Insmed Advances Follow on Biologics Initiative
- Category: Proteins and Peptides
- Published on Tuesday, 13 November 2007 22:50
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Completes Characterization and Scale Up Manufacturing of Two Follow On Biologics Products Initiation of Clinical Studies Planned for First Half of 2008
RICHMOND, VA, USA | November 13, 2007 | Insmed Inc. (Nasdaq:INSM), a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs, today announced the completion of development of two key follow on biologics at its facilities in Boulder, Colorado. The development of INS-19 (Granulocyte Colony Stimulating Factor or G-CSF) and INS-20 (Peg G-CSF) represents a significant milestone for Insmed. By achieving these critical development milestones, Insmed is positioned to initiate clinical studies in the first half of 2008.
Insmed is at the forefront in the United States for the development of follow on biologics. Our application of "state of the art" protein development and manufacturing processes as well as extensive protein characterization approaches and protein manufacturing processes has demonstrated our capability to develop follow on biologics. Over the last six months we have significantly expanded our comprehensive capabilities to characterize, develop and manufacture follow on biologics.
"We are very excited with the progress we have made in the development of these two products. This clearly demonstrates Insmed has the speed and capability of bringing these products to the marketplace, which represents a significant value opportunity to the company," said Steve Glover, President of Insmed Therapeutic Proteins.
More than 250,000 patients in the US are estimated to be treated for neutropenia with G-CSF and Peg G-CSF, which are marketed under the brand names of Neupogen(R) and Neulasta(R) in the United States. Annual sales in the US are estimated at more than $4 billion for the two products. Insmed's strategy is to manufacture high quality medicines and bring them to market following patent expiration of the innovator product, thus providing savings for patients and payors, and expanding access to critically needed medicines.
Insmed has developed a high yield manufacturing process (over 600,000 doses can be produced out of a single production batch) and achieved 99.5% purity with its INS-19 (G-CSF) product. Extensive physicochemical characterization demonstrates that the molecule is highly similar to Neupogen(R). With direct comparison of INS-19 to Neupogen(R), bioassay data demonstrates comparable bioactivity, and pharmacodynamic preclinical studies demonstrate comparable effects on neutrophil count at equivalent doses. Insmed has initiated preclinical toxicology studies with INS-19 and is planning to initiate clinical studies in the first half of 2008. With INS-20 (Peg G-CSF), a longer acting G-CSF with site specific addition of Poly-Ethylene Glycol (PEG), Insmed has already achieved a similar level of purity when compared with Neulasta(R). Preclinical pharmacodynamic and toxicology studies are currently scheduled to be initiated in the first half of 2008 with INS-20, and clinical studies are planned in the second half of 2008.
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our entrance into the follow on biologics market may be unsuccessful, our common stock could be delisted from the Nasdaq Global Market and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
SOURCE: Insmed Inc.