Commercial Partnerships
Partnerships with leading companies are critical to Nastech's business strategy. These partnerships empower our partners through access to Nastech's technology and capabilities. In return they provide Nastech with resources and capabilities necessary to fuel future drug development.
Description: Development and licensing agreement to develop a nasal spray formulation of
exenatide
On June 23, 2006, Nastech and Amylin Pharmaceuticals, Inc. entered into an agreement to develop a nasal spray form of
exenatide for treatment of Type II Diabetes and various therapeutic areas.
Under the terms of the agreement, Amylin is responsible for the development program including clinical, non-clinical and
regulatory activities. Nastech will be reimbursed for any development activities performed and will focus on the areas of drug delivery and chemistry, manufacturing and controls. In addition, Nastech will receive potential milestone
payments of up to $89 million in total and royalties on product sales, based on specific development, regulatory, and
commercialization goals.
No other financial terms of the agreement were disclosed.
About Amylin Pharmaceuticals, Inc.
Amylin is a biopharmaceutical company committed to improving lives through the discovery, development and
commercialization of innovative medicines. With a strong foundation on research and development, their scientists are
primarily focused on investigating the potential utility of new peptide hormone candidates. Amylin’s approach and
dedication are rooted in the belief that they will be “Changing Lives” for millions of people – not only with the drugs
currently in late-stage development, but also with their pipeline of future therapies.
Description: Calcitonin for treatment of Osteoporosis
"We view Par's partnership with Nastech as a unique opportunity to expand our strong generic franchise into proven intranasal delivery. We look forward to working with Nastech to advance this product into commercialization." - Scott Tarriff, President and Chief Executive Officer of Par Pharmaceutical, Inc.
On October 22, 2004, Nastech entered into a license and supply agreement granting Par Pharmaceutical the exclusive U.S. distribution and marketing rights to Nastech's generic calcitonin-salmon intranasal spray. This collaboration combines Nastech's strengths in preclinical and clinical product development, nasal drug formulation and delivery, and commercial-scale nasal manufacturing with Par Pharmaceutical's experience and expertise in the sales and marketing of generic pharmaceutical products.
Under the terms of the agreement with Par Pharmaceutical, Nastech will obtain FDA approval, manufacture and supply finished generic calcitonin-salmon intranasal spray product to Par Pharmaceutical. Par Pharmaceutical will distribute the product in the United States. The financial terms of the agreement include milestone payments, product transfer payments for manufactured product and a profit sharing upon commercialization.
About Par Pharmaceutical, Inc.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and its recently acquired subsidiary, Kali Laboratories, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these in 2005. Par currently manufactures, markets or licenses more than 80 prescription drugs.
Description: Exclusive rights to InterfeRx™ for RNAi Therapeutics
"Alnylam is extremely pleased to be working with Nastech and aiding efforts toward the commercialization of RNAi Therapeutics. Nastech is the third company to participate in our InterfeRx program, which is an important part of our overall strategy to create value today by leveraging our intellectual property portfolio in RNAi through partnerships."
- Dr. John Maraganore, CEO of Alnylam Pharmaceuticals
On July 20, 2005, Nastech was granted an exclusive Alnylam InterfeRx™ license to discover, develop, and commercialize RNAi therapeutics directed against TNF-alpha, a protein associated with inflammatory diseases including rheumatoid arthritis. This collaboration enables Nastech access to Alnylam's intellectual property portfolio in the area of RNAi therapeutics, which will advance Nastech's efforts in utilizing their innovative proprietary delivery technologies to develop RNAi therapies for the treatment of major inflammatory diseases.
The financial terms of this license agreement are undisclosed.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company seeking to develop and commercialize novel therapeutics based on RNA interference, or RNAi. Growing from its foundation as the world's first company focused on RNAi therapeutics, the company's leadership in the field of RNAi is supported by its preeminent founders and advisors and its strengths in fundamental patents, technology, and know-how that underlie the commercialization of RNAi therapeutics. Alnylam is developing a pipeline of RNAi products using Direct RNAi™ to treat ocular, central nervous system, and respiratory diseases and Systemic RNAi™ to treat a broad range of diseases, including oncology, metabolic, and autoimmune diseases.
Description: Nascobal® for Vitamin B12 deficiency
"We are looking forward to working with Nastech and benefiting from their state-of-the art manufacturing capabilities and years of experience with Nascobal." - Trevor Blake, CEO, QOL Medical LLC.
In October 2005, Nastech announced that they will continue to be the exclusive manufacturer of Nascobal® Nasal Spray, following QOL Medical LLC's acquisition of the product from Questcor Pharmaceuticals, Inc. QOL Medical has assumed the rights and obligations of the asset purchase agreement and the separate supply agreement made with Questcor Pharmaceuticals, Inc. in June 2003. QOL Medical will also assume Questcor's obligation to pay Nastech $2 million on the issuance by the US Patent and Trademark Office of a patent covering any formulation which treats any indication identified in Nastech's NDA for Nascobal® Nasal Spray.
Additional financial terms of this agreement are undisclosed.
About QOL Medical LLC.
QOL (quality of life) Medical is a specialty pharmaceutical company dedicated to improving quality of life for patients, their families and caregivers. QOL acquires FDA approved drugs that, for strategic reasons, are no longer promoted and/or have potential new indications. QOL currently markets: Sucraid® (sacrosidase), the first and only oral solution therapy approved by the FDA as an enzyme replacement therapy of the genetically determined sucrase deficiency which is part of congenital sucrase-isomaltase disease; and Elliotts B® Solution (buffered intrathecal electrolyte/dextrose injection), indicated for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
Thiakis Limited
Description: Exclusive worldwide rights to the PYY patent applications in the field of intranasal delivery of PYY and the use of glucagon-like peptide-1 (GLP-1) used in conjunction with PYY for the treatment of obesity, diabetes and other metabolic conditions.
