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Sartorius Stedim Biotech Launches Sartoguard NF Prefilter Series

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  • Innovative nanofleece technology provides high flow rates and total throughput performance in combination with excellent clarification capabilities
  • New series concludes the launch of SSB´s Sartoguard range of prefilters

Goettingen, Germany and  Aubagne, France,  December 5, 2012 / B3C newswire / – Sartorius Stedim Biotech (SSB), a leading international pharma supplier, has launched the Sartoguard NF prefilter series, completing its range of Sartoguard prefilters. These new prefilters feature a unique combination of high performance polyethersulfone (PES) membranes and highly innovative nanofleece technology. This is the first time that PES nanofleece material is being used for liquid prefiltration applications in biopharmaceutical manufacturing. The newly developed nanofleece technology provides an ultrafine fleece structure based on a small nanofiber diameter of 120-150 nm compared with the fiber diameter of conventional fleece materials of >500 nm. The resulting fleece structure offers enhanced clarification capabilities, even for extremely fine contaminants, along with a high-dirt holding capacity, fast flow rates and high total throughput performance.

Sartoguard NF prefilters are the ideal choice for downstream protection of more expensive sterilizing-grade and Mycoplasma-retentive filters in challenging prefiltration applications for biopharmaceutical manufacturing. In combination with their high total throughput performance, Sartoguard NF prefilters offer significant cost-saving potential due to their ultrafine retention performance, which ensures removal even of extremely small particulate-based contaminants. All active filter materials – membranes and nanofleece – of the new prefilter series are made of polyethersulfone, thus ensuring a minimum extractable footprint. This enables users to easily implement Sartoguard NF into existing filtration processes utilizing final filters already based on PES.

Sartoguard NF filter elements are available in all common filter formats offered by Sartorius Stedim Biotech, such as SartoScale devices for small-scale filterability trials, as well as MidiCaps, MaxiCaps and standard filter cartridges for medium- and commercial-scale manufacturing. Sartoguard NF MidiCaps and MaxiCaps are the first fully gamma irradiatable prefilter series and can be easily integrated into single-use process equipment.

Sartoguard NF filters conclude the launch of the Sartoguard prefilter family, which includes the Sartoguard PES and Sartoguard GF prefilter series that have been successfully introduced to the market earlier. The launch of the Sartoguard prefilter family is an important contribution by Sartorius Stedim Biotech in reducing overall filtration costs in biopharmaceutical manufacturing and in helping biomanufacturers cope with the increasing cost pressure while maintaining and improving their high quality standards.

Sartoguard_NF-prefilter
Caption: The new Sartoguard NF prefilter series combines high flow rates and total throughput performance
(For high resolution picture please right click the image and select "Save target as...")


About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.” Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 2,850 people, and in 2011 earned sales revenue of 477.,3 million euros.


Contacts for Sartorius Stedim Biotech

Dominic Grone
Group Corporate Communications
+49 (0)551 308.3324
dominic.grone@sartorius.com

Karin Kleist
Group Corporate Communications
+49 (0)551 308.3615
karin.kleist@sartorius.com


SDK to Enter Purification Resin Market through Strategic Investment

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Tokyo, Japan, and Villach, Austria, December 7, 2012 / B3C newswire / - Showa Denko K.K. (SDK) has signed a strategic partnership agreement with BIA Separations (BIASep), of Austria. The partnership includes SDK’s investment in BIASep as well as joint marketing and R&D. With the partnership, SDK will be ready to expand its business to a market of purification resins used for manufacturing biopharmaceuticals and for industrial applications.

SDK is conducting a separation/refining business, developing, manufacturing, and selling various products pertaining to high-performance liquid chromatography (HPLC*). SDK has been providing a wide variety of analytical HPLC columns** with the brand name of “ShodexTM” for more than 40 years. The ShodexTM columns are delivered to wide-ranging customers in the world, including public institutions and R&D/quality control sectors of private enterprises, through the Showa Denko Group’s global sales network.

This time, SDK decided to enter the purification resin market through the strategic partnership with BIASep, expecting to achieve good synergistic effect in terms of both technology and product mix. The market is expected to grow rapidly with the expansion of the biopharmaceutical industry. SDK will fully utilize the technologies it has amassed through the ShodexTM business to enhance the synergies.

Purification resins are used for refining desired components/chemicals from culture/reaction solutions for biopharmaceutical and industrial manufacturing processes. SDK’s protein analysis technology and know-how acquired through the ShodexTM business will be fully utilized, as protein purification plays a key role in the purifying process for biopharmaceuticals.

Efficiency in purification is generally low, resulting in high production costs of biopharmaceuticals. However, BIASep has developed CIM® Monoliths*** (CIM Convective Interaction Media®), which ensure more efficient purification, compared with competitors’ purification resins. SDK has judged that it is best to enter into a tie-up with BIASep to realize a participation in the purification resin market.

Through the partnership arrangement with BIASep, SDK will acquire know-how concerning development, production, quality control, and marketing of purification resins. Furthermore, SDK will aim to strengthen business relations with producers of biopharmaceuticals, thereby expanding its separation/refining business.  


*HPLC:
A form of chromatography for analyzing compounds. Pressurized liquid is pumped into and passed through a column packed with gels. This process enables efficient separation as well as quick and high-sensitivity detection and determination of various compounds. This technology is applicable to any water- or oil-soluble compounds, and is used in wide areas such as organic chemistry, polymer chemistry, medicine, food, and environmental analysis.  

**HPLC columns: Stainless-steel or plastic columns packed with beads gels (spherical particles). A sample to be analyzed (liquid) is injected into the column from one end. Various chemical components contained in the sample are separated, depending on the characteristics of the particles and chemicals, extracted from the column, and analyzed. SDK offers more than 800 different types of HPLC columns.

*** CIM® Monoliths: Block-type formed media for purification and analytics. As various functional groups are attached to the surface, CIM® Monoliths enable more efficient separation and analytics (PAT) of viral particles and large biomolecules (proteins, DNA, etc.) compared to beads gels.


About BIA Separations
Head office: Villach, Austria
Establishment: 1998
Scope of business: Production and sale of short monolithic chromatographic columns based on CIM Convective Interaction Media® Technology
Managing Director and CEO: Dr. Ales Strancar
Number of employees: 80

CIM_Monolith

CIM® Monoliths

 

Contact:

Lidija Urbas, Ph.D.
BIA Separations
Tel.: +386 59 699 500
lidija.urbas@monoliths.com

AOP Orphan Pharmaceuticals Reports Positive Phase II Data of Novel Mono-Pegylated Interferon ...

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  • AOP Orphan announces results from phase II trial in PV at ASH Annual Meeting in Atlanta, U.S.A.
  • Promising efficacy and safety data support further development of AOP2014/P1101
  • AOP2014/P1101 received Orphan Drug designation in 2011
  • AOP Orphan is initiating a European phase III trial PROUD-PV to support European Marketing Authorization

Vienna, Austria, December 10, 2012 / B3C newswire / - AOP Orphan Pharmaceuticals AG (AOP Orphan) today announced that based on promising phase II data it will initiate a phase III trial to support European Marketing Authorization of a novel mono-pegylated Interferon alpha 2b (AOP2014/P1101) for treatment of Polycythemia Vera (PV).

