Bayer Announces that Loxo Oncology, Inc., Initiates Rolling NDA Submission for Larotrectinib for the Treatment of TRK Fusion Cancers

Completion of NDA submission expected in early 2018

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Dec 20, 2017, 05:46 ET

WHIPPANY, N.J., Dec. 20, 2017 /PRNewswire/ -- Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO) has initiated the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib. The NDA is being submitted for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.

Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth. Loxo Oncology expects to complete the NDA submission in early 2018.

"Research has generated great interest in TRK as a potential target for cancer treatment because while TRK fusions occur rarely, they present broadly in various rare adult and pediatric tumors," said Carsten Brunn, president of Bayer Pharmaceuticals for the Americas Region. "We are pleased with the initiation of the rolling NDA submission for larotrectinib which brings us one step closer to potentially providing a treatment option for these patients."

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is an investigational oral and selective drug in clinical development for the treatment of patients across a wide range of cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation (ODD) by the US Food and Drug Administration. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov or visit www.loxooncologytrials.com. Larotrectinib has not been approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

In November 2017, Bayer and Loxo Oncology entered into an exclusive global collaboration on the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor in clinical development. Bayer and Loxo Oncology will jointly develop the two products, larotrectinib and LOXO-195, and Bayer will lead ex-U.S. regulatory activities as well as worldwide commercial activities. In the U.S. Bayer and Loxo Oncology will co-promote the products. Loxo Oncology will remain responsible for the filing in the U.S.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes four oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

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Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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