Operations and Business Environment
Strategy and Group Management
STRATEGY AND OBJECTIVES
MorphoSys’s goal is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. With our sucessful transition from a technology provider to a drug development organization, we are well underway to reach our goal. This transition is supported by MorphoSys’s powerful technology platform for generating therapeutic antibodies. Meanwhile, the Company has more than 100 drug candidates in development. Last year an application was submitted to the regulatory authorities for the first time seeking approval for an antibody based on MorphoSys’s proprietary technology. Most of the development programs are conducted in partnership with pharmaceutical and biotechnology companies. MorphoSys uses the revenues generated from these partnerships to expand its proprietary development portfolio. This segment, which currently comprises 14 programs, is gaining in importance and builds on top of an even broader pipeline of programs pursued with partners. Our high number of active development programs allow us to compensate for potential setbacks that may arise during the complex drug development process and help us to maximize the value of our technology.
The Proprietary Development segment focuses on developing therapeutic agents based on the Company’s proprietary technology platforms and candidates in-licensed from other companies. During clinical development, the Company determines whether and at which point it may pursue a partnership for later development and commercialization. The drug candidate can then be either completely out-licensed or developed further in cooperation with a pharmaceutical or biotechnology company (co-development). In selected cases, individual projects may be developed on a proprietary basis until they are ready for commercialization.
In the Partnered Discovery segment, MorphoSys generates antibody candidates for partners in the pharmaceutical and biotechnology industries. MorphoSys receives contractual payments including license fees for technologies and funded research, as well as success-based milestone payments and royalties on product sales. The funds generated from these partnerships support the Company’s long-term business model and help fund its proprietary development activities.
Both segments are based on the Company’s innovative technologies. Growth is driven mainly by HuCAL, the industry’s most successful antibody library in terms of the number of clinical development candidates produced, and the follow-on platform Ylanthia, which is today’s largest known library based on antibody Fab fragments. The acquisition of the biopharmaceutical company Lanthio Pharma B.V. in May 2015 secured for MorphoSys access to an innovative platform of therapeutic peptides. Additionally, the Company uses its financial resources to expand and deepen its technological base, for example through in-licensing. The in-licensed programs MOR208 and MOR209/ES414 and the acquisition of Lanthio Pharma are good examples of how we are successfully implementing this strategy.
The Company’s goal is to maximize the portfolio’s full value by investing in proprietary drug candidates while maintaining financial discipline and strict cost control to ensure increasing enterprise value.
GROUP MANAGEMENT AND PERFORMANCE INDICATORS
MorphoSys pays equal attention to financial and non-financial indicators when steering the Group. These indicators help to monitor the success of strategic decisions and give the Company the opportunity to take quick corrective action when necessary. The Company’s management also monitors and evaluates selected early indicators so that it can thoroughly assess a project’s progress and act promptly when problems occur.
FINANCIAL PERFORMANCE INDICATORS
Our financial performance indicators are described in detail in the section “Analysis of Net Assets, Financial Position and Results of Operations.” Earnings before interest and taxes (EBIT), revenues, operating expenses, segment results and liquidity are the key financial indicators we use to measure our operating performance. Segment performance is reviewed monthly, and the budget for the current financial year is revised and updated on a quarterly basis. Every year, the Company prepares a mid-term plan for the three subsequent years. A thorough cost analysis is prepared regularly and used to monitor the Company’s adherence to financial targets and make comparisons to previous periods.
MorphoSys’s business performance is influenced by factors such as milestone and license payments, research and development expenses, other operating cash flows, existing liquidity resources, expected cash inflows and working capital. These indicators are also routinely analyzed and evaluated with special attention being paid to the income statement, existing and future liquidity and available investment opportunities. The net present value of investments is calculated using discounted cash flow models.
01 table Development of Financial Performance Indicators 1
|in million €||2016||2015||2014||2013||2012|
|Revenues from continuing operations2||49.7||106.2||64.0||78.0||51.9|
|Operating expenses from continuing operations||109.8||93.7||70.1||67.9||49.8|
|EBIT (Earnings before interest and taxes) from continuing operations3||(59.9)||17.2||(5.9)||9.9||2.4|
NON-FINANCIAL PERFORMANCE INDICATORS
For reporting purposes, MorphoSys uses the Sustainable Development Key Performance Indicators (SD KPIs) recommended by the SD KPI standard. These indicators include success in proprietary research and development (SD KPI 1) and achievements in partnered programs as benchmarks for the commercialization rate (SD KPI 2). In the past five years, there have been no product recalls, fines or settlements as the result of product safety or product liability disputes (SD KPI 3).
To secure its lead in the market for therapeutics, MorphoSys relies on the steady progress of its product pipeline, not only in terms of the number of therapeutic antibody candidates (114 at the end of the reporting year) but also based on the progress of its development pipeline and prospective market potential. Because successful products are based on superior technologies, another key performance indicator is the progress of the Company’s technology development. In addition to the quality of our research and development, our professional management of partnerships is also a core element of our success and refers to new contracts as well as the continued strategic development of existing alliances. Details on these performance indicators can be found in the section “Research and Development and Business Performance”.
The non-financial performance indicators described in the section “Sustainable Business Development” are also used to manage the MorphoSys Group successfully.
02 table Sustainable Development Key Performance Indicators (SD KPIs) at MorphoSys (December 31)
|Proprietary Development (number of individual antibodies)|
|Programs in Discovery||8||8||5||3||2|
|Programs in Preclinic||1||2||2||0||0|
|Programs in Phase 1||2||1||1||1||1|
|Programs in Phase 21||3||3||2||2||2|
|Partnered Discovery (number of individual antibodies)|
|Programs in Discovery||54||43||40||37||34|
|Programs in Preclinic||22||25||25||22||20|
|Programs in Phase 1||10||9||8||6||8|
|Programs in Phase 2||12||9||8||8||6|
|Programs in Phase 3||2||3||3||2||1|
|R&D Expenses (in million €)|
|R&D Expenses on Behalf of Partners||17.2||22.1||19.6||17.5||16.0|
|Proprietary Development Expenses||77.1||54.1||33.5||27.5||18.1|
|Expenses for Technology Development||1.4||2.5||2.9||4.2||3.6|
MorphoSys monitors a variety of leading indicators to monitor the macroeconomic environment, the industry and the Company itself on a monthly basis. At the Company level, economic data is gathered on the progress of the segments’ individual programs. MorphoSys uses general market data and external financial reports to acquire information on early macroeconomic indicators, such as industry transactions, changes in the legal environment and the availability of research funds, and reviews this data carefully.
