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RICHMOND, Va., Oct. 14 /PRNewswire FirstCall/ Insmed Inc. , a developer of follow on biologics and biopharmaceuticals, today announced Fendi Monster Backpack
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. 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 Fendi Hobo Doctor Bag
"We continue to be pleased by the progress we are making in the development of our FOB portfolio, utilizing our unique protein drug development capabilities and technical expertise," said Dr. Geoffrey Allan, President and CEO of Insmed. "Each development milestone we achieve is further evidence of our strong position as a leader in this evolving industry. We intend to use the data to be generated from the Phase I trial, in combination with the positive pre clinical results previously garnered, as the basis for discussions with the FDA in an effort to establish a Phase III development path for INS 20."
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that it has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I clinical study for the Company's second follow on biologic (FOB) product candidate, INS 20. sales of approximately $2.4 billion in 2007.
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CONTACT: Investor Relations Contact, Brian Ritchie FD, +1 212 850 5683,Related News
the forward looking statements. Securities and Exchange Commission, including our Annual Report on Form 10 K Fendi Accordion Card Case
Pre clinical studies demonstrated that INS 20 and FDA approved Neulasta(R) are comparable in both their pharmacological and toxicological profile. Detailed analytical characterisation also demonstrated that the products have a high degree of similarity. Data from these initial evaluations have been used, in part, to support the Phase I study, which will be initiated immediately. The Phase I study will be conducted in the United Kingdom and will compare the safety and establish the bioequivalence of INS 20 to Neulasta(R). Results from the trial are anticipated in 2009, and are expected to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial.
According to published reports, an estimated $10 billion worth of biologic drugs are expected to come off patent by 2010, with an additional $10 billion by 2015. FOBs would provide safe and effective therapies at a reduced cost following the expiration of Fendi Bag Men the original product's patent. A recent econometric study by economist Dr. Robert J. The pegylated protein has a prolonged biological activity after it is injected into the patient. This allows less frequent dosing for the patient compared to recombinant human G CSF. The FDA approved version of this drug is Neulasta(R). INS 20 is Insmed's follow on biologic version of Neulasta(R).
The initiation of this FOB trial is the second of two planned for 2008 as part of Insmed's development of a portfolio of FOBs. In July 2008, the Company announced that a completed Phase I clinical trial had demonstrated the bioequivalence of INS 19, the Company's recombinant human granulocyte colony stimulating factor (G CSF), compared to Neupogen(R), an FDA approved G CSF product for the treatment of neutropenia that recorded 2007 sales of approximately $1 billion. and launch the products on expiration of the relevant innovator patents, which is in 2013 for Neupogen(R) and 2015 for Neulasta(R).
for the year ended December 31, 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.
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