Swedish Orphan ADR (SWTUY) 10.9800 $SWTUY
Sobi expands Haemophilia development portfolio - elects to include potentially longer-acting Haemophilia A candidate in collaboration agreement with Biogen Idec
M2 - Fri Sep 19, 6:04AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) has elected to add the preclinical rFVIIIFc-XTEN-vWF fusion molecule to the company's collaboration with Biogen Idec. The XTEN technology is proprietary to Amunix Operating, Inc.. Biogen Idec and Amunix signed a worldwide license agreement in April 2014. Under the terms of Sobi and Biogen Idec's agreement, Sobi has the right to elect to include the rFVIIIFc-XTEN-vWF fusion molecule in the collaboration. Sobi is required to make a payment to Biogen Idec to include this program in the collaboration agreement.
Sobi's board of directors exercises authorisation for repurchase of shares for the purpose of securing the company's commitments under the incentive program
Thomson Reuters ONE - Fri Jul 18, 2:01AM CDT
The annual general meeting of Swedish Orphan Biovitrum AB (publ) on 8 May 2014 resolved - for the purpose of ensuring that the company can fulfill its commitments under the long-term incentive program resolved by the annual general meeting - on a directed share issue of no more than 396,180 redeemable and convertible class C shares.
Sobi publishes Report for the Second Quarter 2014
Thomson Reuters ONE - Fri Jul 18, 1:01AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its results for the second quarter 2014. Revenues totalled SEK 662.5 M (520.2), an increase of 27 per cent with contribution from all areas of the portfolio. The 2014 outlook is unchanged.
Invitation - Presentation of Sobi's second quarter results 2014
Thomson Reuters ONE - Wed Jul 09, 1:00AM CDT
On 18 July Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the second quarter 2014.
Sobi awarded Company of the Year at the European Mediscience Awards 2014
GlobeNewswire - Tue Jul 01, 2:32AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) has been awarded the Company of the Year Award at the European Mediscience Awards 2014. The Company of the Year Award is awarded to a company who has gained recognition from analysts and investors for management, financial stability, and growth with a well-defined strategy to deliver its key financial, ethical and social ambitions.
Sobi files for EU approval of Xiapex for Peyronies disease
Thomson Reuters ONE - Thu Jun 26, 9:46PM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc.today announced that Sobi has filed for an extension of the label for Xiapex(R) (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.
BioSpecifics Technologies Corp. Announces Filing by Sobi for EU Approval of XIAPEX for Peyronies Disease
PR Newswire - Wed Jun 25, 3:01PM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, announced today that Swedish Orphan Biovitrum AB (Sobi) has filed for an extension of the label for XIAPEX (the EU trade name for collagenase clostridium histolyticum or CCH) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. XIAPEX is currently approved for the treatment of Dupuytren's contracture in adult patients with a palpable cord. BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) is partnered with Sobi for the marketing of XIAPEX in 71 Eurasian and African countries for the treatment of Dupuytren's contracture, and Peyronie's disease pending applicable regulatory approvals.
Sobi to review preclinical data to potentially add future haemophilia A candidate to collaboration agreement with Biogen Idec
Thomson Reuters ONE - Mon Jun 16, 1:01AM CDT
On Friday, 13 June, Swedish Orphan Biovitrum AB's (publ) (Sobi) received a data package from Biogen Idec regarding a preclinical Hemophilia A program based on Amunix's proprietary XTEN technology. Amunix and Biogen Idec signed a worldwide license agreement in April 2014. Under the terms of Sobi and Biogen Idec's agreement, Sobi has the right to elect to obtain an option to add potential additional Factor VIII:Fc Constructs to the collaboration. Sobi has 120 days to review the preclinincal data, and to determine whether to elect to obtain such option under the collaboration. If Sobi elects to aquire its option, the company will be required to make a payment to Biogen Idec.
