Mylan And India’s Biocon Team Up To Develop Insulin Biosimilars Of Sanofi, Lilly, Novo Nordisk Products

Less than a year after Pfizer broke out of a deal with Biocon, the company announced it is linking up with Mylan to make biosimilars of insulin products made by Sanofi, Lilly and Novo Nordisk.

MUMBAI – Close to a year after Pfizer Inc. walked out of a deal with India’s Biocon Ltd. for development and commercialization of a range of insulins, the Indian company has sprung back forming what it called an “exclusive strategic collaboration” with the world’s fourth-largest generic drug maker Mylan NV

Under the deal, the two companies will develop biosimilars of Sanofi’s Lantus (glargine), Eli Lilly & Co.’s Humalog (lispro) and Novo Nordisk AS’s Novolog (aspart), the three major insulin analogs.

The combined global sales of the three brands reached $11.5 billion in 2012, making it a compelling business plan as regulatory pathways for biosimilars across nations gain further clarity. Lantus alone crossed sales of $6.6 billion last year.

There are, however, a few significant differences between Biocon’s deal with Mylan and the one it signed with Pfizer in 2010 (Also see "With Biocon Deal, Pfizer Expects To Gain First Mover Advantage In Global Biosimilar Insulin Market" - Scrip, 18 Oct, 2010.).

Cost And Profit-sharing Deal

Biocon and Mylan have not revealed the financial details of the deal, except that they will share the development, capital and certain other costs to bring the products to the market, contrasting sharply with the $350 million ($200 million in upfront payments and $150 million in milestones) deal value disclosed by Pfizer.

Biocon Chairperson Kiran Mazumdar Shaw told PharmAsia News that financial details were confidential, but that the deal provided for a “licensing upfront” – but no milestones – that would be backed by a profit-sharing arrangement.

She said the first payment would be reflected in the company’s fourth quarter earnings statement “quite significantly,” noting that 2016 would likely be the earliest launch of the insulin analogs in some key markets.

Human Insulins Excluded

Although the deal with Pfizer included recombinant human insulin, the Mylan deal has kept recombinant human insulin out of the pact. The reason is obvious. Notably, Biocon has a fairly advanced clinical development plan for recombinant human insulin in the European Union, and it hopes to launch its own versions of the product in the EU in the next two to three years. The company completed a Phase III study and is set for dossier submissions, Shaw told PharmAsia News last month (Also see "Biocon Hopes For EU Insulin Launch In Two Years; Pushes On With A Maturing Pipeline" - Scrip, 28 Jan, 2013.).

Biocon’s lispro and aspart analogs have just concluded preclinical and scale up studies and will enter Phase I trials. Glargine had an early start and the company is preparing to commence its Phase III global trials, which will enable it to make simultaneous filings in many countries, Shaw told PharmAsia News.

Recombinant human insulins, however, have moved faster and will be the first of the lot to hit the market. “With its commercial upsides closest to fruition, Biocon may not be willing to bunch it with the agreement for other insulins,” said an industry expert. Shaw said the option to partner for human insulin will be reviewed after development is completed.

Meanwhile, Biocon may have to slug it out with a mighty opponent in Eli Lilly, which recently announced it expects to file its submission for glargine in the EU by the end of the year.

Selling To Two Worlds

One other difference in the two deals is that while Pfizer secured global licensing rights, barring a few countries like India and Germany, Mylan will keep exclusive rights in the developed markets (U.S., Canada, Australia, New Zealand, the European Union and the European Free Trade Association countries), with the two partners retaining co-exclusive rights in the rest of the world.

During a January investor presentation, Biocon said it plans to register human insulins in 40-plus countries while glargine may be launched in five countries. The company is in the process of setting up a large manufacturing site dedicated to insulin with an investment outlay of $200 million.

Biocon and Mylan appear to be natural allies for the insulin programs with a comprehensive deal already in place for a handful of biosimilar monocolonal antibodies (Also see "Biologics Beckon: Biocon, Mylan Strike Deal; Combine To Take Teva, Sandoz Head-on" - Scrip, 29 Jun, 2009.). According to the latest announcements, the alliance has developed a Herceptin (trastuzumab) biosimilar, and is undergoing Phase III studies in India, while global Phase III studies were recently initiated. Some of the other programs under the deal include peg-filgrastim, bevacizumab, adalimumab and etanercept.

Mylan CEO Heather Bresch said the collaboration builds off its existing successful partnership for biosimilars with Biocon and brings Mylan a portfolio of high-value insulin analog products. “This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential,” she said, adding that she hopes to have the opportunity to be the first biosimilar entrant in the developed markets for the set of products.

With diabetes reaching alarming proportions, insulins are the latest attraction for a host of global drug makers. While Lilly is already extending its portfolio to glargine, Sanofi recently announced it would look at developing its own set of analogs to expand its portfolio.

However, with the diabetes space getting more crowded lately, some have already abruptly exited deals. For example, Allergan PLC broke out of an insulin development deal with Bioton SA last month, barely a year after signing the agreement [See Deal].

Pfizer’s withdrawal from its deal with Biocon last year also could have been due to heightened competition and lowered expectations for insulin sales, analysts suggested (Also see "Pfizer’s Diminished Expectations For Insulin Biosimilar Market Likely Scuttled Partnership With Biocon" - Scrip, 14 Mar, 2012.).