• Companies jointly developing kits for quality control of in vitro stem cell cultures
• Partnership combines Sistemic’s microRNA solutions with EMD Millipore’s stem cell expertise
• Collaboration to advance stem cell-based therapeutics toward clinical testing

Glasgow, UK, and Billerica, MA, November 1, 2012 / B3C newswire / — EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, today announced a new initiative with Sistemic Ltd., a leading provider of microRNA-based problem-solving services and kit-based products. The two companies are jointly developing a proprietary monitoring methodology utilizing Sistemic’s microRNA marker detection capability to enable consistent growth of stem cells in EMD Millipore’s Mobius^® CellReady platform.  These markers could also be incorporated into a commercially-available kit for quality control of stem cells in culture.

“To advance the progress of stem cell products toward clinical use, it is critical to ensure the consistency and quality of large-scale culture systems,” said Robert Shaw, Commercial Director of EMD Millipore’s Stem Cell Initiative. “We are excited to be partnering with Sistemic, as the company’s leading microRNA-based solutions will help us continue our efforts toward the commercialization of stem cell processing.” 

“We are delighted to enter this collaborative arrangement with EMD Millipore,” commented Sistemic Chairman and CEO Jim Reid. “The fact that EMD Millipore has chosen Sistemic as its collaborative partner is yet another validation of our ground-breaking research and ability to develop systems for quality control of stem cells, and other mutually beneficial products and programs.”

This announcement was made at the Second Annual Stem Cell Meeting on the Mesa, of which Sistemic and EMD Millipore are co-sponsors, October 29-31 in La Jolla, California.

For more information about EMD Millipore’s Stem Cell Initiative, please visit: www.emdmillipore.com\stemcells.

About EMD Millipore
EMD Millipore is the life science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the life science tools industry, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.
Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2011 revenues of EUR 2.4 billion. EMD Millipore is known as Merck Millipore outside of the U.S. and Canada.

Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany

About Sistemic Ltd
Sistemic’s primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. In addition, the drug development markets are served through a range of products which include SistemTOX™, SistemKB™ and SistemRNA™.

Contacts

Dr. Verna McErlane
Director of Commercial Operations
+ 44 (0)7855 376 358
verna.mcerlane@sistemic.co.uk 

Pegeen DosSantos
Phone: +1 781-533-5336
pegeen.dossantos@merckgroup.com

Inhibitors may have utility in autoimmune disease treatment

Cambridge, UK, November 5, 2012  / B3C newswire / - Domainex Ltd., a UK-based drug discovery company, has developed a number of chemical series with potent and selective activity against two closely-related kinases TBK1 and IKKepsilon. IL-17 mediated signaling is known to induce the expression of cytokines and other effectors that can cause a variety of immunological diseases such as psoriasis and Chronic Obstructive Pulmonary Disease (COPD). Domainex researchers are now the first to report that small-molecule inhibitors of TBK1/IKKepsilon are able to affect IL-17 signaling. These results suggest that the Domainex inhibitors may have utility in a wide range of clinically-important diseases that have great unmet medical needs. 

Recent clinical studies reported in The New England Journal of Medicine by Lilly and Amgen have shown that neutralizing anti-IL-17 monoclonal antibodies can have a major impact on psoriasis (Leonardi et al. 2012 and Papp et al. 2012 respectively). The demonstration by Domainex that small-molecule drugs targeting IKKepsilon can inhibit IL-17 signaling indicates that these compounds have great clinical potential in this disease and other important settings. 

Domainex has developed three series of drug-like compounds, each series having inhibitors with high potency and selectivity against other kinases. The lead compounds have good metabolic properties and the Company is now driving these compounds forwards towards a clinical candidate. 

Domainex’s Research Director, Trevor Perrior, said: “Domainex, in collaboration with The Institute of Cancer Research, has previously shown that its inhibitors of TBK1/IKKepsilon have activity against a variety of cancer cell-lines. Domainex has also demonstrated that its inhibitors are very potent blockers of interferon-beta production in immune cells, showing the compounds may have utility in diseases such as lupus. The latest finding that our TBK1/IKKepsilon inhibitors can also inhibit IL-17 signaling suggests that the compounds are also of potential use for treatment of other major diseases such as psoriasis and COPD. Domainex has recently obtained funding from the government-backed Biomedical Catalyst programme to explore the use of its inhibitors of IKKepsilon in COPD.” 

Eddy Littler, CEO of Domainex, said: “The latest results showing the activity of Domainex’s TBK1/IKKepsilon inhibitors against IL-17 signaling reinforces the fact that this project is of very high interest to pharma. Indeed Domainex is already in discussion with a number of potential partners with a view to them helping us to progress the programme to the clinic, and fully exploit its enormous potential. We are also grateful for the Biomedical Catalyst award that will enable us to extend our work to COPD, and help us fully exploit our intellectual property on inhibitors of TBK1 and IKKepsilon”. 

 
About Domainex

• Domainex uses unique and proprietary technologies to resolve common bottlenecks facing the pharmaceutical and biotechnology industries in the post-genomic era. Major discovery 'gaps' exist between the vast amount of genomic information that is now available, the accessibility of the corresponding proteins for use in target validation and drug discovery, and the identification of robust hits in a cost effective manner. Founded in 2002, Domainex is a privately owned company based in Cambridge, UK.
• Domainex has developed a discovery platform, which enables rapid progression of drug discovery projects from novel target through to Candidate Drug by means of its Combinatorial Domain Hunting technology, LeadBuilder virtual hit screening software, and its integrated approach to medicinal and computational chemistry.
• Domainex is developing an oncology-focused pipeline of novel drug compounds. It has chosen a number of well-validated but challenging targets, that we have successfully unlocked with its Combinatorial Domain Hunting and LeadBuilder technologies. The pipeline is focused upon some exciting kinases and on lysine methyltransferases (KMTs) involved in epigenetics. Domainex intends to take these projects into lead optimization and candidate selection, and looks for collaborators who may be interested in working with Domainex on their further development through the clinic.
• Domainex’s patented CDH technology enables the cloning and expression of soluble drug target protein domains in E. coli, followed by the identification of those constructs that are able to bind a ligand. This enables binding assays to be developed, facilitating hit identification studies. In only 3-4 months, all expressible ligand binding domains of a target protein are identified (from libraries of 20,000-100,000 constructs), enabling key rate limiting steps in early drug discovery to be easily overcome and resulting in large time savings over standard approaches.
• Domainex has also developed LeadBuilder - a virtual screening approach for targets which is specifically aimed at quickly identifying hit molecules that are ideally suited for further development.
• The experienced medicinal chemistry team has a proven track record in supporting biotech or university groups by providing expertise to take hit compounds through lead optimization and on to candidate selection. Three compounds to date arising from these collaborations are currently in clinical evaluation, with two additional drugs in preclinical studies.
• The Biomedical Catalyst, announced by Prime Minister David Cameron in December 2011, is a programme of public funding designed to deliver growth to the UK life sciences sector. Delivered jointly by the Medical Research Council and the Technology Strategy Board, the Biomedical Catalyst provides responsive and effective support for the best life science opportunities arising in the UK. The programme is open to UK academics and SMEs and seeks to support those opportunities which demonstrate the highest scientific and commercial potential, irrespective of medical area. For further information please visit: http://www.innovateuk.org/content/competition/biomedical-catalyst.ashx

For more information contact:

Joanne McCudden
Head of Business Development
Joanne.mccudden@domainex.co.uk
Tel +44 (0)7775 437107

Cologne and Hamburg, Germany, November 5, 2012 / B3C Newswire / - CEVEC Pharmaceuticals (“CEVEC”), the developer of a novel human expression system derived from amniocytes, and CCS Cell Culture Service GmbH (“CCS”), a contract research organization based in Hamburg, Germany, announced today the signing of a strategic license agreement. The license will enable CCS to offer its customers transiently transfected CAP-T^TM cells for cell based assay and protein production applications.

