SANOFI AND REGENERON STRONGLY DISAGREE IN ONGOING PATENT LITIGATION REGARDING PRALUENT

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the companies strongly disagree with a U.S. District Court jury verdict that the asserted claims of two Amgen patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are valid. Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing U.S. patent infringement lawsuit and plan to appeal the judgment.  This decision is the first step in this ongoing litigation and does not impact Praluent or our ability to deliver it to physicians and patients at this time.

 

"It has always been and remains our position that Amgen's asserted patent claims in this matter are invalid," said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

Next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future. 

"This is a complex area of law and science, and we believe the facts and controlling law support our position. We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals," said Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. "Praluent was developed with Regeneron's proprietary science and technology and represents an important medical advance for patients."

In July 2015, Praluent was the first PCSK9 inhibitor to be approved for use in the U.S. It is indicated for use as adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of "bad" (LDL) cholesterol. Praluent is the only PCSK9 inhibitor available in two starting doses that allow physicians to adjust the dose based on a patient's LDL cholesterol lowering needs. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.

Sanofi and Warp Drive Bio in Collaboration

Sanofi and Warp Drive Bio, a privately held biotechnology company using the molecules and mechanisms of nature to discover and develop transformative medicines, announced that they have extended and reshaped their existing collaboration utilizing Warp Drive's proprietary SMART(TM) (Small Molecule Assisted Receptor Targeting) and Genome Mining platforms to discover novel oncology therapeutics and antibiotics. 

 

Sanofi, who has been a major investor and strategic partner since Warp Drive's inception in 2012, and Warp Drive have entered into a research collaboration and exclusive license focused on the development of drugs targeting important human oncogenes including RAS, which has one of the highest mutation rates in cancer - and new antibiotics targeting Gram-negative bacteria. Warp Drive Bio retains the rights to deploy its platforms to pursue discovery and development against all other targets, both alone and in collaboration with other companies.

The collaboration is an outgrowth of Sanofi's Sunrise initiative, a strategic partnership model that seeks to invest in early stage opportunities that align with Sanofi's expert development and commercialization abilities. 

Under the terms of the Agreement, Warp Drive will lead the research collaboration for a period of five years and Sanofi will receive worldwide exclusive licenses to develop and commercialize the candidates discovered during the research term. 

Warp Drive is eligible to receive from Sanofi cumulative payments in excess of $750 million across four successful collaboration programs, including an equity investment by Sanofi, research, clinical, and regulatory milestones, and research and development services

SANOFI AND BOEHRINGER INGELHEIM ON BUSINESS SWAP

Sanofi and Boehringer Ingelheim announced that the companies have entered into exclusive negotiations to swap businesses. The proposed transaction would consist of an exchange of Sanofi animal health business ("Merial") with an enterprise value of €11.4 bn and Boehringer Ingelheim consumer healthcare (CHC) business with an enterprise value of €6.7 bn. Boehringer Ingelheim CHC business in China would be excluded from the transaction. The transaction would also include a gross cash payment from Boehringer Ingelheim to Sanofi of €4.7 bn.

The transaction would allow Sanofi to become the number one ranked player in CHC with expected pro formasales of approximately €5.1 bn in 2015(e) and a global market share close to 4.6%1. Sales of Boehringer Ingelheim CHC business (excluding China) are estimated at about €1.6 bn for 2015 and are highly complementary with those of Sanofi CHC, both in terms of products and geographies. Boehringer Ingelheim CHC would improve the position of Sanofi in Germany and Japan where Sanofi CHC presence is limited, and expand Sanofi presence in its Priority Categories. Sanofi would gain access to iconic brands in Antispasmodics, Gastrointestinal, VMS and Analgesics, and attain critical mass in Cough & Cold. Sanofi CHC business in the US, Europe, Latin America and Eurasia would also expand significantly, giving it multiple leadership postions in key countries and/or on key product categories. 

The animal health industry is a very attractive industry in terms of innovation, growth potential and profitability. Combining Merial's and Boehringer Ingelheim's complementary strengths would create the second largest player in the global animal health market with pro forma sales of approximately € 3.8 bn in 2015(e) with the ability to compete for global market leadership. The combined portfolios and technology platforms in anti-parasitics, vaccines and pharmaceutical specialities would place the combined company in the key growth segments of the industry. The species portfolios are highly complementary building on Merial's expertise in companion animals and poultry and BI's expertise in swine.

Sanofi Reward Four Researchers

Sanofi and the Institut Pasteur have attributed the Sanofi - Institut Pasteur Awards for the fourth year in a row. Four major researchers with international recognition have been rewarded for their works in two major fields for global health: tropical and neglected diseases and immunology.

Doctor Marco Vignuzzi - laureate in the Junior category - Viral Populations and Pathogenesis Research Unit, Institut Pasteur, Paris, France, and CNRS researcher, for his works on viral mutations presenting a short-term epidemic potential.