Sobi assumes direct responsibility for Orfadin(r) (nitisinone) in US and Canada and introduces Orfadin4U(TM)
GlobeNewswire - Tue Apr 01, 1:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today assumed direct responsibility for the distribution of its proprietary product Orfadin in the United States and Canada. Orfadin is the only FDA approved therapy for use as an adjunct to dietary restriction of tyrosine and phenylalanine for the treatment of hereditary tyrosinaemia type 1 (HT-1). Sobi has been responsible for the worldwide development and commercialisation of Orfadin since 1993 and currently distributes the product in over 50 countries around the globe.
Sobi: US FDA approves Alprolix(TM)
GlobeNewswire - Mon Mar 31, 1:05AM CDT
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec have announced that the US Food and Drug Administration (FDA) has approved Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), the first recombinant, DNA derived haemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.
Sobi: Kiobrina pivotal phase 3 study did not meet primary endpoint
GlobeNewswire - Wed Mar 26, 7:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced topline data from the company's pivotal phase 3 study of its enzyme therapy Kiobrina (rhBSSL - recombinant human Bile Salt Stimulated Lipase). The primary endpoint of the study - growth velocity measured after four weeks of treatment with rhBSSL - was not met. No statistically significant improvement in growth velocity was demonstrated in preterm infants treated with rhBSSL compared to placebo.
Cometriq(R) approved in Europe for the treatment of progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Thomson Reuters ONE - Tue Mar 25, 6:01AM CDT
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission has approved Cometriq(R) (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). The European Commission granted conditional marketing authorisation following a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) issued in December 2013. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.
Health Canada approves Alprolix(TM)
GlobeNewswire - Fri Mar 21, 7:10AM CDT
Swedish Orphan Biovitrum AB's (pupl) (Sobi) partner Biogen Idec today announced that Health Canada has approved Alprolix(TM) (Coagulation Factor IX (Recombinant), Fc fusion protein), rFIXFc, for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with haemophilia B. Alprolix is the first approved long-acting haemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic injections scheduled once weekly or once every 10-14 days.
Sobi expands Haemophilia development portfolio - elects to include potentially longer-acting Haemophilia A candidate in collaboration agreement with Biogen Idec
M2 - Fri Sep 19, 6:04AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) has elected to add the preclinical rFVIIIFc-XTEN-vWF fusion molecule to the company's collaboration with Biogen Idec. The XTEN technology is proprietary to Amunix Operating, Inc.. Biogen Idec and Amunix signed a worldwide license agreement in April 2014. Under the terms of Sobi and Biogen Idec's agreement, Sobi has the right to elect to include the rFVIIIFc-XTEN-vWF fusion molecule in the collaboration. Sobi is required to make a payment to Biogen Idec to include this program in the collaboration agreement.
Sobi's board of directors exercises authorisation for repurchase of shares for the purpose of securing the company's commitments under the incentive program
Thomson Reuters ONE - Fri Jul 18, 2:01AM CDT
The annual general meeting of Swedish Orphan Biovitrum AB (publ) on 8 May 2014 resolved - for the purpose of ensuring that the company can fulfill its commitments under the long-term incentive program resolved by the annual general meeting - on a directed share issue of no more than 396,180 redeemable and convertible class C shares.
Sobi publishes Report for the Second Quarter 2014
Thomson Reuters ONE - Fri Jul 18, 1:01AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its results for the second quarter 2014. Revenues totalled SEK 662.5 M (520.2), an increase of 27 per cent with contribution from all areas of the portfolio. The 2014 outlook is unchanged.
Invitation - Presentation of Sobi's second quarter results 2014
Thomson Reuters ONE - Wed Jul 09, 1:00AM CDT
On 18 July Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the second quarter 2014.
Sobi awarded Company of the Year at the European Mediscience Awards 2014
GlobeNewswire - Tue Jul 01, 2:32AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) has been awarded the Company of the Year Award at the European Mediscience Awards 2014. The Company of the Year Award is awarded to a company who has gained recognition from analysts and investors for management, financial stability, and growth with a well-defined strategy to deliver its key financial, ethical and social ambitions.
