WESTMINSTER, Colo., June 16 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) and Hovione announced today that they have entered into a
long-term manufacturing agreement for the supply of EFAPROXYN bulk drug
substance, efaproxiral sodium. Under the agreement, Hovione is committed to
manufacture and supply Allos with sufficient quantities of efaproxiral sodium
to support Allos' anticipated requirements for both the pre-and
post-commercialization phases of production.
EFAPROXYN is currently the subject of a confirmatory Phase 3 trial, called
ENRICH, designed to compare the effect of whole brain radiation therapy with
supplemental oxygen with or without EFAPROXYN in women with brain metastases
originating from breast cancer. This randomized, open-label study will seek
to enroll 360 patients at up to 125 leading cancer centers across North
America, Europe and South America. The trial began in February 2004 and is
expected to complete enrollment during the second half of 2006.
The manufacturing agreement is the most recent step in a relationship
between the two companies that began in 1997. Under a prior agreement between
the parties, Hovione manufactured a majority of the bulk drug substance used
by Allos in its clinical trials of EFAPROXYN. Hovione has already
manufactured four batches of efaproxiral sodium at commercial scale using a
process that they successfully validated in 2001. Hovione is in good standing
with the FDA, having passed recent inspections.
"This manufacturing agreement is an important step in our preparation for
the potential commercialization of EFAPROXYN," said Michael E. Hart, President
and Chief Executive Officer of Allos. "We have benefited from Hovione's
commitment to working with companies like Allos and feel that Hovione's
expertise in production of APIs for injectable products makes them an ideal
partner for us."
About EFAPROXYN
EFAPROXYN is the first synthetic small molecule designed to sensitize
hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by
facilitating the release of oxygen from hemoglobin, the oxygen-carrying
protein contained within red blood cells, and increasing the level of oxygen
in tumors. The presence of oxygen in tumors is an essential element for the
effectiveness of radiation therapy. By increasing tumor oxygenation, Allos
believes that EFAPROXYN has the potential to enhance the efficacy of standard
radiation therapy.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company
focused on developing and commercializing innovative small molecule
therapeutics for the treatment of cancer. Allos' lead product candidate,
EFAPROXYN, is a synthetic small molecule designed to sensitize hypoxic, or
oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is
currently being evaluated as an adjunct to whole brain radiation therapy in a
pivotal Phase 3 trial in women with brain metastases originating from breast
cancer. Allos' other product candidates are: PDX (pralatrexate), a small
molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation
as both a single agent and in combination therapy regimens in patients with
non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small
molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase
currently under evaluation in patients with advanced solid tumors. For more
information, visit the company's web site at http://www.allos.com.
About Hovione
Hovione, based in Portugal, is an international group dedicated to the
process development and synthesis of active pharmaceutical ingredients serving
exclusively the pharmaceutical industry. With FDA inspected plants in Europe
and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione
is committed to the highest levels of service, technical expertise and cGMP
quality standards. Hovione focuses on finding scientific and industrial
solutions for APIs of increased complexity and for Enhanced APIs(TM) having
developed, among other, special process capabilities in the areas of
injectable grade APIs, particle design and inhalation drug delivery. For more
information, visit the company's web site at http://www.hovione.com.
Safe Harbor Statement
This press release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include statements
concerning Allos' projected timelines for completing enrollment in the ENRICH
study, the potential safety and efficacy of EFAPROXYN, and other statements
which are other than statements of historical facts. In some cases, you can
identify forward-looking statements by terminology such as "may," "will,"
"should," "expects," "intends," "plans," anticipates," "believes,"
"estimates," "predicts," "projects," "potential," "continue," and other
similar terminology or the negative of these terms, but their absence does not
mean that a particular statement is not forward-looking. Such forward-looking
statements are not guarantees of future performance and are subject to risks
and uncertainties that may cause actual results to differ materially from
those anticipated by the forward-looking statements. These risks and
uncertainties include, among others: that Allos may experience difficulties or
delays in its clinical trials, whether caused by adverse events, investigative
site initiation rates, patient enrollment rates, regulatory issues or other
factors; and that clinical trials may not demonstrate the safety and efficacy
of Allos' product candidates in their target indications. Additional
information concerning these and other factors that may cause actual results
to differ materially from those anticipated in the forward-looking statements
is contained in the "Risk Factors" section of Allos' Annual Report on Form
10-K for the year ended December 31, 2004 and in Allos' other periodic reports
and filings with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Allos
cautions investors not to place undue reliance on the forward-looking
statements contained in this press release. All forward-looking statements
are based on information currently available to Allos on the date hereof, and
Allos undertakes no obligation to revise or update these forward-looking
statements to reflect events or circumstances after the date of this
presentation, except as required by law.
Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics,
Inc.
SOURCE Allos Therapeutics, Inc.; Hovione
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227,
jneiman@allos.com; or Isabel Pina, Corporate Communication
Manager of Hovione, +351-21-982-9362, ipina@hovione.com
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