Entropin awards packaging contract to Automatic Liquid Packaging
Entropin, Inc., a pharmaceutical development company, recently announced that it has awarded the commercial clinical packaging contract for Esterom, a topical therapeutic for acute painful shoulder and lower back sprain, to Automatic Liquid Packaging (ALP), a subsidiary of Cardinal Health.
Automatic Liquid Packaging is a leading provider of aseptic custom manufacturing and packaging for pharmaceutical and health-care applications. ALP's proprietary, state-of-the-art "Blow/Fill/Seal" technology provides container fabrication, aseptic filling and sealing in an integrated operation for sterile liquid pharmaceuticals and other topical, oral, inhaled and ophthalmic formulations.
Commenting on this milestone, Thomas Tachovsky, PhD, Entropin's president and chief executive officer, said, "The development of this relationship with ALP is an important step as Entropin prepares for upcoming clinical trials and the ultimate commercialization of Esterom. A partnership with a packaging company of ALP's caliber is vital to the progression of our company and our product."
"We are pleased to work with Entropin and anticipate a longstanding and successful relationship," said Frank Leo, president of ALP.
ALP's initial responsibility is to package Esterom(R) for the upcoming clinical trial announced on April 16, 2001. The Entropin team has been planning its next trial since the results of the Phase IIIA trial were released in October 2000. Dr. Tachovsky reported that between October 2000 and April 2001, a "blue ribbon" panel of experts was assembled to assist with the evaluation of the data from the Phase IIIA study and the preparation of the protocol for the upcoming trial.
"We had a very productive meeting with the FDA in March, during which we reviewed the new clinical trial protocol," added Dr. Tachovsky. "We are moving ahead with our next trial, which is scheduled to begin in the third quarter of 2001. Patient enrollment will take approximately six months, and results of the study should be available in the first quarter of 2002. We also intend to continue discussions with potential corporate marketing partners. We are enthusiastic about the next clinical study and looking forward to the anticipated results for the following reasons:
- The Esterom safety profile is strong and well documented.
- Esterom demonstrated statistically significant efficacy in the Phase
II study and positive dose trending in the Phase IIIA study.
- The company's Scientific and Medical Advisory Board (SMAB) and its
expert panel, comprised of renowned scientists and physicians
experienced in soft-tissue injuries of the shoulder, both assisted in
the upcoming trial design.
- Members of Entropin's expert panel will serve as principal
investigators in three of four esteemed clinics selected as sites for
the upcoming trial.
- The new protocol was fully reviewed by the FDA.
- Clinical study monitors have been carefully chosen and will visit each
of the sites regularly.
- An on-line system is in place to provide for daily data collection at a
central location.
- Professional chemistry laboratories have been engaged and are linked to
the central data system via the Web to further integrate scientific
data.
- An investigator-training program has been developed to assure
consistency among the sites with regard to patient screening, clinical
measurements, data collection and overall study supervision.
- Entropin's executive team, along with Glenmere Clinical Research, the company's clinical research organization, will guide and supervise the overall program."
Entropin, Inc. is a pharmaceutical research and development company focused on developing Esterom(R), a novel topical therapeutic for the treatment for painful soft tissue afflictions, such as shoulder tendonitis or back sprain, that result in impaired function. The company recently completed a Phase III trial of Esterom in patients with impaired shoulder function, and plans to initiate its next study in the third quarter of 2001.
Source: Entropin, Inc.
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