Amgen and Five Prime Therapeutics, a clinical-stage biotech corporation focusing on discovering immuno-oncology and personalized cancer treatments, announced on the 4th March that Amgen would procure the company for $38.00 per share in cash, reflecting a $1.9 billion equity valuation. The acquisition extends Amgen’s leading oncology portfolio adding Five Prime’s groundbreaking pipeline.
The acquisition includes Bemarituzumab, a Phase 3 ready, first-In-class program for gastric cancer
Bemarituzumab, Five Prime’s lead asset, is a first-in-class, Phase 3 ready anti-FGFR2b antibody that demonstrated remarkable results in a randomized, placebo-controlled Phase 2 trial in frontline advanced gastric or gastroesophageal junction (GEJ) cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors.
In the frontline care of patients with advanced gastric or GEJ cancer, the bemarituzumab Phase 2 FIGHT study has demonstrated clinically substantial growth in progression-free survival (PFS), overall survival (OS), and overall response rate (ORR).
Additional research revealed a link between efficacy and FGFR2b expression on tumor cells, highlighting both the value of the FGFR2b objective as well as the action of bemarituzumab against this objective. This link suggests that FGFR2b may be involved in other epithelial cancers, along with lung, breast, ovarian, and other cancer forms.
Amgen’s drive to deliver meaningful treatments to oncology patients strengthened by Five Prime’s revolutionary pipeline projects
Amgen’s global growth strategy would be supported by the acquisition of Five Prime. Gastric cancer is one of the most common cancers in the world, with a high prevalence in Asia-Pacific, where Amgen aims to create substantial volume growth in the future. Amgen intends to optimize bemarituzumab’s potential by leveraging its footprint in Japan and other Asia-Pacific markets. Furthermore, Amgen will gain a royalty percentage from on future net sales in Greater China ranging from the high teens to the low twenties from a pre-existing co-development and commercialization agreement between Five Prime and Zai Lab (Shanghai) Co., Ltd.
Bemarituzumab is a strong strategic fit with Amgen’s innovative oncology portfolio
Bemarituzumab (anti-FGFR2b) is a first-in-class selective antibody that stops fibroblast growth factors (FGFs) from binding to and activating FGFR2b, potentially preventing cancer development by suppressing several downstream pro-tumor signaling pathways resulting in impairing cancer progression .
Robert A. Bradway, Chairman and Chief Executive Officer at Amgen stated:
“The acquisition of Five Prime offers a compelling opportunity for Amgen to strengthen our oncology portfolio with a promising late-stage, first-in-class global asset to treat gastric cancer. We look forward to welcoming the Five Prime team to Amgen and working with them to leverage our best-in-class monoclonal antibody manufacturing capabilities to supply additional clinical materials, as well as expanded production quantities, to realize the full potential of bemarituzumab for even more patients around the world as quickly as possible.”
Tom Civik, President and Chief Executive Officer of Five Prime Therapeutics commented:
“This is an exciting day for patients who may one day benefit from the promise of bemaritizumab and our full pipeline. I’m so proud of the Five Prime team and the science we’ve pioneered. We see tremendous complementarity between the two companies. Amgen has global reach, world-class resources, and they share our deep passion for science and commitment to patients. I have full confidence that Amgen is the right company to work with us to bring our innovative cancer treatments to patients and to achieve our mission to rewrite cancer.”
Terms of the merger agreement
Under the terms of the merger agreement, which was approved by the Boards of Directors of both companies, Amgen will commence a tender offer to purchase all of the outstanding shares of Five Prime’s common stock for $38.00 per share in cash. Following the completion of the tender offer, a wholly-owned subsidiary of Amgen will merge with Five Prime and shares of Five Prime that have not been tendered and purchased in the tender offer will be converted into the right to receive the same price per share in cash as paid in the tender offer (other than shares held by stockholders who properly demand and perfect appraisal rights under Delaware law).
The transaction is expected to close by the end of the second quarter and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Five Prime’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Amgen reaffirmed its full-year outlook with Revenue guidance of $25.8 to $26.6 billion and non-GAAP EPS guidance of $16.00-$17.00.
Goldman Sachs acted as financial advisor to Amgen and Sullivan & Cromwell LLP as its legal advisor. Lazard acted as financial advisor to Five Prime and Cooley LLP as its legal advisor.
The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is known to be involved in cancer cell production and growth. FGFR2b is a splice version of FGFR2 that has been identified in epithelial tumors. According to data from the FIGHT study, some 30% of patients with non-HER2 positive gastroesophageal cancers overexpress FGFR2b. Overexpression of FGFR2b has been found in a variety of cancers, including lung, breast, ovarian, and other cancers.
About the FIGHT Trial
The FIGHT study was a randomized, placebo-controlled trial that evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo plus chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive frontline advanced gastric or GEJ cancer. The study enrolled 155 patients from 15 countries in Asia, the European Union, and the United States, with 77 patients receiving bemarituzumab and 78 receiving placebo.
About Gastric Cancer and GEJ Cancer
With over 1,000,000 new patients diagnosed each year, gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, except non-melanoma skin cancer, the fifth most common cancer worldwide. Today Frontline treatment for HER2 negative patients is the same systemic chemotherapy that has been available since the 1990s.
About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. For the last four decades, Amgen has been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Amgen continues to advance the largest pipeline in its history, moving with great speed to advance those innovations for the patients who need them.
To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com.
Source: Press Release – AMGEN