Calgary, Alberta, Canada
December 24, 2008
SemBioSys Genetics Inc. (TSX:SBS), today announced that
MannKind Corporation
(Nasdaq:MNKD) has purchased an option to license rights to
SemBioSys' proprietary plant-produced recombinant human insulin.
The option period ends on March 31, 2009. Terms of the option
stipulate that the primary use of SemBioSys' plant-produced
insulin would be for AFRESA(TM), MannKind's ultra-rapid acting
insulin, which recently completed Phase 3 studies.
SemBioSys will receive in total US$2,500,000 from MannKind,
which includes the purchase by MannKind of 2,400,000 units of
SemBioSys upon closing at a price per unit of US$0.83
(Cdn$1.00). The unit purchase is expected to close on January 5,
2009. Each unit issued by SemBioSys will consist of one common
share of SemBioSys and one-tenth of one common share purchase
warrant of SemBioSys. Each whole warrant will entitle MannKind
to purchase one additional common share of SemBioSys at an
exercise price of Cdn$6.00 for a
period of 36 months from the effective date of the option.
"This option purchase provides further validation of our
plant-produced recombinant human insulin program, and our high
volume protein production platform more generally. MannKind is a
world class partner focused on the
treatment of diabetes that possesses both the clinical and
manufacturing expertise, as well as the financial resources,
required to bring our plant-produced insulin to market," said
Andrew Baum, president and chief
executive officer of SemBioSys. "We believe MannKind's AFRESA
program has the potential to transform the treatment of diabetes
and that our cost-effective production system would provide them
with significant cost benefits over existing production
methods."
About SBS Plant-Produced Insulin
SemBioSys' plant-produced insulin is human insulin produced from
genetically enhanced safflower. SemBioSys has demonstrated that
its plant-produced insulin is physically, structurally and
functionally indistinguishable from pharmaceutical-grade human
insulin through analytical testing and pre-clinical sub-chronic
toxicology studies in rodents and primates. SemBioSys is
currently conducting a Phase I/II clinical trial of its
plant-produced insulin. The three-arm study, of up to 30 healthy
volunteers, is designed to demonstrate the bioequivalence of
safflower-produced insulin to two commercial insulin standards.
Full results are expected to be available
during the first half of 2009.
About AFRESA
AFRESA is an ultra rapid acting insulin product that has
completed Phase 3 trials. MannKind expects to finalize a new
drug application for AFRESA to submit to the FDA in early 2009.
The pharmacokinetic profile of AFRESA sets it apart from all
other insulin products. The large surface area of the lung
provides unique access to the circulatory system. The
pH-sensitive AFRESA particles immediately dissolve upon contact
with the lung surface, releasing insulin monomers that rapidly
enter the bloodstream. It achieves peak insulin levels within
12-14 minutes of administration, effectively mimicking the
release of meal-time insulin observed in healthy individuals,
but which is absent from patients with diabetes.
Calgary, Alberta-based SemBioSys is a biotechnology company
developing protein-based pharmaceuticals using its proprietary
protein production technology. This technology enables the
production of therapeutic proteins in
plant seeds by genetically enhancing the safflower plant.
SemBioSys' lead pharmaceutical candidates are recombinant human
insulin, which is intended to serve the rapidly expanding global
diabetes market, and Apo AIMilano. Apo AIMilano is a variant of
Apo AI, the major protein associated with high density
lipoprotein (HDL), or "good cholesterol", whose function is to
remove excess cholesterol from arteries. In addition to its
pharmaceutical products, SemBioSys' subsidiary, Botaneco
Specialty Ingredients Inc., is selling oleosome-based all
natural products in the global personal care ingredient market.
More information is available and can be accessed at
www.sembiosys.com.
MannKind focuses on the discovery, development and
commercialization of therapeutic products for patients with
diseases such as diabetes and cancer. Its pipeline includes
AFRESA, which has completed Phase 3 clinical trials, and MKC253,
which is currently in Phase 1 clinical trials. Both of these
investigational products are being evaluated for their safety
and efficacy in the treatment of diabetes. MannKind maintains a
website at
http://www.mannkindcorp.com to which MannKind regularly
posts copies of its press release as well as additional
information about MannKind. Interested persons can subscribe on
the MannKind website to email alerts that are sent automatically
when MannKind issues press releases, files its reports with the
SEC or posts certain other information to the website. |
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