MOLOGEN AG: Announcement to holders of the EUR 4.999.990,00 worth of convertible bonds maturing in 2025 (the convertible bonds) (ISIN: DE000A2DANN4, SIN A2DANN)

DGAP-News: MOLOGEN AG / Key word(s): Bond

19.06.2019 / 15:04

The issuer is solely responsible for the content of this announcement.


NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

Mologen AG

Berlin

Announcement to holders of the
EUR 4,999,990.00 worth of convertible bonds maturing in 2025
(the convertible bonds) (ISIN: DE000A2DANN4, SIN A2DANN)

Mologen AG (the Company) notifies holders of the convertible bonds that, under the terms of the convertible bonds (the bond terms) an adjustment for the convertible bonds was made to the conversion price and conversion ratio.

On 8 June 2018, the Annual General Meeting of the Company resolved to create conditional capital amounting to EUR1,507,457.00 (Conditional Capital 2018) and authorized the Executive Board of the Company with the Supervisory Board’s approval to grant conversion and/or option rights on new ordinary bearer shares with no-par value in the Company with a proportional amount in the share capital of up to a total of EUR1,507,457.00 to holders of bonds in the period up to 7 June 2023.

By resolution dated 19 December 2018 and resolution dated 27 December 2018, the Executive Board, with the Supervisory Board’s approval, resolved to issue convertible bonds (Convertible Bond 2019/2027) with partial utilization of the authorization granted by the Annual General Meeting. Convertible Bond 2019/2027 comprise the right of bond holders to convert the convertible bonds initially into up to 1,301,153 ordinary bearer shares in total with a proportional amount in the share capital of EUR1.00 per share.

On 8 June 2018, the Annual General Meeting of the Company resolved to authorize the Company’s Executive Board to increase the Company’s share capital with the Supervisory Board’s approval by issuing new bearer no-par shares against contributions in kind and/or in cash on one or more occasions up to 7 June 2023, however, by a maximum of EUR3,768,643.00 (Authorized Capital 2018).

By resolution dated 13 March 2019, the Executive Board, with the Supervisory Board’s approval of the same date, increased the Company’s share capital, using Authorized Capital 2018, from EUR10,063,715.00 by EUR2,012,220.00 to EUR12,075,935.00 against cash contributions by issuing up to 2,012,220 new bearer no-par shares with a proportional amount in the share capital of EUR1.00 per share.

The shares were subscribed in full and the capital increase was registered in the commercial register on 2 May 2019.

Due to the issuance of Convertible Bond 2019/2027 and the granting of subscription rights to shareholders of the Company, the conversion price and conversion ratio (as defined in the bond terms) were adjusted in accordance with Section 11(3) of the bond terms as follows: the conversion price from EUR7.61 to EUR7.2743 and the conversion ratio from 1.314 to 1.3747.

In accordance with Section 11(10) of the bond terms, the adjusted conversion price and the adjusted conversion ratio came into effect on 2 January 2019.

Due to the capital increase and taking into account the amendment of the bond terms in the meantime by resolution of the Creditors’ Meeting of 28 February 2019, the conversion price and conversion ratio (as defined in the bond terms) were adjusted in accordance with Section 11(2) of the bond terms as follows: the conversion price from EUR2.46 to EUR2.3468 and the conversion ratio from 4.065 to 4.2611.

The adjusted conversion price and the adjusted conversion ratio came into effect on 5 June 2019, following the supplementing of the global certificate at the central securities depository pursuant to Section 21(1) Clause 1 and Clause 2 SchVG (German Act on Issues of Debt Securities).

Mologen AG

The Executive Board

Important note:

This announcement is neither an offer nor an invitation to purchase or to subscribe for securities in the United States, Australia, Canada, Japan or in any jurisdiction in which such an offer or solicitation is unlawful. The securities referred to in this press release have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may be sold or offered for purchase in the USA only with prior registration or without prior registration only on the basis of an exception provided in line with the U.S. Securities Act. There will be no public offering of the securities in the United States of America. Subject to certain exceptions outlined in the Securities Act, the securities referred to herein may not be offered or sold in Australia, Canada or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan.


19.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE000A2LQ900
WKN: A2LQ90
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 827555

 
End of News DGAP News Service

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Polyphor announces enrollment of first patient in FORTRESS Phase III clinical trial for balixafortide in combination with eribulin in patients with metastatic breast cancer

Polyphor AG / Key word(s): Study

19-Jun-2019 / 07:07 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 KR

The issuer is solely responsible for the content of this announcement.


Allschwil, Switzerland, June 19, 2019

Polyphor announces enrollment of first patient in FORTRESS Phase III clinical trial for balixafortide in combination with eribulin in patients with metastatic breast cancer
 

Balixafortide is the most advanced and only CXCR4 antagonist in development in a pivotal Oncology global registration trial.
 

Polyphor today announced the enrollment of the first patient in its FORTRESS clinical trial, the pivotal Phase III study evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer (MBC). Balixafortide is the only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist being developed in solid tumors.

“The enrollment of the first patient in our Phase III clinical study is a significant step forward for the development of balixafortide. There is a significant unmet need for new treatment options for women with metastatic breast cancer who have failed initial standard-of-care chemotherapies. Developing a new treatment option will provide new hope for women with this devastating disease,” said Giacomo Di Nepi, Chief Executive Officer of Polyphor. “We are hopeful that the response rates seen in our proof-of-concept study can be replicated in the FORTRESS trial and that balixafortide can make a positive impact on patient outcomes.”

