– Gilead Gains Forty Seven’s Investigational
Immuno-Oncology Therapy in Multiple Clinical Studies for Diseases
Including Myelodysplastic Syndrome, Acute Myeloid Leukemia and
Diffuse Large B-Cell Lymphoma –
– Transaction Supports Gilead’s Strategic
Focus in Oncology and Gives Access to Potential New First-in-Class
Program and Innovative Pipeline –
Gilead Sciences, Inc. (Nasdaq: GILD) and Forty Seven, Inc.
(Nasdaq: FTSV) announced today that the companies have entered into
a definitive agreement pursuant to which Gilead will acquire Forty
Seven for $95.50 per share in cash. The transaction, which values
Forty Seven at approximately $4.9 billion, was unanimously approved
by both the Gilead and Forty Seven Boards of Directors and is
anticipated to close during the second quarter of 2020, subject to
regulatory approvals and other customary closing conditions.
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the full release here:
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Through the addition of Forty Seven’s investigational lead
product candidate, magrolimab, the acquisition will strengthen
Gilead’s immuno-oncology research and development portfolio.
Magrolimab is a monoclonal antibody in clinical development for the
treatment of several cancers for which new, transformative
medicines are urgently needed, including myelodysplastic syndrome
(MDS), acute myeloid leukemia (AML) and diffuse large B-cell
lymphoma (DLBCL). The investigational therapy targets CD47, a “do
not eat me” signal that allows cancer cells to avoid destruction
thereby permitting the patient’s own innate immune system to engulf
and eradicate those cancer cells. Forty Seven presented promising
results of a Phase 1b study of magrolimab in patients with MDS and
AML at the American Society of Hematology meeting in December 2019.
Magrolimab has the potential to be a first-in-class therapy.
“This agreement builds on Gilead’s presence in immuno-oncology
and adds significant potential to our clinical pipeline,” said
Daniel O’Day, Chairman and Chief Executive Officer of Gilead
Sciences. “Magrolimab complements our existing work in hematology,
adding a non-cell therapy program that complements Kite’s pipeline
of cell therapies for hematological cancers. With a profile that
lends itself to combination therapies, magrolimab could potentially
have transformative benefits for a range of tumor types. We are
looking forward to working with the highly experienced team at
Forty Seven to help patients with some of the most challenging
forms of cancer.”
“This is an exciting day for patients who may one day benefit
from future anti-CD47 therapies and other immuno-oncology
treatments based on our research and an exciting time for Forty
Seven as this allows us to achieve our vision of helping patients
defeat their cancer,” commented Mark McCamish, MD, PhD, President
and Chief Executive Officer of Forty Seven. “We are pleased to join
Gilead and believe that by combining our scientific expertise with
Gilead’s strength in developing treatments that modify the immune
system, we will be able to more rapidly advance our therapies.”
Magrolimab
Forty Seven is initially studying magrolimab in patients with
MDS and AML. Additional studies are ongoing in non-Hodgkin lymphoma
(NHL) and solid tumors. Magrolimab has been granted Fast Track
designation by the U.S. Food and Drug Administration (FDA) for the
treatment of MDS and AML, and for the treatment of relapsed or
refractory DLBCL and follicular lymphoma, two forms of B-cell NHL.
Magrolimab has also been granted Orphan Drug designation by the FDA
for the treatment of MDS and AML and by the European Medicines
Agency for the treatment of AML.
More than 400 patients have received the compound to date
through clinical trials.
Ongoing Phase 1b Clinical Trial
In December 2019, Forty Seven presented promising results of a
Phase 1b trial evaluating magrolimab in combination with
azacitidine in untreated patients with higher risk MDS and
untreated patients with AML, who are ineligible for induction
chemotherapy. This has led to the initiation of a potential
registrational cohort in MDS. All patients received a 1 mg/kg
priming dose of magrolimab, coupled with intrapatient dose
escalation to mitigate on-target anemia. Patients were then treated
with full doses of azacitidine and magrolimab maintenance doses of
30 mg/kg weekly.
As of the data cutoff of November 18, 2019, 62 patients had been
treated with the combination in the Phase 1b portion of the trial,
including 35 patients with MDS and 27 patients with AML.
Clinical Activity Data
As of the data cutoff, 46 patients were evaluable for response
assessment, including 24 patients with untreated higher-risk MDS
and 22 patients with untreated AML, who were ineligible for
induction chemotherapy.
