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Press Releases
(November 20, 2007) • CYDEX ANNOUNCES NEW CORPORATE NAME (October 3, 2007) • PEDIATRIC ASTHMA PROGRAMS WITH CYDEX CAPTISOL® TECHNOLOGY ACQUIRED BY ASTRAZENECA (September 6, 2007) • ARADIGM AND CYDEX SIGN DEVELOPMENT COLLABORATION AGREEMENT (June 12, 2007) • CYDEX LICENSES CAPTISOL® TO CRITICAL THERAPEUTICS FOR INJECTABLE FORMULATION OF ZILEUTON (May 3, 2007) • CYDEX LICENSES CAPTISOL® TO SUNESIS PHARMACEUTICALS FOR ONCOLOGY DRUG CANDIDATE (May 1, 2007) • CYDEX LICENSES CAPTISOL® TO PROTEOLIX, INC.FOR PROMISING ONCOLOGY COMPOUND (April 10, 2007) • CYDEX ANNOUNCES CAPTISOL TECHNOLOGY USED IN INJECTION FORMULATION OF VETERINARY ANTI-EMETIC CERENIA® (maropitant) RECENTLY APPROVED FOR MARKETING IN EUROPE (December 14, 2006) • CYDEX ANNOUNCES CAPTISOL TECHNOLOGY USED IN RECENTLY LAUNCHED INJECTION FORMULATION OF ANTIPSYCHOTIC MEDICATION ABILIFY® (aripiprazole) (August 10, 2005) • CYDEX REPORTS FIRST APPROVAL OF CAPTISOL-ENABLED® DRUG IN JAPAN (November 10, 2004) • CYDEX, INC. PRESENTS PROMISING STUDY RESULTS IN DEVELOPING NEW PHARMACEUTICAL PRODUCTS (October 20, 2004) • CYDEX, INC., EARNS RAPID-GROWTH RANKING (August 17, 2004) • CYDEX, INC. RAISES $17 MILLION IN VENTURE CAPITAL TO ADVANCE DEVELOPMENT OF DRUG CANDIDATES (June 30, 2004) • CYDEX, INC. LICENSES CAPTISOL® TO TARGEGEN, INC. (June 14, 2004) • HOVIONE & CYDEX ANNOUNCE DRUG DEVELOPMENT ALLIANCE FOR SIX POTENTIAL NEW PRODUCTS (April 26, 2004) • CYDEX, INC. ANNOUNCES PRECLINICAL STUDY SHOWING POTENTIAL OF NEW ASTHMA FORMULATION USING CAPTISOL® SOLUTION (March 9, 2004) • CYDEX, INC. ANNOUNCES AGREEMENT WITH ARRAY BIOPHARMA INC. (March 4, 2004) • CYDEX, INC. ANNOUNCES AGREEMENT WITH GILEAD SCIENCES, INC. – PROVIDES GILEAD USE OF CAPTISOL® FOR EARLY CLINICAL STUDY
CYDEX ANNOUNCES NEW CORPORATE NAME Changes Name to “CyDex Pharmaceuticals, Inc.” to Reflect Current Focus on Acute Care Hospital Products Lenexa, KS, November 20, 2007 – CyDex, Inc. announced today that it has changed its name to “CyDex Pharmaceuticals, Inc.” CyDex changed its name to reflect its current focus on developing and commercializing its pharmaceutical product candidates. Historically, CyDex’s focus had been on the licensing of its CAPTISOL® technology to pharmaceutical companies. Future steps in this change of identity will include enhancements to the corporate website (now www.cydexpharma.com). “We determined to change our name to reflect the current focus of our company,” said John M. Siebert, Ph.D, Chief Executive Officer of CyDex Pharmaceuticals. “The goal is to create an identity that captures the new CyDex, and to maintain a cohesive and professional image in all of our communications.” About CyDex Pharmaceuticals CyDex Pharmaceuticals, Inc. is a specialty pharmaceutical company developing products and licensing its CAPTISOL® enabling technology. CyDex is developing its own pipeline of products using its enabling technology solutions, and partnering with leading pharmaceutical, specialty pharmaceutical and biotechnology companies. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexpharma.com CyDex contact: John M. Siebert, Chief Executive Officer, 913.402.3550, jsiebert@cydexinc.com
Captisol® and Captisol-Enabled® are registered trademarks of CyDex Pharmaceuticals, Inc. (Return to Press Release List)
PEDIATRIC ASTHMA PROGRAMS WITH CYDEX CAPTISOL TECHNOLOGY ACQUIRED BY ASTRAZENECA North American Rights to Captisol-Enabled Budesonide Solution Included in Purchase of Pediatric Asthma Development Programs Lenexa, KS, October 3, 2007 – CyDex, Inc. today announced that rights to pediatric asthma development programs that include CyDex’s Captisol-Enabled® technology have been acquired from Verus Pharmaceuticals, Inc. by AstraZeneca. CyDex is a specialty pharmaceutical company with a pipeline of products based on Captisol – an enabling technology that enhances drug solubility, stability and bioavailability. Four Captisol-Enabled licensed products currently are being commercially marketed, and four CyDex products are currently in clinical trials. As part of the acquisition, the license agreement between CyDex and Verus relating to the North American rights to a Captisol-Enabled budesonide solution (controller medication) has been assigned to an AstraZeneca subsidiary. According to a Verus press release, the transaction also includes a proprietary short-acting beta agonist solution (rescue medication), a customized version of eFlow® (novel nebulizer delivery device) for use with both the controller medication and the rescue medication, and other intellectual property and related assets. Captisol is a modified, patent-protected cyclodextrin that improves the solubility, stability and bioavailability of water-insoluble drugs such as budesonide. About CyDex, Inc. CyDex, Inc. is a specialty pharmaceutical company developing products and licensing its Captisol® enabling technology. CyDex is developing its own pipeline of products using its enabling technology solutions, and partnering with leading pharmaceutical, specialty pharmaceutical and biotechnology companies. Four Captisol-Enabled® drugs are currently being commercially marketed. These include Bristol Myers Squibb’s Abilify IM™, Pfizer Animal Health’s Cerenia™ and Geodon for Injection and Vfend IV, both marketed globally by Pfizer Inc. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexinc.com About AstraZeneca AstraZeneca (NYSE: AZN) is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world´s leading pharmaceutical companies with healthcare sales of US $23.95 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. CyDex contact: John M. Siebert, Chief Executive Officer, 913.402.3550, jsiebert@cydexinc.com
Verus® is a registered trademark of Verus Pharmaceuticals, Inc. Captisol® and Captisol-Enabled® are registered trademarks of CyDex, Inc., and eFlow® is a registered trademark of PARI Pharma GmbH. (Return to Press Release List)
ARADIGM AND CYDEX SIGN DEVELOPMENT COLLABORATION AGREEMENT Hayward, CA and Lenexa, KS, September 6, 2007 – Aradigm Corporation (OTC BB: ARDM) (“Aradigm”) and CyDex, Inc. (“CyDex”) today announced they have entered into a two-year Collaboration Agreement (the “Agreement”) for the development and commercialization of combination products containing inhaled corticosteroids, anticholinergics and beta-2 agonists for the treatment of asthma and chronic obstructive pulmonary diseases (COPD). Under the terms of the Agreement, the costs of the collaboration projects will be borne 60% by Aradigm and 40% by CyDex, with third party licensing and sales revenues to be shared in the same ratio. "There is a lot of interest in inhalation products containing a combination of drugs as these have proven to be very popular with millions of asthma and COPD patients," said Igor Gonda, Ph.D., Aradigm´s President and CEO. "We are pleased to be working with CyDex – a company with an excellent track record of developing and partnering innovative pharmaceutical products." John Siebert, CEO of CyDex and a member of Aradigm´s Board of Directors, said “Putting together Cydex’s aqueous formulation capabilities with Aradigm´s palm-size AERx Essence® inhalation delivery system has the potential to generate a family of attractive novel therapies for asthma and COPD patients. We believe that the products containing CyDex´s formulations delivered by the AERx Essence technology could become a new treatment of choice for many of these patients."