Sobi files for EU approval of Xiapex for Peyronies disease
Thomson Reuters ONE - Thu Jun 26, 9:46PM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc.today announced that Sobi has filed for an extension of the label for Xiapex(R) (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.
BioSpecifics Technologies Corp. Announces Filing by Sobi for EU Approval of XIAPEX for Peyronies Disease
PR Newswire - Wed Jun 25, 3:01PM CDT
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, announced today that Swedish Orphan Biovitrum AB (Sobi) has filed for an extension of the label for XIAPEX (the EU trade name for collagenase clostridium histolyticum or CCH) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. XIAPEX is currently approved for the treatment of Dupuytren's contracture in adult patients with a palpable cord. BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) is partnered with Sobi for the marketing of XIAPEX in 71 Eurasian and African countries for the treatment of Dupuytren's contracture, and Peyronie's disease pending applicable regulatory approvals.
Sobi to review preclinical data to potentially add future haemophilia A candidate to collaboration agreement with Biogen Idec
Thomson Reuters ONE - Mon Jun 16, 1:01AM CDT
On Friday, 13 June, Swedish Orphan Biovitrum AB's (publ) (Sobi) received a data package from Biogen Idec regarding a preclinical Hemophilia A program based on Amunix's proprietary XTEN technology. Amunix and Biogen Idec signed a worldwide license agreement in April 2014. Under the terms of Sobi and Biogen Idec's agreement, Sobi has the right to elect to obtain an option to add potential additional Factor VIII:Fc Constructs to the collaboration. Sobi has 120 days to review the preclinincal data, and to determine whether to elect to obtain such option under the collaboration. If Sobi elects to aquire its option, the company will be required to make a payment to Biogen Idec.
Sobi assumes direct responsibility for Orfadin(r) (nitisinone) in US and Canada and introduces Orfadin4U(TM)
GlobeNewswire - Tue Apr 01, 1:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today assumed direct responsibility for the distribution of its proprietary product Orfadin in the United States and Canada. Orfadin is the only FDA approved therapy for use as an adjunct to dietary restriction of tyrosine and phenylalanine for the treatment of hereditary tyrosinaemia type 1 (HT-1). Sobi has been responsible for the worldwide development and commercialisation of Orfadin since 1993 and currently distributes the product in over 50 countries around the globe.
Sobi: US FDA approves Alprolix(TM)
GlobeNewswire - Mon Mar 31, 1:05AM CDT
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec have announced that the US Food and Drug Administration (FDA) has approved Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), the first recombinant, DNA derived haemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.
Sobi: Kiobrina pivotal phase 3 study did not meet primary endpoint
GlobeNewswire - Wed Mar 26, 7:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced topline data from the company's pivotal phase 3 study of its enzyme therapy Kiobrina (rhBSSL - recombinant human Bile Salt Stimulated Lipase). The primary endpoint of the study - growth velocity measured after four weeks of treatment with rhBSSL - was not met. No statistically significant improvement in growth velocity was demonstrated in preterm infants treated with rhBSSL compared to placebo.
Cometriq(R) approved in Europe for the treatment of progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Thomson Reuters ONE - Tue Mar 25, 6:01AM CDT
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission has approved Cometriq(R) (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). The European Commission granted conditional marketing authorisation following a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) issued in December 2013. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.
Health Canada approves Alprolix(TM)
GlobeNewswire - Fri Mar 21, 7:10AM CDT
Swedish Orphan Biovitrum AB's (pupl) (Sobi) partner Biogen Idec today announced that Health Canada has approved Alprolix(TM) (Coagulation Factor IX (Recombinant), Fc fusion protein), rFIXFc, for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with haemophilia B. Alprolix is the first approved long-acting haemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic injections scheduled once weekly or once every 10-14 days.