FORTRESS (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which will investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer. The study will comprise a total of 384 patients with HER2 negative MBC, of which 320 patients receiving third or subsequent line and 64 patients receiving second line chemotherapy. Subject to the data Polyphor will have the possibility to submit a filing for accelerated approval approximately six months after the recruitment is completed on the basis of the analysis of the overall response rate (ORR), confirmed by an independent blinded review, and of the associated durability of response. The full approval would be based on the magnitude of Progression Free Survival (PFS) on blinded independent review, supported by an overall survival trend favoring balixafortide arm and a favorable risk-benefit profile.

For more information about the POL6326-009 clinical trial of balixafortide, please visit www.clinicaltrials.gov (Identifier: NCT03786094)

For further information please contact:

For Investors:
Kalina Scott
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 67
Email: IR@polyphor.com

For Media:
Alexandre Müller
Dynamics Group AG
Tel: +41 43 268 32 31
Email: amu@dynamicsgroup.ch

About Balixafortide (POL6326)
Balixafortide is a potent and highly selective antagonist of CXCR4, a G-protein coupled receptor (GPCR) that regulates the trafficking and homing of both cancer cells and cells of the patient’s immune system. CXCR4 plays a critical role in tumor growth, survival, angiogenesis and metastasis[i]. High CXCR4 levels have been detected in almost all human tumor types, including breast cancer. High CXCR4 expression is known to correlate with aggressive metastatic behavior of cancer cells and a poor prognosis[ii].

Balixafortide is being developed to improve therapy outcomes in cancer, when used in combination with other agents. Balixafortide is the only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist, being developed in solid tumors, being the first product candidate to reach proof of concept. The molecule was discovered based on Polyphor’s proprietary macrocycle technology platform. Balixafortide showed strong results in a Phase Ib/proof of concept clinical trial in combination with eribulin in patients affected with advanced metastatic breast cancer. The development path identified with the input of the FDA is to conduct a single pivotal study to achieve approval in HER-2 negative metastatic breast cancer patients who previously received at least two chemotherapeutic regimens in the metastatic setting. Additionally, there is the possibility of achieving an accelerated approval based on interim results. Polyphor is also conducting preclinical work to establish the potential for balixafortide in combination with other drugs and in other oncology indications.

[i] Otsuka S, Bebb G. J Thorac Oncol. 2008;3(12):1379-1383
[ii] Chatterjee S, Behnam Azad B, Nimmagadda S. Adv Cancer Res. 2014; 124:31-82

About Polyphor
Polyphor is a clinical stage, Swiss biopharmaceutical company focused on the discovery and development of antibiotics and immuno-oncology compounds. It has discovered and is developing the OMPTA (Outer Membrane Protein Targeting Antibiotics). The OMPTA are potentially the first new class of antibiotics against Gram-negative bacteria to have reached phase III stage in the last 50 years. The company’s lead OMPTA, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa – recognized as a critical priority 1 pathogen by WHO; in addition, Polyphor is developing a pipeline of further preclinical antibiotics based on its OMPTA platform. Polyphor is also developing an immuno-oncology candidate, balixafortide (POL6326), which is starting a Phase III trial in combination with eribulin in patients with advanced breast cancer, and exploring in parallel its potential for further combinations and indications. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.

 

Disclaimer
This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor’s results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Additional features:

Document: http://n.eqs.com/c/fncls.ssp?u=EHXFBDLVRI
Document title: Polyphor_Balixafortide_FPD_19.06.2019


End of ad hoc announcement


Language: English
Company: Polyphor AG
Hegenheimermattweg 125
4123 Allschwil
Switzerland
Phone: +41 61 567 1600
Fax: +41 61 567 1601
E-mail: info@polyphor.com
Internet: www.polyphor.com
ISIN: CH0106213793
Listed: SIX Swiss Exchange
EQS News ID: 826943

 
End of Announcement EQS Group News Service

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CENTOGENE Accelerates Rare Disease Diagnosis with new Artificial Intelligence Solution

DGAP-News: CENTOGENE AG / Key word(s): Miscellaneous

18.06.2019 / 16:10

The issuer is solely responsible for the content of this announcement.


CENTOGENE Accelerates Rare Disease Diagnosis with new Artificial Intelligence Solution

Variant Prioritization Tool Driven by World’s Largest Curated Mutation Database

Cambridge, MA USA & Rostock, Berlin GERMANY, 18 June, 2019. In a whitepaper published today, CENTOGENE revealed the progress it is making with its in-house artificial intelligence (AI) program to accelerate rare disease patient diagnosis. The whitepaper demonstrates how the Company’s latest AI initiative – a variant prioritization tool – has not only accelerated the diagnostics process but also outperforms other tools with regards to sensitivity and specificity for flagging ‘pathogenic’ and ‘likely pathogenic’ variants.

With what is believed to be the world’s largest curated data repository CentoMD(R), which includes epidemiologic, phenotypic and heterogenetic anonymized data of more than 420,000 patients and >7.3 million variants, CENTOGENE is ideally positioned to leverage its ‘big data’ for AI-driven accelerated diagnosis.

“Big data is the key enabler of artificial intelligence since AI systems need enormous data sets to train algorithms. The better and more comprehensive the data, the higher the predictive power and accuracy of results from artificial intelligence,” commented Dr. Volkmar Weckesser, CENTOGENE Chief Information Officer. “CENTOGENE finds itself in this enviable position with our data repository CentoMD(R) – our ‘big data’. We have demonstrated that by combining what we believe to be the world’s largest database of genetic information with an AI-based variant prioritization solution, we outperform other tools available and ultimately accelerate the diagnosis of rare disease patients.”

