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Dec 05
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Biocartis announces commercial launch of a new biomarker analysis platform

By Biocartis, Press Release
Press Release.

 

Lausanne, Switzerland – 5 December 2012

Biocartis launches its revolutionary detection platform, Dynamic Multi-Analyte Technology (“DMAT”):

New proteomic and nucleic acid platform provides ultra-high quality data analysis even at higher multiplex formats.

Platform launched well ahead of plan. Biocartis flips from a late-stage development company into a commercial business.

Accurate and fast validation of biomarkers; increasing efficiency in Research and Drug Development DMAT is an innovative and integrated detection platform for high quality biomarker analysis. It enables accelerated development of multiplex assays where several biomarkers can be analyzed at the same time. DMAT dramatically reduces hands-on time and allows users to perform bioassays far more quickly and cost-effectively than with other systems, while ensuring optimal accuracy.

“This revolutionary technology will accelerate the conversion of biomarker discoveries into clinical practice and will help scientists deliver more quickly the promise of personalized medicine,”

said Biocartis CEO Dr. Greg Parekh.

“DMAT is complementary with protein biomarker discovery and next generation sequencing, because the ease of use, sensitivity and accuracy enables rapid validation of new biomarkers initially identified on these other platforms.”

Innovative detection technology combining reproducibility, speed and multiplexing
Conceived in 2007 and developed under design control, DMAT leverages advanced semi-conductor technologies and micro-fluidics to provide fast, flexible and multiplexed detection and quantification of nucleic acid and protein based biomarkers. The platform accelerates biomarker research and yields robust and highly reproducible data over a wide range of analyte concentrations. Demonstrating concordance between single-plex and multiplex assays, the DMAT platform can measure over 2000 analytes simultaneously without deterioration in performance.

For Research Use Only (“RUO”)
The DMAT platform is initially targeting the research market. As such, Biocartis is offering customizable generic test consumables to maximize application flexibility. Biocartis is additionally developing a menu of important RUO assays including a cytokine panel, an oncogene panel and a cell signaling panel.

With the commercialization of DMAT, Biocartis is scaling up its sales force to initially target the Preclinical, Clinical Development and Clinical Research markets.

About Biocartis
Biocartis aims to improve healthcare outcomes by enabling the practice of personalized medicine anywhere, anytime. Biocartis’ ambition is to establish a new gold standard in diagnostic testing.

Biocartis provides innovative research and diagnostic systems with multiplex detection and simplified workflows which require less hands-on time and minimize sample requirements (especially for tumor biopsies). Additionally, Biocartis develops assays which have high clinical utility and compelling health economic value. Oncology is the primary focus of Biocartis as this is one of the greatest unmet needs for personalized medicine. Biocartis is well suited to address the growing need for individualized diagnosis and treatment of cancer patients.

Biocartis is a rapidly growing company; to date Biocartis staff includes over 140 people. The company has raised in total EUR 125 million in equity.

Sep 05
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F2G Ltd Completes $30 Million Financing Round to Fund Pre-clinical and Clinical Development of Novel Anti-fungal Compounds

By F2G, Press Release, Private Companies
Press Release.

 

Manchester, UK, Sept 5th 2012 – F2G Limited, an antifungal drug discovery and development company, today announced the completion of a $30 million equity financing round in which two new investors (Advent Life Sciences and Novartis Bioventures) joined the existing syndicate (Sunstone Capital, Merifin Capital, K Nominees, and Astellas Venture Fund). These funds will be used to select a clinical candidate from the F3 series of advanced preclinical analogs and proceed to first in man studies. The F3 series represents a proprietary group of compounds with highly potent and selective activity against Aspergillus species and other moulds, which act via a totally novel mechanism. Aspergillus infections are a serious threat in immune-compromised patient populations and result in a high rate of mortality even with the most effective treatment currently available. Dr Richard White, chairman of F2G, commented,

“We are delighted to welcome two top tier investors into F2G. We now have a first class international syndicate, including the venture arms of two major pharmaceutical companies”.

Shane Kelly, previously the CEO, is leaving the company to pursue another opportunity. Dr White will assume the expanded role of Executive Chairman and noted

“We would all like to thank Shane for his tireless and steadfast management of the company over the last 10 years and for bringing us to this successful juncture. We wish him well in his new venture”

Dr Raj Parekh of Advent and Dr Anja König of Novartis Venture Funds will both be joining the Board of F2G. Raj Parekh, General Partner at Advent said, “The F2G molecules show a compelling and novel profile and have the genuine potential to be first- and best- in-class agents for the treatment of invasive aspergillosis, which remains a serious unmet medical need. We look forward to working with Richard and the team to bring these molecules to an early clinical evaluation.”

About F2G Ltd:

Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. The antifungal market is currently estimated at over 6 billion dollars annually and is growing steadily year on year. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. The company has impressive internal capabilities, employing a core team of scientists with a unique understanding of the antifungal arena, supported by an experienced management team. For more information visit www.f2g.com

Jul 20
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First gene therapy in Western world receives positive opinion in Europe from CHMP

By Press Release, UniQure
Press Release.