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, 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 CyDex, Inc. CyDex is a specialty pharmaceutical company developing proprietary products and licensing its Captisol® enabling technology. CyDex is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions, and by partnering with the world’s leading pharmaceutical and biotechnology companies. Four Captisol-enabled drugs are currently being commercially marketed. These include Bristol-Myers Squibb’s Abilify IM™, Pfizer Animal Health´s Cerenia™ and Geodon for Injection and Vfend IV, both marketed globally by Pfizer Inc. In addition, CyDex has development agreements with Allergan, Inc.; Bristol-Myers Squibb; Critical Therapeutics, Inc.; Daiichi Asubio Pharma Co., Ltd., of Japan Inc.; Kanisa Pharmaceuticals; Merck & Co., Mitsubishi Corporation; OSI Pharmaceuticals, Inc.; Proteolix, Inc.; Sunesis Pharmaceuticals, Inc.; Taisho Pharmaceuticals; TargeGen, Inc.; and Teva Pharmaceutical Industries Ltd. CyDex also has clinical use agreements with major pharma and biotech companies. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexinc.com
Forward-Looking Statements Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including statements relating to future development and commercialization activities, receipt of revenues and patient acceptance of therapies, as well as the other risks detailed from time to time in Aradigm Corporation´s Securities and Exchange Commission (SEC) Filings, including Aradigm´s Annual Report on Form 10-K, and quarterly reports on Form 10-Q. Aradigm, AERx, and AERx Essence are registered trademarks and the Aradigm Logo is a trademark of Aradigm Corporation. The CyDex Logo and Captisol are registered trademarks of CyDex, Inc. *Other trademarks may be claimed as the property of other parties. Contact: Lippert/Heilshorn & Associates Investor Relations SOURCE: Aradigm and CyDex (Return to Press Release List)
CYDEX LICENSES CAPTISOL® TO CRITICAL THERAPEUTICS FOR INJECTABLE FORMULATION OF ZILEUTON New Injectable Formulation of Zileuton Expected to Enter Phase II Clinical Trials in Second Half of 2007 Lenexa, KS, June 12, 2007 – CyDex, Inc., a specialty pharmaceutical company developing improved products through innovative drug delivery, today announced the signing of a license and supply agreement granting exclusive worldwide rights to its Captisol® enabling technology to Critical Therapeutics, Inc. (NASDAQ: CRTX) for the development of an injectable formulation of zileuton. Critical Therapeutics, and its co-promotion partner, Dey, L.P., currently market asthma drug ZYFLO® (zileuton tablets), in the U.S. On May 30, 2007, the U.S. Food and Drug Administration approved twice-daily ZYFLO CR™ (zileuton) extended-release tablets. Critical Therapeutics and Dey expect to begin marketing ZYFLO CR in the U.S. in the fall of 2007. ZYFLO CR and ZYFLO are indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. The injectable formulation of zileuton is being developed for use in emergency room or urgent care settings for patients experiencing acute exacerbations of asthma. CyDex´s patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs. The CyDex pipeline of licensed and proprietary Captisol-enabled formulations primarily targets the acute care hospital market and includes injectables, oral solutions and capsules, ophthalmic solutions, oral solids and inhalation. Critical Therapeutics expects to initiate a phase II clinical trial for the injectable formulation of zileuton in the second half of 2007, following favorable results from an earlier clinical trial in asthma patients. This phase II trial will be focused on identifying the optimal dose to be tested in phase III clinical trials. "Because Captisol enables the solubilization of a wide range of active pharmaceutical ingredients, it allows pharmaceutical companies to satisfy unmet medical needs by developing dosage forms that might otherwise not be feasible," said John M. Siebert, Ph.D., chief executive officer of CyDex. "We welcome Critical Therapeutics to the global roster of CyDex licensing partners. Including zileuton, these partners have a total of 24 licensed Captisol formulations in their clinical pipelines." "Growth in revenue from royalties and sales of Captisol material to CyDex partners and licensees is enabling us to continue expanding and strengthening our pipeline of proprietary pharmaceuticals," Siebert said. "These developing drugs have the potential to transform CyDex into a full-fledged pharmaceutical products enterprise with a focus on the acute care hospital market." About CyDex, Inc. CyDex is a specialty pharmaceutical company developing proprietary products and licensing its Captisol® enabling technology. CyDex is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions, and by partnering with the world´s leading pharmaceutical and biotechnology companies. Four Captisol-enabled drugs are currently being commercially marketed. These include Bristol-Myers Squibb´s Abilify IM™, Pfizer Animal Health´s Cerenia™ and Geodon for Injection and Vfend IV, both marketed globally by Pfizer Inc. In addition, CyDex has development agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Asubio Pharma Co., Ltd., of Japan; Merck & Co., Inc.; Kanisa Pharmaceuticals™; Mitsubishi Corporation; OSI Pharmaceuticals, Inc.; PTC Pharma AG; TargeGen, Inc.; Taisho Pharmaceuticals; and Teva Pharmaceutical Industries Ltd. CyDex also has clinical use agreements with major pharma and biotech companies. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexinc.com About ZYFLO CR and ZYFLO ZYFLO CR and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO can be continued during acute exacerbations of asthma. The recommended dose of ZYFLO CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. The recommended dose of ZYFLO is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg. ZYFLO CR and ZYFLO are contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled trials showed an increased release of a liver enzyme known as ALT and bilirubin (an orange or yellowish pigment in bile). As a result, the level of liver enzymes in patients treated with ZYFLO CR and ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR and ZYFLO and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR and ZYFLO are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively. For full prescribing information for ZYFLO CR, please visit www.zyflocr.com or call the Company´s toll free telephone number 1-866-835-8216 to request medical information. For full prescribing information for ZYFLO, please visit www.zyflo.com or call the Company´s toll free telephone number 1-866-835-8216 to request medical information. CyDex contact: John Siebert, Chief Executive Officer, 913-402-3550, jsiebert@cydexinc.com