Carsten Ullrich, Director of Artificial Intelligence, added: “CENTOGENE’s diagnostic and pharmaceutical solutions rely on the extensive knowledge and insights held in our data repository. Artificial intelligence enables us to find relationships faster, draw more exact conclusions about relationships in the data and discover patterns that cannot be found with traditional methods.”

In the diagnosis of rare disease patients, variant prioritization is a vital step in discovering causal variants in order to identify disease-causing mutations. Variant prioritization accelerates and simplifies variant interpretation because the results enable the interpretation of variants of unknown significance. Prioritization scores enable the diagnosis of a patient and, indeed, rare disease diagnosis relies heavily on variant prioritization scores in order to determine which variants are likely to affect the function of genes.

Read the whitepaper: https://www.centogene.com/science/whitepapers/centogenes-variant-prioritization-big-data-and-ai-driving-rare-disease-diagnosis.html.

– end –
 

About CENTOGENE

CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients. We are focused on bringing rationality to treatment decisions and accelerating the development of new orphan drugs by using our knowledge of the global rare disease market, including our epidemiological and clinical heterogeneity and our innovative biomarkers.

As one of the largest rare disease companies worldwide, CENTOGENE is dedicated to transforming the science of genetic information into solutions and creating hope for our patients with rare diseases and their families.

 

###

CENTOGENE AG
Ross Bethell
Director, Corporate Communications
ross.bethell@centogene.com


18.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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Vivoryon Therapeutics AG: Vivoryon Therapeutics mandates goetzpartners as strategic business development advisor for expansion of its innovative QPCTL technology into immuno-oncology

DGAP-News: Vivoryon Therapeutics AG / Key word(s): Agreement

18.06.2019 / 07:00

The issuer is solely responsible for the content of this announcement.


Vivoryon Therapeutics mandates goetzpartners as strategic business development advisor for expansion of its innovative QPCTL technology into immuno-oncology
 
 
HALLE (SAALE) and MUNICH, Germany, 18 June 2019 – Vivoryon Therapeutics AG, (Euronext Amsterdam: currently PBD, to be changed to VVY, ISIN: DE0007921835), a clinical stage precision medicine company focused on bringing first-in-class therapies to patients suffering from age-related diseases, and goetzpartners, an independent  advisory firm for strategy, M&A and transformation, today announced their collaboration to explore the expansion of Vivoryon’s proprietary platform based on its Glutaminyl-peptide cyclotransferase-like protein (QPCTL) technology into the field of immuno-oncology. In this context goetzpartners has been mandated as the exclusive strategic business development advisor of Vivoryon Therapeutics.
 
Vivoryon’s lead molecule, PQ912, is currently in clinical stage development for Alzheimer’s Disease (AD) and is a first-in-class, highly specific and potent inhibitor of Glutaminyl cyclases (QPCT and QPCTL). New research has shown that small molecule Glutaminyl cyclase inhibitors could also represent an attractive approach for myeloid immune checkpoint control.
 
Consequently, Vivoryon’s next platform project focuses on immune checkpoint inhibition and the Glutaminyl-peptide cyclotransferase-like protein (QPCTL). QPCTL is a posttranslational modifying enzyme that is essential for the pyroglutamate formation on CD47, a crucial signaling protein in immune response to cancer. Inhibitors of QPCTL, like PQ912 and other small molecule compounds protected under Vivoryon’s patents, have been shown to silence the checkpoint signal from the CD47/SIRPa axis, and thus are offering a novel strategy to augment the efficacy of anti-tumor antibody therapies. Based on Vivoryon’s data, PQ912 could readily be advanced into clinical Phase I studies in cancer. In addition, Vivoryon Therapeutics owns a broader set of highly promising QPCTL inhibitor compounds in advanced preclinical stages of development.
 
“When weighing our options on how to move forward our QPCTL technology into the field of immuno-oncology, we wanted to make sure we did everything possible to bring scientific excellence for the benefit of patients to other indications. Understanding this responsibility, we decided to seek out industry leaders in business development consulting who understood our strategic needs and could provide us with the support necessary to unlock the full potential of our platform by partnering with major pharma players. For this reason, we look forward to working with goetzpartners, who have robust business experience and the expertise to guide us through this process” said Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics.
 
“We are proud to have been selected by Vivoryon Therapeutics as their strategic advisors,” said Ulrich Kinzel, Managing Director at goetzpartners, “The Company is a technology leader with their patented proprietary Glutaminyl Cyclase inhibition platform, and it is an exciting opportunity for us to connect them with the right partner to explore its full potential.”
 

###

 
For more information, please contact:
Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: contact@vivoryon.com
                 
goetzpartners Corporate Finance GmbH
Ulrich Kinzel
Tel: +49 (0) 89 29 07 25 125
 
MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: vivoryon@mc-services.eu
 
Notes to Editors:
About Vivoryon Therapeutics AG
Headquartered in Halle (Saale), Germany, Vivoryon Therapeutics AG, formerly Probiodrug AG (Euronext Amsterdam: currently PBD, to be changed to VVY) is a clinical stage precision medicine company focused on bringing first-in-class therapies to patients suffering from age-related diseases. The company has a successful track record in bringing drugs targeted to post-translational modifying enzymes to the market. Current projects are focusing on the two isoenzymes of Glutaminyl cyclase, QPCT and QPCTL. QPCT is the crucial enzyme for the generation of highly neurotoxic pyroglutamate species of Abeta. Its inhibition by Vivoryon’s lead molecule PQ912, has successfully completed a Phase 2a (SAPHIR) study and the Company has initiated a Phase 2b core program for the treatment of Alzheimer’s disease (AD). QPCTL has been identified as a potential target in cancer therapy. Blocking the enzymatic function of QPTCL by small molecule inhibitors is a novel therapeutic approach to silence the CD47/SIRPa signal in cancer immunotherapy. Vivoryon has a unique and exceptionally strong patent position on QPCT and QPCTL inhibitors.
www.vivoryon.com
 