 

uniQure’s gene therapy Glybera® recommended for approval

• First gene therapy in the Western world to reach important regulatory approval milestone, culminating 40 years of research

• First therapy for LPL deficient patients, a severe disease with no alternative treatment

• Validates uniQure’s unique AAV-based gene therapy platform, consisting of a modular, plug-and-play vector system and unrivaled GMP manufacturing capabilities on a commercial scale

• Heralds new phase in uniQure’s development, including potential revenues from salesand partnerships

• Technology platform can now be leveraged to find solutions for many more severe genetic and other disorders

Amsterdam, The Netherlands – July 20, 2012 – uniQure announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion that recommends marketing authorization of Glybera® (alipogene tiparvovec) as a treatment for lipoprotein lipase deficiency (LPLD) under exceptional circumstances. LPLD is a very rare, inherited disease. Patients with the disease are unable to handle fat particles in their blood plasma, which leads to recurring severe abdominal pain and pancreatitis.

The European Commission (EC) generally follows the recommendations of the CHMP.

“We expect final approval from the EC within 3 months after the CHMP decision,”

says Jörn Aldag, CEO of uniQure.

“After today’s positive recommendation, Glybera is poised to become the first in a class of gene therapy products approved in Europe to treat orphan diseases, rare conditions with a very high unmet medical need.”

Marketing authorization covers all 27 European Union member states.

Mr. Aldag continued:

“Patients with LPLD are afraid of eating a normal meal because it can lead to acute and extremely painful inflammation of the pancreas, often resulting in a visit to intensive care. Now, for the first time, a treatment exists for these patients that not only reduces this risk of getting severely sick, but also has a multi-year beneficial effect after just a single injection. The positive recommendation from the CHMP for Glybera therefore represents a major breakthrough for both LPLD patients and for medicine as a whole. Restoring the body’s natural ability to break down fat particles in the blood in order to prevent pancreatitis and excruciating abdominal pain suffered by patients, is what gene therapy is all about: curing disease at the genetic level.”

“At uniQure we are developing treatments for a number of other rare diseases as well, such as acute intermittent porphyria and Sanfilippo B. But the potential of gene therapy stretches far beyond rare diseases. As shown recently in a publication in the New England Journal of Medicine (N Engl J Med 2011; 365:2357-2365, December 22, 2011), hemophilia patients treated with our proprietary gene are showing a sustained clinical effect over several years, which has allowed prophylaxis treatment to be stopped. In addition, we are advancing programs in degenerative diseases such as Parkinson’s. We believe that just like antibodies, gene therapy will one day be a mainstay in clinical practice,”

Mr Aldag added.

As part of the approval, treatment with Glybera will be offered through dedicated centers of excellence with expertise in treating LPLD and by specially trained doctors to ensure ongoing safety of this novel treatment paradigm. uniQure has also committed to building a patient registry for continued understanding of this devastating, under-researched disease. The Company is now preparing to apply for regulatory approval in the US, Canada, and other markets.

Glybera has been tested in three interventional clinical studies conducted in the Netherlands and in Canada, in which a total of 27 LPLD patients participated. In all three clinical trials, Glybera was well tolerated, with no relevant safety issues observed. Data from these clinical trials indicate that a single dose administration of Glybera resulted in a long-term biological activity of the LPL protein.

About Glybera®
uniQure has developed Glybera as a therapy for patients with the genetic disorder lipoprotein lipase deficiency.

LPLD is an orphan disease for which no treatment exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL protein in patients. This protein is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels. Excess chylomicrons result in recurrent and severe acute inflammation of the pancreas, called pancreatitis, the most debilitating complication of LPLD. Glybera has orphan drug designation in the EU and US. LPL Deficiency affects 1-2 persons per million. For further information on LPLD visit www.lpldeficiency.com.

About uniQure
uniQure is a world leader in the development of human gene based therapies. uniQure has a product pipeline of gene therapy products in development for hemophilia B, acute intermittent porphyria, Parkinson’s disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows uniQure to pursue its strategy of focusing on this sector of the industry. uniQure’s largest shareholders are Forbion Capital Partners and Gilde Healthcare, two of the leading life sciences venture capital firms in the Netherlands. Further information can be found at www.uniqure.com.

Jul 10
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Advent Life Sciences Fund I Receives Additional Investments

By Advent Life Sciences, Press Release
Press Release.

 

Final Fund Size of £101.3 Million ($158 Million)

10th July 2012, London:  Advent Life Sciences today announced an investment into its Life Sciences Fund I from a new institutional investor, and increased commitments from certain existing LPs. This brings the Fund to an aggregate amount of £101.3m (€128m, US$158m). The Fund, which closed in November 2010, was re-opened to accept the new and increased commitments.  Advent Life Sciences Fund I is dedicated largely to early stage UK and European Life Sciences Venture companies.

Raj Parekh, General Partner, commented

“We appreciate the strong support from our new and existing LPs.  Advent Life Sciences Fund I has been raised almost entirely from independent financial investors, despite the difficult fundraising environment.  The Fund has now exceeded our initial target.”

– Ends –

About Advent Life Sciences:
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, 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.

www.adventventures.com

For more information contact:

Advent Venture Partners (London)
Josephine Defty
Ph: +44 (0) 20 7932 2116
Email: Josephine@adventventures.com

Jun 27
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Advent Life Sciences Announces Appointment of Alain Huriez as Venture Partner

By Advent Life Sciences, Press Release
Press Release.

