Daiichi Sankyo Exits U.S. Pain Management Market to Focus on Oncology

Compiled by Fan Dongdong

Daiichi Sankyo’s Brief Enthusiasm for the U.S. Pain Management Market Appears to Have Officially Ended

Recently, Sunao Manabe, the new CEO of Daiichi Sankyo, stated in a conference call that since October, the company has returned Movantik, a treatment for opioid-induced constipation, to AstraZeneca and terminated the licensing agreement with Inspirion Delivery Sciences involving the opioids MorphaBond and RoxyBond. “Through these actions, Daiichi Sankyo will exit the pain management business in the U.S. market and focus on its oncology business,” Sunao added.

Daiichi Sankyo’s entry into the U.S. pain medication market dates back to 2014, when the company agreed to acquire certain hydrocodone combination products from Charleston Laboratories for $650 million. However, after the FDA rejected CL-108, the flagship collaborative project between the two companies, the partnership was announced as terminated in 2017.

To expand its analgesic product portfolio in the United States, Daiichi Sankyo acquired the U.S. marketing rights for MorphaBond, an FDA-approved extended-release morphine formulation from Inspirion, and rebranded it as Roxybond. In 2015, Daiichi Sankyo entered into an agreement with AstraZeneca regarding Movantik, paying a $200 million upfront fee to secure joint marketing rights. However, the drug’s performance fell short of expectations. According to AstraZeneca’s sales data, Movantik’s U.S. sales totaled only $70 million in the first three quarters of this year, representing a 14% year-over-year decline.

It remains unclear whether this business adjustment will impact Daiichi Sankyo’s sales force in the United States. However, a warning notice issued in August indicated that Daiichi Sankyo Inc. plans to lay off 68 employees in New Jersey effective October 7.

Nevertheless, Daiichi Sankyo has not abandoned its pain management business in the Japanese market. In April this year, the company launched Tarlige in Japan for the treatment of peripheral neuropathic pain, challenging Pfizer’s blockbuster drug Lyrica. In September, it further introduced a new generic version of oxycodone hydrochloride in Japan for the continuous management of cancer pain.

Abandoning the U.S. Pain Management Market, Daiichi Sankyo Chooses to Double Down on Oncology. Daiichi Sankyo and AstraZeneca Recently Signed Another Oncology Treatment Agreement, with AstraZeneca Purchasing Daiichi Sankyo’s ADC Drug Trastuzumab Deruxtecan (DS-8201) for $6.9 Billion for the Treatment of HER2-Expressing Cancers. The Application for This Drug in Treating Metastatic Breast Cancer Has Just Received Priority Review Status from the FDA and Will Face Final Regulatory Decisions in the Second Quarter of 2020.

Daiichi Sankyo Has Ambitious Plans for Its Oncology Business. In February 2018, Daiichi Sankyo announced it would restructure its U.S. commercial team to prepare for the upcoming launch of its oncology products. At that time, the company planned to lay off nearly 280 employees. The first product in its oncology portfolio, pexidartinib, received FDA approval in August this year for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. This drug is the first and only medication approved for the treatment of TGCT.

Reference Source: Daiichi Sankyo pulls out of U.S. pain market amid oncology pivot, opioid scrutiny