About PQ912
PQ912, is a first in class, highly specific and potent inhibitor of Glutaminyl-peptide cyclotransferase protein (QPCT), the enzyme that catalyzes the formation of highly neurotoxic pGlu species. PQ912 has shown therapeutic effects in AD animal models. A Phase 1 study in healthy young and elderly volunteers revealed a dose dependent exposure and showed good safety and tolerability up to the highest dose resulting in >90% target occupancy in the spinal fluid. In June 2017, Vivoryon Therpeutics announced promising top-line data of the Phase 2a SAPHIR trial of PQ912 and presented the study results at CTAD 2017. Results strongly support that pGlu species of Abeta are especially neurotoxic and correlate with AD disease progression. The SAPHIR study provides important guidance on how to move forward with the development of PQ912 as a disease-modifying drug for AD. Altogether, the results make the program highly attractive for further development; the company has initiated the preparation of a Phase 2b core program.
 
About Alzheimer’s disease
Alzheimer’s disease is a neurological disorder, which is the most common form of dementia. Today, 50 million people are estimated to live with dementia worldwide, and this number is projected to triple to more than 152 million by 2050. Dementia also has a huge economic impact. Alzheimer’s has an estimated, global societal cost of US$ 1 trillion, and it will become 2 trillion-dollar disease by 2030. (World Alzheimer Report 2018).
 
Glutaminyl-peptide cyclotransferase-like protein (QPCTL)
Glutaminyl-peptide cyclotransferase-like protein (QPCTL) is a posttranslational modifying enzyme that is responsible for the pyroglutamate formation on CD47 – a crucial receptor protein in the immune response to cancer. QPCTL is an isoenzyme of QPCT and can be inhibited by Vivoryon’s lead candidate small molecule PQ912 and other compounds protected under Vivoryon’s patents.
 
Cancer immune checkpoint inhibitors
Checkpoint inhibitor therapy is a novel kind of cancer immunotherapy. This therapy targets key regulators of the immune system that stimulate or inhibit its actions, which tumors commonly use to protect themselves from attacks by the immune system. QPCTL inhibitor therapy can silence inhibitory cancer checkpoints and thereby restore beneficial immune system functions.
 
About goetzpartners Corporate Finance GmbH
goetzpartners, founded in 1991, is an independent advisory firm for all key issues of entrepreneurial activity: strategy, M&A and transformation. As a trusted partner with a valuable track record and a far-reaching network, they are ideally positioned to help companies worldwide to navigate through their business transformation challenges. With more than 350 professionals operating out of 14 offices in 11 countries, they advise decision-makers and top executives in all key industries.
www.goetzpartners.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.
 


18.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Vivoryon Therapeutics AG
Weinbergweg 22
06120 Halle/Saale
Germany
Phone: +49 (0)345 555 9900
Fax: +49 (0)345 555 9901
E-mail: contact@vivoryon.com
Internet: www.vivoryon.com
ISIN: DE0007921835
WKN: 792183
Listed: Regulated Unofficial Market in Berlin, Frankfurt, Munich, Stuttgart; Amsterdam
EQS News ID: 825909

 
End of News DGAP News Service

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Epigenomics AG: New Clinical Data Support the Utility of Epi proColon(R) Blood Test for Colorectal Cancer (CRC) Screening in Patients with Lynch Syndrome (LS), the Most Common Hereditary CRC Syndrome

DGAP-News: Epigenomics AG / Key word(s): Study results/Scientific publication

17.06.2019 / 14:00

The issuer is solely responsible for the content of this announcement.


New Clinical Data Support the Utility of Epi proColon Blood Test for Colorectal Cancer (CRC) Screening in Patients with Lynch Syndrome (LS), the Most Common Hereditary CRC Syndrome

 
Minimally-invasive blood test could complement colonoscopy in high-risk LS patients who are non-compliant with colonoscopy screening recommendations or may develop precancerous lesions in the interval between colonoscopies.
 

Berlin (Germany), June 17, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new study results suggesting that Epi proColon, a colorectal cancer screening test approved for patients who are unwilling or unable to be screened by recommended methods may also be an important complement to colonoscopy for CRC screening in patients with LS, a hereditary disease associated with a 10-80% increase in the risk of developing CRC. The study results appear in the current issue of BMJ Open Gastroenterology.[1]

There is currently no cure for LS, therefore, routine screening that enables early detection and treatment of precancerous lesions has the potential to reduce the risk of CRC and to save lives. Approximately 95 percent of individuals with LS are unaware of their disease status, and nearly a third of patients who know their LS status fail to comply with the recommendation to undergo colonoscopy screening every one to two years. This study evaluated a new approach that could potentially enhance CRC screening for LS patients, which is crucial to reducing the morbidity and mortality associated with the disease.

