• Unstructured hiring practices and over-reliance on personal networks is limiting opportunities for women in biotech
• Germany and The Netherlands have the lowest proportion of women in the boardroom (4.1%), compared to Scandinavia (15.5%) and France (17.4%)
• But there are twice as many women in corporate VC compared to traditional VC (18.1% vs 9.6%)

London, UK, October 23, 2014 / B3C newswire / - Liftstream Ltd, a company providing executive recruitment services to the biotechnology sector, announces the publication of its new gender diversity report, “Diversifying the Outlook – The X&Y of Biotechnology Leadership”, a detailed analysis of women leaders in European and US life biotech companies. The research covers 700 companies, 60 C-level interviews and 530 survey respondents.

The report details how the biotechnology sector is considerably under represented by female executives and Board directors. Female board directors in US & EU Biotech (SMEs) account for only 9.7% and 11.2% of positions respectively, and only 4% of company chairpersons are female. Analysis of large-cap biotech indicated better numbers of female Board members (19.2%) but in terms of female executive leaders (13.9%) it lagged SMEs. Unstructured hiring processes and over-reliance on personal networks among, predominantly male, influencers are identified as underlying causes limiting the opportunities for women in biotech leadership. The research also examines how the sector’s reliance on venture capital financing impacts executive and board appointments, as well as the gender diversity among the VC stakeholder group. The report includes diversity case studies from industry leaders Merck Serono, Cubist, Johnson & Johnson and Biogen Idec.  

Key recommendations include:

• CEOs and chairs must lead the change on gender diversity
• Recruiters should provide greater advocacy to companies and women on leadership 
• Investors should apply structured process to ensure executive appointments are optimised for diversity  

Karl Simpson, CEO at Liftstream commented: “The biotech sector faces considerable challenges in meeting its board and executive leadership requirements. However, this detailed research shows that gender inequality remains a significant problem at the top of companies. Our reported data and examination of influencing factors on the appointment of executives, presents evidence which is designed to help accelerate the opportunities for women to secure vital leadership roles in biotechnology. Improving gender diversity will strengthen leadership teams and lead to better business. At Liftstream we want to provide evidence for leaders to act on and this report improves the sector’s knowledge about gender diversity in biotech leadership.”

Liftstream will be working with their global network of biotechnology and life science executives to develop further initiatives aimed at improving awareness and representation of women leaders in the biotech sector, as well as working with established organisations leading in this area. To download the full free report visit: http://www.liftstream.com/diversity-report.html

About Liftstream
Liftstream Ltd is a leader in executive recruitment services for the biotechnology sector; offering our clients a full capability to recruit board and executive leadership, as well as specialised expertise across the functions comprising R&D, Commercial and Operations. Founded in 2003, Liftstream has extensive sector knowledge which we use to advise and support our clients’ hiring requirements and to deliver the highest quality people through a structured and rigorous search process. Liftstream provides services to its clients from London offices. We are supporters of equal opportunities and diversity.

Contacts

Karl Simpson
CEO
Liftstream Ltd.
T: +44 (0) 20 3178 5864
E: karl.simpson@liftstream.com

Media enquiries:

Daniel Gooch/Gemma Howe
Instinctif Partners (Communications consultancy)
T: +44 (0) 20 7866 7860
E: Liftstream@instinctif.com

Hannover, Germany, October 27, 2014 / B3C newswire / -  Implandata Ophthalmic Products GmbH (Implandata) an ophthalmic surgical product and e-Health start-up company announces the closing of a €3M Series B-Round. Born2Grow Venture Partners, a private fund based in Heilbronn/Germany joins in as new investor. Previous investors Peppermint Charité Beteiligungsfonds/Berlin, Hannover Beteiligungsfonds/Hannover, High-Tech Gründerfonds/Bonn, KfW/Bonn and a group of Business Angels complete the Series B funding round.

With the proceeds of this funding, the company is enabled to complete the  clinical program for CE marking of its first product, to launch further studies for complementary product lines and applications in Germany and abroad, specifically to initiate the first IDE study with Massachusetts Eye and Ear Infirmary, Boston/MA and Kellogg Eye Institute, Ann Arbor/MI. For this purpose and in order to prepare the commercial launch of Implandata’s products in the USA, the company established fully owned US subsidiary Implandata Ophthalmic Products, Inc., located in Wilmington/DE. In very near future the company will start further clinical studies for expansion of product use, for clinical validation of complementary product versions and for integrating its pressure sensing technology platform into other ophthalmic surgical procedures and products.

Implandata is currently conducting multi-centric ARGOS-02 study with its intraocular pressure sensor for continuous monitoring of glaucoma patients eye pressure. During cataract surgery Implandata’s pressure sensing implant is placed in front of the artificial intraocular lens, posterior to the iris. After implantation of the micro sensor the patient’s intraocular pressure can be measured at any chosen frequency, either continuously over the course of 24 hours or on demand at defined time points. Patients can perform measurements by themselves and under normal live conditions. Collected data will be sent via a mobile phone module to the eye doctor’s computer screen, allowing remotely monitoring and managing the patient’s disease and alerting the eye doctor in case of patients uncontrolled intraocular pressure.

Implandata’s intraocular pressure sensor allows close monitoring of the patients disease progression and glaucoma therapy success. Through simple and more frequent measurements of intraocular pressure - which is the key parameter in glaucoma therapy - important information on therapy response is delivered to the eye doctor early on, enabling immediate glaucoma therapy adjustment, contributing to prevention of further vision loss due to uncontrolled intraocular pressure.

About Implandata Ophthalmic Products GmbH
Implandata Ophthalmic Products GmbH is a privately held medical device company founded in 2010, headquartered in Hannover, Germany, since 2014 with a fully owned US subsidiary in Wilmington/DE. Implandata’s product for continuous monitoring of intraocular pressure and e-Health integration will transform management of glaucoma patients, providing dramatically improved quality and quantity of intraocular pressure data, which is key for personalized care and therapy control. Remote patient management will increase glaucoma treatment efficiency and results in cost savings for all stakeholders.

Contact

Max G. Ostermeier
Implandata Ophthalmic Products GmbH
Kokenstrasse 5
30159 Hannover
Phone: +49 511 2204 2581
Fax: +49 511 2204 2589
mostermeier@implandata.com

Zurich, Switzerland, October 27, 2014 / B3C newswire / – Haselmeier announces that Biocon, one of Asia’s premier biotechnology companies, has just launched INSUPen® EZ in India. The INSUPen® EZ is a second generation pen and follows on the success of Biocon’s  premier insulin delivery device INSUPen®. Under the terms of the agreement between the two companies, Biocon has worldwide distribution rights to INSUPen® EZ, for use with Biocon’s insulin, Basalog™ and Insugen™, and insulin analogues.

