CALGARY, Dec. 24 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , today announced that MannKind Corporation 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.
About SemBioSys
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.
About MannKind
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.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and other similar expressions which constitute “forward-looking information” within the meaning of applicable securities laws. Forward-looking statements reflect the Company’s current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions and market size, the acceptance of an IND by the FDA in respect of clinical studies, the submission of a CTA to the appropriate European authorities, the successful initiation and timely and successful completion of clinical studies, the fact that Apo AI is currently a development stage drug, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company’s ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
CONTACT: SemBioSys Genetics Inc., Andrew Baum, President and CEO, Phone:
(403) 717-8767, E-mail: bauma@sembiosys.com; The Trout Group, Christine
Labaree, Managing Director, Phone: (617) 583-1307, E-mail:
clabaree@troutgroup.com; The Equicom Group Inc., Ross Marshall, Vice
President, Phone: (416) 815-0700 ext. 238, E-mail:
rmarshall@equicomgroup.com
