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FDA Grants Full Approval for DepoCyt(R) for the Treatment of Lymphomatous Meningitis.


BRIDGEWATER, N.J. -- Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the US Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted full approval for DepoCyt([R]) (cytarabine liposome liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes.  injection) for the treatment of patients with lymphomatous meningitis, a life-threatening complication of lymphoma. DepoCyt was originally approved under the Accelerated Approval regulations of Subpart H of the Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act

a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration.
, based on a preliminary demonstration of an increased complete response rate compared to unencapsulated cytarabine.

The full approval was based on findings from two randomized controlled clinical trials randomized controlled clinical trials,
n.pl medical research studies in which one or more groups are formed by random assignment to treatments and controls. Allows groups to be more equivalent when comparing he effects of treatment.
 that included over 200 patients with neoplastic meningitis related to solid tumors, lymphoma or leukemia. The first study demonstrated that more patients with lymphomatous meningitis treated with DepoCyt showed an absence of neurological progression of the disease. The second study showed an increase in complete cytologic cytological, cytologic

pertaining to cytology.


cytological examination
examination of material for purposes of cytology. Carried out on cerebrospinal fluid, joint fluid, aspirates of body cavities and cystic lesions.
 responses among patients treated with DepoCyt, as defined by a clearing of malignant cells in the cerebrospinal fluid cerebrospinal fluid (CSF)

Clear, colourless liquid that surrounds the brain and spinal cord and fills the spaces in them. It helps support the brain, acts as a lubricant, maintains pressure in the skull, and cushions shocks.
 (CSF Cerebrospinal Fluid (CSF) Analysis Definition

Cerebrospinal fluid (CSF) analysis is a laboratory test to examine a sample of the fluid surrounding the brain and spinal cord.
).

"The FDA's full approval of DepoCyt is an important milestone for this unique product that has benefited those suffering from this devastating dev·as·tate  
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.

2. To overwhelm; confound; stun: was devastated by the rude remark.
 complication of cancer since its introduction to the market in 1999," said Jeffrey H. Buchalter, Chairman and Chief Executive Officer of Enzon. "Furthermore, we are pleased all of the FDA requirements have been met and we can continue to make this product available to the patients who need it."

DepoCyt is manufactured by SkyePharma Inc.

About DepoCyt

DepoCyt is a sustained release formulation of the chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, , cytarabine, used for the treatment of patients with lymphomatous meningitis. Lymphomatous meningitis can be controlled with cytarabine, but because of the drug's short half-life, a spinal injection is required twice per week, whereas DepoCyt is dosed once every two weeks. DepoCyt gradually releases cytarabine into the cerebral spinal fluid spinal fluid
n.
See cerebrospinal fluid.
 resulting in a significantly extended half-life, prolonged exposure to the therapy, and a more uniform distribution.

Important safety information

DepoCyt([R]) (cytarabine liposome injection) should be administered only under the supervision of a qualified physician experienced in the use of intrathecal intrathecal /in·tra·the·cal/ (-the´k'l) within a sheath; through the theca of the spinal cord into the subarachnoid space.
Intrathecal 
 cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the . Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis.

About Lymphomatous Meningitis

Lymphomatous meningitis is a complication of lymphoma that is characterized by the spread of the cancer to the central nervous system and the formation of secondary tumors within the thin membranes surrounding the brain. Symptoms can include numbness or weakness in the extremities, pain, sensory loss, double-vision or loss of vision, hearings problems, and headaches.

About Enzon

Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development, manufacturing, and commercialization of important medicines for patients with cancer and other life-threatening conditions. Enzon has a portfolio of four marketed products, Oncaspar([R]), DepoCyt([R]), Abelcet([R]) and Adagen([R]). The Company's drug development programs utilize several cutting-edge approaches, including its industry-leading PEGylation technology platform used to create product candidates with benefits such as reduced dosing frequency and less toxicity. Enzon's PEGylation technology was used to develop two of its products, Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other products developed using the technology. Enzon also engages in contract manufacturing for several pharmaceutical companies to broaden the Company's revenue base. Further information about Enzon and this press release can be found on the Company's web site at www.enzon.com.

About SkyePharma Inc.

SkyePharma Inc. is a wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
 of Blue Acquisition Corp., a Delaware corporation, which is controlled and funded by a group of financial investors including MPM MPM Multi-Processing Module (Apache)
MPM Manufacturing Process Management
MPM Milwaukee Public Museum
MPM MMW (Millimeter Wave) Power Module
MPM Master of Project Management (degree) 
 Capital, OrbiMed Advisors, HBM HBM Human Body Model
HBM Human Brain Mapping
HBM Hottinger Baldwin Messtechnik GmbH (German company)
HBM High Bone Mass
HBM Hybrid Bilayer Membrane
HBM Humming Bird Medal
HBM Her/His Britannic Majesty
 Bioventures (Cayman) LTD LTD 1 Laron-type dwarfism 2 Leukotriene D 3 Long-term depression, see there 4. Long-term disability . and Sanderling Ventures,. This business is based in San Diego, CA, and formulates, develops and manufactures controlled-release injectable products based on two proprietary drug delivery platforms: DepoFoam and Biospheres. Revenues are generated from two marketed products: DepoCyt for lymphomatous meningitis and DepoDur for the treatment of post-surgical pain.

Forward Looking Statements

There are forward-looking statements contained herein, which can be identified by the use of forward-looking terminology such as the words "believes," "expects," "may," "will," "should", "potential," "anticipates," "plans" or "intends" and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in such forward-looking statements. Such factors include, but are not limited to the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products, market acceptance of, and continuing demand for, Enzon's products and the impact of competitive products and pricing. A more detailed discussion of these and other factors that could affect results is contained in our filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the 12-month period ended December 31, 2006. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Enzon does not intend to update this information.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 20, 2007
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