Basilea reports solid 2014 full-year results, preparing the ground for commercialization of Zevtera® in Europe
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea reports solid 2014 full-year results, preparing the ground for
commercialization of Zevtera® in Europe
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The issuer is solely responsible for the content of this announcement.
* Antifungal isavuconazole U.S. NDA and European MAA submissions under
regulatory review - decisions expected in Q1 2015 in the U.S. and Q4Â 2015 in
the EU
* First commercial launch of antibiotic Zevtera® (ceftobiprole medocaril)
* Cash and short-term investments of CHFÂ 226Â million
Basel, Switzerland, February 17, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announces its financial results for the financial year 2014 with a solid year-
end cash position of CHFÂ 226.1Â million and a net loss of CHF 41.5 million.
Basilea achieved important milestones in 2014 including its first launch of
Zevtera(®) (ceftobiprole medocaril).
Regulatory submissions for the antifungal isavuconazole for the treatment of
severe mold infections invasive aspergillosis and mucormycosis are currently
under review in the U.S. and the European Union (EU). On January 22, 2015, the
U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory
Committee recommended the approval of the U.S. isavuconazole New Drug
Application (NDA), which was filed by Basilea's partner Astellas. The target
date for the FDA to complete its NDA review is March 8, 2015 (Prescription Drug
User Fee Act/PDUFA date). Regulatory review of Basilea's EU Marketing
Authorization Application (MAA) by the European Medicines Agency (EMA) is
anticipated to be completed in the fourth quarter of 2015.
Treatment failure rates in pneumonia, especially in pneumonia caused by
methicillin-resistant Staphylococcus aureus (MRSA), are still high and have been
attributed in part to inadequate initial antibiotic therapy.[1] Basilea
announced the launch of its antibiotic Zevtera(®) (ceftobiprole medocaril) in
Germany in December 2014. Ceftobiprole is currently approved in 13 European
countries for the treatment of community-acquired pneumonia (CAP) and hospital-
acquired pneumonia (HAP) in adults, excluding ventilator-associated pneumonia
(VAP), under the trade name of Zevtera(®) or Mabelio(®).* Ceftobiprole provides
physicians with a simplified first-line empiric treatment option with its broad-
spectrum activity, including MRSA and Pseudomonas, thus reducing the need for
using combinations of antibiotics.
In addition, Basilea made significant progress on its early-stage development
programs in 2014. Basilea initiated a phase 2a study in solid tumor patients for
its oncology drug candidate BAL101553, an i.v. and orally available, dual-action
microtubule-destabilizing small molecule. Immunocompromised cancer patients are
the largest patient group suffering from invasive bacterial and fungal
infections, creating potential synergy between Basilea's anti-infective drug
portfolio and BAL101553. The company also initiated a phase 1 combination study
with Basilea's Gram-negative antibiotic BAL30072 and meropenem, an antibiotic of
the carbapenem class. The study is being conducted under the development
agreement with the Biomedical Advanced Research and Development Authority
(BARDA), a division within the U.S. Department of Health and Human Services.
Ronald Scott, Basilea's CEO, stated: "We met our major milestones again in
2014. Isavuconazole was filed in the U.S. and the EU as planned. We were very
pleased by the FDA Advisory Committee's recent recommendation for the approval
of isavuconazole in the United States for the treatment of the severe mold
infections invasive aspergillosis and mucormycosis. AÂ regulatory decision by the
FDA is anticipated around the PDUFA date of March 8, 2015 in the U.S.
AÂ regulatory decision by the European authorities related to isavuconazole is
expected in the fourth quarter this year. Our research and development
capabilities and portfolio position Basilea as one of the leading
biopharmaceutical companies focused on the high medical need of overcoming drug
resistance." He added: "We announced the launch of Zevtera in Germany in
December 2014 and anticipate further launches in additional key European markets
in 2015. In the event isavuconazole is approved, Basilea would have the unique
opportunity of bringing two hospital focused anti-infectives to patients in
Europe."