The INSUPen® EZ is a reusable insulin pen, based on Haselmeier’s new i-pen² platform and  is designed to be easy to use and provide a smoother injection experience. It can deliver insulin doses from 1 unit (0.01 ml) to 60 units (0.60 ml) in increments of 1 unit (0.01 ml) with insulin preparations of 100 IU/ml and features an audible sound when dialling a dose for accurate and reliable dosing. The INSUPen® EZ is available in cool grey and three further different colours for differentiating insulins.

The launch of INSUPen® EZ, represents another milestone in the long-standing relationship between Biocon and Haselmeier. “Haselmeier is delighted to collaborate with Biocon and contribute to the market introduction of INSUPen® EZ”, says Sandra de Haan, Director Project Management at Haselmeier GmbH.

 
About Haselmeier
Founded in Stuttgart in 1920, Haselmeier is one of the leading designers and manufacturers of injection systems. Haselmeier’s devices feature unique function, design and technology and are marketed by leading pharmaceutical and biotechnology companies around the world. At five locations on three continents, Haselmeier develops and produces innovative technology for drug delivery which enhances the health and daily life of the patient.

About Biocon
Established in 1978, Biocon Limited (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India's largest biotechnology company by revenue. The Group, promoted by Ms. Kiran Mazumdar-Shaw, is a fully-integrated, innovation-driven healthcare enterprise with strategic focus on biopharmaceuticals and research services. Biocon’s value chain traverses the entire length of discovery, development and commercialization of novel therapeutics. With successful initiatives in clinical development, bio-processing and global marketing, Biocon delivers products and solutions to partners and customers in approximately 75 countries across the globe. Many of these products have USFDA and EMA acceptance. Biocon’s robust product offering includes the world’s first Pichia-based recombinant human Insulin, INSUGEN® and India’s first indigenously produced monoclonal antibody BIOMAb-EGFR(TM).

Contact:

Nadia Di Secli
Marketing Manager
Haselmeier GmbH
Dufourstrasse 32
8008 Zürich
Switzerland
Tel: +41 44 250 58 50
n.secli@haselmeier.com

Global top 20 pharma company streamlines R&D IT with cross-domain platform

London, UK, and Boston, US, October 28 , 2014 / B3C newswire / – Boehringer Ingelheim, one of the top 20 global pharma companies, has introduced IDBS’ E-WorkBook Suite to eliminate data silos in the lab. The cross-domain platform has initially been deployed in North America with the next roll-out planned for Germany. Users are benefiting from streamlined research and development (R&D) with increases in data quality and productivity.

With E-WorkBook, Boehringer Ingelheim scientists can easily and simply capture and record data electronically. Information is both searchable and retrievable for better data sharing and efficiency. Multiple systems are being consolidated for a centralized and highly configurable data flow.

“We are building on our drug discovery excellence combined with a strong focus on external innovation for novel mechanisms and new therapeutic modalities” said Thomas Reith, Head of IT Research & Development and Medicine at Boehringer Ingelheim. “We were looking for an electronic lab notebook that could meet these needs and enables us to derive value from our data across all of our domains including research, development and animal health. IDBS has exceeded our expectations during the pilot program and we can now retire multiple in-house solutions to support our future growth on a global basis.”

“Data quality and cost reduction are both big challenges for the life sciences industry,” said Scott Weiss, Director of Product Strategy at IDBS. “The ability to connect diverse data sources including paper, lab tools and in-house solutions on a comprehensive platform is an attractive proposition to tackle these issues. As firms like Boehringer Ingelheim look to harmonize their data landscape, the flexibility of E-WorkBook’s cross-domain functionalities come into their own.”

Over the next few years, the system is planned to be rolled out to up to 2,400 users globally. The company will also look to integrate E-WorkBook with existing lab infrastructure as well as external LIMs, SAP and data management systems.     

About IDBS
IDBS is a leading global provider of advanced software for research and development (R&D) organizations to securely capture, manage, share and exploit structured and unstructured data. Our technology and domain expertise enable users to link data to data, data to people and people to people to drive innovation, achieve faster time to market and improve margins. Our diverse customer list includes R&D driven international companies in pharmaceuticals, biotechnology, agricultural sciences, chemicals, consumer goods, energy, engineering, food and beverage, and healthcare.

Pleasanton, CA, USA, October 30, 2014 / B3C newswire / - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the launch of the SeqCap RNA Target Enrichment System for RNA-Seq applications. This offering includes a comprehensive lncRNA (long non-coding RNA) design and a full range of custom enrichment offerings. This system was designed to enable researchers to achieve significantly enhanced discovery power and targeting efficiency of RNA-Seq. Researchers in next-generation sequencing are increasingly studying RNA to more deeply understand transcript changes in order to identify potential genetic drivers for diseases.

RNA-Seq has been used increasingly for discovery of novel transcripts, splicing variants, exons and genes. However, the limited sensitivity to low-abundance transcripts,  due to the fact that the majority of the RNA-Seq reads are from a small number of highly expressed genes, has been keeping researchers from achieving their research goals effectively.  The SeqCap RNA System, developed in collaboration with key opinion leaders, dramatically increases RNA-Seq’s sensitivity to low-abundance transcripts without introducing any systematic bias.

“RNAseq has changed the way we look at the transcriptome, identifying many new coding and noncoding RNAs. However, it has become obvious that even the deepest RNAseq is insufficient to deal with the sheer size and complexity of the transcriptome,” said Professor John Mattick, Ph.D., Executive Director, the Garvan Institute of Medical Research. “We have been studying the human and mouse transcriptomes with a targeted approach that offers advanced sequencing depth using Roche NimbleGen's technology. It is pleasing that the new SeqCap RNA system is now available to benefit more researchers.”

With its targeting function, the SeqCap RNA System is also suitable for researchers who would like to focus on a subset of genes or transcripts. This could replace some existing methods, such as highly multiplexing qRT-PCR, for RNA testing on gene panels.

“This is another step towards our goal of providing a complete solution to basic, translational and clinical researchers,” said Dr. Rebecca Selzer, President, Roche NimbleGen. “The SeqCap RNA products, together with the SeqCap EZ and Epi Systems, offer the genomics community comprehensive target enrichment tools for genomic DNA sequencing, bisulfite sequencing and transcriptome research.”

For more information about Roche NimbleGen, please visit www.nimblegen.com

 
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

NIMBLEGEN and SEQCAP are trademarks of Roche.

For life science research only.
Not for use in diagnostic procedures.

All trademarks used or mentioned in this release are protected by law.

For further information please contact:

Roche Sequencing
Beth Button
Phone: +1 317 847 5172
Email : beth.button@roche.com

Uppsala, Sweden, October 30, 2014 / B3C newswire / - Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, announces the launch of Biotage® SNAP ULTRA C18 – a range of high performance, reversed phase flash purification cartridges and samplets.

