Company and financial news
"Sanofi, Boehringer Ingelheim Agree to $25 Billion Asset Swap
Sanofi agreed to a 22.8 billion-euro ($25.1 billion) asset swap with Germany’s Boehringer Ingelheim GmbH that will bolster the French drugmaker’s business in selling over-the-counter drugs.
The companies reached a definitive agreement after announcing exclusive negotiations in December, they said in a statement Monday. The terms are unchanged from the original announcement: Sanofi will trade its Merial animal-health business, valued at 11.4 billion euros, for Boehringer’s 6.7 billion-euro consumer-health operation. Closely held Boehringer will also pay Sanofi 4.7 billion euros in cash.
The deal helps Chief Executive Officer Olivier Brandicourt reshape Sanofi, whose pharmaceuticals division has grappled with declining sales of its best-selling insulin. It also adds to the consolidation in consumer health. GlaxoSmithKline Plc and Novartis AG created a joint venture in 2015, while Bayer AG in 2014 acquired Merck & Co.’s over-the-counter business.
The companies aim to complete the transaction by the end of the year. Sanofi will use part of the proceeds to buy back shares, and it expects the deal to be neutral for earnings next year and add to profit after that, the company said.
"Chiesi agrees to acquire cardiovascular medications from The Medicines Company
Chiesi USA, Inc. agreed to acquire three cardiovascular medications from The Medicines Company on May 9 for up to $792 million.
The Medicines Company plans on selling clevidipine (Cleviprex), cangrelor (Kengreal) and its rights to argatroban.
The deal is subject to customary closing conditions and is expected to close in the third quarter of 2016. The transaction does not require shareholder approval.
Chiesi USA, Inc. is a specialty pharmacy company and a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A., which is based in Italy.
The Medicines Company will receive $260 million in cash at closing, up to $480 million in sales-based milestone payments and approximately $2 million for product inventory. Chiesi will also assume up to $50 million in milestone payment obligations.
Olon (P&R Group) signed the definitive agreement to acquire INFA Group
P&R and Infa Group shareholders have reached the deal closing for the transaction of 100% Infa shares to Olon SpA, one of the largest European developers and manufacturers, supplying APIs for the pharmaceutical industry worldwide both, for Generic as well as for contract manufacturing.
The acquisition will broaden and diversify the portfolio by doubling it up to more than 200 Generic products and will strengthen the presence in the Contract Development & Manufacturing Organization (CDMO).
The merge of Olon and Infa will expand Olon products portfolio already including, among others, fermented and semi-synthetic API, HPAPIs and cytotoxic compounds, controlled substances, retinoids, antivirals, biologics, recombinant peptides.
Olon and Infa will have available about 130 Active US Drug Master Files (DMFs) and more than 50 EU Certificates of Suitability (COS) or Compliance with the European Pharmacopoeia (CEP) and will rely on 8 manufacturing facilities self-identified under GDUFA.
"Impax buys generic drugs from Teva, Allergan for $586 million
The deal is part of the divestiture process mandated by the U.S. Federal Trade Commission in relation to Teva’s acquisition of Allergan’s generics business for $40.5 billion.
Impax, which raised its full-year adjusted earnings per share growth forecast, said the deal will add 15 marketed generics, one approved generic drug as well as a pipeline generic drug.
Northland Capital Markets analyst David Buck attributed the drop largely to the company keeping its revenue growth rate forecast for 2016 unchanged due to pricing pressure on its Diclofenac Gel, used to treat pain and inflammation, and Metaxalone, a muscle relaxant.
Impax said it will also take back from Teva rights to a generic version of Concerta, an ADHD drug made by Johnson & Johnson, adding a near-term launch product to its pipeline.
The acquired marketed generic products generated about $150 million in net sales and about $100 million in gross profit in 2015, Impax said.
Impax Chief Executive Fred Wilkinson said the addition of 15 marketed products is currently expected to add about $80 million of revenue in the second half of 2016.
The company said it expected its adjusted earnings per share to increase by 20 percent in 2016 from a year earlier, up from the 10 percent it forecast previously. Impax reported adjusted earnings of $1.45 per share in 2015.
Sullivan & Cromwell LLP and McDermott Will & Emery LLP served as legal advisers to Impax while RBC Capital Markets is providing fully committed financing.
Greenhill & Co Inc served as financial adviser and Kirkland & Ellis LLP provided legal advice to Teva.
Pharmaceutical Industry Licensing Deals Soared to Record $46.2 Billion in 2015
Licensing deal values in the pharmaceutical industry rose by 37.1% year-to-year, from $33.7 billion in 2014 to $46.2 billion in 2015, driven primarily by Sanofi, which struck three licensing deals that totaled nearly $9 billion, according to research and consulting firm GlobalData.