For active collaborations, there are joint steering committees that meet regularly to update and monitor the programs’ progress. These ongoing reviews give the Company a chance to intervene early when there are any negative developments and provide it with information on expected milestones and related payments well in advance. Partners in non-active collaborations regularly provide a written report to MorphoSys so that we can follow the progress of ongoing therapeutic programs.
The business development area uses market analyses to get an indication of the market’s demand for new technologies. By continuously monitoring the market, MorphoSys can quickly respond to trends and requirements and initiate its own activities or partnerships.
Before a therapeutic product is developed, a target product profile (TPP) is created and continually updated during the development process. This approach gives an early indication of the properties the product should possess to be successful in the market and answers important questions, such as the level of efficacy to be achieved and whether development should be focused on improving the safety profile or changing the drug candidate’s dosage form. The TPP also includes a detailed description of how the product could be positioned in the market and the relevant patient groups. By continuously monitoring the criteria and their fulfillment, the Company can always take the key factors into account during product development and respond promptly to any changes.
ORGANIZATION OF THE MORPHOSYS GROUP
The MorphoSys Group, consisting of MorphoSys AG and its subsidiaries, develops and commercializes high-quality antibodies for therapeutic applications. The activities of the Group’s two business segments are based on leading-edge proprietary technologies. The Proprietary Development segment combines all of the Company’s proprietary research and development of therapeutic compounds. MorphoSys initially develops its proprietary and in-licensed compounds independently with the option to bring them into partnerships or out-license them. As of January 1, 2016, the development of proprietary technologies is now also conducted in this segment. The second business segment, Partnered Discovery, uses MorphoSys’s cutting-edge technologies to make human antibody-based therapeutics on behalf of partners in the pharmaceutical industry. All business activities within the scope of these collaborations are reflected in this segment.
In the 2016 financial year, the Group was located at MorphoSys AG’s registered office, first in the Martinsried district, since autumn in the Steinkirchen district of the municipality of Planegg near Munich, where also MorphoSys’s subsidiary Sloning BioTechnology GmbH is located, and in Groningen, the Netherlands, which is the location of its subsidiary Lanthio Pharma B.V. and its subsidiary LanthioPep B.V. In autumn 2016, MorphoSys AG moved to the Group’s new headquarters, which is also located in the municipality of Planegg near Munich. The central corporate functions such as accounting, controlling, human resources, legal, patent, corporate communications and investor relations, as well as the two segments Proprietary Development and Partnered Discovery, are located at these new headquarters. The subsidiary Lanthio Pharma B.V. and its subsidiary LanthioPep B.V. in Groningen, the Netherlands, are largely autonomous and independently managed. These subsidiaries have their own research and development laboratories, general management and administration, as well as human resources, accounting and business development departments.
Additional information on the Group’s structure can be found in the Notes ( Item 2.2.1).
LEGAL STRUCTURE OF THE MORPHOSYS GROUP: GROUP MANAGEMENT AND SUPERVISION
MorphoSys AG, a German stock corporation listed in the Prime Standard segment of the Frankfurt Stock Exchange, is the parent company of the MorphoSys Group. In accordance with the German Stock Corporation Act, the Company has a dual management structure with the Management Board as the governing body, whose four members are appointed and supervised by the Supervisory Board. The Supervisory Board is elected by the Annual General Meeting and currently consists of six members. Detailed information concerning the Group’s management and control and its corporate governance principles can be found in the Corporate Governance Report. The Senior Management Group, consisting of 22 managers from various departments, supports the Management Board of MorphoSys AG.
MorphoSys develops drugs using its own research and development (R&D) and in cooperation with pharmaceutical and biotechnology partners. Our core business activity is developing new treatments for patients suffering from serious diseases. The Company possesses one of the broadest pipelines in the biotechnology industry with 114 individual therapeutic antibody programs at the end of 2016, 29 of which are in clinical development. Figure 1 shows the revenues of the MorphoSys Group, divided into the business segments Proprietary Development and Partnered Discovery.
MorphoSys has developed a number of technologies providing direct access to fully human antibodies for treating diseases. One of the most widely known MorphoSys technologies is HuCAL, which is a collection of billions of fully human antibodies and a system for their optimization. Another is Ylanthia, which represents the next generation of antibody technology and is currently the largest known antibody library in Fab format. Ylanthia is based on an innovative concept for generating highly specific and fully human antibodies. MorphoSys expects Ylanthia to set a new standard for the pharmaceutical industry’s development of therapeutic antibodies in this decade and beyond. Slonomics gives MorphoSys a patented, fully automated technology for gene synthesis and modification for generating highly diverse gene libraries in a controlled process. The lanthipeptide technology developed by Lanthio Pharma B.V., a fully owned MorphoSys subsidiary, is a valuable addition to our existing library of antibodies and opens up new possibilities for discovering potential drugs based on stabilized peptides.
01 Figure Revenue of the MorphoSys Group by Segment (in million €)
02 Figure MorphoSys's Product Pipeline (December 31, 2016)
An important goal of MorphoSys is to increase enterprise value through the proprietary development of therapeutic programs. To achieve this goal, the Company is focusing on cancer indications and selected programs in inflammatory diseases.
The ability of monoclonal antibodies to bind with specific antigens on tumors, and unleash a therapeutic effect in patients, has led to their dominant role in targeted cancer therapies. According to a study by the QuintilesIMS Institute, expenditure in oncology is expected to be approximately US$ 75 billion worldwide in 2016 and increase to US$ 120–135 billion in the year 2021. MorphoSys is currently investing in the clinical development of three cancer programs: MOR208, MOR202 and MOR209/ES414.
