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Boehringer Banks On Cancer For Future Growth :: “The Pink Sheet” :: Elsevier Business Intelligence

The privately held company has spent the last 20 years building an oncology franchise, based largely on platform deals and in-house R&D.



As 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," Jul. 22, 2013).

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 EGFR-positive 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, Jul. 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. 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 anAmgen 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).

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.


Via Richard Meyer
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Big Data is Growing Rapidly And Every Body Is Responsible (infographic)

Big Data is Growing Rapidly And Every Body Is Responsible (infographic) | Pharma & New Tech |
Data production will occur 44 times faster in 2020 than in 2009.  A sizeable chunk of that will be healthcare data, which is growing rapidly. And every body is responsible for it.

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