Biovitrum (SE) - Kiobrina shows positive phase II results in preterm infants

Stockholm, Sweden - November 25, 2009 - Biovitrum AB (STO: BVT) today announced that the first of two clinical phase II studies, designed to together show proof of concept of Kiobrina(TM) (rhBSSL) in preterm infants, has been completed. The results show statistically significant improvement in the growth velocity in preterm infants when Kiobrina(TM) was added to infant formula compared to placebo. The safety profile was comparable to that of placebo and no drug related serious adverse events were reported.

The study was a prospective randomized double-blind crossover study where Kiobrina(TM), or placebo, was administered in preterm infant formula during one week of treatment. All infants were born before week 32 of gestational age. The next step in the establishment of proof of concept is the completion of the second study where preterm infants are treated with Kiobrina(TM) administrated in pasteurized breast milk. Results from this second trial are expected in the beginning of 2010.

"The initial Phase II clinical results in this high medical need population are very encouraging. If the ongoing parallel study in preterm infants fed with pasteurized breast milk is also positive, we have proof of concept and will advance the program into a registrational stage," said Martin Nicklasson, CEO of Biovitrum.

About Kiobrina Kiobrina is a recombinant human bile-salt-stimulated lipase (rhBSSL) developed by Biovitrum for enzyme replacement therapy to improve growth and development in preterm infants receiving pasteurized breast milk and/or formula. The rationale for substitution of rhBSSL in pasteurized breast milk or infant formula is to restore the natural lipase activity level that is either lost on pasteurization or totally absent in formula.

About Biovitrum Biovitrum is an international pharmaceutical company that markets specialist pharmaceuticals in several regions. Using its expertise and experience Biovitrum takes scientific innovation to patients with significant unmet medical need. Research expertise and capabilities are focused on development and production of biotechnology therapeutics within our prioritized areas of hemophilia, inflammation/autoimmune diseases, cancer supportive care and enhancement of lipid absorption. The company has revenues of approximately SEK 1.2 billion and around 400 employees. The company head office is located in Sweden and it is listed on the Stockholm OMX Nordic Exchange. For more information please visit www.biovitrum.com.

For more information please contact:

Biovitrum AB (publ)

Erik Kinnman, Vice President Investor Relations Phone: +46 73 422 15 40 erik.kinnman@biovitrum.com

Martin Nicklasson, CEO Phone. +46 8 697 2327

 

The clinical phase II studies has been carried out partially with research funding from the European Community's Sixth Framework Program (The Early Nutrition Programming Project, www.metabolic-programming.org<http://www.metabolic-programming.org/>). The press release reflects only the author's views and does not necessarily reflect the views of the European Community or European Commission or their future policy, and they are not liable for any use that may be made of the information contained herein. The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability.

Biovitrum AB (publ) may be required to disclose the information provided herein pursuant to the Swedish Securities Markets Act. The information was provided for public release on November 25, 2009 at 08:30 a.m. CET.

 

Press Release November 25 in PDF Format<http://hugin.info/134557/R/1357039/329994.pdf>

Posted: November 2009

View comments

Hide
(web3)