Sanofi, Hanmi Ink Up-to-$4.2B Long-Acting Diabetes Drug Alliance

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Sanofi will use technology licensed from Hanmi Pharmaceutical to develop a portfolio of long-acting diabetes treatments. The licensing agreement, announced today, indicates that the technology, Hanmi’s Long Acting Protein/Peptide Discovery (LAPSCOVERY) platform, could help the Korean pharma earn as much as €3.9 billion ($4.2 billion).

Sanofi will obtain an exclusive worldwide license to develop and commercialize three Hanmi compounds—efpeglenatide, a late-stage long-acting glucagon-like peptide-1 receptor agonist (GLP1-RA); a weekly insulin; and a fixed-dosed weekly GLP1-RA/insulin drug combination. The three treatment candidates are collectively called the “Quantum Project,” Sanofi and Hanmi said.

“The agreement to develop these three investigational diabetes medicines confirms Sanofi's long-term commitment to people with this disease,” Pascale Witz, Sanofi evp, global divisions & strategic development, said in a statement. She will lead the Global Diabetes and Cardiovascular Care Business Unit in the company's new organizational structure, announced in July and effective in January 2016.

“We now have the opportunity to expand our existing portfolio by including medicines that are administered weekly as well as daily, which could extend our reach in basal insulin and expand our GLP-1-RA and GLP-RA/insulin combination prospects. In these ways, we aim to complement our current offerings and work to serve a broader patient population,” Witz added.

Sanofi is working to retain its diabetes franchise in the face of numerous challenges. Sanofi’s longtime diabetes blockbuster, Lantus, lost U.S. patent protection exclusivity for its active ingredient in February—though the pharma giant launched a new formulation of the basal insulin, Toujeo, on March 30 in the U.S. During the first three quarters of 2015, Toujeo racked up €66 million ($71.7 million) in sales, with €46 million (about $50 million) generated during the third quarter.

Toujeo is one of 18 new drugs Sanofi has committed to launching through the year 2020, generating a projected combined €30 billion ($32.6 billion) in new sales.

Another challenge for Sanofi is diabetes sales. According to results released October 29, Sanofi’s diabetes net sales during the first three quarters of 2015 fell 4.6% from a year earlier at constant exchange rates, to €5.677 billion ($6.17 billion). The slide was led by Lantus, which saw its January-September sales drop 7.3% to €4.854 billion ($5.275 billion). For Q3 itself, diabetes sales fell 6.6% to €1.852 billion ($2.012 billion), with Lantus down 10.8% to €1.561 billion ($1.696 billion).

Sanofi’s first launch of 2015 was Afrezza®, a rapid-acting inhaled insulin therapy that a diabetes treatment it brought to the U.S. market through an up-to-$925 million worldwide exclusive licensing agreement with developer MannKind. Afrezza has so far failed to meet expectations, generating just €5 million (about $5.4 million) in net sales during the first nine months of this year, of which €2 million (nearly $2.2 million) came during Q3. In response to Afrezza’s disappointing sales, MannKind has laid off an undisclosed number of employees in three rounds this year.

However, Sanofi in August launched a new diabetes research collaboration with Evotec that could generate up to €303 million ($329 million)-plus for the German drug alliance and development partnership company.

Sanofi is expected to discuss its diabetes franchise and other areas when it makes public its mid-term strategic and financial outlook tomorrow.

Quantum Portfolio is based on LAPSCOVERY, a platform technology designed to prolong the duration of action of biologics in order to minimize the frequency of treatment and the dose required. Hanmi reasons the technology has potential to lower adverse event rates and optimize efficacy.

“We are confident that we have found the right partner and are excited for the potential this license agreement with Sanofi will bring to the development of Hanmi's Quantum Project and possibilities this could offer to people with diabetes,” stated Hanmi CEO/President Gwan Sun Lee, Ph.D.








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