Navigation Links
Insmed Gains Royalty-Free Worldwide Rights for IPLEX(TM) in Connection with Potential Expanded Access ALS Programs

RICHMOND, Va., Nov. 10 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that Genentech, Ipsen/Tercica and Insmed jointly issued the following statement:

Genentech, Ipsen/Tercica, and Insmed have been contacted by people living with Amyotrophic Lateral Sclerosis (ALS) and their loved ones seeking access to an IGF-I/IGFBP3 product called IPLEX(TM), which is solely manufactured by Insmed. We understand the devastation a disease like ALS causes and that there are a lack of available therapies that provide meaningful clinical benefit.

Although IPLEX(TM) has not been rigorously tested in people with ALS, nor received regulatory approval for use in ALS, all the companies involved appreciate the urgency and desperation for new treatments in the ALS community. We are all working diligently to determine how best to respond to that need.

The availability of IPLEX(TM) is subject to a Court-Ordered Settlement Agreement. On November 8, 2008, Genentech and Ipsen/Tercica signed a letter of intent whereby they have consented to amend the Court-Ordered Settlement Agreement to permit Insmed to supply IPLEX(TM) in connection with named-patient ALS programs worldwide on a royalty-free basis. Insmed's ability to do so will be dependent on satisfying any regulatory requirements in any country where a request for treatment is made.

Ipsen/Tercica and Insmed also plan to enter into negotiations concerning the development of IPLEX(TM) for the treatment of ALS, subject to analyzing the data from the ALS patients in Italy who have received IPLEX(TM), and satisfying any applicable regulatory requirements.

These actions represent each company's commitment to find a solution to the requests coming from the community of patients and their families. Insmed will update the community as further progress is made.

About Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's disease, is a progressive neurodegenerative disease that attacks nerve cells in the brain and spinal cord resulting in muscle weakness and atrophy. The life expectancy of an ALS patient averages about two to five years from the time of diagnosis. For more information about ALS visit


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 ALS in Italy and in Myotonic Muscular Dystrophy.

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

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, we may be unable to secure an appropriate business partner for our follow-on biologics business, 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


Corporate Communications Contact:

John Procter - Gibraltar Associates


SOURCE Insmed Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Insmed to Present at the IBC 5th Annual Global Follow-On Biologics Conference
2. Insmed to Present at Upcoming Healthcare Conferences
3. DNA vaccine against multiple sclerosis appears safe, potentially beneficial
4. Antioxidants show no clear benefit against cardiovascular events, death in high-risk women
5. Despite overeating, morbidly obese mice gain protection against diabetes
6. Alvarado Hospital Files Countersuit Against Blue Shield
7. Texas Supreme Court Rules Against Medicare HMOs in Hospital Reimbursement Fight
8. Claim Filed Against the Company and Nine Other Defendants in the Haifa Magistrates Court
9. First Circuit Court of Appeals Rules Against Philip Morris in Lights Class Action
10. Ranbaxy Gains Approval to Manufacture and Market Carvedilol Tablets in the U.S. Market
11. $52.5 Million Settlement Against Sepracor Inc. Approved
Post Your Comments:
(Date:11/26/2015)... , ... November 26, 2015 , ... ... abuse located in central Michigan, have come together on Thanksgiving Day to share ... video, available for viewing on the Serenity Point YouTube channel, patients displayed what ...
(Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, they ... to buy during the Black Friday and Cyber Monday massage chair sales ... the Internet high and low to find the best massage chair deals, they can ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... eReferral system for diagnostic imaging in the Waterloo region. Using the Ocean Platform, ... Medicine tests directly from their electronic medical record (EMR) without the need for ...
(Date:11/26/2015)... Ashburn, VA (PRWEB) , ... November 26, 2015 ... ... Planners, an American Express Travel Representative. As a franchise owner, Somu now offers ... range of cruise, destination wedding packages, private cruise sales, as well as, cabin ...
(Date:11/26/2015)... ... November 26, 2015 , ... The Catalent ... and the need to integrate dose form selection in early phase drug development. ... membership organization supporting and bringing together the UK’s emerging life sciences companies, corporate ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , Países Bajos, November 26, 2015 ... la terapia fotodinámica de Bremachlorin para el cáncer avanzado. ... la inmunoterapia con la terapia fotodinámica de Bremachlorin para ... Un nuevo enfoque combina la inmunoterapia con la terapia ... Clinical Cancer Research . --> ...
(Date:11/26/2015)... UTRECHT , Nederland, November 26, 2015 ... --> Een nieuwe aanpak combineert ... van gevorderde kanker. ... -->      (Photo: ... van het Leids Universitair Medisch Centrum (LUMC) ...
(Date:11/26/2015)... November 26, 2015 3D bioprinting market ... according to a new report by Grand View Research Inc. ... (CKD) which demands kidney transplantation is expected to boost the ... substitute for organ transplantation. --> 3D bioprinting market ... according to a new report by Grand View Research Inc. ...
Breaking Medicine Technology: