Mylan wins tentative US approval for generic version of Lilly's Alimta — it could be years before it can be sold
Lilly may have fended off competition from a platoon of generic drug makers and their patent challenges on its chemotherapy Alimta, but that has not stopped Mylan from securing tentative US approval for a copycat version.
Alimta was first approved by the FDA in 2004, and the drug’s label has since seen several expansions. It’s cleared for use in several combinations — including with Merck’s star checkpoint inhibitor Keytruda — in certain patients with NSCLC, as well as some patients with malignant pleural mesothelioma. The treatment has already gone off-patent in parts of Europe, and its US patents are set to expire in 2022.
On Wednesday an FDA filing indicated Mylan’s $MYL generic version of Alimta had been granted tentative approval, which is granted by the agency when a product meets its safety, efficacy, and manufacturing quality standards — but is precluded from marketing due to legal protections.
Alimta is Lilly’s $LLY third top-seller — the drug generated about $578 million in the second quarter. As the drug marches towards a patent cliff, the US drugmaker has been working on filling the revenue gap it will eventually face.
In January, the Indianapolis drugmaker agreed to pay $8 billion for Loxo Oncology, which managed to get a drug — a site-agnostic cancer treatment — approved in a relatively sprightly five years. But the main attraction for Lilly is Loxo’s experimental LOXO-292, which has significant commercial potential in patients with NSCLC. Upon the announcement, Stifel analysts suggested the transaction was strategic: “(A)approximately 55-60% of the end-market for LOXO-292 – the valuation centerpiece of this transaction per LLY – is represented by RET-fusion NSCLC and thus represents a readily-accessible opportunity requiring minimal infrastructure build-out.”
In March, another Lilly drug showed potential for use in the lucrative NSCLC market. The company’s Cyramza, in combination with Roche’s Tarceva, helped stem the spread and growth of cancer as an initial treatment in certain patients with metastatic NSCLC in a pivotal study.
Earlier this month, Lilly said a US Court of Appeals for the Federal Circuit ruled in its favor, confirming that Alimta’s patent would be infringed by Pfizer’s $PFE Hospira and Dr. Reddy’s versions. Mylan, along with Neptune Generics and Novartis’ $NVS Sandoz unit was hit with the same roadblock in April in response to their legal challenge.
If the patent is ultimately upheld through all remaining cases, Alimta will maintain US exclusivity until May 2022.