MOR208 is directed against the target molecule CD19, which is implicated in many B cell malignancies. The market research firm Decision Resources expects the therapeutic market for the B cell malignancy non-Hodgkin’s lymphoma (NHL) to reach approximately US$ 19 billion in 2025. Current biological therapies for the treatment of B cell malignancies, including the blockbuster rituximab (trade name Rituxan®), obinutuzumab (trade name Gazyva®) and ofatumumab (trade name Arzerra®) are directed against the CD20 target molecule. Because the target molecule CD19 is expressed on a larger number of B cell subtypes, CD19 antibodies may offer a more promising therapeutic approach. The activity of MOR208 is enhanced by a modification in the Fc part of the antibody, which is intended to lead to higher antibody-dependent cell-mediated cytotoxicity (ADCC) and an improvement in antibody-dependent cellular phagocytosis (ADCP), and thereby more effective tumor cell killing. The most advanced therapeutic approach against CD19 is currently the bispecific antibody blinatumomab (trade name Blincyto®) approved for acute lymphoblastic leukemia (ALL). Other clinical programs directed against the same target molecule use alternative approaches to increase the antibody’s efficacy, for example by coupling with toxic substances or changing the antibody’s glycosylation pattern. Another therapeutic approach against CD19 is the CAR-T technology. This therapy extracts a certain type of immune cells (T cells) from the patients’ blood that are then altered outside of the body so that they can be better directed to the patients’ tumor cells and kill them. When these T cells are later re-administered into the patients’ blood via infusion, they subsequently bind and destroy targeted cancer cells. Alternative approaches using small molecules are also being developed in the field of B cell malignancies.
MOR202 is directed against the CD38 target molecule and is currently being developed for the treatment of multiple myeloma (MM). After MorphoSys regained its rights to MOR202 from Celgene in March 2015, the Company continued developing MOR202 independently. Although MM is a relatively small area of oncology in terms of frequency of occurrence, the MM market has shown strong growth in recent years. Significant achievements in clinical practice and the introduction of effective new treatments have helped the market expand. However, there is still untapped market potential in terms of therapies that have better survival rates and lower side effects compared to currently available compounds. Despite significantly higher survival rates, the disease is seldom curable and a majority of patients experience a relapse. This has increased the attractiveness of alternative treatments, such as those targeting CD38. The approval of the CD38 antibody daratumumab (trade name Darzalex®) by the FDA (Food and Drug Administration) in November 2015 validated this treatment approach.
MorphoSys and its partner Aptevo Therapeutics (formerly Emergent BioSolutions) have been developing MOR209/ES414 since 2015 in a phase 1 clinical study in patients suffering from metastatic castration-resistant prostate cancer (mCRPC). MOR209/ES414 is a bispecific anti-PSMA/anti-CD3 antibody based on Aptevo’s (formerly Emergent) ADAPTIR™ platform (modular protein technology). The immunotherapeutic protein is intended to activate the body’s T cell immune response against prostate cancer cells bearing prostate specific membrane antigen (PSMA), an antigen commonly over-expressed in this tumor. The anti-CD3 binding domains of the compound selectively bind to the T cell receptor on cytotoxic T cells, which become activated when the anti-PSMA binding domains crosslink them to the cancer cells. Prostate cancer is the most commonly occurring cancer in men with approximately 900,000 new cases annually worldwide. As preclinical in vitro and in vivo studies have shown, MOR209/ES414 redirects T cell cytotoxicity toward prostate cancer cells expressing PSMA.
INFLAMMATORY AND AUTOIMMUNE DISEASES*
Chronic inflammatory and autoimmune diseases affect millions of patients worldwide and impose an enormous social and economic burden. The QuintilesIMS Institute estimates the global market for the treatment of autoimmune diseases amounted to roughly US$ 45 billion in the year 2016 and should increase to US$ 75–90 billion in 2021.
MOR103/GSK3196165 is a HuCAL antibody, which MorphoSys fully licensed to GlaxoSmithKline (GSK) in 2013. GSK is developing the antibody independently and bears all of the related costs. MorphoSys participates in the compound’s development and commercialization through milestone payments up to a total of € 423 million and through tiered, double-digit royalties on net sales. In 2013, MorphoSys received an upfront payment of € 22.5 million. MOR103/GSK3196165 is directed against the target molecule GM-CSF (granulocyte macrophage colony-stimulating factor), a central player in the emergence of inflammatory diseases such as rheumatoid arthritis (RA). Biotechnologically produced drugs already comprise the majority of this market’s total revenue. The overall market for RA drugs is growing steadily and Datamonitor expects it will reach US$ 18 billion in the year 2020. MorphoSys estimates that MOR103/GSK3196165 has the potential to be the first marketed anti-GM-CSF antibody.
MOR106, the first drug candidate for identifying and developing new antibody therapies jointly developed with Belgian company Galapagos NV, has been in phase 1 clinical development for atopic dermatitis since 2016. MOR106 is the first publicly disclosed monoclonal antibody targeting IL-17C in clinical development worldwide. MOR106 selectively targets and inhibits IL-17C, which is associated with inflammatory skin disorders. Atopic dermatitis, also known as atopic eczema, is a chronic pruritic (itching) inflammatory skin disease. According to a report by the market research firm GlobalData in 2015, there were 66.3 million atopic dermatitis patients in the nine major markets (US, Germany, UK, France, Italy, Spain, Japan, China and India) in 2014.
The acquisition of the Dutch pharmaceutical company Lanthio Pharma B.V. in 2015 enhanced MorphoSys’s proprietary portfolio with the addition of MOR107 (formerly LP2). MOR107 is a novel lanthipeptide that has demonstrated potent angiotensin II type 2 (AT2) receptor-dependent activity in preclinical in vivo studies, and has potential to treat a variety of diseases.
A political goal of many countries is to provide proper medical care for the public as demographic change drives the need for new forms of therapy. Cost-cutting could slow down the industry’s development. As part of their austerity measures, governments in Europe, the United States and Asia have tightened their healthcare restrictions and are closely monitoring drug reimbursement.
Generic competition, which is already common in the field of small molecule drugs, now poses an increasing challenge to the biotechnology industry because of drug patent expiries. The technological barriers for generic biopharmaceuticals, or biosimilars, will remain high. Nevertheless, many drug manufacturers, particularly those from Europe and Asia, are now entering this market and placing more competitive pressure on established biotechnology companies. In the US, the approval of biosimilars as an alternative form of treatment has been very slow; they are, however, gaining more attention because of increasing pressure in the healthcare sector to reduce costs. Industry experts believe the global market for biosimilars will reach US$ 20 billion in 2025.
In the Partnered Discovery segment, MorphoSys applies technologies for the research, development and optimization of therapeutic antibodies as drug candidates in partnership with pharmaceutical and biotechnology companies. While the development costs are borne by the respective partners, MorphoSys profits from research financing, milestone payments and potential royalties on the sales of products from successful programs.
