Basilea announces acquisition of fosmanogepix, a phase-3-ready
broad-spectrum antifungal
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, November 13, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a
commercial-stage biopharmaceutical company committed to meeting the
needs of patients with severe bacterial and fungal infections,
announced today that it has entered into an asset purchase
agreement with Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer
Inc., to acquire the rights to fosmanogepix, a clinical-stage
broad-spectrum antifungal candidate. In addition, Basilea has
acquired the rights to a preclinical antifungal compound.
Fosmanogepix is a potential first-in-class antifungal treatment
candidate with a novel mechanism of action. It is available in
intravenous and oral formulations and has been evaluated for
efficacy and safety in a phase 1 / phase 2 program, including three
open-label phase 2 studies for the treatment of Candidemia,
including Candida auris, and invasive mold infections.1, 2, 3,
4
David Veitch, Chief Executive Officer of Basilea, said: “With
fosmanogepix, we are adding a very promising drug candidate to our
late-stage clinical antifungal pipeline. It has the potential to
become an important treatment option for difficult-to-treat,
invasive fungal infections. We plan to initiate the first phase 3
study with fosmanogepix mid-2024. This is a transformative
transaction for us, as it provides a strong commercial near-term
opportunity beyond our currently marketed anti-infectives Cresemba
and Zevtera. We have now executed three transactions over the
course of the last few weeks that have significantly strengthened
our clinical-stage portfolio, and we continue to see interesting
opportunities for further transactions in the future.”
He continued: “Basilea has a successful track record of bringing
novel hospital anti-infectives through clinical development to the
market and a proven business model of collaborating with other
pharmaceutical companies for the commercialization phase of our
assets. We are currently in collaboration with Pfizer for the
commercialization of our antifungal Cresemba in most of Europe, as
well as in China and the Asia-Pacific region, and they now retain
the right of first negotiation for commercial rights for
fosmanogepix, once phase 3 development is successfully
completed.”
Under the terms of the agreement, Basilea will make an upfront
payment of USD 37 million and potential commercial milestone
payments of up to USD 110 million based on future product
sales.
Basilea assumes all rights and obligations from previous
agreements, comprising potential development, regulatory, and
commercial milestone payments of up to USD 396 million, as well as
tiered single-digit royalty payments.
Updated full-year 2023 financial guidance
Reflecting the transaction, the company updates its financial
guidance for the full-year (FY), confirming that it expects
operating and net profits for both FY 2023 and FY 2024. The
transaction has no impact on the guidance for Cresemba and
Zevtera-related revenue. However, the guidance on total revenue is
reduced by CHF 3 million. The reason for this is that the US Food
and Drug Administration (FDA) has waived the application fee for
Basilea's new drug application (NDA) for its antibiotic
ceftobiprole in the United States as part of a program to support
small businesses. Correspondingly, the BARDA reimbursements, as
well as operating expenses, will be reduced by the amount of such
application fee.
(in CHF million) |
FY 2023e(new) |
FY 2023e(previous) |
FY 2022 |
Cresemba &
Zevtera related revenue
of which royalty
income |
147 to 150~76 |
147 to 150~76 |
122.365.0 |
Total revenue |
154 to 157 |
157 to 160 |
147.8 |
Cost of products sold |
~27 |
25 to 27 |
24.6 |
Operating expenses |
~115 |
~80 |
104.6 |
Operating profit |
11 to 15 |
50 to 55 |
18.5 |
Net profit |
2 to 6 |
41 to 46 |
12.1 |
Conference call and webcast
Basilea Pharmaceutica Ltd, Allschwil will host a conference call
and webcast today, Monday, November 13, 2023, at 4 p.m. (CET),
to discuss the fosmanogepix transaction and updated guidance.
Via audio webcast with presentation
The live audio webcast of the results presentation can be
followed here:
https://media.choruscall.eu/mediaframe/webcast.html?webcastid=eyl6vgk3.
Please note that there is no function to ask questions via webcast.
For questions, please additionally dial-in via phone (see
below).
Via phone
To listen by phone and ask questions, please use the dial-in
details below. To ensure prompt access, please call approximately
five minutes prior to the scheduled start of the call.