AOP Orphan has exclusively licensed AOP2014/P1101 for development and commercialization in the field of Myeloproliferative Disorders (MPDs) with the territory of Central Europe, CIS and Middle East from Pharmaessentia Corp. a biotech company based in Taiwan. In contrast to other pegylated Interferons that require weekly administration, AOP2014/P1101 is applied only every other week, resulting in higher convenience and potentially improved tolerability, compliance and long term treatment outcomes.

Results from a phase II trial sponsored and conducted by AOP Orphan were presented yesterday Dec 9, 2012 in an oral presentation by Prof. Dr. Heinz Gisslinger from Vienna, Austria at this year´s prestigious annual ASH (American Society of Hematology) meeting held in Atlanta, U.S.A.

“Pegylated Interferons represent the most promising treatment modality for patients suffering from MPDs, even providing a chance for cure”, comments Prof. Gisslinger, University Hospital for Internal Medicine I, Hematology, General Hospital Vienna, Austria.

Data from 41 PV patients showed no dose limiting toxicities in a dose range from 50-540 μg given every two weeks, with a side effect profile in line with expectations based on other pegylated Interferons. The overall response rate exceeded 90%, at 12 months of treatment 45-50% of patients showed a complete response based on normalization of hematological parameters. A trend for normalization of spleen size was also observed at this relatively early time point. Importantly, after one year all patients were completely independent from phlebotomies. Furthermore, JAK2 allelic burden was reduced significantly and sustained starting from week 28 of treatment. Molecular responses are regarded as important disease modification with the ultimate potential for cure.

“We are extremely happy with these promising results of AOP2014/P1101, and will take all efforts to make this novel treatment available to patients”, said Dr. Rudolf Widmann, CEO of AOP Orphan.

Based on these results AOP Orphan is initiating a pivotal phase III trial involving Polycythemia Vera patients. The trial termed PROUD-PV will commence early in 2013 and will include centers all across Europe. Design and endpoints of this trial have been discussed between the European Medicines Agency EMA and AOP Oprhan to support a European Marketing Authorization, using EMAs centralized procedure. AOP2014/P1101 has received Orphan Drug designation already in 2011.


About Polycythemia Vera
Polycythemia Vera (PV) is a Rare Disease of the blood-building cells in the bone marrow primarily resulting in a chronic increase of red blood cells (erythrocytes), thereby having adverse impact on blood rheology. Circulatory disorders such as thrombosis and embolism, and also malignant transformation to myelofibrosis or leukemia, are possible outcomes of the disease.With proper treatment, the majority of PV patients have a near-normal life expectancy.

About AOP Orphan Pharmaceuticals AG (AOP Orphan)
AOP Orphan is a multinational Austrian company with a strong focus on clinical research , development and distribution of medicines for rare and complex diseases. Supplying patients and medical specialists with such medications requires the provision of extended services. Big global companies encounter frequent problems in serving such market segments optimally, a fact reflected in the rapid growth of AOP Orphan as we provide individualized and customized services to meet and accommodate for the needs of physicians and patients. AOP Orphan provides its services across all Central Europe, Middle East & Asia. Currently AOP Orphan is concentrating on orphan and complex diseases in hematology / oncology, cardiology, pulmonology, intensive care medicine, neurology and psychiatry.

About PharmaEssentia Corp.
PharmaEssentia Corporation is a fully integrated biopharmaceutical company established by a group of Taiwanese-American scientists. Headquartered at the state-of-the art facility - NanKang Science Park - Taipei, Taiwan, creating and providing products to improve the quality of life for patients suffering from various diseases. Our mission is to discover, develop, and bring to the market efficacious, safe and cost-effective therapeutic products for human disease. Our strategy is to leverage our resources in a flexible and dynamic way for the benefit of patients and the best return for our shareholders.


Contacts
AOP Orphan Pharmaceuticals AG
Mag. Daniela Gruber
Wilhelminenstraße 91/IIf
1160 Wien
T +43 1 503 72 44-42
F +43 1 503 72 44-61
M daniela.gruber@aoporphan.com

PharmaEssentia Corp.
Shu-Fen Li , MBA
Director, Strategic Planning and Business Development
shufen_li@pharmaessentia.com
Tel: +886-2-26557688 #7812
Address: 13F, No.3, YuanQu St. NanKang Dist. Taipei 115, Taiwan

PharmaTainer™ Single Use Bottles and Carboys Now Meet USP 788

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Bascharage, Luxembourg, December 11, 2012 / B3C newswire / - Cellon SA announced today that their entire range of PharmaTainer™ bottles and carboys are now certified “clean,” meeting USP 788 Particulate Matter in Injections, and the equivalent EP and JP quality standards.

Pharmatainer™ products are currently manufactured in PC and PET in sizes from 125ml to 20 litres. Cellon opened its state-of-the-art production moulding facility in Luxembourg in 2011. The plant is 100% dedicated to production of clean, single- use products for use in the vaccine and bio-processing sector, and operates under an ISO 9001-2008 quality system.

Micron

Caption: 10/25 Micron particulate in 125 mL bottle vs. limit.
(For high resolution picture please right click the image and select "Save target as...")

PharmaTainer™ carboys and bottles are manufactured in an ISO class 5 (class 100) environment and sterilised by irradiation to a SAL of 10-6. Certification to the USP 788 is based on liquid particle count analysis on a lot by lot basis.

Designed specifically for the storage and transport of bulk vaccines, biopharmaceuticals, bulk intermediates and other biotech materials, PharmaTainer™ products also provide tamper evident packaging and are first in the industry to provide bottle labelling for individual bottle traceability and inventory control.

Speaking for Cellon, Managing Director Richard Fry said, “The PharmaTainer™ range addresses directly the main quality concerns for single-use storage and transport containers in the industry, i.e. particulate and traceability. By dedicating our facility to production of clean products, we ensure that all our products are made to a single, high standard. We reduce risk by manufacturing for a single purpose and quality standard. So, there is less opportunity for error in our operations than in multipurpose moulding facilities that manufacture products of differing levels of cleanliness using multiple grades of materials.

We welcome customers and prospective customers to visit and/or audit our facility so they may see first-hand the quality systems we have in place”.

For more information on particulate testing and PharmaTainer™ cleanliness, visit www.cellon.lu or www.biofluidfocus.com.


About Cellon
For 25 years, Cellon has provided products and services to the biopharma and vaccine manufacturing industries in Europe. Innovation, quality and customer service have made Cellon a trusted vendor for many of the world’s leading biopharma and vaccine manufacturing companies. Sterile, single-use products and tissue culture apparatus are areas of special focus.

