Tekmira Pharmaceuticals Corporation

Tekmira Pharmaceuticals Corporation

November 21, 2007 08:30 ET

Tekmira Provides Update on Partners Clinical Progress

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Nov. 21, 2007) - Tekmira Pharmaceuticals Corporation ("Tekmira") (TSX:TKM) reported today that two of its partners, Aradigm Corporation ("Aradigm") (OTCBB:ARDM) and Hana Biosciences, Inc. ("Hana") (NASDAQ:HNAB) have initiated two separate Phase 2 clinical trials using technology licensed from Tekmira.

On November 19, 2007, Aradigm announced the initiation of a Phase 2 clinical trial of inhaled liposomal ciprofloxacin in patients with cystic fibrosis. This trial follows the recent successful completion of a Phase 1 trial that measured safety, tolerability and pharmacokinetics in healthy volunteers. The Phase 2 trial is a multicenter trial in 24 adult patients with cystic fibrosis and will measure effectiveness, safety and tolerability. More information on this trial can be found at www.aradigm.com.

Tekmira entered into a licensing agreement with Aradigm in 2004 whereby Aradigm licensed Tekmira's liposomal technology for the delivery of ciprofloxacin. Under this agreement, Tekmira is eligible to receive milestones based on progress as well as royalties on product sales. The initiation of the liposomal ciprofloxacin Phase 2 trial will trigger a US$250,000 milestone payment under the agreement.

On November 20, 2007, Hana announced the initiation of a Phase 2 clinical trial of Marqibo® (vincristine sulfate injection, OPTISOME™) in patients with metastatic malignant uveal melanoma. The objectives of the Phase 2 trial are to measure safety and effectiveness of Marqibo in this patient population. Hana expects to enroll up to 30 patients in this clinical trial, which is being conducted at the University of Texas MD Anderson Cancer Center. More information on this trial can be found at www.hanabiosciences.com.

The Marqibo Phase 2 clinical trial is supported by data from a Phase 1 clinical trial of Marqibo in patients with metastatic melanoma. Data from the Phase 1 trial were presented earlier this year at the 43rd American Society of Clinical Oncology (ASCO) Annual Meeting and showed an objective response rate of 13 percent and a stable disease rate of 20 percent in 15 patients with histologically confirmed, surgically non-resectable metastatic cutaneous, mucosal, or uveal melanoma. In this study, Marqibo was generally well tolerated and showed promising single agent activity against metastatic melanoma.

Hana Biosciences is developing and commercializing Marqibo under a licensing partnership agreement with Tekmira. Hana Biosciences is paying development costs and will also pay to Tekmira milestones based on progress and royalties based on sales. Tekmira also licensed two other products to Hana under the partnership: Alocrest™ (previously referred to as INX-0125) and Brakiva™ (previously referred to as INX-0076).

Timothy M. Ruane, President and CEO of Tekmira, said, "Our partners continue to make strong progress as they advance products based on technology licensed from Tekmira. There are now four products using our technology in clinical development and we look forward to providing additional updates as these products move through development towards commercialization."

About Cystic Fibrosis

Cystic fibrosis is the most fatal genetic disorder in Caucasians. It is estimated that it affects approximately 30,000 people in the US and about 70,000 worldwide. The defective gene causes production of thick mucus that clogs the lungs and often leaves patients vulnerable to life threatening lung infections by organisms such as Pseudomonas Aeruginosa.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. Current activities include partnered and self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, pulmonary hypertension, asthma and bronchitis, inhalation anthrax infections and smoking cessation.

In addition, Aradigm's AERx® insulin Diabetes Management System (iDMS), which has been licensed to Novo Nordisk for development and commercialization in return for royalties, is in Phase 3 testing for Type 1 and Type 2 diabetes. Under the agreements with Novo Nordisk, Novo Nordisk is responsible for all further clinical, manufacturing and commercial development, while Aradigm and Novo Nordisk continue to cooperate and share in technology development, as well as intellectual property development and defense. More information about Aradigm can be found at www.aradigm.com.

About Uveal Melanoma

Uveal melanoma is a relatively rare cancer of the colored part of the eye and the surrounding areas, called the uvea. Uveal melanoma is the most common primary intraocular malignant tumor in adults and represents five to six percent of all melanoma diagnoses. The incidence of uveal melanoma is reported to be 3,500-4,000 per year. Metastasis is via vascular spread, and approximately 40-50 percent of patients with primary uveal melanoma will ultimately develop metastases. At the time of diagnosis, over 95 percent of patients have disease limited to the eye, but at least 30 percent of these patients will die of systemic metastases at five years and 45 percent at 15 years. The liver is involved in up to 90 percent of individuals who develop metastatic disease. In general, metastatic uveal melanoma is unresponsive to systemic chemotherapy.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (NASDAQ:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best in-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Further information on Hana Biosciences can be found at www.hanabiosciences.com.

About Tekmira

Tekmira Pharmaceuticals Corporation is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer and other diseases. 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

  • Tekmira Pharmaceuticals Corporation - Investors
    Ian Mortimer
    Senior Vice President, Finance and Chief Financial Officer
    (604) 419-3200
    Website: www.tekmirapharm.com
    James Hoggan & Associates Inc. - Media
    Nicole Rizgalla
    (604) 742-4268
    Email: nrizgalla@hoggan.com