Ad-hoc notification in accordance with Sec. 17 of the MAR
Drägerwerk AG & Co. KGaA: preliminary results for 2019 and guidance for 2020

Lübeck – Based on preliminary figures, in 2019 Dräger’s order intake increased by approximately 4.2 percent (approximately 3.0 percent net of currency effects). Net sales rose significantly over the course of the year, by approximately 7.3 percent (approximately 6.0 percent net of currency effects) to EUR 2.78 billion (2018: EUR 2.59 billion). The gross margin was roughly on a par with the prior year (2018: 42.7 percent) and functional costs rose proportionately to net sales. Consequently, earnings before interest and taxes (EBIT) were slightly higher than in the prior year. The EBIT margin is expected to have stood between 2.3 percent and 2.5 percent (2018: 2.4 percent).

Net sales growth and the EBIT margin therefore stood within the range most recently forecast by Dräger (currency-adjusted net sales growth of between 4.0 and 6.0 percent and an EBIT margin of between 1.0 and 3.0 percent).

The development of order intake and net sales was positive in all three regions. The rise in net sales was particularly high in the Asia, Africa, and Australia region and in the Americas region. In both regions net sales rose in nominal terms by roughly 10 percent. In the Europe region net sales increased by approximately 5 percent over the prior year’s level.

Outlook 2020:
Order intake in 2019 did not keep up with strong net sales development in 2019, so Dräger expects somewhat weaker net sales development in the current fiscal year. The company expects to see currency-adjusted net sales growth of between 1.0 and 4.0 percent in fiscal year 2020 (2019: currency-adjusted net sales growth of around 6.0 percent). The current exchange rates would result in negligible currency effects on the reported net sales growth (2019: approximately +1.3 percentage points) for the year as a whole. Dräger expects the gross margin to be roughly on par with the prior year. Due to the current lengthy regulatory approval times and increased uncertainty regarding the timing of market launches for new medical products for the US-market, Draeger forecasts an EBIT margin of between 1.0 and 4.0 percent. The assessment regarding margin development provided here assumes unchanged exchange rates.

Dräger will publish its full, audited results for fiscal year 2019 on March 5, 2020.

Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23558 Lübeck, Deutschland
www.draeger.com

Investor Relations:
Thomas Fischler
Tel. +49 451 882-2685
thomas.fischler@draeger.com

Corporate Communications:
Melanie Kamann
Tel. +49 451 882-3998
melanie.kamann@draeger.com

Disclaimer
This ad hoc report contains statements on the future development of Dräger Group. These forward-looking statements are based on the current expectations, presumptions, and forecasts of the Executive Board as well as the information available to date. They were compiled to the best of the company’s knowledge. Dräger does not provide any warranty nor assume any responsibility for the future developments and results described above. These are dependent on a number of factors. They entail various risks and contingencies outside of the company’s influence and are based on assumptions which could prove to be incorrect. Dräger does not assume any responsibility for updating the forward-looking statements contained in this report. This does not infringe any legal stipulations on the adjustment of forecasts. Please go to Investor Relations / Definitions of financial indicators at www.draeger.com for information on alternative performance measures used.

CO.DON AG (ISIN: DE DE000A1K0227)

Member of the Management Board Ralf M. Jakobs resigned

Berlin / Teltow, January 16, 2020 – Mr. Ralf M. Jakobs resigned today from the Management Board of co.don Aktiengesellschaft; the decision was made in mutual agreement with the Supervisory Board. The Supervisory Board thanks Mr. Jakobs for his past services. Mr. Tilmann Bur, as remaining member of the Management Board, will manage the company’s business as of now and until further notice as sole chairman.