The study was conducted as a retrospective analysis of preserved tissue and frozen plasma samples from patients with a confirmed diagnosis of LS who underwent either surgical resection for a diagnosis of CRC or removal of a polyp during colonoscopy between March 2006 and February 2019. Study objectives included a comparison of SEPTIN9 gene methylation status (the marker measured by Epi proColon) between patients with LS and patients with non-hereditary forms of CRC and exploratory analyses of the sensitivity and specificity of Epi proColon in LS patients. Key findings from the study include:

  • In tissue samples from LS patients, differential SEPTIN9 methylation was found in 97.3% of primary CRC and 90.0% of advanced adenomas, demonstrating that LS-related neoplasia frequently produce the SEPTIN9 biomarker.
  • Of 20 plasma samples collected between 138 and 1 days prior to surgical resection of a primary CRC tumor, all had valid tests and 14 were SEPTIN9 positive, for a sensitivity of 70.0%.
  • Of 18 plasma samples collected within one year (328 days to 20 days) prior to a colonoscopy-based diagnosis of CRC, 17 had valid tests, and three of the 17 were SEPTIN9 positive. These three were among five patients with a colonoscopy-based stage I-III CRC diagnosis, for a sensitivity to detect CRC approximately two months prior to diagnosis of 60%.
  • Of 13 plasma samples collected after surgical resection of a primary CRC tumor, all had valid tests and 12 were SEPTIN9 positive, for a sensitivity to detect metastatic CRC of 92.3%.
  • Of 34 plasma samples from a cancer-free control group, 31 had valid tests and all were SEPTIN9 negative, for a specificity of 100%.

The study authors conclude that Epi proColon may have similar diagnostic performance characteristics in LS patients as in the average-risk population and suggest that a larger, prospective study to confirm these preliminary findings is warranted.

“The sensitivity and specificity that the Epi proColon blood test demonstrated in this first study in LS patients are very promising,” said Megan Hitchins, PhD, Associate Professor, Center for Bioinformatics and Functional Genomics at Cedars-Sinai and lead author on the study publication. “Although preliminary, the study results suggest that Epi proColon may have potential as a screening tool for colorectal cancer in LS and for post-surgical detection of metastatic disease as well. Epi proColon may provide an alternative CRC screening method for the LS patients who are non-compliant with colonoscopy screening recommendations. Confirmation of our findings in larger, prospective studies would be an important advance in the clinical management of LS. Dr. Henry Lynch, the first to identify LS cancers as hereditary and the senior author on this, passed away last week. I can think of no better way to honor his already substantial legacy than to continue advancing the care and outcomes for LS patients.”

“Although colonoscopy is the gold standard for CRC screening, diagnosis and polyp removal, compliance with colonoscopy screening recommendations is suboptimal, even among patients with an LS diagnosis who know that they are at increased risk of CRC and could benefit from CRC screening every one to two years,” said Greg Hamilton, Chief Executive Offer of Epigenomics AG. “Pre-cancerous lesions can progress to invasive CRC very rapidly in LS patients, so the 10-year colonoscopy screening interval recommended for average-risk individuals does not adequately protect patients with undiagnosed LS from a late-stage CRC diagnosis, even if they are compliant. Alternative screening methods that could be used in the interval between colonoscopies, such as Epi proColon, might increase early detection of CRC for undiagnosed LS patients and other individuals with increased, but undiagnosed CRC risk.”
 

About colorectal cancer (CRC)

Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new colorectal cancer cases and about 76% of colorectal cancer deaths and costs. Approximately $18 billion is spent annually on this preventable disease. Over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed.
 

About Lynch Syndrome

Lynch Syndrome (LS) is a hereditary disorder caused by a mutation in one of at least five genes (MLH1, MSH2, MSH6, MPS2 or EPCAM) that are involved in the repair of mistakes that occur when DNA is copied in preparation for cell division. The accumulation of errors in DNA can result in cells that grow uncontrolled and may become cancerous. Individuals with LS have an increased risk of developing colorectal cancer, endometrial cancer, and various other types of aggressive cancers, often at a young age. Lynch tumors are extremely aggressive and may metastasize more rapidly (less than two year) than sporadic cancer (often more than five years). Consequently, it is recommended that LS patients undergo CRC screening more frequently than the individuals with average CRC risk (every 1-2 years for LS compared with every 10 years in the average risk population) and beginning at an earlier age. A key challenge in achieving these screening recommendations is that only 5% of affected individuals are aware of their LS status.
 

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods. It is a qualitative, in vitro diagnostic blood test for CRC that uses real-time PCR to detect methylation of a target DNA sequence within the Septin 9 gene promoter; methylation of this DNA sequence is associated with the occurrence of CRC and can be detected in cell-free DNA that circulates in the plasma.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

Epi proColon is recipient of the 2019 Excellence in Molecular Diagnostics by Corporate LiveWire’s Innovation and Excellence Awards.

For more information on Epi proColon, visit www.epiprocolon.com.

 

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

 

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

 

Contact Epigenomics AG
Frederic Hilke
IR.on AG
Phone +49 221 9140 970
ir@epigenomics.com

 

Media Contact – Lazar Partners
Erich Sandoval
917-497-2867
esandoval@lazarpartners.com

 

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

[1] Hitchins MP, Vogelaar IP, Brennan K, Haraldsdottir S, Zhou N, Martin B, et al. Methylated SEPTIN9 plasma test for colorectal cancer detection may be applicable to Lynch syndrome. BMJ Open Gastro. 2019;6:e000299. doi:10.1136/bmjgast-2019-000299.


17.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Epigenomics AG
Geneststraße 5
10829 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir@epigenomics.com
Internet: www.epigenomics.com
ISIN: DE000A11QW50
WKN: A11QW5
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 825655

 
End of News DGAP News Service

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MetrioPharm AG: Last Patient Last Visit in MetrioPharm’s Phase II Clinical Trial in Psoriasis

EQS Group-News: MetrioPharm AG / Key word(s): Study

17.06.2019 / 13:25


 

– The last psoriasis patient underwent final medical examinations on June 12th 2019

– MetrioPharm still content with safety profile of lead compound MP 1032

– Starting the data cleaning with subsequent analysis

Zurich, June 17, 2019. MetrioPharm AG, a pharmaceutical development company, announces that the last patient was now examined during the currently ongoing clinical psoriasis Phase II study (Last Patient Last Visit).