The transient CAP-T^TM protein production technology is based on CAP^® cells, an immortalized cell line for stable protein production developed by CEVEC. These non-tumor origin cell lines exhibit high protein expression, have been adapted to serum-free suspension culture and show post-translational modifications that are human-like, including authentic human glycosylation patterns.

The collaboration combines CEVEC’s proprietary CAP-T^TM expression system with CCS' expertise to produce and process bulk quantities of transiently transfected cells for drug discovery research in pharmaceutical companies worldwide.

“CCS Cell Culture Services is a very experienced and trusted partner for the custom supply of cell based assay reagents. We’re very pleased that they will add our CAP-T cells to their cell based assay technology portfolio and we’re convinced that the cells will contribute significantly to the drug discovery process in the pharma industry “ stated Wolfgang Kintzel, CEO at CEVEC. 

Oliver Wehmeier, Managing Director of Cell Culture Services said: “We are excited about the potential of CEVEC’s CAP-T technology. The cells meet all requirements for a host cell line in terms of robustness, transfection efficacy, expression level, and scalability. We obtained outstanding results from transient transfections of various secreted, intracellular, or membrane bound target proteins in CAP-T cells and we are pretty sure that this expression system will be of great benefit to our customers"

 
About CEVEC Pharmaceuticals GmbH
 CEVEC Pharmaceuticals GmbH, operational since 2004 and located in Cologne, Germany, is a biopharmaceutical company that specializes in developing and producing therapeutic proteins, vaccines and monoclonal antibodies with human glycosylation patterns. CEVEC's novel proprietary and patent-protected human CAP® and CAP-T^TM expression systems are ideal for manufacturing complex biopharmaceutical molecules and various vaccines. CEVEC is licensing out its human cell-based expression platform as well as its own biobetter candidates through partnerships with renowned pharmaceutical and biotech companies.

About Cell Culture Service GmbH
For more than thirteen years, CCS has been supporting research departments of pharmaceutical and biotechnology companies with custom made functionally validated cell based reagents. CCS is one of the leading suppliers of recombinant cell lines, assay-ready frozen cells, qualified membranes, and proteins for high-throughput screening. Major pharmaceutical companies all over Europe and the USA rely on the custom products and services of CCS.

 
Contacts:

Wolfgang Kintzel
CEO
CEVEC Pharmaceuticals GmbH
Gottfried-Hagen Straße 62
D-51105 Köln, Germany
fon +49 (0) 221-46 02 08 – 00
fax +49 (0) 221-46 02 08 – 01
info@cevec.com

Dr. Oliver Wehmeier
Managing Director
CCS Cell Culture Service GmbH
Falkenried 88
20251 Hamburg, Germany
fon +49 (0)40 47196560
fax: +49 (0)40 471 965 66
info@CellCultureService.com

First Patient Dosed in First Proof-Of-Concept Study in Untreated Acromegaly Patients

Tel Aviv, Israel, November 6, 2012 / B3C newswire / - Aspireo Pharmaceuticals Limited, (“Aspireo”) an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), announced today that the first patient has been enrolled in a phase IIa study in acromegaly patients.

The study is designed to investigate the safety, tolerability and efficacy of Somatoprim (DG3173) in untreated acromegaly patients. Up to 20 patients are planned to receive ascending single doses of Somatoprim and one dose of octreotide, the current gold standard of medical therapy for acromegaly, with each patient receiving all doses of Somatoprim as well as octreotide.

Carsten Dehning, CEO of Aspireo said: “Based on extensive preclinical and early clinical profiling Somatoprim has demonstrated the potential to become best-in-class somatostatin analog due to improved safety and efficacy. This first phase II study is designed to demonstrate efficacy in acromegaly patients in terms of reduction of growth hormone levels. Effects on growth hormone levels will also be compared with those of octreotide, the current market leading SSA. These data, together with data which is currently being gathered in a phase Ib multi-ascending-dose clinical study in healthy volunteers will form the basis for further clinical development and is expected to provide a clear path towards approval.”

Initial data from this study is expected to be available in the first quarter of 2013.

About Somatoprim
Somatoprim (DG3173) is a novel and proprietary somatostatin analog (SSA) that is based on a novel amino acid composition. Somatoprim has demonstrated a unique receptor binding and pharmacological profile which is significantly differentiated from SSAs that are currently marketed or in clinical development. In particular, Somatoprim has shown an improved side effect profile with reduced adverse effects on the gastrointestinal tract and metabolic control. Furthermore, assessment of growth hormone secretion in cultured human somatotroph adenoma tissue treated with Somatoprim indicates that it has the potential to significantly increase the response rate of acromegalic patients to SSA therapy. Somatoprim is in phase I/II of clinical development with a phase Ib study in Switzerland and a Phase IIa study in the Ukraine, both currently underway. Somatostatin analogs have been approved for the treatment of acromegaly, carcinoid tumours, and Cushing’s disease but also have demonstrated significant potential in diabetic retinopathy. Somatostatin analogs are generating more than USD 1.5 billion in annual sales in a continually growing market.

About Aspireo
Aspireo Pharmaceuticals Ltd is a biopharmaceutical company focused on the development of a novel somatostatin analog (SSA) for the treatment of diseases resulting from hormone-active tumors, such as acromegaly, neuroendocrine and gastroenteropancreatic tumors, Cushing’s Disease and diabetic retinopathy. Aspireo’s sole development compound is Somatoprim (DG3173), a novel and proprietary somatostatin analogue that is based on a novel amino acid composition and a unique backbone cyclization technology used for stabilization of the peptide. Aspireo is an Israeli company established in 2010 by TVM Capital as a Project Focused Company (PFC). In September 2012 Aspireo and Evotec AG, Hamburg, Germany, entered into a strategic advisory agreement whereby Evotec will support Aspireo in the partnering of Somatoprim.

For further information please contact

Carsten Dehning
Chief Executive Officer
Aspireo Pharmaceuticals Limited
+49 (170) 6308687
dehning@aspireo.com

Laupheim, Germany, November 7, 2012 / B3C newswire / - The family-owned business based in Laupheim has expanded its management board. As a contract manufacturing organization, Rentschler Biotechnologie GmbH performs research on, develops, and produces biologicals for its international clientele. 

