米製薬大手のイーライ・リリーは7日、同業の米ロキソ・オンコロジーを買収すると発表した。買収額は80億ドル（約8600億円）。ロキソ社は独バイエルと共同開発したがん治療薬をもつ。イーライ・リリーはがん分野の企業を相次ぎ買収しており、開発競争が激化するがん分野で品ぞろえを増やし競争力を高める考えだ。
米FDAはバイエル/ロキソ・オンコロジーの初のTRK阻害の抗がん剤ビトラクビを承認.
2018年11月26日、米国食品医薬品局（FDA）は、既知の後天的な耐性変異を伴わない神経栄養因子受容体チロシンキナーゼ（NTRK）融合遺伝子を有し、転移がみられるか外科的切除による重篤な合併症の発症率が高く、適切な治療がない、もしくは治療後にがんの進行がみられた固形腫瘍を有する成人および小児患者に対して、larotrectinib［ラロトレクチニブ］（VITRAKVI［ビトラクビ］、Loxo Oncology Inc.社とBayer社) を迅速承認した。
ロキソ社の発行済み株式を1株235ドルで買収する。イーライ・リリーの開発部門のトップを務めるダニエル・スコブロンスキー氏は「ロキソ・オンコロジーがもつポートフォリオにより、がん患者に新たな治療の機会を提供することができる」とコメントした。
がん医薬の分野で大規模なM&A（合併・買収）が加速している。米製薬業界では今月、米ブリストル・マイヤーズスクイブが米セルジーンを740億ドルで買収すると発表した。
イーライ・リリーは売上高ランキングで世界10位の大手で、認知症治療薬の開発なども手がける。2018年にはがん免疫薬を手がけるアーモ・バイオサイエンシズを16億ドル（約1700億円）で買収するなど、がん領域で存在感を高める戦略をとってきた。今回、買収するロキソは肺がんや血液がんなど、幅広いがんの治療薬を持っている。
Lilly Announces Agreement To Acquire Loxo Oncology
- Acquisition will broaden the scope of Lilly's oncology portfolio into precision medicines through the addition of a marketed therapy and a pipeline of highly selective potential medicines for patients with genomically defined cancers.
-
Loxo Oncology's pipeline includes LOXO-292, an oral RET inhibitor being studied across multiple tumor types, which recently was granted Breakthrough Therapy designation by theFDA and could launch in 2020. -
Loxo Oncology's Vitrakvi® (larotrectinib) is an oral TRK inhibitor developed and commercialized in collaboration with Bayer that was recently approved by theFDA . - Lilly will
commence a tender offer to acquire all outstanding
shares of
Loxo Oncology for a purchase price of$235.00 per share in cash, or approximately$8.0 billion . - Lilly will
conduct a conference call with the investment
community and media today at
8:45 a.m. EST .
The acquisition would
be the largest and latest in a series of transactions
Lilly has conducted to broaden its cancer treatment
efforts with externally sourced opportunities for
first-in-class and best-in-class therapies.
- LOXO-292, a
first-in-class oral RET inhibitor that has been
granted Breakthrough Therapy designation by the
FDA for three indications, with an initial potential launch in 2020. LOXO-292 targets cancers with alterations to the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types, including certain lung and thyroid cancers as well as a subset of other cancers. - LOXO-305, an oral BTK inhibitor currently in Phase 1/2. LOXO-305 targets cancers with alterations to the Bruton's tyrosine kinase (BTK), and is designed to address acquired resistance to currently available BTK inhibitors. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas.
- Vitrakvi, a
first-in-class oral TRK inhibitor developed and
commercialized in collaboration with Bayer that was
recently approved by the
U.S. Food and Drug Administration (FDA ). Vitrakvi is the first treatment that targets a specific genetic abnormality to receive a tumor-agnostic indication at the time of initialFDA approval. - LOXO-195, a
follow-on TRK inhibitor also being studied by
Loxo Oncology and Bayer for acquired resistance to TRK inhibition, with a potential launch in 2022.