Contact:
Matthias Meißner, M.A.
Director Investor Relations / Public Relations
Tel. +49 (0)30-240352330
Fax +49 (0)30-240352309
E-Mail: ir@codon.de

• JUST – EVOTEC BIOLOGICS WILL APPLY ITS FULLY INTEGRATED TECHNOLOGY PLATFORM IN ORDER TO ACCELERATE ONCORESPONSE’S LEAD PRODUCT CANDIDATE THROUGH DEVELOPMENT AND INTO THE CLINIC

Hamburg, Germany, 16 January 2020: Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that its wholly-owned Seattle-based subsidiary company Just – Evotec Biologics, Inc. has established a collaborative relationship with OncoResponse, Inc., a biotech company developing human antibodies as product candidates for multiple high value targets associated with immunosuppressive myeloid biology. OncoResponse’s lead antibody product candidate, OR2805, is a fully human antibody derived from an elite responder that reverses immunosuppression in the tumour microenvironment and promotes greater cancer killing that will lead to higher response rates and more cures.

Under the agreement, Just – Evotec Biologics will leverage its integrated technology platform, J.DESIGN, to provide OncoResponse with services to accelerate OR2805 into the clinic. The services include cell line development, process development, and Phase I/II cGMP clinical manufacturing of a selected drug candidate for use in human clinical trials.

Clifford Stocks, Chief Executive Officer of OncoResponse, commented: “We are thrilled to have Just – Evotec Biologics develop and manufacture our lead therapeutic antibody. Just – Evotec Biologics’ background, expertise and guidance combined with their track record and unique technology platform will play a critical role in the successful production of our molecule for clinical studies.”

Dr James Thomas, EVP Global Head Biotherapeutics, President U.S. Operations at Just – Evotec Biologics, commented: “We are delighted to be working with the experienced and dynamic team at OncoResponse on the development and manufacturing of this exciting immunotherapy approach to cancer.”

ABOUT ONCORESPONSE
OncoResponse, Inc., an immuno-oncology focused biotech company, in a broad strategic alliance with MD Anderson Cancer Center uses a proprietary B-cell technology platform to mine the immune system of cancer patients who have responded to cancer immunotherapy to discover novel targets and antibodies, and develop therapeutic monoclonal antibodies to treat cancer. OncoResponse has several antibodies directed at modulating immunosuppression of the tumor microenvironment in pre-clinical development. OncoResponse, Inc. is a privately held company backed by investment from MD Anderson Cancer Center, Rivervest Venture Partners, Qatar Investment Authority, Redmile Group, ARCH Venture Partners, GreatPoint Ventures, Helsinn Investment Fund, Canaan Partners, Shire, Buchang Pharma (China), Alexandria Real Estate Equities and William Marsh Rice University. For more information please visit: www.oncoresponseinc.com

ABOUT JUST – EVOTEC BIOLOGICS
Just – Evotec Biologics wholly owned by Evotec SE is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio.

ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 2,900 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women’s health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Evotec SE:
Gabriele Hansen, SVP Corporate Communications, Marketing & Investor Relations, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

First Patient Enrolled in DONIMI Study Evaluating Domatinostat in the Neoadjuvant Setting in Melanoma

Planegg-Martinsried, Germany, 15 January 2020 – 4SC AG (4SC, FSE Prime Standard: VSC) today announced that the Netherlands Cancer Institute in Amsterdam has enrolled the first patient in DONIMI – a multicenter, investigator-sponsored phase 1b study, testing the combination of domatinostat, nivolumab, and ipilimumab, in high risk stage III melanoma in the neoadjuvant setting.

Immunotherapy, and particularly checkpoint inhibitors like anti-PD-1 (e.g. Nivolumab) and anti-CTLA4 (Ipilimumab), are increasingly investigated not only in the advanced unresectable or metastatic setting but also in earlier stages of disease. The rationale for such treatment is to activate the immune system before resection of the tumor to generate an immune memory. The study is conducted by Prof. Christian Blank, MD, Staff Member at the Department of Medical Oncology, and Group Leader at the Division of Immunology, The Netherlands Cancer Institute, Amsterdam. A second site will be opened soon at the University of Sydney, Australia, with the support of Prof. Georgina Long, MD, Co-Medical Director of Melanoma Institute Australia. NKI_AVL and University of Sydney are part of the International Neoadjuvant Melanoma Consortium (https://melanoma-inc.org ).

