but did not reach that of hemostatically normal mice. Notably, at the mid expression group only hFVIII-RH expressing mice had corrected blood loss to normal hemostasis (hFVIII-RH vs hFVIII-WT p < 0.02). In the high dose all mice (FVIII-RH and FVIII-WT) exhibited blood loss similar to that of hemostatically normal mice. The increased effect of hFVIII-RH is a result of more stable clot as seen in the FeCl3- carotid artery injury model. At comparable FVIII levels, 15/16 mice expressing hFVIII-RH form stable occlusive thrombi whereas only 14/21 in hFVIII-WT group.

Laser-induced injury at microcirculation resulted in increased fibrin deposition by 2-3 fold in HA mice expressing FVIII-RH (n=4 mice, 20 injuries) compared to those expressing FVIII-WT (n=3, 10 injuries). Similar findings were obtained upon injection of recombinant protein to achieve ~40% of normal for both FVIII-RH (n=3, 13 injuries) and FVIII-WT (n=3, 18 injuries). Moreover, we assessed the immunogenicity of hFVIII-RH by administering AAV vectors to transgenic HA mice tolerant to B-domain deleted hFVIII-WT. At 4 weeks post AAV administration all mice exhibited stable hFVIII-WT/hFVIIl-RH levels (n=5/group) with no evidence of inhibitor by Bethesda assay or by mouse specific-hFVIII-IgG titers. In summary, FVIII-RH is superior to FVIII-WT in terms of expression levels and total hemostastic function without evidence of increased immunogenicity. Therefore FVIII-RH is an attractive molecule for protein replacement and gene/cell-based strategies for HA.
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Dr. Reddy breidt belang in Octoplus uit tot 78,1%


AMSTERDAM (Dow Jones)--De Indiase farmaceut Dr. Reddy's Laboratories Ltd. (RDY) heeft maandag 182.588 aandelen Octoplus nv (OCTO.AE) gekocht voor EUR0,52 per aandeel, goed voor 0,3% van het uitstaand aandelenkapitaal.

Dr. Reddy's vergroot daarmee zijn belang in het Nederlandse concern tot 78,1%.

Donderdag lanceerde de Indiase farmaceut zijn officiele bod op Octoplus voor EUR0,52 per aandeel. De biedingsperiode eindigt op 8 februari 2013 om 18.00 uur.

De aandeelhouders van Octoplus krijgen 15 januari de kans zich uit te spreken over het bod. Op die datum vindt er in Leiden een buitengewone algemene vergadering van aandeelhouders (BAVA) waarbij het overnamebod centraal zal staan.


- Door Elco van Groningen; Dow Jones Nieuwsdienst; +31 20 571 52 00; elco.vangroningen@dowjones.com
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Heer Sijmen, wanneer krijgen wij, (ex)-aandeelhouders zoiets te lezen?

Dr. Reddy's breidt belang in Octoplus uit tot 78,2%


AMSTERDAM (Dow Jones)--De Indiase farmaceut Dr. Reddy's Laboratories Ltd. (RDY) heeft dinsdag 37.460 aandelen Octoplus nv (OCTO.AE) gekocht voor EUR0,52 per aandeel, goed voor 0,1% van het uitstaand aandelenkapitaal.

Dr. Reddy's vergroot daarmee zijn belang in het Nederlandse concern tot 78,2%.

Donderdag lanceerde de Indiase farmaceut zijn officiele bod op Octoplus voor EUR0,52 per aandeel. De biedingsperiode eindigt op 8 februari 2013 om 18.00 uur.

De aandeelhouders van Octoplus krijgen 15 januari de kans zich uit te spreken over het bod. Op die datum vindt er in Leiden een buitengewone algemene vergadering van aandeelhouders (BAVA) waarbij het overnamebod centraal zal staan.


