Acquisition Includes Bemarituzumab, A Phase
3 Ready, First-In-Class Program For Gastric Cancer, the Third
Leading Cause of Cancer Mortality Worldwide
Bemarituzumab is a Strong Strategic Fit With
Amgen’s Innovative Oncology Portfolio
Amgen to Host Investor Call at 10:30 a.m.
EST
Amgen (NASDAQ: AMGN) and Five Prime Therapeutics (NASDAQ: FPRX),
a clinical-stage biotechnology company focused on developing
immuno-oncology and targeted cancer therapies, today announced an
agreement under which Amgen will acquire Five Prime Therapeutics
for $38.00 per share in cash, representing an equity value of
approximately $1.9 billion. This acquisition adds Five Prime’s
innovative pipeline to Amgen’s leading oncology portfolio.
- Five Prime’s lead asset, bemarituzumab, is a first-in-class,
Phase 3 ready anti-FGFR2b antibody with positive data from a
randomized, placebo-controlled Phase 2 study in frontline advanced
gastric or gastroesophageal junction (GEJ) cancer. Bemarituzumab
targets FGFR2b, which has been found to be overexpressed in
approximately 30% of patients with non-HER2 positive gastric
cancer, as well as other solid tumors.
- The bemarituzumab Phase 2 FIGHT trial demonstrated clinically
meaningful improvements in progression-free survival (PFS), overall
survival (OS) and overall response rate (ORR) in the frontline
treatment of patients with advanced gastric or GEJ cancer.
Additional analysis showed a positive correlation between efficacy
and expression of FGFR2b on tumor cells, confirming both the
importance of the FGFR2b target and the activity of bemarituzumab
against this target.
- This correlation suggests that FGFR2b could play a role in
other epithelial cancers, including lung, breast, ovarian and other
cancers.
- The acquisition of Five Prime also supports Amgen’s
international expansion strategy. Gastric cancer is one of the
world’s most common forms of cancer and is particularly prevalent
in the Asia-Pacific region, where Amgen expects to generate
significant volume growth in the coming years. Amgen plans to
leverage its presence in Japan and other Asia-Pacific markets to
maximize bemarituzumab’s potential. In addition, as part of this
transaction, Amgen will receive a royalty percentage on future net
sales in Greater China ranging from the high teens to the low
twenties from a pre-existing co-development and commercialization
agreement between Five Prime and Zai Lab (Shanghai) Co., Ltd.
- Five Prime’s additional innovative pipeline programs complement
Amgen’s efforts to bring meaningful therapies to oncology
patients.
“The acquisition of Five Prime offers a compelling opportunity
for Amgen to strengthen our oncology portfolio with a promising
late-stage, first-in-class global asset to treat gastric cancer,”
said Robert A. Bradway, chairman and chief executive officer at
Amgen. “We look forward to welcoming the Five Prime team to Amgen
and working with them to leverage our best-in-class monoclonal
antibody manufacturing capabilities to supply additional clinical
materials, as well as expanded production quantities, to realize
the full potential of bemarituzumab for even more patients around
the world as quickly as possible.”
“This is an exciting day for patients who may one day benefit
from the promise of bemaritizumab and our full pipeline. I’m so
proud of the Five Prime team and the science we’ve pioneered,” said
Tom Civik, president and chief executive officer of Five Prime. “We
see tremendous complementarity between the two companies. Amgen has
global reach, world-class resources, and they share our deep
passion for science and commitment to patients. I have full
confidence that Amgen is the right company to work with us to bring
our innovative cancer treatments to patients and to achieve our
mission to rewrite cancer.”
Transaction Terms
Under the terms of the merger agreement, which was approved by
the Boards of Directors of both companies, Amgen will commence a
tender offer to acquire all of the outstanding shares of Five
Prime‘s common stock for $38.00 per share in cash. Following the
completion of the tender offer, a wholly-owned subsidiary of Amgen
will merge with Five Prime and shares of Five Prime that have not
been tendered and purchased in the tender offer will be converted
into the right to receive the same price per share in cash as paid
in the tender offer (other than shares held by stockholders who
properly demand and perfect appraisal rights under Delaware
law).
The transaction is expected to close by the end of the second
quarter and is subject to customary closing conditions, including
the tender of at least a majority of the outstanding shares of Five
Prime’s common stock and the expiration or termination of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976.
Amgen reaffirmed its full-year outlook with Revenue guidance of
$25.8 to $26.6 billion and non-GAAP EPS guidance of
$16.00-$17.00.
Goldman Sachs acted as financial advisor to Amgen and Sullivan
& Cromwell LLP as its legal advisor. Lazard acted as financial
advisor to Five Prime and Cooley LLP as its legal advisor.
Amgen Webcast Investor Call
Amgen will host a webcast call for the investment community on
Thursday, March 4, 2021, at 10:30 a.m. EST. Peter H. Griffith,
executive vice president and chief financial officer, David M.
Reese, M.D., executive vice president of Research and Development,
and Murdo Gordon, executive vice president of Global Commercial
Operations at Amgen will participate.
