Pacira grants Molteni exclusive EXPAREL rights across EU and UK

Pacira BioSciences has signed an exclusive commercialisation agreement with Italy's Molteni Farmaceutici covering EXPAREL (bupivacaine liposome injectable suspension) across the European Union and the United Kingdom. Under the deal, Molteni will lead regulatory filings, market access, and sales activity in licensed territories, while Pacira retains manufacturing responsibility. The financial terms include an undisclosed upfront payment, a supply price, and royalties on future net sales.

Molteni plans a sequential launch beginning in Italy, Germany, Austria, and Poland, with Switzerland also targeted for regulatory approval. The first commercial sale is expected in 2027, giving the partnership roughly a year of preparation time before revenue generation begins. Locust Walk acted as financial adviser to Pacira on the transaction.

The deal

EXPAREL is a long-acting local analgesic that encapsulates bupivacaine within multivesicular liposomes, designed to provide sustained drug release at the surgical site. Pacira says a single dose can reduce cumulative pain scores and cut opioid consumption by up to 78 per cent compared with standard bupivacaine, though it notes that the clinical benefit of the opioid reduction was not demonstrated in pivotal studies. The product is already approved in the United States, where it has been marketed since 2011 across a range of surgical nerve block and wound infiltration indications in adults and in patients aged six years and older for infiltration.

Gianluca Corbinelli, chief executive of Molteni Farmaceutici, described the agreement as "highly complementary with Molteni's strategic priorities" and said the company sees a "significant unmet need for effective postsurgical pain management across Europe." Molteni brings more than 130 years of history as a specialty pharmaceutical business, with established commercial infrastructure in pain management and oncology supportive care across continental Europe.

Market context

The European postsurgical analgesics market presents a meaningful opportunity for opioid-sparing alternatives, given sustained regulatory and clinical pressure across the EU and UK to reduce perioperative opioid use. Several national health authorities have introduced or tightened prescribing guidelines over the past five years, and enhanced recovery after surgery programmes increasingly prioritise multimodal, opioid-minimising protocols. This environment should, in principle, suit a product positioned around opioid reduction.

EXPAREL's competitive landscape in Europe is, however, more complex than in the United States. Standard bupivacaine and ropivacaine formulations are deeply entrenched, generic, and low-cost. Liposomal bupivacaine will need to demonstrate health-economic value to payers and formulary committees in price-sensitive systems such as Germany's statutory insurance framework and Italy's regional reimbursement structure. Market access timelines can extend well beyond initial regulatory approval in these markets, so the 2027 first-sale target is likely to reflect Italy or Germany as a lead country rather than broad simultaneous access.

For Pacira, the agreement is consistent with its stated 5x30 growth strategy, which the company has described as a plan to expand EXPAREL into five new markets or indications by 2030. The NASDAQ-listed company also has ZILRETTA, an extended-release intra-articular corticosteroid for osteoarthritis knee pain, on the US market, and is advancing PCRX-201, a locally administered gene therapy for knee osteoarthritis, through Phase 2 clinical development. The European partnership diversifies revenue geography without requiring Pacira to build a dedicated commercial organisation on the continent, a capital-efficient approach that is common among mid-cap US specialty pharmaceutical companies entering fragmented European markets.