- In higher-risk MDS, the overall response rate (ORR) was 92
percent, with 12 patients (50 percent) achieving a complete
response (CR), eight patients (33 percent) achieving a marrow CR
and two patients (8 percent) achieving hematologic improvement. Two
patients (8 percent) had stable disease.
- In untreated AML, the ORR was 64 percent, with nine patients
(41 percent) achieving a CR, three patients (14 percent) achieving
a CR with complete blood count recovery (CRi) and one patient (5
percent) achieving a morphologic leukemia-free state (MLFS). Seven
patients (32 percent) had stable disease and one patient (5
percent) had progressive disease.
- The median time to response among MDS and AML patients treated
with the combination was 1.9 months.
- Median duration of response and median overall survival have
not been reached for either MDS or AML patients, with a median
follow-up of 6.4 months (range 2.0 to 14.4 months) for MDS and 8.8
months (range 1.9 to 16.9 months) for AML.
Safety Data
As of the data cutoff, the combination of magrolimab and
azacitidine was well-tolerated, with no evidence of increased
toxicities compared to azacitidine alone. Adverse events (AEs) were
consistent with prior clinical experience. No deaths were observed
in the first 60 days on combination treatment and only one patient
out of 62 (1.6 percent) discontinued treatment due to a
treatment-related AE.
Additional Programs
Beyond magrolimab, Forty Seven is preparing to advance two
additional investigational compounds into clinical testing.
FSI-174, an anti-cKIT antibody, is being developed in combination
with magrolimab as a novel, all-antibody conditioning regimen to
address the limitations of current stem cell transplantation
conditioning regimens. FSI-189, an anti-SIRPα antibody, is being
developed for the treatment of cancer, as well as certain
non-oncology settings, including transplantation conditioning.
Terms of the Transaction
Under the terms of the merger agreement, a wholly-owned
subsidiary of Gilead will promptly commence a tender offer to
acquire all of the outstanding shares of Forty Seven’s common stock
at a price of $95.50 per share in cash. Following successful
completion of the tender offer, Gilead will acquire all remaining
shares not tendered in the offer through a second step merger at
the same price as in the tender offer.
Consummation of the tender offer is subject to a minimum tender
of at least a majority of outstanding Forty Seven shares plus Forty
Seven shares underlying vested options, the expiration or
termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act and other customary conditions.
Gilead plans to pay all cash consideration for the transaction.
The tender offer is not subject to a financing condition.
Citi and J.P. Morgan are acting as joint financial advisors to
Gilead. Centerview Partners LLC is acting as the exclusive
financial advisor to Forty Seven. Skadden, Arps, Slate, Meagher
& Flom LLP is serving as legal counsel to Gilead and Cooley LLP
is serving as legal counsel to Forty Seven.
Conference Call
At 8:00 a.m. Eastern Time today, Gilead's management will host a
conference call and a simultaneous webcast to discuss the
transaction. A live webcast of the call can be accessed at Gilead’s
Investors page at http://investors.gilead.com. Please connect to
the website at least 15 minutes prior to the start of the call to
allow adequate time for any software download that may be required.
Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393
(international) and dial the conference ID 8479332 to access the
call.
Telephone replay will be available approximately two hours after
the call through 8:30 a.m. Eastern Time, March 4, 2020. To access
the replay, please call 855-859-2056 (U.S.) or 404-537-3406
(international) and dial the conference ID 8479332. The webcast
will be archived on www.gilead.com for one year.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
About Forty Seven
Forty Seven, Inc. is a clinical-stage immuno-oncology company
that is developing therapies targeting cancer immune evasion
pathways and specific cell targeting approaches based on technology
licensed from Stanford University. Forty Seven’s lead program,
magrolimab, is a monoclonal antibody against the CD47 receptor, a
“don’t eat me” signal that cancer cells commandeer to avoid being
ingested by macrophages. This antibody is currently being evaluated
in multiple clinical studies in patients with myelodysplastic
syndrome, acute myeloid leukemia, non-Hodgkin lymphoma, and solid
tumors. For more information on Forty Seven, please visit the
company’s website at www.fortyseveninc.com.
