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Press Releases |
PRESS RELEASES
Cirrus Pharmaceuticals, Inc. is excited to announce the expansion of our current capacity for stability storage via the addition of 3 LUWA Walk-in Stability Chambers. Cirrus will add three large capacity chambers, each with 1,100 cubic feet of storage space. These chambers will be cGMP compliant meeting FDA and ICH guideline requirements for stability. "With an increase in our existing and new client sponsor requests for long-term stability storage and testing, expanding our capacity is a logical investment in Cirrus Pharmaceuticals' progression as a contract research service provider" said Jean-Marc Bovet, Ph.D. Executive Senior Vice President.
The new additions include the following storage conditions:
With the expansion to cGMP-compliant Walk-In stability chambers, Cirrus will be able to increase its current core capabilities of formulation and strategic product development services for various dosage forms including inhalation, nasal, parenteral, oral, topical and transdermal. In addition, Cirrus will enhance its release testing and stability testing in support of clinical trials, IND and NDA submissions. Validation of the chambers, including temperature and humidity mapping and monitoring systems are on schedule for completion by November of this year.
Cirrus Pharmaceuticals, Inc. is pleased to announce it has been qualified and
designated by Solvay Fluor as its exclusive provider of batch release testing
services to perform independent analyses of Solvay’s Solkane® propellants,
HFA-134a and HFA-227 in the US.
Solvay is a world leader in the rapidly expanding fluorochemicals market. With
this designation from Solvay, Cirrus now has the ability to conduct the analysis
on Solkane® propellants HFA-134a and HFA-227, using Solvay’s proprietary
validated test methods that were transferred to Cirrus’ facilities in Research
Triangle Park, NC.
This ability will allow Cirrus to provide clients with an independent quality review
of Solvay’s Solkane® propellants for HFA testing purposes. This type of testing is
an FDA requirement for release of a drug product into the U.S. market.
“Cirrus is very excited to be designated by Solvay Fluor as the exclusive service
provider to perform release testing for Solvay’s Solkane® propellants. Solvay
chose Cirrus due to its inhalation expertise and the quality of services it provides
its clients. With the increase in demand for HFA propellants due to the CFC
phase out, this service sector of our business will help speed up product
development and the registration process for our clients,” said Uli Foley, Cirrus’
Director, Business Development.
Cirrus Pharmaceuticals is a contract research and product development
company located in Research Triangle Park, North Carolina, USA. Cirrus can
assist or manage projects as needed by providing a broad array of R&D services
including physical and chemical characterization, formulation development,
stability testing, container/closure selection, process development, scale-up and
technical transfer for inhaled, nasal, oral, parenteral, topical and transdermal
products. Services can include submission-ready regulatory documentation and
assistance with regulatory submission questions.
Solvay is an international chemical and pharmaceutical group with headquarters
in Brussels. It employs more than 28,000 people in 50 countries. In 2007,
Solvay's consolidated sales amounted to EUR 9.6 billion, generated by its three
sectors of activity: Chemicals, Plastics and Pharmaceuticals.
For further information, contact us at 919-321-4049 or email BizDev@cirruspharm.com
Cirrus Pharmaceuticals, Inc. has begun a month-long celebration of its 10th anniversary of serving the pharmaceutical and biotech industry in June 2007. Cirrus Pharmaceuticals is a contract product development company that assists biotechnology and pharmaceutical companies with formulation development and regulated testing of pharmaceutical products throughout their development life cycle. As part of the celebration, Cirrus has invited its business associates and welcomes industry-related professionals to join them at an Open House on Tuesday, June 12th from 2 p.m. to 6 p.m. at their facility located at 511 Davis Drive, Suite 100 in Research Triangle Park, North Carolina.
During the entire anniversary month, Cirrus will hold a series of events that reflect on its history, growth, contributions to pharmaceutical research and development, and its appreciation to the business community and its employees. "None of this growth would have been possible without the tremendous efforts of all our employees and the respect and confidence Cirrus has gained by serving its clients needs and providing them with timely solutions," stated co-founder Dr. Anthony Hickey, who serves as Cirrus's President and CEO. Cirrus's keynote event for its 10th anniversary will take place on Tuesday, June 12th from 2 p.m. to 6 p.m. with an Open House reception. Highlights include talks by the Senior Advisor to the Governor for Science and Technology, Dr. Robert McMahan, and President and CEO of Inspire Pharmaceuticals, Dr. Christy Shaffer. When Cirrus opened its doors in 1997, Inspire Pharmaceuticals was their first client. Paul McGlynn, Senior Director of Aerosol Product Development of long-time Cirrus client Sepracor, Inc. added, "Since 1999, Cirrus has been a preferred partner for our Aerosol Development group at Sepracor. Our success comes from a spirit of collaboration between our two companies which is the same now as it was when we started working together". Cirrus helped Sepracor in the formulation of Sepracor's drug Xopenex HFA® which treats asthma and chronic obstructive pulmonary diseases (COPD) and the formulation led to the successful Xopenex HFA® product launch in January 2006.
