- Acquire PRL-02, prostate cancer treatment program being developed by Propella Therapeutics -

TOKYO and PITTSBORO, N.C., Nov. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella") today announced that Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella. Propella is a privately held biopharmaceutical company that has leveraged a wholly owned proprietary platform that combines medicinal chemistry with lymphatic targeting to create new oncology drugs.

Through the acquisition of Propella, Astellas will acquire PRL-02 (abiraterone decanoate), a next-generation androgen biosynthesis inhibitor being developed by Propella to treat prostate cancer. PRL-02 is a novel, long-acting prodrug* of abiraterone that, following intramuscular injection, is expected to achieve high concentrations in target tissues where the active moiety, abiraterone, is continuously released. PRL-02 may provide improved efficacy and safety compared to existing treatment options by high CYP17 lyase inhibition selectivity. PRL-02 is currently in a Phase 1 clinical trial and is expected to enter Phase 2a clinical trials in 2024.

Naoki Okamura, President and CEO, Astellas
"The acquisition fits with Astellas' strategy to provide patients with therapeutic options for diseases with high unmet medical needs. Propella has a promising program, PRL-02, targeting prostate cancer. We believe that the synergy with Astellas' global development and commercialization capabilities in the cancer and urology fields will accelerate the development of PRL-02 and deliver new VALUE to patients with prostate cancer."

William Moore, President and CEO, Propella 
"Propella has focused on the research and development of proprietary, highly selective inhibitors that precisely block the synthesis of androgens, the main driver of prostate cancer, without significant changes in other steroids that are known to reduce clinical activity and safety. We are gratified that Astellas recognizes and values PRL-02's potential as a best-in-class therapeutic for the treatment of men with prostate cancer. We are delighted that Astellas has chosen PRL-02 for further development and we are committed to supporting Astellas' plans to accelerate PRL-02 development to improve treatment options for prostate cancer patients globally."

Under the agreement, Astellas will pay approximately US$175million to acquire all of the outstanding common stock and equity interests in Propella. Subject to customary closing conditions, the transaction is expected to occur during Astellas' fiscal year 2023 (which ends on March 31, 2024). 

The impact of this transaction on Astellas' financial results in the fiscal year ending March 31, 2024, will be limited.

Overview of Acquisition 

1. Stock acquirer: Astellas US Holding, Inc.
2. Major shareholders of Propella: TPC- API LLC, Employees, etc.
   (including stock options)
3. Consideration: Cash (using cash on hand)
4. Financial terms: Astellas will pay approximately US$175million to acquire all of the outstanding common stock and equity interests in Propella
5. Estimated Date of Closing: Astellas' fiscal year 2023  (which ends on March 31, 2024) 

Overview of Propella

1. Company: Propella Therapeutics, Inc.
2. Address: Pittsboro, North Carolina, US
3. Representative's Title and Name: President & CEO, William Moore 
4. Year of Establishment: 2020
5. Employees: 5 employees (as of end of October 2023)
6. Business Relationship: There is no business relationship between Astellas and Propella.

Stifel, Nicolaus & Company, Incorporated is acting as exclusive financial advisor and Cooley LLP provided legal advice to Propella on this transaction.

* Prodrug: drugs with increased bioavailability by utilizing metabolic reactions in the body

About Propella
Propella Therapeutics, Inc. is a biopharmaceutical company that has developed a platform that combines medicinal chemistry with lymphatic targeting to create best- or first-in-class oncology drugs that have validated MOAs and biological targets but suffer from efficacy and safety limitations. Lymphatic targeting enables therapies to be delivered directly to therapeutic target tissues including the lymph nodes and bone, thereby enhancing efficacy and bypassing plasma compartment safety and efficacy limitations and first-pass liver effects. Propella is currently in the Phase 1 portion of a Phase 1/2a study of its lead product candidate, PRL-02, for the treatment of metastatic prostate cancer. The privately held development-stage company, based in Pittsboro, N.C., is dedicated to meeting the needs of cancer patients currently underserved by existing standards of care.

About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.

Cautionary Notes (Astellas)
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

SOURCE Astellas Pharma Inc.