"Using tailored
medicines to target key tumor dependencies offers an
increasingly robust approach to cancer treatment," said
"We are gratified
that Lilly has recognized our contributions to the field
of precision medicine and are excited to see our
pipeline benefit from the resources and global reach of
the Lilly organization," said
"Lilly Oncology is
committed to developing innovative, breakthrough
medicines that will make a meaningful difference for
people with cancer and help them live longer, healthier
lives," said
"We are excited to
have reached this agreement with a team that shares our
commitment to ensuring that emerging translational
science reaches patients in need," said
Under the terms of
the agreement, Lilly will commence a tender offer to
acquire all outstanding shares of
The tender offer
represents a premium of approximately 68 percent to
This transaction will
be reflected in Lilly's financial results and financial
guidance according to Generally Accepted Accounting
Principles (GAAP). Lilly will provide an update to its
2019 financial guidance, including the expected impact
from the acquisition of
For Lilly,
About LOXO-292
LOXO-292 is an oral and selective investigational new
drug in clinical development for the treatment of
patients with cancers that harbor abnormalities in the
rearranged during transfection (RET) kinase. RET fusions
and mutations occur across multiple tumor types with
varying frequency. LOXO-292 was designed to inhibit
native RET signaling as well as anticipated acquired
resistance mechanisms that could otherwise limit the
activity of this therapeutic approach. LOXO-292 has been
granted Breakthrough Therapy Designation by the U.S.
About LOXO-305
LOXO-305 is an investigational, highly selective
non-covalent Bruton's tyrosine kinase (BTK) inhibitor.
BTK plays a key role in the B-cell antigen receptor
signaling pathway, which is required for the
development, activation and survival of normal white
blood cells, known as B-cells, and malignant B-cells.
BTK is a validated molecular target found across
numerous B-cell leukemias and lymphomas including
chronic lymphocytic leukemia, Waldenstrom's
macroglobulinemia, mantle cell lymphoma and marginal
zone lymphoma.
About Vitrakvi®
(larotrectinib)
Vitrakvi is an oral TRK inhibitor for the treatment of
adult and pediatric patients with solid tumors with a
neurotrophic receptor tyrosine kinase (NTRK) gene fusion
without a known acquired resistance mutation that are
either metastatic or where surgical resection will
likely result in severe morbidity, and have no
satisfactory alternative treatments or have progressed
following treatment. This indication is approved under
accelerated approval based on overall response rate and
duration of response. Continued approval for this
indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
About LOXO-195
LOXO-195 is a selective TRK inhibitor that is being
investigated to address potential mechanisms of acquired
resistance that may emerge in patients receiving
Vitrakvi® (larotrectinib) or other
multikinase inhibitors with anti-TRK activity.
About Eli Lilly and
Company
Lilly is a global healthcare leader that unites caring
with discovery to create medicines that make life better
for people around the world. We were founded more than a
century ago by a man committed to creating high-quality
medicines that meet real needs, and today we remain true
to that mission in all our work. Across the globe, Lilly
employees work to discover and bring life-changing
medicines to those who need them, improve the
understanding and management of disease, and give back
to communities through philanthropy and volunteerism. To
learn more about Lilly, please visit us at
www.lilly.com and
www.lilly.com/newsroom/social-channels. C-LLY
About Loxo Oncology
Loxo Oncology is a biopharmaceutical company focused on
the development and commercialization of highly
selective medicines for patients with genomically
defined cancers. Our pipeline focuses on cancers that
are uniquely dependent on single gene abnormalities,
such that a single drug has the potential to treat the
cancer with dramatic effect. We believe that the most
selective, purpose-built medicines have the highest
probability of maximally inhibiting the intended target,
with the intention of delivering best-in-class disease
control and safety. Our management team seeks out
experienced industry partners, world-class scientific
advisors and innovative clinical-regulatory approaches
to deliver new cancer therapies to patients as quickly
and efficiently as possible. For more information,
please visit the company's website at
http://www.loxooncology.com.