Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus
Executive Summary
US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.
As attention on the need for cheaper insulin intensifies, Mylan NV has secured a patent victory that positions it to launch a follow-on version of
Sanofi's Lantus (insulin glargine), which is pending at FDA. The US Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) ruled Dec. 12 in favor of Mylan in an inter partes review (IPR) proceeding, agreeing that two formulation patents for the vial form of insulin glargine sold in 100 units/mL are unpatentable.
Mylan's follow-on product, a biosimilar of sorts (FDA is in the process of recategorizing insulins as biologics), is the next best chance to get a third version of insulin glargine on the market after Eli Lilly & Co.'s Basaglar.
Merck & Co. Inc. surprised many industry watchers in October when it announced that it would not launch an insulin glargine product, a vial and pen called Lusdana, that had already been tentatively approved by FDA, pending the outcome of patent litigation. Merck said at the time that it made the decision after assessing the market environment for insulin glargine, including pricing and the cost of production. (Also see "Merck Steps Out Of Insulin Glargine Market, But Says It Remains Committed To Biosimilars" - Scrip, 11 Oct, 2018.)
The insulin market has been dominated by just three companies – Sanofi, Lilly and Novo Nordisk AS. Just this week at the FDA/CMS Summit, FDA Commissioner Scott Gottlieb highlighted the high cost of insulin for patients and efforts by the agency to get interchangeable insulins onto the market. (Also see "US FDA's Gottlieb Shuts The Door On Exclusivity For 'Transition' Biologics" - Pink Sheet, 11 Dec, 2018.)
Mylan has stood by its commitment to bring an alternative product to market. During the company's third quarter conference call, President Rajiv Mallick said, "We believe Lantus is a very important product. We believe there is a market and there's a need." He said the company remains confident that it will be able to produce the product at a positive gross margin, despite Merck's apparent concerns.
IPR Decision Centers On The Vial, A Smaller Market Opportunity
The IPR ruling in favor of Mylan relates only to the 100 units/mL vial formulation of Lantus and US Patent Nos. 7,476,652 and 7,713,930. Sanofi also commercializes Lantus in the disposable injection pen called SoloSTAR, which is the bigger market opportunity. The pen accounts for about two-thirds of the Lantus dollar share, according to IQVIA data provided by Mylan.
Patents for the pen formula are still tied up in an IPR review and an ongoing patent infringement suit. Sanofi filed patent infringement litigation against Mylan in New Jersey district court in October 2017, which involves the two patents invalidated by PTAB and other patents covering the SoloSTAR pen. That litigation is pending and no trial date has been set, according to Mylan.
The IPR proceedings have become a big thorn in the side of brand drug manufacturers who feel they unfairly allow a double patent challenge. Nonetheless, the US Supreme Court upheld the constitutionality of the proceedings in April. (Also see "Inter Partes Patent Challenges Are Constitutional, US Supreme Court Rules" - Pink Sheet, 24 Apr, 2018.)
Lilly settled patent litigation with Sanofi to launch Basaglar, available in a vial and Kwikpen injection, in December 2016. Lilly agreed to pay Sanofi royalties on sales of Basaglar, though details of the agreement were not disclosed. (Also see "Sanofi-Lilly Settlement Paves Way For Biosimilar Lantus" - Scrip, 28 Sep, 2015.)
Mylan's NDA for generic versions of Lantus and Lantus SoloSTAR, filed under the 505(b)(2) regulatory pathway, are under review by FDA. The company and its partner
Biocon Ltd. received a complete response letter from FDA earlier this year, related to a change in the manufacturing site from Biocon's Bangalore facility to Malaysia. (Also see "Keeping Track: Mylan Wins First US FDA Approval For Neulasta Biosimilar, But Lands A CRL For Insulin Glargine; Genentech Nabs Broad Full Approval For Venclexta, PV Indication For Rituxan" - Pink Sheet, 8 Jun, 2018.) The Bangalore site had been cited for manufacturing violations in May. (Also see "GMP Lapses At Biocon’s Indian Site – Jitters for Neulasta Biosimilar Plans?" - Pink Sheet, 3 May, 2018.)
Analysts say the IPR ruling paves the way for Mylan to launch the vial product in the US in 2020
"This might be one of the most meaningful launch opportunities for Mylan in the next 18 to 24 months, especially because the key other generic Lantus developer, Merck, decided to pull out," Evercore ISI analyst Umer Raffat said in a Dec. 13 research note.
The insulin product could be one of the last follow-on insulins approved through the 505(b)(2) NDA pathway before the March 2020 implementation of the Biologics Price Competition and Innovation Act provisions, which transitions insulins and certain other protein products to biologics. (Also see "When Drugs Become Biologics: US FDA Guidances Explain 'Transition Provisions'" - Pink Sheet, 11 Dec, 2018.)