Navigation Links
Chiasma Receives Orphan Drug Designation From the FDA for Octreolin™ for the Oral Treatment of Acromegaly
Date:6/27/2010

NEW YORK and JERUSALEM, June 28 /PRNewswire/ -- Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration (FDA) has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer (TPE) technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

If a New Drug Application (NDA) is approved, Octreolin should qualify for seven years of market exclusivity, potential tax credits, and a waiver of the prescription drug user fee for the marketing application.

Chiasma has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of Octreolin, which demonstrated a PK profile similar to that of subcutaneously injected octreotide acetate.  In addition, no serious adverse safety events were reported for Octreolin. The Company intends to initiate a pivotal (Phase 3) trial by the end of the year for Octreolin in acromegaly.

Chiasma will submit an application for Orphan Medicinal Product Designation to the European Medicines Agency (EMA) shortly. The Company intends to submit an NDA using the "505(b)(2) regulatory pathway" in the United States and its equivalent, the "Hybrid Application," in Europe.

Octreolin would provide patients with the benefit of an oral alternative to the currently approved subcutaneous and intramuscular injections. The pool of patients eligible for Octreolin treatment for acromegaly is estimated to be between 10,000 and 15,000 in the U.S. and an equal number in Europe.

In addition, the Company is developing Octreolin as a potential treatment for patients with portal hypertension (PHT); a clinical trial to evaluate this new indication is expected to start in December of 2010. Chiasma will evaluate whether Octreolin may improve quality of life, prevent or reduce bleeding events, and lower mortality rates for the estimated 80,000 PHT patients in the U.S. and an equal number in Europe. There are currently no drugs approved for PHT in the U.S.

The Company plans to request orphan drug designations for Octreolin for PHT in the U.S. and in Europe.  The Company also intends to proceed with the aforementioned 505(b)(2) NDA regulatory pathway in the U.S. and its equivalent, the Hybrid Application, in Europe.

How Octreolin Works

Octreolin is a product in capsule form that contains octreotide acetate, a 1.0 kDa peptide, and the Company's unique TPE technology. The TPE system allows its drug cargo to cross mucosal epithelia in the small intestine by inducing a temporary opening of the Tight Junctions that seal and regulate passage between cells (the paracellular route). This effect on the epithelia is rapid and fully reversible. The drug reaches the bloodstream effectively in its native active form.

About Chiasma

Chiasma is evaluating its proprietary technology with approved drugs, which may enable their being switched from injectable to oral, and potentially may also result in new indications or otherwise improved labels.  The Company's TPE technology promotes the delivery of drugs to the GI wall and from there to the liver.  It is applicable to macromolecules that, to date, can be administered only by injection. TPE can be utilized also with small molecules that are already orally available but are poorly absorbed. The Company has successfully demonstrated proof-of- principle in delivering small proteins, peptides, saccharides and heretofore-insoluble small molecules via the oral route.

The Company is backed by ARCH Venture Partners, MPM Capital, F2 Ventures, 7 Health Ventures and the MPM Novartis Strategic Fund.

Chiasma is a Delaware corporation with a 100% owned Israeli subsidiary.

Additional information can be found at: www.ChiasmaPharma.com.

Forward-Looking Statements

This press release contains forward-looking statements about the business, goals an prospects of Chiasma, Inc., including, without limitation, statements about the development of drugs in the TPE system. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. Chiasma is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Chiasma, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Chiasma Reports Successful Oral Delivery Of A Peptide In Clinical Study
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
4. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
5. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
6. IsoTis Receives FDA Clearance for Accell Family of Products
7. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
8. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
9. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
10. XTL Receives Staff Letter From NASDAQ
11. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2017)... ... 2017 , ... Cancer diagnostics and pathology workflow solution provider ... Association for Pathology Informatics Annual Summit at the Wyndham Grand Hotel ... Diagnostic Cockpit and Consultation Portal, Inspirata will present research it led to help ...
(Date:5/19/2017)... ... May 19, 2017 , ... The ... Academic researchers with technologies ripe for commercialization, and who are affiliated with the ... encouraged to submit proposals. QED, now in its tenth round, is the first ...
(Date:5/18/2017)... ... ... NDA Partners Chairman Carl Peck, MD , announced today that Richard ... of Pharmaceutical Development Business Unit of Cardinal Health, has joined the firm as an ... former Chief Operating Officer at Anaborex, Senior VP and General Manager of the San ...
(Date:5/18/2017)... ... May 17, 2017 , ... HOLLOWAY AMERICA, a leading ... and dairy, munitions, and pharmaceutical/biotech, recently introduced The Revolution Lift™, a new precision-controlled ... improvement in technology comes on the heels of HOLLOWAY’s release of the intelliVessel™, ...
Breaking Biology Technology:
(Date:4/11/2017)... , April 11, 2017 NXT-ID, Inc. ... technology company, announces the appointment of independent Directors Mr. ... to its Board of Directors, furthering the company,s corporate governance ... Gino ... we look forward to their guidance and benefiting from their ...
(Date:4/5/2017)... -- KEY FINDINGS The global market for ... of 25.76% during the forecast period of 2017-2025. The ... the growth of the stem cell market. ... INSIGHTS The global stem cell market is segmented on ... stem cell market of the product is segmented into ...
(Date:3/30/2017)... KONG , March 30, 2017 The ... a system for three-dimensional (3D) fingerprint identification by adopting ground breaking ... into a new realm of speed and accuracy for use in ... at an affordable cost. ... ...
Breaking Biology News(10 mins):