The Company’s largest relationship to date is the strategic alliance formed in 2007 with Novartis – a pharmaceutical partner with a growing pipeline of biotechnologically developed drugs – which is scheduled to end at the end of November 2017. This alliance was expanded in 2012 through a supplementary cooperation agreement under which the companies collaborate on creating therapeutic antibodies using MorphoSys’s next generation antibody platform Ylanthia in addition to HuCAL.
Partnered discovery programs for drug development include not only programs in MorphoSys’s core areas of oncology and inflammatory diseases, but also those in indications where the Company has not yet established proprietary expertise.
Examples of partnered discovery programs include:
Guselkumab, a HuCAL antibody targeting IL-23, is being developed by MorphoSys’s partner Janssen in plaque psoriasis and psoriatic arthritis (PsA). In November 2016, Janssen submitted an application seeking approval of guselkumab for the treatment of moderate to severe plaque psoriasis in the US and Europe. If approved, guselkumab would be the first marketed HuCAL antibody. Psoriasis is a chronic, autoimmune inflammatory disorder characterized by abnormal itching and physically painful skin areas. It is estimated that as many as 125 million people worldwide have psoriasis with approximately 25 % suffering from cases that are considered moderate to severe. Independent market experts forecast the market for psoriasis to grow from € 7.5 billion in 2014 to € 12 billion in the year 2024.
Anetumab ravtansine (BAY 94-9343), a HuCAL antibody-drug conjugate (ADC) against the target mesothelin, is a potential treatment for mesothelioma and other solid tumors which is being developed by Bayer. Bayer believes if the potentially pivotal phase 2 study in mesothelioma, which started in early 2016, shows positive results, the next step could be an application for regulatory approval. Mesothelioma is a tumor that develops in the lungs primarily as a result of exposure to asbestos. Bayer highlighted this program (as a Lighthouse Project) in September 2016 as a promising compound with extraordinary potential. Bayer believes the peak sales potential for this compound is in excess of € 2 billion per year.
Utomilumab (PF-05082566) is a HuCAL antibody developed by Pfizer in the field of immuno-oncology. The compound is directed against the target 4-1BB (CD137) on T cells and is currently being tested in several phase 1/2 clinical trials in both solid and hematological tumors. According to Pfizer, preclinical findings show the combination of utomilumab with checkpoint inhibitors could strengthen the immune response against cancer.
Gantenerumab is a HuCAL antibody developed by MorphoSys’s partner Roche targeting amyloid beta. It adds a potential treatment for Alzheimer’s disease to MorphoSys’s pipeline. This compound is being investigated in several clinical studies to see if there is a positive effect from intervening at an early stage in the disease’s progression. In two of these studies, Roche is evaluating the compound in around 1,000 patients with mild Alzheimer’s disease and 800 patients with prodromal Alzheimer’s disease. Roche has converted these trials into open-label studies to test higher doses after the temporary discontinuation of earlier studies at the end of 2014. There are currently no drugs that fundamentally improve the course of Alzheimer’s disease.
Several years ago, MorphoSys started its Innovation Capital initiative to combine the traditional investment approach of an industry partner with the cooperative elements of compound development as flexibly as possible. This allowed the Company to make selective investments in promising young companies whose products and technologies may potentially benefit MorphoSys. One example for this initiative is the investment in Lanthio Pharma in 2012 and the acquisition of the all remaining shares in the company in 2015.
Research and Development and Business Performance
2016 BUSINESS PERFORMANCE
MorphoSys’s business is strongly focused on advancing its therapeutic programs in research and development to increase the Company’s value. With the clinical development of proprietary programs as the focal point of the Company, we strive to gain access to novel disease-specific target molecules, advanced product candidates and innovative technology platforms to expand our proprietary development pipeline. MorphoSys also participates in the development success of its partners’ therapeutic programs. The first of these antibodies based on MorphoSys’s technology is approaching the market.
The key measures of value and success of MorphoSys’s research and development include:
- collaborations and partnerships with other companies to broaden the Company’s technology base and pipeline of compounds and commercialize its therapeutic programs
- the initiation of projects and the progression of individual development programs
- clinical and preclinical research results
- regulatory guidance of health authorities to pursue commercialization of individual therapeutic programs
- robust patent protection to secure MorphoSys’s market position
COLLABORATIONS AND PARTNERSHIPS
In May 2016, MorphoSys and the University of Texas MD Anderson Cancer Center announced a long-term strategic alliance. With MorphoSys applying its Ylanthia technology platform, the partners plan to work together to identify, validate and develop novel anti-cancer antibodies up to the clinical proof of concept. The alliance aims to investigate numerous targets in a variety of oncology indications. MorphoSys and MD Anderson will conduct early clinical studies of therapeutic antibody candidates after which MorphoSys has the option to continue developing selected antibodies in later stages of clinical development for its own proprietary pipeline.
In November 2016, MorphoSys and LEO Pharma announced a strategic alliance for the discovery and development of therapeutic antibodies for the treatment of skin diseases. The objective of the alliance is to identify novel, antibody-based therapeutics for unmet medical needs that will be valuable additions to both companies’ development pipelines. MorphoSys will apply its Ylanthia technology platform to generate fully human antibody candidates against the targets selected by LEO Pharma and will conduct all development activities up to the start of clinical testing. LEO Pharma will be responsible for clinical development and commercialization of resulting drugs in all indications outside of cancer. In skin cancer indications, MorphoSys will have options to co-develop and, in Europe, co-promote the respective antibody drugs. In addition, MorphoSys will have certain options to develop and commercialize therapeutic programs arising from the collaboration in other cancer indications. MorphoSys will receive R&D funding as well as success-based development, regulatory and commercial milestone payments, plus royalties on net sales of drugs commercialized by LEO Pharma. Assuming all development, regulatory and sales objectives are achieved, milestone payments could add up to € 111.5 million per antibody program.
PROJECT INITIATIONS AND PROGRESS, TRIAL EXTENSIONS
During the 2016 financial year, the number of therapeutic programs in the MorphoSys pipeline grew to a total of 114 (December 31, 2015: 103 programs) Proprietary Development and Partnered Discovery projects. At the end of 2016, MorphoSys had 14 projects (December 31, 2015: 14) in its Proprietary Development portfolio, five of which were in clinical development and nine in preclinical development or the discovery phase. The number of programs being pursued by our partners in the Partnered Discovery segment grew to a total of 100 (December 31, 2015: 89), 24 of which were in clinical development, 22 in preclinical development and 54 in the discovery phase. MorphoSys’s partnered and proprietary clinical pipeline currently comprises 29 unique antibody molecules that are being evaluated in more than 60 clinical trials.