Biotage® SNAP ULTRA C18 reversed phase cartridges are optimized for use with Biotage ACI™ and Isolera™ flash systems and are available in 12 g, 30 g, 60 g, 120 g, 400 g, 950 g and 1850 g cartridge sizes.  They enable chemists to confidently load 2-3% weight percentage of samples onto reversed phase columns, a marked improvement when compared to the currently typical 0.5 - 1% loads. The time taken for purification and solvent usage can therefore be reduced by 50% or a smaller cartridge can be used for the same purification, often with improved purification results.

The new reversed phase cartridges are packed with the new, Biotage® HP-Sphere C18 25 micron spherical silica particles that give a boost to resolution with higher purity peaks over standard reversed phase cartridges.  The silica is chemically neutral with no adverse interactions, ensuring higher yields and better recoveries; a wide diversity of purifications are possible, including the use of both acidic or basic modifiers.

“It is no longer enough for suppliers to arbitrarily work on single aspects of the workflow and purification – today a more holistic approach is required, one that involves a combination of factors; with this product range we have further augmented the Biotage ACI™ and Isolera™ flash systems and have created a superior product for purification” says Dr Sunil Rana, Global Product Manager, 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.

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 290 employees with sales of 444.6 MSEK in 2013. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange.

For further press information from Biotage please contact:

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

Already a Leader in Comparability of Biosimilars, New R&D Initiative Aligns BioOutsources’ Strategy with the Next Generation of Biosimilars, to Support Client Testing Requirements and Leverage Rapid Growth in Biosimilars Market

Glasgow, Scotland, UK and Cambridge, Mass., USA,  November 3, 2014 / B3C newswire / - BioOutsource Ltd. (“BioOutsource”), a global leader in biologics contract testing and biosimilar characterisation for the biopharmaceutical industry, today announced a major initiative in new research and development programs to support the next generation of biosimilars.

“We are proud to have established a reputation as one of the top providers in comparability of biosimilars,” commented BioOutsource CEO, Gerry MacKay. “For this, we are deeply appreciative of our existing clients, with whom we have worked closely to develop a range of new assays supporting early stage development.  With global biosimilar sales last year of $1.3 billion expected to explode to $35 billion by 2020, now is the time to leverage our base of knowledge and dramatically expand our R&D efforts to support the next generation of biosimilars. This investment will benefit both new and existing clients and enable them to ride the biosimilars wave with us.”

This major investment in BioOutsource’s  R&D roadmap aims to align the company’s strategy to the next generation of biosimilar molecules including Stelara (ustekinumab, for plaque psoriasis), Yervoy (ipilimumab, for melanoma), Orencia (abatacept, for rheumatoid arthritis), Synagis (palivizumab, for respiratory viral infections) and Actemra (tocilizumab, also for rheumatoid arthritis).

Mr. MacKay added, “We also plan to organize R&D Development Workshops with both current and future clients, to review future biosimilar development and align our R&D activities to support market requirements.  This is all in keeping with our over-riding client-centric focus.”

The new R&D initiative will initially be focused on establishing and validating the primary mechanism of action bioassay and affinity (surface plasmon resonance, SPR), progressing to completion of a new, full biosimilar characterisation package.

Those who would like more information about the R&D Development Workshops may send a query via this link.

About BioOutsource Ltd
BioOutsource provides contract testing services to the biopharmaceutical industry. Our core offering includes a comprehensive range of services to support the testing of Biologics, Vaccines & Biosimilars throughout their development. We possess an unparalleled combination of commercial, regulatory and technical knowledge that enables us to truly stand out as the industry’s preferred testing partner. We understand the importance of our service to support our client’s critical testing requirements and as a result, continually strive to provide a world class service globally.

 
Contacts

Gemma Fulton
Marketing Executive
BioOutsource, Ltd.
+ 44 (0) 141 946 4222  
gfulton@biooutsource.com

or

Bill Douglass
Gotham Communications, LLC
1-646-504-0890
bill@gothamcomm.com

• Proposed indication is treatment for accelerated healing of partial thickness wounds
• Oleogel-S10 ointment aims to become first-in-class prescription pharmaceutical with proven efficacy in accelerating wound healing
• Day 120 scheduled on February 26^th, 2015
  

Niefern-Öschelbronn, Germany, November 3, 2014 / B3C newswire / - Birken AG, a biopharmaceutical and dermo-cosmetic company, announces that the European Medicines Agency (EMA) has accepted its Oleogel-S10 Marketing Authorization Application (MAA) for review. Birken’s MAA seeks approval of Oleogel-S10 ointment for accelerated healing of partial thickness wounds.

Dr. Armin Scheffler, board member at Birken AG and inventor of Oleogel-S10, stated: “We are very happy about EMA’s acceptance of our MAA submission for review. This is an important milestone in the development of Oleogel-S10 and the history of Birken AG. Partial thickness wounds are painful and at risk for infections and wound healing complications, therefore an acceleration of the healing process would be very beneficial. Oleogel-S10 addresses an unmet medical need, as no other pharmaceutical is currently approved by the EMA for accelerated healing of partial thickness wounds. Birken is dedicated to bring this new therapeutic option to hospitals and patients.”

The submission includes results from the three Phase III trials that have demonstrated a significantly faster wound healing with Oleogel-S10 compared to current standard of care consisting mainly of applying wound dressing materials.

The EMA will review the application under the centralized marketing authorization procedure. If approved by the EMA, Oleogel-S10 would receive marketing authorization in all 28 member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. Birken anticipates a decision until end of 2015.

About Oleogel-S10
Oleogel-S10 is an innovative, sterile ointment which consists only of the active pharmaceutical ingredient ‘dry extract from birch bark’ and sunflower oil. In this unique and internationally patent protected formulation the active pharmaceutical ingredient also functions as sole galenic substance. This formulation of only two ingredients minimizes the risk of wound healing irritations caused by additives.

Several pre-clinical and clinical studies have shown that dry extract from birch bark accelerates wound healing and skin regeneration processes. Dry extract from birch bark transiently upregulates pro-inflammatory cytokines (e.g., IL-6) and cyclooxygenase-2 (COX-2) on gene and protein level.  Dry extract from birch bark promotes keratinocyte migration, putatively by increasing the formation of actin filopodia, lamellipodia and stress fibers (Ebeling et al., PLoS One, 2014), and promotes keratinocyte terminal differentiation in a TRPC6 calcium channel dependent manner (Woelfle et al., J Invest Dermatol, 2010).

Oleogel-S10 aims to become the new standard in the treatment of partial thickness wounds at a new level of medical evidence in this indication.

About Birken
Birken AG is a biopharmaceutical and dermo-cosmetic company. The company was founded in the year 2000. Birken’s core business is the extraction of active ingredients from birch bark and the development and sales of medical skin care products as well as pharmaceuticals for acceleration of wound healing.

Disclaimer
The development, approval and manufacturing of Oleogel-S10 is subject to extensive oversight by various regulatory agencies. Submissions may be subject to lengthy review and ultimately rejected. Moreover, regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could increase operating costs or delay product launches.

