Basilea reports acceptance for regulatory review of Pfizer’s marketing authorization application for antifungal isavuconazole (Cresemba®) in invasive aspergillosis in China
- Second indication under review following mucormycosis
Basel, Switzerland, November 25, 2020
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the marketing authorization application (MAA) for the antifungal isavuconazole (Cresemba®) for the treatment of adult patients with invasive aspergillosis, which was submitted by Basilea’s license partner Pfizer Inc. (NYSE: PFE, “Pfizer”), has been accepted for regulatory review by the Center for Drug Evaluation at the National Medical Products Administration (NMPA) of China. In August 2020, Basilea had announced that an MAA for Cresemba for the treatment of mucormycosis was accepted for review by the NMPA.
David Veitch, Chief Executive Officer, said: “Invasive aspergillosis and mucormycosis are the two most frequent forms of invasive mold infections and important causes of morbidity and mortality in patients with hematologic malignancies undergoing intensive chemotherapy regimens. China is commercially a very important market for Cresemba, accounting for more than 15 percent of the global market for newer antifungals. We are therefore very pleased with the progress Pfizer is making in China. The acceptance of the isavuconazole marketing authorization applications for regulatory review is an important milestone in bringing Cresemba to the Chinese market and addressing the unmet medical needs of patients suffering from invasive mold infections.”
In November 2017, Basilea and Pfizer extended their existing license agreement for Europe (excluding the Nordics), Russia, Turkey and Israel, to include China, including Hong Kong and Macao, and sixteen countries in the Asia Pacific region. Under the agreement with Pfizer, Basilea is still eligible for regulatory and sales milestone payments of up to approximately USD 630 million, in addition to receiving mid-teen royalties on sales.
Cresemba has been approved in more than 50 countries to date and is currently marketed in 48 countries, including the United States, most EU member states and several additional countries inside and outside of Europe. For the twelve-month period to the end of June 2020, total "in-market" sales of Cresemba amounted to USD 230 million, a 30 percent growth year-on-year.1
About Cresemba (isavuconazole)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. In the 27 European Union member states, as well as in Iceland, Liechtenstein, Norway and the U.K., isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.2 Cresemba is also approved in the United States and several additional countries in Europe and beyond.3 It has orphan drug designation in the U.S., Europe and Australia for its approved indications. Basilea has entered into several license and distribution agreements for isavuconazole covering the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, Turkey and Israel.
Basilea Pharmaceutica Ltd. is a commercial-stage biopharmaceutical company, focused on the development of products that address the medical challenges in the therapeutic areas of oncology and infectious diseases. With two commercialized drugs, the company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.
This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For further information, please contact:
|Peer Nils Schröder, PhD|
Head of Corporate Communications & Investor Relations
|Phone||+41 61 606 1102|
This press release can be downloaded from www.basilea.com.
- IQVIA, June 2020. In-market sales reported as moving annual total (MAT) in U.S. Dollar corrected for currency fluctuations.
- European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: November 24, 2020]
- The registration status and approved indications may vary from country to country.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK TREASURY BILLS15.1.2021 16:20:00 CET | Press release
Bid procedure, 2021-01-18BillsSWEDISH T-BILL: SE0014555991. 2021-06-16 SWEDISH T-BILL: SE0014808747, 2021-09-15 Bid date2021-01-18Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SE0014555991: 500 mln SEK +/-250 mln SEK SE0014808747: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)SE0014555991: 500 mln SEK per bid SE0014808747: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2021-01-20Delivery of billsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-01-15 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and
CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK MUNICIPAL BONDS15.1.2021 16:20:00 CET | Press release
Anbudsförfarande kommuner och regioner, 2021-01-19BondsFloating-rate Notes(FRN) issued in SEK by Municipalities or Regions with maturity in: 2023 The following issuers are accepted for delivery: Borås Stad Göteborgs Stad Helsingborgs Stad Huddinge Kommun Lunds Kommun Malmö Stad Norrköpings Kommun Region Skåne Stockholms Stad Region Stockholm Sundsvalls Kommun Södertälje Kommun Täby Kommun Uppsala Kommun Västerås Stad Örebro Kommun Östersunds Kommun Delivery may not be made in Bonds purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Specific terms, i.e. the purchase may not have been made after: 2021-01-08BidsBids are made to tel 08-696 69 70 and confirmed in writing by a filled-in Bid form by e-mail to EOL@riksbank.se Bid date2021-01-19Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 1000 +/- 1000 millionHighest permitted bid volume (corresponding nominal amount)The total bid volume from
