XSpray a Karolinska Development portfolio company, announces positive data from dog studies with their novel formulation strategy for PKIs. Plasma levels of nilotinib in dogs increased over 700% with the XSpray formulation when compared with the commercially available product in dogs with neutralized stomachs.

In addition, XSpray has demonstrated an improvement in solubility in-vitro with novel formulations of a range of different marketed PKI’s.

The majority of these orally administered targeted anticancer compounds are weak bases that exhibit pH-dependent solubility. Suppression of gastric acidity with acid-reducing agents such as antacids or H₂ proton pump inhibitors can impair their absorption.

Per Andersson, CEO of XSpray said, “These are very encouraging results as our formulation strategy may, in addition to improving bioavailability, also make formulating PKIs with pH independent absorption possible.”

A recent study performed by Medco highlights the fact that about 23 to 75 percent of patients on these oral targeted anticancer drugs may not be getting the full benefit of their treatment.

XSpray will be presenting these results at this year’s AAPS in Chicago (October 14-18) at booth number 1635.

For more information, please contact:

Per Andersson, CEO
Email: 

About XSpray

XSpray Microparticles AB is a drug delivery company targeting the poor bioavailability and pH dependent absorption of many oral targeted anticancer agents, in particular protein kinase inhibitors.  XSpray’s RightSize™ technology is a product platform technology that overcomes the inherent drawbacks exhibited by many active pharmaceutical compounds.

The technology is used both to improve and enhance the product profile of currently marketed drugs and to speed up the development of new drugs for the future.

XSpray has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP material, at a state-of-the-art facility.

XSpray’s RightSize™ technology, innovations and the extensive expertise of employees and specialist partners are available through partnering activities. Contact XSpray to find out more.

“We are very pleased with this partnership. We believe that RightSize™ technology offers significant advantages in the development of HPAIs”, commented XSpray’s CEO, Dr. Per Andersson. “This partnership is an important step towards the development of HPAIs with unique characteristics.”

The formulation and manufacturing abilities of XSpray’s RightSize™ technology offer the opportunity to improve drug substances through various strategies, enabling full control over particle design and production – simplifying drug formulation, extending delivery options and allowing the addition of innovative properties that truly benefit patients.

RightSize™ technology not only provides a superior process to traditional methods. It can also be effectively scaled from discovery scale up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles using supercritical fluid technology.

One of the advantages of this technology is that the moderate temperatures used make it ideal for particle size reduction of thermolabile compounds.

“We are enthusiastic about this partnership with XSpray. Access to RightSize™ technology will strengthen our API development and manufacturing for third parties”, says Dr. Gabriel Haering, CEO of Cerbios. “Through the use of this innovative technology for HPAIs, Cerbios will be able to offer a unique capability, enabling the generation not only of particles having narrow particle size
distribution but also different crystal forms and/or polymorphs up to the full control of particle design, including solid state form . In combination with other technologies available at Cerbios it will generate intellectual property that will definitely help our partners in their success.”

Financial terms for access to XSpray’s RightSize™ technology and expertise will not be disclosed.

For more information, please contact:

Cerbios-Pharma SA
Andrea Tam, Director Business Development
Email:

XSpray Microparticles AB
Karen Frost, Marketing Director
Email:

About Cerbios-Pharma SA
Cerbios is a privately held self-financed company located in Lugano (Switzerland) specialized in the development and manufacturing of chemical and biological APIs for partners world-wide.

APIs made by Cerbios cover small molecules (Chemical Division), biopharmaceuticals including Monoclonal Antibodies, Recombinat Proteins and Probiotics (Biological Division).

Services for third parties under exclusive manufacturing are offered in the area of HPAIs for the Chemical Division and Monoclonal Antibodies and Recombinant Proteins for the Biological Division.

Full CMC support is provided to partners in order to provide them with the supply of cGMP clinical batches, registration/validation material and APIs from commercial manufacturing. Paramount to this is the supply of all documentation required for a successful registration.

AboutXSpray
XSpray Microparticles AB is a drug delivery company with a cutting-edge, scaleable platform technology – RightSize™ technology – and an in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process.

XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art manufacturing facility.

XSpray’s RightSize™ technology, innovations and the extensive expertise of employees and specialist partners are available through partnering activities. Contact XSpray to find out more.

Berlin, Germany

Contact us if you would like to arrange a meeting at this event.

More information about this event
can be found at:
http://www.ddfevent.com/

XSpray was chosen from among more than 250 companies that had applied for funding from Vinnova’s ‘Research&Grow’ program. The program awarded grants to 42 companies – less than ten of which are from the life science sector – as part of its second round of funding for 2010. XSpray’s grant of SEK 2.3 million was the fifth highest grant to be awarded during this round.

XSpray’s RightSize™ technology produces nanoparticles with a consistent size below 200 nm. The proprietary technology provides complete control over particle production, enhancing drug formulation options and optimizing the performance of challenging drug substances, such as poorly soluble compounds.