Contact

Dr. Mike Bastian
Business Development Manager
Birken AG
Streiflingsweg 11
75223 Niefern-Öschelbronn
Germany
Phone: +49 7233 9749-115
presse@birken.eu
www.birken.eu

Vienna, Austria, November 4, 2014 / B3C newswire / - The pharmaceutical company AOP Orphan, a European pioneer in the field of rare diseases, is expanding its sales area for the special preparation Thromboreductin® to include the large Russian market. This means that the drug, which represents an innovative treatment option for patients afflicted by Essential Thrombocythemia, is available in core Central European markets such as Austria, Hungary, Switzerland, Czech Republic and Poland as well as in Turkey, Israel, Kazakhstan and Russia. “We have started to offer our entire range of products, focusing on rare diseases, in Russia as well as the Middle East,” says Dr. Rudolf Widmann, CEO of AOP Orphan. “These regions are exciting markets. Above all, this way we can open up new treatment possibilities for patients in these countries."

Essential Thrombocythemia (ET) is a rare but serious bone marrow disease, characterized by a significantly elevated blood platelet (thrombocyte) count. This considerably increases the risk of suffering a blood clot or bleeding. In cases of ET where the thrombocytes only function to a limited extent, patients suffer from bleeding in the nose, mouth, stomach and intestines. In other cases where the excessive number of thrombocytes is largely functional, patients carry with them the risk of developing life-threatening thromboses or infarctions.

Thromboreductin® (active ingredient: anagrelide) lowers the blood platelet count and thereby reduces the risk of complications – without the risk of leukemogenesis as is the case with cytostatic agents. If treatment is successful, most patients with Essential Thrombocythemia have an almost normal life expectancy.

About AOP Orphan
AOP Orphan researches, develops, produces and distributes innovative drugs and administration methods to treat rare diseases – and has become a European pioneer in the field of orphan diseases.The company’s focus is on the areas hematology and oncology, cardiology and pulmonology, neurology and psychiatry, and metabolic ­diseases­. AOP Orphan is one of the foremost providers in the sector, generating a turnover of more than EUR 60 million as an Aus­trian company with transnational operations. It has an export ratio of around 70% and employs over 140 people. The rare disease specialist has branch offices situated in its core markets within the EU, Switzerland and the Middle East. The international markets are handled and operated by long-term, close partners of the company. AOP Orphan has a total of twelve locations.

Further inquiries

AOP Orphan Pharmaceuticals AG
Public Affairs
Wilhelminenstraße 91/2f
1160 Vienna
T +43 1 503 72 44-24
F +43 1 503 72 44-5
M office@aoporphan.com

Cambridge, MA, USA and Krakow, Poland, November 7, 2014 / B3C newswire / - Felicitex Therapeutics, a leader in the diagnostics and development of therapeutics for quiescent cancers, and Selvita (PL: SLV), the largest drug discovery company in Central and Eastern Europe, announced today that they have entered into a strategic collaboration to develop breakthrough personalized cancer therapeutics  for some of the deadliest and most resistant cancers, such as pancreatic, colon, ovarian, lung and hematopoietic tumors.

During the first phase of the collaboration the companies seek to discover and develop selective inhibitors of the cancer quiescence target kinase family, in order to generate multiple novel drug candidates against the quiescent cancer cells. The ultimate aim of the joint project is to deliver clinical candidates for unmet oncology indications. The companies plan joint projects on other targets related to cancer quiescence in the future.

It is currently well accepted in the scientific community that populations of malignant cells are highly heterogeneous and whereas some of the cancer cells divide rapidly, some of the cancer cells are quiescent.  All currently available cancer chemotherapies target proliferating cancer cells. Quiescent cancer cells are invulnerable to these treatments because quiescent cells are not dividing.  Moreover, when cancer cells are under stress, such as from chemotherapy, anti-angiogenesis therapy, or radiation, cancer cells often go to “sleep”, or use quiescent state as a niche to hide.  After the completion of treatment, these cells begin growing again and cause cancer recurrence.  

Felicitex Therapeutics’ technology targets quiescent, non-responsive cancer cells with two therapeutically beneficial outcomes – firstly making cancer cells vulnerable to conventional treatments, and secondly preventing cancer cells from hiding in the quiescent state for indeterminate period of time and thereby delaying or eliminating cancer recurrence.  

“Cancer cell quiescence is a major and as yet unaddressed mechanism of cancer resistance – says Maria Vilenchik, PhD, Founder, Chief Executive Officer and Scientific Director of Felicitex Therapeutics. At Felicitex we strive to develop treatments for some of the deadliest and most resistant to therapy cancers, among which pancreatic cancer is particularly vicious. Our collaboration with Selvita creates the opportunity to identify novel therapeutic solutions and bring hope to cancer patients”.

Selvita is highly experienced in the area drug discovery and particularly in development of kinase inhibitors. Over the last five years, Selvita has built a premium scientific team with one of the world’s most robust kinase inhibitor discovery platforms.

“We want to partner with best scientific teams in the world in order to explore different approaches against neoplastic processes – says Pawel Przewiezlikowski, Chief Executive Officer of Selvita. The unique know-how of Felicitex in the area of cancer quiescence together with scientific expertise of Selvita team will highly increase our chances to develop new highly-differentiated therapeutics. ”

The alliance of Felicitex Therapeutics and Selvita allows to combine Felicitex’s experience in targeting cancer quiescence with Selvita’s significant know how on cancer quiescence target kinases, leading to a potentially breakthrough cooperation and delivery of  much needed effective antineoplastic medicines.

“The primary focus of our R&D efforts is development of personalized targeted therapies that address unmet medical needs in oncology” – says Krzysztof Brzozka, PhD, Chief Scientific Officer of Selvita. “The collaboration with Felicitex Therapeutics will be an important part of our strategy of diversified R&D approach and will even more broaden the current pipeline of anticancer projects that we are involved in.”

As part of the research collaboration Selvita will receive from Felicitex guaranteed research funding and a value share in joint projects which may in future be monetized through milestone payments from Felicitex or a portion of revenues from programs partnered by Felicitex. The first committed  research period will be 15 months with an option for Felicitex to extend the collaboration for additional 12 months. Selvita will also receive royalties after the jointly discovered drugs have been approved.

About Felicitex Therapeutics
Felicitex Therapeutics is a privately-owned drug discovery company at the forefront of one of the most promising areas in oncology  –  quiescent (sleeping) cancer cells.  Felicitex develops treatments and diagnostic assays to improve the effectiveness and long-term outcomes of treatments for the deadliest and most resistant to therapy cancers: pancreatic, colorectal, non-small cell lung, and ovarian.  The CEO of Felicitex Dr. Maria Vilenchik led Drug Discovery programs at Hoffman-La Roche, and Memorial Sloan Kettering Cancer Center and worked in business development at Keryx Biopharmaceuticals and Advanced Bio Design. Dr. Vilenchik authored 20 publications in peer reviewed journals and 8 patents. Felicitex Therapeutics was founded in 2012 and is based in Cambridge, Massachusetts.

