December 13, 2017

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Bayer to Highlight New Research at ASH 2017

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WHIPPANY, N.J., Dec. 7, 2017 /PRNewswire/ — Bayer announced today that the latest findings from its growing body of research in hematologic malignancies for copanlisib and larotrectinib will be presented at the 59th Annual Meeting of the American Society of Hematology (ASH), taking place December 9-12 in Atlanta.

“At Bayer, our goal is to bring the needs of patients to the forefront of our research and development efforts,” said Dario F. Mirski, MD, Senior Vice President and Head of Medical Affairs, Americas. “For patients facing hematologic malignancies that can persist over many years, Bayer is committed to developing potential treatments. At ASH we will present several data sets from clinical trials that demonstrate progress towards serving the unmet needs of patients with hematologic malignancies.”

The copanlisib data includes a pharmacodynamic study in patients with non-Hodgkin’s lymphoma (NHL) and other diseases, and safety data from a pooled analysis of patients with relapsed indolent NHL. Rounding out the company’s ASH lymphoma data are two presentations from the Phase II CHRONOS-1 study: an updated safety and efficacy analysis investigating late-onset severe toxicities and a subset analysis in patients with marginal zone lymphoma (MZL).

Data from this study were published online in the Journal of Clinical Oncology in October 2017. CHRONOS-1 also served as the basis of the recent U.S. Food and Drug Administration (FDA) approval of Aliqopa™ (copanlisib), for the treatment of relapsed follicular lymphoma in adult patients who have received at least two prior systemic therapies.

Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Aliqopa is associated with the following Warnings and Precautions: serious, including fatal, infections, Grade 3 or 4 hyperglycemia, Grade 3 hypertension, non-infectious pneumonitis (NIP), Grade 3 or 4 neutropenia, Grade 3 or 4 cutaneous reactions, and embryo-fetal toxicity. Please see the full Important Safety Information below.

Larotrectinib is an investigational drug that is being developed between Bayer and Loxo Oncology. Larotrectinib has been granted breakthrough therapy designation, rare pediatric disease designation and orphan drug designation (ODD) in the U.S.

See below for the listing of copanlisib and larotrectinib studies to be featured at ASH 2017:

Copanlisib Pharmacodynamic Study

Copanlisib Safety and Efficacy Studies

Larotrectinib Study

About Aliqopa (copanlisib)
Aliqopa is an inhibitor of PI3K with inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. The PI3K pathway is involved in cell growth, survival and

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