+41 (0) 58 310 5000 |
(Europe and RoW) |
+1 (1) 866 291 4166 |
(USA) |
+44 (0) 207 107 0613 |
(U.K.) |
Replay
The webcast, along with the presentation will be available
online (same link as live audio webcast above) shortly after the
event and accessible for three months.
About fosmanogepix
Fosmanogepix is a clinical-stage broad-spectrum antifungal. It
has a novel mechanism of action and its active moiety has shown
activity against common species of Candida and Aspergillus,
including multi-drug-resistant strains, such as Candida auris and
Candida glabrata, as well as rare difficult-to-treat molds
including Fusarium spp., Scedosporium spp., and some fungi from the
Mucorales order.1 Fosmanogepix’ intravenous and oral formulations
have been evaluated in clinical phase 2 studies for the treatment
of patients with Candidemia, including Candida auris, and invasive
mold infections.1
Fosmanogepix has received Fast Track and Orphan Drug
designations from the US Food and Drug Administration for seven
separate indications, and is designated as a Qualified Infectious
Disease Product (QIDP) for the treatment of four indications.
About invasive mold infections
Invasive aspergillosis and invasive infections with rare molds
(e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are
life-threatening infections that predominantly affect
immunocompromised patients, including patients with hematologic
malignancies (blood cancer), transplant patients, or patients with
other immunodeficiency disorders. These infections are associated
with high morbidity and mortality.5, 6
About invasive candidiasis
Invasive candidiasis, including deep-seated tissue candidiasis
and candidemia, is an increasingly important nosocomial infection,
especially in patients hospitalized in intensive care units.
Candida species are ranked as the fourth main cause of bloodstream
infections in hospitals in the US.7 The prognosis of invasive
candidiasis remains difficult, with a reported mortality rate for
invasive candidiasis as high as 40%, even when patients receive
antifungal therapy.8
About Basilea
Basilea is a commercial-stage biopharmaceutical company founded
in 2000 and headquartered in Switzerland. We are committed to
discovering, developing and commercializing innovative drugs to
meet the needs of patients with severe bacterial and fungal
infections. We have successfully launched two hospital brands,
Cresemba for the treatment of invasive fungal infections and
Zevtera for the treatment of bacterial infections. In addition, we
have preclinical and clinical anti-infective assets in our
portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).
Please visit 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, Allschwil 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, Allschwil to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. Basilea Pharmaceutica Ltd, Allschwil 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 RelationsBasilea Pharmaceutica
International Ltd, Allschwil Hegenheimermattweg 167b4123
AllschwilSwitzerland |
Phone |
+41 61 606 1102 |
E-mail |
media_relations@basilea.cominvestor_relations@basilea.com |
This ad hoc announcement can be downloaded from
www.basilea.com.
References
- K. J. Shaw, A. S. Ibrahim. Fosmanogepix:A Review of
the First-in-Class Broad Spectrum Agent for the Treatment of
Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6),
239
- M. R. Hodges, E. Ople, P. Wedel et al. Safety and
Pharmacokinetics of Intravenous and Oral Fosmanogepix, a
First-in-Class Antifungal Agent, in Healthy Volunteers.
Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22
- J. A. Vazquez, P. G. Pappas, K. Boffard et al.
Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix,
in Patients with Candidemia Caused by Candida auris: Results from a
Phase 2 Trial. Antimicrobial Agents and Chemotherapy2023 (67),
e01419-22
- P. G. Pappas, J. A. Vazquez, I. Oren et al. Clinical
safety and efficacy of novel antifungal, fosmanogepix, for the
treatment of candidaemia: results from a Phase 2 trial. Journal of
Antimicrobial Chemotherapy 2023 (78), 2471-2480
- J. Cadena, G. R. Thompson 3rd, T. F..Patterson.
Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious
Disease Clinics of North America 2021 (35), 415-434
- M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive
infections due to filamentous fungi other than Aspergillus:
epidemiology and determinants of mortality. Clinical Microbiology
and Infection 2015 (21), 490.e1-490.e10
- Candidemia (Blood Infection) and Other Candida Infections. 2019
Factsheet by the American Thoracic Society:
https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed:
November 12, 2023)
- B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis.
The New England Journal of Medicine 2015 (373), 1445-1456
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