About Selvita
Selvita is a Polish biotechnology company engaged in the discovery and development of breakthrough medicines to treat oncology, CNS and autoimmune disorders, as well as provision of drug discovery services. It was established in 2007 and currently employs 220 people, including 70 PhDs. Selvita has currently several internal projects at early or late discovery stage and is expected to move its first candidates to the clinic in 2015. The most advanced programs at Selvita are SEL24, a pre-clinical PIM/FLT3 kinase inhibitor, with multiple indications in hematopoietic tumors and SEL120, first-in-class small molecule inhibitor of cyclin dependent kinase CDK8. Other innovative projects currently in development include SEL201 – novel small molecule MNK1/2 inhibitors in oncology, cancer metabolism platform and inflammasome platform. Drug discovery clients of Selvita include more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe. Selvita is listed on the NewConnect market of the Warsaw Stock Exchange in Poland (SLV).

Contacts

Selvita S.A.
Natalia Baranowska
+48 784 069 418
natalia.baranowska@selvita.com

Felicitex
Maria Vilenchik
+1 (919) 213-0025
mvilenchik@felicitex.com

• Core team dedicated to the development of trifunctional, bispecific antibodies as cancer immunotherapeutics
• Round A capitalization in process

Munich, Germany, November 7, 2014 / B3C newswire / - Horst Lindhofer, CEO of LINDIS Biotech and inventor of the trifunctional antibody technology succeeded in regaining the relevant IP and know-how from TRION Pharma out of the insolvency proceedings. Currently, LINDIS consolidates these patents and know-how with relevant LINDIS IP and hosts several advanced trifunctional antibody programs. The Company plans to hire a limited number of highly experienced staff in order to continue clinical development once it has raised additional capital.

Dr Horst Lindhofer explained: “We seek to capitalize the Company that now houses a pipeline of three new potential treatments against malignant tumors based on the trifunctional platform. One is in late pre-clinical and two are in Phase I/II clinical stage. The fund-raising comes at a great time given the compelling and positive clinical update of our Lymphomun program.”

“When the industry converted to human/humanized antibodies, we chose to further develop our murine-based antibody platform due to its vaccination effect and the direct tumor-cell-killing potential that we discovered as early as 1997. Today we are unique because of this special characteristic. Our powerful effects on solid tumors were first verified in 2006,” explained Dr Lindhofer.

“We are grateful to our Advisors, IMI Consulting GmbH (IMI) and Partners, for supporting us during the TRION Pharma insolvency process. IMI will now resume the discussions with potential investors for Round A,” Dr Lindhofer further added.

Pioneer in the battle against cancer that carries the hopes of cancer patients worldwide

Founded by Dr Lindhofer in 1998, the original TRION Pharma was a pioneer in the search for new therapies for cancer patients. As the first German biopharmaceutical company, TRION Pharma saw a breakthrough in 2009 when its proprietary cancer treatment was launched. Removab® (catumaxomab) is the first and only multispecific antibody worldwide to receive a market approval. The initial EU approval was followed by approvals in Israel, Canada and Russia. Due to illiquidity Trion was forced to file for insolvency last year.

“The trifunctional antibody therapy is a platform that carries the hopes of cancer patients worldwide as it triggers the patient’s own immune system to recognize and destroy the cancer cells and, moreover, to induce a lasting immune memory against the individual mutations of the patient’s tumor cells. These antibodies can easily be adapted to fight many different types of cancers,” added Dr Lindhofer.

 
About LINDIS Biotech GmbH
LINDIS Biotech GmbH hosts all relevant trifunctional antibody IP and know-how, and focuses on the development of these antibodies in oncology. As a biopharmaceutical company with a highly innovative platform technology and an advanced pipeline, LINDIS is uniquely positioned in the cancer immunotherapy market. It is the only oncology company that offers strong cancer cell-killing properties while offering a vaccination against the patients’ own tumor cells. This is due to its unique murine-based platform.

About IMI Consulting GmbH
IMI Consulting GmbH specializes on pharmaceutical and biotechnology merger and acquisition transactions, strategic restructuration and capital raising. It boosts 23 years of contributions for its clients and has a worldwide network of over 150 Associate Partners all experts in their specialty areas. IMI has been involved in many biotechnology and pharmaceutical transactions in Europe and the USA.

For further information please contact:

LINDIS Biotech GmbH
Dr Horst Lindhofer
CEO
Am Klopferspitz 19
82152 Martinsried / Germany
Phone: +49 (0) 89 70 07 66 24

IMI Consulting GmbH
Mariana Brea-Krueger
Managing Director
Auf dem Amtshof 3
30938 Burgwedel / Germany
Phone: +49 (0) 5139 99180
E-mail: mbk@imiconsulting.com

Zurich, Switzerland, November 10, 2014 / B3C newswire / - Haselmeier was able to successfully grow over the past few years, allowing the company to carve out a solid position in the market for medical devices. In keeping with this progress, the Haselmeier Group has restructured its management organisation to ensure this forward momentum continues successfully. The company has introduced a Group Executive Board tasked with coordination and decision-making for all Haselmeier locations. The Group Executive Board will ensure consistent, effective management of the Haselmeier sites, thereby coordinating the group's strategy.

Mr. Andreas Schieber - as a supervisory board representative of Medico Invest AG - has been appointed to set up the new organisation and will coordinate the Group Executive Board.

The structure of the new Group Executive Board is as follows:

Cologne, Germany, November 12, 2014 / B3C newswire / - New Oncology announced today that it has entered into a collaboration with the National Cancer Centre Singapore (NCCS). Under this agreement, New Oncology will apply its proprietary diagnostic platform ‘NEO’ that enables physicians to select optimal targeted therapies for their patients. NEO provides a fully informative molecular cancer profile from the smallest quantities of patient samples with short turn-around times. No financial details were disclosed.

“Personalised therapy based on the individual genetic tumour profile of the patient has led to a paradigm change in oncology. Understanding how gene defects result in diseases has made the leap from research into practice, leading to therapeutic options providing an unprecedented benefit for cancer patients. As the number of known genetic changes that predict responses to targeted therapies continues to grow, comprehensive genomic diagnosis is a pivotal step to optimize clinical care” commented Prof. Axel Ullrich, founder of New Oncology.

“We are very pleased to work with NCCS, one of the most prestigious centres for research and treatment of cancer in Southeast Asia. We are looking forward to building a productive partnership with NCCS, and consider this move to be a major milestone in our international business expansion” said Dr Andreas Jenne, CEO of New Oncology.

