Navigation Links
Insmed Gains Royalty-Free Worldwide Rights for IPLEX(TM) in Connection with Potential Expanded Access ALS Programs
Date:11/10/2008

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 http://www.alsa.org

About 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 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 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, 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

212-850-5683

brian.ritchie@fd.com

Corporate Communications Contact:

John Procter - Gibraltar Associates

202-879-5808

jprocter@gibraltar-llc.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to ... a new, often overlooked aspect of head lice: the parasite’s ability to live away from ... common occurrence, but a necessary one in the event that lice have simply gotten out ...
(Date:6/25/2016)... Lewisville, TX (PRWEB) , ... June 25, 2016 , ... ... in the United States, named Dr. Sesan Ogunleye, as the Medical Director of its ... be the facility Medical Director of our new Mesquite location,” said Dr. James M. ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from PsychTests.com reveals ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on ... today announced that patient enrollment in its ongoing ... Duchenne) has exceeded 50% of its 24-patient target. ... in the third quarter of 2016, and to ...
(Date:6/23/2016)... , June 23, 2016 Bracket , a ... its next generation clinical outcomes platform, Bracket eCOA (SM) ... on June 26 – 30, 2016 in Philadelphia ... electronic Clinical Outcome Assessment product of its kind to fully ... Bracket eCOA 6.0 is a flexible platform for ...
Breaking Medicine Technology: