AT&T to Spin Off Interest in WarnerMedia to Shareholders

 AT&T to Spin Off Interest in WarnerMedia to Shareholders

Alphabet Announces Fourth Quarter and Fiscal Year 2021 Results more

 Alphabet Announces Fourth Quarter and Fiscal Year 2021 Results  more

Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data Raise in peak sales expectations follows presentation of positive Phase III trial ARASENS with darolutamide (Nubeqa) in metastatic hormone-sensitive prostate cancer at 2022 ASCO GU Cancers Symposium and publication in The New England Journal of Medicine on February 17, 2022 / Broad development program underway with three additional ongoing or planned large clinical studies for darolutamide across a broad spectrum of prostate cancer

Berlin, February 17, 2022 – At the 2022 ASCO GU Cancers Symposium Bayer presented results from the Phase III ARASENS trial which demonstrated that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001). At the data cutoff date for the primary analysis (October 25, 2021), the median treatment duration was longer for darolutamide plus ADT and docetaxel (41.0 months) versus ADT plus docetaxel (16.7 months). Amid these positive results Bayer raised peak sales expectation for Nubeqa™ (darolutamide) to exceed €3 billion. “Subject to regulatory approval, the team at Bayer is excited to be able to offer even more patients suffering from prostate cancer an additional treatment option backed by strong clinical data,” said Stefan Oelrich, Member of the Board of Management of Bayer and President of the Pharmaceuticals Division. “With the confirmation of darolutamide’s clinical profile and expansion into the metastatic setting as well as the investments that we are making in clinical trials in other potential indications, we feel that Nubeqa has the potential to generate peak sales of more than 3 billion euros”. Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Based on results from the pivotal Phase III ARAMIS trial, the compound is already approved for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease, in more than 60 markets worldwide. Results from the second Phase III ARASENS trial evaluating darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) were presented yesterday as an oral presentation at the 2022 ASCO GU Cancer Symposium and simultaneously published in The New England Journal of Medicine. Bayer is already in discussions with health authorities worldwide regarding the submission for marketing authorization in this additional indication. Darolutamide is being investigated in a broad development program with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease. This includes another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov. In addition, a study to explore the potential of darolutamide in the early setting for patients who have been treated with surgery or radiation and now see a rise in their prostate specific antigen (PSA) levels is also planned. About Nubeqa™ (darolutamide) Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS and ARASENS Phase III trials and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial. The product is approved under the brand name Nubeqa™ in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also currently being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

Thessaloniki Port Authority Societe Anonyme EBITDA €

 Thessaloniki Port Authority Societe Anonyme   EBITDA € 

OPAP: the VALEA FOUNDATION, and the entities controlled by, and acting in concert with, VALEA FOUNDATION and following SAZKA Group a.s.’ acquisitions from the market since 16 December 2021, indirectly control in total 48.09% of the total share capital and voting rights in OPAP

17/02/2022


SAZKA Entertainment AG operating under the brand name Allwyn (“Allwyn”) today announced that RUBIDIUM HOLDINGS LIMITED (“Rubidium”) through which Allwyn indirectly holds non-voting shares of OPAP S.A. (“OPAP”) reached an agreement with Yeonama Holdings Co. Limited (“Yeonama”) to purchase the remaining minority non-voting shares of Yeonama in SAZKA Delta AIF Variable Investment Company Ltd (“SAZKA Delta”), an entity through which Allwyn holds part of its interest in OPAP for consideration of €327.4 million (the “Transaction”). As a result, Allwyn’s economic interest (i.e. the percentage representing, regardless of control of SAZKA Delta, the participation in distributions but not the voting rights) in OPAP will increase from approximately 41.2% to approximately 48.1%. It is reminded that reference to the non-voting shares held by Yeonama was made in the Information Memorandum in relation to the voluntary tender offer launched by SAZKA Group a.s., which has been approved by the HCMC on 30 September 2019.

Taking into account the net debt and working capital of SAZKA Delta, the Transaction implies a premium of more than 10% on OPAP’s current market share price. The purchase price will be financed with cash from the balance sheet, including cash raised by the recent €600 million bond issuance.

The Transaction has no impact on the sole control exercised by VALEA FOUNDATION over SAZKA Delta, and thus no impact on the number and percentage of shares and voting rights in OPAP indirectly controlled by VALEA FOUNDATION and the entities controlled by, and acting in concert with, VALEA FOUNDATION within the meaning of Law 3556/2007, which according to latest TR-1 notification by VALEA FOUNDATION dated 7 January 2022 was equal to 47.13% as of 16 December 2021.

As of today the VALEA FOUNDATION, and the entities controlled by, and acting in concert with, VALEA FOUNDATION and following SAZKA Group a.s.’ acquisitions from the market since 16 December 2021, indirectly control in total 48.09% of the total share capital and voting rights in OPAP, as follows:



Corporate Name

Percentage


VALEA FOUNDATION

48.09


Valea Holding AG

48.09


KKCG Holding AG

48.09


KKCG AG

48.09


SAZKA Entertainment AG

48.09


SAZKA Group a.s.

48.09


Sazka Delta Management Ltd. (formerly Emma Delta Management Ltd.)

48.09


SAZKA Delta AIF Variable Capital Investment Company Ltd. (formerly Emma Delta Variable Capital Investment Company Ltd.)

48.09


SAZKA Delta Hellenic Holdings Limited (formerly Emma Delta Hellenic Holdings Limited)

48.09