About New Oncology
New Oncology’s proprietary diagnostic platform ‘NEO’ empowers physicians to select the optimal targeted therapy for their patients, including participation in suitable clinical trials. Our pan-cancer diagnostic test NEOplus reliably detects actionable genetic alterations with short turn-around times. In contrast to conventional testing, NEOplus identifies all types of therapeutically relevant alterations, i.e. mutations, amplifications, insertions/deletions, as well as novel and known translocations, from one single patient sample. We work with a tumour board comprising renowned cancer experts, facilitating translation of the latest targeted therapy findings into optimized patient care. New Oncology is the molecular diagnostics division of Blackfield AG, a company specialising in cancer genome analysis.

Contact

Dr. Jutta Fritz
New Oncology / Blackfield AG
Email: info@blackfield.de

Sydney, Australia, November 17, 2014 / B3C newswire / - Cellmid Limited (ASX:CDY) signed an agreement with Zoetis for the evaluation and option to license one of Cellmid’s anti-midkine antibodies (MK antibody) for therapeutic use in companion animals.

Cellmid’s proprietary MK antibodies have previously been shown to be effective in animal models of a number of diseases. Zoetis has extensive experience in the development and commercialization of animal health products and will evaluate the performance of Cellmid’s MK antibody in their proprietary models with the view to license.

The agreement is exclusive for the use of Cellmid’s MK-antibody in animals. The terms of the agreement include upfront and exclusivity payments until such time as the option to license is exercised by Cellmid’s partner. Additional financial details of the agreement are not disclosed.

 
About Cellmid Limited (ASX: CDY)
Cellmid is an Australian biotechnology company with lead drug candidates in oncology and a product pipeline in inflammatory diseases in humans. The Company is developing innovative novel therapies and diagnostic tests for a number of cancer indications, in particular solid tumours. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to the novel oncology target midkine and midkine antagonists globally. The Company’s most advanced development programmes involve using its anti-midkine antibodies in addition to commercialising midkine as a biomarker for the early diagnosis and prognosis of cancer.

About Midkine (MK)
Midkine is a growth factor that is highly expressed during embryonic development. Midkine modulates many important biological interactions such as cell growth, cell migration and cellular adherence. These functions are relevant to cancer, inflammation, autoimmunity, ischemia, nerve growth/repair and wound healing. Midkine is barely detectable in healthy adults and only occurs as a consequence of the pathogenesis of a number of different disorders. Midkine expression is often evident very early in disease onset, even before any apparent physical symptoms. Accordingly, midkine is an important early marker for diagnosing cancers and autoimmune diseases. Finally, midkine is only present in a disease context, and targeting midkine is not expected to harm normal healthy tissues.

 
Contact:

Maria Halasz, CEO
Cellmid Limited
T +612 9221 6830
twitter: @mariahalasz

Academia in 17 countries enjoy unlimited access to Cambridge Structural Database

Cambridge, UK and Piscataway, NJ, USA, November 20, 2014 / B3C newswire / - Today, the Cambridge Crystallographic Data Centre (CCDC) announced that National Affiliated Centres covering Australia, Croatia, Finland, Hungary, FYR Macedonia, Norway, Russia, Serbia, Slovenia, Spain and Sweden secured countrywide access granting all of their academic institutions unlimited and open use of the Cambridge Structural Database System. These agreements expand the CCDC’s national access initiatives to 17 countries adding to those already in place in Brazil, Israel, Taiwan, The Netherlands, Switzerland and South Africa. Through local and web applications, academic researchers and educators enjoy immediate access to the CSD, the definitive resource for experimental organic and metal-organic crystal structure information.

“Providing all academic institutions in these countries with unfettered access to the CSD System aligns directly with both our open access philosophy for academia and our not-for-profit and charity status,” said Colin Groom, the Executive Director of the Cambridge Crystallographic Data Centre. “We will continue to expand this programme around the world to ensure researchers, educators and students benefit from the CSD and the associated software packages for knowledge-based modelling of molecular structure and interactions.”

Several NAC partners commented on the significance of the agreements. “Beginning in 2015, Spanish institutions will have unlimited access to the Cambridge Structural Database System through a new countrywide arrangement. The current 34 academic and research institutions at the Spanish NAC will now have the opportunity to expand access to the CSD system within their own institutions”, said Agnès Ponsati Obiols, Director, Unit of Information Resources for the Research Spanish National Research Council. “In addition, countrywide CSD provision enables us to extend access to new research groups in Spain. Such groups, normally small or from adjacent research areas, would otherwise never have the opportunity to take advantage of the CSD database and all the included tools.”

In Finland, academic users have accessed the Cambridge Structural Database System since 1990 through the CSC - IT Centre for Science. “For 2015, we are taking a great step forward by opting for a national agreement. This arrangement will increase access to the database for a larger group of researchers and in turn make their research more efficient”, said Atte Sillanpää, PhD, Senior Application Scientist, the programme manager for the last nine years.

In Brazil, Mario Ximenes, Dotlib Commercial Coordinator for CAPES stated, "By offering access to the Cambridge Structural Database to the whole Brazilian academic community working in Chemistry and Physics, we will increase database usage, the potential of harvesting results, and the awareness of the product’s capabilities by all stakeholders enrolled.”

About The Cambridge Crystallographic Data Centre
The Cambridge Crystallographic Data Centre (CCDC) supports structural chemistry research through its Cambridge Structural Database (CSD), established in 1965 and still the world’s only comprehensive and fully curated database. It contains all 750,000 published small molecule crystal structures, and through knowledge-based tools is used to support receptor modelling, ligand design, docking, lead optimization and formulation studies. Over 1,200 academic institutions, all of the world’s top pharmaceutical companies and research operations worldwide use the CSD and modelling systems.

The CCDC is a fully independent non-profit organisation and, since 1989, a registered charity. The CCDC recovers it operational costs entirely through annual contributions received for the Cambridge Structural Database System and industry-leading software such as GOLD and Relibase+. These have allowed the CCDC to provide free access to crystal structures for almost 50 years. Researchers at the CCDC have a strong record of accomplishment exhibited through more than 7,800 peer-reviewed publications, attracting more than 18,000 citations in the international scientific literature.

For more information, please contact:

Paul Davie
General Manager
Cambridge Crystallographic Data Centre Inc.
+1 848.445.4869
ccdc-usa@ccdc.cam.ac.uk
www.ccdc.cam.ac.uk

New Asia Pacific office will support customer relations and the development of new business

Ravensburg, Germany, November 20, 2014 / B3C newswire / - Vetter, a global leader in the aseptic fill and finish of injection systems, servicing the top-ten pharm/biotech companies worldwide along with mid-size firms and emerging startups, today announced the opening of a new representative office in Singapore. The announcement was made at a ceremony attended by members of local government agencies and a number of executives of pharmaceutical/biotech companies with a presence in the Asian region, as well as Vetter executives.

The new office will allow Vetter to take better advantage of the rapidly growing Asian healthcare market by increasing the presence of the company in this market. It will be staffed by Chervee Ho, Director Key Account Management Asia Pacific. Prior, the company’s Asian customers were handled by the German-based departments of Key Account Management, Project Management and Customer Service. Ms. Ho will be responsible for supporting the German departments to better serve the existing customer base due to geographic and time proximity as well as the development of new markets.

