Bristol-Myers Squibb’s (BMY) acquisition of Celgene (CELG) will add the latter’s blockbuster multiple myeloma (or MM) drugs, Revlimid and Pomalyst, to the company’s portfolio. According to Bristol-Myers Squibb’s investor presentation, the deal will also add other late-stage high-value assets such as luspatercept, liso-cel, bb2121, and fedratinib, which belong to different drug classes such as CelMOD, BCMA, and CAR-T, to the combined company’s portfolio, in the coming one to two years. These assets are expected to strengthen Bristol-Myers Squibb’s position in the hematology segment.
In addition to hematology, the acquisition of Celgene has also bolstered Bristol-Myers Squibb’s immunology and inflammation portfolio by adding a commercialized product, Otezla, and two high-value near-term assets: ozanimod and TYK2.
According to Bristol-Myers Squibb’s investor presentation, the submission of the new drug application (or NDA) for the US market and marketing authorization application (or MAA) for the EU market for Ozanimod have been planned for the first quarter of 2019. The company aims to expand the label of Ozanimod beyond multiple sclerosis in areas such as inflammatory bowel disease (or IBD), ulcerative colitis, and Crohn’s disease.
Revlimid generic erosion
According to Bristol-Myers Squibb’s investor presentation, Revlimid’s composition of matter patent is set to expire in October 2019, while the risk evaluation and mitigation strategy (or REMS) patents will be expiring in October 2020. Bristol-Myers Squibb expects the earliest decisions from ongoing Hatch-Waxman litigations by late 2019 to early 2020. The company also expects the earliest decisions from appeals filed by generic players by 2021.
According to Bristol-Myers Squibb’s investor presentation, in March 2022, as per the settlement with Celgene signed in December 2015, Natco Pharma will launch the generic version of Revlimid in a volume-limited and phased manner. In the first full year, Natco will be supplying a mid-single-digit percentage of the total Revlimid capsules dispensed in the US, and this share may gradually rise to 30% of the total capsules dispensed by 2025. According to Bristol-Myers Squibb’s investor presentation, Natco Pharma is allowed full entry for Revlimid generics beginning January 31, 2026.
The phased generic erosion of Revlimid is expected to give significant time to the combined company to offset the lost revenues.