- Door Elco van Groningen; Dow Jones Nieuwsdienst; +31-20-5715200; elco.vangroningen@dowjones.com


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Arseus neemt B&B Pharmaceuticals over in de VS


AMSTERDAM (Dow Jones)--Arseus nv (RCUS.BT) meldt donderdagochtend de marktpositie van het bedrijfsonderdeel Fagron te hebben versterkt door middel van een overname van het in de Verenigde Staten gevestigde B&B Pharmaceuticals.

B&B Pharmaceuticals behaalt in 2012 naar verwachting een omzet van circa $6 miljoen en een EBITDA-marge die boven het gemiddelde van de Fagron Groep ligt, meldt Arseus.

Fagron heeft een multiple van 5,5 keer EBITDA voor deze overname betaald. B&B Pharmaceuticals wordt vanaf 1-12-2012 geconsolideerd, aldus het concern.


Door Ellen Proper; Dow Jones Nieuwsdienst: +31-20-5715200; ellen.proper@dowjones.com


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Phase II Study Indicates that Fibrinogen Concentrate Given as a First-Line Therapy Safely Reduces Need for Transfusion after Aortic Surgery

Source Press Release
Company CSL Behring
Tags Trial Results, Protein Therapeutic, Blood, Phase II
Date December 19, 2012
Phase II Study Indicates that Fibrinogen Concentrate Given as a First-Line Therapy Safely Reduces Need for Transfusion after Aortic Surgery

- Hannover Medical School collaborates with CSL Behring to demonstrate a significant reduction in need for transfusion of blood products following aortic replacement surgery

- This is the world's largest randomized, double-blind, placebo-controlled study of fibrinogen concentrate therapy

- Results suggest proactive, targeted treatment with fibrinogen concentrate may safely reduce the need for transfusions, restore clotting ability, and protect patients undergoing aortic surgery from the adverse events associated with donor blood transfusion

MARBURG, Germany, Dec. 19, 2012 /PRNewswire/ -- Clinical study results published today in the journal Anesthesiologyshowed that human fibrinogen concentrate can significantly reduce the need for blood transfusion when given as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery.

The Phase II prospective study, performed by CSL Behring and collaborators at the Hannover Medical School, Germany, enrolled 61 patients to assess the ability of fibrinogen concentrate to improve clotting and reduce the need for transfusion following elective aortic replacement surgery with cardiopulmonary bypass (CPB). Patients who received fibrinogen concentrate required fewer allogeneic blood product transfusions than patients receiving placebo (a median of 2 units in the fibrinogen concentrate group compared with 13 units in the placebo (p<0.001)). In the fibrinogen concentrate group, 45 percent (13 out of 29 patients) avoided transfusion entirely, whereas all 32 placebo patients required transfusion (p<0.001).

A novel approach to dosing was used in the study. The group in Hannover has developed and validated a model for individualized dosing of fibrinogen concentrate,[1],[2] based on measuring the firmness of the fibrin-based clot, which is mainly dependent on plasma fibrinogen levels.[3] Maximum clot firmness (MCF) of the fibrin-based clot can be monitored using FIBTEM, a commercially available thromboelastometry point-of-care test.

"Aortic replacement surgery puts patients at risk for potentially life-threatening bleeding events because the surgery depletes fibrinogen levels and delays clotting, which may require extensive blood transfusion to restore a patient's clotting ability," said Niels Rahe-Meyer, M.D. Ph.D., of the Clinic for Anesthesiology and Intensive Care Medicine, Hannover Medical School and lead author of the study. "This is the largest study of its kind in patients undergoing aortic replacement surgery and strongly indicates that proactive treatment with fibrinogen concentrate may safely reduce the need for transfusions, restore clotting ability, and consequently protect aortic surgery patients from possible adverse events associated with donor blood transfusion."

In the study, reported treatment-emergent adverse events were similar in both groups and typical for patients undergoing cardiac surgery, with the most common being fluid buildup around the lungs (pleural effusion) and abnormal heart rhythm (atrial fibrillation). None of the treatment-emergent adverse events were ascribed to study medication or led to discontinuation from the study. The study was not powered to compare mortality or morbidity between groups."