Captisol and Captisol-enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX LICENSES CAPTISOL® TO SUNESIS PHARMACEUTICALS FOR ONCOLOGY DRUG CANDIDATE Phase I Clinical Trial for Treatment of Patients with Solid Tumors Planned for 2007 Lenexa, KS, May 3, 2007 – CyDex, Inc., a specialty pharmaceutical company developing improved products through innovative drug delivery, today announced an agreement licensing its Captisol® enabling technology to Sunesis Pharmaceuticals, Inc. for formulation of a selective Aurora kinase inhibitor with potent anti-tumor activity across a number of nonclinical human cancer models. CyDex´s patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs. The CyDex pipeline of licensed and proprietary Captisol-enabled formulations targets a range of market segments including injectables, oral solutions and capsules, ophthalmic solutions, oral solids and inhalation. CyDex granted Sunesis global rights to Captisol for a formulation of SNS-314 – a selective small molecule inhibitor of Aurora kinases that potently inhibits proliferation of a wide panel of human cancer cell lines. Aurora kinases are over expressed in several types of cancer, including colon, breast, ovarian, bladder, esophageal, gastric and pancreatic. As demonstrated in multiple nonclinical models, the combination of potency, selectivity and robust in vivo activity, coupled with tumor growth inhibition through intermittent dosing, suggests that SNS-314 may be a best-in-class Aurora kinase inhibitor for the treatment of diverse human malignancies. An IND has been submitted for SNS-314, and a Phase 1 clinical trial for the treatment of patients with solid tumors is planned to begin in the second quarter of 2007. Sunesis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapeutics for oncology and other serious diseases. “Adding Sunesis to our roster of technology licensing partners is an important advance for CyDex,” said John M. Siebert, Ph.D., chief executive officer of CyDex. “We are pleased to be participating in the process of developing SNS-314 and potentially creating a significant new therapeutic alternative for oncology. Including SNS-314, our partners have a total of 23 licensed Captisol formulations involved in clinical trials around the world. We look forward to further expanding CyDex’s technology licensing activity in the months and years ahead. At the same time, we expect to continue making progress on our proprietary products strategy. Our current proprietary pipeline includes eight hospital acute care and four other Captisol-enabled drugs that have the potential to provide unique therapeutic benefits and satisfy unmet medical needs.” About CyDex, Inc. CyDex is a specialty pharmaceutical company developing proprietary products and licensing its Captisol® enabling technology. CyDex is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions, and by partnering with the world’s leading pharmaceutical and biotechnology companies. Four Captisol-enabled drugs are currently being commercially marketed. These include Bristol-Myers Squibb’s Abilify IM™, Pfizer Animal Health’s Cerenia™ and Geodon for Injection and Vfend IV, both marketed globally by Pfizer Inc. In addition, CyDex has development agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Asubio Pharma Co., Ltd., of Japan; Merck & Co., Inc.; Kanisa Pharmaceuticals™; Mitsubishi Corporation; OSI Pharmaceuticals, Inc.; PTC Pharma AG; TargeGen, Inc.; Taisho Pharmaceuticals; and Teva Pharmaceutical Industries Ltd. CyDex also has clinical use agreements with major pharma and biotech companies. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexinc.com CyDex contact: John Siebert, Chief Executive Officer, 913-402-3550, jsiebert@cydexinc.com
Captisol and Captisol-enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX LICENSES CAPTISOL® TO PROTEOLIX, INC.FOR PROMISING ONCOLOGY COMPOUND Phase I Clinical Trials Under Way at Six Leading Oncology Centers Lenexa, KS, May 1, 2007 – CyDex, Inc., a specialty pharmaceutical company developing improved products through innovative drug delivery, today announced an agreement licensing its Captisol® enabling technology to Proteolix, Inc. for use with a proteasome inhibitor that has shown promise in treating certain cancers such as multiple myeloma and mantle cell lymphoma. CyDex´s patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs. The CyDex pipeline of licensed and proprietary Captisol-enabled formulations targets a range of market segments including injectables, oral solutions and capsules, ophthalmic solutions, oral solids and inhalation. CyDex granted Proteolix global rights to Captisol for a formulation of PR-171 a novel proteasome inhibitor derived from the natural product epoxomicin. PR-171, also known as carfilzomib, is potent on heme tumor cell lines and induces programmed cell death in multiple myeloma cells taken from patients, including those that are resistant to current therapies. The compound is currently in Phase I clinical trials at six leading oncology centers in the United States and Canada. These trials are designed to measure the safety and tolerability of PR-171 in multiple myeloma and lymphoma patients and to describe preliminary evidence of anti-tumor responses. Proteolix, Inc., a San Francisco Bay Area biopharmaceutical company, is dedicated to developing proteasome inhibitors for multiple therapeutic uses. “We are excited that Proteolix has selected Captisol as an enabling drug delivery technology in developing this promising new cancer therapy,” said John M. Siebert, Ph.D., chief executive officer of Cydex. “Including PR-171, our partners have a total of 22 licensed Captisol formulations involved in clinical trials around the world. We look forward to further expanding CyDex´s technology licensing activity in the months and years ahead. At the same time, we expect to continue making progress on our proprietary products strategy. Our current proprietary pipeline includes eight hospital acute care and four other Captisol-enabled drugs that have the potential to provide unique therapeutic benefits and satisfy unmet medical needs.” About CyDex, Inc. CyDex is a specialty pharmaceutical company developing proprietary products and licensing its Captisol® enabling technology. CyDex is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions, and by partnering with the world’s leading pharmaceutical and biotechnology companies. Four Captisol-enabled drugs are currently being commercially marketed. These include Bristol-Myers Squibb´s Abilify IM™, Pfizer Animal Health’s Cerenia™ and Geodon for Injection and Vfend IV, both marketed globally by Pfizer Inc. In addition, CyDex has development agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Asubio Pharma Co., Ltd., of Japan; Merck & Co., Inc.; Kanisa Pharmaceuticals™; Mitsubishi Corporation; OSI Pharmaceuticals, Inc.; PTC Pharma AG; TargeGen, Inc.; Taisho Pharmaceuticals; and Teva Pharmaceutical Industries Ltd. CyDex also has clinical use agreements with major pharma and biotech companies. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexinc.com CyDex contact: John M. Siebert, 913-402-3550, jsiebert@cydexinc.com