Gianfranco Zeppetelli, GlobalData’s Deals Analyst, explains: “Sanofi inked two key partnerships for metabolic indications, the first of which was a $4.3 billion partnership with South Korea’s Hanmi Pharma. Sanofi gained exclusive worldwide license to develop and commercialize three pipeline products for the treatment of type 2 diabetes.
“Sanofi also made a $1.7 billion agreement with Lexicon Pharma to manufacture and sell sotagliflozin (LX-4211), an investigational oral dual inhibitor of SGLT-1 and SGLT-2 currently in Phase III development.”
There has been a surge in investment of deals in the Immuno-Oncology (I-O) space over the past five years, as immunotherapies have advanced significantly, becoming the pillar of cancer treatment. In the I-O space, Sanofi signed a $2.7 billion deal to co-develop Regeneron’s REGN-2810, a programmed cell death protein 1 (PD-1) inhibitor currently in Phase I testing.
Another important I-O partnership was Pfizer’s $2.9 billion agreement with Merck KGaA to develop and commercialize avelumab (MSB-0010718C), an investigational anti-PD-L1 monoclonal antibody in Phase II development as a potential treatment for multiple metastatic and advanced solid tumors, including breast and prostate cancer. Under the terms of the agreement, Merck KGaA will receive an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments of up to approximately $2 billion.
Zeppetelli continues: “We believe deal prices will continue to rise in 2016, as many big pharma companies look to increase their market share in specific therapeutic areas against their competitors.”
Source: Press Release, comments provided by Gianfranco Zeppetelli, GlobalData’s Deals Analyst.
Products & Services
Humira Approved for the Treatment of Non-Infectious Uveitis
Food and Drug Administration (FDA) has approved Humira (adalimumab) from Abbvie for the treatment of non-infectious intermediate, posterior, and panuveitis. This approval marks the first non-corticosteroid treatment approved for adults with non-infectious intermediate, posterior, and panuveitis. Non-infectious uveitis is an immune-mediated disease that can flare and impair vision. Humira works by targeting and blocking tumor necrosis factor alpha (TNF-α), a source of inflammation that can play a role in uveitis. The approval was based on data from two Phase 3 studies, VISUAL-I and VISUAL-II, which showed that adults with active and controlled non-infectious intermediate, posterior, and panuveitis treated with Humira had a significantly reduced risk for treatment failure vs. placebo (hazard ratio [HR] 0.5, 95% CI: 0.36–0.70; P<0.001). Treatment failure was defined as a combination of uveitic flare and decrease in visual activity.
Humira is already indicated for use in various arthritis/rheumatic disorders, colorectal disorders, psoriasis, and hidradenitis suppurativa. It is available as 10mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL solution for subcutaneous (SC) injection.
"Kyprolis wins new indication in Europe
Amgen’s cancer treatment Kyprolis has won a new indication from EMA that should allow it to be used more widely.
The drug’s second indication in less than a year will let it be used with dexamethasone alone in adults with multiple myeloma who have received at least one prior therapy.
Last November it was approved in Europe in combination with Celgene’s Revlimid (lenalidomide) as well as dexamethasone in this therapy area, after receiving the green light in the US more than three years ago. The European Commission has been convinced to allow the new variation based on the head-to-head Phase III ENDEAVOR study.
This showed that Kyprolis (carfilzomib) plus dexamethasone offered progression-free survival (PFS) for patients with multiple myeloma of 18.7 months - compared to 9.4 months in those receiving Janssen’s Velcade (bortezomib) plus dexamethasone. Multiple myeloma is a rare, incurable blood cancer which is characterised by resistance to treatment: in Europe, around 39,000 patients are diagnosed each year and there are 24,000 patient deaths annually.
Health Authority news
"FDA Issues New Draft Guidance on Elemental Impurities
The US Food and Drug Administration (FDA) issued new draft guidance on elemental impurities in drugs, with the goal of helping manufacturers comply with recent International Council for Harmonisation (ICH) and United States Pharmacopeial Convention (USP) standards. Specifically, the guidance is meant to help sponsors of new and generic drugs comply with standards established in USP General Chapters <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures and ICH Q3D – Guideline for Elemental Impurities, which go into effect in 2018.
Elemental impurities are traces of metals that can end up in finished drug products. These impurities can come from multiple points in the manufacturing process, such as residual catalysts from a product’s synthesis or from contact with manufacturing equipment, containers and other materials.
Because these impurities do not contribute to a drugs therapeutic effect, and in some cases can cause patients harm, FDA and other regulatory and standards bodies have developed guidelines to measure and control the presence of these impurities.
While both ICH Q3D and USP General Chapters <232> and <233> are scheduled to go into effect in 2018, FDA says it encourages manufacturers to comply with the standards as early as possible, as they “provide significant improvements over existing approaches.