Basilea announces supply, distribution and license agreement with Grupo Biotoscana for CRESEMBA® (isavuconazole) and Zevtera® (ceftobiprole) in Latin America
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea announces supply, distribution and license agreement with Grupo
Biotoscana for CRESEMBA® (isavuconazole) and Zevtera® (ceftobiprole) in Latin
America
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The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, September 13, 2016 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that Basilea Pharmaceutica International Ltd. (Basilea) has
entered into a supply, distribution and license agreement with Grupo Biotoscana
S.L., (GBT) for Basilea's antifungal CRESEMBA(®) (isavuconazole) and antibiotic
Zevtera(®) (ceftobiprole) in 19 countries in Latin America including Brazil,
Mexico, Argentina and Colombia.
Under the terms of the agreement, GBT holds an exclusive license to
commercialize isavuconazole and ceftobiprole in key Latin American countries. In
total, Basilea will receive upfront payments of CHF 11 million for both drugs
and will be eligible to receive payments upon achievement of regulatory and
commercial milestones. GBT will be responsible for marketing authorization
applications, market access, commercialization and distribution of isavuconazole
and ceftobiprole in the countries covered by the agreement.
David Veitch, Basilea's Chief Commercial Officer, stated: "We are pleased to
have signed a distribution agreement with GBT, a leading biopharmaceutical
company in Latin America. Latin America is one of the fastest growing markets in
the world. With its presence in more than 90% of the Latin America market, GBT
has the capability to successfully commercialize isavuconazole and ceftobiprole
in this important region."
About isavuconazole
Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active
agent of the prodrug isavuconazonium sulfate. It is approved in the United
States for patients 18 years of age and older in the treatment of invasive
aspergillosis and invasive mucormycosis.(1) In Europe, isavuconazole received
marketing authorization 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) Isavuconazole has orphan drug designation
for the approved indications in Europe and the US. Basilea commercializes
isavuconazole as CRESEMBA(®) in Germany, Italy, the UK and Austria and is
seeking national pricing and reimbursement in additional EU countries. In the
US, the drug is commercialized by Basilea's license partner Astellas Pharma US.
Outside the US and the EU, isavuconazole is currently not approved for
commercial use.
About invasive aspergillosis and mucormycosis
Invasive aspergillosis and mucormycosis are life-threatening fungal infections
that predominantly affect immunocompromised patients, such as patients with
cancer. Invasive aspergillosis is known for high morbidity and mortality.
Mucormycosis (also known as zygomycosis) is a rapidly progressing and life-
threatening invasive fungal infection, known for high morbidity and mortality.
About ceftobiprole
Ceftobiprole is a broad-spectrum antibiotic from the cephalosporin class for
i.v. administration with bactericidal activity against certain Gram-positive and
Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus
(MRSA) and susceptible Pseudomonas spp. Ceftobiprole is 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).(3, 4 )The drug is
currently available in Germany, Italy, the United Kingdom, France, Austria and
Switzerland.
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.5 Methicillin-resistant Staphylococcus aureus
(MRSA) is one of the most frequent causes of hospital-acquired pneumonia.(6)
Community-acquired pneumonia (CAP) is a common condition with up to 60% of the
patients requiring hospital admission and intravenous antibiotics.(7) 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 biopharmaceutical company developing products
that address 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 potentially 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 Grupo Biotoscana
Grupo Biotoscana (GBT) is a biopharmaceutical group that operates in the fast
growing Latin American region and focuses on rapidly growing market segments
such as oncology, hematology, high-complexity genetic disorders, rare disease,
infectious disease, HIV and other specialty treatments. GBT operates throughout
Latin America under its companies Biotoscana, United Medical and LKM. GBT's
strong portfolio combines world-class licenses and proprietary products with
annual revenues of USD 250 million. GBT is controlled by the global private
equity firm Advent International, with other significant shareholders including
Essex Woodlands and a number of private investors. To find out more about Grupo
Biotoscana, please go to www.grupobiotoscana.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 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 CRESEMBA® US prescribing information [Accessed: September 12, 2016]
2 European Public Assessment Report (EPAR) CRESEMBA®:
http://www.ema.europa.eu [Accessed: September 12, 2016]
3 UK Summary of Product Characteristics (SPC) Zevtera®:
http://www.mhra.gov.uk/ [Accessed: September 12, 2016]
4 European trade name Zevtera® or Mabelio®, depending on the country. The drug
has received national licenses in 13 European countries for the treatment of
adult patients with community- and hospital-acquired pneumonia (CAP, HAP),
excluding ventilator-associated pneumonia (VAP): Austria, Belgium, Denmark,
Finland, France, Germany, Italy, Luxembourg, Norway, Spain, Sweden, Switzerland
and the United Kingdom
5 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
6 R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010
(51), S81-S87
7 W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care Clinics
2013 (29), 563-601
Press release (PDF):
http://hugin.info/134390/R/2041661/761897.pdf
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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
Unternehmensinformation / Kurzprofil:
Datum: 13.09.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 494287
Anzahl Zeichen: 9877
contact information:
Town:
Basel
Kategorie:
Business News
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