NEKTAR THERAPEUTICS

NEKTAR THERAPEUTICS

Previous company name
INHALE THERAPEUTIC SYSTEMS, INC.
Name change date
1/15/2003
Company Overview
Nektar Therapeutics, with registered office address in San Carlos, is a US-based private company active in the pharmaceutical industry. It was formed as Inhale Therapeutic Systems, Inc. by John S. Patton in 1990 and changed its name to Nektar Therapeutics in 2003.
The company is specialized in the development of differentiated therapeutics with its PEGylation and pulmonary drug development platforms. These products are use to cure diabetes, infectious disease, and oncology. It also delivers solutions to treat the local lung for infections as well as to deliver medicines for fast-onset treatment of pain. The company’s products enable partners to improve more in the pharmaceutical industry. These partners include the world’s leading pharmaceutical and biotechnology companies such as Pfizer, Roche, Chiron, and Amgen.
It’s Exubera (human insulin) Inhalation Powder, which has been approved in the U.S., European Union, Brazil and Mexico for the treatment of type 1 and type 2 diabetes patients. The company is also a market leader in PEG-based drug delivery and development.
Nektar Therapeutics has predominant operations in San Carlos, California with additional operations in Huntsville, Alabama; Galway, Ireland; and Hyderabad, India. The company is a leading provider of advanced drug technologies that offers highly differentiated products. Its goal is to help its pharmaceutical and biotechnology partners realize the full potential of their molecules by solving complex development challenges to create breakthrough therapeutics, extend product franchises, and fuel product pipelines.
Business Summary
Nektar Therapeutics (Nektar) is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar’s research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient. Neltar’s product candidate, Oral NKTR-118, is a peripheral opioid antagonist that is being evaluated for the treatment of opioid-induced constipation.
Description and history
Nektar Therapeutics (Nektar), incorporated in 1990, is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar’s research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient. Neltar’s product candidate, Oral NKTR-118, is a peripheral opioid antagonist that is being evaluated for the treatment of opioid-induced constipation. NKTR-119 is an early stage research development program that combines a range of opioids with Oral NKTR-118.

Nektar’s other product candidate, NKTR-102, a topoisomerase I inhibitor-polymer conjugate, is being evaluated in three separate Phase II clinical trials for ovarian, breast and colorectal cancers. In addition, in 2009, the Company commenced a Phase I clinical trial for NKTR-105 (PEGylated docetaxel) for patients with refractory solid tumors. In addition to its product candidate pipeline, the Company has a number of collaborations and license, manufacturing and supply agreements for its technology with biotechnology and pharmaceutical companies, including Affymax, Amgen Baxter, Roche, Merck, Pfizer, Inc. and UCB Pharma. Nektar also has a collaboration with Bayer Healthcare LLC to develop BAY41-6551 (NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside antibiotic.

PEGylation is a technology platform for the development of therapeutics, such as Roche’s PEGASYS (PEG-interferon alfa-2a) and Amgen’s Neulasta (pegfilgrastim). PEG (polyethylene glycol) is a technology and is a water soluble, amphiphilic, non-toxic, non-immunogenic compound that is safely cleared from the body. Its use has been in approved biologic drugs to favorably alter their pharmacokinetic or pharmacodynamic properties. With its technology in PEGylation, Nektar has created a PEGylation technology. Its polymer conjugate technology platform is designed to overcome the limitations of the first generation technology platform and allow the platform to be utilized with a range of molecules across many therapeutic areas.

Small Molecule Stable Polymer Conjugates

Nektar’s customized approaches for small molecule polymer conjugates allows for the fine-tuning of the physicochemical and pharmacological properties of small molecule oral drugs to improve their therapeutic benefit. In addition, this approach enables oral administration of subcutaneously or intravenously delivered small molecule drugs that may have shown low bioavailability when delivered orally. Oral NKTR-118 is an application of membrane transport inhibition reducing transport across the blood-brain barrier. Oral NKTR-118 is a peripheral opioid antagonist that completed Phase II clinical development in 2009.

Small Molecule Pro-Drug Releasable Polymer Conjugates

The pro-drug polymer conjugation approach can be used to optimize the pharmacokinetics and pharmacodynamics of a small molecule drug to improve its side effect profile. Nektar is using this platform with oncolytics, which has sub-optimal half-lives that can limit their therapeutic efficacy. With its technology platform, these drugs can be modulated for programmed release within the body, optimized bioactivity and increased sustained exposure of active drug to tumor cells in the body. The Company is using this approach with the two oncolytic candidates in its pipeline, NKTR-102, a topoisomerase I inhibitor-polymer conjugate in Phase II clinical development, and NKTR-105, a polymer conjugate form of docetaxel that is in Phase I clinical development.

Large Molecule Polymer Conjugates (Proteins and Peptides)

Nektar’s approach with molecule polymer conjugates has enabled numerous PEGylated biologics on the market. The Company is using its polymer conjugation technology-based approach to enable peptides, which are smaller in size than other biologics, such as proteins and antibody fragments. The Company is in the early stages of discovery research with a number of peptides that utilize this approach.

Antibody Fragment Polymer Conjugates

Antibody fragment polymer conjugates uses a molecular weight polyethylene glycol (PEG) conjugated to antibody fragments in order to improve their toxicity profile, extend their half-life and allow for ease of synthesis with the antibody. This approach can be used to reduce antigenicity, reduce glomerular filtration rate, improve uptake by inflamed tissues, and retain antigen-binding affinity and recognition.

The Company competes with The Dow Chemical Company, Enzon Pharmaceuticals, Inc., SunBio Corporation, Novo Nordisk A/S, Mountain View Pharmaceuticals, Inc., NOF Corporation, Progenics Pharmaceuticals, Inc., Adolor Corporation, Mundipharma Int. Limited, Sucampo Pharmaceuticals, Alkermes, Takeda Pharmaceutical Company Limited., Genentech, Inc., Eli Lilly & Co., Bristol-Myers Squibb Company, Pfizer, Inc., GlaxoSmithKline plc, Antigenics, Inc., F. Hoffman-La Roche Ltd, Novartis AG, Cell Therapeutics, Inc., Neopharm Inc., Meditech Research Ltd, Alchemia Limited.

Formed as Inhale Therapeutic Systems, Inc. By John S. Patton and changed its name to Nektar Therapeutics in 2003

Business Line
Specialized in the development of differentiated therapeutics with its PEGylation and pulmonary drug development platforms
Subsidiary
AEROGEN, INC.
Advisor
ERNST & YOUNG LLP
IPO date
5/1994
US SIC Code
2834
Company Address
201, Industrial Road

City province or state postal code
94070, SAN CARLOS, CA
Phone: +1 650 631 3100
Fax: +1 650 631 3150
Country address: UNITED STATES OF AMERICA
Website url: www.nektar.com