Allos Therapeutics and Hovione Enter Into Manufacturing Agreement for EFAPROXYN(TM) Bulk Drug Substance
17 June 2005 - 5:28AM
PR Newswire (US)
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/
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