 

27th June 2012, London: – Advent Life Sciences announced today the appointment of Alain Huriez MD, as a Venture Partner.   Alain brings 22 years of experience in management, drug development and financing in the life sciences sector, including as CEO of TcLand Expression and Neovacs, Associate Partner at Truffle Capital and Vice President at Quintiles.   Prior to this, he was a practising physician.   Alain has also been responsible for several initiatives in Europe within the areas of personalised medicine, biomarkers and high value diagnostics through his work as chairman of EPEMED, the European Personalised Medicine Association.

– Ends –

About Advent Life Sciences:
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, 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 contact:

Advent Venture Partners
Josephine Defty
Ph: +44 (0) 20 7932 2116
Email: Josephine@adventventures.com

Jun 10
Love0

Need a light? It’s okay, I’ll just plug it in

By Advent Life Sciences, CN Creative, Press Release
Press Release.

 

Louise Hodgetts has struggled to overcome her 30-a-day habit.  A smoker for two decades, she worries about her family’s history of cancer, but nicotine patches and gum failed to free her from the addiction.

Now, the 34-year-old is trying something new- an electronic E-cigarette.

So far, so good.  With the help of the 3in-long piece of plastic she hasn’t smoked the real thing for a month, feels better for it, and has bought a television with the money saved.

“Its working- and I’ve recommended it to my brother,”

said Hodgetts, from Bracknell, Berkshire.

Substitute cigarettes are not new, but the market is beginning to boom.  And tobacco companies are ready to plough substantial sums into finding the next gadget to supply smokers with a guilt-free kick.

With the market for tobacco in relentless decline in the West, cashing in on those who want to quit is the obvious source of growth.

Imperial Tobacco, maker of brands such as Davidoff and Lambert & Butler, has recently done a secret deal to invest in one business that believes it may have the magic formula.

In April, Lorillard, the American company behind Newport cigarettes, bought Blu e-cigarettes for $135m ( £87m).  Japan Tobacco International, owner of Benson & Hedges, has a minority stake in Ploom, another manufacturer, and is working on plans to commercialise the devices globally.

Philip Morris International, the world’s biggest listed tobacco company, is working on a next- generation version of the technology, while British American Tobacco has set up a subsidiary to target the market.

There is good reason for the rush of activity.

“The growth of e-cigarettes has been unbelievable, particularly in the past 12 months,”

said Damien Scott of Skycig, an e-cigarette brand owned by Gibraltar-based Zeus Ventures.

“I don’t think it will stop any time soon.”

Sales of e-cigarettes in America, where there are more than 100 brands, are likely to double this year to $500m, according to analysts at UBS, the investment bank. That is tiny compared with the tobacco market-Americans spent $88 billion on cigarettes last year-yet the growth prospects are enough to lure investors into “non-tobacco nicotine delivery devices”.

Britain is expected to follow the same pattern as America.

An estimated 21% of adults smoke, of whom three-quarters have tried to quit. Businesses and investors backing the new technology hope that it will appeal to those millions-and provide a new source of revenue.  Critics claim the devices simply replace one addiction with another, albeit less harmful without the tar and other damaging substances.

Strikingly, the growth of e-cigarettes does not appear to have hit sales of nicotine patches and gum.  Glaxo Smith Kline, maker of Nicorette, saw worldwide sales of its range grow 3% in the first quarter of this year.  But, with smokers forced out of public places onto the streets for a puff, the new aids are catching on fast.

Most of the market is based on the battery-powered cigarette developed by a Chinese pharmacist in 2003.  These rechargeable devices heat up a cartridge of nicotine in water, releasing vapour to be inhaled.  To date, they have not been hampered by the strict controls placed on medical devices and real cigarettes, but many in the industry expect this to change.

Venture capital firms have also been vying for a piece of the burgeoning market.  In January, Britain’s Advent Life Sciences led a £2m fundraising for CN Creative, which is developing a new type of “smoking cessation device”.

Across the Atlantic, Catterton Partners,which has backed businesses such as Kettle crisps, has invested $20m in Njoy, an American e-cigarette manufacturer.

Two young British entrepreneurs are among those aiming to produce the next generation of cigarette substitutes.

Alex Hearne is the founder of Kind Consumer, which has received investment from business figures such as Sir Terry Leahy, former boss of Tesco, Jon Moulton, the venture capitalist, and Sir Peter Davis, previously head of Prudential.

An asthma sufferer as a child, with parents who smoked, Hearn had good reason to develop a device to help reduce tobacco consumption.

After spending a decade on research, producing more than 700 prototypes, Kind Consumer hopes to apply for approval from the Medicines and Health-care Products Regulatory Agency within 12 months.

“We strongly believe that these devices should be regulated.  The public should know what they are buying,” said Hearn, 29.

His design is not electronic but a kind of cigarette-shaped aerosol that delivers a burst of nicotine through a breath-operated valve.  A battery is not needed.

The device, as yet unnamed, will be sold like cigarettes in a pack, with each one thrown away when the nicotine has been exhausted.

With the battery-powered e-cigarettes, users by one device and then replacement nicotine cartridges as needed.  Hearn said, “No substitute is going to be exactly the same [as a cigarette], but we wanted to try to make our device as close as possible to the experience of smoking.”

His company has received backing from British American Tobacco, the second biggest cigarette maker outside china.  Its Nicoventures subsidiary is funding development and will be the distributor.