Fibrinogen concentrate has been well-characterized for the treatment of specific inherited blood clotting disorders," said Andrew Cuthbertson, CSL Chief Scientist. "CSL Behring is committed to exploring the use of fibrinogen concentrate in patients at high risk of bleeding, particularly those in the hospital setting where fibrinogen has been shown to be depleted by surgical procedures and where a quick intervention is needed to improve clotting and prevent serious bleeding events."
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About the Study
The Phase II prospective, randomized, double-blind, placebo-controlled, parallel-group, stratified clinical study was conducted at the Hannover Medical School, Hannover, Germany. The study enrolled patients 18 years or older who were undergoing elective aortic replacement surgery with cardiopulmonary bypass. Patients were excluded from the study if they had undergone previous surgery at the same aortic site, had a congenital or acquired coagulation disorder, had a myocardial infarction or stroke in the previous two months, or if they used aspirin, clopidogrel or vitamin K antagonists before the surgery.

Before surgery, patients were randomized to receive either fibrinogen concentrate or placebo. Study medication was administered if clinically relevant bleeding occurred. Each 50 mL syringe contained either 1 g fibrinogen concentrate (Haemocomplettan® P, RiaSTAP®, CSL Behring, Marburg, Germany) diluted in 50 mL sterile water, or an equivalent volume of 0.9 percent saline as placebo. Doses were determined from the MCF value of the FIBTEM test, using a model developed in previous studies for individualizing fibrinogen concentrate dosing.[1], [2] The FIBTEM test was performed by point-of-care thromboelastometry (ROTEM® device, TEM International, Munich, Germany), using blood samples taken 20 min before the end of cardiopulmonary bypass. The time taken to obtain the MCF value was 15 min. The medications were administered intravenously within five minutes after bleeding measurement.

The primary endpoint was the total number of units of allogeneic blood components (red blood cells plus fresh frozen plasma plus platelet concentrate) given to patients between administration of study medication and 24 hours thereafter. Safety was evaluated by treatment-emergent adverse events occurring within 10 days of treatment, with follow-up for serious adverse events extended to 45 days.

About Acquired Bleeding and Fibrinogen
In addition to bleeding caused by injury or a surgical intervention itself (surgical bleeding), critical reduction in the level of coagulation factors can lead to additional non-surgical bleeding complications that can be difficult to control (e.g., coagulopathic bleeding). Such patients can have critically low concentrations of many coagulation factors. In general, it is necessary to replace the missing coagulation factors in order to reverse the critical condition. The first factor to be depleted is fibrinogen (also called Factor I), a protein needed to form blood clots.[4] Fibrinogen levels in plasma determine the potential clotting ability and activity in the body. Diminished concentrations of fibrinogen limit the body's ability to form a clot. A simple blood test can detect the level of fibrinogen; the normal range is 150–450 milligrams per deciliter.[5] CPB-induced coagulopathy is complex. Fibrinogen is one of the coagulation factors to be significantly depleted during CPB; decreases in plasma level of 34 to 42 percent have been reported, and can increase the risk of post-operative bleeding.[4],[6]

For nearly a hundred years the approach to managing bleeding has been simplistic; replacing loss of blood with blood. This currently standard approach is empirical and not based on rigorous scientific evidence. There is growing evidence that this may not be the most effective or appropriate approach.

As a leader in the field of bleeding management for anaesthetists, haematologists and other managers of coagulopathy, CSL Behring is pioneering an evidence-based approach to management of bleeding. The aim is to allow the anaesthetist and haematologist to tailor the treatment to the precise needs of the patient. This efficient method allows timely, adaptive and cost-effective interventions that improve patient outcomes, by helping provide the right factor at the right time to the right patient.

About fibrinogen concentrate [human]

CSL Behring manufactures a purified fibrinogen concentrate marketed under the name Haemocomplettan® P which is licensed for an acquired bleeding indication in the following countries: Austria, Brazil, Bulgaria, Czech Republic, Germany, Hungary,Iran, Israel,Kuwait, Netherlands, Portugal, Romania, Switzerland, Taiwan, and Turkey.