About Biofluid Focus
Biofluid Focus is a distributor of plastic products for biotechnology industries and is the exclusive North American distributor of PharmaTainer™ products. Staff members are experienced in manufacturing processes and quality requirements for a broad range of single-use products, including tissue culture labware and containers.


Contact

Richard Fry
Cellon SA
ZAE Robert Steichen
16, rue Hèierchen
L-4940 Bascharage
G.D. Luxembourg
Phone: 352-263-373
Email: richard.fry@cellon.lu  

Vetter Receives “Known Consignor” Approval from Germany's Federal Aviation Office

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The CDMO meets new requirements six months ahead of deadline

Ravensburg, Germany, December 11, 2012 / B3C newswire / – Vetter has announced that it has now been approved as a “Known Consignor” by the German Federal Aviation Office. The agency officially granted the pharmaceutical service provider the certificate of approval following an audit at Vetter´s Holbeinstrasse and Ravensburg Vetter West facilities. The approval means that customers will continue to have their air cargo products loaded, transported and delivered quickly and safely, saving valuable time and money.

Vetter had already been designated as a “Known Consignor” back in 2006. The goal of the certification is primarily to provide more security for air cargo. Until recently, logistics companies themselves issued the certificate. New EU regulations concerning the so-called "safe supply chains" require that companies must now have their status audited and approved by the Federal Aviation Office. The criteria for certification are extensive and include elaborating a safety concept, training personnel, and the assurance that the shipping of freight is performed in a way that cannot be tampered with. Any attempt to open the shipment would be immediately evident. The Federal Aviation Office grants the certificate for five years and carries out unannounced controls on a regular basis.

"Our approval as a "Known Consignor" allows our customers fast and smooth loading of air freight packages at the airport, including a high level of security,” said managing director Thomas Otto. “Once time-consuming x-rays and searches are no longer necessary, saving invaluable effort and cost. For Vetter, the status of ”Known Consignor” is further proof of the high product quality that we offer our customers.”


About Vetter

Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States. For more information about Vetter, visit www.vetter-pharma.com.

 
Contact
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Phone: +49 (0)751-3700-3729
Fax: +49 (0)751-3700-7707
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com

euroPLX Meetings to Continue Strongly in 2013

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Dielheim, Germany, December 13, 2012 / B3C newswire / - After 50 successful euroPLX Meetings that have been held all over Europe in the past 18 years this international business development platform for the pharmaceutical and biopharmaceutical industries announces the confirmed events for 2013:

 

euroPLX 51 Limassol (Cyprus)
March 4 + 5, 2013
Amathus Beach Hotel, Limassol

euroPLX 52 Munich (Germany)
June 10 + 11, 2013
Sofitel Munich Bayerpost

euroPLX 53 Barcelona (Spain)
November 25 + 26, 2013
Hotel Rey Juan Carlos I

euroPLX Meetings are not only the most often held partnering conference of this industry worldwide, they are also among the most international and most productive, with an average of 23 to 25 pre-scheduled negotiations per company held at each euroPLX Meeting and 35 to 36 countries represented.

Contrary to other partnering events, the euroPLX concept does without any distracting features such as shows, exhibitions, presentations, or lectures, but focuses on business deals only.

Registrations for all 2013 events are now accepted online on www.europlx.com.


Contact
Dr. Norbert Rau
RauCon
Kurfürstenstr. 1A
69234 Dielheim, Germany
T +49 (0) 6222 9807-11
nr@raucon.com
www.raucon.com

PDC Biotech GmbH Announces Successful Clinical Phase I for Its Lead Compound PDC31

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Vienna, Austria, December 13, 2012 / B3C newswire / - PDC Biotech GmbH (PDC) today announced that it has successfully completed a phase I clinical trial for its lead compound for the treatment of preterm labour . This study was designed to evaluate safety as well as provide proof-of-concept for the ability of the compound to inhibit excessive uterine contractility.

The study was conducted in healthy women with primary dysmenorrhea , a condition associated with painful, labour-like contractions which occur during menstruation. PDC31 infusion was associated with a dose-dependent relief of pain, as well as a reduction in intrauterine pressure. In addition, the drug was very well tolerated and there were no dose limiting toxicities.

The results from this study support the continued development of PDC31 for both preterm labour and primary dysmenorrhea. Dr. Roman Götz, Managing Director of the company said: “We are pleased with the encouraging results of this study, which now enable us to move forward into further development for the preterm labour indication.”

Dr. Ernest Loumaye (Chairman of the Board) said: ”The first administration in human study is an important step toward the development of this first in class compound, as the compound is well tolerated and pharmacodynamic results provide preliminary evidence in man of the validity of the target for the selected indications.”


About PDC31
PDC31 is a synthetic octapeptide which was designed to act as an allosteric modulator of the receptor for prostaglandin F2? (FP receptor). PDC31 exerts its effects at a site distinct from the binding site for PGF2?; the putative mechanism of action is that it interferes with certain interactions between specific FP receptor domains, thereby biasing PGF2?-mediated signaling via the G?q-PKC-MAPK pathway, while decreasing signaling through the G?12-Rho-ROCK pathway. The net effect of this altered signaling is the inhibition of contraction.

Preterm Labour
Preterm labour is defined as regular uterine contractions associated with cervical changes occurring before 37 weeks of gestation. Preterm birth, which is associated with increased risk of neonatal morbidity and mortality, is most often preceded by preterm labour. Preterm birth rates, currently 8 to 12 % of all births, are rising worldwide. Preterm birth is the leading cause of neonatal death and is associated with an increased risk of neonatal morbidity as well as longer term development deficits.

Primary Dysmenorrhea
Primary dysmenorrhea is a disabling condition found in women of childbearing age with a high prevalence among adolescent females. Severe abdominal pain is caused by frequent and prolonged uterine contractions that decrease blood flow to the myometrium resulting in ischemia.

About PDC Biotech GmbH
PDC Biotech GmbH (PDC) is an Austrian biotechnology company focused on women's health. PDC is a developing novel compound which targets the prostaglandin F2a receptor for the treatment of preterm labour and primary dysmenorrhea. PDC has licensed exclusive worldwide rights to a family of FP receptor antagonists from Theratechnologies Inc. (www.theratech.com). The company’s development efforts have been significantly supported by its lead investors MIG (www.mig.ag ) and Edmond de Rothschild Investment Partners (www.edrip.fr ) as well as by the AWS (Austrian public funds) and the ZIT (public funds of the City of Vienna).


For more information, please contact
PDC Biotech GmbH
info@pdcbiotech.com

Phenex Enters Into a Research Collaboration and License Agreement with Janssen for Autoimmune ...

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Phenex will receive an upfront payment and is eligible to receive development-related milestones.

