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 The leading web portal for pharmacy resources, news, education and careers August 16, 2017
Pharmacy Choice - Pharmaceutical News - GNW-News: Basilea announces agreement with FDA on Special Protocol Assessments for antibiotic ceftobiprole phase 3 clinical studies in bloodstream and skin infections (english) - August 16, 2017

Pharmacy News Article

 4/21/17 - GNW-News: Basilea announces agreement with FDA on Special Protocol Assessments for antibiotic ceftobiprole phase 3 clinical studies in bloodstream and skin infections (english)

Basilea announces agreement with FDA on Special Protocol Assessments for antibiotic ceftobiprole phase 3 clinical studies in bloodstream and skin infections



Basilea Pharmaceutica AG /
Basilea announces agreement with FDA on Special Protocol Assessments for 
antibiotic ceftobiprole phase 3 clinical studies in bloodstream and skin 
infections 
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement. 

* Initiation of ceftobiprole pivotal phase 3 clinical program under BARDA

    contract anticipated within the next three to six months
Basel, Switzerland, April 21, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that it has reached agreement with the US Food and Drug
Administration (FDA) on Special Protocol Assessments (SPAs) for its two planned
phase 3 clinical studies of Basilea's antibiotic ceftobiprole. The two studies
will evaluate ceftobiprole for the treatment of Staphylococcus aureus bacteremia
(bloodstream infections) and acute bacterial skin and skin structure infections.
If successful, the studies would be cross-supportive for a US registration in
both indications and could separately support label extensions in other parts of
the world.

Prof. Achim Kaufhold, Basilea's Chief Medical Officer, said: "With the agreement
on the SPAs, we are on track to initiate the pivotal phase 3 program under our
contract with BARDA within the next three to six months. We plan to initially
seek US registration for the treatment of bloodstream and skin infections as
there is a significant medical need in these indications. In particular, there
are only a limited number of approved therapies available for the treatment of
bacteremia caused by methicillin-resistant Staphylococcus aureus."

In 2016, Basilea entered into a contract with the Biomedical Advanced Research
and Development Authority (BARDA) for the clinical phase 3 development of
ceftobiprole to support a potential regulatory filing in the US.(1) BARDA is
providing initial funding of approximately USD20million for the preparation of
the phase 3 program. The total value of the BARDA contract could reach
USD100million over a period of 4.5 years if pre-defined milestones are met.

Both phase 3 studies will be multi-center, double-blind, randomized non-
inferiority studies. One study will compare ceftobiprole with daptomycin in the
treatment of adult patients with Staphylococcus aureus bacteremia, including
infective endocarditis. The FDA-agreed primary endpoint is overall success at a
post-treatment visit 70 days after randomization, assessed by an independent
Data Review Committee. The other study will compare ceftobiprole with vancomycin
and aztreonam in the treatment of adult patients with acute bacterial skin and
skin structure infections. The FDA-agreed primary endpoint of this study is
early clinical response at 48-72 hours after start of treatment.

Ceftobiprole provides Gram-positive antibacterial coverage with rapid
bactericidal activity against both methicillin-susceptible and resistant
Staphylococcus aureus bacteria (MSSA, MRSA) and also covers clinically important
Gram-negative bacteria.(2,3) Previously conducted phase 3 studies demonstrated
the potential utility of ceftobiprole in the treatment of bacterial skin
infections.(4) The potential of ceftobiprole in the treatment of Staphylococcus
aureus bacteremia is supported by preclinical data that showed rapid clearance
of heart valve bacterial vegetations and also by data of patients with
bacteremia treated in previously conducted phase 3 studies.(5,6 )

About Special Protocol Assessments (SPAs)

An SPA provides agreement between the study sponsor and the FDA that the design and planned analysis of a clinical study adequately address the objectives necessary to support a regulatory submission for the approval of a drug.

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. The drug is
approved for sale in 13 European countries (European trade name Zevtera() or
Mabelio(), depending on the country) and several non-European countries for the
treatment of adult patients with community-acquired bacterial pneumonia (CABP)
and hospital-acquired bacterial pneumonia (HABP), excluding ventilator-
associated bacterial pneumonia (VABP).(2) Basilea is currently marketing the
drug in Germany, Italy, the UK, France, Austria and Switzerland. Ceftobiprole
received Qualified Infectious Disease Product (QIDP) designation from the US FDA
for the potential treatment of community-acquired bacterial pneumonia (CABP) and
acute bacterial skin and skin structure infections (ABSSSI). The drug is not
approved for commercial sale in the United States.