“For more than 35 years, the name Vetter has been synonymous with high-quality aseptically pre-filled injection systems. The office in Singapore, known as a vibrant city conveniently located in the heart of the Asia Pacific region, will help to increase the awareness of our comprehensive service portfolio in the Asian market”, said chairman of the advisory board and company owner Udo J. Vetter. “With a growing market demand, Vetter responds by strengthening its global position as a strategic partner for both the development phase, and commercial manufacturing of parenteral drugs. The new location enforces that strategy within Asia”, adds managing director Peter Soelkner.

Mr Kevin Lai, Executive Director Biomedical Sciences of the Singapore Economic Development Board, congratulated Vetter on this momentous occasion: “We are pleased that Vetter, a leading company in aseptic fill and finish, will be establishing its representative office in Singapore – its first in Asia. Vetter’s decision is a strong recognition of Singapore’s status as a global biomedical sciences hub and endorsement of our continuous efforts to build a diversified and vibrant biomedical manufacturing sector supplying medicines across the world.”

Caption: Ribbon cutting ceremony for the opening of Vetter’s new representative office in Singapore with Thomas Otto (Managing Director Vetter), Kevin Lai (Executive Director, Biomedical Sciences EDB) and Peter Soelkner (Managing Director Vetter) from left to right
For high resolution please click the image.

 
About Vetter
Vetter is a premier contract development and manufacturing organization (CDMO) and a global leader in the fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, with facilities in Germany and the United States, Vetter provides state-of-the-art manufacturing, from early clinical development through commercial filling and packaging of parenteral drugs. Our extensive experience covers a broad range of complex compounds, including monoclonal antibodies, peptides and interferons. We support our clients every step of the way, guiding their products through development, regulatory approval, launch and life cycle management. Known for quality, Vetter offers a foundation of experience spanning more than 35 years, including dozens of product approvals for novel bio/ pharmaceutical compounds. Visit www.vetter-pharma.com.

Contact

Vetter Pharma International GmbH
Oskar Gold
Senior Vice President Key Account Management,
Marketing /Corporate Communications
Eywiesenstrasse 5, 88212 Ravensburg
Phone: +49 (0)751-3700-3023
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com

New study by the Chamber of Industry and Commerce (IHK), the City of Munich and Bio^M confirms the importance of this sector

Munich, Germany, November 21, 2014 / B3C newswire / - The biotech sector in the Greater Munich area continues to demonstrate significant growth in revenue and staff numbers despite ever-increasing international competition. This continues Munich's status as one of the pre-eminent locations for this future-oriented industry. This was confirmed by the latest study carried out by the City of Munich, the IHK and Bio^MGmbH based on a survey and questionaire of different businesses and experts.

In 2013, 23,000 people were working here in a total of 377 biotechnology and pharmaceutical companies, generating a turnover of around 8.5 billion euros (not including companies from the medical engineering sector). This is in addition to around 10,000 employees in public and private research facilities and universities.

According to criteria set out by the OECD, around 15 % of German biotechnology firms have their headquarters in the Greater Munich area, with 30 % of the nation's biotechnological development of drugs taking place here.

"This study shows that companies in Munich have done an excellent job of getting through the difficult times and that the international appeal of this location has been boosted even further", says the Head of the Department for Work and Economy, Mayor Josef Schmid, and he continues: "The economic success of this sector is not only based on an outstanding scientific community but also on recognised and effective management of the network."

The local nucleus of companies researching, developing and manufacturing therapeutic and diagnostic agents comprises the area around the IZB (Innovation and Start-Up Centre for Biotechnology) in Martinsried, in South-West Munich and its administrative district (see map). A particularly heavyweight contender is found further South in Penzberg in the form of Roche Diagnostics: these are the largest entities in Europe dedicated to the research, development and manufacture of biopharmaceuticals and diagnostic agents, and with their 5100+ employees they contribute a significant amount to the character of this biotechnology cluster.

According to a ranking of “Genetic Engineering & Biotechnology News, GEN”, March 2014, (www.genengnews.com), the greater Munich region ranks within the TOP 9–10 of all listed US clusters when looking at employment, public funding and granted patents!

An upbeat mood prevails in the Greater Munich area for this sector: around 75 % of companies located here are expecting continuous improvements in their business situation until 2017. More than 20 % of them assume at the very least that the current situation will stabilise further.

Dr Horst Domdey, Managing Director of Bio^M Biotech Cluster Development GmbH comments on these results: "The scale of networking between scientific organisations as well as with industry is huge, as the rates of satisfaction reflected in the survey have clearly shown.  That having been said, there is always room for further improvement and we constantly have to respond to new demands. A special challenge lies in introducing the region to notable global trends at an early enough stage, and in developing a solid competitive position as we managed to do in the field of 'personalised medicine.'"

The study shows that companies are highly diversified in terms of science and technology and are able to assimilate new trends quickly and successfully. Over the last few years, a number of businesses have relocated from the USA, Japan and India, demonstrating Munich's appeal as a centre for research, development and sales. This wave of relocation to Munich included Actavis, Exosome Diagnostics, Myriad Genetics, Vertex and Panacea Biotec. Crucial in this respect are both a qualified workforce and outstanding scientific studies that generate a steady supply of fresh energy for new technological applications and product ideas. The company Morphosis is the perfect example of a leading global technology provider, as demonstrated by around 70 research projects with global Big Pharma partners. In terms of financial volume, huge business acquisitions over the last few years have in fact not led to "expertise being sold off", but have generally encouraged the new parent company to forge even stronger ties with Munich as a great location for this sector. Since its takeover of the biotech company Micromet, the research facility run by Amgen in Munich is now their largest outside of the USA. Daichii Sankyo has commissioned the development of its biotechnological oncology pipeline in Martinsried and has laid the foundations for this by acquiring U3 Pharma.

The full study can be viewed online at:

http://www.bio-m.org/en/information-material.html

Contact:
Bio^M Biotech Cluster Development GmbH
Dr. Georg Kääb
Am Klopferspitz 19a
82152 Martinsried
Email: kaeaeb@bio-m.org
Tel. (+49) (0)89 / 89 96 79 19
Fax (+49) (0)89 / 89 96 79 79

Continued recognition by industry and non-industry experts as unique partner in Orphan Drug Development

Hoofddorp, The Netherlands, November 24, 2014 / B3C Newswire / - The PSR-Agility Orphan Drug Development partnership has for the second consecutive year been awarded “Best Orphan Drug Contract Research Organisation” in the Rare & Orphan Advocacy and Research (ROAR) Awards (http://goo.gl/CUyAly).

The ROAR Awards were announced during the 5th Annual World Orphan Drug Congress Europe, November 12-14, 2014, in Brussels, Belgium. The 2014 awards recognize those who have done outstanding work in the rare disease field, honour those who have made significant contributions to the development of the sector, and celebrate the great achievements made in the world of orphan drugs in the last year.

