Hanmi Pharmaceutical Co. Ltd. picked up its biggest partnership yet in a potential €3.9 billion (US$4.25 billion) global deal with Sanofi SA to develop a portfolio of long-acting diabetes treatments.

Hanmi, of Seoul, is set to receive an up-front payment of €400 million and is eligible for up to €3.5 billion in development, registration and sales milestones, plus double-digit royalties on net sales. In return, Paris-based Sanofi will obtain an exclusive global license to develop and commercialize a trio of assets. They include efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP1-RA) that completed a phase II trial in non-insulin-dependent diabetes and a phase IIb trial in obesity, plus two earlier-stage candidates: a weekly insulin therapy and a fixed-dosed weekly GLP-1-RA/insulin drug combination.

Hanmi retained an exclusive option to co-commercialize the diabetes products in Korea and China.

Hanmi presented data from five clinical and nonclinical studies on efpeglenatide at the American Diabetes Association Scientific Session in June. The biotech has a half-dozen candidates in development in insulin- and non-insulin-dependent diabetes and obesity, according to Cortellis Competitive Intelligence.

Collectively, the trio of diabetes candidates in the Sanofi partnership is known as the Quantum Project, advanced through Hanmi's long-acting protein/peptide discovery platform, known as Lapscovery. The platform technology is designed to prolong the duration of action of biologics, potentially minimizing the frequency of treatment and the required dose with the goal of lowering adverse event rates and optimizing efficacy.

Hanmi also used Lapscovery to advance a long-acting granulocyte stimulating factor, or GCSF, drug, SPI-2012 (eflapegrastim), that was in-licensed by Spectrum Pharmaceuticals Inc., of Henderson, Nev., and has completed a phase II program. (See BioWorld Today, Sept. 10, 2014.)

Sanofi has been sifting a variety of partnerships to keep the light shining on its diabetes franchise, which has reported slipping sales since early in the year. (See BioWorld Today, May 1, 2015.)

In August, the pharma signed on to a diabetes alliance with Evotec AG, of Hamburg, Germany, focused on beta cell regeneration, in return for €3 million up front and more than €300 million in milestone payments. (See BioWorld Today, Aug. 10, 2015.)

In September, the pharma inked a deal with Google's life sciences team, seeking more efficient ways to collect, analyze and understand multiple sources of information to improve diabetes care. (See BioWorld Today, Sept. 1, 2015.)

The company also reported in September that it was on track to complete a fourth quarter regulatory submission of Lixilan, the fixed-ratio combination of its basal insulin (Lantus; insulin glargine) and its GLP-1 receptor agonist Lyxumia (lixisenatide), on the back of a positive readout from the second of two phase III trials in type 2 diabetes patients. The pharma also is eyeing a European filing in the first quarter of 2016. (See BioWorld Today, Sept. 15, 2015.)

The moves are critical for Sanofi as Lantus goes off patent this year, especially considering that roughly one-fifth of the company's $38 billion in revenues are derived from its diabetes treatments.

Sanofi and Hanmi said their partnership is subject to customary closing conditions, including review under the Hart-Scott-Rodino Antitrust Improvements Act.

Sanofi is expected to unveil a five-year strategic plan Friday. Last week, the pharma reported third quarter financials that missed net sales consensus by 2 percent and business operating income by 4 percent, although earnings per share were in line due to lower expenses and taxes. However, "a negative update on the midterm expectations for global diabetes sales implies a €1 billion to €1.8 billion sales shortfall," Jefferies LLC analyst Jeffrey Holford wrote in a pharma earnings update.

On Thursday, Sanofi's shares (NYSE:SNY) closed at $50.65 for a gain of 51 cents.

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