The Phase II study was carried out in multiple clinical trial centers in Germany and Poland. A total of 154 patients with moderately-to-severe plaque-psoriasis were randomized. Patients received orally 150 mg or 300 mg of MP1032 or a placebo, twice a day.

The primary goal of the study is to evaluate clinical efficacy and safety of MP1032 in various dosages.

Dr. Petra Schulz, Senior Manager Drug Development: “After the last patient finalized the regular four week long follow-up period, we are confident, that MP1032 is proving its outstanding safety profile for the time period of the entire study.”

Dr. Wolfgang Brysch, CEO of MetrioPharm AG: “We are grateful to all the investigators, as well as all the patients, who made this study possible. The team at MetrioPharm is now awaiting the validation of the data. Afterwards we will immediately start the data analysis. We are expecting the study’s final results within the next few months.”

 

About MetrioPharm

MetrioPharm AG is a pharmaceutical development company developing drugs for chronic inflammatory diseases such as psoriasis, arthritis, and multiple sclerosis. Such chronic diseases pose the greatest individual health risk. The goal of MetrioPharm AG is to make the therapy of chronic inflammatory diseases more effective and more tolerable. We hope to achieve a healthspan expansion for patients: We want to stop the progression of chronic inflammatory diseases as early as possible and significantly prolong the healthy lifespan of millions of people.

MetrioPharm AG was founded in 2007 and is headquartered in Zurich with research facilities in Berlin.

 

About MP1032

MP1032 is the lead compound of a class of proprietary immune modulators developed by MetrioPharm. MP1032 is believed to modulate the oxidative stress-mediated activation state of macrophages and downregulate the M1 state. In contrast to other immune-modulating and disease-modifying drugs, MP1032 does not impact T-cells and preferentially affects macrophages at the sites of inflammation. MP1032 has shown anti-inflammatory activity in animal models of disease and a favorable toxicology profile in pre-clinical studies.

For the first Phase II study with MP1032, the indication psoriasis was selected because this immune-induced inflammatory disease is regarded as a so-called »door-opener indication«. Successes in the treatment of psoriasis have already led to first indications of promise for use in other chronic inflammatory diseases, such as arthritis and multiple sclerosis.

 

Forward-looking statements

This press release contains forward-looking statements that involve risks and uncertainties and are consistent with MetrioPharm’s assessment as of the date of this release. Such forward-looking statements are neither promises nor guarantees, but are subject to numerous risks and uncertainties, many of which are beyond MetrioPharm’s control, that could cause actual results to differ materially from those contemplated in these forward-looking statements. MetrioPharm does not assume any obligation to update forward-looking statements with respect to changed expectations or new events, conditions or circumstances on which these statements are based. A liability or guarantee and, if applicable, claims for topicality, correctness and completeness of these data and information are excluded and cannot be derived either explicitly or impliedly.

Your Contact

Eva Brysch

Head of Investor Relations & Corporate Communications

MetrioPharm AG
Bleicherweg 45
CH-8002 Zurich

MetrioPharm Deutschland GmbH
Am Borsigturm 100
D-13507 Berlin

T +49 (0) 30 33 84 395 40
F +49 (0) 30 33 84 395 99

E invest@metriopharm.com
W www.metriopharm.com


Additional features:

Document: http://n.eqs.com/c/fncls.ssp?u=KWVWNQHRNX
Document title: MetrioPharm Press Release Last Patient Last Visit


End of Corporate News


Language: English
Company: MetrioPharm AG
Bleicherweg 45
8002 Zurich
Switzerland
Phone: +41 (44) 515 21 97
Fax: +41 (44) 201 74 75
E-mail: info@metriopharm.com
Internet: www.metriopharm.com
ISIN: CH0107076744
Valor: A0YD9Q
EQS News ID: 825745

 
End of News EQS Group News Service

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CO.DON AG: successful Annual General Meeting 2019

DGAP-News: CO.DON AG / Key word(s): AGM/EGM

17.06.2019 / 11:00

The issuer is solely responsible for the content of this announcement.


CO.DON: successful Annual General Meeting 2019

Teltow/Berlin, 17.06.2019 – This year’s annual general meeting of CO.DON AG (ISIN DE000A1K0227) took place in Berlin on 12 June 2019 and was chaired by Professor Hans Bauerfeind, the Chairman of the Supervisory Board. Mr Tilmann Bur introduced himself to the shareholders and proxies in attendance as the CO.DON AG Executive Board member responsible for Sales and Marketing from 1 June 2019. Mr Ralf Jakobs, the spokesman of the company’s Executive Board, then reported on the financial year 2018 and the company’s performance in the opening months of the current financial year. “2018 was a year of upheaval and restructuring for CO.DON AG, in which we laid important foundations for the successful development of our company, including the definition of a corporate strategy for the next seven years, ensuring that our core product qualifies for reimbursement and initial steps in the political arena to establish and expand awareness of our method.” Jacobs continued: “As a result of this turbulent year full of changes we can say today: We have been able to reposition CO.DON AG in 2018 and set it up for the future. We have established a stable business case for CO.DON AG for the years ahead, which we will build on deliberately and precisely.” In his other comments he focused on a general presentation of CO.DON AG’s plans for further development, particularly including the internationalisation of its business and the expansion of its product portfolio. The general discussion that followed showed the great interest of those present in the opportunities presented.

