Swedish Orphan Biovitrum has decided to move Kiobrina® into phase III development


Stockholm, Sweden - April 21, 2010 - Swedish Orphan Biovitrum (STO: BVT) today
announced the results from the second Kiobrina(®) clinical phase II study. The
study demonstrated an improvement in preterm infant growth velocity when
Kiobrina(®) was administered in pasteurized breast milk. As a consequence of
this outcome and the previously announced positive results from a phase II study
in preterm infant formula, Swedish Orphan Biovitrum has taken the decision to
move Kiobrina(®) into phase III development.

The combined results of the two clinical studies showed a statistically
significant increase (p<0.001) in growth velocity, which is a medically relevant
parameter. The safety profile was comparable to that of placebo and no
drug-related serious adverse events were reported. The results from these
studies will be published during 2010, starting with a presentation of the
results from the first clinical study with infant formula at "The Power of
Programming 2010. International conference on developmental origins of health
and disease" in Munich, Germany on May 6-8, 2010.

"Kiobrina holds a great opportunity to fill a substantial medical need in
neonatal care. The result from our phase II program is an important step towards
a valuable product that will support preterm infants in their growth and
development" said Peter Edman, CSO of Swedish Orphan Biovitrum Group.

"This is yet another exciting late stage development progress for Swedish Orphan
Biovitrum with a potential of creating a unique medical value in neonatal care
as well as business growth for our company" said Martin Nicklasson, CEO.



About Kiobrina
Kiobrina is a recombinant human bile-salt-stimulated lipase (rhBSSL) developed
by Swedish Orphan Biovitrum, aiming to improve growth and development in preterm
infants receiving pasteurized breast milk and/or infant formula. The rationale
for adding rhBSSL to 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.

The phase II Kiobrina program was designed as two parallel prospective
randomized double-blind crossover studies where Kiobrina(®), or placebo, was
administered in pasteurized milk, or preterm infant formula, during one week of
treatment. All infants were born before week 32 of gestational age. The
objectives were to study the lipid absorption, growth velocity, safety and
tolerability.



About Swedish Orphan Biovitrum
On January 14, 2010, Biovitrum AB (publ) completed the acquisition of Swedish
Orphan International Holding AB and created Swedish Orphan Biovitrum - a leading
company focused on treatment of rare diseases.

Swedish Orphan Biovitrum is a Swedish based specialty pharmaceutical company
with an international market presence. The company is focused on providing and
developing orphan and niche specialist pharmaceuticals to patients with high
medical needs. The portfolio consists of about 60 marketed products and an
emerging late stage clinical development pipeline within rare diseases. Swedish
Orphan Biovitrum has pro-forma revenues 2009e of about 2 BSEK and approximately
500 employees. The head office is located in Sweden and the share (STO: BVT) is
listed on NASDAQ OMX Stockholm. For more information please visit
www.biovitrum.com <http://www.biovitrum.com/>.



For more information please contact:

Swedish Orphan Biovitrum:
Peter Edman, CSO
Phone. +46 8 697 21 77

Erik Kinnman, EVP Investor Relations
Phone: +46 73 422 15 40
erik.kinnman@biovitrum.com <mailto:erik.kinnman@biovitrum.com>

Martin Nicklasson, CEO
Phone: +46 8 697 20 00



The clinical phase II studies have 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.



Swedish Orphan Biovitrum may be required to disclose the information provided
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on April 21, 2010 at 8:30 a.m. CET.



[HUG#1406112]


Attachments

Press release in PDF format.pdf