Key figures
+--------------------------------------------------+----------+----------+
| (In CHF million, except per share data) | 2014 | 2013 |
+--------------------------------------------------+----------+----------+
| Contract revenue | 42.1 | 40.5 |
+--------------------------------------------------+----------+----------+
| Revenue from R&D services | 0.4 | 0.4 |
+--------------------------------------------------+----------+----------+
| Other income | 0.1 | 0.4 |
+--------------------------------------------------+----------+----------+
| Total operating income | 42.6 | 41.4 |
+--------------------------------------------------+----------+----------+
| Â Research & development expenses | (54.4) | (53.3) |
+--------------------------------------------------+----------+----------+
|  Selling, general & administrative expenses/ |  (30.1) |  (21.3) |
| General & administrative expenses | | |
+--------------------------------------------------+----------+----------+
| Total operating expenses | (84.5) | (74.7) |
+--------------------------------------------------+----------+----------+
| Operating loss | (41.8) | (33.3) |
+--------------------------------------------------+----------+----------+
| Net loss | (41.5) | (33.0) |
+--------------------------------------------------+----------+----------+
| Net cash used for operating activities | (71.5) | (59.5) |
+--------------------------------------------------+----------+----------+
| Cash and short-term investments | 226.1 | 273.9 |
+--------------------------------------------------+----------+----------+
| Basic and diluted loss per share, in CHF | (4.17) | (3.40) |
+--------------------------------------------------+----------+----------+
Notes: Consolidated figures in conformity with US GAAP; rounding was
consistently applied.
The consolidated financial statements of Basilea Pharmaceutica Ltd. for 2014 can
be found on the company's website at http://annualreport.basilea.com.
Financial summary
Contract revenue in the financial year 2014 amounted to CHFÂ 42.1Â million (2013:
CHFÂ 40.5Â million), including CHFÂ 36.9Â million (2013: CHFÂ 36.9Â million) related
to the global agreement with Stiefel for Toctino(®) and CHF 3.9 million (2013:
CHFÂ 1.9Â million) related to the license agreement with Astellas for
isavuconazole. Total operating income in 2014 amounted to CHFÂ 42.6Â million
(2013: CHFÂ 41.4Â million).
Research and development expenses amounted to CHFÂ 54.4Â million in 2014 (2013:
CHFÂ 53.3Â million) and were mainly related to activities for the preparation and
support of the regulatory filing in the European Union of isavuconazole, for
maintaining the supply chain for isavuconazole as well as ceftobiprole, for the
phase 1 development of BAL30072 and the phase 2a development of BAL101553. The
Company recognized CHFÂ 9.5Â million in 2014 (2013: CHFÂ 0.0Â million) under the
agreement with BARDA related to reimbursement of agreed development costs for
BAL30072.
Selling, general and administrative expenses increased to CHFÂ 30.1Â million
(2013: CHFÂ 21.3Â million), mainly related to commercial activities to prepare and
support the launch of ceftobiprole in Germany and additional major European
countries.
In 2014, operating loss amounted to CHFÂ 41.8 million, compared to
CHFÂ 33.3Â million in 2013. This change is mainly due to higher operating expenses
related to commercial pre-launch and launch activities for ceftobiprole. The net
loss amounted to CHFÂ 41.5Â million (2013: CHF 33.0 million) and the basic and
diluted loss per share to CHF 4.17 (2013: CHF 3.40).
The net cash used for operating activities in 2014 amounted to CHFÂ 71.5Â million
as compared to CHFÂ 59.5Â million in 2013.
Combined cash and short-term investments amounted to CHFÂ 226.1Â million as of
December 31, 2014, compared to CHFÂ 273.9Â million as of December 31, 2013.