"Nastech's technology and capabilities for peptide drug delivery has enabled the advancement of PYY3-36 in the clinic. We are excited that our contribution will play a part in the development of such a promising therapy for the treatment of obesity." - Dr. John Burt, CEO of Thiakis Limited
On September 27, 2004, Nastech announced its acquisition of exclusive worldwide rights to the Imperial College Innovations and Oregon Health & Science University PYY patent applications in the field of intranasal delivery of PYY and the use of glucagon-like peptide-1 used in conjunction with PYY for the treatment of obesity, diabetes and other metabolic conditions. The patent applications were sublicensed from Thiakis Limited, the exclusive licensee of the applications. Under the agreement, Nastech made an equity investment in Thiakis and paid an initial license fee. Thiakis is entitled to receive additional milestone fees and patent-based royalties based on future progress of the patent application and product development processes.
About Thiakis Limited
Thiakis Limited is a private biopharmaceutical company, founded in June 2004 and based in London, UK. The company is developing novel medicines for the treatment of obesity and metabolic disease. Thiakis is the exclusive licensee of 4 patent families relating to use of PYY3-36, glucagon-like peptide-1 (GLP-1) and oxyntomodulin for the treatment of obesity and associated conditions. The patents relating to oxyntomodulin are derived from the research of Professor Steve Bloom and his team from the Division of Investigative Science, at Hammersmith Hospital, Imperial College London, partly funded by Diabetes UK. Patents relating to PYY3-36 results from a joint collaboration between Imperial College London and Oregon Health & Science University, partly funded by Wellcome Trust, who also holds an equity position in Thiakis. Thiakis is led by Dr. John Burt, former Head of Medical & Life Sciences, Imperial Innovations and previously with Vernalis and GlaxoSmithKline.
Institution / Academic Partnerships
Nastech has many ongoing relationships with non-commercial institutions and academics. These associations provide Nastech with access to early, cutting-edge research and intellectual property which is synergistic with our current research and clinical programs.
City of Hope
Description: Exclusive & non-exclusive Dicer-Substrate RNAi intellectual property and technology licenses.
"The Dicer-Substrate RNAi technology may help to accelerate the development of a new class of therapeutics. We are very pleased to enter into this agreement with Nastech, a leading company in the development of RNAi therapeutics and delivery technology." - John Rossi, Chair, Division of Molecular Biology, City of Hope
On November 8, 2006, Nastech entered into a license agreement with City of Hope for rights to Dicer-Substrate RNAi intellectual property and technology. Novel Dicer-Substrate RNAi technology could offer potency for drug development as compared to conventional RNAi technology. The City of Hope license includes exclusive rights to five undisclosed targets and non-exclusive rights to siRNAs directed against all mammalian targets; subject to certain City of Hope limitations that will have no impact on Nastech's programs.
About City of Hope
City of Hope is a leading research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as a Comprehensive Cancer Center, the highest honor bestowed by the National Cancer Institute, and a founding member of the National Comprehensive Cancer Network, City of Hope's research and treatment protocols impact care throughout the nation.
Cedars-Sinai Medical Center
Description: Exclusive worldwide license to the only currently issued U.S. patent claiming the use of PYY or PYY analogs for inducing satiety.
"History has shown the administration of PYY has been difficult. To date, Nastech's nasal approach seems to have solved the barriers to safe and painless administration. We hope that further research and clinical trials will bring PYY along as a potential remedy to the curse of obesity and the other diseases it causes. We are pleased to be able to contribute to Nastech's accelerated PYY development and future commercialization of this important investigational product." - Rich Katzman, Vice President of Academic Affairs at Cedars-Sinai Medical Center
Imperial College of London
Description: Exclusive worldwide rights to the PYY patent applications in the field of intranasal delivery of PYY and the use of glucagon-like peptide-1 (GLP-1) used in conjunction with PYY for the treatment of obesity, diabetes and other metabolic conditions.
"The results of this study are extremely exciting and give new hope to the overweight that a simple new therapy may be on its way. Nastech gets going where others merely contemplate -- I would like to congratulate the company for being the first to develop a practical way to administer PYY." - Dr. Stephen R. Bloom, Professor of Metabolic Medicine, Imperial College of Medicine, London, UK
Mayo Clinic
Description: Clinical research collaboration with Mayo Clinic to evaluate Nastech's RNA interference (RNAi)-based therapeutic formulations in immune cells from patients with rheumatoid arthritis (RA) for the purpose of selecting a candidate for preclinical and clinical development.
Oregon Health Sciences
Description: Exclusive worldwide rights to the PYY patent applications in the field of intranasal delivery of PYY and the use of glucagon-like peptide-1 (GLP-1) used in conjunction with PYY for the treatment of obesity, diabetes and other metabolic conditions.
The University of Cincinnati
Description: Exclusive worldwide rights to the patent estate with respect to certain analogs of PYY relating to all routes of delivery.
"Our PYY analogs, we believe, have significant potential to treat obesity because they are smaller (making them easier to be absorbed nasally), are more stable in the bloodstream and have greater specificity for the Y2 receptors than the endogenous PYY(3-36) molecule. Our portfolio also includes a unique set of tripeptide based anorexigenic compounds. These are non-PYY(3-36) related compounds, and if successfully delivered to the brain, using Nastech nasal delivery techniques and brain delivery technology within my licensed patents, could evolve into an entirely new and powerful class of drugs to control obesity," " - Dr. Ambikaipakan Balasubramaniam, Ph. D., Professor, Department of Surgery, University of Cincinnati Medical Center.