Ludwigshafen, Germany, December 17, 2012 / B3C newswire / -  Phenex Pharmaceuticals AG (Phenex) today announced it has entered into an agreement with Janssen Biotech, Inc. and its affiliates (Janssen) to jointly discover compounds that target the nuclear hormone receptor RORγT and may have utility in the treatment of chronic autoimmune and inflammatory disorders including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Under the terms of the agreement Phenex will receive an upfront payment and milestone payments upon the achievement of specific development and regulatory events that could total as much as US$135 million. In addition, Phenex will also be eligible to receive tiered royalties and milestones on the worldwide sales of products that arise from the collaboration.

Researchers from Phenex and Janssen will work collaboratively towards the goal of identifying compounds that are active against RORγT and optimized for preclinical development. Thereafter, Janssen will have sole responsibility for the continued development and worldwide commercialization of any compounds that arise from the collaboration.

“This collaboration represents a landmark deal for Phenex” comments Dr. Claus Kremoser, CEO of Phenex. “It combines Phenex’s nuclear receptor expertise, the accomplishments of itsRORγT program and the immunology expertise of Janssen so that we will work together to discover new RORγT based treatments for autoimmune diseases. We hope that small molecule drugs that target ROR?T will prove to be a safe, effective and affordable means to treat autoimmune disease, a marketplace within which there remains a need for differentiated therapies. ”

Thomas Hoffmann, CFO of Phenex complements: “The upfront payment and near-term milestones that may be achieved through this collaboration are quite important for Phenex as the funds received will make it possible for us to both collaborate with Janssen on RORγT and continue the clinical development of our proprietary FXR program through the next few years. By way of this agreement Phenex will be able to fund its operations and does not expect to seek further equity financing. Phenex maintains a favourable and exciting position in its ability to both help the patients who could benefit from RORγT based therapies and provide our shareholders with a satisfactory return on their investments.”

 
About the target RORgamma(t):
RORgamma(t) RORγT) is a Nuclear Receptor that was recently identified as a key differentiation factor of Th-17 cells; immune cells that produce and secrete Interleukin-17, which is believed to be a key player in chronic autoimmune-related inflammation. The relevance of the IL-17 pathway has been highlighted by the fact that antibodies that target key cytokines in this pathway have demonstrated impressive efficacy in reducing symptoms in patients with plaque psoriasis. RORγT induces the production of IL-17 and is known to bind small molecules. Thus, small molecule therapies that act on RORγT have the potential to block the IL-17 pathway in a similar fashion to monoclonal antibodies. The effectiveness of inhibiting the IL-17 pathway through small molecule RORγT inhibitors was recently demonstrated in animal models in two adjacent publications in Nature (Huh et al., Nature 472(7344) 486-90(2011); Solt et al., Nature 472(7344) 491-4 (2011)).

About Phenex Pharmaceuticals AG:
Phenex is a privately held drug discovery and development company headquartered in Ludwigshafen and with a research site in Heidelberg. The company focuses on novel attractive nuclear receptor targets to develop innovative small molecule therapeutics, including in the fields of liver diseases / Non-Alcoholic Steatohepatitis (FXR program) and autoimmune diseases / inflammatory disorders (RORγT program).

Phenex’s most advanced program is based on Px-102, for which two Phase I studies have recently been completed. Px-102 targets and is an agonist of the nuclear bile acid receptor FXR. Px-102 has unique properties in showing beneficial effects of lipid lowering, improving insulin sensitivity, reducing body weight and ameliorating the liver inflammation and fibrosis that is a hallmark of Non-Alcoholic Steatohepatitis (NASH). NASH is a metabolically induced liver disease having a worldwide prevalence of at least 25 million affected individuals. If untreated, NASH can progress towards liver cirrhosis and liver failure, or even to Hepatocellular Carcinoma (HCC). There is no approved treatment for NASH. Px-102 addresses this medical need and presents a significant commercial opportunity.

Phenex is financed through four consecutive rounds of funding totalling 22 million Euros. The current circle of investors into Phenex includes EVP Capital Partners/VRP, LBBW Venture, Creathor Venture, KfW, and CD Venture, as well as private individuals and key people from the pharmaceutical and high-tech industry.


Contact 

Phenex Pharmaceuticals AG
Dr. Claus Kremoser
Thomas Hoffmann
Donnersbergweg 1
D-67059 Ludwigshafen
Germany
Phone: +49-6221-65282-0
Fax:      +49-6221-65282-10
info@phenex-pharma.com

 

 


Sartorius Stedim Biotech Expands PAT Software Portfolio for Optimization of Biopharmaceutical ...

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  • Chemometrics software for Design of Experiments (DoE) and multivariate data analysis (MVA)
  • Global partnership with Swedish software manufacturer Umetrics AB

Goettingen, Germany, December 18, 2012 / B3C newswire / –Sartorius Stedim Biotech (SSB), a leading international pharmaceutical and biotech supplier, has entered into a global sales partnership with Umetrics AB, a Swedish software manufacturer. Umetrics is a highly specialized, leading provider of chemometrics software worldwide for modeling and optimizing biopharmaceutical development and manufacturing processes.

The cooperation agreement provides that SSB will assume global marketing and distribution of the complete Umetrics portfolio for the pharmaceutical and biopharmaceutical industries. SSB will integrate Umetrics software programs as private label products into its own bioprocess portfolio and market these as stand-alone solutions under both brands under a dual branding arrangement. Stefan Schlack, Senior Vice President of Marketing at SSB commented: “These software solutions will help our customers to better understand their cell culture processes and to identify potential for optimization and robust process control – an ideal addition to our bioprocess portfolio.”

The major areas of application for these software systems are critical process steps, such as cell culture processes or specific purification steps in the biopharmaceutical industry. Multivariate data analysis (MVA) enables all process parameters to be added in batch trajectories, among other things, so that process variations and their causes can be displayed transparently in real time. DoE software (Design of Experiments) permits these critical process parameters to be efficiently identified and quantified and development cycles to be considerably shortened.

Umetrics stands to benefit from the global sales structures of SSB. “With SSB, we can gain access to substantially more customers thanks to its international reach and solid market standing in the biopharma sector. SSB’s integrated solutions for the complete biopharmaceutical process clearly create added value for our customers. I anticipate that this will considerably boost the biopharmaceutical industry’s interest in and usage of our products,” says Lars Lindstorm, General Manager of Umetrics.


About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.” Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 2,850 people, and in 2011 earned sales revenue of 477.3 million euros.

About Umetrics
Umetrics is a world leader in multivariate technology, providing software for design of experiments (DOE) and multivariate data analysis (MVDA). Umetrics offers complete solutions for both off-line and online data analysis (continuous and batch processes), all supported by training and consulting services. Umetrics is a subsidiary of MKS Instruments, Inc. (NASDAQ: MKSI), a worldwide provider of monitoring and control technologies.