03 Figure Active Clinical Studies with MorphoSys Antibodies (December 31)
Based on clinical results obtained with MOR208, MorphoSys initiated a phase 2 trial program in 2016 for its further development in combination with other cancer drugs for B-cell-based malignancies.
- A trial initiated in April 2016 is evaluating MOR208 in combination with lenalidomide in patients suffering from relapsed or refractory diffuse large B cell lymphoma (DLBCL) (L-MIND study). The trial is designed as an open-label, single-arm study with the primary endpoint being the overall response rate (ORR) and multiple secondary endpoints, including progression-free survival (PFS), overall survival (OS) and time to progression (TTP). In August 2016, MorphoSys announced the successful completion of the safety run-in phase of the L-MIND trial. No unexpected safety signals were detected and the trial was continued as planned.
- In September 2016, MorphoSys disclosed that the first patient had been dosed in the safety evaluation part of a phase 2/3 clinical combination trial of MOR208. The B-MIND (Bendamustine-MOR208 IN DLBCL) trial will evaluate the safety and efficacy of MOR208 combined with the chemotherapeutic agent bendamustine in comparison to rituximab plus bendamustine. This trial will enroll 330 adult patients worldwide with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplantation. The trial’s phase 2 safety run-in is currently evaluating the safety and tolerability of MOR208 with bendamustine in comparison to rituximab plus bendamustine. After the safety run-in, the trial will transition into a pivotal phase 3 trial, planned to start in 2017.
- In addition to the two combination studies with MOR208 inDLBCL, MorphoSys announced in December 2016 the start of a phase 2 combination study with MOR208 in a further indication. The trial which has been named COSMOS (CLL patients assessed for ORR & Safety in MOR208 Study), is designed to evaluate the safety and efficacy of MOR208 in combination with idelalisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The patients enrolled must have been refractory or shown relapse or intolerance to a prior therapy with a BTK inhibitor such as ibrutinib. This patient cohort shows a particularly high medical need.
The HuCAL antibody MOR202 targeting CD38 is currently being evaluated in a phase 1/2a dose-escalation study alone and in combination with the immunomodulatory cancer drugs (IMiDs) lenalidomide and pomalidomide, in each case with dexamethasone, in patients with relapsed/refractory multiple myeloma (MM). In this trial, a growing number of patients in the reporting year were treated with the highest dose cohort of 16 mg/kg MOR202 in combination with lenalidomide and pomalidomide.
MOR209/ES414, which we are co-developing with our partner Aptevo Therapeutics (a spin-off of Emergent BioSolutions), is in a phase 1 trial in patients suffering from metastatic castration-resistant prostate cancer. The first patient was recruited for the trial according to the amended trial protocol in the fourth quarter of 2016.
The HuCAL antibody MOR103/GSK3196165, which was out-licensed to GlaxoSmithKline (GSK), is currently being developed in a phase 2b study in patients with rheumatoid arthritis. In April 2016, GSK announced the initiation of a phase 2a clinical trial to investigate the safety and efficacy of MOR103/GSK3196165 in patients with inflammatory hand osteoarthritis. GSK also initiated a mechanistic phase 2a trial of MOR103/GSK3196165 in rheumatoid arthritis to further investigate the GM-CSF signaling pathway.
In 2016, MOR106 became the fifth drug candidate from MorphoSys’s proprietary pipeline in clinical development. In April, MorphoSys and its development partner Galapagos NV announced the initiation of a phase 1 clinical trial to evaluate MOR106 in healthy volunteers. The trial was expanded at the end of September to include patients suffering from atopic dermatitis after MOR106 showed favorable safety results in healthy volunteers during the first phase of the study. MOR106 is the first antibody generated using MorphoSys’s proprietary Ylanthia technology to enter clinical development. This phase 1 trial investigates the safety, tolerability and pharmacokinetic profile of MOR106 in single ascending doses in healthy volunteers as well as multiple ascending doses in patients with atopic dermatitis. MOR106 is the first publicly disclosed antibody targeting IL-17C in clinical development worldwide. Galapagos and MorphoSys jointly discovered MOR106 and are co-developing this compound in clinical studies.
In January 2016, MorphoSys’s partner Bayer initiated a phase 2 clinical study in mesothelioma with the HuCAL-based antibody drug conjugate anetumab ravtansine (BAY 94-9343) which targets mesothelin. MorphoSys recognized the related milestone payment in the first quarter of 2016. Bayer’s objective is to apply for market approval based on the results of this study, if successful.
On April 21, 2016, MorphoSys announced that its partner Novartis confirmed that a phase 2b/3 study investigating the HuCAL antibody bimagrumab (BYM338) in the rare disease sporadic inclusion body myositis (sIBM) did not meet its primary endpoint. All three of the phase 3 studies in this indication were discontinued. The HuCAL antibody’s active phase 2 clinical trials in sarcopenia, a form of age-related muscle loss, and muscular atrophy after hip operations continued as planned. In December 2016, Novartis announced on the website clinicaltrials.gov, that a phase 2 trial with bimagrumab in another indication will be started. This trial is designed to assess the safety, pharmacokinetics and efficacy of the HuCAL antibody versus a placebo in around 60 obese patients with type 2 diabetes.
In July and October of 2016, MorphoSys announced the receipt of milestone payments from Novartis. These payments were triggered by the initiation of phase 1 clinical trials with novel HuCAL antibodies for the prevention of thrombosis and in the field of cancer. The number of HuCAL antibodies investigated by Novartis in clinical trials rose to a total of 14 after the initiation of a clinical study of a further HuCAL antibody in the field of asthma in 2016.
In October, MorphoSys announced that its licensee Janssen Research & Development, LLC (Janssen) reported positive results from a phase 3 clinical study of guselkumab in 837 patients with moderate to severe plaque psoriasis (“VOYAGE 1” study). Janssen reported that both of the trial’s co-primary endpoints were met, including improving the symptoms of psoriasis, while delivering clear or almost clear skin (measured by the parameters IGA 0 or 1 and PASI 90) at week 16 in patients receiving guselkumab, compared to those receiving a placebo. Janssen also reported that all major secondary endpoints achieved statistical significance in comparisons of guselkumab versus adalimumab (Humira®). In November 2016, Janssen submitted a regulatory filing to the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA) for the treatment of adults living with moderate to severe plaque psoriasis.