The voting shareholders attending, who represented 36.35 % of the 7,773,786 million voting shares, approved all the proposals put forward by company management. The members of the Executive Board and Supervisory Board were discharged of responsibility for the financial year 2018. Mazars GmbH & Co. KG Wirtschaftsprüfungs- und Steuerberatungsgesellschaft, Hamburg, was appointed as auditor of the financial statements and the consolidated financial statements for 2019. Resolutions were passed approving the revocation of Authorised Capital 2017 and the creation of new Authorised Capital 2019 and amending the articles of association to reflect modern corporate governance practice and contemporary communications methods. This concerned the term of office and resignations by Supervisory Board members, ways of passing resolutions, options for attending the annual general meeting, transferring the chair of the meeting to another person if the Supervisory Board Chairman is unable to attend, voting majorities, amendments relating to the financial statements and transfers to retained earnings and changes to the purpose of the company.

The final item on the agenda was a resolution on the supplementary motion concerning new elections to the Supervisory Board. Since Dr Wegener had resigned his seat on the Supervisory Board with effect from the close of the Annual General Meeting 2019, a proposal was made to the annual general meeting to elect his successor, in order to ensure that the Supervisory Board continued to have six members in accordance with the company’s articles of association. Univ.-Prof. Dr.-Ing. Habil. Prof. e.h. Mult. Dr. h.c. Mult. Hans-Jörg Bullinger, Professor of Technology Management and former President of the Fraunhofer-Gesellschaft, resident in Stuttgart, was proposed to succeed Dr. Wegener. It was proposed that Prof. Bullinger’s term of office should begin at the close of the Annual General Meeting 2019 and continue for the remainder of Dr Wegener’s regular term of office, in accordance with the articles of association.

Professor Bullinger introduced himself to the shareholders and proxies present, outlining his biography and career and the reasons for his proposed involvement.

The annual general meeting approved the supplementary motion and elected Professor Bullinger to the Supervisory Board of CO.DON AG. Thanks and appreciation were expressed to Dr. Wegener for his long-standing contribution to the work of the Supervisory Board and the Executive Board.

CO.DON AG develops, produces and distributes autologous cell therapies for the minimally invasive repair of cartilage defects. The product being marketed is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint that uses only the patient’s own cartilage cells (“autologous chondrocytes”). CO.DON’s method is currently used in over 200 clinics in Germany and more than 14,000 patients have already been treated. In July 2017 CO.DON AG received central EU marketing authorisation for this product from the European Medicines Agency (EMA). The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Ralf M. Jakobs (Spokesman), Tilmann Bur (COO).

Further information is available from www.codon.de

Investor Relations and Press Contact:

Matthias Meißner, M.A.
Tel. +49 (0)30 240352330
Fax +49 (0)30 240352309
Email:
ir@codon.de


17.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: CO.DON AG
Warthestraße 21
14513 Teltow
Germany
Phone: 03328 43460
Fax: 03328 434643
E-mail: info@codon.de
Internet: www.codon.de
ISIN: DE000A1K0227
WKN: A1K022
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Stuttgart, Tradegate Exchange
EQS News ID: 825567

 
End of News DGAP News Service

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Elite Pharmaceuticals, Inc. Delays Fourth Quarter and Year End 2019 Earnings Release Date and Conference Call

Northvale, 06/14/2019 / 16:00, EST/EDT – EQS Newswire – Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. Delays Fourth Quarter and Year End 2019 Earnings Release Date and Conference Call

NORTHVALE, NJ / ACCESSWIRE / June 14, 2019 / Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCQB: ELTP), announced today that it has delayed its previously announced earnings release and conference call to allow additional time to complete its Form 10-K for the year ended March 31, 2019. The Company has filed a Form 12b-25, Notification of Late Filing, with the U.S. Securities and Exchange Commission and currently expects to file its Form 10-K within the 15-day extension period.

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties. These forward-looking statements are not guarantees of future action or performance. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com

SOURCE: Elite Pharmaceuticals, Inc.

06/14/2019 EQS Newswire / EQS Group AG

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MOLOGEN AG: Announcement to holders of the EUR 2,707,050.00 worth of convertible bonds maturing in 2027 (the convertible bonds) (ISIN: DE000A2NBMN3, SIN A2NBMN)

DGAP-News: MOLOGEN AG / Key word(s): Bond

14.06.2019 / 15:17

The issuer is solely responsible for the content of this announcement.


NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

Mologen AG

Berlin

Announcement to holders of the
EUR 2,707,050.00 worth of convertible bonds maturing in 2027
(the convertible bonds) (ISIN: DE000A2NBMN3, SIN A2NBMN)

Mologen AG (the Company) notifies holders of the convertible bonds that, under the terms of the convertible bonds (the bond terms) and according to calculations of the Company for the convertible bonds, an adjustment was made to the conversion price and conversion ratio.

On 8 June 2018, the Annual General Meeting of the Company resolved to authorize the Company’s Executive Board to increase the Company’s share capital, with the Supervisory Board’s approval, by issuing new bearer no-par shares in exchange for contributions in kind and/or in cash on one or more occasions up to 7 June 2023, however, by a maximum of EUR3,768,643.00 (Authorized Capital 2018).

By resolution dated 13 May 2019, the Executive Board, with the Supervisory Board’s approval of the same date, increased the Company’s share capital, using Authorized Capital 2018, from EUR10,063,715.00 by EUR2,012,220.00 to up to EUR12,075,935.00 in exchange for cash contributions by issuing up to 2,012,220 new bearer no-par shares with a proportional amount in the share capital of EUR1.00 per share.