Jason Loveridge, Ph.D., CEO of 4SC: “Such a very rapid start to DONIMI signals a high level of interest in both the neoadjuvant setting as well as the combination of domatinostat and checkpoint blockade in this population and we look forward to further patients enrolling in 2020.”

Prof. Dr. Christian Blank, NKI: “We are delighted having enrolled the first patient into the DONIMI study – after less than one year’s preparation, this is an extraordinary achievement. As the major oncology conferences in 2019 have clearly highlighted neoadjuvant immunotherapy as one of the most interesting areas of clinical research, we are excited to investigate domatinostat in combination with checkpoint inhibitor in the neoadjuvant setting in melanoma.”

– Press release ends –

Related articles

16 October 2019, 4SC and Netherlands Cancer Institute Collaborate on Clinical Evaluation of Domatinostat in the Neoadjuvant Setting in Melanoma

14 January 2019, 4SC’s domatinostat (4SC-202) begins Phase II gastrointestinal cancer clinical trial

27 December 2018, Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma

20 September 2018, Domatinostat plus chemotherapy – Overcoming drug resistance

15 August 2018, FDA approves IND application for domatinostat (4SC-202) in melanoma

Further information

About 4SC

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. 4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises two drug candidates in clinical development: resminostat and domatinostat.

4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 47 employees as of 30 September 2019 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

About The Netherlands Cancer Institute

The Netherlands Cancer Institute (NKI), including the Antoni van Leeuwenhoek Hospital, is the only dedicated Comprehensive Cancer Centre in the Netherlands and has been at the international forefront of cancer care and research for more than a century. In 2017, the European Academy of Cancer Sciences designated the NKI a Comprehensive Cancer Centre of Excellence for translational research. The NKI maintains an important role as a national and international centre of scientific and clinical expertise, development and training. Research focus areas are molecular biology, immunotherapy, personalized medicine, image-guided interventions and cancer survivorship.

Nowadays, The Netherlands Cancer Institute accommodates approximately 650 scientists and scientific support personnel. The Antoni van Leeuwenhoek Hospital has 222 medical specialists, 212 beds, an out-patients clinic with around 134,000 visits, 12 operating theatres and 12 irradiation units for radiotherapy.

About domatinostat

Domatinostat is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response. Domatinostat also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.

Domatinostat has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating domatinostat’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma (SENSITIZE) and data from the first part of the study was presented at ESMO in Barcelona. A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab in patients with advanced-stage microsatellite-stable gastrointestinal cancer is being conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust, London, UK (EMERGE).

About neoadjuvant treatment

Neoadjuvant treatment is given as a first treatment step in patients with locally advanced tumors to shrink the tumor before the main treatment, which is usually surgery, is given. Surgical treatment carries the risks of morbidities and potential complications that could be lasting. In addition, patients with locally advanced tumors, i.e. patients with resectable stage III melanoma continue to have a high risk of relapse and death despite the use of standard adjuvant therapy. Neoadjuvant therapy has the potential to significantly improve the clinical outcome of these patients, particularly in the era of newer and effective targeted and immunotherapeutic agents.

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact

ir-pr@4sc.com
+49 89 700763-0

/
PRESS RELEASE

Biotest’s CMV-specific hyperimmunoglobulin Cytotect CP Biotest receives UK marketing authorisation

• Approval of Cytotect CP Biotest in the UK will support further growth
• Cytotect CP Biotest is indicated for prophylaxis of clinical manifestations of Cytomegalovirus (CMV) infections
• Patients benefit from an additional therapy option to combat CMV infection
• Cytotect CP Biotest is the only CMV hyperimmunoglobulin available in Europe

Dreieich, 15 January 2020. Biotest AG has announced today that United Kingdom (UK) marketing authorisation has been granted for its CMV-specific hyperimmunoglobulin preparation, Cytotect CP Biotest. The successful finalisation of the Repeat Use Procedure (RUP) as well as the UK approval of Cytotect CP Biotest were completed in less than 90 days.

“We are pleased that approval has been granted for Cytotect CP Biotest in the UK. Cytomegalovirus is one of the most common opportunistic pathogens after solid organ and stem cell transplantation. The availability of Cytotect CP Biotest will provide transplant physicians with additional strategies to prevent and manage CMV infection and thereby improve patient care and post-transplant recovery”, says Patricia Morey, Managing Director, Biotest UK.

In the UK, annually more than 3,700 patients receive a kidney, lung, heart or liver transplant^[1], while almost 1,700 patients undergo allogeneic hematopoietic stem cell transplantation^[2]. Infection with CMV can occur in up to one third of these patients and, if left untreated, can cause serious complications leading to organ rejection, graft-versus-host disease (GvHD) as well as tissue-invasive disease (e.g. colitis, pneumonitis or retinitis).

Worldwide, Biotest is one of only two providers of this class of product, with Cytotect CP Biotest being the only CMV hyperimmunoglobulin available in Europe. Cytotect CP Biotest is indicated for prophylaxis of clinical manifestations of CMV infections in patients subjected to immunosuppressive therapy, particularly in transplant recipients, and is recommended as concomitant therapy alongside virostatic agents. Cytotect CP Biotest has a specific and targeted unique mode of action, which is different, yet complementary to antivirals.

Cytotect CP Biotest is an important contributor to Biotest’s future business, is sold in more than 30 countries, and has seen a double-digit sales increase in 2019.

Now that Cytotect CP Biotest has been approved, patients throughout the UK can benefit from an additional therapy option to prevent the clinical manifestations of CMV infection.

About Cytotect CP Biotest^(R)
Cytotect CP Biotest^(R) is a cytomegalovirus-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for prophylaxis of clinical manifestations of CMV infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients. The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis. Cytotect CP Biotest^(R) is also marketed as Megalotect^(R), Megalotect CP^(R), Cytomegatect^(R) and NeoCytotect^(R) in different countries.

About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: investor_relations@biotest.de

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

^[1] NHS Blood and Transplant, Organ Donation and Transplantation Directorate, https://www.organdonation.nhs.uk/
^[2] British Society of Blood and Marrow Transplantation and Cellular Therapy (BSBMT), http://bsbmt.org/activity/2018/

BRAIN AG publishes annual report for financial year 2018/19

Zwingenberg, Germany, 14 January 2020

Today, B.R.A.I.N. Biotechnology Research and Information Network AG (“BRAIN AG”) published its annual report 2018/19 including the detailed consolidated financial statements for the financial year 2018/19.

In total, the BRAIN Group increased its consolidated revenue by 42.5 percent from EUR 27.1 million to EUR 38.6 million in the past financial year. The revenue growth is equally attributable to the acquisition of the Biocatalysts Group in March 2018 and organic revenue growth. Total operating performance in the reporting period from October 1, 2018 to September 30, 2019 increased by 35.3% from EUR 30.5 million to EUR 41.2 million compared with the prior-year period.

Adjusted EBITDA improved from EUR -5.3 million in the previous year to EUR -2.1 million due to economies of scale and the associated disproportionately lower cost development. A contributing factor to this improvement was the increasing expansion of the product business in the BioIndustrial segment, which contributed EUR 2.8 million to adjusted EBITDA. The improvement in EBIT from EUR -9.6 million in the previous year to EUR -7.2 million was a little less pronounced due to the additional amortization of goodwill following the sale of Monteil Cosmetics International GmbH. The net result for the year after non-cash-relevant accounting effects in the financial result amounted to EUR -10.5 million compared to EUR -8.1 million in the previous year. Due to a correction following the preparation of the preliminary figures, the above-mentioned earnings figures are each slightly better than those published on 12 December 2019. The positive business development is also reflected in the cash flow from operating activities, which increased from EUR -5.4 million in the previous year to EUR -3.4 million. With liquid funds of EUR 15.2 million, BRAIN AG maintains a strong capital base for the expected future growth of the company.