Another Briton hoping to crack the market is David Newns, 27, who co-founded CN Creative in 2008.  The company already sells an electronic cigarette, the Intellicig, but is also working towards producing an inhaler under the name Nicadex.  It, too, hopes to receive approval from Health Watchdogs in Britain, Europe and America and will begin the application process towards the end of the year.

That will be one more smoke-free competitor for the tobacco companies, many of which are reluctant to reveal much about there plans to enter the new market.

Bristol –based Imperial Tobacco is the latest of the giants to become involved.  The company admitted it had made “a very small investment” in an e-cigarette business, but refuse to disclose the details beyond saying that the investment did not involve taking an equity stake.

Imperial said the arrangement was designed simply to “build knowledge and expertise in the area”.

The importance of the involvement of the big names should not be underestimated, though. Newns said: “In the past they have said that cigarettes are their business.  For the first time, they are opening their eyes to other innovations, Its very encouraging.”

Cashing in on those who want to stop is the obvious source of growth.

For more information on CN Creative please visit their website here

May 30
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CN Creative advances regulatory initiatives for its Nicadex™ and Intellicig®

By CN Creative, Press Release
Press Release.

 

UK Manufacturing Facility Receives “Pharmaceutical Grade” cGMP Designation

Plans for Clinical Trial of Nicadex Electronic Inhaler Nicotine Replacement Therapy on Track

Will Leverage MHRA Marketing Submission to Advance European and US Regulatory Strategy

 

MANCHESTER, UK, May 30, 2012 – CN Creative, Ltd. (CNC), a healthcare company providing innovative and sustainable solutions to reduce smoking and smoking-related illnesses, today reported advances in the company’s regulatory and market initiatives for its Nicadex™ electronic inhaler nicotine replacement therapy (NRT) product and Intellicig® electronic cigarettes.

Nicadex is being developed for use as part of medically supervised smoking harm reduction programmes, with a Marketing Authorisation Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) targeted for year-end. CN Creative plans soon to initiate a UK clinical trial of Nicadex that will provide data for the MAA submission. The company also intends to apply the data and materials generated for the MAA submission in the UK to its regulatory strategy for Europe and the US, in consultation with its expert advisors, European regulatory authorities and the US Food and Drug Administration.

Intellicig is a high quality electronic cigarette currently marketed in 26 countries. The nicotine containing cartridge for both Intellicig and Nicadex is manufactured in the company’s own facilities in the UK using pharmaceutical grade materials that are now fully certified as cGMP, meaning that the manufacturing process adheres to the rigorous guidelines required for medically regulated products such as pharmaceuticals and medical devices. In addition, the electronic device components of Nicadex will be produced in the UK under ISO 13485 standards.

“From the start, our strategy has been to engineer and produce our electronic inhaler nicotine delivery products to medical standards, and we believe this approach is especially appropriate in view of the evolving regulatory situation,”

said David Newns, a co-founder and Company Director of CN Creative.

“Our plans for a clinical trial of Nicadex in the UK are proceeding well and we are on track to file an MAA around the end of this year. We plan to use data and materials from our UK dossier to support Nicadex and Intellicig regulatory filings in Europe and the US, where regulatory requirements are currently being formulated and where the rapidly growing demand for high quality electronic cigarettes is providing considerable traction as we ramp up Intellicig’s market presence.”

About CN Creative
CN Creative has developed a portfolio of products and services focused on harm reduction and smoking cessation including user-friendly nicotine delivery systems and patient-focused smoking cessation and support services such as QuitDirect,, the Intellicig® electronic cigarette, ECOpure high purity nicotine preparations and NRT Direct. CNC’s Nicadex™ electronic inhaler nicotine replacement therapy product is in development for use as part of medically supervised smoking cessation programmes.

 

For more information, please contact:

CN Creative
Media Corporate
Barbara Lindheim, BLL Partners

David Newns, CN Creative
blindheim@bllbiopartners.com
david.newns@cncbio.com
+1 212 584-2276 +44 (0) 7834 767 367

May 09
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4-Antibody AG and Evotec AG form Strategic Collaboration

By 4-Antibody, Press Release
Press Release.

 

4-Antibody AG
Hochbergerstrasse 60C
CH-4057 Basel, Switzerland
Phone: +41-61-633-2260
ir@4-antibody.com
www.4-antibody.com

Basel, Switzerland, & Hamburg, Germany, 9th May, 2012

4-Antibody AG and Evotec AG Form Strategic Collaboration

4-Antibody and Evotec launch a new high-content screening platform for early antibody functionality testing

Basel, Switzerland, & Hamburg, Germany, 9th May, 2012: 4-Antibody AG and Evotec AG (Frankfurt
Stock Exchange: EVT, TecDAX) today announced the signing of a strategic collaboration agreement
under which Evotec will offer a fully integrated antibody discovery and development service. Evotec’s novel and unique high throughput and high content screening approach coupled with 4-Antibody’s high throughput antibody selection approach will now allow screening of large and diverse antibody populations for desired functionality and activity at a much earlier stage of selection. This unique combined approach is expected to substantially reduce attrition rates at later development stages and is also expected to be particularly beneficial in aiding earlier distinction and selection between antagonist and agonist antibodies.