Contact for Sartorius Stedim Biotech
Karin Kleist
Group Corporate Communications
+49.(0)551.308.3615
karin.kleist@sartorius.com

Contact for MKS Umetrics AB
Amos Dor
Director of WW Sales & Operations
134 Rio Robles Dr., San Jose, CA 95134
+1 (408) 750.2907
amos.dor@umetrics.com

Sartorius Stedim Biotech Expands Portfolio by Adding Cell Culture Media

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Lonza Logo sarto-stedim-bio logo
  • Sartorius Stedim Biotech assumes global sales and marketing of media and buffer solutions for biopharmaceutical manufacture
  • Long-term collaboration, supply and distribution agreement with Swiss-based life science group Lonza

Goettingen, Germany, December 19, 2012 / B3C newswire / – Sartorius Stedim Biotech (SSB), a leading international pharmaceutical and biotech supplier, today announced a substantial expansion of its product array in the cell culture range. The company signed a cooperation agreement with the Swiss-based life science group Lonza on long-term, global collaboration in the field of cell culture media. Cell culture media are growth substances and nutrients for cells or microorganisms and are required in every biopharmaceutical manufacturing process.

The cooperation agreement provides that SSB will assume global sales and marketing of Lonza’s media and buffers used in the manufacture of protein-based therapeutics and vaccines, while Lonza will continue to carry out development, manufacture and logistics operations for these products. New product development will be mutually performed. The cell culture media, which are usually sold in liquid or powder form to biopharmaceutical customers, are to be successively converted to packaged forms as ready-to-use, prefilled SSB sterile single-use bags. Furthermore, Lonza and SSB have agreed that these cell culture media will be sold under both brands in a co-branding arrangement.

In fiscal 2011, Lonza generated revenue of around 20 million euros with its cell culture media business. SSB will take over Lonza’s commercial team of approximately 15 media specialists. Both parties have agreed not to disclose further contractual conditions.

Lonza’s cell culture media represent an ideal fit with the portfolio of products supplied by Sartorius Stedim Biotech, which already offers bioreactors and single-use bags and containers as key components for cell cultivation. “I am very pleased that we will now be adding a market-leading, high-quality array of media and buffers to our product offering,” commented SSB’s Member of the Board of Directors, Reinhard Vogt. “Just like our single-use bags and bioreactors, culture media are critical to the success of safe and efficient manufacture of drug materials. The demand for ready-to-use and innovative products is accordingly high. In the manufacture of biologicals, our customers will benefit from obtaining fully integrated single-use solutions for their entire cell culture process all from a single source.”

“For Lonza this agreement provides great upside potential as it will allow us to capture additional value from our Media Business in the form of additional revenue leading to higher capacity utilization”, comments Lukas Utiger, COO of Lonza Bioscience. “Lonza and Sartorius are a great fit as both partners bring complementary strengths to the benefit of our customers.”

This press release contains statements about the future development of the Sartorius Stedim Biotech Group. We cannot guarantee that the content of these statements will actually apply because these statements are based upon assumptions and estimates that harbor certain risks and uncertainties

 
About Lonza
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of chemical and biological active pharmaceutical ingredients. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. Its activities encompass the areas of water treatment, personal care, health and hygiene, industrial preservation, materials protection, and wood treatment. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza is not subject to the SGX-ST’s continuing listing requirements. Lonza is subject to the listing rules of the SIX Swiss Exchange, which do not have specific requirements equivalent to the listing rules of the SGX-ST in respect of interested person transactions, acquisition and realizations, and delisting. In 2011, the company had sales of CHF 2.692 billion. Further information can be found at www.lonza.com.

About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.” Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 2,850 people, and in 2011 earned sales revenue of 477.3 million euros.

 
Contact for Sartorius Stedim Biotech
Petra Kirchhoff
Group Corporate Communications and Investor Relations
Tel +49 (0)551 308 1686
petra.kirchhoff@sartorius.com

Contacts for Lonza
Lonza Group Ltd
Head of Corporate Communications
Dominik Werner
Tel +41 61 316 8798
Fax +41 61 316 9798
dominik.werner@lonza.com

Lonza Group Ltd
Investor Relations
Dirk Oehlers
Tel +41 61 316 8540
Fax +41 61 316 9540
dirk.oehlers@lonza.com

Lonza Group Ltd
Media Relations
Melanie Disa
Tel +1 201 316 9413
Fax +1 201 696 3533
melanie.disa@lonza.com

 

New Drug Discovery Company NeRRe Therapeutics Created to Develop Neurokinin Antagonists from GSK

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11.5 million GBP Series A Financing from Novo A/S and Advent Venture Partners

London, UK, December 19, 2012 / B3C newswire / -  NeRRe Therapeutics Ltd, is launched today to develop a portfolio of clinical and pre-clinical neurokinin receptor antagonists divested from GlaxoSmithKline (“GSK”).

NeRRe has raised £11.5 million ($18.4 million) in Series A financing to support the progression of these molecules into clinical studies in diseases for which there is substantial unmet medical need.

The initial focus of the funding is on the most advanced neurokinin-1 receptor antagonist in this pipeline which is being repositioned for a new indication.

The Company founders, Dr Emiliangelo Ratti and Dr Mike Trower, are both former senior leaders of neurosciences drug discovery at GSK and have intimate knowledge of the transferred assets and the neurokinin field. Dr Ratti will become Chief Executive Officer of NeRRe and Dr Trower will take the role of Chief Scientific Officer.

NeRRe Therapeutics’ shareholders include Novo A/S (Novo), Advent Venture Partners (AVP), and GSK. Dr Martin Edwards (Novo Ventures) and Dr Raj Parekh (AVP) will each join NeRRe’s Board.

The Company will be based at the state-of-the-art Stevenage Bioscience Catalyst, the UK's first open innovation bioscience campus.

Commenting on today’s launch of NeRRe, Dr Emiliangelo Ratti, Chief Executive Officer, said: "I am extremely excited about the prospect of progressing further the development of NeRRe’s neurokinin receptor antagonist pipeline. With our knowledge and insights into the neurokinin receptor system, we look forward to developing these assets in high value indications where there is unmet need. I am pleased to acknowledge the strong support received from GSK to launch this new enterprise together with the commitment received from our investors, who share our belief in the potential of the company’s portfolio."


About NeRRe Therapeutics
NeRRe Therapeutics was formed in November 2012 and is focussed on the development of neurokinin receptor antagonists acquired from GlaxoSmithKline (“GSK”). NeRRe is led by the company founders, Dr Emiliangelo Ratti, Chief Executive Officer and Dr Mike Trower, Chief Scientific Officer; who together have extensive experience in the neurokinin field. NeRRe Therapeutics is funded by leading life science investors, Novo A/S and Advent Venture Partners.

About Novo A/S
Novo A/S is the holding company of the Novo Group, and is wholly owned by the Novo Nordisk Foundation. It was established in 1999 to manage the assets of the foundation and actively make investments on its behalf. Novo Ventures is the part of Novo A/S focused on life sciences venture capital, and is active in both Europe and North America. The firm has four partners in Copenhagen, one in London and three in San Francisco. With an evergreen structure, it annually invests approximately $100M in venture capital into private life sciences companies. For more information, visit: www.novo.dk

About Advent Venture Partners
Advent Life Sciences is the dedicated Life Sciences team at Advent Venture Partners, one of Europe’s best established growth and venture capital firms. Advent Life Sciences invests predominantly in early-stage and growth equity life sciences companies in the UK, Europe and the US. It will back companies that have a first- or best-in-class approach in a range of sectors within the life sciences sector, including new drug discovery, enabling technologies, med-tech and diagnostics.