XSpray’s CEO, Per Andersson, said, “We are very excited about receiving this grant from Vinnova. It will enable us to broaden the application of our technology more quickly. It is also pleasing that the technology’s capabilities have been recognized in this way. There is a lot of competition for these grants. The fact that Vinnova shares our belief in RightSize™ technology is very encouraging.”

For more information, contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00
Email:

About VINNOVA
VINNOVA is Sweden’s innovation agency. Its aim is to increase the competitiveness of Swedish researchers and companies. VINNOVA’s task is to promote sustainable growth in Sweden by funding needs-driven research and the development of effective innovation systems. To this end, the agency has 220 million euro to invest in new and ongoing projects each year. www.vinnova.se/en/

About XSpray
XSpray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ manufacturing – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules and inhalation systems. RightSize™ technology addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize™ technology is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art manufacturing facility in Malmö, Sweden.

The technology uses supercritical fluid (SCF) as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The new patent approval covers both design and method patents relating to XSpray’s unique nozzle head, where precipitation of the drug substance takes place.

The breakthrough design enables reproducible production of small particles of specific sizes, required for the development of inhalable drugs. It also enables nanoparticles to be produced with a consistent particle size below 200 nm. The technology is compatible with a wide range of excipients. These can, for example, be added to increase stability and/or wettability in amounts from >50% down to trace amounts.

The dimensions of the actual fluid mixing and spray forming regions are kept constant at all scales. This means the technology can be effectively scaled up to drug manufacturing volumes. Consistent high-quality particles are produced, with full control over particle size, size distribution and polymorph, irrespective of production scale.

XSpray’s CEO, Per Andersson, commented, “RightSize™ production offers significant advantages over traditional micronization technology. It provides an easy-to-operate, single-step process that gives the user full control over particle properties. As well as being used for developing new chemical entities, it is also ideally suited to drug reformulation and life cycle management.”

“As a fully scalable SCF-based technology, RightSize™ production represents a significant breakthrough in drug particle manufacturing. Today, we already offer GMP production of clinical trial materials to support our growing customer base. As such, the patent is an important step that further strengthens the company’s intellectual property rights in the US,” added Dr. Andersson.

For more information, contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00
Email:

About XSpray
XSpray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ manufacturing – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules and inhalation systems. RightSize™ technology addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize™ technology is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art manufacturing facility in Malmö, Sweden.

Stockholm, Sweden – August 20, 2009. XSpray Microparticles AB, the Swedish life science technology company, today announced the launch of its new GMP production facility in Malmö, Sweden. This means, in addition to offering particle development and characterization services, XSpray can now provide its customers with high quality drug particles and powders for use in their clinical studies.

XSpray’s RightSize™ Manufacturing Technology is a ground-breaking solution for pharmaceutical particle development and production based on supercritical fluid technology. It overcomes many of the drawbacks of traditional micronization and is well suited to demanding applications, such as inhaled compounds, sparingly soluble compounds and biopharmaceuticals. As well as offering all the advantages of earlier supercritical fluid technologies it also enables full scalability.

The new GMP facility has been developed in collaboration with Galenica AB, an established Swedish CRO focused on pharmaceutical formulation. Manufacturing will be carried out by Galenica at the company’s state-of-the-art GMP suites in Malmö, Sweden.

XSpray’s CEO, Per Andersson, said, “We are extremely pleased to have this facility in place. Not only does it mean that we can now satisfy our customers’ needs for GMP material but it is also proof of the scale-up capability of the technology. As such, it is an important step towards developing full pharmaceutical manufacturing capabilities.” Dr. Andersson continued, “We are also very pleased with the collaboration with Galenica. We have every confidence that our customers will benefit from an extremely high quality, professional service.”

Galenica’s CEO, Ronnie Wallin, added, “Testing of the technology has gone very smoothly and we have established a production capacity that meets clinical study requirements. Our facilities comply with both EU and US regulatory standards and, in addition to manufacturing, we also provide packaging and release testing services. We are currently in the final stage of installation and are able to start manufacturing for XSpray’s customers as soon as required.”

For more information, please contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00 
Email:  

About XSpray
XSpray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules and inhalation systems. RightSize™ Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize™ Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art GMP manufacturing facility in Malmö, Sweden.

About Galenica
Galenica is a pharmaceutical technology CRO located in Malmö, Sweden. The company  offers preformulation and formulation, analysis, stability studies, documentation (CMC), GMP production together with project management. Galenica is authorized and audited by the Swedish Medical Agency for GMP production of clinical trial material for Phase I-III. The company has broad skills and experience in development projects and manufacturing of pharmaceutical preparations, comprising the most common types of dosage forms. Galenica can assist within all phases of a project, from the identification of an efficacious substance until a complete pharmaceutical is in commercial production. For more information see:  www.galenica.se

Stockholm, Sweden – April 20, 2009. Xspray Microparticles AB, the Swedish life science technology company, has developed a cutting-edge solution for pharmaceutical particle production based on supercritical fluid technology. The Company’s RightSize™ Manufacturing Technology overcomes many of the drawbacks of traditional micronization and is well suited to demanding applications. As well as offering all the advantages of earlier supercritical fluid technologies it also provides scalability. This means pharmaceutical companies have the opportunity to produce better quality particles and powders, from discovery all the way through to drug manufacture.

