Boehringer Banks On Cancer For Future Growth

Elsevier Business Intelligence
PRESCRIPTION PHARMACEUTICALS AND BIOTECHNOLOGY
Founded 1939
July 22, 2013
Boehringer Banks On Cancer For Future Growth
Emily Hayes e.hayes@elsevier.com
A
s it gears up for its first launch in oncology, Boehringer
Ingelheim GMBH thinks it has built a cancer franchise
that will be a cornerstone of future growth. The privately held firm takes pride in a pipeline built in-house, but it
also has a number of partnerships in place taking advantage
of outside technology.
Cancer now accounts for three out of eight Phase III candidates in the pipeline published on Boehringer’s website. In
addition to newly approved Gilotrif (afatanib), which inhibits EGFR, HER2 and ErbB4, Boehringer has two other oncologics in late-stage development – the triple angiokinase
inhibitor nintedanib, which is in Phase III in lung and ovarian
cancer, and volasertib, a polo-like kinase 1 (PLK1) inhibitor
in Phase III for acute myeloid leukemia (see related story,
“Gilotrif Leads Way For The Rest Of Boehringer’s Cancer
Pipeline” — “The Pink Sheet,” p. 30).
The family-owned firm has a number of targeted monoclonal
antibodies in early stages of development. For example, BI
836845 is a fully human antibody that binds to insulin-like
growth factor (IGF)-1 and IGF-2 in Phase I for advanced solid
tumors. And BI 836858 is an anti-CD33 mAb engineered for
antibody-dependent cellular toxicity (ADCC) in Phase I for
refractory/relapsed AML.
“One thing that is unique is that all of the assets in the pipeline are home-grown,” William Goeckeler, director of oncology medical affairs at Boehringer, said in an interview prior
to Gilotrif’s approval.
Boehringer began to invest in oncology about 20 years ago
and currently has 400 employees working in cancer drug
discovery and development, including 200 scientists at a
dedicated research facility in Vienna.
But Gilotrif is the first approval of a cancer drug for the firm.
FDA cleared the drug July 12 for first-line treatment of EGFRpositive metastatic non-small cell lung cancer, along with a
companion diagnostic developed by Qiagen NV (“Gilotrif
Approval Gives Boehringer Milestone, But Can It Compete
With Tarceva?” — “The Pink Sheet” DAILY, July 12, 2013).
Boehringer says that it has made a significant investment in
oncology, though it won’t specify just how much. During its
annual press conference on April 24, Boehringer noted that
2012 sales increased 11.5% to €14.7 billion ($19.12 billion) and
that it spent 19% of total net sales on R&D in 2012. In light
of R&D investment, operating income declined from €2.3 billion to €1.9 billion. Nevertheless, the company said that it
was satisfied with performance because as a private business, it was prioritizing long-term economic sustainability
over short-term profits.
“A well-filled pipeline of Phase III projects naturally leads
to corresponding expenditure. We will continue to pursue
this strategy of high investment in our own research and
development, regardless of increasingly difficult overall conditions, as we thereby secure our future and also the company’s independence,” said Andreas Barner, chairman of the
board of directors.
One positive aspect of in-house development is that you
are not sharing revenue streams with other companies, but
most investors and doctors don’t care who originally developed the drug, commented Gordon Gochenauer, director of
oncology commercial strategies at Kantar Health. Rather,
they are more attuned to the reputation of the company
marketing the drug.
“It’s a feel-good message rather than anything significant,” he said.
Similarly, Michelle Hasson, managing director of life sciences
at the consultancy Navigant (formerly Easton Associates),
said she doesn’t see how in-house development creates tremendous value, except in the fact that the assets are not partnered commercially, so revenue does not need to be shared.
There may be opportunity for faster lifecycle management
in clinical development. Also, key opinion leaders in oncology want to see that sponsors are “committed to the space
and are not just a one-hit wonder,” she said. For that reason,
it’s important that sponsors show that they are committed
to fully exploring the potential of the products, for example,
by testing them in a number of indications.
While BI says that all of the candidates originated in-house,
the company has complemented its own research through
collaborations with academic groups and other companies.
Reprinted with Permission from “The Pink Sheet.” Please see Copyright Notice on the end page
www.ElsevierBI.com/publications/The-Pink-Sheet
However, the deals have mostly been about getting access
to technology and science, rather than in-licensing of candidates or acquisition of companies, explained Kevin Lokay,
head of Boehringer’s oncology business unit.
Among other deals in recent years, the company forged
partnerships with Micromet Inc., now an Amgen Inc. subsidiary, and MacroGenics Inc. related to the development of
bispecific antibodies. Both companies have platforms that
can be used to harness the immune system to kill cancer
cells (see table below).
Looking forward, the company still has a “rich pipeline” of
its own to develop, but it is open to in-licensing if it sees
opportunities that are synergistic with the pipeline and portfolio it already has, Lokay said.
Boehringer Ingelheim Oncology Deals: 2007-2013
Partner/Deal Date
Deal Summary
Oxford BioTherapeutics
April 2013
Discovery of novel antibody targets across a range of cancer indications using OBT’s OGAP discovery platform.
Horizon Discovery
January 2013
Five-year collaboration to support the identification of predictive biomarkers for new molecular entities.
Harvard University
July 2012
Translational research collaboration to identify novel signaling pathways and targets in oncology and other diseases in
areas of unmet need. Includes research into cancer stem cell survival.
Forma Therapeutics
January 2012
Four-year R&D collaboration. Forma to screen and optimize small-molecule oncology candidates.
F-star Biotechnology
November 2010
Joint discovery of antibody fragments called Fcabs against seven targets in many possible indications, using F-star’s Modular
Antibody Technology. Includes rights to develop Fcabs or for use in producing bispecific antibodies.
Macrogenics
October 2010
Global alliance to discover, develop and commercialize up to 10 bispecific antibody therapeutics in oncology and other
therapeutic areas, using Macrogenics’ Dual-Affinity Re-Targeting platform.
Micromet
May 2010
Co-development and commercialization of a bispecific (BiTE) antibody for multiple myeloma.
Priaxon
January 2010
Worldwide collaboration to develop mdm2/p53 inhibitors for cancer.
Qiagen
May 2009
Development of companion diagnostic for afatinib to screen for EGFR mutations.
Ablynx
September 2007
Alliance to discover, develop and commercialize up to 10 different Nanobody therapeutics in oncology and other diseases.
Source: Boehringer Ingelheim, Elsevier Strategic Transactions Database
© 2013 F-D-C Reports, Inc.; An Elsevier Company; All Rights Reserved.
Reproduction, photocopying, storage or transmission by magnetic or electronic means is strictly prohibited by law. Authorization to photocopy items for internal or personal use
is granted by F-D-C Reports, Inc., when the fee of $25.00 per copy of each page is paid directly to Copyright Clearance Center, 222 Rosewood Dr., Danvers, MA 01923, (978)
750-8400. The Transaction Reporting Service fee code is: 1530-6240/12 $0.00 + $25.00. Violation of copyright will result in legal action, including civil and/or criminal penalties, and suspension of service. For more information, contact custcare@elsevier.com.