CSL Behring is conducting a Phase III study to further investigate the utility of fibrinogen concentrate in complex cardiovascular surgery. Its utility is also being investigated in a range of other clinical indications, including liver disease, postpartum haemorrhage and trauma, in which a critical reduction in the level of coagulation factors can lead to additional non-surgical bleeding complications.

In the United States, fibrinogen concentrate is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia. Afibrinogenaemia, or congenital fibrinogen deficiency, is a rare and life-threatening disorder that results from a deficiency in fibrinogen that prevents blood from clotting normally. This disease is inherited and can occur in men and women.[7] Approximately one in one million people in Western countries have this disorder.[8]

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including haemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited(ASX: CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
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ViroPharma and Halozyme Therapeutics Announce Initiation of Phase 2b Dose Ranging Combination Study for Subcutaneous Administration of Cinryze® (C1 esterase inhibitor [human]) With Hyaluronidase (rHuPH20)

Source Press Release
Company ViroPharma, Halozyme Therapeutics
Tags Trial Initiation, Protein Therapeutic, Immunology, Phase II
Date December 19, 2012
ViroPharma and Halozyme Therapeutics Announce Initiation of Phase 2b Dose Ranging Combination Study for Subcutaneous Administration of Cinryze® (C1 esterase inhibitor [human]) With Hyaluronidase (rHuPH20)

EXTON, Pa., Dec. 19, 2012 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics (Nasdaq: HALO) announced today that ViroPharma has initiated its Phase 2b double blind, multicenter, dose ranging study to evaluate the safety and efficacy of subcutaneous (SC) administration of Cinryze® (C1 esterase inhibitor [human)] in combination with Halozyme's Enhanze™ technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), in adolescents and adults with hereditary angioedema (HAE) for prevention of HAE attacks. Cinryze is currently approved for intravenous (IV) administration.

"Routine prevention of attacks of hereditary angioedema is an important therapeutic option for many patients," commented Prof. Dr. med. Marcus Maurer, Department of Dermatology, Venerology and Allergy, Charite – University Medicine Berlin, Germany and principal investigator of the study in Germany. "While the current IV formulation of Cinryze is an important option for patients seeking to prevent their attacks, a subcutaneous formulation could represent a more convenient alternative for many."

This double blind, cross-over, dose ranging study will be conducted in approximately 40 adolescent and adult subjects in the U.S. and Europe. Qualified subjects will be randomized into one of two 8-week treatment sequences of either 1000 U Cinryze with 24,000 U rHuPH20 or 2000 U Cinryze with 48,000 U rHuPH20 as a twice weekly SC injection. Each subject will participate for approximately 6 months. The primary efficacy endpoint is the normalized number of angioedema attacks recorded during each treatment period. In addition, several secondary endpoints will be assessed, including attack severity, quality of life parameters using a novel angioedema tool, and number of angioedema attacks requiring acute treatment. Additional information about this Phase 2 subcutaneous Cinryze clinical trial can be found at clinicaltrials.gov."

Our goal is to optimize the delivery and convenience of self administration of Cinryze, and we believe that the combination with rHuPH20 offers us the best opportunity to achieve that goal," commented Jennifer Schranz, MD, ViroPharma's vice president, clinical research. "The initiation of this important phase 2 study is an essential step toward continually enhancing the Cinryze experience for all patients who seek greater control over their disease through routine prevention."
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CSL Behring Launches Its First Co-Pay Assistance Program to Ease Financial Burden of Treating Hereditary Angioedema

Source Press Release
Company CSL Behring, CSL
Date January 02, 2013
CSL Behring Launches Its First Co-Pay Assistance Program to Ease Financial Burden of Treating Hereditary Angioedema

Berinert® Co-Pay BENefit covers up to $12,000 of patient's yearly out-of-pocket expenses