Captisol and Captisol-enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX ANNOUNCES CAPTISOL TECHNOLOGY USED IN INJECTION FORMULATION OF VETERINARY ANTI-EMETIC CERENIA® (maropitant) RECENTLY APPROVED FOR MARKETING IN EUROPE Lenexa, KS, April 10, 2007 – CyDex, Inc., a specialty pharmaceutical company developing improved products through innovative drug delivery, today announced that a subcutaneous injection formulation of the veterinary anti-emetic medication Cerenia® (maropitant) from Pfizer Limited contains CyDex´s Captisol® enabling technology. On September 29, 2006, the European Medicines Agency approved both the subcutaneous injection and tablet formulations of Pfizer´s Cerenia for marketing throughout the European Union. Cerenia for Injection is used in dogs to prevent vomiting and treat vomiting such as that caused by chemotherapy. Cerenia for Injection is the fourth drug formulation utilizing Captisol to receive marketing approval. The other three Captisol-enabled drugs currently are commercially available. These include Geodon IM and Vfend IV, marketed globally by Pfizer Inc., and ABILIFY Injection marketed in the United States by Bristol-Myers Squibb and Otsuka Pharmaceutical Co. CyDex´s patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs. In addition to injectable products, the CyDex pipeline of licensed and proprietary Captisol-enabled formulations targets a range of market segments including oral solutions and capsules, ophthalmic solutions, oral solids and inhalation. "Pfizer´s launch of Cerenia for Injection further illustrates the power of Captisol as an agent for improving aqueous solubility and thus enabling new dosage forms that can both broaden and lengthen the sales revenue stream for new drugs," said CyDex Chief Executive Officer John M. Seibert. "CyDex´s pharmaceutical industry partners recognize that Captisol can serve as a valuable tool for drug lifecycle management, and we are working toward additional product launches by an expanding roster of partners in future years."” About CyDex CyDex is a specialty pharmaceutical company developing proprietary products and licensing its Captisol® enabling technology. CyDex is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions, and by partnering with the world’s leading pharmaceutical and biotechnology companies. In addition to Cerenia® for Injection, the commercially available pharmaceuticals enabled by Captisol include Geodon IM and Vfend IV, marketed globally by Pfizer Inc., and ABILIFY Injection marketed in the United States by Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd., CyDex has development agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Asubio Pharma Co., Ltd., of Japan; Merck & Co., Inc.; Mitsubishi Corporation, of Japan; OSI Pharmaceuticals, Inc.; PTC Pharma AG, of Switzerland; TargeGen, Inc.; Taisho Pharmaceuticals of Japan and Teva Pharmaceutical Industries Ltd., of Israel. CyDex also has clinical use agreements with major pharma and biotech companies. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexinc.com CyDex contact: John Siebert, 913-402-3550, jsiebert@cydexinc.com
Captisol and Captisol-enabled are registered trademarks of CyDex, Inc. Cerenia, Geodon IM and Vfend IV are registered trademarks of Pfizer Inc. ABILIFY is a registered trademark of Otsuka Pharmaceutical Co., Ltd. (Return to Press Release List)
CYDEX ANNOUNCES CAPTISOL TECHNOLOGY USED IN RECENTLY LAUNCHED INJECTION FORMULATION OF ANTIPSYCHOTIC MEDICATION ABILIFY® (aripiprazole) Lenexa, KS, December 14, 2006 – CyDex, Inc., a specialty pharmaceutical company developing improved products through innovative drug delivery, today announced ABILIFY® Injection, a new intramuscular form of the antipsychotic medication ABILIFY® (aripiprazole) from Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd., contains CyDex’s Captisol Technology. ABILIFY Injection is the third drug formulation commercially available in the United States utilizing CyDex’s Captisol® enabling technology. The U.S. Food and Drug Administration (FDA) approved ABILIFY Injection on September 20, 2006. CyDex’s patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs. In addition to injectable products, the CyDex pipeline of licensed and proprietary Captisol-enabled formulations targets a range of market segments including oral solutions and capsules, ophthalmic solutions, oral solids and inhalation. “Bristol-Myers Squibb’s and Otsuka’s launch of ABILIFY Injection further demonstrates the value of Captisol in supporting line extension strategies for successful pharmaceuticals,” said CyDex Chief Executive Officer John M. Seibert. “An expanding roster of CyDex pharmaceutical industry partners recognize that Captisol offers tremendous solubility advantages, and we look forward to future product launches by these partners in the years ahead.” About CyDex CyDex is a specialty pharmaceutical company developing proprietary products and licensing its Captisol® enabling technology. CyDex is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions, and by partnering with the world’s leading pharmaceutical and biotechnology companies. In addition to Geodon for Injection and Vfend IV, marketed globally by Pfizer Inc., and ABILIFY Injection marketed in the United States by Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd., CyDex has development agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Asubio Pharma Co., Ltd., of Japan; Merck & Co., Inc.; Mitsubishi Corporation, of Japan; OSI Pharmaceuticals, Inc.; PTC Pharma AG, of Switzerland; TargeGen, Inc.; Taisho Pharmaceuticals of Japan and Teva Pharmaceutical Industries Ltd., of Israel. CyDex also has clinical use agreements with major pharma and biotech companies. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexinc.com CyDex contact: John Siebert, 913-402-3550, jsiebert@cydexinc.com
Captisol and Captisol-enabled are registered trademarks of CyDex, Inc. ABILIFY is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Geodon IM and Vfend IV are registered trademarks of Pfizer Inc. (Return to Press Release List)
