- Gossamer to receive $160 million development
reimbursement payment and eligible to receive up to $146 million in
regulatory and $180 million in sales milestones -
- Gossamer leading US commercialization
activities in PAH and PH-ILD; 50 / 50 commercial profit split in US
and global development cost sharing arrangement -
- Chiesi, a global leader in the pulmonary and
rare disease spaces, obtains exclusive ex-US commercial rights,
with Gossamer to receive mid-to-high teens royalties on net sales
-
- Gossamer and Chiesi plan to initiate Phase 3
Trial of Seralutinib in PH-ILD in Mid-2025 -
Gossamer Bio, Inc. (“Gossamer”) (Nasdaq: GOSS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of seralutinib for the treatment of pulmonary
hypertension, and Chiesi Farmaceutici S.p.A (“Chiesi Group”), an
international, research-focused biopharmaceutical group, today
announced that they have entered into a global collaboration and
license agreement to develop and commercialize seralutinib.
This global collaboration combines the strengths of both Chiesi
and Gossamer to support ongoing work in pulmonary arterial
hypertension (PAH) and to accelerate development in pulmonary
hypertension associated with interstitial lung disease (PH-ILD),
enabling the expansion of the seralutinib franchise to reach more
patients with pulmonary hypertension world-wide. Patients will
benefit from both Chiesi’s expertise in global respiratory, rare
disease, and inhaled drug development and commercialization and
Gossamer’s world-class PAH and PH-ILD development and
commercialization teams.
“This partnership with Chiesi allows us to meaningfully deepen
and rapidly accelerate our investment in seralutinib as a potential
treatment for PAH, PH-ILD, and other indications of high unmet
medical need,” said Faheem Hasnain, Co-Founder, Chairman and CEO of
Gossamer. “We are particularly thrilled that this collaboration
enables seralutinib to move directly into a Phase 3 trial in
PH-ILD, an indication with a paucity of available treatments, and a
disease which we believe seralutinib is specifically designed to
address.”
“Seralutinib is a potential paradigm shifting therapy in PAH and
PH-ILD, and we could not be more excited to partner with Gossamer
to develop and bring this therapy to patients world-wide,” said
Giuseppe Accogli, Group CEO of Chiesi. “Gossamer shares Chiesi’s
commitment to using innovation to promote the health and well-being
of people around the world and we are proud to add this
collaboration as a key pillar to our next phase of growth.”
Prevalence estimates vary widely, but PAH is believed to affect
approximately 30,000 to 50,000 people in the US, with a similar
prevalence in Europe. While many approved PAH treatments are
available, most are primarily vasodilators and do not impact the
progressive course of the disease. Median 5-year overall survival
rate for patients with PAH is approximately 57%. In the past,
PH-ILD has not been as readily diagnosed as PAH, in part due to a
lack of approved treatment options for these patients. Based on
prevalence figures for various forms of ILD and reported rates of
PH in ILD patient cohorts, we estimate that PH-ILD affects
approximately 60,000-100,000 patients in the US. Patients with
PH-ILD in the US have access to only one approved therapy, while no
therapies to treat PH-ILD are approved outside of the US. Median
5-year overall survival rate for patients with PH-ILD is
approximately 23%.
Seralutinib is an inhaled PDGFRα/β, CSF1R, and c-KIT inhibitor
designed to be delivered via dry powder inhaler for the potential
treatment of pulmonary hypertension. Following the positive readout
of the Phase 2 TORREY Study in patients with PAH, Gossamer
initiated the Phase 3 PROSERA Study in 2023. Gossamer and Chiesi
plan to initiate a global Phase 3 registrational study in PH-ILD in
mid-2025 and to evaluate seralutinib in additional indications of
high unmet need.
Under the terms of the agreement, Gossamer will continue to lead
global development of seralutinib in PAH and PH-ILD, and the
companies will evenly split development costs, except with respect
to the PROSERA Study, for which Gossamer will remain financially
responsible. In the US, the companies will evenly share commercial
profits and losses. Gossamer will lead commercialization and book
sales for PAH and PH-ILD in the US, with both companies
contributing 50 percent of commercial efforts. Chiesi will lead US
commercialization in additional indications. Chiesi will have the
exclusive right to commercialize seralutinib outside of the US and
will pay Gossamer an escalating mid-to-high teens royalty on net
sales. Chiesi will pay Gossamer $160 million as a development
reimbursement. Additionally, Gossamer will be eligible to receive
up to $146 million in regulatory milestones and $180 million in
sales milestones.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live
audio webcast to discuss the partnership today, May 6th, at 8:30
a.m. EDT.