Reiner Winkelbauer, who has been the company’s Commercial Manager for the past four years, was appointed Managing Director of Finances. He was previously the Controlling and Chief Financial Officer of AEG in Ulm and later became the Commercial Manager at EADS also in Ulm.

Since September 1, 2012, Thomas Siklosi has strengthened the management board in the GMP Operations area. Before he started working at Rentschler Biotechnologie as manager of the Active Substance Department in 1984, Siklosi worked for Boehringer Mannheim for 10 years. In 2008, he took over the management of GMP Operations at Rentschler.

In the future, Siklosi will also be responsible for the “operational excellence” program at Rentschler that will focus on customer needs and on optimizing quality and efficiency. Starting from November 1, 2012, he will be actively supported by Luca Dellacroce, the “new face” in Rentschler’s management board. In the past, Dellacroce worked for notable companies such as Motorola and Nokia in process optimization.

Frank Ternes will also be a new addition to the management level at Rentschler beginning February 1, 2013. After 25 years at Boehringer Ingelheim where he last served as Senior Vice President of Biopharmaceutical Contract Manufacturing, Ternes will now become Managing Director of Sales at Rentschler.

Dr. Nikolaus F. Rentschler, CEO and owner, explains the necessary changes that led to a larger management board as follows:

“To accommodate the rapid growth of the company during the past 10 years, the management board had to also “grow.” Internal processes must be constantly reconsidered and optimized in order to serve our customers even better and more efficiently. For this reason, I decided to implement the necessary steps to achieve process optimization in my company. I wish Messrs. Winkelbauer, Siklosi, Dellacroce, and Ternes the strength and fortitude, as well as the determination and perseverance to act in the interests and for the success of my company.”

 
About Rentschler
Rentschler Biotechnologie GmbH is a global full-service contract manufacturer with more than 35 years of experience in the development, production and approval of biopharmaceuticals in compliance with international GMP standards (EMA/FDA). Rentschler has nine GMP suites with volumes of 30, 50, 250, 500, 1,000 and 2,500 liters, allowing the production of material for clinical trials (phases I to III) and for market supply and also provides regulatory advice, protein analytics, quality control, and the sterile filling of syringes and injection vials. The company is family-owned and independent and has currently about 650 employees.

Media Contact

Friederike Braun
Director Marketing
Rentschler Biotechnologie GmbH
Phone: +49 7392 701-478
friederike.braun@rentschler.de

Regensburg, Germany, November 8, 2012 / B3C newswire / - Lophius Biosciences, a leader in the field of novel T cell based diagnostic test systems, reported today about its first successfully concluded clinical Proof of Principle study with respect to detection of active tuberculosis (TB) using its novel T-Track® TB test which is based on Lophius Biosciences proprietary Reverse T Cell Technology (RT Technology).

The clinical Proof of Principle was concluded in India with a cohort of 44 patients. Results demonstrate that the T-Track® TB test was able to detect active TB in in 10 of 12 non-treated patients. Besides its high sensitivity and specificity the T-Track® TB test also demonstrated a remarkably short turnaround time of 2 days which compares favorably to currently used classical detection methods. In summary, these results imply that the T-Track® TB test could represent an innovative and fast detection approach for this area of strong medical need.

For further test development Lophius Biosciences has been awarded research funding of 140K EUR under the scope of the ZIM-solo-program from the German government. This funding should help to broaden the scope of the T-Track® TB tests with respect to detection of latent TB and potential patient-monitoring of treated TB subjects. The company will present first results at Medica mid November 2012 in Düsseldorf.

„We are very pleased to have accomplished clinical Proof of Principle for our second proprietary technology platform. Our short-term goal is geared towards test optimization and further validation in a bigger patient cohort” said Dr. Michael Lutz, CEO of Lophius Biosciences.

 
About Lophius Biosciences
Lophius Biosciences GmbH develops and markets innovative T cell based testing systems for diagnostics and possible therapy control in the fields of transplantation, infection and autoimmune diseases.

Contact  
Lophius Biosciences GmbH
Josef-Engert-Str. 13
D-93053 Regensburg
Phone: +49 941 6309 1972
Email: info@lophius.de
www.lophius.de

Lophius Biosciences weist erste klinische Machbarkeit für T-Track® TB für den Nachweis einer aktiven Tuberkuloseerkrankung nach und erhält Forschungsförderung

Lophius Biosciences, ein führender Entwickler von neuartigen T-Zell-basierten diagnostischen Testsystemen, berichtet heute über eine erste erfolgreiche klinische Machbarkeitsstudie hinsichtlich des Nachweises einer aktiven Tuberkuloseerkrankung (TB) mittels des neuartigen T-Track® TB Tests. Der T-Track® TB Test beruht auf dem proprietären Reversen T-Zelltechnologieverfahren (RT-Technologie).

Die klinische Machbarkeitsstudie wurde in Indien an 44 Probanden durchgeführt. Dabei konnte gezeigt werden, dass mit Hilfe des T-Track® TB Tests eine aktive Tuberkulose in 10 von 12 unbehandelten Erkrankten nachgewiesen werden konnte. Neben der hohen Sensitivität und Spezifität zeichnete sich der T-Track® TB Test durch eine kurze Nachweisdauer von maximal 2 Tagen aus, was deutlich unter Nachweisdauern derzeitiger klassischer Standardverfahren für eine aktive TB liegt. In Summe legen diese Ergebnisse nahe, dass der T-Track® TB Test ein neuartiges und schnelles Verfahren für diesen Bereich mit extrem hohem medizinischem Bedarf darstellt.

Lophius Biosciences hat zur Weiterentwicklung des T-Track® TB Tests eine Förderung vom BMWi im Rahmen des ZIM-solo-Programms über 140.000 EUR erhalten. Diese Förderung soll helfen, den Anwendungsbereich des T-Track® TB Tests auch auf latente Infektionen auszuweiten und darüber hinaus zu ermitteln, ob sich das Testverfahren auch zu einem Monitoring behandelter aktiver TB-Patienten eignet. Erste Ergebnisse werden im Rahmen der weltgrößten Diagnostikausstellung Medica Mitte November in Düsseldorf präsentiert.

„Wir sind sehr erfreut mit Hilfe der durchgeführten Machbarkeitsstudie die klinische Wirksamkeit unserer zweiten proprietären Technologieplattform, der RT-Technologie, zeigen zu können. Unser kurzfristiges Ziel ist es eine weitere Testoptimierung mit Hilfe eines größeren Patientenkollektivs betreiben zu können. Die Vorbereitungen hierzu sind weit fortgeschritten” sagte Dr. Michael Lutz, Geschäftsführer von Lophius Biosciences.

Über Lophius Biosciences
Lophius Biosciences GmbH entwickelt und vermarktet innovative T-Zell-basierte Testsysteme für die Diagnostik und mögliche Therapiesteuerung in den Bereichen Transplantation, Infektion und Autoimmunerkrankungen.

