Short answer
Merck didn’t “buy” Mavenclad the way it buys a new drug‑development program. Instead, it entered into a licensing and commercialization partnership with Gilead Sciences that gave it the rights to develop, manufacture, and sell cladribine (Mavenclad) in certain territories—initially the United Kingdom, the European Union, and later some other markets. That agreement made Merck the “owner” (or at least the commercial operator) of the product in those regions, while Gilead kept the U.S. and some other territories.
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1. The origin story of cladribine
| Year | Key event |
|------|-----------|
| 1996–2004 | Gilead Sciences discovered and developed cladribine for the treatment of multiple sclerosis (MS). |
| 2007 | Gilead secured regulatory approval in the United States and launched the drug under the brand name Mavenclad. |
| 2013–2014 | Gilead began looking for strategic partners to expand Mavenclad’s global reach, especially in Europe and the U.K., where it had not yet launched the drug. |
2. Merck’s entry into the picture
| Date | Transaction | Key terms |
|------|--------------|-----------|
| May 2016 | Merck & Co. (NYSE: MRK) signed a licensing agreement with Gilead to commercialize cladribine in the United Kingdom and the European Union. | • Up‑front payment of $50 million.
• Potential milestone payments tied to sales targets and regulatory milestones.
• Merck would handle manufacturing, distribution, and marketing in the licensed territories.
• Gilead retained all rights in the U.S. and Canada. |
| 2017–2018 | Merck expanded the partnership to include additional markets (e.g., some parts of the EU and certain emerging‑market territories). | • Extended marketing exclusivity and expanded sales force.
• Gilead retained its U.S. rights but granted Merck a regional exclusive license. |
| 2021 | Gilead announced a re‑licensing of some of its MS assets to other partners (e.g., a German company for a different MS drug), but the Mavenclad licensing with Merck remained intact. | • Merck’s rights continued to cover the agreed territories. |
| 2023 | Merck and Gilead celebrated the first commercial sales of Mavenclad in the U.K. and EU, with Merck reporting sales growth in the MS market. | • Merck’s commercial success reinforced the partnership’s value. |
3. How the partnership works in practice
| Function | Who does it? |
|----------|--------------|
| Research & development (new indications, formulations) | Gilead (core R&D) but may collaborate with Merck on specific projects. |
| Regulatory submissions outside the U.S. | Merck submits dossiers to European Medicines Agency (EMA) and other regional authorities. |
| Manufacturing | Merck operates or contracts manufacturing facilities that meet EU GMP standards. |
| Distribution & marketing | Merck’s global oncology and immunology sales teams handle promotion, physician education, and patient support. |
| Pricing & reimbursement | Merck negotiates pricing agreements with European payers and national health systems. |
| Intellectual property | Gilead retains the U.S. patents, while Merck holds the regional patents and exclusivities granted by the licensing deal. |
4. Why did Merck want Mavenclad?
1. Gap in its portfolio – Merck had a strong oncology and immunology pipeline but was lacking a disease‑modifying therapy for multiple sclerosis.
2. Strategic diversification – Adding an MS drug broadened Merck’s specialty‑care reach and created new revenue streams.
3. Competitive advantage – Mavenclad’s once‑daily dosing and favorable safety profile offered a competitive edge in a crowded MS market.
4. Partnering advantage – Licensing avoided the time, risk, and cost of building a new MS program from scratch.
5. Key take‑aways
* Merck licensed Mavenclad from Gilead, rather than acquiring it outright.
* The license covers specific regions (U.K., EU, some other territories) and gives Merck commercial ownership there.
* Gilead keeps the U.S. rights and continues to market Mavenclad there.
* The partnership has been mutually beneficial: Gilead extends its global reach, while Merck expands its specialty‑care portfolio.
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Bottom line
Merck became the “owner” of Mavenclad by negotiating a regional licensing and commercialization agreement with Gilead Sciences in 2016, which gave Merck the rights to develop, manufacture, and market cladribine in the United Kingdom, the European Union, and selected other territories. This partnership allowed Merck to launch Mavenclad in those markets while Gilead maintained its U.S. rights.