Advent Life Sciences is a leader in European life sciences venture capital. Its investments include: PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases that was acquired by Johnson & Johnson; EUSA Pharma, a transatlantic speciality pharmaceutical company acquired by Jazz Pharmaceuticals; Avila Therapeutics, a biotechnology company developing targeted covalent drugs acquired by Celgene Corporation, Micromet, a biotechnology company acquired by Amgen and Algeta (OSE: ALGETA), an oncology company developing treatments for bone metastases and disseminated tumours.


For more information about NeRRe Therapeutics, please contact:

Dr Emiliangelo Ratti
Chief Executive Officer
Tel : +39 348 2690238

CEVEC Pharmaceuticals Signs License Agreement with Yuhan Corporation of South Korea

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Cologne, Germany, December 20, 2012 / B3C newswire / - CEVEC Pharmaceuticals (“CEVEC”), the developer of a novel human expression system derived from amniocytes, and Yuhan Corporation (“Yuhan”), a leading manufacturer of pharmaceutical products based in Seoul, South Korea announced today the signing of a CAP-Technology license agreement. The license will enable Yuhan to utilize CEVEC’s CAP-T™ and CAP® cell expression systems for the production and development of various therapeutic proteins.

CAP-T™ CAP® cells are immortalized cell lines for transient and 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 Technology allows for superior protein yields in a shorter time frame than traditional methods.

“With Yuhan Corporation we have won one of the most prestigious Asian Pharma Companies as a customer. We’re very pleased that Yuhan has chosen our CAP and CAP-T expression sytems as a pivotal platform to develop therapeutically relevant molecules. I’m convinced that the cells will have a major impact to develop more efficient biologics and will also shorten the timeline to enter clinical phases “ stated Wolfgang Kintzel, CEO at CEVEC. 

Dr. Jong-Gyun Kim, Head of the Bio-Innovation Unit at Yuhan Research Institute said: “After evaluating CAP and CAP-T we are excited about the potential of CEVEC’s CAP Technology. We obtained outstanding results from transfections of various target proteins in CAP-cells and we are convinced that this expression system with it’s authentic human glycosylation profile will be of great benefit to further develop our pipeline molecules"


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™ 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 Yuhan
Yuhan Corporation, the leading pharmaceutical company in South Korea, is focusing its R&D capabilities on new chemical entities, new biologics, herbal medicines, and APIs for global markets. For the last 86 years, Yuhan is committed to deliver advanced and innovative medicines with a slogan “Innovative, Nimble, and Translational R&D”. In 2007, ‘Revanex’, the world’s first acid pump agonist was out-licensing to China, and is now supplied world-wide to markets in Asia. Yuhan is to become the global premiere customer-focused pharma company with value driven, globally competitive R&D capability.


Contact

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
www.cevec.com

Jong-Gyun Kim, Ph.D.
Head, BioInnovation Unit, Yuhan Corporation
416-1 Gongse-dong, Yongin-si, Korea
Tel +82 31-899-4168
Fax +82 31-275-6145
myseed@yuhan.co.kr

CEVEC Pharmaceuticals and Vakzine Projekt Management Sign Exclusive License Agreement on the ...

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Cologne, Germany, January 3, 2013 / B3C newswire / - CEVEC Pharmaceuticals (“CEVEC”), the developer of the CAP® Technology, a novel human expression system derived from amniocytes, and VPM – Vakzine Projekt Management GmbH, announced today the signing of an exclusive license agreement on VPM’s proprietary human CMV dense body technology.

CAP® Technology is based on an immortalized human cell line for vaccine and protein production developed by CEVEC for industrial use. The serum-free suspension culture of this proprietary cell line allows for high virus yields for a broad variety of human pathogenic viruses. CAP® cells are uniquely suited to produce vaccines against challenging viral targets like human CMV. The non-infectious dense bodies are considered to be one of the most promising new CMV vaccine approaches since they result in efficient and long-lasting immunity. The CMV dense body project is foreseen to enter clinical development within the next 18 months. CEVEC receives exclusive word-wide development and commercialization rights from VPM and VPM will substantially contribute by taking over development project management services for the project. The inventor of the CMV dense body technology, Prof. Dr. Plachter, an internationally reputed CMV expert, actively supports in the project as leading scientific expert.

“With VPM we are teaming up with a very reputed development partner in the field of state-of-the art vaccines for current high-medical need diseases like human CMV. We’re very pleased that VPM and CEVEC are combining our CAP® suspension cells as the enabling production platform with VPMs unique dense body technology. I’m convinced that the dense body technology and CAP® are a perfect match and the combined efforts will substantially shorten the timeline to enter clinical phases,“ stated Wolfgang Kintzel, CEO at CEVEC.  "This project shows a scientific and commercial potential untapped in the field of currently pursued viral vaccine targets, " Dr. Rainer Lichtenberger, CFO/COO at CEVEC complements.

“It is a great success story in translational research for VPM and Helmholtz Centre for Infection Research that we were able to bring this early stage vaccine project from academia to industry. With the out-licensing of the CMV dense body project to CEVEC, VPM could again demonstrate that its translational business model is instrumental in developing promising vaccine candidates to a stage of maturity where they can envisage a full pharma development. Cooperating with Cevec will help this potentially live-saving vaccine to tap its full potential”, added Dr. Bernd Eisele CEO of VPM.


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-TTM 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 and is developing the CAP technology as a superior production platform to enable difficult to produce viral targets.

About VPM – Vakzine Projekt Management GmbH
VPM was founded in 2002 from Helmholtz-Center for Infection Research. VPM has been active in developing promising biopharmaceutical candidates from academic research. Several products, ranging from small molecules, recombinant proteins up to live vaccines and ATMPs, have successfully been brought into clinical phase I and II trials by VPM and its team members. VPM now offers its experience in translational project management and regulatory liason to its clients in Pharma, Biotech, and Academia. VPM moves developmental products to the clinical stage faster, more cost-efficiently, and with higher success rates.


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
www.cevec.com

Bernd Eisele, MD, CEO
Vakzine Projekt Management GmbH
Mellendorfer Straße 9
D-30625 Hannover, Germany
fon: +49 511 1699080
fax: +49 511 16990829
info@vakzine-manager.de
www.vakzine-manager.de

Ethris Announces Research Based Alliance on SNIM® Modified RNA with Shire

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ethris Logo

Munich, Germany January 7, 2013 / B3C newswire / - Ethris GmbH and Shire today announce the initiation of a research based alliance focused on the development and commercialization of novel RNA-based therapeutics.