The live audio webcast may be accessed through the “Events /
Presentations” page in the “Investors” section of the Company’s
website at www.gossamerbio.com. Alternatively, the conference call
may be accessed through the following:
Date / Time: May 6, 8:30am EDT Domestic Dial-in Number:
1-800-285-6670 Conference Reference: Gossamer Bio Announcement
Presentation Live Webcast:
https://edge.media-server.com/mmc/p/5y35ojfx
A replay of the audio webcast will be available for 30 days on
the “Investors” section of the Company’s website,
www.gossamerbio.com.
About Gossamer Bio
Gossamer Bio is a clinical-stage biopharmaceutical company
focused on the development and commercialization of seralutinib for
the treatment of pulmonary hypertension. Its goal is to be an
industry leader in, and to enhance the lives of patients living
with, pulmonary hypertension.
About Chiesi Group
Chiesi is a research-oriented international biopharmaceutical
group that develops and markets innovative therapeutic solutions in
respiratory health, rare diseases, and specialty care. The
company’s mission is to improve people’s quality of life and act
responsibly towards both the community and the environment.
By changing its legal status to a Benefit Corporation in Italy,
the US, and France, Chiesi’s commitment to create shared value for
society as a whole is legally binding and central to company-wide
decision-making. As a certified B Corp since 2019, we’re part of a
global community of businesses that meet high standards of social
and environmental impact. The company aims to reach Net-Zero
greenhouse gases (GHG) emissions by 2035.
With over 85 years of experience, Chiesi is headquartered in
Parma (Italy), with 31 affiliates worldwide, and counts more than
7,000 employees. The Group’s research and development centre in
Parma works alongside 6 other important R&D hubs in France, the
US, Canada, China, the UK, and Sweden.
For further information please visit www.chiesi.com
Forward-Looking Statements
Gossamer cautions you that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. These statements are based on the
Company’s current beliefs and expectations. Such forward-looking
statements include, but are not limited to, statements regarding:
the potential reimbursement, regulatory and sales milestones
payable to Gossamer pursuant to the collaboration and license
agreement; the development and commercialization potential of
seralutinib; the worldwide expansion of the seralutinib franchise;
the anticipated timing of commencing a Phase 3 registrational study
in PH-ILD; the ability to develop seralutinib in additional
indications; and each of Gossamer’s and Chiesi’s respective
obligations under the collaboration and license agreement to lead
commercialization efforts and split development costs. The
inclusion of forward-looking statements should not be regarded as a
representation by Gossamer that any of its plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Gossamer’s
business, including, without limitation: the expected benefits of,
and opportunities related to, the partnership with Chiesi may not
be realized by Gossamer or may take longer to realize than
anticipated; potential delays in the commencement, enrollment and
completion of clinical trials; disruption to our operations from
pandemics, including clinical trial delays; the Company’s
dependence on third parties in connection with product
manufacturing, research and preclinical and clinical testing; the
results of preclinical studies and early clinical trials are not
necessarily predictive of future results; the success of Gossamer’s
clinical trials and preclinical studies for seralutinib; regulatory
developments in the United States and foreign countries; unexpected
adverse side effects or inadequate efficacy of seralutinib that may
limit its development, regulatory approval and/or
commercialization, or may result in clinical holds, recalls or
product liability claims; Gossamer’s ability to obtain and maintain
intellectual property protection for seralutinib; Gossamer’s
ability to comply with its obligations in collaboration agreements
with third parties or the agreements under which it licenses
intellectual property rights from third parties; unstable market
and economic conditions and adverse developments with respect to
financial institutions and associated liquidity risk may adversely
affect our business and financial condition and the broader economy
and biotechnology industry; Gossamer may use its capital resources
sooner than it expects; and other risks described in the Company’s
prior press releases and the Company’s filings with the Securities
and Exchange Commission (SEC), including under the heading “Risk
Factors” in the Company’s annual report on Form 10-K and any
subsequent filings with the SEC. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof, and Gossamer undertakes no obligation
to update such statements to reflect events that occur or
circumstances that exist after the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary
statement, which is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240506306603/en/
For Investors and Media: Bryan Giraudo, Chief Operating
Officer and Chief Financial Officer Gossamer Bio Investor Relations
ir@gossamerbio.com
For Media Chiesi Group Carla Arrieta Head of Global External
Communications Tel:+393408849754 mediarelations@chiesi.com
Gentry Lassier Sr. Director Communications & Public Affairs
US Office +1 (888) 466-6505 x1549 us.mediarelations@chiesi.com
Grafico Azioni Gossamer Bio (NASDAQ:GOSS)
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Grafico Azioni Gossamer Bio (NASDAQ:GOSS)
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