Live audio of the conference call will be broadcast over the
internet simultaneously and will be available to members of the
news media, investors and the general public. The webcast, as with
other selected presentations regarding developments in Amgen's
business given at certain investor and medical conferences, can be
accessed on Amgen's website, www.amgen.com, under Investors.
Information regarding presentation times, webcast availability and
webcast links are noted on Amgen's Investor Relations Events
Calendar. The webcast will be archived and available for replay for
at least 90 days after the event.
About FGFR2b
The fibroblast growth factor (FGF)/fibroblast growth factor
receptor (FGFR) pathway is implicated in the development and growth
of cancer cells. FGFR2b is a splice variant of FGFR2 which can be
found in tumors of epithelial origin. Data from the FIGHT trial
suggests that approximately 30 percent of patients with non-HER2
positive gastroesophageal cancers overexpress FGFR2b.1 FGFR2b has
also been shown to be overexpressed in numerous other cancers,
including lung, breast, ovarian and other cancers.
About Bemarituzumab
Bemarituzumab (anti-FGFR2b) is a first-in-class targeted
antibody that blocks fibroblast growth factors (FGFs) from binding
and activating FGFR2b, inhibiting several downstream pro-tumor
signaling pathways and potentially slowing cancer progression. Five
Prime Therapeutics granted an exclusive license to Zai Lab Limited
to develop and commercialize bemarituzumab in Greater China, and
Zai Lab collaborated with Five Prime Therapeutics on the Phase 2
FIGHT trial in Greater China.
About the FIGHT Trial
The FIGHT study was a randomized, placebo controlled trial that
evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo
plus chemotherapy in patients with fibroblast growth factor
receptor 2b-positive (FGFR2b+), non HER2 positive frontline
advanced gastric or GEJ cancer. The trial enrolled 155 patients in
15 countries across Asia, the European Union, and the United
States, with 77 patients randomized to the bemarituzumab arm and 78
patients to the placebo arm.
About Gastric Cancer and GEJ Cancer
Gastric cancer, also known as stomach cancer, is the third most
common cause of cancer death worldwide and, excluding non-melanoma
skin cancer, the fifth most common cancer worldwide, with over
1,000,000 new cases diagnosed each year.2 For HER2 negative
patients, frontline therapy available today is the same systemic
chemotherapy available since the 1990s.3,4
About Five Prime Therapeutics
Five Prime Therapeutics is a clinical stage biotechnology
company relentlessly focused on rewriting cancer. By tackling the
tough scientific questions and untapped pathways, we aim to offer
new hope by developing novel, breakthrough therapies that have
potential to alter the course of disease in cancers with few
treatment options. This vision is what defines us and guides our
research, clinical development and partnerships. To build a better
tomorrow for people with cancer, we are teaming up with patients,
physicians, scientists, and industry partners to make a meaningful
difference in patients’ lives. Five Prime collaborates with leading
global pharmaceutical companies and has therapies in pre-clinical
and clinical development.
About Amgen Oncology
Amgen Oncology is searching for and finding answers to
incredibly complex questions that will advance care and improve
lives for cancer patients and their families. Our research drives
us to understand the disease in the context of the patient's life –
not just their cancer journey – so they can take control of their
lives.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our heritage, Amgen continues to
advance the largest pipeline in our history, moving with great
speed to advance those innovations for the patients who need
them.
At Amgen, we are driven by our commitment to transform the lives
of cancer patients and keep them at the center of everything we
do.
To learn more about Amgen's innovative pipeline with diverse
modalities and genetically validated targets, please visit
AmgenOncology.com. For more information, follow us on
www.twitter.com/amgenoncology.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people’s lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world’s leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Important Information
This press release is for informational purposes only and is
neither an offer to purchase nor a solicitation of an offer to sell
securities. The tender offer for the outstanding shares of common
stock of Five Prime described in this press release has not
commenced. At the time the tender offer is commenced, Amgen and its
acquisition subsidiary, Franklin Acquisition Sub, Inc.
(“Purchaser”), will file, or will cause to be filed, tender offer
materials on Schedule TO with the U.S. Securities and Exchange
Commission (the “SEC”) and Five Prime will file a
Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC, in each case with respect to the tender offer. THE TENDER
OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER
OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT
INFORMATION THAT SHOULD BE READ CAREFULLY WHEN THEY BECOME
AVAILABLE AND CONSIDERED BEFORE ANY DECISION IS MADE WITH RESPECT
TO THE TENDER OFFER. Those materials and all other documents filed
by, or caused to be filed by, Amgen and Purchaser and Five Prime
with the SEC will be available at no charge on the SEC’s website at
www.sec.gov. The tender offer materials and related materials also
may be obtained for free (when available) under the “Investors –
Financials” section of Amgen’s website at
https://investors.amgen.com/financials/sec-filings, and the
Solicitation/Recommendation Statement and such other documents also
may be obtained for free (when available) from Five Prime under the
“Investors & Media – Financial Information” section of Five
Prime’s website at
https://investor.fiveprime.com/index.php/sec-filings. FIVE PRIME’S
SHAREHOLDERS ARE ADVISED TO READ THE TENDER OFFER MATERIALS AND THE
SOLICITATION/RECOMMENDATION STATEMENT, AS EACH MAY BE AMENDED OR
SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS
FILED BY FIVE PRIME OR AMGEN WITH THE SEC WHEN THEY BECOME
AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER
OFFER. THESE MATERIALS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE
TENDER OFFER, FIVE PRIME AND AMGEN.