In November 2016, MorphoSys announced that its licensee Janssen Research & Development, LLC (Janssen) had presented positive results from a phase 2a clinical study evaluating guselkumab in patients with active psoriatic arthritis (PsA). The data published by Janssen showed that a substantially higher percentage of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of the disease (ACR 20) at week 24, the study’s primary endpoint, compared with patients receiving placebo. Janssen announced that it will now evaluate the compound further in a phase 3 program in PsA.
CLINICAL STUDY DATA FROM CURRENT PROJECTS
In 2016, MorphoSys announced data from clinical studies of its proprietary drug programs MOR202 and MOR208 at several industry conferences.
Current data from a phase 2a clinical study with anti-CD38 antibody MOR208 in patients with subtypes of relapsed or refractory non-Hodgkin’s lymphoma (NHL) was presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting (June), the Congress of the European Hematology Association (EHA) in June, the Annual Conference of the German, Austrian and Swiss Associations of Hematology and Medical Oncology (DGHO) in October and the Annual Meeting of the American Society of Hematology (ASH) in December. This data primarily concerned the patient subgroup analysis and the duration of response to continued therapy. In June 2016, MorphoSys also announced the publication of a clinical case report from this study in the Journal of Medical Case Reports.
This open-label, multi-center phase 2a study is evaluating the efficacy and safety of weekly doses of 12 mg/kg MOR208 in 92 pre-treated patients with various subtypes of relapsed/refractory NHL. Included in this study were patients with diffuse large B cell lymphoma (DLBCL) and patients with indolent NHL (iNHL) including follicular lymphoma (FL). All patients had received at least one prior rituximab-containing therapy. The most recent data presented at the ASH Annual Meeting in December 2016 showed continued long-lasting responses in patients after more than 26 months, confirming results from previous trials. Three patients with DLBCL and six with iNHL showed ongoing response to therapy; seven of whom achieved a complete response (CR) and two with a partial response (PR). The overall response rate (ORR) was 36 % in the DLBCL subgroup and 33 % in iNHL patients (both based on evaluable patients). The progression-free survival rate (PFSR) after 12 months was 39 % for both subgroups. In addition to the patients with an objective response (PR or CR), the majority of patients with stable disease (SD) had a reduction in target lesion size (5/6 DLBCL and 14/17 iNHL). The duration of progression-free survival (PFS) was similar in patients with rituximab non-refractory and rituximab refractory tumors who were treated with MOR208. This shows that MOR208 demonstrated clinical activity independent of any response to previous anti-CD20-based therapies.
Updated results for safety and clinical activity from another ongoing phase 2 study with MOR208 were announced at the ASH Annual Meeting in December 2016. In this investigator-initiated trial (IIT) conducted by scientists at the Ohio State University, MOR208 is being evaluated in various CLL patient populations, among others, in combination with the immunomodulator lenalidomide. The trial also includes a fourth cohort of CLL patients with identified resistance mutations to ibrutinib in which MOR208 was added to the ibrutinib therapy. According to the abstract submitted at the ASH conference, of the group of CLL patients with ibrutinib-resistant cells in the study, four out of seven patients had already been receiving MOR208 in addition to ibrutinib for at least three cycles of 28 days each, and no patient had developed progressive disease at the time the abstract data was submitted. Preliminary data show activity in patients in all cohorts, including ibrutinib-resistant CLL patients.
MorphoSys’s anti-CD38 antibody MOR202 is currently being evaluated in an ongoing phase 1/2a clinical study in pre-treated patients suffering from relapsed/refractory multiple myeloma. Updated results on safety and tolerability from this study were released at several conferences in 2016, including the ASCO Annual Meeting and EHA Congress in June, the DGHO Annual Meeting in October and the ASH Annual Meeting in December. This study is a dose-escalation study investigating MOR202 alone and in combination with the immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom), plus dexamethasone (Dex). The study’s results were consistent with earlier data and generally showed further improved responses as the number of patients in the higher dosing cohorts increased. MOR202 showed encouraging clinical response rates, especially in combination with IMiDs, with a very short 2-hour infusion time with rare and comparatively mild infusion-related reactions (IRRs) of grades 1 and 2 occurring in just 7 % of patients. No unexpected safety signals were observed.
The latest presentation at the ASH Annual Meeting in December 2016 reported the following early efficacy data for MOR202:
- The patients receiving MOR202 plus Len/Dex showed an objective response rate of 91 % (10 out of 11 patients) across all clinically relevant dose cohorts (8 mg/kg and 16 mg/kg). All 7 patients in the highest dosing cohort of 16 mg/kg MOR202 plus Len/Dex showed an initial overall response (OR) to therapy.
- Of the heavily pre-treated patients in the cohort treated with a combination of MOR202 (dose cohorts 8 mg/kg and 16 mg/kg) and Pom/Dex, 4 out of 7 patients showed an overall response; although, at the time of evaluation, two patients in the highest dose cohort of 16 mg/kg had been in treatment for only a relatively short time. Of the 4 patients showing an overall response, 2 patients achieved a complete response (CR).
- Of the patients treated with MOR202 alone in combination with Dex (dose cohort of 4 mg/kg, 8 mg/kg and 16 mg/kg), 29 % (5 out of 17) responded to therapy. The median progression-free survival (PFS) of these patients was 4.7 months.
- In 14 of the 19 cases observed, patients are still showing response to therapy with the longest response to date being 14 months.
- Biomarker data suggests that the antibody’s CD38 expression on the surface of the MM patients’ bone marrow plasma cells is preserved during MOR202 therapy.
During the reporting year, partners of MorphoSys continued to develop HuCAL antibodies and presented their progress and data on the following programs at scientific conferences, such as the Annual Conference of the American Society of Clinical Oncology (ASCO) in Chicago in June 2016:
- Bayer presented an ongoing pivotal phase 2 study in mesothelioma with the HuCAL antibody-drug conjugate anetumab ravtansine.
- Bayer also presented data from a phase 1 study of anetumab ravtansine in patients with solid tumors.
- Pfizer presented phase 1 data from its study of the anti-4-1BB antibody PF-05082566 (utomilumab) in combination with pembrolizumab in patients with solid tumors.
- Boehringer Ingelheim presented first phase 1b data from a phase 1b/2 study of BI-836845 in patients with breast cancer.