CYDEX REPORTS FIRST APPROVAL OF CAPTISOL-ENABLED® DRUG IN JAPAN Lenexa, KS, August 10, 2005 – CyDex, Inc. today announced the first regulatory approval in Japan of a pharmaceutical product using CAPTISOL®, the advanced CyDex drug delivery technology designed to improve the delivery of insoluble and unstable active drug ingredients. Pfizer Japan confirmed that Japan´s Ministry of Health, Labor and Welfare approved manufacturing of Vfend® (voriconazole), an antifungal product that Pfizer has marketed in the United States and Europe since 2002. Pfizer introduced Vfend intravenous and oral forms last month in Japan. The I.V. formulation combines the active ingredient voriconazole with CAPTISOL, a proprietary CyDex molecule. "We are very pleased that Pfizer has achieved approval for this Captisol-Enabled® product in the three major pharmaceutical markets: the United States, Europe and now Japan. Approval in the world´s second-largest pharmaceutical market solidifies the global regulatory acceptance of CAPTISOL and points the way to potential future successes in bringing new pharmaceutical products to Japanese patients," said Dr. John M. Siebert, Chairman and Chief Executive Officer of CyDex. Pfizer licensed CAPTISOL from CyDex in 1993 for use in formulations of antifungals and other Pfizer -owned new drugs. In addition to Vfend, Pfizer markets a second Captisol-Enabled drug, Zeldox®/Geodon® (ziprasidone mesylate) for Injection, in the United States and Europe. CAPTISOL enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. When given by injection, a Captisol-Enabled formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. In oral and inhaled formulations, CAPTISOL can improve bioavailability by improving dissolution and solubility of drug compounds. CyDex, Inc. is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions and by partnering with the world?s leading pharmaceutical and biotechnology companies. In addition to the relationship with Pfizer, CyDex has agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi-Suntory Pharma Co., Ltd., of Japan; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; PTC Pharma AG, of Switzerland; TargeGen, Inc.; Taisho Pharmaceuticals of Japan and Teva Pharmaceutical Industries Ltd., of Israel. CyDex also has 5 clinical use agreements with major pharma and biotech companies. CyDex is a privately owned company located in suburban Kansas City. To learn more about our partnerships and pipeline, visit www.cydexinc.com
CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. Vfend, Zeldox and Geodon are registered trademarks of Pfizer Inc. (Return to Press Release List)
CyDex, Inc. PRESENTS PROMISING STUDY RESULTS IN DEVELOPING NEW PHARMACEUTICAL PRODUCTS Baltimore, MD, November 10, 2004 – CyDex, Inc. this week presented posters at the annual meeting of the American Association of Pharmaceutical Scientists (AAPS) in Baltimore, demonstrating the promise of its proprietary CAPTISOL Ò technology to provide solubilization, taste masking, improved stability and bioavailability in pharmaceutical products. The scientific presentations highlight the application of CyDex drug delivery technology to develop oral products, as well as parenteral and inhaled formulations. The specialty pharmaceutical company presented posters on preclinical and clinical results of Captisol-Enabled® product candidates for asthma and allergies, cardiovascular disease and depression. "CyDex has built a track record of providing solutions for solubilization problems in the development of pharmaceutical products and creating novel formulations. We are now demonstrating the ability to develop a growing pipeline of products with significant differentiation," said John M. Siebert, Ph.D., Chief Executive Officer of CyDex. "These posters illustrate the range of specialty pharmaceutical products that CyDex is developing to address unmet needs in the market." Among several posters at AAPS, CyDex presented results of an early-stage clinical study demonstrating the potential bioequivalence and taste-masking benefit of Captisol-Enabled Sertraline Oral Solution, the company´s first oral drug candidate to enter clinical trials. A separate poster describes the use of CAPTISOL technology to produce an aqueous-based oral formulation that is stable, biocompatible and taste-masked, while meeting chemistry, manufacturing and control (CMC) requirements. Other posters include a demonstration that CAPTISOL formulations of parenteral or oral liquid products can be made with or without preservatives, and a description of new solubilization methods for a parenteral formulation of amiodarone, a pharmaceutical product for cardiac arrhythmias. In addition to the posters at AAPS, CyDex presented an overview of its business and a pipeline update on Tuesday to investors at the CIBC World Markets Fifteenth Annual Healthcare Conference in New York. About CAPTISOL and CyDex CAPTISOL enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. When given by injection, a Captisol-Enabled formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. In oral and inhaled formulations, CAPTISOL can improve bioavailability by improving dissolution and solubility of drug compounds. Pfizer Inc. currently markets two Captisol-Enabled formulations that have been approved in the United States and Europe. CyDex, Inc. is bringing important new medications to patients by developing its own pipeline of proprietary products with advanced drug delivery solutions and by partnering with the world´s leading pharmaceutical and biotechnology companies. CyDex has agreements with Allergan, Inc.; Array Biopharma Inc.; Bristol-Myers Squibb; Daiichi-Suntory Pharma Co., Ltd., of Japan; Gilead Sciences, Inc.; Hovione, of Portugal; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; Pfizer Inc; OncoPept AG, of Switzerland; Taisho Pharmaceuticals, of Japan; Teva Pharmaceutical Industries Ltd., of Israel; and TargeGen Inc. CyDex is a privately owned company located in suburban Kansas City. To learn more about our partnerships and pipeline, visit www.cydexinc.com . CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX, INC., EARNS RAPID-GROWTH RANKING (Lenexa, KS, October 20, 2004) – CyDex, Inc., which is creating new pharmaceutical products through innovative drug delivery technologies, today announced that CyDex was named to the Deloitte Technology Fast 500, a ranking of the fastest-growing science and technology-based companies. A revenue increase of 626 percent for the past five years earned CyDex a place on the rapid-growth list, selected from public and private companies in North America by the accounting firm of Deloitte & Touche, LLP. "Achieving a spot in the Fast 500 places CyDex among this decade´s small but emerging rapid-growth companies in the pharmaceutical industry," said Dr. John M. Siebert, Chief Executive Officer. "CyDex has laid the foundation for creating valuable new pharmaceutical products with novel technologies. At $4.6 million in 2003 revenues, we have just begun to ramp up through licensed products coming to market. The future potential will come through commercializing our pipeline of internally developed proprietary products to address important patient needs." "Being one of the 500 fastest