Basilea announces license agreement for antibiotic Zevtera® (ceftobiprole) with Shenzhen China Resources Gosun Pharmaceutical Co., Ltd.
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea announces license agreement for antibiotic Zevtera® (ceftobiprole) with
Shenzhen China Resources Gosun Pharmaceutical Co., Ltd.
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, September 28, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that Basilea Pharmaceutica International Ltd. (Basilea) has
entered into a license agreement with Shenzhen China Resources Gosun
Pharmaceutical Co., Ltd. (CR Gosun) for Basilea's antibiotic Zevtera(®)
(ceftobiprole) in China, Hong Kong and Macao (the Territory).
Under the terms of the agreement, CR Gosun is granted an exclusive license to
develop, manufacture and to commercialize ceftobiprole in the Territory. Basilea
will receive an execution payment of CHF 3 million and is eligible to receive up
to approximately CHF 145 million additional payments upon achievement of pre-
specified regulatory and commercial milestones.
CR Gosun will bear all costs for regulatory and development activities,
including the conduct of clinical studies necessary for obtaining marketing
authorization in the Territory. 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.
Ronald Scott, Basilea's Chief Executive Officer, stated: "China is one of the
largest markets for antibiotics with bacterial resistance rates among the
highest in the world. Zevtera's broad spectrum anti-bacterial coverage including
MRSA addresses a significant medical need of patients who are suffering from
severe bacterial infections. We look forward to making Zevtera available to
patients in China through our partnership with CR Gosun, which is the anti-
infectives platform subsidiary of the second largest pharmaceutical group in
China and has a long history in the field of antibiotics."
Ceftobiprole is currently approved for sale in 13 European countries and several
non-European countries for the treatment of adult patients with community-
acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding
ventilator-associated pneumonia (VAP).(1)
About ceftobiprole
Ceftobiprole is a cephalosporin antibiotic for intravenous administration with
rapid bactericidal activity against a wide range of Gram-positive and Gram-
negative bacteria, including methicillin-susceptible and resistant
Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.(1) Basilea
is preparing a clinical phase 3 program aiming at the regulatory approval of
ceftobiprole in the United States. It consists of two cross-supportive phase 3
studies, one in the treatment of Staphylococcus aureus bacteremia (bloodstream
infections) and the second one in acute bacterial skin and skin structure
infections (ABSSSI). The program receives funding from the Biomedical Advanced
Research and Development Authority (BARDA), the U.S. Department of Health and
Human Services, Office of the Assistant Secretary for Preparedness and Response,
under contract number HHSO100201600002C.
About hospital-acquired and community-acquired pneumonia
Hospital-acquired pneumonia (HAP) is one of the most common hospital-acquired
infections and has been shown to have among the highest mortality rates of all
hospital-acquired infections.(2) Methicillin-resistant Staphylococcus aureus
(MRSA) is one of the most frequent causes of hospital-acquired pneumonia.(3)
Community-acquired pneumonia (CAP) is a common condition with up to 60% of the
patients requiring hospital admission and intravenous antibiotics.(4) Prompt
empiric intervention with an appropriate broad-spectrum antibiotic treatment is
considered a best medical practice. The increasing incidence of bacteria
resistant to many established antibiotics is a major concern.
About Basilea
Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company
developing products that address the medical challenge of increasing resistance
and non-response to current treatment options in the therapeutic areas of
bacterial infections, fungal infections and cancer. 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.
About Shenzhen China Resources Gosun Pharmaceutical Co., Ltd.
Established in 1991, Shenzhen China Resources Gosun Pharmaceutical Co., Ltd. is
the anti-infectives platform of the second largest pharmaceutical group in China
engaging in the development, manufacture and commercialization of anti-
infective, respiratory, digestive, orthopedic and analgesic drugs. The company
is the first pharmaceutical company in China that received EU-GMP approval for
both sterile API and formulation facilities. As a leader in the domestic
antibiotic industry, Shenzhen China Resources Gosun Pharmaceutical Co., Ltd. has
established long-term cooperative relationships with various multinational
pharmaceutical companies and oversea pharmaceutical companies. Shenzhen China
Resources Gosun Pharmaceutical Co., Ltd. is headquartered in Shenzhen, China.
Additional information can be found at the company's website www.999.com.cn.
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. 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 |
| +41 61 606 1102 |
| media_relations(at)basilea.com |
| investor_relations(at)basilea.com |
+-------------------------------------------------------+
This press release can be downloaded from www.basilea.com.
References
1 U.K. Summary of Product Characteristics (SPC) Zevtera(®):
http://www.mhra.gov.uk/
[Accessed: September 27, 2017]
2 C. Rotstein et al. Clinical practice guidelines for hospital-acquired
pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of
Infectious Diseases & Medical Microbiology 2008 (19), 19-53
3 R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia
and ventilator-associated bacterial pneumonia. Clinical Infectious Diseases
2010 (51), S81-S87
4 W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care
Clinics 2013 (29), 563-601
Press release (PDF) :
http://hugin.info/134390/R/2137480/818094.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Basilea Pharmaceutica AG via GlobeNewswire
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