Many devastating human diseases are the result of an inability of the body’s cells to make specific proteins that have an essential function for the whole body. The replacement of proteins with normally functioning ones provides a potential approach to treat multiple devastating diseases. Ribonucleic acids (RNAs) that encode for such proteins have been the focus of much biopharmaceutical research and development, however, RNA’s inherent instability and immunogenicity has proven to be a significant hurdle in the past.

Based in Munich, Germany, ethris and its co-founders – Dr. Carsten Rudolph and Prof. Christian Plank, have developed a novel RNA modification technology that creates Stable and Non-Immunogenic Messenger RNA (SNIM®-RNA) molecules that are ideally suited for use in protein replacement therapies to treat monogenic genetic diseases.

“We are delighted to extend our existing collaboration with Shire that may bring novel therapeutics to patients suffering diseases with significant unmet medical need. We aim to provide significant numbers of patients with new therapeutic alternatives that may provide a lasting solution to their disease,” stated Dr. Carsten Rudolph, CEO and co-founder of ethris.

“As a leader in the treatment of rare diseases, we are pleased to be working with ethris to develop SNIM®-RNA based therapies, with the objective of developing new treatment options to patients suffering from these rare disorders” said Dr. Philip J. Vickers, Global Head of Research and Development, Shire Human Genetic Therapies.

“With Shire we have a partnership based on a shared appreciation of the importance of our SNIM® technology. Under this partnership, we are aiming to develop an RNA modification and delivery technology that efficiently results in protein replacement in relevant cellular populations, providing hope to patients suffering from genetic diseases which have devastating clinical outcomes” commented Prof. Christian Plank CSO and co-founder of ethris.

The financial details of the alliance have not been disclosed.

 
About ethris GmbH
Ethris GmbH is a young biopharmaceutical company based in Munich, Germany. Founded by Dr. Carsten Rudolph and Prof. Christian Plank, recognized opinion leaders in the field of ribonucleic acid-based science. The company currently employs 17 scientists. ethris is financed by QureInvest II, a life sciences investment fund managed by HS LifeSciences, Düsseldorf Germany.


Contact

Ethris GmbH
Carsten Rudolph, PhD
CEO
+49 (0) 89 89 55 788 0
info@ethris.com

 

Aspireo Reports Somatoprim Phase I b Interim Data

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Preliminary Data Analysis Supports Excellent Safety and Side Effect Profile of Somatoprim

Tel Aviv, Israel, January 7, 2013 / B3C newswire / - Aspireo Pharmaceuticals Limited, (“Aspireo”) an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), today announced results of an interim analysis of a phase I b study. This single centre study is investigating the safety, side effect profile, as well as pharmacokinetic and pharmacodynamic profile of multiple ascending doses of Somatoprim in healthy male volunteers, when administered alone and in combination with octreotide.

The preliminary data confirms the excellent safety profile of Somatoprim, with the maximum tolerated dose not reached. No serious adverse events were reported. The few reported adverse events were generally mild to moderate and transient. Somatoprim also demonstrated a dose-dependent lowering effect on growth hormone (hGH), as shown by an analysis of the pharmacodynamic effect on hGH, when stimulated by growth hormone releasing hormone. The interim analysis also supports the beneficial side effect profile of Somatoprim when compared to octreotide.

The company expects final data to be available in Q2 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 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 currently in phase I/II of clinical development. 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.

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 analog 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 additional information please go to www.aspireopharma.com


For further information please contact

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


Priaxon Enters Collaboration with GSK on Protein-Protein-Interactions

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Priaxon announces a collaboration with GlaxoSmithKline (GSK) to establish and develop novel drug discovery approaches to address protein-protein-interactions with small molecules

Munich, Germany, January 8, 2013 / B3C newswire / - Priaxon, an emerging pharmaceutical company based in Germany, today announced a collaboration with GlaxoSmithKline (GSK) to research and develop small molecule modulators of protein-protein-interactions. Priaxon will provide its innovative and proprietary small molecule drug discovery expertise which is particularly suited to investigating the modulation of protein-protein interactions (PPIs). PPIs play an important role in many cell signaling pathways and cell-surface receptor-ligand interactions that become dysregulated in disease states.

This collaboration will work to identify and advance candidates from hits to leads for pre-clinical development, with the long term interest of developing and commercialising drug candidates. The agreement has been signed following a successful pilot project. Financial details as well as therapeutic fields of the collaboration are not disclosed.

"Using the strength of its unique drug discovery platform Priaxplore®, Priaxon will develop new small molecule modulators for hard-to-drug PPI targets," said Dr. Juergen Kolb, CEO of Priaxon. "Our collaboration with GSK and its experts provides the resources and the capabilities to drive these programs forward. We are looking forward to working together with the goal to develop small molecule modulators for various protein-protein interaction of high potential."


About PPIs
Protein-protein-interactions (PPIs) are highly attractive targets for a variety of indications and could become successors of kinases as prime targets for a whole era. PPIs pertain to numerous therapeutic fields like cardiovascular and metabolic diseases or oncology. This class of targets has been regarded as undrugable for a long time. Now, successful approaches to address this class together with their high relevance in cellular signaling pathways and regulation make them attractive potential targets for future developments. Chemistry and technology of Priaxon are particularly suited for addressing PPIs.

About Priaxon
Priaxon is an emerging pharmaceutical company building a pipeline of novel drug candidates in different therapeutic fields, but mainly focusing on protein-protein interactions in oncology and other diseases. Priaxon uses its unique and proprietary drug discovery technology platform Priaxplore® which employs novel methods of chemical synthesis and computational design to discover and develop new chemical entities as candidates for validated but hard-to-drug targets.


Contact

Dr Jürgen Kolb, CEO
Priaxon AG
Gmunder Str. 37-37a
D-81379 München
Phone: +49 - 89 - 4521308-20
kolb@priaxon.de
www.priaxon.com

NovAliX Enters into Fragment-Based Drug Discovery Alliance with Kyowa Hakko Kirin

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Strasbourg, France, January 14, 2013 / B3C newswire / - NovAliX SAS announced today that it has entered into a fragment-based drug discovery alliance with Kyowa Hakko Kirin Co., Ltd., Japan.

Within the alliance, the companies will collaborate to develop novel drug candidates against protein-protein interaction targets. NovAliX will generate novel lead candidates using the broad spectrum of its biophysical capabilities and its medicinal chemistry expertise.

Under the terms of the agreement NovAliX will receive technology access fees as well as further research funding payments and milestones.

Stephan Jenn, President of NovAliX, stated, "For NovAliX this drug discovery alliance represents a significant development of our established relation with Kyowa Hakko Kirin. This drug discovery collaboration with a leading Japanese pharmaceutical company also confirms the quality of our discovery platforms and its ability to deliver valuable lead candidates."