growing technology companies in North America is an impressive accomplishment. We commend CyDex for making the Deloitte Technology Fast 500 with a phenomenal 626 percent growth rate over five years," said Mark A. Evans, national managing partner of Deloitte´s Technology, Media & Telecommunications Group. Fast 500 Selection and Qualifications The Fast 500 list is compiled from Deloitte´s 19 regional North American Fast 50 programs, nominations submitted directly to the Fast 500, and public company database research. To qualify for the Fast 500, entrants must have had 1999 operating revenues of at least $50,000 USD and $75,000 CD for the United States and Canada, respectively; and 2003 operating revenues must be at least $1 million USD or CD . Entrants must also be public or private companies headquartered in North America and must be a technology company, defined as a company that owns proprietary technology that contributes to a significant portion of the company´s operating revenues; or d evotes a significant proportion of revenues to the research and development of technology. Using other companies´ technology in a unique way does not qualify . About CyDex CyDex, Inc. offers innovative drug delivery solutions using CAPTISOL®, its advanced formulation system, to help bring important new medications to patients. The company is developing its own pipeline of Captisol-Enabled® products, as well as partnering with leading pharmaceutical and biotechnology companies. A total of 12 Captisol-Enabled drug formulations are currently in or near clinical development. Pfizer Inc. currently markets two Captisol-Enabled formulations that have been approved in the United States and Europe. CyDex has ongoing licensing agreements with Allergan, Inc.; Bristol-Myers Squibb Co.; Daiichi Suntory Pharma Co., Ltd., of Japan; Hovione, of Portugal; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; Pfizer; OncoPept AG, of Switzerland; TargeGen, Inc.; and Teva Pharmaceutical Industries Ltd., of Israel. CyDex is a privately owned company located in suburban Kansas City. CAPTISOL enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. When given by injection, a Captisol-Enabled formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. In oral and inhaled formulations, CAPTISOL can improve bioavailability by improving dissolution and solubility of drug compounds. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu, a Swiss Verein, its member firms and their respective subsidiaries and affiliates. As a Swiss Verein (association), neither Deloitte Touche Tohmatsu nor any of its member firms has any liability for each other´s acts or omissions. Each of the member firms is a separate and independent legal entity operating under the names Deloitte, Deloitte & Touche, Deloitte Touche Tohmatsu, or other related names. Services are provided by the member firms or their subsidiaries or affiliates and not by the Deloitte Touche Tohmatsu Verein. Deloitte & Touche USA LLP is the U.S. member firm of Deloitte Touche Tohmatsu. In the U.S., services are provided by the subsidiaries of Deloitte & Touche USA LLP (Deloitte & Touche LLP, Deloitte Consulting LLP, Deloitte Tax LLP, and their subsidiaries), and not by Deloitte & Touche USA LLP. CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX, INC. RAISES $17 MILLION IN VENTURE CAPITAL TO ADVANCE DEVELOPMENT OF DRUG CANDIDATES Lenexa, KS, August 17, 2004 – CyDex, Inc., a leader in improving pharmaceutical product solubility, today announced the closing of a $17 million Series B investment from a global syndicate of venture capital investors. The life sciences fund of Sanders Morris Harris, a Houston-based investment firm, led the transaction. SR One Limited, the venture arm of GlaxoSmithKline, and Eastman Ventures, the venture capital arm of Eastman Chemical Company also participated in the financing. They were joined by several existing investors, including Techno Venture Management (TVM), Private Equity Direct Finance, Paul Leach (individual investor), Clariden Investment and members of CyDex´s management. This investment will enable CyDex to move ahead with development of several promising new pharmaceutical products. "An outstanding group of life science investors is joining us in building the value of CyDex by supporting the development of new products with our advanced formulations," said Dr. John M. Siebert, Chief Executive Officer . "We believe this investment by experienced U.S. and European venture funds will enable CyDex to develop new, proprietary pharmaceutical products that provide significant product differentiation and address unmet patient needs. Potentially that includes products in the anti-infective, respiratory, central nervous system and oncology areas. If our development efforts are successful, these products will add to our existing revenue streams within the next few years." "CyDex has an impressive capability to create new and improved pharmaceutical products through its innovative drug delivery technology," stated James Gale, managing director of Sanders Morris Harris. "The financing should enable the Company to expand its growing client base and continue to develop its portfolio of products. In our view, the quality of the Company´s diverse client base and the success of commercialized products using its technology validates the potential of the technology. We eagerly look forward to the launch of additional products." CIBC World Markets managed the Series B private-placement offering for CyDex. CyDex, Inc. offers innovative drug delivery solutions using CAPTISOL®, its advanced formulation system, to help bring important new pharmaceutical products to patients. The company is developing its own pipeline of Captisol-Enabled® products, as well as partnering with leading pharmaceutical and biotechnology companies. A total of 12 Captisol-Enabled® drug formulations are currently in development. Captisol is used in 18 product candidates which have active Investigational New Drug applications (INDs) or foreign INDs. Pfizer Inc. currently markets two Captisol-Enabled® formulations that have been approved in the United States and Europe. CyDex has ongoing licensing agreements with Allergan, Inc.; Bristol-Myers Squibb Co.; Daiichi Suntory Pharma Co., Ltd., of Japan; Hovione, of Portugal; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; Pfizer; OncoPept AG, of Switzerland; TargeGen, Inc.; and Teva Pharmaceutical Industries Ltd., of Israel. CyDex is a privately owned company located in suburban Kansas City. CAPTISOL® enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. When given by injection, a Captisol-Enabled® formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. In oral and inhaled formulations, CAPTISOL can improve bioavailability by improving dissolution and solubility of drug compounds.
CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX, INC. LICENSES CAPTISOL ® TO TARGEGEN, INC. Lenexa, KS, June 30, 2004 – CyDex, Inc., which is creating new pharmaceutical products through innovative drug delivery technologies, today announced an agreement licensing CAPTISOL ® , its advanced formulation system, to TargeGen, Inc. for use with a novel drug under development for treatment of cardiovascular diseases. The agreement brings to 18 the number of Captisol-Enabled ® products in or near clinical development. CyDex granted TargeGen global rights to CAPTISOL for a formulation of TG 100-115, a new kinase inhibitor being developed by TargeGen for treatment of acute myocardial infarction. In preclinical studies TG 100-115 shows promise in reducing the amount of heart muscle that is killed in a heart attack, preserving heart function and reducing mortality. In the agreement CyDex granted similar licensing terms to TargeGen for use of CAPTISOL with additional proprietary compounds developed in the next five years. Financial terms of the agreement were not disclosed. "We are excited that TargeGen has chosen CAPTISOL as a drug delivery vehicle in developing this promising new therapy for heart attack patients," said Dr. John M. Siebert, Chief Executive Officer of CyDex . "TargeGen research is confronting the leading causes of death in the industrialized world heart attack, cancer and stroke. CyDex is pleased to have TargeGen as a partner, and we hope TG 100-115 is just the first of several promising Captisol-Enabled drugs to emerge from this agreement." CAPTISOL enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. When given by injection, a Captisol-Enabled formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. In oral and inhaled formulations, CAPTISOL can improve bioavailability by improving dissolution and solubility of drug compounds. CyDex, Inc. offers innovative drug delivery solutions to help bring important new medications to patients. The company is developing its own pipeline of Captisol-Enabled drug formulations as well as partnering with leading pharmaceutical and biotechnology companies. Pfizer currently markets two Captisol-Enabled formulations that have been approved in the United States and Europe. CyDex has ongoing agreements with Allergan, Inc.; Array Biopharma, Bristol-Myers Squibb Co.; Daiichi Suntory Pharma Co., Ltd., of Japan; Gilead Sciences, Inc ., Hovione, of Portugal; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; Pfizer; OncoPept AG, of Switzerland; and Teva Pharmaceutical Industries Ltd., of Israel. CyDex is a privately owned company located in suburban Kansas City. TargeGen, Inc. is a privately-held biopharmaceutical company based in San Diego. The company combines a focus on vascular biology (vasculostasis) with expertise in small molecule medicinal chemistry. TargeGen develops small-molecule drugs that suppress disease-related changes in vascular permeability and vascular proliferation associated with ischemic diseases (such as heart attack and stroke) and cancer.
CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
HOVIONE AND CYDEX ANNOUNCE DRUG DEVELOPMENT ALLIANCE FOR SIX POTENTIAL NEW PRODUCTS Lisbon, Portugal and Lenexa, KS June 14, 2004 - Hovione, an international pharmaceutical fine chemicals company and CyDex, Inc., which is creating new pharmaceutical products through innovative drug delivery technologies, today announced an alliance to develop and commercialize improved formulations of drugs that are off-patent or soon will be off-patent. The collaboration will use CAPTISOL®, a proven technology from CyDex, to develop formulations offering advantages such as improved bioavailability, dissolution and stability. The companies agreed to develop Captisol-Enabled® formulations of six drugs initially but, for competitive reasons, did not announce the products. Hovione´s CEO, Guy Villax commented, "We are very pleased to add this further dimension to our collaboration with CyDex. Our companies have very complementary proprietary know-how and synergistic market presences - Hovione has a good understanding and a long-established presence in the generics market and CyDex´s CAPTISOL is well known to formulation development scientists at most innovative pharma companies. "Partnering with Hovione increases our capabilities and adds to our pipeline of proprietary drugs under development. Hovione already is manufacturing CAPTISOL for CyDex, and expanding the relationship unites our companies´ complementary skills in a way that can create significant value for both," said John M. Siebert, Ph.D., Chief Executive Officer of CyDex. "CyDex also continues to make progress with pharmaceutical and biotech partners on developing several Captisol-Enabled formulations of innovative drugs. The technology is proven, as two of these formulations already are approved and being marketed." CAPTISOL is a rationally designed delivery system currently used in two prescription products developed and marketed by Pfizer Inc. in the United States and Europe, Vfend® and Geodon® . Additional Captisol-Enabled products are under development. CAPTISOL enables safe, effective delivery by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. In oral and inhaled formulations, CAPTISOL can improve bioavailability by improving the solubility and dissolution of drug compounds. When given by injection or inhalation, a Captisol-Enabled formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. Hovione, based in Loures, Portugal, is an international group dedicated to the process development and synthesis of active pharmaceutical ingredients serving exclusively the pharmaceutical industry. With FDA-inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service and quality. Hovione´s capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards. Hovione has process capabilities in the areas of particle design and inhalation drug delivery. CyDex, Inc. offers advanced drug delivery solutions to bring important new medications to patients by developing its own pipeline of Captisol-Enabled proprietary drug formulations and by partnering with the world´s leading pharmaceutical and biotechnology companies. CyDex has agreements with Allergan, Inc.; Bristol-Myers Squibb Co.; Daiichi Suntory Pharma Co., Ltd., of Japan; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; Pfizer Inc.; PTC Pharma AG, of Switzerland; and Teva Pharmaceutical Industries Ltd., of Israel. CyDex is a privately owned company located in suburban Kansas City. For further information about Hovione, please visit Hovione site www.hovione.com or contact Isabel Pina , Corporate Communications Dept., +351 21 982 9200 hello@hovione.com PR Nº 2004/02. To learn more about CyDex´ partnerships and pipeline, please visit www.cydexinc.com or contact: Michelle Baragary, Business Development Coordinator, 913-402-3534. CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX, INC. ANNOUNCES PRECLINICAL STUDY SHOWING POTENTIAL OF NEW ASTHMA FORMULATION USING CAPTISOL ® SOLUTION Palm Desert, CA, April 26, 2004 – CyDex, Inc. today presented results of a preclinical study demonstrating the potential of its proprietary Captisol-Enabled ® formulation of budesonide, a widely used asthma medicine, for delivery by a variety of nebulizing inhalation devices. The poster presentation at the Respiratory Drug Delivery IX Conference supports the feasibility of using CAPTISOL Ò to create solutions of inhaled corticosteroids, which may offer advantages over existing formulations, such as reduced time of treatment and accommodation in a broad array of nebulizer formats leading to improved patient compliance. "This in vitro study points to the potential of Captisol-Enabled formulations to offer efficient, patient-friendly delivery of drugs by inhalation, an important medical need, especially among