Since its inception ten years ago, Cirrus has been recognized as one of the fastest growing private companies at the Triangle Business Journal's annual Fast 50 Awards ceremony. In 2005, Dr. Hickey was elected as a Fellow of the prestigious American Association for the Advancement of Science for his contributions to science and medicine in the area of pulmonary drug delivery research. Additionally, Cirrus strives to give back to the local community by annually sponsoring, the Cirrus MS 150 Team's participation in the 150-mile bike ride to raise money for multiple sclerosis research.
Cirrus Pharmaceuticals, Inc. was recognized as one of the fastest growing private companies in the Triangle at Triangle Business Journal's annual Fast 50 Awards ceremony on November 2, 2006.
The Research Triangle-based Cirrus Pharmaceuticals ranked 13th on the list of top 50 companies. The rankings were determined by PricewaterhouseCoopers LLP, who evaluated locally headquartered private companies based on a formula that takes into account both dollar growth and percentage rate of growth over a three-year period. To be considered companies were required to have had at least $3 million in revenue in 2005. "Cirrus success stems from the collaborative research environment we have fostered with our clients and employees. This collaborative environment provides both the client and Cirrus' staff the flexibility to make quick decisions thus making the drug development process shorter and less expensive in the long-run. This award is also a testament to the quality of service Cirrus provides its clients as well as to the quality of employees at Cirrus" says Dr. Tony Hickey, CEO & President.
"Each of the Fast 50 companies has contributed a great deal to the Triangle community," says Charlene Grunwaldt, Triangle Business Journal publisher. "They are dynamic businesses representing diverse industries. The stories of their successes are very compelling."
Cirrus Pharmaceuticals, Inc., a contract product development company that assists biotechnology and pharmaceutical companies with pharmaceutical product development, announces that Sepracor Inc. has successfully launched XOPENEX HFA Inhalation Aerosol, a hydrofluoroalkane (HFA) metered-dose inhaler (MDI).
XOPENEX HFA is an HFA MDI that is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease. Reversible obstructive airway disease includes respiratory disorders such as asthma and the reversible component of chronic obstructive pulmonary disease. Cirrus' contributions to the development of XOPENEX HFA included assistance with pre-formulation studies, device selection, development of the HFA formulation, and manufacturing process development. XOPENEX HFA received regulatory approval in the shortest FDA review cycle for an HFA MDI to date.
"Cirrus' approach is to be a partner with our clients. We both share our drug development expertise." Dr. Hickey added, "Cirrus appreciates the opportunity to work with Sepracor on this novel drug product for adults and children who suffer from bronchospasm."
Cirrus has signed a contract with pSivida a global nanotechnology company to accelerate and expand development of a number of specific drug candidates formulated in BioSilicon™ to expand a BioSilicon™ product pipeline of reformulated drugs.
"Cirrus is a leader in the field in terms of being able to create new opportunities in reformulating drugs," observes Brian Leedman, a spokesman in pSivida's Perth headquarters. "We're looking for opportunities to reformulate our BioSilicon technology, so this collaboration represents a faster way to market." "The Cirrus collaboration represents an extended use of another company's facilities to conduct further experimentation," Leedman says. "We see this as a cost-effective way to expand our product portfolio." "This new collaboration represents a further significant commitment and investment by pSivida in the core area of our business, which leverages a critical U.S.-based, FDA-experienced development resource" adds Gavin Rezos, the company's managing director.
A dedicated team of Cirrus researchers will assist pSivida in generating new products based on reformulating existing specific generic and proprietary drugs and their delivery utilizing BioSilicon™. To the extent that such new reformulations or delivery demonstrate improved efficacy, safety and/or compliance as compared to the original product, pSivida will be able to claim patent protection on its new products. All intellectual property developed through this collaboration relating to BioSilicon™ will be wholly owned by pSivida.
Cirrus has been selected by Solvay to act as Solvay's exclusive HFA control test laboratory in the United States. HFA's are components in inhaled drug products like those commonly used to treat asthma This collaboration will allow Cirrus to provide Solvay with an independent quality review for HFA testing purposes. This testing is necessary for FDA approval for any inhaled drug product Solvay wants to introduce to the U.S. market.
Co-founder and Executive Senior Vice President Dr. Jean-Marc Bovet believes this is a tremendous opportunity for Cirrus. "To be selected as the exclusive test laboratory for Solvay is a testament to the quality of service that Cirrus provides to all its clients". Dr. Bovet added that he appreciates the opportunity to work with such a progressive pharmaceutical company that has the same shared vision for quality pharmaceutical product development.
Cirrus has acquired an additional 8,300 square feet of space to increase its total square footage to 29,811. The expansion will enable Cirrus to continue its progressive growth by allowing Cirrus to add three new lab facilities and an employee training room. Cirrus also expects to expand its number of employees from 60 to 80 by December 2005.
Co-founder and Executive Senior Vice President Dr. Jean-Marc Bovet, attributes the growth of the company to its focus on providing timely research and project development support to the pharmaceutical industry and to the diverse professional and educational backgrounds of the staff. Jean-Marc also expressed his appreciation for each employee's hard work in making this growth possible. |
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For more information, call us in North Carolina, USA at (919) 884-2064 or email us at info@cirruspharm.com.
© 2010 Cirrus Pharmaceuticals, Inc. |
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