GlobeNewswire by notified

Basilea’s partner Asahi Kasei Pharma filed New Drug Application for the marketing authorization of isavuconazole in Japan

Share

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland, September 30, 2021

Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that its partner Asahi Kasei Pharma Corporation (Asahi Kasei Pharma) has filed a New Drug Application (NDA) for the marketing authorization of isavuconazole (Cresemba®) in Japan for the treatment of the fungal infections aspergillosis, mucormycosis and cryptococcosis. The filing triggers a CHF 5 million milestone payment from Asahi Kasei Pharma to Basilea.

David Veitch, Chief Executive Officer, said: “We congratulate our partner Asahi Kasei Pharma on the filing of the NDA for isavuconazole in Japan. This is a significant step towards the goal to make isavuconazole available for patients in Japan, which is one of the commercially most important market opportunities for the brand.”

The partnership between Basilea and Asahi Kasei Pharma was established in September 2016. Under the terms of the agreement, Asahi Kasei Pharma was granted an exclusive license to develop and commercialize isavuconazole in Japan. Basilea received an upfront payment of CHF 7 million and, in addition to the now triggered CHF 5 million milestone payment, will be eligible to receive further payments up to approximately CHF 55 million upon achievement of regulatory and commercial milestones. Basilea will also receive double-digit tiered royalties on product sales in Japan.

Cresemba has been approved in almost 60 countries to date and is currently marketed in 54 countries, including the United States, most EU member states and several additional countries inside and outside of Europe. For the 12 months to the end of June 2021, total "in-market" sales of Cresemba amounted to USD 285 million, a 24 percent growth year-on-year.1

About isavuconazole (Cresemba)

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.

About Basilea

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the medical needs of patients with cancer and infectious diseases. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of severe bacterial infections. We are conducting clinical studies with two targeted drug candidates for the treatment of a range of cancers and have a number of preclinical assets in both cancer and infectious diseases in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

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
E-mail media_relations@basilea.com
investor_relations@basilea.com

This ad hoc announcement can be downloaded from www.basilea.com.

References

  1. IQVIA, June 2021. In-market sales reported as moving annual total (MAT) in U.S. Dollar.
  2. European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: September 29, 2021]
  3. The registration status and approved indications may vary from country to country.

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified 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 by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Inventiva announces the design of LEGEND, a Phase IIa combination trial with lanifibranor and SGLT2 inhibitor empagliflozin in patients with NASH and type 2 diabetes27.10.2021 22:00:00 CEST | Press release

The LEGEND trial is a proof-of-concept Phase IIa clinical trial to evaluate the safety and efficacy of lanifibranor in combination with the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance®1) in patients with non-alcoholic steatohepatitis (NASH) and type 2 diabetes (T2D)The trial will be conducted in several sites in the United States and Europe with a treatment duration of 24 weeks, and a total enrollment target of 63 patients with T2D and non-cirrhotic NASHThe initiation of the trial is planned for H1 2022 and the publication of topline results is expected for H2 2023 Daix (France), Long Island City (New York, United States), October 27, 2021 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced the design of a proof-of-concept Phase IIa co

Johnson & Johnson partially converts its convertible loan27.10.2021 19:03:46 CEST | Press release

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – October 27, 2021 Idorsia Ltd (SIX: IDIA) today announced that Cilag Holding AG, an indirect subsidiary of Johnson & Johnson, notified Idorsia that it will convert a second tranche of the remaining principal amount of CHF 445 million convertible loan, such that CHF 110 million will be converted into 9.6 million shares of Idorsia. As a result of the conversion, Idorsia will issue 9’581’882 new shares and Idorsia share capital will increase from CHF 8’364’748.55 to CHF 8’843’842.65, divided into 176’876’853 Idorsia shares. As a result of conversion of the second tranche of the convertible loan, Cilag Holding AG will hold 5.7% of Idorsia’s issued share capital. Following conversion, the remaining principal amount of the convertible loan will be CHF 335 million, convertible into 29.1 million shares of Idorsia. Notes to the editor About the convertible loan On June 15, 2017, Cilag Holding AG (“Cilag”) provided a loan of CHF

AMG Advanced Metallurgical Group N.V. Reports Third Quarter 2021 Results27.10.2021 18:00:00 CEST | Press release

Coronavirus Update Active cases at AMG remain at a very low level. We continue to apply all safety measures at our disposal with the highest degree of attention in order to ensure our employees are working in the lowest risk environment possible. Strategic Highlights The construction of AMG Vanadium’s second spent catalyst recycling facility in Zanesville, Ohio, a $325 million investment and AMG’s largest capital project to date, is proceeding as planned. Commissioning starts in the first quarter of 2022 and the plant is forecast to achieve full run rate capacity in the fourth quarter of 2022.Spodumene 1+ will increase Brazil’s spodumene production by 40,000 tons. The project is currently in detailed engineering and commissioning is planned to start in the second quarter of 2023.AMG’s Supervisory Board approved the construction of the first module of a battery grade lithium hydroxide upgrader in Bitterfeld, Germany in its meeting on October 27, 2021. The total expenditure of $120 milli