pediatric and geriatric populations," said John M. Siebert, Ph.D., president and chief executive officer of CyDex. "The budesonide study is one of four in this scientific poster session that explore the potential for pulmonary delivery of proprietary drug candidates using CAPTISOL." The study compared the delivery of Pulmicort Respules (budesonide inhalation suspension), an AstraZeneca brand, and a 5% CAPTISOL and budesonide solution prepared by CyDex. Using four different nebulizing devices, the amount of Captisol-Enabled budesonide delivered in each case was significantly higher than the amount of Pulmicort suspension. In an air jet nebulizer, the device specified in the prescribing information of Pulmicort Respules, the mean emitted dose of Captisol-Enabled budesonide was 44 percent higher than the marketed suspension form. In three ultrasonic nebulizers, which are smaller and generally faster than air jets in delivering drug dosages, the emitted dose of Captisol-Enabled budesonide ranged from 111 percent to 267 percent greater than Pulmicort Respules. The package insert of Pulmicort Respules limits administration to air jet devices and notes that the suspension is not for use with ultrasonic devices. However, the Captisol-Enabled budesonide data indicate a strong potential for delivering therapeutic doses via the newer ultrasonic devices. Because the rate of delivery was significantly higher for Captisol-Enabled budesonide, the data also suggest the potential to reduce the time of administration from the typical 5 to 10 minutes currently needed for young children. In addition, the study compared the distribution of particles delivered with Captisol-Enabled budesonide vs. Pulmicort Respules. Using either a standard air jet or an ultrasonic nebulizer, the Captisol-Enabled solution delivered a larger proportion of the budesonide in finer particles than the suspension, suggesting the potential for deeper penetration of the lungs. Authors of the study are R.O. Zimmerer, Jr., and J.D. Pipkin of CyDex, Inc.; S. Somaraju, J. D. Suman and G. Su of Next Breath, LLC; and R.N. Dalby of the University of Maryland, Baltimore. Dr. Zimmerer is presenting the poster. The data will be published in the Respiratory Drug Delivery IX Proceedings , available online at www.rddonline.org . CAPTISOL is a rationally designed delivery system currently used in two prescription products developed and marketed by Pfizer Inc in the United States and Europe. A number of additional new Captisol-Enabled products are under development by CyDex and its corporate partners. CAPTISOL enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. In oral formulations, CAPTISOL can improve bioavailability by improving the solubility and dissolution of drug compounds. When given by injection, a Captisol-Enabled formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. CyDex, Inc. offers advanced drug delivery solutions to bring important new medications to patients by developing its own pipeline of Captisol-Enabled proprietary drug formulations and by partnering with the world´s leading pharmaceutical and biotechnology companies. CyDex has agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Suntory Pharma Co., Ltd., of Japan; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; Pfizer Inc; PTC Pharma AG, of Switzerland; and Teva Pharmaceutical Industries Ltd., of Israel. CyDex is a privately owned company located in suburban Kansas City. To learn more about our partnerships and pipeline, visit www.cydexinc.com . CAPTISOL is a registered trademark and Captisol-Enabled has been filed as a trademark of CyDex, Inc. (Return to Press Release List)
CYDEX, INC. ANNOUNCES AGREEMENT WITH ARRAY BIOPHARMA INC. Lenexa, KS, March 9, 2004 – CyDex, Inc., an innovator in drug delivery technologies, today announced an agreement with Array BioPharma Inc. regarding its advanced formulation system CAPTISOL®. The agreement provides Array BioPharma the ability to utilize CAPTISOL in formulation studies. "We are excited that Array has selected CAPTISOL as a potential, enabling drug delivery technology," said Dr John M. Siebert, president and CEO of CyDex. "Array´s impressive scientific capabilities make it an outstanding partner for CyDex." CAPTISOL enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. CAPTISOL is a donut-shaped molecule that complexes water insoluble active drugs in its central cavity. When given by injection, a Captisol-Enabled® formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. In oral formulations, CAPTISOL can improve bioavailability by improving dissolution and solubility of drug compounds. CyDex, Inc. provides innovative drug delivery solutions to pharmaceutical and biotechnology companies. Pfizer currently markets two Captisol-Enabled formulations that have been approved and are commercially available in the United States and Europe. CyDex is also commercializing its own pipeline of proprietary drug candidates. Besides Array BioPharma, CyDex has agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Suntory Pharma Co., Ltd., of Japan; Merck & Co., Inc, OSI Pharmaceuticals, Inc; Pfizer Inc; PTC Pharma AG, of Switzerland; Taisho Pharmaceuticals of Japan and Teva Pharmaceutical Industries Ltd ., of Israel. The CAPTISOL drug delivery technology arises from sulfobutylether beta-cyclodextrins originally synthesized and patented by scientists at the University of Kansas Higuchi Biosciences Center for Drug Delivery Research. CyDex is a privately owned company in suburban Kansas City. Learn more at www.cydexinc.com. CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. (Return to Press Release List)
CYDEX, INC. ANNOUNCES AGREEMENT WITH GILEAD SCIENCES, INC. PROVIDES GILEAD USE OF CAPTISOL® FOR EARLY CLINICAL STUDY Lenexa, KS, March 4, 2004 – CyDex, Inc., an innovator in drug delivery technologies, today announced the fact that it has entered into a limited use agreement with Gilead Sciences, Inc. for CyDex´s advanced formulation system CAPTISOL®. CAPTISOL enables the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. CAPTISOL is a donut-shaped molecule that complexes water insoluble active drugs in its central cavity. When given by injection, a Captisol-Enabled® formulation helps carry a drug into the patient´s bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. In oral formulations, CAPTISOL can improve bioavailability by improving dissolution and solubility of drug compounds.
CyDex, Inc. provides innovative drug delivery solutions to pharmaceutical and biotechnology companies. Pfizer currently markets two Captisol-Enabled formulations that have been approved and are commercially available in the United States and Europe. CyDex is also commercializing its own pipeline of proprietary drug candidates. Besides Gilead, CyDex has agreements with Allergan, Inc.; Bristol-Myers Squibb; Daiichi Suntory Pharma Co., Ltd., of Japan; Merck & Co., Inc, OSI Pharmaceuticals, Inc; Pfizer Inc; PTC Pharma AG, of Switzerland; Taisho Pharmaceuticals of Japan and Teva Pharmaceutical Industries Ltd ., of Israel. The CAPTISOL drug delivery technology arises from sulfobutylether beta-cyclodextrins originally synthesized and patented by scientists at the University of Kansas Higuchi Biosciences Center for Drug Delivery Research. CyDex is a privately owned company in suburban Kansas City. Learn more at www.cydexinc.com. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has six commercially available products and focuses its research and clinical program on anti-infectives. Headquartered in Foster City, California, Gilead has operations in the United States, Europe, Australia and Canada. For more information, contact Public Affairs at 1-800-GILEAD-5 (1-800-445-3235) or 1-650-574-3000, or at public_affairs@gilead.com. CAPTISOL and Captisol-Enabled are registered trademarks of CyDex, Inc. |