The annual report 2018/19 of BRAIN AG titled “Pioneering Bioproducts” is available at
https://www.brain-biotech.com/investors/financial-publications/2018-19

For the 2019/20 financial year, the Management Board expects a positive business development with substantial organic revenue growth in both segments and a considerably improved, but still negative adjusted EBITDA. With a significantly improved earnings situation in both segments, the BioIndustrial segment is expected to post a further increasing positive adjusted EBITDA and the BioScience segment a continued negative adjusted EBITDA.

Further Information

BRAIN AG Annual Report 2018/19:
https://www.brain-biotech.com/investors/financial-publications/2018-19

Upon request, a printed copy of the annual report can be sent by mail.

About BRAIN

B.R.A.I.N. Biotechnology Research and Information Network AG (BRAIN AG; ISIN DE0005203947 / WKN 520394) is one of Europe’s leading technology companies in the field of industrial biotechnology, the core discipline of Bioeconomy. As such, BRAIN identifies previously untapped, efficient enzymes, microbial producer organisms or natural substances from complex biological systems that can be put to industrial use. The innovative solutions and products developed by help of this “Toolbox of Nature” are successfully applied in the chemistry, the cosmetics and the food industries. BRAIN’s business model is based on two pillars. The BioScience segment comprises mainly of the research and development business with industrial partners (the “Tailor-Made Solutions” cooperation business), and the company’s own research and development. The BioIndustrial segment consists mainly of the industrially scalable products business. Further information is available at www.brain-biotech.com.

B.R.A.I.N
Biotechnology Research
And Information Network AG
Darmstädter Str. 34-36
64673 Zwingenberg
Germany
www.brain-biotech.com

Contact Investor Relations
Martina Schuster
Tel.: +49-6251-9331-69
E-Mail IR: ir@brain-biotech.com

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN AG and are based on information currently available to the management. Forward-looking statements are not guarantees of future performance and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. There are numerous factors which could influence the future performance by and future developments at BRAIN AG and the BRAIN group of companies. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, and other factors. BRAIN AG does not undertake any obligation to update or revise any forward-looking statements.

• MSD TO GAIN ACCESS TO MANUFACTURING KNOW-HOW WITHIN JUST – EVOTEC BIOLOGICS’ J.POD^(R) FACILITY (“FACILITY OF THE FUTURE”)
• MULTI-YEAR COLLABORATION IN FORM OF CAPACITY RESERVES FOR PRODUCTION OF MSD BIOLOGICS

Hamburg, Germany, 14 January 2020: Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that its wholly-owned Seattle-based subsidiary company Just – Evotec Biologics, Inc. has expanded its collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, regarding the development of innovative technologies for the production of biologics of the highest quality.

Under the terms of the agreement, Just – Evotec Biologics grants MSD access to capacity in the J.POD^(R) facility in Redmond, Washington, which is currently under construction. The J.POD^(R) facility gives MSD access to manufacturing capacity, which is compatible with the innovative manufacturing platform co-developed by MSD and Just – Evotec Biologics under a previous agreement announced in 2015.

J.POD^(R) (manufacturing and plant design) is an integral part of Just – Evotec Biologics’ J.DESIGN platform that combines data analytics and machine learning through all activities involved with the discovery, development, and manufacture of biologics. The integrated J.POD^(R) facility will be capable of delivering tens of kilograms to metric tons of the highest quality products in an efficient and flexible manufacturing setting. Highly productive processes will be scaled out without scaling up; fine tuning capital expenditure to demand with no operational scale-up risk.

The terms of the collaboration include an upfront payment of $ 15 m, near term milestone payments based on completion of the construction of the J.POD^(R) facility as well as a broad collaboration around reserved capacities.

Dr James Thomas, EVP Global Head Biotherapeutics Development and President US Operations at Just – Evotec Biologics, commented: “We’re pleased to expand the scope of our collaboration with MSD in the biomanufacturing area to include execution of full-scale continuous (connected) processing in our new flexible commercial J.POD^(R) facility. We’ve greatly enjoyed the synergistic relationship with MSD and look forward to expanding our relationship with them and future partners in the biologics space.”