Financial outlook
Basilea is focused on launching and establishing ceftobiprole in hospitals in
Germany, France, Italy and the UK in 2015. Total operating expenses for 2015 are
estimated at approximately CHFÂ 9Â million on average per month. Basilea's average
operating loss in 2015 is estimated at approximately CHF 4 million per month,
with the vast majority of operating income driven by revenue recognition from
upfront and milestone payments.
Pipeline update
Ceftobiprole (ceftobiprole medocaril) - a new-generation broad-spectrum
intravenous cephalosporin antibiotic with rapid bactericidal activity against
Gram-positive and Gram-negative bacteria, including methicillin-resistant
Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp.[2]
Ceftobiprole is approved in thirteen European countries for the treatment of
community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) in
adults, excluding ventilator-associated pneumonia (VAP).*
In July 2014, Basilea entered into an agreement with Quintiles to commercialize
Zevtera(®)/Mabelio(®) (ceftobiprole medocaril) in key European countries. In May
2014, ceftobiprole early clinical benefit data in pneumonia, based on post-hoc
analyses of phase 3 data were presented at the European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID).[3], [4]
Basilea owns the worldwide rights to ceftobiprole and is in discussions with
potential regional partners. Ceftobiprole is currently not approved by the U.S.
FDA and is not registered in the USA.
Isavuconazole (isavuconazonium sulfate) - an investigational once-daily
intravenous and oral broad-spectrum antifungal for the treatment of severe and
life-threatening invasive fungal infections, which predominantly occur in
immunocompromised patients such as cancer patients undergoing chemotherapy
Isavuconazole was designated as a Qualified Infectious Disease Product (QIDP) by
the U.S. FDA under the U.S. Generating Antibiotics Incentives Now (GAIN) Act for
the treatment of invasive aspergillosis, mucormycosis, and candidiasis. In
addition, it has EU and U.S. orphan drug status for invasive aspergillosis and
mucormycosis, and U.S. orphan drug designation for invasive candidiasis. QIDP
and orphan drug designations provide certain benefits including extended market
exclusivity in the event of approval.
Patient enrolment into the phase 3 ACTIVE study, assessing isavuconazole in the
treatment of candidemia and other invasive Candida infections in adults, was
completed in January 2015. Topline data are anticipated for the second half of
2015, following completion of treatment and follow-up periods.
Isavuconazole is being co-developed with Astellas Pharma Inc. Basilea holds full
global rights to isavuconazole except for the U.S. and Canada where Astellas is
the exclusive license holder. In 2014, Basilea received a CHF 12 million
milestone payment from Astellas related to the U.S. FDA's acceptance of the NDA
submission for the treatment of invasive aspergillosis and mucormycosis. Basilea
is entitled to further milestone payments totaling up to CHF 362 million.
BAL30072 - an investigational phase 1 intravenous monosulfactam antibiotic with
activity against many clinically relevant multidrug-resistant Gram-negative
bacteria
In June 2014, Basilea initiated a phase 1 clinical study to evaluate the safety,
tolerability, and pharmacokinetics of multiple-ascending doses of intravenously
administered BAL30072 alone and in combination with meropenem, a carbapenem
antibiotic. In-vitro data showed synergistic or additive activity of BAL30072
with antibiotics from this class.[5] The phase 1 study is being conducted under
a contract with BARDA. Based on milestone achievement, the contract provides
development funding of approximately USDÂ 17Â million for an initial 22-month
period, with potential funding extending to up to USD 89 million over a six-year
period in total.
BAL101553 - an investigational phase 2a intravenous and oral dual-action
microtubule-destabilizing small-molecule anti-cancer drug
BAL101553, the water soluble prodrug of the active moiety BAL27862, has shown
initial evidence of clinical anti-tumor activity in phase 1, during which the
maximum tolerated dose was established. Currently available phase 1 data
indicate a dual-action effect on tumor cell-proliferation and tumor
vascularization.[6]
A phase 2a study was initiated in July 2014, assessing the safety and
tolerability and obtaining efficacy data of two different doses of BAL101553 in
different solid tumor types in adult patients refractory to current therapy in
order to facilitate the selection of tumor indications to be included in future
expanded phase 2 studies. The study continues biomarker testing to further
evaluate dose and the patient populations most likely to respond to treatment.
