SWTUY News Alert Swedish Orphan ADR (SWTUY) 10.8600 02/15/2015

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Swedish Orphan ADR (SWTUY) 10.8600 $SWTUY

Invitation - Presentation of Sobi's fourth quarter and full year results 2014
Thomson Reuters ONE - Thu Feb 12, 1:00AM CST
On 19 February, at 08:00 CET, Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the fourth quarter and full year 2014.

BioSpecifics Technologies wins approval for XIAPEX in the EU for treating Peyronie's Disease
M2 - Tue Feb 03, 5:16AM CST
Biopharmaceutical company BioSpecifics Technologies (NasdaqGM:BSTC) reported on Monday the receipt of approval by the Swedish Orphan Biovitrum AB (Sobi) from the EU Commission to market XIAPEX for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees.
BSTC: 38.14 (-0.85)

Exelixis and Swedish Orphan Biovitrum AB (Sobi) Extend and Restructure Distribution Agreement for COMETRIQ(R) for Medullary Thyroid Cancer
Business Wire - Wed Jan 07, 7:30AM CST
Exelixis, Inc. (NASDAQ:EXEL) today announced that it has extended and restructured its agreement with Swedish Orphan Biovitrum AB (Sobi) to support the distribution and commercialization of COMETRIQ(R) (cabozantinib) for progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC) in the European Union (EU), Switzerland, Norway, Russia, and Turkey. The agreement, which was established in February 2013 and due to expire on December 31, 2015, will now extend to December 31, 2019. Moreover, the payment structure of the partnership will transition from fixed fees paid by Exelixis to Sobi to support initial build out of COMETRIQ European commercial infrastructure to a sales margin-based approach. Exelixis continues to maintain commercial rights for all other potential cabozantinib oncology indications on a global basis.
EXEL: 2.48 (+0.20)

Sobi awarded CHMP's positive opinion for Xiapex for the treatment of Peyronie's disease
M2 - Tue Dec 23, 5:37AM CST
Healthcare company Swedish Orphan Biovitrum AB (Sobi) and partner Auxilium Pharmaceuticals on Monday jointly announced the receipt of positive opinion for Xiapex for treating adult men with Peyronie's disease, a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis.
AUXL: 36.47 (-0.06)

Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease
PR Newswire - Mon Dec 22, 6:00AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) and partner Auxilium Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of Xiapex® (collagenase clostridium histolyticum) for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
AUXL: 36.47 (-0.06)

Sobi's 2011 Long-Term incentive Programme meets all objectives
Thomson Reuters ONE - Fri Dec 19, 1:00AM CST
Swedish Orphan Biovitrum AB's (publ) (Sobi) Board of Directors today announced that the company's 2011 Long-Term Incentive programme met its objectives set and has vested in full. The total number of shares awarded to Sobi employees enrolled in the 2011 programme is 514 808.

Sobi CEO Geoffrey McDonough sells a portion of 2014 incentive shares
Thomson Reuters ONE - Tue Dec 09, 7:16AM CST
During the first week of December 2014 Sobi's CEO Geoffrey McDonough sold 350,000 of the shares he holds in Sobi. The sale was made in order to cover the estimated US tax liability for both the company's CEO incentive share programme, which vested in September 2014, and for the vesting in mid-December 2014 of the company's 2011 long-term incentive programme. This is the first time during his employment at Sobi that the CEO has been awarded shares under the incentive programmes.

Sobi exercises opt-in right for Elocta(TM)
Thomson Reuters ONE - Fri Nov 21, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) announced today that the company has decided to exercise its opt-in right to take over final development and commercialisation of Elocta (rFVIIIFc) for the territory composed of Europe, North Africa, Russia and most Middle Eastern markets. Elocta/Eloctate(TM) is a recombinant factor VIII Fc fusion protein product candidate for the treatment of haemophilia A. Sobi will make a payment to Biogen Idec of USD 10 million, which will be held in escrow pending the EU regulatory approval of Elocta. Details about this and other compensation are described in the Collaboration Agreement section below.
BIIB: 391.66 (-0.45)

Biogen Idec and Sobi announce European Medicines Agency validates Elocta(TM) (rFVIIIFc) Marketing Authorisation Application for review
Thomson Reuters ONE - Fri Oct 31, 3:10PM CDT
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) of Elocta(TM) (rFVIIIFc), a recombinant factor VIII Fc fusion protein product candidate for the treatment of haemophilia A. The validation of the MAA initiates the EMA's review process.
BIIB: 391.66 (-0.45)

Sobi publishes Report for the Third Quarter 2014
Thomson Reuters ONE - Thu Oct 30, 2:01AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its results for the third quarter 2014. Revenue totalled SEK 666 M (517), an increase of 29 per cent with contribution from all areas of the portfolio. Product revenues excluding income from Manufacturing and Royalty from ReFacto grew 35 per cent to SEK 532 M.

Invitation - Presentation of Sobi's third quarter results 2014
Thomson Reuters ONE - Thu Oct 16, 1:01AM CDT
On 30 October Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the third quarter 2014.

Pharming and Swedish Orphan Biovitrum amends and extends Ruconest distribution agreement in Austria, Germany and Netherlands
M2 - Tue Oct 14, 6:10AM CDT
Biotech company Pharming Group NV (Amsterdam HARM.AS) reported on Monday the amendment and extension of the Ruconest distribution agreement with Swedish Orphan Biovitrum AB (publ) (SS:SOBI).

Sobi's collaboration partner Biogen Idec files marketing authorisation application for Elocta(TM) (rFVIIIFc) in Europe
Thomson Reuters ONE - Thu Oct 09, 2:01PM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that Biogen Idec has submitted a Marketing Authorisation Application (MAA) for Elocta (rFVIIIFc) to the European Medicines Agency (EMA). Sobi has an exclusive opt-in right to assume final development and commercialisation of Elocta in Europe, Russia, the Middle East and Northern Africa.
BIIB: 391.66 (-0.45)

Sobi opens North American operations
GlobeNewswire - Mon Sep 22, 10:07AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today formally opened the company's new North American office in Waltham, Massachusetts with a ribbon cutting ceremony arranged in collaboration with the Massachusetts Life Sciences Center (MLSC).

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.
BIIB: 391.66 (-0.45)




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