October 28, 2016
By Alex Keown, BioSpace.com Breaking News Staff
TOKYO – In an effort to expand its oncology pipeline, Japan-based Astellas Pharma plunked down $1.4 billion to acquire the small privately-held German company Ganymed Pharmaceuticals and its experimental Phase II drug IMAB362 as a first-line treatment in gastric cancer.
IMAB362 is a first-in-class monoclonal antibody targeting the cell surface molecule Claudin18.2. Phase II data, revealed at the American Society of Clinical Oncology meeting in June, showed the drug significantly extended median overall survival when added to standard chemotherapy—13.2 months vs. 8.4 months. Additionally, patients with a higher dose of Claudin18.2 demonstrated a longer median overall survival of 16.7 months vs nine months. The drug is moving into Phase III trials.
The data was promising enough for Astellas to strike. Astellas said IMAB362 will expand the company’s oncological platform, which is a key economic driver for the company. Yoshihiko Hatanaka, president and chief executive officer of Astellas, said the acquisition of Ganymed and IMAB362 provides the company with “a late-stage antibody asset with the potential to establish a new pillar following Xtandi.”
IMAB362 has received orphan drug designation in the U.S. and Europe for gastric and pancreatic cancer.
Xtandi was approved in 2012 for late-stage prostate cancer. The drug does have an expensive price tag of about $100,000 per year – before any discounts or rebate programs. That cost has drawn the ire of lawmakers who are incensed over the high costs of medications, particularly those developed with public funding. Xtandi’s development had the backing of grants from the U.S. Army. Sales of Xtandi, which was co-developed by the Bay Area’s Medivation (and now Pfizer , after that company bought Medivation for $14 billion), grew 73 percent in the U.S. in 2015 and 116 percent globally. In addition to using Xtandi for prostate cancer, Medivation and Astellas have teamed up to explore its efficacy in treating triple-negative breast cancer. Earlier this month, the two companies launched a Phase III trial evaluating the efficacy and safety of enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic TNBC.
Under terms of the deal, Astellas provided Ganymed with $460 million in up-front payments and an additional $937 million in milestones. The deal is expected to be completed within the next few weeks, barring any unforeseen regulatory issues. Astellas investors appear to be happy with the deal as shares of the drug are up more than 2 percent this morning, trading at $15.10. That’s certainly better news for investors than the recent news the company was suspended for one year by the Association of British Pharmaceutical Industries for misrepresenting an event it held for physicians in 2014. The meeting in Milan, Italy was described as “promotional stunt” designed to encourage physicians to become high prescribers of Xtandi.