Evotec’s fully integrated drug discovery and development infrastructure has been adapted to facilitate screening of human antibody populations in combination with high throughput/high content screening coupled to specific biological assays. The new collaboration integrates the output from 4-Antibody’s proprietary high throughput in vitro Retrocyte Display® technology for rapid discovery of fully human antibodies into Evotec’s high throughput cell-based assay platform.

The Retrocyte Display® technology (Retroviral B lymphocyte Display) is a high throughput cellular antibody expression platform which allows expression and screening of full-length immunoglobulin antibody libraries in mammalian B-lineage cells for the identification of antigen-specific fully human monoclonal antibodies. B-lineage cells are designed by nature for optimal antibody display and are capable of generating ‘better-behaved’, fully human antibodies.

Dr Robert Burns, 4-Antibody’s CEO, said:

“We’re delighted to announce this collaboration with Evotec which will allow pharma players who elect to fully out-source antibody drug discovery access to our platform. This is an ideal partnership since it gives 4-Antibody access to a broader market beyond its primary targets – the companies we think of as ‘technology internalizers’. These companies license our cellular antibody libraries to allow them to screen large number of targets through our technology platform in their own in-house research labs. So, our primary business model remains unchanged but with the Evotec collaboration we can now offer a fully integrated discovery-to-development model in the antibody drug space for pharma players who are looking for complete out-sourcing. Everyone in the drug discovery space understands the desirability of introducing functional testing as early as possible in the selection of drug candidates; and I don’t see other service players who can offer this fully integrated discovery to development capability in the antibody drug space.”

Dr Werner Lanthaler, CEO at Evotec added:

“We are excited to launch our high-content screening capabilities for antibody selection in conjunction with 4-Antibody, one of the technological leaders in the antibody field. Through a combination of our capabilities, we target an approach to select for functional antibodies. This “EVOmAb” turn-key solution will deliver to our customers a much higher chance to bring an antibody to the market than traditional affinity-selected antibody approaches”

Both parties agreed to share financial rewards of this approach. Evotec will initially pay a €2m access fee to 4-Antibody, which will be fully reimbursed from future returns. Going forward the Parties will share profits.
About 4-Antibody AG

4-Antibody is a biopharmaceutical company with a powerful fully-human antibody drug-discovery technology platform which is generating an emerging pipeline of antibody therapeutics. The company’s proprietary discovery engine is the in vitro Retrocyte Display® technology, a fast and highly efficient source of antibody drug candidates. Retrocyte Display® generates high quality therapeutic antibody drug candidates quickly using a rapid, high-throughput, flow cytometry approach incorporating full-length IgG format human antibody libraries expressed in mammalian B cells. 4-Antibody provides access to its technologies to select pharmaceutical R&D collaborators and is also generating an in-house pipeline of antibody drugs. 4-Antibody is a private company with strong, commercially-experienced leadership located in Basel, Switzerland and Jena, Germany. For more information please visit: www.4-antibody.com

About Evotec AG
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies. We operate worldwide providing the highest quality stand-alone and integrated drug discovery solutions, covering all activities from target-to-clinic. The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuroscience, pain, metabolic diseases as well as oncology and inflammation. Evotec has long-term discovery alliances with partners including Boehringer Ingelheim, CHDI, Genentech, Medimmune/Astra Zeneca, and Ono Pharmaceutical. In addition, the Company has existing development partnerships and product candidates both in clinical and preclinical development. These include partnerships with Boehringer Ingelheim, MedImmune and Andromeda (Teva) in the field of diabetes, and with Roche in the field of Alzheimer’s disease. For additional information please go to www.evotec.com

.
-ends-

Further Information:

Dr Robert Burns
CEO
4-Antibody AG
t: +41-61-633-22-60
e: robert.burns@4-antibody.com

Dr Werner Lanthaler
CEO
Evotec AG
t: + 49.40.56081.242
e: Werner.Lanthaler@evotec.com

Dr Robert Mayer
Account Manager
College Hill
t: +49-89-5238-8030
e: robert.mayer@collegehill.com

Apr 26
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Jazz Pharmaceuticals to Acquire EUSA Pharma

By Press Release
Press Release.

 

  • Terms include $650 million in cash plus a potential $50 million milestone payment
  • Transaction would be immediately accretive to Jazz Pharmaceuticals’ adjusted EPS
  • Transaction would add significant U.S. marketed product, Erwinaze™ (asparaginase Erwinia chrysanthemi), a life-saving treatment for a form of leukemia that primarily affects children
  • Combined company to market diversified product portfolio in U.S. and Europe
  • Investor conference call to be held on, April 26 at 5:00 PM EDT

DUBLIN and LANGHORNE, PA, April 26, 2012 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and EUSA Pharma Inc. today announced that the companies have signed a definitive agreement under which Jazz Pharmaceuticals has agreed to acquire EUSA Pharma, a privately-held, specialty pharmaceutical company with headquarters in the United States and United Kingdom, for $650 million in cash1 and a potential $50 million milestone payable in cash based upon its lead product, Erwinaze™ (asparaginase Erwinia chrysanthemi), achieving a specified U.S. net sales target in 2013.