“Successively winning this award as the PSR-Agility Orphan Drug Development partnership is a clear appreciation by all stakeholders of our continued commitment in the rare disease community,” says Roger Legtenberg, CEO of PSR Orphan Experts. “Our efforts to provide crucial patient assistance by a range of services in order to lower the burden of rare disease patients in clinical trials, together with added infrastructure to be able to offer innovative patient recruitment solutions, have among others contributed considerably towards winning this award.”

“We’re thrilled that our commitment to innovating clinical development strategies for clients developing orphan drugs has been recognized consistently during our company’s first two years of partnership,” says Ellen Morgan, CEO of Agility. “Our vision for making a difference by dedicating ourselves to this specialty has become a reality.” 

Orphan drugs present fundamentally different regulatory and operational challenges compared to their traditional counterparts. PSR-Agility Orphan Drug Development specializes in assisting companies to develop efficiencies and economies of scale to bring innovative new orphan products to market, thereby contributing to the IRDiRC 2020 goal to deliver 200 new therapies for rare diseases. Our staff are all highly engaged to the rare disease cause, by providing education, taking part in fundraising events and being involved in public-private partnerships. Building successful partnerships with all stakeholders, including patient organizations, industry and key opinion leaders, and actively collaborating with them, is of crucial importance.

Caption: The PSR-Agility Orphan Drug Development partnership has been awarded “Best Orphan Drug Contract Research Organisation”. From left to right: Thijs op de Weegh, Kristi Clark, Roger Legtenberg and ‘Award ceremony representative’.

About PSR-Agility Orphan Drug Development
PSR Orphan Experts and Agility Clinical partnered early 2013 in order to benefit from a unique synergy and extend the partnership’s capabilities across the Atlantic. PSR Orphan Experts was established in 1998 and has become a leading expert in orphan drug development in Europe. Agility Clinical, founded in April 2012 with an experienced executive management team, specializes in orphan drug development in North America. PSR-Agility’s mission is to help small and virtual pre-clinical and clinical stage companies design and execute successful clinical development programs for orphan indications. The partnership specializes in complex clinical development programs requiring innovative regulatory and clinical approaches. In addition to consulting (orphan drug designations, scientific advice / protocol assistance, (pre-)IND, pediatric investigation plans, NDA/MAA), the partnership provides customized full clinical trial services including project management, clinical operations, data management, biostatistics, medical, regulatory, and scientific affairs, and medical writing. PSR-Agility has a true appreciation for the challenges its clients face in obtaining the expertise they need.

Media contact:

Roger J. Legtenberg
Chief Executive Officer
PSR Orphan Experts
+31 23 556 3221
roger.legtenberg@psr-group.com

• OGT’s molecular genetics business delivers 54% growth in commercial revenues to £11.9m
• Growth attributed to acquisition of Cytocell Ltd coupled with robust performance of CytoSure microarray products and Genefficiency next generation sequencing services 
  

Oxford and Cambridge, UK, December 2, 2014 / B3C newswire / - Following its successful acquisition and integration of Cytocell Ltd, Oxford Gene Technology (OGT), the molecular genetics company, has provided an operational and financial update for the company’s financial year ended 30 September 2014.

Operational highlights

• Creation of a focused molecular genetics business addressing large markets in cancer, molecular cytogenetics and reproductive health with a class-leading product portfolio in next generation sequencing (NGS) sample preparation, microarrays and fluorescence in situ hybridisation (FISH)
• Successful acquisition and integration of Cytocell, a leading provider of DNA technology for the detection of gene rearrangements related to inherited genetic disease and cancer
• Smooth transition from Cytocell’s North America distributor to direct sales and support from OGT
• Further expansion of OGT’s sales and support infrastructure in the United States, Canada, UK, Germany and France, with sales in over 60 countries
• New high-value products launched, including SureSeq™ for NGS sample preparation, the CytoSure™ Medical Research Exome and CytoSure™ Embryo Screen arrays as well as new FISH products from Cytocell
• Strong R&D portfolio, including an array-based Non-Invasive Prenatal Test (NIPT) for Down’s syndrome that has just entered clinical trials, and a well-defined pipeline of NGS sample preparation products

Financial highlights

A new service allowing for the explicit identification of drug packaging  

Ravensburg, Germany, December 2, 2014 / B3C newswire / - Vetter has announced a major milestone in the issue of drug safety. The contract development and manufacturing organization (CDMO) now offers the option of clearly identifying packaging used for drugs. Vetter's comprehensive and flexible serialization service is in response to stricter guidelines from the regulatory authorities of many countries aimed at combatting counterfeit drugs. Pharma and biotech companies can use Vetter's individually customizable solutions as a basis for their own track-and-trace programs to optimize their supply chain.

The number of counterfeit drugs on the market is growing and has quickly become a serious global challenge, putting patients at considerable risk, and costing the pharmaceutical industry a significant amount of money. Lawmakers and regulatory agencies around the world have responded by creating new guidelines to increase drug safety. Government and industry both agree that the best available solution is tracking and tracing drugs from production to distribution, on through to the dispensary or the pharmacy. The key to reaching that goal is serialization and Track-and-Trace; the distinct identification of the smallest packaging unit with a unique identification number.

In some countries, like Turkey, India, China, and Argentina, regulators are already calling for drugs to be serialized. Many other markets will be following suit in the coming years, including South Korea, Brazil, the U.S, and the EU. The requirements and specific serialization guidelines however, are country specific, which is why pharmaceutical companies operating internationally need flexible solutions to meet these differing requirements. That is why Vetter offers various options for the serialization of drugs. These include making available different serial number and code formats, interfaces and reports or various aggregation depths. And there are, of course, national differences that must be taken into account. South Korea for example, expects that by 2015, serialization will be included on the item level, while China follows still another concept, including 1D linear codes as well as aggregation with shipping boxes.

"Our serialization service allows for unique identification of the unit level and transportation packaging," says Thomas Otto, Vetter Managing Director. Therefore, we are providing a flexible response to the stricter demands of official agencies, while at the same time actively contributing to greater drug safety. Our customers benefit additionally from the fact that they can use the new service as a basis for their own track-and-trace program. Transparency in distribution prevents counterfeits, but it also promotes greater efficiency for processes along the supply chain."

About Vetter
Vetter is an international leading contract development and manufacturing organization (CDMO) specialized in high-quality aseptic filling and final packaging of drug-delivery systems. For more than 35 years now, the family-owned company is a reliable partner, providing efficient solutions from preclinical development through global market supply and lifecycle management. With no drug products on its own, Vetter focuses on the special needs of its client’s products and has extensive experience in handling complex compounds and lyophilized-drugs. Headquartered in Ravensburg, Germany, Vetter employs approx. 3,300 staff across Germany and the United States.

Contact

Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Phone: +49 (0)751-3700-3706
Fax: +49 (0)751-3700-7707
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com