- OncoMed published data from a phase 1b study of tarextumab in small cell lung cancer.
- OncoMed also published data from a phase 1b study of vantictumab in breast cancer.
In November 2016, MorphoSys’s partner Janssen submitted applications in the United States (FDA) and Europe (EMA) seeking approval of the HuCAL antibody guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. If approved, guselkumab could become the first marketed antibody based on MorphoSys’s technology. In this case, MorphoSys would benefit from royalties on net sales.
During the 2016 financial year, MorphoSys continued to consolidate and expand the patent protection of its development programs and its growing technology portfolio, which are the Company’s most important value drivers.
On April 4, 2016, MorphoSys announced that it filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech and Genmab A/S for patent infringement of U.S. Patent Number 8,263,746. This patent, which is owned by MorphoSys, describes and claims antibodies with particular features that bind to CD38. By its complaint, MorphoSys seeks redress for the infringing manufacture, use and sale of Janssen’s and Genmab’s daratumumab, an antibody targeting CD38.
At the end of the financial year, the Company maintained over 50 different proprietary patent families worldwide in addition to the numerous patent families it pursues with its partners.
In September 2016, MorphoSys announced the establishment of a Scientific Advisory Board (SAB), which was set up to advise the Company on strategic issues and future perspectives within its research and development activities. The inaugural members are Dr. Günther R. Adolf (previously at Boehringer Ingelheim, Vienna, Austria), Prof. Dr. Bruce D. Cheson (Georgetown University Hospital, Washington D.C., USA), Dr. Sergio Quezada (University College London Cancer Institute, London, UK) and Dr. Raymond W. Sweet (previously at Janssen, J&J, Pennsylvania, USA).
In September 2016, MorphoSys’s Dutch subsidiary Lanthio Pharma B.V., specializing in the development of lanthipeptides, announced the appointment of Axel Mescheder, MD as Chief Medical Officer. Dr. Mescheder has more than 20 years of management experience in R&D for the pharmaceutical and biotechnology industry. At Lanthio Pharma, Dr. Mescheder will be primarily focused on developing Lanthio Pharma’s lanthipeptide portfolio, and preparing and executing the clinical development of MOR107.
In November 2016, MorphoSys completed a private placement via an accelerated book building process raising gross proceeds of approximately € 115.4 million. MorphoSys issued 2,622,088 new shares from authorized capital to institutional investors in Europe and North America at a price of € 44.00 per share. The offering represented approximately 9.9 % of the registered pre-transaction common stock and brought the total number of shares to 29,159,770. The new shares were admitted to trading on the Frankfurt Stock Exchange following their issue. The Company intends to use the proceeds in particular to fund the further clinical development of its proprietary programs. Furthermore, the proceeds of the transaction will be used to advance pre-clinical assets as well as to fund potential in-licensing of oncology product candidates or additional technologies.
Group Headcount Development
Motivated, exceptionally skilled employees who are both creative and dedicated are the foundation of MorphoSys’s success. On December 31, 2016, the MorphoSys Group had 345 employees (December 31, 2015: 365), 137 of whom hold PhD degrees (December 31, 2015: 145). The MorphoSys Group employed an average of 354 employees in 2016 (2015: 356).
04 Figure Total Headcount of the MorphoSys Group (December 31)
A competitive remuneration system and favorable working environment are crucial factors when competing for the best employees. To be a competitive employer, MorphoSys compares the Company’s compensation with that paid by other companies in the biotech industry and similar sectors and makes adjustments when necessary. The remuneration system at MorphoSys includes fixed compensation and a variable annual bonus that is linked to the achievement of corporate goals. Individual goals promote both the employees’ personal development and the achievement of key corporate goals.
In addition, a “spot bonus” (given “on the spot”) is promptly awarded to employees for exceptional accomplishments. We made significant use of this instrument during the reporting year.
A detailed overview of headcount development and MorphoSys’s activities to promote successful long-term human resource development can be found in the section “Sustainable Business Development.”
Development of the Business Environment
Forecasts by the International Monetary Fund (IMF) predict a slowdown in global economic growth to 3.1 % in 2016 (2015: 3.2 %). This slightly lower forecast reflects the rather subdued outlook for the advanced economies after the Brexit vote in the UK in June 2016 and weaker than expected growth in the United States.
Although the market’s response to the Brexit vote has been somewhat moderate, increasing economic, political and institutional uncertainty, coupled with a decline in trade and finance between the UK and the rest of the European Union, is expected to have a negative impact on the overall economy, especially in the UK. As a result, the 2016 growth forecast for the advanced economies was reduced to 1.6 % (2015: 2.1 %). After five years of declining growth rates, the emerging and developing economies are expected to report slightly higher growth of 4.1 % (2015: 4.1 %). The outlook for these countries varies but is generally less optimistic than in the past. Based on its outlook published in January 2017, the IMF expects the economic recovery in the eurozone to continue and projects growth of 1.7 % for 2016 (2015: 2.0 %). The 2016 forecast for Germany is also 1.7 % (2015: 1.5 %), with growth being driven by strong domestic demand. The US economy has lost momentum in recent quarters and expectations are for growth of 1.6 % for the whole of 2016 (2015: 2.6 %). The impact on the US and global economy after the election of Donald Trump is not yet clear. The global economy’s growth engine, China, is expected to grow 6.7 % (2015: 6.9 %) thereby remaining within its official target range of 6.5 to 7 %, thanks to policy measures and strong credit growth. Russia continues to be stuck in a recession, although the economic trend improved slightly with a projected decline of just 0.6 % in 2016 compared to a reported –3.7 % in 2015. The Brazilian economy continued to contract (2016 forecast: –3.5 % vs. 2015: –3.8 %).
MorphoSys takes into account all potential macroeconomic risks and opportunities when conducting business activities. Political uncertainty in the global markets did not cause the Company to refrain from or change any of its key activities in the past financial year. MorphoSys’s operations were also not affected by any fluctuations within individual countries and, therefore, in this respect were not directly impacted by global economic developments.
The euro and the US dollar continued to edge toward parity in 2016. Following the rate increase by the US Federal Reserve in December 2016, further rate increases are expected in 2017. There is little evidence that the European Central Bank is planning to change the course of its monetary policy characterized by negative interest rates and large bond buying programs. These policies have placed pressure on the euro in 2016 causing it to reach a 13-year low in mid-December as it fell below the US$ 1.05 threshold. At the end of 2015, the euro was still at US$ 1.09. After the election of Donald Trump, Citigroup revised its forecast and now expects the euro to fall to $ 0.98 in the next six to 12 months.
