Janssen Pharmaceuticals unloads NUCYNTA franchise

The company has sold the pain management drug to Depomed Inc. for $1.05 billion

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NEWARK, Calif.—Depomed Inc. has announced the signing of a definitive agreement with Janssen Pharmaceuticals Inc. by which it will acquire the U.S. rights to the NUCYNTA franchise for $1.05 billion. With this deal, Depomed gains NUCYNTA ER (tapentadol) extended-release tablets for pain management, including neuropathic pain associated with diabetic peripheral neuropathy, severe enough to necessitate daily, around-the-clock, long-term opioid treatment, and NUCYNTA (tapentadol), an immediate-release version of the drug, for moderate to severe acute pain management in adults. NUCYNTA oral solution is an approved oral form of tapentadol yet to be launched. NUCYNTA received U.S. Food and Drug Administration (FDA) approval in November 2008, and NUCYNTA received FDA approval in August 2011. NUCYNTA ER is the only opioid approved by the FDA for both chronic pain and diabetic peripheral neuropathy.
Depomed will pay Janssen $1.05 billion in cash, for which it will assume the U.S. license and related royalty obligations for NUCYNTA to Grunenthal, the originator of tapentadol. The company placed $500 million in an escrow account upon the signing of the agreement, which Janssen will receive once the transaction closes. The closing is expected to close in the second quarter of this year, subject to termination or expiration of the waiting period under the Hart-Scott-Rodino Antitrust Act, completion of financing and other customary closing conditions. Depomed's board of directors has unanimously approved the deal, which the company expects to be immediately accretive.
"We believe that NUCYNTA is an ideal strategic fit for Depomed – a rare opportunity to add a proprietary, differentiated drug with a lengthy period of exclusivity that fits precisely into our therapeutic focus," Jim Schoeneck, president and CEO of Depomed, said of the deal. "NUCYNTA meets all of our criteria for product acquisition that we have laid out over the past two years. The NUCYNTA franchise generated U.S. net sales of approximately $166 million for the 12 months ended September 2014. NUCYNTA has composition of matter patent protection to August 2022, a potential pediatric extension into 2023 and additional patents that could extend beyond that timeframe. Finally, the synergies between NUCYNTA and our existing pain and neurology call points create a number of opportunities to grow not only the NUCYNTA franchise, but to enhance the growth of our current business as well."
Depomed reported that it plans to re-launch the two products with a focus on the dual mechanism of action, and intends to support both versions of tapentadol with an expanded sales force of more than 250 representatives.
In other product news for Janssen Pharmaceuticals, the company announced on January 14 that a new post-marketing study evaluating the safety of once-daily XARELTO (rivaroxaban) has demonstrated that in patients with non-valvular atrial fibrillation, rates and patterns of major bleeding in routine clinical practice are generally consistent with those seen in the Phase 3 trials the drug's approval was based on.
“After more than three years on the market and more than 10 million patients prescribed, we continue to monitor the safety performance of our medicine. We are pleased with these findings, which demonstrate XARELTO is performing as expected in the real-world setting,” Dr. Paul Burton, vice president of Medical Affairs at Janssen, said in a press release. “With studies completed in over 85,000 patients and ongoing post-marketing studies that will include more than 74,000 patients, we continue to advance our real-world data to ensure doctors and patients are equipped with the latest information about XARELTO to optimize patient care.”

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