The transaction would provide Jazz Pharmaceuticals with an expanded portfolio of specialty pharmaceutical products and an enhanced commercial platform, incorporating EUSA Pharma’s specialty commercial infrastructure in the United States and Europe and its international distribution network. The combined organization’s portfolio would have products marketed in the U.S. and Europe, including Erwinaze, a life-saving treatment for patients with acute lymphoblastic leukemia (ALL). The transaction is expected to be immediately accretive to Jazz Pharmaceuticals’ adjusted earnings per share upon closing in 2012 and in 2013 is expected to provide additional revenue of $210 to $230 million, additional adjusted EBITDA of $75 to $85 million, and an additional $0.75 to $0.85 in adjusted earnings per share.

“EUSA Pharma is a compelling strategic fit with our specialty focus and commercial expertise, and furthers our mission to improve patients’ lives by delivering therapies that address serious unmet medical needs,”

said Bruce C. Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.

“This transaction would expand our global footprint and marketed product portfolio to include Erwinaze, a treatment for a life-threatening form of leukemia, as well as other highly specialized products. Our organizations are highly complementary, and we look forward to working with our new colleagues to build an even stronger rapidly-growing company.”

“The combination of Jazz Pharmaceuticals and EUSA Pharma would bring together two highly successful businesses, with teams who are passionate about providing patients with access to vital specialty therapies,”

said Bryan Morton, founder, president and chief executive officer of EUSA Pharma.

“There is a strong fit between our two companies’ products, people and values, and the combination would represent a positive transaction for the patients we serve, our collective employees and our shareholders. As a larger and stronger combined organization, we would have greater resources to continue our growth toward becoming a leader in the specialty pharmaceutical sector, bringing our medicines to patients worldwide.”

EUSA Pharma is a specialty pharmaceutical company founded in 2006, with a portfolio of 10 oncology, critical-care and oncology supportive care products currently marketed directly in the U.S. and Europe and via distributors in other countries. The company’s first quarter 2012 net sales were approximately $46 million. Its largest product is Erwinaze, developed as a treatment option for patients with ALL who are hypersensitive to E. coli-derived asparaginase. Approximately 3,600 people younger than 20 years are diagnosed with ALL each year, with a peak incidence between ages 2-5 in the United States.2,3 Erwinaze was approved by the U.S. Food and Drug Administration in November 2011, and has orphan drug exclusivity through November 2018 and biologic data exclusivity through 2023. In addition, it is currently approved in seven countries outside the U.S., where it is marketed by EUSA Pharma under the trade name Erwinase®.

In addition to ongoing development to expand the available methods of Erwinaze administration to include IV delivery, EUSA Pharma’s pipeline includes two additional drug candidates: Asparec®, a pegylated recombinant Erwinia asparaginase currently in phase I development in Europe for the treatment of ALL in patients with hypersensitivity to standard-of-care E. coli-derived asparaginase therapy; and Leukotac® (inolimomab), an anti-CD25 monoclonal antibody in a phase III pivotal study in Europe for treatment of steroid-refractory acute graft versus host disease.

EUSA Pharma’s other products in the U.S. are Caphosol® (supersaturated calcium phosphate rinse), ProstaScint® (capromab pendetide) and Quadramet® (Samarium Sm 153 Lexidronam Injection). Outside the U.S., EUSA Pharma’s principal products are Caphosol®, Collatamp® (lyophilized collagen implant impregnated with the aminoglycoside antibiotic gentamicin), Fomepizole® (fomepizole), Kidrolase® (Escherichia coli L-asparaginase), and Xenazine® (tetrabenazine).

EUSA Pharma has approximately 180 employees, with operations in the U.S. (Langhorne, PA) and Europe (including offices in Oxford, UK and Lyon, France). EUSA Pharma’s Founder, President and Chief Executive Officer, Bryan Morton, would remain with the organization with responsibility for the new international operations.

Transaction Close and Financing

The proposed acquisition, which has been approved by the boards of directors of both companies and the stockholders of EUSA Pharma, is subject to the satisfaction of customary closing conditions and regulatory approvals, including antitrust approval in the U.S. The proposed acquisition is not subject to approval by the shareholders of Jazz Pharmaceuticals. The closing of the transaction is anticipated to occur in June 2012.

Jazz Pharmaceuticals expects to finance the transaction with a combination of cash on hand and proceeds from a new $500 million term loan for which Barclays Bank PLC has provided a binding commitment letter. The commitment letter also provides for an additional $100 million revolving credit facility. The commitment to provide the term loan and revolving credit facility is subject to the satisfaction of customary conditions.

Advisors
Jazz Pharmaceuticals’ financial advisor for the transaction is Barclays, and its primary legal advisors are Cooley LLP, Baker & McKenzie and A&L Goodbody (Dublin).

EUSA Pharma’s financial advisor for the transaction is Morgan Stanley, and its primary legal advisor is K&L Gates. EUSA Pharma’s stockholders include Essex Woodlands, 3i, Advent Venture Partners, SV Life Sciences, TVM Capital, NeoMed and NovaQuest.

Conference Call Information
Jazz Pharmaceuticals will host a conference call and live audio webcast today at 5:00 pm EDT/10:00 pm IST to discuss this transaction and comment on Xyrem® (sodium oxybate) first quarter performance. The live webcast may be accessed from the Investors section of the company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing 877-210-9834 in the U.S., or 779-232-1729 outside the U.S., and entering passcode 75780843.