CONDITIONS FOR PURCHASES OF CORPORATE BONDS15.1.2021 16:20:00 CET | Press release
Bid procedure, 2021-01-20BondsBonds issued in SEK by Swedish non-financial undertakings. The following bonds are eligible for delivery: AKELIUS RESIDENTIAL AB: XS1692931980, 2021-10-04 AKELIUS RESIDENTIAL AB: XS1889043359, 2023-10-03 FASTIGHETS AB BALDER: SE0013359726, 2022-07-01 FASTIGHETS AB BALDER: SE0012675940, 2022-01-28 WILLHEM AB: SE0012193985, 2025-02-22 WILLHEM AB: SE0011088921, 2022-01-11 LUNDBERGFORETAGEN AB: SE0012676666, 2024-12-06 LUNDBERGFORETAGEN AB: SE0012676609, 2025-11-13 TELE2 AB: XS2187707463, 2025-06-10 TELE2 AB: XS1571151627, 2023-02-24 Delivery of a Bond may not occur if the Counterparty has purchased the Bond from the issuer more recently than one month prior to the date of announcement of the Special terms, that is, the purchase may not have taken place after: 2020-12-20Bid date2021-01-20Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)XS1692931980: 30 mln SEK +/-30 mln SEK XS1889043359: 30 mln SEK +/-30 mln SEK SE0
CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK COVERED BONDS15.1.2021 16:20:00 CET | Press release
Bid procedure, 2021-01-21BondsSTADSHYPOTEK AB: 1590. SE0012676690. 2025-09-03 NORDEA HYPOTEK AB: 5534, SE0012230415, 2024-09-18 SKANDINAVISKA ENSKILDA: 576, SE0010049841, 2023-12-20 DANSKE HYPOTEK AB: 2312, SE0011116474, 2023-12-20 LANSFORSAKRINGAR HYPOTEK: 518, SE0011309244, 2025-09-17 SWEDISH COVERED BOND: 146, SE0013381571, 2025-06-11 SWEDBANK HYPOTEK AB: 194, SE0012142206, 2024-09-18 Bid date2021-01-21Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)1590: 1500 mln SEK +/-500 mln SEK 5534: 1300 mln SEK +/-500 mln SEK 576: 900 mln SEK +/-450 mln SEK 2312: 400 mln SEK +/-200 mln SEK 518: 800 mln SEK +/-400 mln SEK 146: 800 mln SEK +/-400 mln SEK 194: 1300 mln SEK +/-500 mln SEK Highest permitted bid volume (corresponding nominal amount)1590: 1500 mln SEK per bid 5534: 1300 mln SEK per bid 576: 900 mln SEK per bid 2312: 400 mln SEK per bid 518: 800 mln SEK per bid 146: 800 mln SEK per bid 194: 1300 mln SEK per bid Lowest permitted bid volume
CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS15.1.2021 16:20:00 CET | Press release
Bid procedure, 2021-01-22BondsSWEDEN I/L BOND: 3112. SE0008014062. 2026-06-01 SWEDEN I/L BOND: 3111, SE0007045745, 2032-06-01 Bid date2021-01-22Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)3112: 500 mln SEK +/-250 mln SEK 3111: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)3112: 500 mln SEK per bid 3111: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNo later than 10.10 (CET/CEST) on the Bid dateDelivery and payment date2021-01-26Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-01-15 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions can be r
Nykredit Bank A/S är nytt emissionsinstitut under Klöverns icke-säkerställda MTN-program15.1.2021 13:30:00 CET | Pressemelding
Nykredit Bank A/S har genom ett avtal daterat den 14 januari 2021 tillträtt som emissionsinstitut under Klövern AB (publ)s icke-säkerställda MTN-program (”MTN-programmet”) i enlighet med de allmänna villkoren för MTN-programmet ursprungligen daterade den 4 februari 2020 och såsom ändrade den 6 oktober 2020. Övriga emissionsinstitut under MTN-programmet är Danske Bank A/S, Danmark, Sverige Filial, Nordea Bank Abp och Swedbank AB (publ). Mer information om MTN-programmet finns på Klöverns webbplats (www.klovern.se). Klövern AB (publ) För ytterligare information, vänligen kontakta: Jens Andersson, Finanschef, 076-855 67 02, firstname.lastname@example.org Rutger Arnhult, VD, 070-458 24 70, email@example.com Lars Norrby, IR, 076-777 38 00, firstname.lastname@example.org Klövern är ett fastighetsbolag som med närhet och engagemang erbjuder attraktiva lokaler i tillväxtregioner. Klövern är noterat på Nasdaq Stockholm. Ytterligare information finns på www.klovern.se. Klövern AB (publ), Bredgränd 4,
Nykredit Bank A/S is new dealer under Klövern’s unsecured MTN Program15.1.2021 13:30:00 CET | Press release
Nykredit Bank A/S has through an agreement dated on 14 January 2021 acceded to Klövern AB (publ)’s unsecured MTN program (the ”MTN Program”) as dealer in accordance with the general terms and conditions of the MTN Program originally dated on 4 February 2020 and as amended on 6 October 2020. The other dealers under the MTN Program are Danske Bank A/S, Danmark, Sverige Filial, Nordea Bank Abp and Swedbank AB (publ). Further information about the MTN Program can be found on Klövern’s website (www.klovern.se). Klövern AB (publ) For additional information, please contact: Jens Andersson, Head of Finance, +46 (0)76-855 67 02, email@example.com Rutger Arnhult, CEO, +46 (0)70-458 24 70, firstname.lastname@example.org Lars Norrby, IR, +46 (0)76-777 38 00, email@example.com Klövern is a real estate company committed to working closely with customers to offer them attractive premises in growth regions. Klövern is listed on Nasdaq Stockholm. For further information, see www.klovern.se. Klö