About Staphylococcus aureus bacteremia


Staphylococcus aureus bacteremia is a leading cause of bloodstream infections,
responsible for a broad variety of complications and has been associated with
significant morbidity and a mortality of 20 to 40%.(7,8) Several studies have
demonstrated that MRSA bacteremia is associated with a significantly higher
mortality rate compared with methicillin-susceptible Staphylococcus aureus
(MSSA) bacteremia.(9,10) Infections of the inner lining of the heart or heart
valves (infective endocarditis) and bone infections (osteomyelitis) are common
complications of Staphylococcus aureus bacteremia.

About acute bacterial skin and skin structure infections

Acute bacterial skin and skin structure infections (ABSSSIs) are among the most
common infections encountered in both community and hospital settings, and
include infections with resistance to previously effective antibacterial
treatments.(11) Increasing in incidence, they have become a challenging medical
problem associated with high direct and indirect costs to both the medical
system and society.(12) Infections due to bacteria with resistance to previously
effective antibacterial treatments, such as methicillin-resistant Staphylococcus
aureus (MRSA), are increasing in incidence and have led to higher rates of
complications and hospitalization. MRSA has emerged as the most common cause of
pus-forming infections in the United States and many other areas.

About Basilea


Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products
that address the medical problem of increasing resistance and non-response to
current treatment options in the therapeutic areas of bacterial infections,
fungal infections and cancer. The company uses the integrated research,
development and commercial operations of its subsidiary Basilea Pharmaceutica
International Ltd. to discover, develop and commercialize 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 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 Schrder, PhD                               |

| Head of Corporate Communications & Investor Relations | | +41 61 606 1102

                                       |
| media-relations@basilea.com                           |
| investor-relations@basilea.com                        |

+-+

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

References

1 Contract No. HHSO100201600002C. BARDA is a division within the Office of

the Assistant Secretary for Preparedness and Response in the US Department

    of Health and Human Services

 2  UK Summary of Product Characteristics (SPC) Zevtera:
    http://www.mhra.gov.uk/
    [Accessed: April 20, 2017]

3 G. G. Zhanel et al. Ceftobiprole - a review of a broad-spectrum and anti-

    MRSA cephalosporin. American Journal of Clinical Dermatology 2008 (9),
    245-254

 4  A. Deitchman et al. Ceftobiprole medocaril (BAL-5788) for the treatment of

complicated skin infections. Expert Review of Anti-infective Therapy 2016

(14), 997-1006

5 P. Tattevin et al. Ceftobiprole is superior to vancomycin, daptomycin, and

linezolid for treatment of experimental endocarditis in rabbits caused by

methicillin-resistant Staphylococcus aureus. Antimicrobial Agents and

Chemotherapy 2010 (54), 610-613

6 J. Rello et al. A pooled analysis of clinical cure and mortality with

ceftobiprole medocaril versus comparators in staphylococcal bacteraemia in

complicated skin infections and community- and hospital-acquired pneumonia.

European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

2016, oral presentation O318

7 A.G. Jensen et al. Treatment and outcome of Staphylococcus aureus

bacteremia: a prospective study of 278 cases. Archives of Internal Medicine

2002 (162), 25-32

8 J.L. Wang et al. Comparison of both clinical features and mortality risk

associated with bacteremia due to community-acquired methicillin-resistant

    Staphylococcus aureus and methicillin-susceptible S. aureus. Clinical
    Infectious Diseases 2008 (46), 799-806

 9  S.I. Blot et al. Outcome and attributable mortality in critically Ill

patients with bacteremia involving methicillin-susceptible and methicillin-

resistant Staphylococcus aureus. Archives of Internal Medicine 2002 (162),

2229-2235

10 S.E. Cosgrove et al. Comparison of mortality associated with methicillin-

resistant and methicillin-susceptible Staphylococcus aureus bacteremia: a

meta-analysis. Clinical Infectious Diseases 2003 (36), 53-59

11 M.S. Dryden. Complicated skin and soft tissue infection. Journal of

Antimicrobial Chemotherapy 2010 (65, Suppl 3), iii35-iii44

12 C.V. Pollack et al. Acute Bacterial Skin and Skin Structure Infections

(ABSSSI): Practice Guidelines for Management and Care Transitions in the

Emergency Department and Hospital. Journal of Emergency Medicine 2015 (48),

    508-519





Press release (PDF): 
http://hugin.info/134390/R/2097439/793906.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

http://www.basilea.com



Copyright dpa-AFX.

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