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Regeneron Pharmaceuticals Gets Approval of Kevzara With Sanofi For Rheumatoid Arthritis

Posted by on February 1, 2017 7:47 AM
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February 1, 2017: Regeneron Pharmaceuticals, Inc. and Sanofi today announced that Health Canada approved Kevzara™ (sarilumab), an interleukin-6 (IL-6) receptor antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

Kevzara is a fully human monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors.1 Local production of IL-6 by synovial and endothelial cells in joints affected in chronic inflammatory disease, such as RA, may play an important role in development of the inflammatory processes.

RA is a systemic inflammatory disease that can affect multiple joints in the body. In RA, inflammation manifests in the lining of the joints causing pain, swelling, joint damage and can lead to deformity. RA impacts 70 million adults worldwide.2,3 In Canada alone, RA affects approximately 300,000 people. RA is most common in people between 40 and 60 years old; however, it can occur in adults at any age.

The Health Canada approval of Kevzara was based on data from the global SARIL-RA clinical trial program which includes approximately 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. Kevzara demonstrated clinically-meaningful improvements, either as monotherapy or in combination with conventional DMARDs, including methotrexate, in reducing signs and symptoms, improving physical function, and inhibiting radiographic progression of structural damage of RA in approximately 1,743 patients with moderately to severely active RA. Kevzara should be used in combination with methotrexate or other traditional DMARDs, or may be given as monotherapy in cases of intolerance or contraindication to methotrexate or DMARDs. The recommended dose of Kevzara is 200 mg once every two weeks given as a subcutaneous injection; dosage can be reduced from 200 mg to 150 mg once every two weeks to help manage certain laboratory abnormalities.

Patients treated with Kevzara are at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent adverse reactions (occurring in at least 3% of patients treated with Kevzara in combination with DMARDs) observed with Kevzara in the clinical studies were neutropenia (6-10%), increased alanine aminotransferase (4-5%), injection site erythema (3-4%), and upper respiratory tract infections (3%).

Kevzara is expected to be available to patients in Canada soon and there will be a patient support program at the time of product availability. The companies are committed to helping patients who are prescribed Kevzara gain access to the medicine and receive the support they may need. In Canada, Kevzara will be marketed by Sanofi Genzyme, the specialty care global business unit of Sanofi.

Update on U.S. and European Regulatory Submissions

The resubmission of the sarilumab Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) is expected in the first quarter of 2017. This resubmission is subject to successful completion of an inspection by FDA of Sanofi’s Le Trait fill and finish facility, with an anticipated action date in the second quarter.

The European Medicines Agency accepted for review the Marketing Authorization Application for sarilumab in July 2016 and a decision is expected later this year.

December 20, 2016: Credit Suisse raised Regeneron Pharmaceuticals to an Outperform rating, from Neutral, and set a price target of $485. Credit Suisse thinks the upcoming Dupixent launch in April and a PCSK9 outcomes read-through from Amgen in 1Q are catalysts.

December 16, 2016: BTIG raises Regeneron Pharmaceuticals to a Buy from Neutral.

December 15, 2016: Regeneron Pharmaceuticals Inc acquires TangenX Technology Corp for $39 million in cash. Announced that it has acquired TangenX Technology Corporation (TangenX) of Shrewsbury, MA, maker of the innovative single-use Siusline of tangential flow filtration (TFF) cassettes and hardware used in downstream biopharmaceutical manufacturing processes. Sius TFF is used in the filtration of biological drugs, complementing Repligens OPUSline of Pre-Packed Chromatography Columns used in downstream purification. Single-use Sius TFF cassettes are designed to deliver superior performance to traditional (reusable) TFF cassettes in a cost-competitive format that provides user-ready convenience and flexibility. The Sius portfolio also strengthens the Companys existing capability in filtration, where its XCellATF products (both stainless steel and single-use) are used for perfusion and cell culture intensification in upstream manufacturing processes.

Prior to the acquisition, TangenX was controlled by Novasep Holding SAS of Lyon, France. The acquisition by Repligen was completed through an all cash transaction of EUR 37.0 million (USD 39.0 million). Repligen expects sales of TangenX products to achieve double-digit growth and contribute $7.0-$7.5 million in revenue for the year 2017. This acquisition is expected to be accretive on both a GAAP EPS and adjusted EPS basis in 2017. Goodwin Procter LLP served as legal counsel to Repligen in the deal, and EC Mergers and Acquisitions, a EuroConsult company, provided financial advisory services.

December 12, 2016: Regeneron Pharmaceuticals stock moves higher on news of Ophthotech’s failed Fovista and Lucentis combination treatment. Ophthotech’s Fovista and Lucentis combination treatment did not result in a benefit in visual acuity at the 12-month time point in two pivotal Phase 3 clinical trials.

The bad news on Fovista was good news for macular degeneration drug EYELEA belonging to Regeneron. A successful outcome of Ophthotech product Fovista combination would have become a strong competitor against the best-selling Regeneron drug Eyelea. It did not happen, which caused Regeneron Pharmaceuticals stock to run higher today.

December 12, 2016: Chardan Capital Markets raised Regeneron Pharmaceuticals to a Hold rating from a Sell rating, and set a price target of $350. The price target was raised to $350 from $300 on the announced failure today of Novartis’ Fovista in pivotal phase III trials in wet AMD.

Regeneron Pharmaceuticals Stock Chart

The Finviz screener settings used to find Regeneron Pharmaceuticals are: Sector Healthcare, EPS growth this year 80% – 100%, EPS growth past 5 years Over 30%, Sales growth past 5 years Over 30%, EPS growth qtr over qtr High (>25%)

Regeneron is a leading science and technology company delivering life-transforming medicines for serious diseases.

Founded by physician-scientists nearly 30 years ago, our science-driven approach has resulted in four FDA-approved medications and numerous product candidates in a range of conditions, including ophthalmology, rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases.

In addition to our medicines, our innovations include the VelociSuite® technologies, world-class manufacturing operations, one of the largest human genetics sequencing efforts in the world and rapid response technologies being used for global good.