KING OF PRUSSIA, Pa., Jan. 2, 2013 /PRNewswire/ -- CSL Behring announced today the launch of a financial assistance program designed to cover patients' out-of-pocket expenses for Berinert®,C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute laryngeal, facial and abdominal attacks of hereditary angioedema (HAE). HAE is a rare and potentially fatal genetic disorder. BerinertCo-Pay BENefit is the most recent addition to the BerinertExpert Network (B.E.N.®), a full-service support program for healthcare providers and HAE patients and their caregivers. Berinert is available through specialty pharmacies and distributors in the United States.

Berinert Co-Pay BENefit assists with co-pay costs related to a patient's prescription for Berinert. On behalf of program participants, CSL Behring will coordinate with the patient's specialty pharmacy to cover the patient's out-of-pocket co-pay costs up to $12,000 in eligible expenses per year. The program is available to new or existing Berinertpatients, age 12 or older, who are U.S. residents insured in the U.S. and who receive product through a specialty pharmacy. Patients covered by state or federally funded programs, such as Medicare, Medicaid and Veterans Health Insurance, are not eligible.

"Berinert Co-Pay BENefit is the most recent example of CSL Behring's commitment to provide HAE patients and healthcare providers with quality products and comprehensive service and support programs," said Lynne Powell, Sr. VP of North American Commercial Operations. "For many hereditary angioedemapatients, enrollment in this program will increase their access to Berinert and result in no out-of-pocket expenses related to treatment."

In addition to Berinert Co-Pay BENefit, CSL Behring through B.E.N. provides information and assistance designed to help healthcare providers and HAE patients, including:

Comprehensive service and support on insurance and reimbursement – B.E.N. will help patients address such issues and questions as prior authorizations, coverage appeals, and letters of medical necessity
Patient Advocates for Learning and Support (PALS)– Through a peer-to-peer type program, HAE patient advocates share their experiences with new Berinert patients to help ease their transition onto therapy
Assurance and Assistance – The CSL Behring Assurance and Assistance Programs, working through B.E.N., ensure that:
Patients who experience a lapse in third-party, private health insurance can access Berinert
Qualified patients who are uninsured, underinsured or unable to afford their prescribed therapy can obtain Berinert
"As a person with HAE, I understand first-hand the difficulties patients experience dealing with confusing insurance reimbursement issues," said Janet Long, HAE patient and executive vice president of the Hereditary Angioedema Association. "As an organization, we are extremely grateful for programs that help ease the financial burden faced by HAE patients."

To enroll in the Berinert Co-Pay BENefit program, or for more information on B.E.N. 24 hours a day, seven days a week, call toll-free 1-877-BEN-4HAE (1-877-236-4423) or visit www.Berinert.com.
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quote:

RRR schreef op 2 januari 2013 22:32:

CSL Behring Launches Its First Co-Pay Assistance Program to Ease Financial Burden of Treating Hereditary Angioedema

Source Press Release
Company CSL Behring, CSL
Date January 02, 2013
CSL Behring Launches Its First Co-Pay Assistance Program to Ease Financial Burden of Treating Hereditary Angioedema

Berinert® Co-Pay BENefit covers up to $12,000 of patient's yearly out-of-pocket expenses

KING OF PRUSSIA, Pa., Jan. 2, 2013 /PRNewswire/ -- CSL Behring announced today the launch of a financial assistance program designed to cover patients' out-of-pocket expenses for Berinert®,C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute laryngeal, facial and abdominal attacks of hereditary angioedema (HAE). HAE is a rare and potentially fatal genetic disorder. BerinertCo-Pay BENefit is the most recent addition to the BerinertExpert Network (B.E.N.®), a full-service support program for healthcare providers and HAE patients and their caregivers. Berinert is available through specialty pharmacies and distributors in the United States.

