Celgene, Impact Biomedicines Do $7B
January 08, 2018
and Impact Biomedicines have signed 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
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-naļve 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.
the terms of the agreement, Celgene will make an upfront cash payment of
approximately $1.1 billion. In addition, Impact Biomedicines'
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.
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-naļve 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
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.