Forward Looking Statements
This press release contains forward-looking statements. These
forward-looking statements generally include statements that are
predictive in nature and depend on or refer to future events or
conditions, and include words such as “expect,” “anticipate,”
“outlook,” “could,” “target,” “project,” “intend,” “plan,”
“believe,” “seek,” “estimate,” “should,” “may,” “assume” and
“continue” as well as variations of such words and similar
expressions. By their nature, forward-looking statements involve
risks and uncertainty because they relate to events and depend on
circumstances that will occur in the future, and there are many
factors that could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking
statements. Forward-looking statements include, among other things,
statements about the potential benefits of the proposed
transaction; the prospective performance and outlook of Five
Prime’s business, performance and opportunities; any potential
strategic benefits, synergies or opportunities expected as a result
of the proposed transaction; the ability of the parties to complete
the proposed transaction and the expected timing of completion of
the proposed transaction; potential marketing or regulatory
approvals for bemarituzumab, or potential future revenues from such
product; as well as any assumptions underlying any of the
foregoing.
These statements are not guarantees of future performance and
they involve certain risks, uncertainties and assumptions that are
difficult to predict. We caution you that actual outcomes and
results may differ materially from what is expressed, implied or
forecasted by our forward-looking statements. There can be no
guarantee that the proposed tender offer or the transaction
described in this press release will be completed, or that it will
be completed as currently proposed, or at any particular time.
Neither can there be any guarantee that Amgen or Five Prime’s
product, bemarituzumab, will achieve any particular future
financial results, or that Amgen will be able to realize any of the
potential strategic benefits, synergies or opportunities as a
result of the proposed acquisition. Nor can there be any guarantee
that bemarituzumab will be submitted or approved for sale in any
market, or at any particular time. Neither can there be any
guarantee that such product will be successfully commercialized
even if regulatory approvals are obtained. In particular, our
expectations could be affected by, among other things:
uncertainties as to the timing of the tender offer and the merger;
the risk that the proposed transaction may not be completed in a
timely manner or at all; uncertainties as to the percentage of Five
Prime’s stockholders tendering their shares in the tender offer;
the possibility that competing offers or acquisition proposals for
Five Prime will be made; the possibility that any or all of the
various conditions to the consummation of the tender offer or the
merger may not be satisfied or waived, including the failure to
receive any required regulatory approvals from any applicable
governmental entities (or any conditions, limitations or
restrictions placed on such approvals); regulatory actions or
delays or government regulation generally, including potential
regulatory actions or delays relating to the completion of the
potential transaction described in this release, as well as
potential regulatory actions or delays with respect to the
development of bemarituzumab; the occurrence of any event, change
or other circumstance that could give rise to the termination of
the merger agreement; the effect of this announcement or pendency
of the proposed transaction on Five Prime’s ability to retain and
hire key personnel, its ability to maintain relationships with its
customers, suppliers and others with whom it does business, its
business generally or its stock price; risks related to diverting
management’s attention from Five Prime’s ongoing business
operations; the risk that stockholder litigation in connection with
the proposed transaction may result in significant costs of
defense, indemnification and liability; the potential that the
strategic benefits, synergies or opportunities expected from the
proposed acquisition may not be realized or may take longer to
realize than expected; the successful integration of Five Prime
into Amgen subsequent to the closing of the transaction and the
timing of such integration; and other risks and factors referred to
from time to time in Amgen’s and Five Prime’s filings with the SEC,
including Amgen’s current Form 10-K and Five Prime’s current Form
10-K on file with the SEC, including those related to the
uncertainties inherent in the research and development of new
healthcare products, including clinical trial results and
additional analysis of existing clinical data; our ability to
obtain or maintain proprietary intellectual property protection;
safety, quality or manufacturing issues; changes in expected or
existing competition; and global trends toward health care cost
containment, including government, payor and general public pricing
and reimbursement pressures. The effects of the COVID-19 pandemic
may give rise to risks that are currently unknown or amplify the
risks associated with many of these factors. Amgen and Five Prime
are providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking
statements as a result of new information, future events or
otherwise.
References
1. Data on file. Five Prime Therapeutics; 2020.
2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer
statistics 2018: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J Clin.
2018;68(6):394-424. doi:10.3322/caac.21492
3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for
advanced gastric cancer. Cochrane Database Syst Rev.
2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4
4. Drugs approved for stomach (gastric) cancer. Food and Drug
Administration. Updated April 21, 2020. Accessed October 14, 2020.
https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210304005385/en/
Amgen, Thousand Oaks Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631(media) Arvind Sood, 805-447-1060
(investors)
Five Prime Media and Investor Contact Martin Forrest,
415-365-5625
Five Prime Therapeutics (NASDAQ:FPRX)
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