Berlin, Germany, November 12, 2012 / B3C newswire /- ProBioGen announces the launch of a comprehensive set of engineered, royalty-free biopharmaceutical CHO production cell lines, individually optimized for enhanced ADCC activity, adjusted galactosylation levels and/or increased production of the target antibodies or proteins. This elaborate cellular toolbox allows the rapid and targeted creation of antibody and protein molecules with specific pre-defined properties.

The cell’s fitness for purpose can either be proven via fee-for-service-based demonstration studies at ProBioGen or by providing the cell lines under research licenses to interested parties. The engineered cell lines are royalty-free and are suitable for clinical and commercial production. All engineered cells are based on ProBioGen’s biopharmaceutical CHO platform of DG44 and K1 cell lines and can be freely combined with ProBioGen’s stable expression vector system and chemically defined media platform.

Besides applying the described permanent cell modifications to newly created cells lines and molecules, all technologies can also be rapidly introduced into existing protein producer cell lines and even into any clients’ own expression platforms.

CHO cells with the following modifications are available:

The GlymaxX® technology boosts antibody ADCC activity by preventing the addition of the sugar “fucose” to the N-linked antibody carbohydrate part in antibody-producing cells. The GlymaxX^® technology is based on the introduction of a gene for an enzyme which deflects the cellular pathway of fucose biosynthesis. GlymaxX^® is universally applicable to different CHO hosts and to any other eukaryotic cell line; it is also simple and potent. It can be applied in a few weeks to any existing antibody producer cell line, or can be included into newly developed cell lines. ProBioGen offers this technology royalty-free to third parties.

The Galactosylation Adjustment Technology is a genetically controlled way to adjust protein galactosylation levels through the additional presence of an enzyme in the producer cells (as opposed to media supplementation to influence galactosylation levels). CHO cells predominantly produce G0 structures (no Galactose molecules).Galactosylation adjustment can increase protein drug galactosylation to almost maximal extent (G2).

The gradual activity of this stably transfected enzyme allows a carefully adjusted or maximized galactosylation of antibodies or proteins. This is desirable e.g. for matching originators galactosylation levels when developing biosimilars, for half-life extension or other reasons.

The Pathway Modulator Technology is highly versatile and readily applicable to any animal cell line and, notably, even to existing producer cell lines, optimizing their productivity. It works through the additional expression of an engineered non-human enzyme in the producer cells. Upon stable transfection, the modulator enzymes’ concerted action on several cellular pathways results in substantially enhanced volumetric productivities of protein drugs. For various monoclonal antibodies and fusion proteins tested in CHO, the stable modification increased yields between 1.3 and 2.6-fold.

 
About ProBioGen
ProBioGen is an internationally operating technology provider and Contract Development and Manufacturing Organization (CDMO) with almost 20 years of experience in cell culture, process development, and GMP-manufacturing. ProBioGen is a competent and reliable CDMO partner, offering customized solutions for even the most challenging development and manufacturing requirements. This is backed by the company’s established, fee-for-service-based CHO cell and media platform, and its innovative platform technologies, as well as the comprehensive portfolio of cell-based activity assays. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).

ProBioGen was founded 1994 and is located in Berlin, Germany.

Contact

Dr Gabriele Schneider
Vice President Business Development
ProBioGen AG
Goethestrasse 54
13086 Berlin
Germany
Phone: +49 (0)30 924 006-0
Email: cmo@probiogen.de

Billingham, UK/Morrisville, NC, USA, November 14, 2012 / B3C newswire / – Fujifilm Diosynth Biotechnologies has added another licensed product to its list of commercial biopharmaceutical products, following the announcement that ThromboGenics’ has received FDA approval for the launch of JETREA® (ocriplasmin) in the USA for the treatment of Symptomatic Vitreomacular Adhesion (VMA). 

The two companies announced a long-term commercial supply agreement for manufacture of the bulk substance in September 2010 when the product had completed its Phase III trials and have worked together to complete validation and establish a well characterised process. 

Fujifilm Diosynth Biotechnologies is one of the world’s leading providers of contract process development and manufacturing services for biopharmaceuticals and the UK business has been working with ThromboGenics for over seven years as the drug progressed through its clinical trials. This illustrates the value of long-term deep collaboration in securing both cost effective and timely commercialisation of such complex new medicines. 

Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies’ Billingham, UK, said “we are delighted that ThromboGenics has received FDA approval for the launch of JETREA® in the USA. It is very gratifying for our team to see that their hard work in developing and manufacturing the product over the years has resulted in a drug being available to people suffering from distressing ophthalmic conditions. This is fifth licensed biopharmaceutical manufactured by Fujifilm Diosynth Biotechnologies and the second made at our Billingham site, demonstrating our growing expertise in helping to transition biopharmaceuticals from the clinic to become marketed new drugs”. 

Dr. Patrik De Haes, CEO of ThromboGenics said ”Fujifilm Diosynth Biotechnologies has been a key partner in helping to bring our first drug to market. Their team at Billingham have done an excellent job in developing and validating a robust process and manufacturing material to enable us to launch the product on schedule”. 

About Fujifilm Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies UK Limited is an industry leading biologics Contract Development and Manufacturing Organization. Fujifilm Diosynth Biotechnologies has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems. The company offers a comprehensive list of services from cell line development, including its proprietary pAVEway™ system to process development, analytical development, clinical and commercial manufacturing. Fujifilm Diosynth Biotechnologies is also located in Research Triangle Park, NC, USA as FUJIFILM Diosynth Biotechnologies U.S.A., Inc. Both sites have been FDA-approved for the production of commercial biopharmaceutical products

About FUJIFILM Holdings Corporation
FUJIFILM Holdings Corporation, Tokyo, Japan, brings continuous innovation and leading-edge products to a broad spectrum of industries, including electronic imaging, digital printing equipment, medical systems, life sciences, graphic arts, flat panel display materials, and office products, based on a vast portfolio of digital, optical, fine chemical and thin film coating technologies. The company was among the top 17 companies around the world granted U.S. patents in 2011, and in the year ended March 31, 2012, had global revenues of $27.8 billion*. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit www.fujifilmholdings.com.
* At an exchange rate of 79 yen to the dollar.

About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company’s lead product, JETREA® (ocriplasmin), has been approved by the FDA for the treatment of symptomatic VMA. ThromboGenics has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic VMA, sometimes referred to as Vitreomacular Traction (VMT). The marketing Authorisation Application (MAA) for ocriplasmin is under review in Europe.

ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, New Jersey (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com.

Contact :
Bridget Hall
Communications Manager
Fujifilm Diosynth Biotechnologies
Tel : +44 (0)1642 367320
+44 (0)7796 938929
Email : bridget.hall@fujifilmdb.com

Dielheim, Germany, November 14, 2012 / B3C newswire / - The 50th euroPLX Meeting which was held on 5 and 6 November 2012 in Sorrento, Italy, marks an important milestone for euroPLX, the global platform for partnering deals in the pharmaceutical industry. It made euroPLX the most often held partnering event in this industry. 