Dr Joe Miletich, SVP preclinical and process development research at MSD, added: “We are very pleased to continue our work with the Just – Evotec Biologics team to advance our biologics production capabilities at MSD. As we learn together how best to meet the challenging future demands of biologics, access to Just – Evotec Biologics’ platform technology is an integral part of our overall drug development and manufacturing de-risking strategy.”

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: “We value the strong collaboration between Just – Evotec Biologics and MSD in demonstrating the benefit of collaboration to use innovative technologies, best-in-class execution and smart processes for addressing the most urgent requirements of our partners. Relationships like this will transform industry’s approach to biologics development and manufacturing.”

ABOUT JUST – EVOTEC BIOLOGICS
Just – Evotec Biologics wholly owned by Evotec SE is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio.

ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 2,900 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women’s health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Evotec SE:
Gabriele Hansen, SVP Corporate Communications, Marketing & Investor Relations, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

Vivoryon Therapeutics and Nordic Bioscience Enter Research and Development Collaboration

HALLE (SAALE), Germany and Herlev, Denmark, 14 January 2020 – Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835) and Nordic Bioscience, announced today an agreement to collaborate for the clinical development of PQ912 for Alzheimer’s Disease (AD). In addition to taking on the role as CRO (Clinical Research Organization) for Vivoryon Therapeutics’ Phase 2b SAPHIR 2 trial, Nordic Bioscience and Vivoryon will enter into a collaboration to benefit from Nordic Bioscience’s world leading expertise in the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with PQ912, the Company’s Phase 2 clinical-stage candidate in AD.
 

Current methods used to diagnose AD remain invasive and relatively complex. Therefore, there is a need to develop and establish reliable, less invasive and efficient biomarkers and technologies in clinical practice. To address this, Nordic Bioscience has been pioneering the development of blood-based biomarkers for decades and is therefore the ideal partner for identifying molecular fingerprints in blood of patients. This supports Vivoryon’s therapeutic approach of targeting neurotoxic pGlu-Abeta by inhibiting its producing enzyme Glutaminyl Cyclase.
 

For the biomarker activities, blood samples of patients in the European SAPHIR 2 Phase 2b trial will be collected and analyzed by a mutual team of scientists from Nordic Bioscience and Vivoryon Therapeutics with the goal to identify correlations with clinical responses.
 

“We believe our collaboration with Nordic Bioscience has the potential to bring tremendous benefit to patients suffering from this complex and devastating disease. The ability to select patients who have a greater chance of responding to PQ912 could transfer an already proven principle of precision medicine into Alzheimer’s Disease. We look forward to the start of our Phase 2b clinical trial in the first quarter of 2020.” commented Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics AG.
 

“Vivoryon’s approach to treating Alzheimer’s disease provides multiple options to identify predictive response markers in blood. As such, we are excited about the potential of this partnership.” said Claus Christiansen, Chairman of Nordic Bioscience.
 

###

For more information, please contact:
Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: contact@vivoryon.com

Nordic Bioscience
Thomas Nielsen, CFO
Email: tn@nordicbio.com

Trophic Communications
Gretchen Schweitzer / Joanne Tudorica
Tel: +49 172 861 8540 / +49 176 2103 7191
Email: Trophic@vivoryon.com

About Vivoryon Therapeutics AG
With 20+ years of unmatched understanding in identifying post-translational modifying enzymes that play critical roles in disease initiation and progression, Vivoryon’s scientific expertise has facilitated the creation of a discovery and development engine for small molecule therapeutics. This platform has demonstrated success by developing a novel therapeutic in type 2 diabetes. In its current programs Vivoryon Therapeutics is advancing its lead product, PQ912, in Alzheimer’s disease and its entire portfolio of QPCT and QPCTL inhibitors in oncology and other indications.

