Bayer Acquires Noria and PSMA Therapeutics to Expand Pipeline in Prostate Cancer

• Broadens company’s oncology platform of Targeted Alpha Therapies (TATs)
• Acquisition includes actinium-225 labeled differentiated prostate-specific membrane antigen (PSMA) small molecule being studied as an investigational compound in prostate cancer

Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. (Noria) and PSMA Therapeutics Inc. Through this acquisition, Bayer will obtain exclusive rights to a differentiated alpha radionuclide investigational compound based on actinium-225 and a small molecule directed towards prostate-specific membrane antigen (PSMA). The acquisition broadens Bayer’s existing oncology portfolio of targeted alpha therapies (TATs), which currently includes Xofigo^® (radium Ra 223 dichloride), which is approved for metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone metastases and no known visceral metastases, and the proprietary platform of investigational TATs based on thorium-227.

The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men.¹

“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that have the potential to improve patient outcomes throughout the different stages of the disease,” said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. “This acquisition is another important milestone in enhancing Bayer’s oncology portfolio through both in-house expertise and strategic collaborations and agreements.”

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine.

“Weill Cornell Medicine is committed to bringing our faculty’s innovations to market so that patients can benefit from the latest therapeutics,” said Dr. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. “Bayer’s acquisition of Noria and PSMA Therapeutics which have nurtured Dr. Babich’s radiopharmaceutical and diagnostic technology, is an important milestone in drug development, and we look forward to the advances this collaboration can make to enhance prostate cancer therapies.”

With the first and only approved targeted alpha therapy Xofigo, Bayer has successfully established Xofigo as a TAT for men with mCRPC, symptomatic bone metastases and no known visceral metastases. Adding actinium-225-labeled small molecule to the company’s platform of investigational targeted thorium conjugates, supports our commitment to researching differentiated treatment options for cancer patients.

“Despite increased cancer survivorship overall, there continues to be a significant unmet need in oncology,” said Marianne De Backer, MBA, PhD, Member of the Executive Committee of the Pharmaceuticals Division and Head Strategy and Business Development & Licensing at Bayer. “We remain committed to exploring collaborations for innovative and pioneering scientific research for patients with unmet needs.”

Financial terms of the agreement were not disclosed.

About Targeted Alpha Therapies (TAT) at Bayer

Targeted Alpha Therapies (TAT) are a class of radionuclide compounds being studied in various difficult to treat tumors. They deliver alpha radiation to tumors inside the body either via their bone-seeking property (radium-223) or by combining alpha radionuclides, such as, actinium-225 or thorium-227, with specific moieties.

Bayer’s Xofigo^® (radium Ra 223 dichloride) is the first and only approved TAT. Xofigo is indicated for the treatment of patients with mCRPC, symptomatic bone metastases and no known visceral metastatic disease. More than 76,000 patients have been treated worldwide since launch. Xofigo is currently under further evaluation in a broad clinical development program.

With its proprietary platform of investigational targeted thorium conjugates (TTC), Bayer is advancing a series of drug candidates with potential across multiple cancers. PSMA-TTC, which is combining a prostate-specific membrane antigen (PSMA)-targeting antibody with thorium-227, is a leading TTC project at Bayer. It is currently in Phase I clinical evaluation in patients with metastatic castration-resistant prostate cancer. PSMA is highly expressed on the surface of prostate cancer cells. With this acquisition, Bayer broadens its existing TAT development portfolio by adding an actinium-labeled PSMA-targeted alpha therapy. It is planned to be investigated as a treatment option across multiple stages of prostate cancer.

About Prostate Cancer at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines for people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men¹ and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa^® and Xofigo^®) and several compounds in development, including advancing targeted alpha therapies. Bayer is focused on addressing the medical needs of prostate cancer patients.

About Xofigo^® (radium Ra 223 dichloride) Injection²

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information for Xofigo^® (radium Ra 223 dichloride) Injection

Warnings and Precautions:

• Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.
  
  
  
  Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure
• Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 10⁹/L, the platelet count ≥100 × 10⁹/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 10⁹/L and the platelet count ≥50 × 10⁹/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care
• Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued
• Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established
• Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo

Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

Please see the full Prescribing Information for Xofigo (radium Ra 223 dichloride).

About NUBEQA® (darolutamide)³

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.³ A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at www.clinicaltrials.gov.

INDICATION

NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the prescribing information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

About Noria Therapeutics (Noria) / PSMA Therapeutics Inc.

Noria is a research and development company managed by experienced radiopharmaceutical development leaders and focused on the development of novel targeted alpha therapeutics and theranostic agents. PSMA Therapeutics Inc. is a subsidiary of Noria to advance the platform of prostate-specific membrane antigen (PSMA) targeting radiotherapeutics. These companies have exclusive world-wide rights to technology licensed from Weill Cornell Medical College and Johns Hopkins University. It is headquartered in New York City.

© 2021 Bayer

BAYER, the Bayer Cross, Xofigo and Nubeqa are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer 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.

1. GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. CA: A Cancer Journal for Clinicians. https://onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21492.

2. XOFIGO® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019.

3. NUBEQA® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, January 2021.

COR-PFM-ONC-US-0003-1                                                                                

06/21

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