Insmed Advances Follow on Biologics Initiative



    Completes Characterization and Scale Up Manufacturing of Two Follow On
Biologics Products

    Initiation of Clinical Studies Planned for First Half of 2008

    RICHMOND, VA., November 13 /CNW/ - 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.

    About Insmed

    Insmed Inc. is a biopharmaceutical company with unique protein process
development and manufacturing experience and a proprietary protein platform
aimed at niche markets with unmet medical needs. For more information, please
visit www.insmed.com. To be added to Insmed's investor lists, please contact
Haris Tajyar at htajyar@irintl.com or at 818-382-9702.

    Forward-Looking Statements

    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.




For further information:

For further information: Investor Relations International Haris Tajyar,
818-382-9702 htajyar@irintl.com

Organization Profile

INSMED INC.

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890