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Press Release / Jun 14, 2004

Hovione and CyDex announce drug development alliance for six potential new products

Hovione and CyDex, today announced an alliance to develop and commercialize improved formulations of drugs that are off-patent or soon will be off-patent.

Lisbon, Portugal and Lenexa, Kan. -14th June 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.

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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