With 150 attending delegates from 36 countries and five continents it is also one of the most international partnering conferences. For the first time, Bosnia and Herzegovina, Ecuador, and Thailand were represented. 

What is more important in the eyes of participants, however, is the high number of pre-scheduled appointments per company. euroPLX 50 Sorrento delivered an average of 23.6 pre-scheduled appointments per company and met 89.0% of all appointment requests, a benchmark for partnering conferences. 

Says Dr. Norbert Rau, owner of RauCon business development, the organisers of euroPLX: "A conference's total number of scheduled one-on-one appointments is often bragged about, but entirely irrelevant for the individual participant. Only the number of appointments that have been scheduled for the individual participant counts. The more appointments for him or her, the larger the probability of landing a partnering deal. And euroPLX Meetings feature about two to three times more than mainstream partnering conferences." 

Next year's euroPLX Meetings will be held in Limassol, Cyprus, on 4 and 5 March, in Munich, Germany, on 10 and 11 June, and in Barcelona, Spain, on 25 and 26 November, 2013. Details and online registration on www.europlx.com

Caption: Celebrating the 50th jubilee euroPLX Meeting
(For high resolution picture please right click the image and select "Save target as...")

Caption: euroPLX participants trying to prepare the world's largest pizza doe in the honour of the 50th euroPLX Meeting
(For high resolution picture please right click the image and select "Save target as...")

Contact
Dr. Norbert Rau
RauCon
Kurfürstenstr. 1A
69234 Dielheim, Germany
T 06222 9807-11
E nr@raucon.com
www.raucon.com
www.europlx.com

Munich, Germany, November 15, 2012 / B3C newswire / – Definiens AG, the leader in image analysis for Digital Pathology, today announced that Dr. Gerald Möller, has joined the company's supervisory board as an independent member and has been appointed chairman. Following the recent financing round, Dr. Möller will guide the expansion of Definiens’ current business and the development and commercialization of innovative products for clinical Digital Pathology.  

Definiens’ image analysis solutions are currently deployed by all major biopharmaceutical companies, leading cancer centers and key pathology reference labs. Building on the leadership position in the life sciences sector, Definiens is rapidly growing its footprint in tissue based diagnostics, including the development of new companion diagnostic tests. These novel companion diagnostic tests will further accelerate the growth of Definiens’ business in Clinical Digital Pathology. 

“I am very excited to join Definiens’ supervisory board at this defining point in time,” commented Gerald Möller. “Quantitative Digital Pathology will not be possible without image analysis as provided by Definiens. I am very much looking forward to working with the Definiens team to further expand the leadership position in image analysis for Digital Pathology and grow the business in companion diagnostics and Clinical Digital Pathology.” 

Previously, Dr. Möller spent 23 years at Boehringer Mannheim in Germany, Japan and the US, where he held a number of leadership positions, including president of Decentralized Diagnostics, president of Advanced Diagnostics and Biochemicals, and CEO of Boehringer Mannheim Therapeutics. In 1995 he became CEO of the worldwide Boehringer Mannheim Group. Following the company's acquisition by Roche, Dr. Möller became head of Global Development and Strategic Marketing, Pharmaceuticals, and a member of the Executive Committee at Hoffmann LaRoche. In addition to Definiens, Dr. Möller is chairman of the board at Morphosys AG and sits on several further life sciences and diagnostics boards, including Illumina Inc., Bionostics Inc., and Vivacta Ltd. He also is chairman of the Foundation for Innovative New Diagnostics (FIND), a product development and implementation partnership financed in part by the Bill & Melinda Gates Foundation. He holds a Ph.D. in physical chemistry from the University of Kiel in Germany.  

"We are delighted to have Dr. Möller as chairman of our board of directors. Gerald’s strong track record in the healthcare space and his unmatched expertise in advanced diagnostics will be invaluable as Definiens expands into Clinical Digital Pathology,” said Thomas Heydler, CEO of Definiens. “His commitment and vision will be instrumental to further strengthen Definiens as the leader in Quantitative Digital Pathology for life science research, tissue based companion diagnostics and clinical routine.” 

About Definiens
Definiens is the leading provider of image analysis and data mining solutions for Quantitative Digital Pathology in the life sciences, diagnostic biomarkers and healthcare industries. Definiens software provides detailed readouts from whole tissue slides, cell-based assays and full body scans, and allows the correlation of this information with data derived from other sources. By automating analysis workflows, Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and support better decisions in research, diagnostics and therapy. Definiens’ vision is to open new fields of research, to contribute to development of personalized medicine and to significantly improve the quality of patients’ lives.  

Definiens is headquartered in Munich, Germany, and has offices throughout the United States. Further information is available at www.definiens.com.

 
Media Contact
Definiens AG
Dr. Markus Rinecker
Chief Financial Officer
mrinecker@definiens.com

Uppsala, Sweden, November 15, 2012 / B3C newswire / – Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, introduced their new Universal Phase Separators, a flexible alternative to the traditional glass funnel separation of immiscible liquids. The Biotage Universal Phase Separation columns are fitted with a selectively permeable insert that separates aqueous phases from organic solvents under gravity; solving the age old problem of how to remove an upper organic phase from a lower aqueous phase, during a traditional liquid-liquid extraction process, without creating additional process steps.

The unique design allows the organic phase to pass through the internal frit wherever it is located, providing a universal approach to separating two liquid phases while its one-size-fits-all approach enables any volume under 80 mL to be processed in one step, or larger volumes by serial batches. Made from inert proprietary polymers, the Biotage Universal Phase Separators come in an easy-to-use kit form and refill packs, ready to use in seconds straight out of the box.

“Biotage Universal Phase Separators are the modern day alternative to separating with the glass separating funnel. Ideal for working with a range of organic solvents, or in parallel this product is economical, flexible and extremely simple to use. There are no moving parts, with nothing to prime, it’s all achieved by fundamental physical principles and clever product design.” says Dr. Sunil Rana, Product Manager Chemistry Applications and Resins and Work-Up Products at Biotage.

For further information visit www.biotage.com or call: in Europe +46 18 56 57 10, in North America toll free 1 800 446 4752, in Japan +81 422 28 1233, other areas please call +46 18 56 57 10.

Caption: The Biotage^® Universal Phase Separator is a simple solution to the classic problem of separating an upper organic phase from an aqueous during a traditional liquid-liquid extraction.
(For high resolution picture please right click the image and select "Save target as...")

About Biotage
Biotage offers solutions, knowledge and experience in the areas of analytical and medicinal chemistry. Customers include the world’s top pharmaceutical and biotechnology companies, as well as leading academic institutes. The company is headquartered in Uppsala, Sweden, with offices in China, Japan, the United Kingdom, the United States and a worldwide network of distributors. Biotage has 272 employees with sales of 428.4 MSEK in 2011. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange.

