Press Release: Basilea announces approval of antibiotic Zevtera(R) in China to treat community-acquired pneumonia and hospital-acquired pneumonia

-- National Medical Products Administration (NMPA) granted Drug Approval

License to Basilea's partner CR Gosun

-- Basilea will receive CHF 3 million milestone payment from CR Gosun

Basel, Switzerland, November 06, 2020

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its license

partner Shenzhen China Resources Gosun Pharmaceuticals Co. Ltd. (CR

Gosun) has received a Drug Approval License from the National Medical

Products Administration (NMPA) in China for Basilea's antibiotic

Zevtera(R) (ceftobiprole). With the Drug Approval License Authorization,

Zevtera is now approved in China for the treatment of adult patients

with community-acquired pneumonia (CAP) and adult patients with

hospital-acquired pneumonia (HAP), excluding ventilator-associated

pneumonia (VAP). The granting of the Drug Approval License triggered a

milestone payment of CHF 3 million, from CR Gosun to Basilea.

David Veitch, Basilea's CEO, said: "The approval of Zevtera in China is

an important milestone for the brand. We believe that China represents

the second largest global commercial opportunity. Our focus will now be

on supporting our partner, CR Gosun, to make Zevtera available to

patients in China with bacterial lung infections."

Zevtera is currently approved and marketed in major European countries

and a number of countries in Latin America, the Middle East and North

Africa (MENA) regions as well as in Canada for the treatment of adult

patients with CAP or HAP, excluding VAP.(1) It is not approved in the

United States. In order to support a potential registration in the U.S.,

Basilea is conducting a phase 3 program, with a successfully completed

study in acute bacterial skin and skin structure infections (ABSSSI) and

an ongoing study in Staphylococcus aureus bacteremia (bloodstream

infections), which is anticipated to complete patient enrolment in the

second half of 2021.(2)

Basilea entered into the agreement with CR Gosun in September 2017.

Under the terms of the agreement, CR Gosun was granted an exclusive

license to develop, manufacture and commercialize ceftobiprole in China

mainland, Hong Kong and Macao. Basilea will initially supply CR Gosun at

a transfer price and will be eligible for tiered double-digit royalties

on product sales, once CR Gosun manufactures ceftobiprole itself.

Basilea is also eligible for pre-specified sales milestone payments.

About ceftobiprole

Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole,

is a cephalosporin antibiotic for intravenous administration with rapid

bactericidal activity against a wide range of Gram-positive and

Gram-negative bacteria. This includes methicillin-susceptible and

resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas

spp.(1) The drug is approved and marketed as Zevtera(R) and Mabelio(R)

in a number of countries in Europe and beyond. Basilea has entered into

license and distribution agreements for the brand in Europe, Latin

America, China, Canada, Israel, and the Middle East and North Africa

(MENA) regions.

About Basilea

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.

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 press release can be downloaded from www.basilea.com.

References

1. Summary of Product Characteristics (SmPC) Zevtera:

https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: November

05, 2020]

2. The ceftobiprole phase 3 program is funded in part (up to USD 130

million, which is approximately 70% of the total estimated program costs)

with federal funds from the U.S. Department of Health and Human Services;

Office of the Assistant Secretary for Preparedness and Response;

Biomedical Advanced Research and Development Authority (BARDA), under

Contract No. HHSO100201600002C.

Attachment

-- Press release (PDF)

https://ml-eu.globenewswire.com/Resource/Download/497ada54-0063-4831-a56c-29bf4485adf8

(END) Dow Jones Newswires

November 06, 2020 01:15 ET (06:15 GMT)