Memorandum

Merck and Samsung Bioepis moving insulin glargine biosimilar candidate into phase 3 – February 10, 2014

Executive Highlights

  • Earlier today, Merck announced a collaboration with Korean biopharmaceutical and biosimilar manufacturer Samsung Bioepis to develop an insulin glargine biosimilar.
  • Phase 3 testing of the candidate, MK-1293, will begin “soon” for both type 1 and type 2 diabetes patients.

Today, Merck announced that it is collaborating with Samsung Bioepis to develop and commercialize its insulin glargine biosimilar candidate, MK-1293 (read Merck’s press release). Under the agreement, Merck and Samsung Bioepis will collaborate on MK-1293’s clinical development, regulatory filing, and manufacturing; Merck will commercialize the agent. Quite notably, phase 3 trials in both type 1 and type 2 diabetes are expected to begin “soon.” Merck management confirmed in a conversation with us earlier today that the bulk of the manufacturing of the compound will occur out of its Elkton, VA manufacturing facility, and that Samsung Bioepis will share the responsibility of generating additional manufacturing capacity as needed.

As background, Samsung Bioepis is a joint venture between the US-based biotechnology company Biogen Idec and Samsung Biologics (part of the Korean-based Samsung Group best known for its electronics products). Samsung Bioepis works to develop and manufacture biopharmaceutical and biosimilar medicines. In February 2013, Merck entered into a broad agreement with Samsung Bioepis to develop and commercialize a then-undisclosed set of biosimilar candidates.

We first publicly heard about MK-1293 during the Q&A portion of Merck’s 3Q13 financial update. At that time Merck declined to comment on the candidate. Minutes from an April 2013 meeting of the New Zealand Southern Health and Disability Ethic Committee indicate that MK-1293 and Sanofi’s Lantus (the original insulin glargine) have the same amino acid sequence, physiochemical properties, and formulation. We found one trial of MK-1293 registered on the UK NHS’ National Research Ethics Service website. The single center, double blind, randomized, two-way crossover study is to evaluate the safety, tolerability, and PK/PD profile of MK-1293 relative to Lantus. The profile does not indicate if participants are to have type 1 or type 2 diabetes. We also found two studies on the website of the New Zealand-based clinical research company P3 Research comparing MK-1293 to Lantus; the first study is in type 1 diabetes patients, and the second is in type 2 diabetes patients. We do not know the status of these studies, but assuming they are phase 2 trials, we imagine they have completed or are close to doing so, especially since Merck/Samsung Bioepis are planning phase 3 trials, as noted above.

The insulin glargine biosimilar arena heated up late last month when Sanofi filed a US lawsuit against Lilly regarding the Lilly’s insulin glargine biosimilar, which is currently under regulatory review in the US and EU (read our Lilly 4Q13 Report for details). The suit automatically triggered a hold on the drug’s US approval for 30 months, or until the case is resolved in Lilly’s favor – whichever comes first. Neither Sanofi nor Lilly has provided much detail on the specifics of the lawsuit, and the obvious question is if Sanofi will make similar allegations against Merck’s product. Predictably, Merck declined to address how this lawsuit has impacted its development plans for MK-1293, though we assume if they made this announcement today, they don’t expect to be sued tomorrow.

  • The two other major global insulin companies are working on next-generation basal insulins that could produce headwinds for Sanofi’s Lantus.
    • Novo Nordisk’s ultra-long-acting Tresiba (insulin degludec) has launched in Europe and other markets; following its complete response letter in the US, Novo Nordisk began a cardiovascular outcomes study for insulin degludec (DEVOTE), which could enable an FDA resubmission in 2016 (see our Novo Nordisk 4Q13 Report for more).
    • Lilly, in addition to its partnered insulin glargine biosimilar, is developing a novel basal insulin named peglispro, which is a PEGylated version of insulin lispro (see our Lilly 4Q13 Report for further details). 
  • Sanofi is developing its own new insulin glargine, a concentrated U-300 formulation, which seems to have a hypoglycemia benefit over the original U-100 formulation in the phase 3 EDITION program (see our Sanofi 4Q13 Report for more). Sanofi plans to file the candidate in the US and EU in 2Q14.
  • For more details on MK-1293, see our Merck 3Q13 Report. The report includes more details on the registered trials we unearthed on the candidate, tidbits from the minutes of the New Zealand Southern Health and Disability Ethics Committee Meeting, and the competitive landscape for insulin glargine biosimilars. 

Close Concerns Outstanding questions

  • Where do Merck and Samsung Bioepis plan to manufacture the insulin? On Merck's 3Q13 call there was a listener mentioned an insulin facility being completed in Virginia, however, we have not heard this confirmed.
  • How was the Sanofi suit with Lilly over Lilly's biosimilar insulin glargine impacted Merck and Samsung Bioepis's approach for developing an insulin glargine? 
  • Does Merck/Samsung's insulin glargine have any differentiating factors from Lantus or other insulin glargines in development?

 

-- by Manu Venkat, Hannah Deming, and Kelly Close