Insmed Provides Update on Follow-On Biologics and IPLEX(TM) Programs
29 Avril 2008 - 3:00PM
PR Newswire (US)
- Company on Schedule to Have Two Follow-on Biologics in Clinical
Studies by Year-End RICHMOND, Va., April 29 /PRNewswire-FirstCall/
-- Insmed Inc. (NASDAQ:INSM), a developer of follow-on biologics
(FOBs) and biopharmaceuticals, today provided an update of the
status of its initial FOB development candidates, INS-19 (a FOB of
Neupogen(R)) and INS-20 (a FOB of Neulasta(R)) which represent
combined 2007 sales of over $4 billion. The Company also reported
recent progress made with its IPLEX(TM) development program.
Follow-On Biologics Program Insmed recently received regulatory
approval from the United Kingdom's Medicines and Healthcare
products Regulatory Agency (MHRA) to initiate a clinical trial for
Insmed's most advanced FOB candidate, INS-19. Pre-clinical
pharmacological, pharmacokinetic and toxicological studies have
demonstrated that INS-19 and FDA-approved Neupogen(R) are
comparable, and detailed analytical characterisation has also
demonstrated that the products have a high degree of similarity.
Screening for participants for the Phase 1 study has begun, with
dosing of the first patient expected in May 2008. Data to support
human similarity is expected in July 2008. Insmed's second FOB
product candidate, INS-20, has also completed pre- clinical
pharmacological and pharmacokinetic studies, which have
demonstrated that INS-20 and FDA-approved Neulasta(R) are
comparable. Detailed analytical characterisation has also
demonstrated that the products have a high degree of similarity.
The Company intends to initiate clinical studies for INS-20 in the
fourth quarter of 2008. Insmed also has several other FOB products
which are currently at an earlier stage of cell line development
and product characterisation. IPLEX(TM) IPLEX(TM) is a complex of
recombinant human insulin-like growth factor-I (rhIGF-I) and its
predominant binding protein IGFBP-3 (rhIGFBP-3). The drug, approved
in the United States in December 2005 for the treatment of children
with growth failure due to severe primary IGF-I deficiency, is
currently being investigated in Myotonic Muscular Dystrophy (MMD)
and Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig's disease. A
Phase 2 trial of IPLEX(TM) in MMD is on-going and a substantial
portion of the external costs associated with the study are
expected to be covered by an approximately $2.1 million grant
awarded to Insmed by the Muscular Dystrophy Association in late
2007. MMD Phase 2 trial at-a-glance: -- All sites have been
initiated, received Investigational Review Board approvals and are
actively recruiting trial participants. -- The trial is currently
more than 50 percent enrolled. -- The trial is on target to
complete enrollment by mid-year 2008 -- Interim data analysis
scheduled for fourth quarter 2008. IPLEX(TM) is also in use as part
of an Expanded Access Program (EAP) in partnership with the Italian
Ministry of Health for the treatment of ALS. Since early 2007, the
EAP has grown to include 20 physicians, and approximately 90
subjects have been enrolled into the program to date with
additional subjects being enrolled as the program progresses.
IPLEX(TM) continues to be safe and well tolerated in the subject
population. During the first quarter of 2008, the EAP generated
$2.3 million in cost recovery revenue for Insmed, compared to $0.7
million during the same period last year, and $2.0 million in the
fourth quarter of 2007. "We are pleased with the development
progress and results to date of IPLEX(TM) in both MMD and ALS,
especially considering the level of investment these therapeutic
programs currently require from Insmed," noted Dr. Geoffrey Allan,
CEO of Insmed. "The market potential for MMD alone is estimated in
excess of $800 million. Thus, we consider our current program for
IPLEX(TM) one of minimal risk and high potential reward. Also, our
substantial capabilities in the evolving, potential multi-billion
dollar, follow-on biologics industry provide us with a unique
growth driver not available to the vast majority of biotechnology
companies our size. As evidenced by the initiation of the INS-19
clinical trial in the UK, we are committed to being at the
forefront of the follow-on-biologics market. We remain confident
that our company will be one of the few initial U.S.
follow-on-biologics market entrants upon the establishment of a
regulatory pathway, and look forward to providing patients with
cost-effective access to important biotechnology medications when
the innovator products come off patent." About INS-19 Recombinant
human G-CSF is a protein that is produced in bacterial cells and is
used to treat certain medical conditions where a person's
neutrophils are too low (neutropenia), such as in cancer patients
who are receiving certain chemotherapeutic regimens, patients
receiving bone marrow transplants, or in patients who have
chronically low neutrophils for other reasons. The FDA approved
version of this drug is Neupogen(R). INS-19 is Insmed's follow-on
biologic version of Neupogen(R). About INS-20 Pegylated recombinant
human G-CSF is a chemically modified version of G-CSF in which a
water soluble polymer called polyethylene glycol is attached to the
protein. 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). About IPLEX(TM)
IPLEX(TM) was approved in the United States in December 2005 for
the treatment of children with growth failure due to severe primary
IGF-I deficiency (Primary IGFD). IPLEX(TM) (rhIGF-I/rhIGFBP-3), is
a complex of recombinant human insulin-like growth factor-I
(rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3).
The drug is also being investigated for various other indications
with unmet medical needs including Myotonic Muscular Dystrophy
(MMD) and Amyotrophic Lateral Sclerosis (ALS). 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 http://www.insmed.com/. 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,
the FDA may not establish specific guidelines for the approval of
FOB products, FOB products may not be accepted by consumers,
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 Capital Market and other
risks and challenges detailed in our filings with the U.S.
Securities and Exchange Commission, including our Annual Report on
Form 10-K 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.
Investor Relations Contact: Brian Ritchie - FD 212-850-5683
Corporate Communications Contact: John Procter - Gibraltar
Associates 202-879-5808 DATASOURCE: Insmed Inc. CONTACT: Investor
Relations, Brian Ritchie - FD, +1-212-850-5683, ; Corporate
Communications, John Procter - Gibraltar Associates,
+1-202-879-5808, , both for Insmed Inc. Web site:
http://www.insmed.com/
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