James Churchill
Marketing Communications
Biotage GB Ltd
Distribution Way
Dyffryn Business Park
Ystrad Mynach
Hengoed, Wales CF82 7TS
United Kingdom
Tel: +44 (0)1443 811 849
Mobile: +44(0)7875484778
Email: james.churchill@biotage.com

Suzhou, China, November 16, 2012 / B3C newswire / - Innovent Biologics, Inc., a company dedicated to the development and manufacturing of monoclonal antibodies to be marketed in the rapidly growing China market and elsewhere around the world, has raised $25 Million in a Series B financing to put toward the continued expansion of its pipeline and manufacturing capabilities. The money comes from Lilly Asia Ventures, part of the innovative global pharmaceutical company Eli Lilly, and from Fidelity Biosciences and Fidelity Growth Partners Asia, a division of Fidelity, one of the world’s leading financial services companies. Fidelity is a follow-on investor from the Series A.

“We are fortunate to have world’s premier investors believing in our team and business. Biologics are going to be a huge category in China just as they are worldwide, which presents a unique, once in a lifetime opportunity. Innovent has positioned itself to be a leading biologics company in China”, Said Michael Yu, Ph.D., Co-founder, President and CEO of Innovent Biologics.

The team at Innovent brings extensive experience in the discovery, development and manufacture of biologics in the US, Europe and worldwide and were involved in the launch of such products as Bexxar, Conbercept, Humira, Natrecor, Oncorine, Orencia, and others.

Innovent has a GMP-compliant pilot plant for the production of clinical trial material and is building a new campus located in Suzhou near Shanghai China.  In addition to laboratories and offices, the campus will house a commercial manufacturing plant with multiple 12,000 L bioreactors and a pilot plant, with two 1000L bioreactors, for production of clinical materials.  The 90,000m² biopharmaceutical facility will be the largest biologics production facility in China designed to comply with international requirements for cGMP as defined by the European EMA and the US FDA, as well as meet China SFDA cGMP regulations.

Companies who want to leverage the Innovent commitment to bring quality manufacturing and development to the expanding China biologics market have helped Innovent begin building a pipeline of biologics. The pipeline currently includes a CD20 antibody for Non-Hodgkins Lymphoma (NHL) and other B cell mediated diseases, a bispecific antibody for cancer and an antibody for oncology.   Innovent continues to actively seek product candidates for in-licensing and co-development. 

For more information about Innovent, see www.InnoventBio.com

Contact:
Vivian Zhang 
Phone: +86 18626151600
email: Vivian.Zhang@innoventbio.com 

Over 150 prenatal diagnostic practices and clinics now offer the blood test for the detection of fetal trisomy 21

Constance, Germany, November 19, 2012 / B3C newswire / - In the first three months after market launch, close to 1,000 pregnant women have opted for the PrenaTest®, Europe's first non-invasive molecular genetic blood test for the detection of fetal trisomy 21. All of them were at risk for trisomy 21 in the unborn child. The pregnant women were mainly from Germany, Austria and Switzerland, but also from other European countries. Meanwhile over 150 qualified prenatal practices and clinics in Germany, Austria, Liechtenstein and Switzerland are now offering the PrenaTest®, more than twice as many as in August this year. Several private health insurance companies in Germany have already reimbursed the cost for the PrenaTest®.

Evaluation of all PrenaTest® analyses carried out to date shows that the vast majority of 97 % of the tested women could be relieved with regard to the presence of trisomy 21 in their unborn child. Only 1.5 % of the analyzed blood samples carried fetal trisomy 21. As far as known, these positive results have been confirmed by amniocentesis in accordance with the recommendations of the Bundesverband niedergelassener Pränatalmediziner (BVNP), the German Society of Human Genetics (gfh) as well as the International Society for Prenatal Diagnosis (ISPD). Another 1.5 % of the blood samples could initially not be reported primarily due to a low amount of cell-free fetal DNA.

„These results clearly show how useful the PrenaTest® is in particular as a complement to the first trimester screening, because significantly less women actually need to undergo invasive testing and could be relieved quite early during their pregnancy,” said Dr. Wera Hofmann, Chief Scientific Officer of LifeCodexx AG. "Having this new method now established as a high quality lab routine process, we are currently working hard to further reduce the turnaround time between sample receipt and reporting. We aim to give the patient clarity as quickly as possible.”

"The number of blood tests carried out until now shows that physicians increasingly trust the PrenaTest® as a guidance for the woman for or against an invasive diagnostic procedure," said Dr. Michael Lutz, Chief Executive Officer of LifeCodexx AG. "Soon the test will be able to reliably detect trisomies 13 and 18, too. Then the physician will be able to detect the three most common types of autosomal  trisomy without any risk for the pregnant woman and her unborn child."

The PrenaTest® is the only non-invasive molecular genetic blood test for the detection of fetal trisomy 21 in Europe, which has successfully completed the conformity assessment procedures required for CE marking, thus proven its efficiency in terms of the in-vitro diagnostics directive of the European Union. LifeCodexx is currently evaluating the expansion of test availability to other countries of the European Union.


About PrenaTest^®
Based on the use of Next Generation Sequencing technology, the noninvasive molecular genetic PrenaTest^® is able to reliably exclude or confirm fetal trisomy 21 from maternal blood samples. As an addition to noninvasive prenatal diagnostics, it is a risk-free alternative to common invasive examination methods such as amniocentesis. PrenaTest^® is only available to pregnant women which are in the 12th week of pregnancy or later and which must have a higher risk of chromosomal alterations in the unborn child. Furthermore, in Germany, women with high-risk pregnancies will need to take advice and be informed without prejudice about human genetics by a qualified physician in accordance with the German Genetic Diagnostics Act and the guidelines of the Genetic Diagnostic Commission.

About LifeCodexx AG
LifeCodexx AG is a German life science company focusing on the development of clinically validated molecular diagnostic tests based on the use of next generation sequencing techniques. Last year the company has partnered with Sequenom, Inc. (USA) for the commercialization of prenatal laboratory testing services in Europe. 

 
Press contact
Elke Decker
Director Strategic Marketing, Communication & Business Administration
e.decker@lifecodexx.com
Tel. +49 173 31 30 780

Heidelberg, Germany, November 19, 2012 / B3C newswire / - BioCat, a distributor of research reagents and cutting-edge technologies in the fields of genomics, proteomics, and cell biology, announces the signing of an exclusive distribution agreement with ALPCO Diagnostics. The agreement names BioCat as the exclusive distributor for ALPCO products in Germany. Representatives of BioCat and ALPCO met in the course of the MEDICA 2012 in Düsseldorf, Germany, the world's largest medical trade fair, to sign the agreement.

ALPCO Diagnostics is renowned for their insulin ELISA kits and other market-leading metabolism assays. The ALPCO assays cover all aspects of metabolism and associated diseases, for example assays for factors involved in diabetes and obesity or cardiovascular diseases.

Dr. Michael Ehret, CEO at BioCat comments: "Thanks to the outstanding quality of the ALPCO ELISA kits we were able to build a solid customer base in the past. The exclusive distribution agreement will bring this collaboration to a new level."