About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, pain, psychiatry and women’s health. The company’s marketed products in these areas include: Xyrem® (sodium oxybate), Prialt® (ziconotide intrathecal infusion), FazaClo® (clozapine USP) HD and LD, Luvox CR® (fluvoxamine maleate) and Elestrin® (estradiol gel 0.06%).

About EUSA Pharma
EUSA Pharma is a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the U.S., a pan-European presence and a wider distribution network in numerous additional territories. EUSA Pharma currently has a portfolio of specialist hospital products which are sold in over 80 countries globally. These include Erwinase/Erwinaze and Kidrolase® for the treatment of ALL, Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Collatamp®, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint® for imaging the extent and spread of prostate cancer and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. EUSA Pharma also has several product candidates in development.

About Erwinaze
Erwinaze is an asparaginase enzyme that depletes the level of asparagine in the bloodstream. Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia. Asparaginase products are derived from bacteria, and approximately 15 – 20% of patients develop hypersensitivity to modern products derived from Escherichia coli, preventing their continued treatment.4,5,6 Erwinaze, which is produced by Erwinia chrysanthemi, is immunologically distinct from these therapies and is suitable for patients with hypersensitivity to E. coli-derived treatments. Erwinaze was originally discovered by the UK Health Protection Agency. The U.S. FDA approved Erwinaze in November 2011.

Indication and Usage: Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

Important Safety Information

Contraindications: History of serious hypersensitivity reactions to Erwinaze, including anaphylaxis or history of serious pancreatitis, serious thrombosis or serious hemorrhagic events with prior L-asparaginase therapy.
Warnings and Precautions: Discontinue Erwinaze if serious hypersensitivity reactions, including anaphylaxis or severe or hemorrhagic pancreatitis occur. Warnings include: monitor glucose (intolerance may not be reversible; insulin may be needed for hyperglycemia); thrombosis and hemorrhage: discontinue until resolved. Do not use in lactating women and use in pregnant women only if clearly needed.

Common Adverse Reactions ≥ 1%: Serious hypersensitivity including anaphylaxis, pancreatitis, and abnormal transaminases, coagulation abnormalities (thrombosis, hemorrhage), nausea, vomiting, and hyperglycemia.

Please see full prescribing information available at www.erwinaze.com.

Non-GAAP Financial Measures
In this press release, Jazz Pharmaceuticals uses the non-GAAP measures adjusted EBITDA and adjusted earnings per share. Jazz Pharmaceuticals believes these non-GAAP financial measures are helpful in understanding its past financial performance and its potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Jazz Pharmaceuticals’ management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. Compensation of Jazz Pharmaceuticals’ employees is based in part on the performance of its business based on these non-GAAP measures. In addition, Jazz Pharmaceuticals believes that the use of these non-GAAP measures enhances the ability of investors to compare its results from period to period. Investors should note that adjusted EBIDTA and adjusted earnings per share, as used by Jazz Pharmaceuticals, may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by Jazz Pharmaceuticals’ competitors and other companies.

This press release contains forward-looking estimates of adjusted EBITDA and adjusted earnings per share contributions resulting from the proposed business combination. As used in this press release, with respect to estimated adjusted earnings per share contribution resulting from the proposed business combination, adjusted earnings per share excludes from GAAP net income per diluted share: stock-based compensation, amortization of intangible assets, transaction and integration costs and inventory purchase price adjustments associated with the proposed business combination between Jazz Pharmaceuticals plc and EUSA Pharma, and non-cash interest expense associated with a debt discount and debt issuance costs. With respect to estimated adjusted EBITDA contribution resulting from the proposed business combination, Jazz Pharmaceuticals defines adjusted EBITDA as GAAP net income before interest, income taxes, depreciation and amortization, excluding stock-based compensation, transaction and integration costs and inventory purchase price adjustments associated with the proposed business combination between Jazz Pharmaceuticals and EUSA Pharma. Reconciliations of estimated adjusted EBITDA and adjusted earnings per share contributions to GAAP net income is not provided because GAAP net income generated by the EUSA Pharma operations for the applicable future period is not accessible or estimable at this time. In this regard, Jazz Pharmaceuticals has not yet completed the necessary valuation of the various assets to be acquired in the proposed acquisition, for accounting purposes, or an allocation of the purchase price among the various types of assets. In addition, the final interest and debt expense associated with the transactions contemplated by the commitment letter have not been finalized and are therefore unavailable. Accordingly, the amount of depreciation and amortization and interest and debt expense that will be included in the additional GAAP net income assuming the proposed acquisition is consummated is not accessible or estimable at this time, and is therefore not available without unreasonable effort. The amount of such additional resulting depreciation and amortization and applicable interest and debt expense could be significant, such that actual GAAP net income would vary substantially from the estimated adjusted EBITDA and estimated adjusted EPS contributions included in this presentation.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated consummation of the acquisition of EUSA Pharma and the timing and benefits thereof, the expected financing for the acquisition, the combined company’s, and each respective company’s plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, anticipated product portfolio and pipeline opportunities, future regulatory matters, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Jazz Pharmaceuticals’ ability to complete the acquisition on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of closing conditions and the availability and terms of the financing for the acquisition; risks associated with business combination transactions, such as the risk that acquired businesses will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; risks related to future opportunities and plans for the combined company, including uncertainty of the expected financial performance and results of the combined company following completion of the proposed acquisition; disruption from the proposed acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the calculations of, and factors that may impact the calculations of, the purchase price in connection with the proposed acquisition and the allocation of such purchase price to the net assets acquired in accordance with applicable accounting rules and methodologies and the possibility that if Jazz Pharmaceuticals does not achieve the perceived benefits of the previously completed Azur Pharma merger and/or the proposed acquisition of EUSA Pharma as rapidly or to the extent anticipated by financial analysts or investors, the market price of Jazz Pharmaceuticals’ ordinary shares could decline; as well as other risks related Jazz Pharmaceuticals’ business, including dependence on sales of Xyrem® and the ability to increase sales of Jazz Pharmaceuticals’ products; competition, including potential generic competition; dependence on single source suppliers and manufacturers; the ability of Jazz Pharmaceuticals to protect its intellectual property and defend its patents; regulatory obligations and oversight; cash flow; and those other risks detailed from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s SEC filings and reports (Commission File No. 001-33500), including in the Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on behalf of, and as successor to, Jazz Pharmaceuticals, Inc. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.