The first commercial agreement with a customer began in Q4, 2008. Since then, two additional, major pharmaceutical companies have also undertaken evaluation projects. Each of the companies is using the technology for a different purpose; one is studying crystallization, another is looking at solid dispersion and the third is working with nanonization (the production of nano-sized particles).

”Interest from pharmaceutical companies has been steadily increasing over the last twelve months or so,” commented Per Andersson, Xspray’s CEO. ”Despite the current economical climate we have secured three commercial agreements, which shows that customers are convinced by the benefits of the technology. This is an important step for the Company and confirms that we have a strong offering, capable of adding real value throughout the pharmaceutical process from development to production.”

To support the ongoing evaluation projects, and to meet an expected increase in future demand, Xspray has recently doubled the size of its service lab. The strengthening of human resources began in mid 2008 with the appointment of Mikael Bisrat as Chief Scientific Officer. Dr. Bisrat has more than 15 years experience in the industry and has a thorough understanding of the needs within pharmaceutical development projects. The most recent recruit is Helene Dérand, PhD, who joined the company in March 2009 as Sales and Marketing Director. Ms Dérand has broad-based experience gained from more than ten years in the biotechnology and medical technology sectors. She has held various management positions in both global and start-up companies with responsibilities ranging from R&D and clinical operations to business development.

Per Andersson continued, “We have recently expanded our service offering to include solid state characterization and analysis capabilities. Plus, we will be opening our new GMP production facility within the next month or so. There are some exciting opportunities ahead for Xspray, so it is important that we have a capable, dynamic organization in place to take full advantage of them.”

For more information, please contact:
Per Andersson, CEO, Xspray Microparticles AB
Tel: +46 (0)8 730 37 00  
Email:

About Xspray
Xspray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules, and inhalation systems. RightSize™ Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize™ Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

Xspray Microparticles has its headquarters and development laboratories in Stockholm, Sweden.

Stockholm, Sweden – December 01, 2008. The Swedish life science technology company, Xspray Microparticles AB, now offers solid state characterization services to complement its cutting-edge solution for pharmaceutical particle production. The new service will allow the Company to reduce project development times by offering high quality characterization and analysis of solid state particle properties. 

Dr. Mikael Bisrat, who joined Xspray in mid 2008 as Chief Scientific Officer, is responsible for the new service area. Dr. Bisrat has more than 15 years experience in the pharmaceutical industry, including several positions overseeing solid state characterization. In addition to his analytical skills, Dr. Bisrat also has a thorough understanding of the underlying needs within pharmaceutical development projects.

“At Xspray we are offering a high quality analysis service that is capable of meeting specific project and customer requirements. Using the latest analytical procedures and techniques we are able to provide comprehensive characterization of pharmaceutical solids,” commented Dr. Bisrat.

Xspray’s CEO, Per Andersson, explains the value of the new service, “We are obviously delighted to have someone of Mikael’s background and experience behind this initiative. It means we now have some fantastic resources in this area, which should greatly benefit our customers. Not only will it improve the infrastructure within development work but it will speed up the whole process. Rather than waiting on external lab resources we can now generate our own data far more quickly.”

The new service is available for both Xspray manufactured powders and particles, and those produced by third parties.

About Xspray
Xspray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules, and inhalation systems. RightSize™ Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize™ Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

Xspray Microparticles has its headquarters and development laboratories in Stockholm, Sweden.

Org number: 556649-3671

Telephone: +46 8 730 37 00

Email: 

Stockholm, Sweden – August 01, 2008. Xspray Microparticles AB, the Swedish life science technology company, has appointed Dr. Mikael Bisrat, PhD, as Chief Scientific Officer. The appointment comes at a time when several pharmaceutical companies begin evaluations of Xspray’s cutting-edge particle production technology.

Prior to joining Xspray Dr. Bisrat was Director of Pharmaceutics at Biovitrum. He has more than 15 years of industrial experience as a formulation scientist, a research scientist and in managerial positions. His roles have included Associate Director Pharmaceutical Development at AstraZeneca and Director Pharmaceutics at Pharmacia Upjohn.

Commenting on the appointment, Per Andersson, Xspray’s CEO, said, “We are obviously extremely pleased to have someone with Mikael’s extensive experience on board. It is a crucial time for the Company as we start working directly with customer projects. Mikeal’s capabilities are an important factor both in terms of ensuring successful customer development projects and for Xspray’s long term strategic growth.” 

Dr. Bisrat is a co-author of three patents in the area of supercritical crystallization and he is also one of the co-founders of Xspray Microparticles. As such, he has a thorough understanding of the technology. “I am very excited about joining Xspray in a managerial capacity. RightSize™ Manufacture has fantastic potential. It is a robust technology, but most importantly it allows companies to produce high quality particles right through the pharmaceutical development process, from discovery to manufacture,” commented Dr. Bisrat.

About Xspray
Xspray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules, and inhalation systems. RightSize™ Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize™ Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

Xspray Microparticles has its headquarters and development laboratories in Stockholm, Sweden.