Karen Stein, Vice President of Sales and Marketing for ALPCO Diagnostics, stated: “We are very excited to have BioCat as our exclusive distributor in Germany. They are well known for their commitment to life science research and their excellent technical support, making them an ideal partner to represent ALPCO in Germany.”

 
About BioCat
BioCat GmbH (Heidelberg, Germany) supplies the scientific community with innovative and high quality kits and reagents. BioCat's product portfolio provides modular solution packages to help deciphering the complex regulation of biological networks.

About ALPCO Diagnostics
ALPCO Diagnostics (Salem, NH, U.S.A) provides industry-leading metabolism immunoassays for use in a number of diagnostic and research areas with focus on metabolites involved in diabetes and obesity, cardiovascular diseases, kidney injury, bone metabolism and many more. Their kits are developed by scientists committed to supporting scientists. This is clearly reflected by the quality and the versatile panel of immunoassays for metabolic disease research.

Contact
BioCat GmbH
Im Neuenheimer Feld 584
D-69120 Heidelberg
Germany
Tel.: +49 (0) 6221 71415 16
Fax: +49 (0) 6221 71415 29
E-Mail: info@biocat.com
www.biocat.com

Amsterdam, The Netherlands, November 20, 2012 / B3C newswire / – Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, announced today that it has raised EUR 10 million in an equity financing round. This round was led by the Company’s largest shareholder LSP (Life Sciences Partners) and supported by a large investment from DFJ-Esprit. Other investors included Alta Partners, Quest for Growth and NOM. The financing will enable Kiadis Pharma to perform a confirmatory multi-center Phase II proof-of-concept study with its lead product ATIR™, and to prepare a pivotal Phase II/III study.

Manfred Ruediger, PhD, CEO of Kiadis Pharma, commented: “We are delighted with the enthusiastic support from existing and new investors, which attests to the exciting clinical data generated for ATIR™ so far and to the progress the Company has achieved over the last year. We are determined to advance ATIR™ in close cooperation with our clinical investigators in North America and Europe.”

 
About ATIR™
ATIR™ is a cell based medicinal product candidate enabling stem cell transplantations from mismatched (haploidentical) family donors to patients suffering from blood cancer. Stem cell transplantation is the only potentially curative option for many patients but a matching donor is available for only half of the patients in need. ATIR™ thus has the potential to address this unmet need and to make stem cell transplantations available for patients worldwide.

Those T-cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR™. ATIR™ is administered as an adjunctive treatment on top of a haploidentical stem cell transplantation enhancing early immune reconstitution without causing GvHD.

In a Phase I/II study with ATIR™, safety and proof of concept were provided in terms of absence of grade III/IV GvHD, reduced rates of infection, reduced Transplant Related Mortality and improved Overall Survival. ATIR™ has been granted Orphan Drug Designation both in the EU and the USA. Together, both regions represent a combined primary market potential of more than EUR 1 billion per year.

About Kiadis Pharma
Kiadis Pharma B.V. is a clinical stage biopharmaceutical company developing innovative and potentially life-saving therapies for patients with late stage blood cancers and related disorders, an area of significant unmet medical need.

The Company is collaborating with renowned centers in Europe, Canada and the United States to further develop ATIR™. Kiadis Pharma is based in Amsterdam, The Netherlands.

Contact:
Manfred Ruediger, CEO
Kiadis Pharma
Entrada 231-234
1096 EG AMSTERDAM
The Netherlands
Tel. +31 20 314 02 50
communication@kiadis.com

Somatoprim Recommended For Designation as Orphan Medicinal Product for Acromegaly 

Tel Aviv, Israel, November 26, 2012 / B3C newswire / - Aspireo Pharmaceuticals Limited, (“Aspireo”) an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), announced today that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion on an application for orphan medicinal product status for Aspireo’s Somatoprim (DG3173) for the treatment of acromegaly.

The positive opinion and recommendation has been forwarded to the European Commission for approval. The designation would grant Aspireo ten years of marketing exclusivity in the European Union upon obtaining market authorization as an orphan medicinal product. In addition, Aspireo would benefit from reduced regulatory fees.

“EMA’s decision to recommend Somatoprim for orphan medicinal product status is an important milestone in the development of this drug”, said Carsten Dehning, CEO of Aspireo. “By this resolution, EMA recognizes the potential of Somatoprim to offer significant medical benefit over existing treatments for acromegaly and it supports our efforts to provide valuable treatment alternatives for the many patients that could benefit from it. The ongoing clinical phase 1b and phase 2a studies are expected to support the claim that Somatoprim offers an effective and safe treatment for acromegaly patients.”

 
About Somatoprim
Somatoprim (DG3173) is a novel and proprietary somatostatin analog (SSA) that is based on a novel amino acid composition. Somatoprim has demonstrated a unique receptor binding and pharmacological profile which is significantly differentiated from SSAs that are currently marketed or in clinical development. In particular, Somatoprim has shown an improved side effect profile with reduced adverse effects on the gastrointestinal tract and glucose metabolism. Furthermore, assessment of growth hormone secretion in cultured human somatotroph adenoma tissue treated with Somatoprim indicates that it has the potential to increase the response rate of acromegalic patients to SSA therapy. Somatoprim is in phase I/II of clinical development with a phase Ib study in Switzerland and a phase IIa study in the Ukraine, both currently underway. Somatostatin analogs have been approved for the treatment of acromegaly, carcinoid tumours, and Cushing’s disease but have also demonstrated significant potential in diabetic retinopathy. Somatostatin analogs are generating more than USD 1.5 billion in annual sales in a continually growing market.

Uppsala, Sweden, November 28, 2012 / B3C newswire / - Beactica, the leading Swedish fragment-based drug discovery company, today announced that it has added a project under its ongoing research services agreement with Janssen Research & Development, a division of Janssen Pharmaceutica NV. Under the research services agreement, Beactica will use its proprietary drug discovery platform Sprint™ to identify novel allosteric modulators targeting undisclosed central nervous system (CNS) proteins of therapeutic interest to Janssen. Financial terms of the agreement were not disclosed.

“We are pleased to extend our collaboration with Janssen and look forward to further supporting their efforts to discover innovative medicines” said Beactica CEO, Dr Per Källblad. “The extension of our relationship testifies to the ability of our Sprint™ platform to generate novel, high-quality medicinal chemistry starting points against challenging drug targets”.

Beactica initiated their first research services project with Janssen in early 2011.

About Beactica
Beactica AB is a specialist drug discovery company, utilising its proprietary methodologies to evaluate the interactions of molecules in order to generate novel and mechanistically defined therapeutics. The Company offers expertise and services in the area of surface plasmon resonance (SPR) biosensor-based small molecule interaction analysis and partnerships for fragment-based lead generation using its proprietary Sprint™ platform. Founded in 2006 based on research carried out at Uppsala University and first-hand experience from the drug discovery industry, Beactica has established a robust reputation as the leader in SPR-based small molecule drug discovery. As well as providing services and building collaborations with external companies, Beactica is progressing its own drug discovery programmes. The Company has its headquarter in Uppsala, Sweden. For more information, please visit www.beactica.com.

