Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics and Hovione Enter Into Manufacturing Agreement
for EFAPROXYN(TM) Bulk Drug Substance
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.
DATASOURCE: Allos Therapeutics, Inc.; Hovione
CONTACT: Jennifer Neiman, Manager, Corporate Communications of Allos
Therapeutics, +1-720-540-5227, ; or Isabel Pina, Corporate
Communication Manager of Hovione, +351-21-982-9362,
Web site: http://www.hovione.com/
Web site: http://www.allos.com/