Berinert Co-Pay BENefit assists with co-pay costs related to a patient's prescription for Berinert. On behalf of program participants, CSL Behring will coordinate with the patient's specialty pharmacy to cover the patient's out-of-pocket co-pay costs up to $12,000 in eligible expenses per year. The program is available to new or existing Berinertpatients, age 12 or older, who are U.S. residents insured in the U.S. and who receive product through a specialty pharmacy. Patients covered by state or federally funded programs, such as Medicare, Medicaid and Veterans Health Insurance, are not eligible.

"Berinert Co-Pay BENefit is the most recent example of CSL Behring's commitment to provide HAE patients and healthcare providers with quality products and comprehensive service and support programs," said Lynne Powell, Sr. VP of North American Commercial Operations. "For many hereditary angioedemapatients, enrollment in this program will increase their access to Berinert and result in no out-of-pocket expenses related to treatment."

In addition to Berinert Co-Pay BENefit, CSL Behring through B.E.N. provides information and assistance designed to help healthcare providers and HAE patients, including:

Comprehensive service and support on insurance and reimbursement – B.E.N. will help patients address such issues and questions as prior authorizations, coverage appeals, and letters of medical necessity
Patient Advocates for Learning and Support (PALS)– Through a peer-to-peer type program, HAE patient advocates share their experiences with new Berinert patients to help ease their transition onto therapy
Assurance and Assistance – The CSL Behring Assurance and Assistance Programs, working through B.E.N., ensure that:
Patients who experience a lapse in third-party, private health insurance can access Berinert
Qualified patients who are uninsured, underinsured or unable to afford their prescribed therapy can obtain Berinert
"As a person with HAE, I understand first-hand the difficulties patients experience dealing with confusing insurance reimbursement issues," said Janet Long, HAE patient and executive vice president of the Hereditary Angioedema Association. "As an organization, we are extremely grateful for programs that help ease the financial burden faced by HAE patients."

To enroll in the Berinert Co-Pay BENefit program, or for more information on B.E.N. 24 hours a day, seven days a week, call toll-free 1-877-BEN-4HAE (1-877-236-4423) or visit www.Berinert.com.
Uitzonderlijke manier van klanten binden.
Maar of dit nu een oplossing is?
Eerder spreekt er angst uit voor de komende Ruconest golf.

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GTC Biotherapeutics, Inc., an LFB Group Company, Announces Name Change to rEVO Biologics and Renewed Commitment to Evolving Recombinant Medicine

Source Press Release
Company LFB
Tags Company Strategy
Date January 03, 2013
GTC Biotherapeutics, Inc., an LFB Group Company, Announces Name Change to rEVO Biologics and Renewed Commitment to Evolving Recombinant Medicine

FRAMINGHAM, Mass., Jan. 3, 2013 /PRNewswire/ -- GTC Biotherapeutics announced today that it has changed its name to rEVO Biologics. The name change reflects the recent commercial growth of the company, and better aligns with the company's business strategy of evolving recombinant medicine for the treatment of rare diseases.

(Logo: photos.prnewswire.com/prnh/20130103/N... )

Our company is taking a revolutionary approach to the development of recombinant therapies, as evidenced by our lead product ATryn® Antithrombin (Recombinant) and its remarkable growth over the past year," stated rEVO Biologics President Yann Echelard, Ph.D. "With this change, our name now reflects that core strength. Our rPRO Technology enables us to maintain all of the advantages that recombinant science offers, but through an entirely different approach. The result is better efficiency, better scalability, better cost control and ultimately better patient access to these innovative therapies."

ATryn® Antithrombin (Recombinant) is the first and only recombinant antithrombin concentrate, and is currently the fastest-growing antithrombin product with market share that has tripled in the last 12 months.

The original GTC Biotherapeutics name dates back to when the company was Genzyme Transgenics Corporation, and a spinoff of Genzyme Corporation. Today, the company is a subsidiary of LFB Biotechnologies S.A., a leading European-based biopharmaceutical group. rEVO Biologics corporate offices are in Framingham, MA, with protein production facilities in Charlton, MA.