The shares were subscribed in full and the capital increase was entered in the commercial register on 2 May 2019.

In view of the capital increase, the conversion price and conversion ratio (as defined in the bond terms) were adjusted in line with Section 11(2) of the bond terms as follows: the conversion price from EUR2.0805 to EUR1.9847 and the conversion ratio from 4.8070 to 5.0385.

In accordance with Section 11(10) of the bond terms, the adjusted conversion price and the adjusted conversion ratio came into effect on 19 March 2019.

Mologen AG

Important note:

This announcement is neither an offer nor an invitation to purchase or to subscribe for securities in the United States, Australia, Canada, Japan or in any jurisdiction in which such an offer or solicitation is unlawful. The securities referred to in this press release have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may be sold or offered for purchase in the USA only with prior registration or without prior registration only on the basis of an exception provided in line with the U.S. Securities Act. There will be no public offering of the securities in the United States of America. Subject to certain exceptions outlined in the Securities Act, the securities referred to herein may not be offered or sold in Australia, Canada or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan.

Mologen AG

The Executive Board


14.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE000A2LQ900
WKN: A2LQ90
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 825143

 
End of News DGAP News Service

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MorphoSys’s Licensee Janssen Announces Top-line Phase 3 Results for Guselkumab (Tremfya(R)) in Adults with Active Psoriatic Arthritis (news with additional features)

DGAP-News: MorphoSys AG / Key word(s): Study

14.06.2019 / 13:58

The issuer is solely responsible for the content of this announcement.


Planegg/Munich, Germany, June 14, 2019

MorphoSys’s Licensee Janssen Announces Top-line Phase 3 Results for Guselkumab (Tremfya(R)) in Adults with Active Psoriatic Arthritis

 

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) announced today that its licensee Janssen Research & Development, LLC (Janssen), reported top-line results from the phase 3 DISCOVER 1 and 2 studies in a press release issued today. The studies evaluated the efficacy and safety of guselkumab (Tremfya(R)) compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). According to Janssen, both studies met their primary endpoints of American College of Rheumatology 20 percent score improvement (ACR20), and the safety profiles observed for guselkumabin the DISCOVER program were consistent with previous studies of guselkumab and Tremfya(R) current prescribing information.

The DISCOVER program comprises the first-ever phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis. Janssen announced that data will be presented at upcoming scientific medical meetings and that data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.

Guselkumab is a human anti-IL-23 monoclonal antibody developed by Janssen that was generated utilizing MorphoSys’s proprietary HuCAL antibody technology.

Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: “We are very pleased to see these positive topline results from two phase 3 studies of guselkumab in psoriatic arthritis. This disease is very debilitating and severely restricts the mobility of patients. We look forward to the further development of guselkumab as a potential treatment option in this indication.”

Guselkumab (tradename Tremfya(R)) has been approved in the U.S., Canada, the European Union, and several other countries for the treatment of plaque psoriasis and in Japan for the treatment of various forms of psoriasis, psoriatic arthritis, and palmoplantar pustulosis. Guselkumab is currently being investigated in clinical studies in several indications, including additional studies in plaque psoriasis, pediatric psoriasis, psoriatic arthritis, Crohn’s disease, hidradenitis suppurativa, ulcerative colitis and familial adenomatous polyposis. MorphoSys is eligible to certain milestone payments and receives royalties on net sales of Tremfya(R).

More information about guselkumab clinical studies is available on clinicaltrials.gov.
 

About the DISCOVER program
The DISCOVER program consists of DISCOVER-1 and DISCOVER-2, two randomized, double-blind, multicenter phase 3 studies designed to evaluate efficacy and safety of subcutaneous guselkumab in patients with active PsA compared to placebo. In addition to the primary endpoint of ACR20 response at week 24, multiple secondary endpoints were assessed that included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS). DISCOVER-2 also assessed effect on structural damage (vdH-S) as a key secondary endpoint.
DISCOVER-1 included 381 participants, including participants previously treated with anti-TNF biologics. The study continued through 52 weeks. DISCOVER-2 included 739 bio-naive participants and continued through 100 weeks.
 

About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 29 are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys’s antibody technology to receive regulatory approval. The Company’s most advanced proprietary product candidate, tafasitamab (MOR208), has been granted U.S. FDA breakthrough therapy designation for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has approximately 330 employees. More information at https://www.morphosys.com.

HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R) and LanthioPep(R) are registered trademarks of the MorphoSys Group. Tremfya(R) is a trademark of Janssen Biotech, Inc.

MorphoSys forward looking statements
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the clinical development of guselkumab in psoriatic arthritis led by Janssen, the further clinical development of guselkumab by Janssen as well as interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for guselkumab in psoriatic arthritis. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys’ expectations regarding the clinical development of guselkumab in psoriatic arthritis led by Janssen, the further clinical development of guselkumab by Janssen as well as interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for guselkumab in psoriatic arthritis, MorphoSys’ reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys’s Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
 

For more information, please contact:

MorphoSys AG
Dr. Sarah Fakih
Head of Corporate Communications & IR

Alexandra Goller
Director Corporate Communications & IR

Dr. Julia Neugebauer
Director Corporate Communications & IR

Dr. Verena Kupas
Manager Corporate Communications & IR

Tel: +49 (0) 89 / 899 27-404
investors@morphosys.com


Additional features:

Document: http://n.eqs.com/c/fncls.ssp?u=CYYQJPPEOU
Document title: Media Release


14.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: investors@morphosys.com
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: MDAX, TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 825063

 
End of News DGAP News Service

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