September 20, 2016
By Alex Keown, BioSpace.com Breaking News Staff
JERUSALEM – Teva Pharmaceutical Industries is banking big time on New York-based Regeneron ’s investigational NGF antibody, fasinumab, for the treatment of osteoarthritis pain and low back pain.
Israel-based Teva is investing up to $2.6 billion to develop and commercialize the drug, which is currently in Phase II and III trials for back pain and osteoarthritis pain respectively. Under terms of the deal, Teva will pay Regeneron $250 million upfront and share equally in the global commercial value, as well as ongoing research and development costs of approximately $1 billion. In its Form 8-K filed with the U.S. Securities and Exchange Commission, Regeneron said it is also eligible for additional contingent payments of up to $1.9 billion upon achievement of specified annual net sales amounts.
Rob Koremans, chief executive officer of Global Specialty Medicines for Teva, called the deal a “significant transaction” for Teva.
“… we look forward to our collaboration with Regeneron, a leader in the research and development of innovative biologics, which aligns with our overall corporate strategy. With our commercial footprint, we will be able to widely educate healthcare providers about this new treatment option when it becomes available,” Koremans said in a statement.
Fasinumab is a fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in patients with chronic pain conditions.
One of the benefits of fasinumab, if it is approved, could be the reduction of dependence on opioid-based medications to combat acute pain. Opioid prescriptions account for 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.
“Fasinumab has shown proof of concept in early clinical trials, and represents an exciting, novel target for pain relief. Adding the promise of fasinumab to our developing pipeline of pain products also provides a strong, strategic cornerstone to our pain franchise at Teva,” Michael Hayden, Teva’s chief scientific officer, said in a statement.
It is estimated that 30 million people suffer pain from osteoarthritis and the same number with chronic low back pain in the United States, Hayden added.
Regeneron also has another agreement regarding commercialization of fasinumab. Mitsubishi Tanabe Pharma has exclusive development and commercial rights to fasinumab in Japan, Korea and nine other Asian countries. Regeneron will lead global development and U.S. commercialization, with both companies sharing commercialization and marketing efforts. Both Regeneron and Teva will split U.S. profits. Outside of the U.S. and Asia, Teva will lead commercialization and marketing efforts, the companies jointly said.