About rEVO Biologics
rEVO Biologics is a rare disease company focused on developing and delivering first- and next-generation therapeutics that are more cost effective to produce than traditional recombinant therapies. Through its proprietary rPRO Technology platform -- a scalable, transgenic, and cost-effective method of protein production -- rEVO Biologics is bringing safe and reliable therapeutic proteins to address critical medical needs. The company's lead product, ATryn® Antithrombin (Recombinant), is the first and only plasma-free antithrombin concentrate. ATryn received FDA approval in 2009. The company has a number of products in its pipeline and in clinical trials in the areas of hematology, oncology, genetic disorders and autoimmune disease, and is actively seeking additional indications for its lead product.

About LFB
LFB Biotechnologies S.A. is a wholly-owned subsidiary of LFB S.A, a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, including Hemostasis, Immunology and Intensive Care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide and is also among the leading European companies for the development of new-generation medicinal products based on biotechnologies. The LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. To that end, the LFB Group currently markets its products in 20 countries around the world with a global turnover of euro 432 millions in 2011.
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weet eigenlijk niet meer of ik dit al had geplaatst...

Item 1.01 Entry into a Material Definitive Agreement.

On December 6, 2012, ViroPharma SPRL (“VP SPRL”), a wholly-owned subsidiary of ViroPharma Incorporated (the “Company”), entered into a first amendment to the Manufacturing and Distribution Agreement (Europe and ROW) between VP SPRL and Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation) (“Sanquin”) (the “ROW Agreement”). The first amendment to the ROW Agreement (the “First Amendment”) expands the VP SPRL territory to worldwide, with the exception of all countries in North America and South America (other than the Dutch Overseas Territories, Argentina and Brazil) and Israel. The territories of North and South America (other than the Dutch Overseas Territories, Argentina and Brazil) are the subject of a pre-existing agreement between another wholly-owned subsidiary of the Company and Sanquin. The First Amendment also grants Sanquin the license to commercialize VP SPRL C1-INH product in certain countries in which Sanquin has pre-existing marketing arrangements, including Belgium, Luxembourg, The Netherlands, Finland, Turkey, Indonesia, and Egypt (the “Sanquin Licensed Territories”). In the event that the marketing arrangements in the Sanquin Licensed Territories expire or are terminated, VP SPRL has a right of first refusal to include such country in its territory and/or to exclude such country from the countries covered by its license to Sanquin. As a result of the First Amendment, the Company, through wholly-owned subsidiaries, has worldwide rights to commercialize C1-INH products other than in the Sanquin Licensed Territories. In connection with the First Amendment, ViroPharma will make a payment of $1.3 million to Sanquin.

Additionally, under the First Amendment, Sanquin agrees to withdraw its Cetor and Cebitor product from certain markets in which it is currently being sold in order to transition to VP SPRL’s C1-INH product, Cinryze, and its future forms and formulations. The transition will be on a country by country basis and on a schedule agreed by VP SPRL and Sanquin to avoid supply interruptions to patients using Sanquin’s Cetor and/or Cebitor products. The First Amendment also provides that in the countries in which Sanquin is licensed to commercialize VP SPRL C1-INH product, Sanquin shall have the right to liaise with regulators to set the reimbursement price, unless regulators require VP SPRL to do so.

VP SPRL and Sanquin agreed to certain provisions restricting the sale of competitive products relating to C1-INH without the other’s consent. VP SPRL may not directly or indirectly commercially exploit competitive products in the VP SPRL territory without Sanquin’s consent. On a country by country basis, following the applicable transition date in each country, Sanquin agrees not to directly or indirectly commercially exploit competitive products to any person anywhere in the world. The First Amendment provides Sanquin with the right to sell and supply Cetor and/or Cebitor before the transition date and VP SPRL’s C1-INH product thereafter to a named manufacturer provided that the named manufacturer uses the products solely in connection with the manufacturer’s manufacture of certain plasma products under its own marketing authorization and corporate brand.
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