www.vivoryon.com

About Nordic Bioscience
Nordic Bioscience is dedicated to preclinical and clinical drug development, and specialized in precision medicine using unique biomarker technologies. Nordic Bioscience engage with biotech and pharmaceutical clients to identify projects most suitable for clinical development by utilizing a proprietary biomarker technology.
Nordic Bioscience has more than 25 years’ experience in biomarker development and clinical trials and has particularly acquired extensive expertise in rheumatology. Combining experience in preclinical and clinical research enables a faster and smarter detection of signals of the potential clinical viability of drug candidates.

www.nordicbioscience.com

Forward Looking Statements
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Vivoryon Therapeutics AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

• THE J.POD^(R) TECHNOLOGY EXPANDS EVOTEC’S CAPABILITIES INTO FLEXIBLE COMMERCIAL BIOLOGICS MANUFACTURING
• CONFIRMS EVOTEC’S ROLE AS LEADING EXTERNAL INNOVATOR FOR THE INTEGRATED OUTSOURCING OF DRUG DISCOVERY AND DEVELOPMENT
• ADDS CLINICAL DEVELOPMENT AND COMMERCIAL SUPPLY FOR BOTH NICHE AND LARGER QUANTITIES OF DRUG SUBSTANCE
• EVOTEC’S PARTNERS WILL BENEFIT FROM FLEXIBLE, HIGH QUALITY MANUFACTURING TO DE-RISK DRUG DISCOVERY AND DEVELOPMENT

Hamburg, Germany, 14 January 2020: Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that the wholly-owned Seattle-based company Just – Evotec Biologics initiated the construction of a late-stage clinical and commercial manufacturing facility for biologics in Redmond, Washington.

The innovative cGMP biomanufacturing facility employs Just – Evotec Biologics’ J.POD^(R) technology using small, intensified bioprocessing operations housed inside autonomous cleanrooms. The design of the physical plant and the processes used for manufacture are fully optimised for high efficiency and flexibility; reducing the plant footprint, environmental impact and the overall time of construction and cost involved with biologics manufacturing. Dedicated quality control and process development laboratories for both clinical and commercial products are being built into the facility.

With the site, Just – Evotec Biologics will be able to supply small and large quantities of high quality clinical or commercial grade biologics to meet the needs of its customers and partners. Fast and efficient change-over times will provide partners with the flexibility and security to produce portfolios of biologics.

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: “We are delighted to initiate the construction of the first-ever J.POD^(R) facility in North America shortly after the acquisition of Just – Evotec Biologics. The space-saving and cost efficient modular setup will make J.POD^(R) the technology of choice for Pharma and biotech customers who need both high-yielding and flexibly scalable cGMP production facilities for their biologics. J.POD^(R) is also ready for the future of personalised medicine which will require production of smaller batches of specialised biologics.”

J.POD^(R) (manufacturing and plant design) is an integral part of the Just – Evotec Biologics’ J.DESIGN platform that integrates data analytics and machine learning through all activities involved with the discovery, development, and manufacture of biologics. This includes design of discovery libraries (J.DISCOVERY^(TM)), molecules (J.MD^(TM)), processes (JP3^(R)) and the manufacturing facility, J.POD^(R).

Dr James Thomas, EVP Global Head Biotherapeutics, President U.S. Operations, commented: “We are excited about the opportunity to expand our capabilities and apply the J.POD^(R) approach to later stage clinical development and commercial supply of biologics. This is foundational to accelerate drug development and to expand biotherapeutic access to a greater patient population. The flexible J.POD^(R) facility will be capable of efficiently manufacturing a few kilograms to metric tons of drug substance. Instead of scaling-up capacity all at once, we will be scaling-out capacity as needed. This approach alleviates risk to both capital and operations because the same scale of operation will be used for both clinical and commercial manufacturing.”

Just – Evotec Biologics’ existing Seattle facility, which includes development labs and an early clinical phase manufacturing plant, will continue to operate as an integral part of Just – Evotec Biologics’ J.DESIGN capabilities.