References
1. Subject to working capital adjustments
2. SEER Stat Fact Sheets: Acute Lymphocytic Leukemia. Available Online. Information: It is estimated that 6,050 men and women (3,450 men and 2,600 women) will be diagnosed with and 1,440 men and women will die of acute lymphocytic leukemia in 2012. From 2005-2009, the median age at diagnosis for acute lymphocytic leukemia was 14 years of age. Approximately 59.8% were diagnosed under age 20
3. Swensen AR, Ross JA, Severson RK, Pollock BH, Robison LL. The age peak in childhood acute lymphoblastic leukemia: exploring the potential relationship with socioeconomic status. Cancer. 1997 May 15;79(10):2045-51. [http://www.ncbi.nlm.nih.gov/pubmed/9149034]
4. Woo MH, Hak LJ, Storm MC et al. Hypersensitivity or development of antibodies to asparaginase does not impact treatment outcome of childhood acute lymphoblastic leukemia. J Clin Oncol 2000;18:1525–1532
5. Vrooman LM, Supko JG, Neuberg DS et al. Erwinia asparaginase after allergy to E. coli asparaginase in children with acute lymphoblastic leukemia. Pediatr Blood Cancer 2010;54:199–205
6. Wang B, Relling MV, Storm MC et al. Evaluation of immunologic crossreaction of antiasparaginase antibodies in acute lymphoblastic leukemia (ALL) and lymphoma patients. Leukemia 2003;17:1583–1588

Contact
Ami Knoefler
Executive Director, Investor Relations & Corporate Communications
Jazz Pharmaceuticals plc

International: + 353 1 638 1032
U.S.: + 1 650 496 2947
Email: ami.knoefler@jazzpharma.com

Apr 04
Love0

CN Creative appoints Chief Financial Officer

By CN Creative, Press Release
Press Release.

 

MANCHESTER, UK, April 4, 2012 – CN Creative, Ltd. (CNC), a healthcare company providing innovative and sustainable solutions to reduce smoking and smoking-related illnesses, today announced that Tim Byrne has been appointed Chief Financial Officer.

Mr. Byrne, who is a Fellow of the Institute of Chartered Accountants, is an accomplished financial executive whose experience ranges from start-up ventures to international publicly listed companies. Most recently, he was a Founding Partner of The Management Alliance, which provides strategic and financial consulting and management services. Previously, Mr. Byrne was CEO and CFO of Airtours plc, a FTSE 250 listed company with diversified global operations and an annual turnover of £5.2 billion.

CN Creative markets a portfolio of products and services for smoking cessation and harm reduction. The company’s Nicadex™ electronic inhaler nicotine replacement therapy (NRT) is to commence clinical trials shortly and the company intends to submit a Marketing Authorisation Application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) later this year. Regulatory submissions in other European territories and the US will follow.

“Tim’s extensive experience in growing global firms is proving invaluable, and we are delighted to have him as part of CNC’s management team,”

said David Newns, co-founder and Company Director of CN Creative.

“His broad expertise is especially helpful as we are advancing our pioneering electronic inhaler nicotine replacement therapy towards MHRA submission, while also expanding our existing businesses in the UK and overseas.”

Dale R. Pfost, PhD, Chairman of CN Creative and a General Partner at Advent Ventures, commented,

“Tim brings us a global financial perspective and a keen appreciation of how to manage the challenges of high growth companies, and he is well-grounded in the nuts and bolts of implementing the financial management systems critical to our success.”

About CN Creative
CN Creative has developed a portfolio of products and services focused on harm reduction and smoking cessation, including user-friendly nicotine delivery systems and patient-focused smoking cessation and support services, such as QuitDirect, the Intellicig® electronic cigarette, ECOpure high purity nicotine preparations and NRT Direct. CNC’s Nicadex™ electronic inhaler nicotine replacement therapy product is in development for use as part of medically supervised smoking cessation programmes. For more information, visit www.cncbio.co.uk.

For more information, please contact:

CN Creative Media
Barbara Lindheim,
BioCom Partners
blindheim@biocompartners.com
+1 212 584-2276

Corporate
David Newns, CN Creative
david.newns@cncbio.com
+44 (0) 7834 767 367