Contact
Dr Per Källblad
Beactica CEO
+46 18 56 08 80

Contact for the Americas:
AMSilk GmbH
Mathias U. Woker
Chief Business Officer
Phone: +1 (781) 864-5868
Email: bd(at)amsilk.com

GATC Biotech customers can expect highest quality standards for Next Generation Sequencing projects from official accreditation

Konstanz, Germany, December 3, 2012 / B3C newswire / – Being the first in Europe, the Next Generation Sequencing Laboratories of the Constance Genome and Diagnostics Centre has been accredited according to ISO 17025 from the national accreditation body for the Federal Republic of Germany (DAkks). The independent governmental institution has acknowledged the high quality standard of the sequencing service on technology platforms Illumina HiSeq and Roche GSFLX sequencing.

“As an accredited service provider we assure our customers the latest state-of-the-art standards in our methods, technologies and data quality at all times. This is especially important to our customers from the industry or diagnostics. A reliable and continuously high quality of the analysis service is of great importance to them. The accreditation allows all customers to compare the quality of service providers on the international sequencing market”, explains Dr. Marcus Benz, COO of GATC Biotech AG.

“While inspecting the laboratories, we met a very qualified and motivated team that has developed a high competency for the complex analysis. Apart from the staff and the excellent equipment, the LIMS system has to be highlighted. This in-house developed software system allows a wide monitoring of the processes and contributes especially to internal quality management”, says the DAkkS expert.

Since June 2012, the accreditation according to ISO 17025 has been official and has been confirmed by extensive audits. The Genome and Diagnostics Centre of GATC Biotech in Constance meets essential requirements for the competence of analysis and calibration laboratories such as DIN EN ISO/IEC 17025, DIN EN ISO 9001 and all further conditions. The compliance of standards is monitored by the DAkkS regularly.

About GATC Biotech
GATC Biotech is Europe’s leading service provider of DNA sequencing. For over two decades the company has offered sequencing and bioinformatics solutions for single samples, transcriptomes and regulomes, up to whole genomes. GATC has sequenced more than 5 million samples, ten thousands of bacterial, plant or other whole genomes as well as hundreds of whole human genomes for its more than 10.000 academic and industrial customers worldwide.
GATC Biotech offers true multiplatform sequencing using all leading sequencing technologies in its own labs. GATC´s acknowledged bioinformatics solutions allow high-end data analysis for its customers in pharmaceutical, diagnostic, chemical or food industries as well as in academics. As an Agilent and Illumina Certified Service Provider, GATC enables full compliance with latest state-of-the-art standards. GATC acts as a supplier for the ICGC, the International Cancer Genome Consortium.

GATC´s subsidiary LifeCodexx emphasizes the development of clinically validated molecular diagnostic tests and offers a risk-free alternative to common invasive examination methods such as amniocentesis.

Press Contact:

GATC Biotech AG
Lisa-Annina Quintes
Jakob-Stadler-Platz 7
78462 Konstanz
Phone: +49 (0) 7531-81604117
Fax:     +49 (0) 7531-816081
Email:  l.quintes@gatc-biotech.com

Ness Ziona, Israel, December 5, 2012 / B3C newswire / - Sol-Gel Technologies Ltd. announced today positive results for a Phase II trial in the U.S. targeting mild-to-severe rosacea using a benzoyl peroxide drug product developed by Sol-Gel. Although benzoyl peroxide is an established treatment for acne, until now it has not been used for the treatment of rosacea because it causes a high degree of skin irritation. Sol-Gel's proprietary silica-based microencapsulation drug delivery system, successfully demonstrated in the study that it can ultimately provide a safe and effective first-in-class treatment.

Study Results
"The study results, could change the way physicians treat rosacea," said Dr. Alon Seri-Levy, Sol-Gel’s co-founder and CEO. Noting that encapsulated benzoyl peroxide (E-BPO) is the first drug in Sol-Gel's pipeline of innovative topical dermatological drugs to complete Phase II studies, he added: "We plan to initiate Phase III studies for E-BPO next year".

The double-blind, randomized, vehicle-controlled, dose-range study was carried out at eight medical centers in the U.S. on 92 rosacea patients. The patients received one of two doses of E-BPO or a vehicle gel (control group). The length of the treatment was 12 weeks. The two tested doses were 1% and 5% E-BPO.

The primary objective of the study was to identify the lowest dose of E-BPO gel that demonstrates both safety and effectiveness in the treatment of rosacea.

There were two primary efficacy endpoints: the proportion of subjects with the primary measure of success, defined as a 2-grade improvement in the Investigator Global Assessment (IGA) relative to Baseline at Week 12, with patients at Week 12 IGA being clear or almost clear of symptoms; and the change in inflammatory lesion count at Week 12.

In the current study, 53 percent of the patients treated with doses of 5% E-BPO achieved the primary success criteria compared to 20 percent of the vehicle control group.

Reduction in mean inflammatory lesion count was 69 percent for the 5% E-BPO group compared to 33 percent in the vehicle control group.

5% E-BPO gel showed a favorable safety profile and was well tolerated.

About Rosacea
Rosacea, a chronic and recurrent inflammatory dermatological disorder of unknown etiology, is common, especially in fair-skinned people of Celtic and northern European heritage. Rosacea affects about 16 million Americans; of these patients, only about 10 percent are treated. Rosacea, often misdiagnosed as acne vulgaris, usually starts as flushing and subtle redness on the cheeks, nose, chin, or forehead, and if left untreated, can slowly worsen over time. As the condition progresses, subjects experience inflammatory lesions (papules and pustules), vivid erythema, and telangiectasia. The onset of the disorder is usually between the ages of 30 years and 50 years. Alcohol, hot drinks, spicy foods, stress, sunlight, and extreme heat or cold can trigger the onset of this disease.

About Sol-Gel Technologies
Sol-Gel Technologies is a specialty pharmaceuticals company that develops innovative topical products for the dermatology market. Sol-Gel's patented delivery systems are designed to enhance the efficacy, safety and stability of topical drugs.
With topical drugs, there is often a trade-off between high efficacy on the one hand, and uncompromised tolerability on the other. Sol-Gel’s patented drug delivery systems provide an optimal solution by encapsulating active ingredients in an inert, silica shell. Sol-Gel’s microcapsules create an unnoticeable barrier between the active ingredient and the skin. The active ingredient migrates through the pores of the microcapsules, delivering effective doses into the skin, while the barrier improves tolerability of the active ingredient.

The Company was founded in 1997 to commercialize a breakthrough technology developed by co-founder Professor David Avnir of the Hebrew University of Jerusalem.

Contact:

Alon Seri-Levy
CEO
Sol-Gel Technologies Ltd.
7 Golda Meir St.Weizmann Science Park
Ness Ziona
74036, Israel
alon.seri-levy@sol-gel.com
Tel:  +972-8-9313433