Doctor Mohamed-Ali Hakimi - laureate in the Junior category - Host-Pathogen Interactions & Immunity to Infections, Institut Albert Bonniot, Université Grenoble Alpes, France, Inserm - CNRS, for his researches on the functioning of the parasite Toxoplama gondii responsible for toxoplasmosis.

Professor Keith Matthews - laureate in the Mid-career category - Center for Immunity, Infection and Evolution, School of Biological Sciences, University of Edinburgh, United Kingdom, for his researches on the parasite Trypanosama brucei responsible for sleeping sickness.

Professor Emil Unanue - laureate in the Senior category - Department of Pathology and Immunology, Washington University School of Medicine, Saint Louis, USA, for his work on the recognition of proteins by the immune system, paving the way to the research of therapies against autoimmune diseases such as type 1 diabetes, multiple sclerosis or rheumatoid polyarthritis.

Sanofi and Hanmi Announce License Agreement

Sanofi and Hanmi Pharmaceutical Co. Ltd announced a worldwide license agreement to develop a portfolio of experimental, long-acting diabetes treatments.

Under the terms of the agreement, Hanmi will receive an upfront payment of €400 million and is eligible for up to €3.5 billion in development, registration and sales milestones, as well as double digit royalties on net sales. Sanofi will obtain an exclusive worldwide license to develop and commercialize 1.) efpeglenatide, a late-stage long-acting glucagon-like peptide-1 receptor agonists (GLP1-RA); 2.) a weekly insulin and 3.) a fixed-dosed weekly GLP-1-RA/insulin drug combination. Collectively, these therapeutic offerings are known as the "Quantum Project" utilizing Hanmi's proprietary Long Acting Protein / Peptide Discovery Platform LAPSCOVERY technology. Hanmi will retain an exclusive option to co-commercialize the products in Korea and China.

The Quantum Portfolio is based on Hanmi's proprietary LAPSCOVERY (Long Acting Protein/Peptide Discovery) Technology which is a platform technology that prolongs the duration of action of biologics. The objective is to minimize the frequency of treatment and the dose required, thereby potentially lowering the adverse event rates and optimizing efficacy, according to Hamni.

Sanofi and BioNTech Announce Collaboration

Sanofi and BioNTech announced that they have entered into a multiyear exclusive collaboration and license agreement. This research collaboration between Sanofi and BioNTech will leverage the scientific expertise of the two organizations to discover and develop up to five cancer immunotherapies, each consisting of a mixture of synthetic messenger RNAs (mRNAs).

Sanofi and BioNTech have agreed to $60 million in upfront and near-term milestone payments, payable to BioNTech under the terms of the agreement. Further, BioNTech could receive over $300 million in development, regulatory and commercial milestones and other payments per product. If commercialized successfully, BioNTech would also be eligible for tiered royalties on net sales up to double digits. In addition, BioNTech has the option to co-develop and co-commercialize two of the five mRNA therapeutics products with Sanofi in the European Union and the United States.

Complementing Sanofi's global oncology footprint and scientific expertise, BioNTech will combine the use of its proprietary mRNA technology platform with its extensive capabilities in developing immune-stimulating pharmaceuticals. As part of this effort, BioNTech will utilize its mRNA formulation technology, which enables targeted mRNA delivery in vivo, to generate novel cancer immunotherapies. BioNTech will also supply part of the mRNA material needed for development activities from its in-house GMP manufacturing unit.

Lilly and Sanofi Reach Settlement Agreement

Eli Lilly and Company has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar®. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the U.S. on December 15, 2016. 

 Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar in the Kwikpen® device globally. Further details regarding the settlement are confidential. The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.

Sanofi Announce New Data on Praluent

Sanofi and Regeneron Pharmaceuticals Inc announced that in a new pooled analysis of heterozygous familial hypercholesterolemia (HeFH) patients included in the ODYSSEY clinical trial program, Praluent^® (alirocumab) significantly reduced bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C). This analysis included 1,257 HeFH patients, the largest group of HeFH patients ever studied in a Phase 3 program. At week 24, when the primary efficacy endpoint was assessed, patients treated with Praluent had an average 56 percent greater reduction in LDL-C compared to placebo (p<0.0001) in both arms. Reductions were observed as early as week 4 and were maintained for the duration of therapy, until week 78.

Across the pooled analysis, the most common adverse events (occurring in at least 5 percent of patients in any Praluent group) were nasopharyngitis, injection site reaction, influenza, headache, upper respiratory tract infection, arthralgia, back pain, urinary tract infection, and myalgia.

People with HeFH have an inherited form of high cholesterol and are unable to process the body's natural supply of cholesterol in the liver, leading to very high levels of LDL-C that can block arteries (atherosclerosis) and can lead to a heart attack or stroke. If left untreated, people with HeFH typically have LDL-C levels of 200-400 milligrams/deciliter (mg/dL), are at high risk for premature atherosclerosis and cardiovascular (CV) events, and at 20 times greater risk of developing heart disease.