About NovAliX

NovAliX is providing enabling chemistry and biophysical technologies to support the pharmaceutical industry’s outsourcing needs from discovery to manufacturing. With its proprietary Graffinity SPR technology, X-ray protein crystallography, native mass spectrometry and chemistry NovAliX offers comprehensive integrated services for small molecule drug discovery. With advanced NMR technologies, NovAliX provides fine characterization of biologics, thorough analysis of APIs and polymorphism studies to support pharmaceutical development and manufacturing teams. NovAliX Group, a team of 130 scientists, is located in Strasbourg-Illkirch (France) and Heidelberg (NovAliX’s Graffinity subsidiary in Germany).

About Kyowa Hakko Kirin
Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on its core business area of oncology, nephrology and immunology/allergy. Kyowa Hakko Kirin leverages antibody-related leading-edge technologies to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world.


Contact:

Denis Zeyer, CEO
NovAliX
Bld Sébastien Brant, BP 30170
F-67405 Illkirch CEDEX FRANCE
Phone : +33 368 330 200
info@novalix-pharma.com

 

DSM Announces License Agreement with Amgen for Use of DSM's XD® Cell Culture Patents

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Parsippany, USA, January 15, 2013 / B3C newswire / -  DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), announced today that it has signed a non-exclusive license agreement with Amgen Inc. for access to DSM's proprietary XD® high cell density process patents.

Karen King, President of DSM Biologics, commented “We are pleased to enter into this license agreement with Amgen, a global leader in biopharmaceutical drug development and manufacturing. We believe our proprietary XD® technology will play an important role in the next generation of biopharmaceutical manufacturing." XD® technology is a highly intensified cell culture process with typical titer achievement of 8-to-10 times higher compared to current standard biomanufacturing processes. For some products, titer improvements of up to 15 times have been achieved. It is widely applicable for multiple biological products including proteins, fusion proteins and antibodies, and has been successfully employed across the full spectrum of mammalian cell systems.

Alexander Wessels, President and CEO of DSM Pharmaceutical Products also commented, "DSM continuously strives to provide its clients with added value through our innovative service and technology offerings." With typical XD® titer improvement of 8-10X, a 500L bioreactor can provide a DSM licensee with the same amount of drug substance as a 5000L stainless steel bioreactor at an overall lower cost. DSM's proprietary technologies drive down cost, processing times and capital requirements while increasing flexibility to meet market demand for life saving medications. XD® has also shown impressive results for biosimilars and innovator drugs with respect to both volume and product quality.

Financial terms were not disclosed.

XD® is a registered trademark of DSM


About DSM – Bright Science. Brighter Living.™
Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of about € 9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsmbiologics.com and www.dsm.com.


Forward-looking statements
This press release may contain forward-looking statements with respect to DSM’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law. The English language version of the press release is leading.        


For more information:

Guy Tiene
Director, Marketing and Communications
DSM Pharmaceutical Products
tel. +1 973 257 8160        
email guy.tiene@dsm.com           

Karen King
President
DSM Biologics
tel. +1 973 257 8427        
email karen.king@dsm.com

Hyglos Extends its Endotoxin Detection Portfolio and Introduces EndoZyme® - Enhanced ...

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Munich, Germany, 17 January, 2013 / B3C newswire / - Hyglos is today pleased to announce the commercial launch of EndoZyme®, a homogeneous fluorescence microplate assay using recombinant Factor C derived from horseshoe crab, for measuring endotoxin (Lipopolysaccharides, LPS) in pharmaceuticals, biologics and medical equipment.

Taking up on the pioneering work published by the Japanese scientists around Prof. Sadaaki Iwanaga, the test developers at Hyglos have been able to finalize an improved recombinant Factor C (rFC) assay.

Recombinant Factor C, which is the essential part of EndoZyme®, is the endotoxin-specific principal receptor in the LAL enzyme cascade. In the assay recombinant Factor C is activated by any endotoxin present in the sample, recombinant Factor C enzymatically cleaves a synthetic substrate resulting in a fluorescence signal.

EndoZyme® at a glance:

  •     Improved sensitivity and measurement range 0.005 EU/ml to 50 EU/ml
  •     Excellent correlation to LAL
  •     No false-positive glucan reaction due to endotoxin-specific recombinant technology
  •     Reliability and lot-to-lot consistency
  •     No animal material, therefore saving the diminishing horseshoe crab population

Lipopolysaccharides (LPS), or endotoxins, are biologically active components (toxins) of the outer cell membrane of all Gram-negative bacteria. Presence of endotoxins in the blood stream causes a triggering of the signaling cascade and may lead to endotoxic shock. In production of parental drugs, infusions and certain medical devices it is mandatory to control endotoxin.

EndoZyme Product Picture
Caption: EndoZyme® rFC Assay. Homogeneous fluorescence microplate assay for the quantitative determination of endotoxins (lipopolysaccharides) in pharmaceuticals, biologics and medical equipment.
(For high resolution picture please right click the image and select "Save target as...")


About Hyglos and its Endotoxin Detection products:
Hyglos core competency is to exploit its proprietary phage-ligand technology in developing test solutions for research, manufacturing and clinical applications. With the 2011 introduction of EndoLISA®, the world’s first commercially available solid-phase based method for endotoxin detection, Hyglos paved the way for a new era in endotoxin testing. Thanks to its heterogeneous assay format, EndoLISA® is particularly suited for complex sample matrices. With the launch of EndoZyme®, Hyglos now also offers a homogeneous test format suitable for all less demanding samples.


Press contact
Hyglos GmbH
Karolina Heed, Director Marketing & Sales
E-mail: karolina.heed@hyglos.de
Address: Am Neuland 3, D-82347 Bernried am Starnberger See, Germany
Tel: +49 (0) 8158-9060-0; Fax: +49 (0) 8158-9060-210

Kiadis Pharma Granted U.S. Patent for its Blood Cancer Treatment ATIR (TM)

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Amsterdam, The Netherlands, January 21, 2013 / B3C newswire / – Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, announced today that it has received a Notice of Allowance for its U.S. Patent Application No. 10/969,011 regarding the Company’s lead product ATIR™. ATIR™ is a cell-based product that enables stem cell transplantations from mismatched donors.

The U.S. patent covers the composition of matter of a rhodamine derivative used in manufacturing ATIR™, all key steps of the manufacturing process of ATIR™ and the therapeutic use of ATIR™ to prevent graft-versus-host disease associated with allogeneic stem cell transplantations. Kiadis Pharma has previously been granted similarly broad patent protection for ATIR™ in Europe.

Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are delighted about the broad patent protection for ATIR™ in the world’s largest pharmaceutical market. This broad patent protection provides a strong basis for future commercialization of ATIR™ to the benefit of patients”.

Denis-Claude Roy, MD, Professor of Hematology at the Maisonneuve-Rosemont Hospital and the University of Montreal, and Inventor, added: “ATIR™ has the potential to change the current paradigm in allogeneic stem cell transplantation for patients with advanced blood cancers. We are excited that our invention of selectively removing patient reactive cells from a stem cell donation is being developed by Kiadis Pharma to prevent graft-versus-host disease and improve patient outcome”.


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 high 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.


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

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