For immediate release: June 20, 2007
Vancouver, BC – Tekmira Pharmaceuticals Corporation ("Tekmira"; TSX:TKM) will provide a progress update at today’s Annual General Meeting of Shareholders including its plan to have eight products in clinical development in the next 12-18 months, being advanced internally and in collaboration with corporate partners. The AGM presentation can be accessed from the Company’s website (www.tekmirapharm.com) after the conclusion of today’s meeting.
Tim Ruane, President and CEO of Tekmira, said the eight products include three products already in clinical trials. All eight products utilize the Company’s proprietary lipid-based technology, in which active drug agents are encapsulated so they can be protected and delivered intact through the bloodstream to the disease site.
"Our internal development program, our joint development partnerships with other companies and our strong financial position combine to place Tekmira in a leading position among development-stage Canadian biotech companies," said Ruane.
"Our progress over the past year has demonstrated that we are well on our way to developing drugs that will be at the leading of edge of new treatments for cancer and other diseases over the next few years."
Ruane said Tekmira’s achievements over the past year include two broad partnerships, bringing the Company US$19.5 million in upfront funding, an additional US$9 million in committed near-term funding as well as funding as milestones are achieved; a $16 million Canadian equity financing; and a pipeline of drugs from research-stage to late-stage clinical development.
Internal drug development
Tekmira’s internal development is focused on novel oligonucleotide drugs.
Oligonucleotides are short sequences of deoxyribonucleic acid, or DNA, and ribonucleic acid, or RNA. DNA and RNA are the molecules that determine the genetic building plan of any organism. Oligonucleotide drugs can treat disease by either stimulating the body’s immune system or by switching off genes that produce disease-causing proteins.
Because DNA and RNA rapidly break down in the bloodstream, it is essential to combine them with Tekmira’s proprietary drug delivery systems so they can be delivered safely through the bloodstream to the disease site.
Tekmira’s lead internal product, INX-0167, uses DNA oligonucleotides to stimulate the immune system to treat cancer. The Company will file an investigational new drug (IND) application in 2008 for approval to evaluate INX-0167 in clinical trials.
Tekmira is also developing drugs based on technology from its partnership with Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY). The partnership was initiated in 2006 and expanded in early 2007. Alnylam is a leader in RNA interference (RNAi) therapeutics. The discovery of RNAi was recognized for its potential impact in medicine with the award of the 2006 Nobel Prize for Physiology or Medicine. Alnylam has demonstrated in preclinical studies that its drug candidates can switch off — or silence — genes that produce disease-causing proteins.
The Alnylam partnership brought Tekmira a license to develop three drugs that use Alnylam’s RNAi gene silencing technology and to develop immune stimulatory drugs using Alnylam’s RNA technology.
Partnership with Alnylam
The partnership between Tekmira and Alnylam is developing drugs that consist of Alnylam’s proprietary small-interfering RNA (siRNA) oligonucleotides encapsulated in Tekmira’s drug delivery technology.
Alnylam is advancing two drugs using Tekmira's technology, ALN-PCS-01, a siRNA gene-silencing product targeting hypercholesterolemia, and ALN-VSP01, a siRNA gene-silencing product targeting liver cancer and, potentially, other solid tumours.
Out-licensed drug development
Tekmira has several partnerships in which the Company’s proprietary technology is licensed to other companies for development. These partners are paying development costs and will also pay to Tekmira milestones based on progress and royalties based on any eventual sales.
Tekmira’s partnership with Hana Biosciences Inc. (NASDAQ: HNAB) covers the development and commercialization of three Tekmira products: Marqibo® (vincristine sulfate liposomes injection), INX-0125 (Alocrest) and INX-0076.
Hana's plans for 2007 include initiating a Phase 2 clinical trial to evaluate Marqibo as a treatment for relapsed acute lymphoblastic leukemia (ALL), initiating a Phast 3 clinical trial to evaluate Marqibo as a treatment for first-line ALL, completion of a Phase 1 clinical trial for INX-0125 (Alocrest), and commencement of a Phase 1 clinical trial for INX-0076.
Tekmira also has out-licensing partnerships with two other companies, Esperion Therapeutics, Inc. (now owned by Pfizer Inc.) and Aradigm Corporation.
Pfizer is continuing a Phase 2 clinical trial evaluating liposomes to treat atherosclerosis and Aradigm is advancing liposomal ciprofloxacin towards Phase 1 clinical trials.
Spin-out from Inex Pharmaceuticals
On April 30, 2007, Tekmira was spun out of Inex Pharmaceuticals Corporation (INEX). Under the Plan of Arrangement, all of INEX’s business, assets and liabilities and contractual arrangements, including all cash and cash equivalents, all intellectual property, products, technology and partnership arrangements, were transferred to Tekmira. In addition, all outstanding shares of Tekmira were distributed to INEX shareholders.
Immediately before the spin-out of Tekmira, INEX common shares were consolidated on the basis of two current common shares for one new common share. Pre-spin-out INEX shareholders own 100% of the new common shares of Tekmira and 20% of the new common shares of INEX.
Effective May 1, 2007, the new common shares of INEX were de-listed from the TSX and INEX was re-named 1322256 Alberta Ltd. 1322256, which now has no active business, is seeking new investment opportunities under new management. At an appropriate time, it is the objective of 1322256 to re-list as a publicly-traded company.
Tekmira Pharmaceuticals Corporation is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about Tekmira and this news release can be found at www.tekmirapharm.com.
Forward Looking Statements
There are forward-looking statements and information contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects," and similar expressions, and the negative of such expressions. Such forward-looking statements and information involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements and information. Such factors include, among others, Tekmira’s stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market Tekmira’s products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements or information. Tekmira disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements or information contained herein to reflect future results, events or developments, except as required by law.
Contact Information for Tekmira Pharmaceuticals Corporation
Senior Vice President, Finance and Chief Financial Officer
James Hoggan & Associates Inc.
The common shares of Tekmira are traded on the Toronto Stock Exchange under the trading symbol "TKM".