Celgene to Acquire Impact Biomedicines, Adding Fedratinib to Its Pipeline of Novel Therapies for Hematologic Malignancies
January 07 2018 - 06:00PM
Business Wire
- Fedratinib is a highly selective JAK2
kinase inhibitor that is being evaluated for myelofibrosis and
polycythemia vera
- Fedratinib demonstrated clinical
improvement in a phase III trial with treatment-naïve myelofibrosis
patients and in a phase II trial with myelofibrosis patients
resistant or intolerant to ruxolitinib
- A New Drug Application (NDA) submission
for fedratinib in myelofibrosis is planned for mid-2018
Celgene Corporation (NASDAQ:CELG) and Impact Biomedicines today
announced the signing of a definitive agreement in which Celgene
will acquire Impact Biomedicines, which is developing fedratinib
for myelofibrosis and polycythemia vera. Under the terms of the
agreement, Celgene will pay approximately $1.1 billion upfront and
up to $1.25 billion in contingent payments based on regulatory
approval milestones for myelofibrosis. Additional future payments
for regulatory approvals in additional indications and sales-based
milestones are also possible.
Fedratinib, a highly selective JAK2 kinase inhibitor, was
evaluated in 877 patients across 18 clinical trials. In a
randomized, placebo-controlled, phase III pivotal trial (JAKARTA-1)
for patients with treatment-naïve myelofibrosis, fedratinib
demonstrated statistically significant improvements in the primary
and secondary endpoints of splenic response and total symptom
score, respectively. In an exploratory subgroup analysis, these
improvements were observed regardless of a patient’s baseline
platelet count.
A multi-center, single-arm phase II trial (JAKARTA-2) evaluated
fedratinib in myelofibrosis patients who were found to be resistant
or intolerant to ruxolitinib (Jakafi®), a JAK1/JAK2 inhibitor. In
this second-line setting, fedratinib demonstrated clinically
meaningful improvements in splenic response and total symptom
score.
As previously reported, JAKARTA-2 was stopped prematurely due to
a clinical hold placed on the fedratinib program by the U.S. Food
and Drug Administration (FDA) after potential cases of Wernicke’s
encephalopathy (WE) were reported in eight out of 877 patients
receiving one or more doses (less than one percent of treated
patients). The FDA removed the clinical hold in August 2017.
Based on the reported benefit risk profile of fedratinib from
the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory
applications in myelofibrosis are planned beginning in the middle
of 2018.
“Myelofibrosis is a disease with high unmet medical need as the
number of patients who are ineligible for or become resistant to
existing therapy continues to increase,” said Nadim Ahmed,
President, Hematology and Oncology for Celgene. “We believe
fedratinib is uniquely positioned as a potential treatment for
myelofibrosis and it provides strategic options for us to build
leadership in this disease with luspatercept and other pipeline
assets.”
“We launched Impact Biomedicines and based on our thorough
review of the data, fedratinib presents a compelling risk benefit
profile in both treatment-naïve patients and patients who are
resistant or intolerant to other JAK2 therapies,” said Dr. John
Hood, Chief Executive Officer of Impact. “We believe Celgene is the
ideal organization to follow through on our mission of maximizing
fedratinib’s potential for patients with myelofibrosis.”
Deal Terms
Under the terms of the agreement, Celgene will make an upfront
cash payment of approximately $1.1 billion. In addition, Impact
Biomedicines’s shareholders are eligible to receive contingent
payments based on regulatory approval and sales-based milestones.
The maximum aggregate amount payable for regulatory approval
milestones is $1.4 billion relating to approvals for myelofibrosis
and other indications. Starting from global annual net sales of
$1.0 billion, aggregate tiered sales-based milestone payments could
total a maximum of $4.5 billion if global annual net sales exceed
$5.0 billion.
Credit Suisse acted as financial advisor and Hogan Lovells acted
as legal counsel to Celgene on the transaction. PJT Partners acted
as exclusive financial advisor and Latham & Watkins acted as
exclusive legal counsel to Impact Biomedicines on the transaction.
The acquisition is subject to customary closing conditions and
applicable waiting period under the Hart Scott Rodino Antitrust
Improvements Act. The transaction is expected to close in the first
quarter of 2018.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and
YouTube.
About Impact Biomedicines
Impact Biomedicines is pioneering the development of life
changing treatments for patients with complex cancers. The
Company’s pipeline is centered around fedratinib, a highly
selective oral small molecule JAK2 kinase inhibitor that is being
developed initially for the treatment of myelofibrosis (MF) and
polycythemia vera (PV). Impact was financed by Medicxi and Oberland
Capital.
Forward-Looking Statement
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual
Report on Form 10-K and our other reports filed with the Securities
and Exchange Commission.
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purposes only. Celgene bears no responsibility for the security or
content of external websites.
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version on businesswire.com: http://www.businesswire.com/news/home/20180107005114/en/
Celgene:Investors:Patrick E. Flanigan III, (908)
673-9969Corporate Vice PresidentInvestor RelationsorMedia:Brian P.
Gill, 908) 673-9530Vice PresidentCorporate
CommunicationsorImpact Biomedicines Media:MacDougall
Biomedical CommunicationsCammy Duong,
781-591-3443cduong@macbiocom.com
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