Toctino(®) (oral alitretinoin) - the only drug approved in certain countries for
systemic use in adults with severe chronic hand eczema unresponsive to potent
topical corticosteroids; in the U.S., oral alitretinoin is an investigational
drug and not approved by the FDA
Global rights to Toctino(®) were transferred to Stiefel, a GlaxoSmithKline
company, in July 2012. Stiefel's preparations of a U.S. NDA for alitretinoin for
the treatment of severe chronic hand eczema are ongoing. Basilea is eligible for
a milestone payment related to the U.S. launch of alitretinoin and participation
in future U.S. product sales.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Tuesday, February 17, 2015, 4 p.m. (CET), during which the company will discuss
today's press release.
Dial-in numbers are:
+41 (0) 58 310 5000 (Europe and ROW)
+1 (1) 631 570 5613 (USA)
+44Â (0)Â 203Â 059Â 5862Â (UK)
A playback will be available 1 hour after the conference call until Thursday,
February 19, 2015, 6Â p.m. (CET). Participants requesting a digital playback may
dial:
+41 (0) 91 612 4330 (Europe and ROW)
+1 (1) 866 416 2558 (USA)
+44Â (0)Â 207Â 108Â 6233Â (UK)
and will be asked to enter the ID 11378 followed by the # sign.
Note to shareholders
The shareholders of Basilea Pharmaceutica Ltd. are informed that the Ordinary
General Meeting of Shareholders of Basilea Pharmaceutica Ltd. will take place on
Wednesday, April 29, 2015 at 2Â p.m. at the Hilton Hotel in Basel, Switzerland.
The invitation will be published in the Swiss Official Gazette of Commerce
(Schweizerisches Handelsamtsblatt, SHAB). Shareholders who are recorded in the
share register with voting rights on April 17, 2015 will be entitled to
participate and exercise their voting rights.
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 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:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, PhD | Barbara Zink, PhD, MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.
References
* Ceftobiprole (European trade name Zevtera(®) or Mabelio(®), depending on
the country) has received national licenses for the treatment of CAP and
HAP (excluding VAP) in adults in Austria, Belgium, Denmark, Finland,
France, Germany, Italy, Luxembourg, Norway, Spain, Sweden, Switzerland and
the United Kingdom. Reimbursement and pricing authorization in several
countries including Spain is ongoing
[1] C. Woods, G. Colice. Methicillin-resistant Staphylococcus aureus pneumonia
in adults. Expert Review of Respiratory Medicine 2014 (8), 641-651
[2] Y. Y. Syed. Ceftobiprole medocaril: A review of its use in patients with
hospital- or community-acquired pneumonia. Drugs 2014 (74), 1523-1542
[3] T. Scheeren et al. Early clinical improvement and clinical cure in a
randomised controlled phase 3 study of ceftobiprole versus
ceftazidime/linezolid in patients with hospital-acquired pneumonia.
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID) 2014, presentation O151
[4] T. Welte et al. Early clinical response in a randomised controlled phase
3 study of ceftobiprole versus ceftriaxone with or without linezolid in
patients with community-acquired pneumonia requiring hospitalisation.
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID) 2014, poster eP431
[5] I. Morissey et al. Activity of BAL30072 alone and in combination with
carbapenems against Gram-negative bacteria. European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) 2014, poster P0296
[6] L. R. Molife et al. Phase 1/2a trial of the novel microtubule inhibitor
BAL101553 in advanced solid tumors: Phase 1 completed. American Society of
Clinical Oncology (ASCO) annual meeting 2014, abstract 2562
Press release (PDF):
http://hugin.info/134390/R/1894915/671924.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
[HUG#1894915]
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Datum: 17.02.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 371859
Anzahl Zeichen: 22025
contact information:
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