Construction on the greenfield site, located in Redmond Ridge Business Park, was recently initiated and the new facility is expected to be completed by late 2020 and operational in the first quarter of 2021 – approximately 19 months from breaking ground to full operations. The 130,000 square foot facility will contain manufacturing pods for implementing intensified fed-batch or continuous processing up to 1,000 L scale, with the capability of manufacturing metric tons of drug substance. Also included are supporting quality labs, a warehouse, process development labs and collaborative office and meeting spaces for approximately 200 employees at full capacity.

ABOUT JUST – EVOTEC BIOLOGICS
Just – Evotec Biologics wholly owned by Evotec SE is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio.

ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 2,900 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases and fibrosis. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Celgene, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Evotec SE:
Gabriele Hansen, SVP Corporate Communications, Marketing & Investor Relations, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

Biofrontera announces 1-year follow-up results for its phase III study of photodynamic therapy for actinic keratosis on the extremities and trunk/neck

Leverkusen, Germany, January 14, 2020 – Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today announced follow-up results for its Phase III clinical study evaluating the safety and efficacy of photodynamic therapy (PDT) with Ameluz^(R) and the BF-RhodoLED^(R) lamp for the treatment of actinic keratosis (AK) on the extremities, trunk and neck. After 12 months, the overall lesion recurrence rates were 14.1% after Ameluz^(R) treatment, compared to 27.4% after placebo treatment in the Full Analysis Set (FAS; 11.7% vs. 24.6% in the Per Protocol Set, respectively).

“I am not aware of another pivotal clinical study showing similarly high clearance rates and low recurrence rates for the pharmaceutical treatment of actinic keratoses in the periphery,” commented Biofrontera’s CEO Prof. Hermann Luebbert. “With an overall lesion clearance rate of 77% one year after treatment, Ameluz^(R) has once again demonstrated its unreached clinical efficacy.”

The multi-center, randomized, double-blind, intra-individual study included 50 patients at six study sites in Germany, each with four to ten clinically confirmed AK lesions in comparable areas on the right and left side of the extremities and/or trunk/neck. Mild, moderate and severe actinic keratoses were treated with one or, if at least one lesion on each patient’s side persisted after three months, two PDT applications. Each PDT consisted of the application of Ameluz^(R) on one side of the patient, and an identically looking, feeling and smelling placebo gel on the other side. PDT illumination with 10 minutes of red light using the BF-RhodoLED^(R) lamp followed after a 3-hour incubation with occlusion. The final examination of the patients took place three months after the last PDT. This clinical study phase was followed by a follow-up phase of up to one year after the last PDT, in which recurrence rates and numbers of new AKs and skin tumors were determined.

The results for the primary regulatory endpoint, demonstrating that Ameluz^(R) was superior (p<0.0001) to placebo based on its mean total lesion clearance rate of 86% compared to 33% for placebo had been published in a Biofrontera press release on March 20, 2019.

The following table represents the treatment outcome after 3 months and the recurrence rates during one year after the last PDT (FAS).

Of the patients who were cleared of all AK lesions 3 months after treatment (67.3%), 62.5% overall and 60.9% of the patients treated on extremities (placebo 66.7% and 66.7%, respectively) remained fully cleared up to one year after the last PDT. No new AKs and only one basal cell carcinoma (BCC) skin tumor were identified in the treatment area after one year whereas outside the treatment area 6 AKs or skin tumors (BCC, squamous cell carcinoma) where identified.

-End-
 

About Biofrontera:

Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.

The Germany-based company, with almost 200 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin. The company’s lead product is the combination of Ameluz^(R), a topical prescription drug, and medical device BF-RhodoLED^(R) for the photodynamic therapy of certain superficial skin cancers and their precursors. Ameluz^(R) has been marketed in the EU since 2012 and in the United States since May 2016. In addition, the company markets the prescription medication Xepi^(TM) for the treatment of impetigo in the United States. In the EU, the company also sells the dermocosmetics series Belixos^(R), which offers specialized care for damaged or diseased skin.

Biofrontera is the first German founder-led pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the US NASDAQ.www.biofrontera.com.