The world’s first fully accessible art depot opens its doors in 10 days27.10.2021 16:36:25 CEST | Press release

Depot Boijmans Van Beuningen in Rotterdam Rotterdam, Oct. 27, 2021 (GLOBE NEWSWIRE) -- The world’s first fully accessible art depot opens its doors in 10 days Depot Boijmans Van Beuningen is set to open its doors in 10 days – on 6 November 2021 – making the entire internationally renowned art collection of Museum Boijmans Van Beuningen accessible to the public. Museums around the world usually display just 6 to 10 percent of their collections; the rest lies in storage. Depot Boijmans Van Beuningen breaks with this hidden tradition and makes all the invisible artworks visible – a world first. In the iconic, mirrored art depot designed by MVRDV the museum’s 151,000 artefacts are placed at the heart of the city. The depot’s ovoid shape makes it a building that is open in every direction. The bowl-like form means that the footprint is small and the rooftop area as expansive as possible. The fully mirrored edifice consists of 6,609 square metres of glass, divided into 1,664 mirror panels, w

Workday presenterar en djupare digital upplevelse för anställda med Workday Everywhere27.10.2021 16:24:43 CEST | Pressemelding

Obegränsad upplevelse etablerar Workday inom populära arbetsområden och företagsappar för att hjälpa anställda att hålla sig engagerade, produktiva och uppkopplade. STOCKHOLM, Sweden, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Workday, Inc. (NASDAQ: WDAY), en ledande leverantör inom molnlösningar för företag inom ekonomi och HR, tillkännagav idag lanseringen av Workday Everywhere, paketerade anslutningar som tar uppgifter och insikter från Workday direkt till digitala arbetsmiljöer för att hjälpa organisationer att förbättra anställdas upplevelser. Med Workday Everywhere kan anställda snabbt få tillgång till Workday i sitt arbetsflöde utan att växla mellan olika applikationer. Arbetsgivare kan använda Workday Everywhere för att leverera en enkel och uppkopplad upplevelse som förbättrar medarbetarnas produktivitet och engagemang. Workday Everywhere är det senaste erbjudandet från Workday för medarbetare upplevelser och stödjer en pågående satsning för att öka engagemanget med en öppen och frikti

Aspo’s financial reporting in 202227.10.2021 12:00:00 CEST | Press release

Aspo Plc Stock Exchange Release October 27, 2021 at 1 p.m. Aspo’s financial reporting in 2022 In 2022, Aspo Plc will publish its financial statement release, half year financial report and two interim reports as follows: - financial statement release for 2021 on Wednesday, February 16, 2022 - interim report for January-March on Wednesday, May 4, 2022 - half year financial report for January-June on Wednesday, August 10, 2022 - interim report for January-September on Wednesday, November 2, 2022 The Financial Statements and Sustainability Report 2021 will be published on the company’s website during week 10. Aspo’s Annual Shareholders’ Meeting is scheduled for Wednesday, April 6, 2022, in Helsinki, Finland. The Board of Directors will give a separate notice of the Annual Shareholders’ Meeting later. Possible requests from shareholders to include matters on the agenda of Aspo’s 2021 Annual Shareholders’ Meeting shall be sent to Aspo’s Board of Directors not later than February 9, 2022. Th

Correction: RESULT RIKSBANK PURCHASES OF CORPORATE BONDS27.10.2021 11:35:12 CEST | Press release

AuctionResult of auctionAuction date2021-10-27NameHeimstaden Bostad ABIsinXS2259781230Coupon, spread1.368Maturity2025-02-25Tendered volume, SEK mln30 +/- 30Offered volume, SEK mln-Volume bought, SEK mln-Number of bids-Number of accepted bids-Average yield, DM-Lowest accepted yield, DM-Highest yield, DM-Accepted at lowest yield, %- AuctionResult of auctionAuction date2021-10-27NameCastellum ABIsinSE0012675916Coupon, spread1.545Maturity2025-11-27Tendered volume, SEK mln30 +/- 30Offered volume, SEK mln6Volume bought, SEK mln6Number of bids1Number of accepted bids1Average yield, DM1.400%Lowest accepted yield, DM1.400%Highest yield, DM1.400%Accepted at lowest yield, %100.00 AuctionResult of auctionAuction date2021-10-27NameCastellum ABIsinSE0011062827Coupon, spread1.650Maturity2023-05-17Tendered volume, SEK mln30 +/- 30Offered volume, SEK mln-Volume bought, SEK mln-Number of bids-Number of accepted bids-Average yield, DM-Lowest accepted yield, DM-Highest yield, DM-Accepted at lowest yield,