Because most of the Company’s business is transacted in euros and US dollars, changes in these currencies could have an effect on MorphoSys’s future costs and revenues. Continued weakness in the euro versus the US dollar has a direct influence on the Company’s operating results because a growing share of its costs stem from clinical studies conducted in the United States. MorphoSys deals with this risk with appropriate hedge accounting measures.
The healthcare industry’s regulatory environment is dominated by continually rising product quality, safety and efficacy requirements, which places ever-higher demands on the companies involved. Novel drugs are required to demonstrate a significant benefit over existing therapies in order to be approved, gain the market’s acceptance and be financially reimbursed. In the United States, which represents the world’s largest healthcare market, it is not yet clear what type of health policy will be pursued by the new Trump administration. Discussions have ranged from a withdrawal to an adaptation of the Affordable Care Act, but further details have not yet been disclosed.
The US Food and Drug Administration (FDA) approved a total of 22 medications in 2016, including six for the treatment of cancer, or half of the previous year’s number (2015: 45). In the period from 2006 to 2014, the FDA approved an average of 28 new compounds every year. Nevertheless, a strong importance is still placed on the industry’s continued commitment to innovation and developing technologically better products and optimizing already approved treatments.
DEVELOPMENT OF THE PHARMACEUTICAL AND BIOTECHNOLOGY SECTORS
In comparison to an exceptionally strong year for the global pharmaceutical industry in 2015, the outlook for the industry in 2016 turned somewhat discouraging. Analysts expect the largest ten pharmaceutical companies to generate growth of just 2 % p.a. on average in 2016 and 2017. Experts cite two main causes for the growth slowdown: one is the decline in new innovative drugs in 2016 and the corresponding decline in the number of approvals; the other is fear of a growing price pressure in the United States.
Political uncertainty for both the overall economy and the pharmaceutical industry has increased with the November 2016 election of Donald Trump as the new US president. Initially, the pharma industry was concerned it would be forced to face stricter price controls under a Clinton administration. These concerns have died down with Trump’s election win. In addition, a public petition in California demanding price caps for drugs in state-funded healthcare programs, which received strong public attention, was lost in November 2016. In early January 2017, Trump stirred up the industry again with his criticism of drug pricing and the location policies of US pharmaceutical companies. This resulted in a painful loss for the pharmaceutical indices on the stock markets. Given the sharp rise in prices for certain products, such as Mylan’s EpiPen, which led to hearings in the US Congress and caused nationwide criticism in 2016, the public demands for price controls continue to exist.
A report from the International Trade Administration of the US Department of Commerce expects worldwide pharmaceutical sales to grow annually by 4.9 %, or from roughly US$ 1 trillion to US$ 1.3 trillion between 2015 and 2020. The demand for pharmaceutical products is being driven by a variety of demographic and economic trends, including a rapidly aging world population and the associated increased incidence of chronic diseases, increasing urbanization and greater disposable income, higher public health spending and a growing demand for more effective treatments.
The market for cancer drugs – the most important market for MorphoSys’s development pipeline – is one of the most attractive and fastest-growing segments of the pharmaceutical market. The US market research institute QuintilesIMS Institute estimates that, in 2015, the worldwide oncology market amounted to US$ 107 billion. A continuous increase in innovative therapies is the market’s key driver. The report from IMS expects the global market for oncology products to grow between 7.5 % and 10.5 % and reach US$ 150 billion in 2020. The majority of this growth is a result of the broader diversity of new products, especially immunotherapies, which is offsetting the decline in some of the existing therapies with poorer clinical results. IMS also expects insurers to negotiate harder with manufacturers and introduce new payment models to achieve better prices for drugs. The World Health Organization (WHO) anticipates a 70 % increase in the number of cancer-related diseases worldwide over the next 20 years.
According to the global auditing company PricewaterhouseCoopers (PWC), the number of mergers and acquisitions in the pharmaceutical and healthcare sector in 2016 declined significantly compared to the prior year. A total of 387 M&A transactions with a reported total value of US$ 197.0 billion were completed in 2016 compared to 435 transactions with a reported value of US$ 286.6 billion in the same period of 2015.
Further information on the development of the stock market environment can be found in the section “Shares and the Capital Market.”
DEVELOPMENT OF THE ANTIBODY SECTOR
The year 2016 was a very dynamic and successful year for the clinical development of therapeutic antibodies. The FDA granted regulatory approval to seven antibodies – after a record of nine antibodies in the prior year. In a follow-up article to the scientific magazine mAbs Journal’s article “Antibodies to watch in 2016,” the Antibody Society disclosed that by the middle of 2016 a total of 53 antibodies were in phase 3 clinical trials (year-end 2015: 53), of which 15 are intended for treating cancer (year-end 2015: 17).
In November 2016, an application for regulatory approval was submitted to the FDA for guselkumab, a compound derived with the help of MorphoSys’s technology. The application was submitted after a phase 3 clinical trial conducted by MorphoSys’s development partner Janssen delivered positive results for this compound in psoriasis.
Antibody compounds in the field of cancer immunotherapy continued to dominate the headlines in 2016. Clinical data shown in 2015 further corroborated the efficacy of the anti-PD1 and anti-PD-L1 antibodies, which act by blocking immune checkpoints. These compounds, which trigger the body’s own immune system using antibodies to identify and kill tumor cells, were again a dominant theme at the spring 2016 ASCO Meeting, the world’s premier cancer conference.
In 2016, the following antibodies received their first regulatory approval:
- Zinplava® (bezlotoxumab) against Clostridium difficile infections
- Lartruvo® (olaratumab) against soft tissue sarcoma
- Zinbryta® (daclizumab) for multiple sclerosis
- Tecentriq® (atezolizumab) used to treat the most common form of bladder cancer
- Cinqair® (reslizumab) against severe asthma
- Taltz® (ixekizumab) for moderate to severe manifestations of psoriasis
- Anthim® (obiltoxaximab) for the treatment of inhalation anthrax
After the FDA granted first-time approval to a biosimilar (Zarxio®, filgrastim-sndz) in 2015, approval of the first biosimilar antibody followed in April 2016, namely Inflectra® (infliximab-dyyb). Inflectra® is the biosimilar of Remicade® (infliximab).