Forward-Looking
Statements
This communication contains forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, related to Gilead, Forty Seven and the acquisition of Forty
Seven by Gilead that are subject to risks, uncertainties and other
factors. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements,
including all statements regarding the intent, belief or current
expectation of the companies’ and members of their senior
management team. Forward-looking statements include, without
limitation, statements regarding the business combination and
related matters, prospective performance and opportunities,
post-closing operations and the outlook for the companies’
businesses, including, without limitation, the ability of Gilead to
advance Forty Seven’s product pipeline, including magrolimab,
FSI-174 and FSI-189; regulatory approval of magrolimab, FSI-174 and
FSI-189 on a timely basis; the anticipated timing of clinical data;
the possibility of unfavorable results from clinical trials;
filings and approvals relating to the transaction; the expected
timing of the completion of the transaction; the ability to
complete the transaction considering the various closing
conditions; difficulties or unanticipated expenses in connection
with integrating the companies; and any assumptions underlying any
of the foregoing. Investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties and are cautioned not to place
undue reliance on these forward-looking statements. Actual results
may differ materially from those currently anticipated due to a
number of risks and uncertainties. Risks and uncertainties that
could cause the actual results to differ from expectations
contemplated by forward-looking statements include: uncertainties
as to the timing of the tender offer and merger; uncertainties as
to how many of Forty Seven’s stockholders will tender their stock
in the offer; the possibility that competing offers will be made;
the possibility that various closing conditions for the transaction
may not be satisfied or waived, including that a governmental
entity may prohibit, delay or refuse to grant approval for the
consummation of the transaction; the effects of the transaction on
relationships with employees, other business partners or
governmental entities; the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; other business effects, including
the effects of industry, economic or political conditions outside
of the companies’ control; transaction costs; actual or contingent
liabilities; and other risks and uncertainties detailed from time
to time in the companies’ periodic reports filed with the U.S.
Securities and Exchange Commission (the “SEC”), including current
reports on Form 8-K, quarterly reports on Form 10-Q and annual
reports on Form 10-K, as well as the Schedule 14D-9 to be filed by
Forty Seven and the Schedule TO and related tender offer documents
to be filed by Gilead and Toro Merger Sub, Inc., a wholly owned
subsidiary of Gilead. All forward-looking statements are based on
information currently available to Gilead and Forty Seven, and
Gilead and Forty Seven assume no obligation and disclaim any intent
to update any such forward-looking statements.
Additional Information and Where to
Find It
The tender offer described in this communication has not yet
commenced. This communication is for informational purposes only
and is neither an offer to purchase nor a solicitation of an offer
to sell shares of Forty Seven, nor is it a substitute for any
tender offer materials that Gilead, its acquisition company or
Forty Seven will file with the SEC. A solicitation and an offer to
buy shares of Forty Seven will be made only pursuant to an offer to
purchase and related materials that Gilead intends to file with the
SEC. At the time the tender offer is commenced, Gilead will file a
Tender Offer Statement on Schedule TO with the SEC, and Forty Seven
will file a Solicitation/Recommendation Statement on Schedule 14D-9
with the SEC with respect to the tender offer. FORTY SEVEN’S
STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER
MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF
TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY
DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to
Purchase, the related Letter of Transmittal and certain other
tender offer documents, as well as the Solicitation/Recommendation
Statement, will be sent to all stockholders of Forty Seven at no
expense to them. The Tender Offer Statement and the
Solicitation/Recommendation Statement will be made available for
free at the SEC's web site at www.sec.gov. Additional copies may be
obtained for free by contacting Gilead or Forty Seven. Free copies
of these materials and certain other offering documents will be
made available by Gilead by mail to Gilead Sciences, Inc., 333
Lakeside Drive, Foster City, CA 94404, attention: Investor
Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by
directing requests for such materials to the information agent for
the offer, which will be named in the Tender Offer Statement.
Copies of the documents filed with the SEC by Forty Seven will be
available free of charge under the “Investors” section of Forty
Seven’s internet website at ir.fortyseveninc.com.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, Gilead and Forty Seven
file annual, quarterly and current reports, proxy statements and
other information with the SEC. Gilead’s and Forty Seven’s filings
with the SEC are also available for free to the public from
commercial document-retrieval services and at the website
maintained by the SEC at www.sec.gov.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200302005443/en/
Gilead Sciences, Inc. Douglas Maffei, PhD, Investors
(650) 522-2739
Amy Flood, Media (650) 522-5643
Forty Seven, Inc. Hannah Deresiewicz, Investors (212)
362-1200
Ann Rhoads, Investors (650) 352-4853
Sarah Plumridge, Media (312) 506-5200
Forty Seven (NASDAQ:FTSV)
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