Natco Pharma eager to make generic of Eli Lilly's drug Olumiant

Hyderabad, India-based Natco Pharma (BSE: 524816) is seeking to file a compulsory licensing application for a generic version of Eli Lilly's (NYSE: LLY) arthritis drug baricitinib, in a move that could potentially lead to a legal battle over intellectual property rights (IPR), reports The Pharma Letter’s local correspondent.

Branded Olumiant, the drug is used to treat patients with rheumatoid arthritis. Eli Lilly repurposed it for COVID-19 infections and received approval from the US Food and Drug Administration on November 19 under the Emergency Use Authorization provisions.

India's Natco has sought the Indian regulator's nod for the manufacture and marketing of baricitinib bulk drug and tablets in 1mg to 4mg versions, according to a December 4 notification by the Central Drug Standard Control Organization (CDSCO).

Approved in more than 50 countries worldwide, Olumiant is a once-daily oral therapy for rheumatoid arthritis. In 2018, Eli Lilly (India) had launched Olumiant, a few days ahead of World Arthritis Day marking the firm’s entry into the autoimmune segment in India.

Despite the multiple options available for rheumatoid arthritis in India, there still exists an unmet need. More than half of the patients with moderate-to-severe rheumatoid arthritis do not experience remission through conventional DMARDs.

Patent lawyers have touted the high price of the drug in the Indian market as grounds for Natco to file for Compulsory License (CL). If Natco does approach Lilly for a voluntary licence and if the request is declined by the US drugmaker, patent lawyers state it could bolster Natco's application for a CL.

Natco patent wars

The Indian company's strategy has been to go after niche and difficult-to-make products. Natco has been contesting several patents, and settling some.

Celgene, now part pf Bristol Myers Squibb (NYSE: BMY), has already settled a patent litigation with Natco, agreeing to a deal that will allow the rollout of a volume-limited authorized generic from 2022.

In July 2020, Natco Pharma (Canada) entered into a settlement agreement with Celgene for lenalidomide capsules in Canada. The agreement allows Natco Pharma to start with a limited generic launch in March 2022, and allows Natco to start selling 'mid-single-digit percentages' of Revlimid’s (lenalidomide) total volume that month, with the figure gradually increasing over time to up to one-third of Revlimid's numbers.

On December 11, 2020, Celgene agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the US beginning on a confidential date that is some time after March 2022

Also battling with Taiho

In another IPR battle, Taiho Pharmaceutical, a subsidiary of Japanese drug major Otsuka Pharmaceutical (TYO: 4768), and its group company have moved a US court against Natco Pharma, alleging that the Indian drug maker was attempting to come out with a generic version of its cancer medicine Lonsurf (trifluridine and tipiracil), before expiration of its patent.

Taiho alleged that the Indian drug maker's proposed generic Lonsurf will infringe the patent and sought the court to pass an injunction order against manufacturing, importing and selling that drug in the US.

Taiho Oncology sells and distributes Lonsurf in the USA, while Taiho Pharmaceuticals is the owner of the right, title, and interest of the patent.

Earlier, the Indian drugmaker had notified that it submitted abbreviated new drug application (ANDA) to the US FDA seeking approval to engage in commercial manufacture and sell the generic version in America prior to the expiration of the patents-in-suit.

While Taiho alleged that Natco's proposed ANDA violates the Lonsuf's patents on six counts, Natco informed the Japanese drug major that its ANDA will not infringe the patents through 'Paragraph IV notice letter'.

In yet another case, Eli Lilly is contesting an IPR challenge from Natco for its Verzenio (abemaciclib), indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer.

It may be recalled that in 2017, Eli Lilly had staked its claim for a slice of sales in a new class of breast cancer drugs adding its medicine Verzenio to standard therapy.

In July 2020, the Delhi High Court, in ‘Eli Lilly and Company versus Natco Pharma’ granted an ad-interim injunction in favor of the plaintiffs restraining the defendants from making commercial use of the plaintiff’s patented drug abemaciclib.  

On September 28, 2020, Lilly approached the CDSCO for permission to conduct Phase IV clinical trials of abemaciclib, a CDK4 and CDK6 inhibitor, in combination with endocrine therapy (anastrozole/letrozole or Fulvestrant).

The US FDA approved abemaciclib to treat adults with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced or metastatic breast cancer that has progressed after endocrine therapy.

Abemaciclib is indicated in combination with the endocrine therapy fulvestrant (Faslodex, AstraZeneca) after cancer has progressed on endocrine therapy. It is also indicated on its own for patients who were previously treated with endocrine therapy and chemotherapy after the cancer had metastasized.

India's CDSCO has granted permission to Eli Lilly to conduct the clinical trial under the provisions of New Drugs and Clinical Trial Rules.