Raptor Pharmaceutical Presents Results from Meta-Analysis Demonstrating Efficacy of QUINSAIR™ Comparable to Other Approved,...
07 Septembre 2016 - 9:30AM
Raptor Pharmaceutical Corp. (Nasdaq:RPTP), a biopharmaceutical
company developing and commercializing transformative treatments
for rare diseases, today presented results from a network
meta-analysis comparing inhaled antibiotics for cystic fibrosis
(CF) patients with lung infections involving Pseudomonas
aeruginosa. The study showed that QUINSAIRTM, a levofloxacin
inhalation solution, had efficacy comparable to three other
inhalable antibiotics also approved for use in Europe. These data
were presented today at the European Respiratory Society (ERS)
International Congress 2016 in London.
“Chronic P. aeruginosa lung infection is the primary cause of
progressive lung function decline in patients with CF, and
long-term maintenance therapy with inhaled antibiotics is
recommended to suppress infection, reduce acute pulmonary
exacerbations and preserve lung function,” said Stuart Elborn,
M.D., Professor of Respiratory Medicine in Queen’s University and
Director of the Adult CF Centre at Belfast City Hospital. “As
patients with CF with chronic P. aeruginosa infections frequently
require changes in treatment, the availability of levofloxacin
provides a useful option to preserve respiratory function over a
longer period of time.”
Utilizing a systematic literature search, the network
meta-analyses leveraged data from all randomized clinical trials of
inhaled antibiotics in CF patients with at least 4 or 24 weeks of
follow-up, and compared the effect of inhaled antibiotics
tobramycin, colistimethate sodium, aztreonam and levofloxacin
against P. aeruginosa infections. Of the 685 articles identified, 7
and 9 unique studies were included in the 4 weeks and 24 weeks
analysis, respectively.
Aztreonam, dosed at 75 mg three times daily, was predicted to
result in the greatest numerical increase in forced expiratory
volume in 1 second (FEV1%) at 4 weeks, while levofloxacin
inhalation solution was predicted to be numerically greater than
colistimethate sodium, tobramycin inhaled solution and tobramycin
inhaled powder. The analyses for many of the outcomes did not
provide evidence to indicate that the other treatments were more
effective than levofloxacin. At 24 weeks, levofloxacin inhalation
solution was associated with the lowest risk of hospitalization
with a 96.5% of probability to be the best treatment. P. aeruginosa
sputum density scores, additional antipseudomonal antibiotics use,
and study withdrawal rates were comparable among all inhaled
antibiotics at all times.
“This network meta-analysis suggests that inhaled levofloxacin
provides a useful addition to our armory in the fight against this
common and difficult to treat infection,” said Krishna R. Polu,
M.D., Chief Medical Officer of Raptor. “Given the chronicity and
reduction in survival caused by P. aeruginosa infection in CF, the
availability of inhaled levofloxacin is an important option for
clinicians to maintain lung function in CF patients and an
important step in tackling the unmet need in the CF community.”
About Raptor Pharmaceutical
Raptor Pharmaceutical Corp. is a global biopharmaceutical
company focused on the development and commercialization of
transformative therapeutics for rare, debilitating and often fatal
diseases. Raptor is leading the global commercialization of two
products for orphan diseases: PROCYSBI®, for the management of
nephropathic cystinosis in adults and children ages two years and
older; and QUINSAIR™, an inhaled fluoroquinolone antibiotic for the
management of chronic pulmonary infections due to Pseudomonas
aeruginosa in adult patients with cystic fibrosis (CF). Raptor’s
R&D pipeline includes RP103, known commercially as PROCYSBI,
for Huntington's disease and mitochondrial disorders, including
Leigh syndrome. The pipeline also includes MP-376, known
commercially as QUINSAIR, which has Qualified Infectious Disease
Product (QIDP) designation for three distinct indications: the
treatment of chronic pulmonary infections due to Pseudomonas
aeruginosa in patients with CF; in patients with bronchiectasis
(BE); and in patients with nontuberculous mycobacteria (NTM).
Raptor holds orphan drug designations in the U.S. and EU for
PROCYSBI for nephropathic cystinosis. Raptor also holds orphan drug
designation in the U.S. for MP-376 for the treatment of CF, which,
when added to the five years of exclusivity associated with QIDP
designation, would confer 12 years of regulatory exclusivity upon
FDA approval. For additional information, please visit
www.raptorpharma.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995. These statements are indicated by words or phrases such as
“believes,” “expects,” “anticipates,” “estimates,” “plans,”
“intends,” “continuing,” “ongoing,” “projected,” “potential” and
similar words or phrases and relate to future events, including
statements regarding: timing and occurrence of anticipated upcoming
milestones, PROCYSBI as a treatment option for patients with
nephropathic cystinosis and RP103 as a treatment option for
patients with Huntington’s disease and mitochondrial disorders,
including Leigh syndrome, the availability of orphan drug
exclusivity for MP-376 therapy in the U.S., Raptor’s plans and
timing to develop MP-376 as a treatment for Pseudomonas aeruginosa
in CF in the U.S., BE and potentially also NTM in all markets and
Raptor’s other development programs. These statements are only
predictions and involve known and unknown risks, uncertainties and
other factors, which may cause the company’s actual results to be
materially different from these forward-looking statements. Raptor
cautions readers not to place undue reliance on any such
forward-looking statements, which speak only as of the date they
were made. Factors which may contribute to differences in actual
results include, among others: continued and increased market
acceptance and sales of PROCYSBI and QUINSAIR; Raptor’s ability to
expand the use of RP103 and MP-376 and to receive regulatory
approval for other indications; Raptor’s reliance on single active
pharmaceutical ingredient suppliers for PROCYSBI and QUINSAIR and
other third parties in connection with drug product development;
compliance with healthcare regulations, ongoing regulatory
requirements and potential penalties; any serious adverse side
effects associated with PROCYSBI, QUINSAIR or any other future
products; any product liability claims; third-party payor coverage,
reimbursement and pricing for PROCYSBI, QUINSAIR and future
products; enacted and future healthcare legislation; Raptor’s
ability to obtain and maintain orphan drug or other regulatory
exclusivity for PROCYSBI, QUINSAIR or any other future products;
the integration of European operations with U.S. operations;
relationships with key scientific and medical collaborators;
intellectual property protection and claims and continued license
rights; and Raptor’s ability to fund its operations and make
required payments on its debt. Certain of these risks,
uncertainties and other factors are described in greater detail in
the Company’s filings from time to time with the Securities and
Exchange Commission (SEC), which Raptor strongly urges you to read
and consider, including: Raptor’s annual report on Form 10-K for
the twelve months ended December 31, 2015 filed with the SEC on
February 26, 2016, as amended by Amendment No. 1 to Form 10-K filed
with the SEC on April 29, 2016, Raptor's quarterly report on Form
10-Q for the quarter ended March 31, 2016 filed with the SEC
on May 5, 2016, Raptor’s quarterly report on Form 10-Q for the
quarter ended June 30, 2016 filed with the SEC on August 4, 2016
and Raptor’s other periodic reports filed with SEC, all of which
are available free of charge on the SEC’s web site at
http://www.sec.gov. Subsequent written and oral forward-looking
statements attributable to Raptor or to persons acting on its
behalf are expressly qualified in their entirety by the cautionary
statements set forth in Raptor’s reports filed with the SEC. Raptor
expressly disclaims any intent or obligation to update any
forward-looking statements except as may be required by law.
COMPANY CONTACT:
Kimberly Lee, D.O.
Vice President, Corporate Strategy and Communications
Raptor Pharmaceutical Corp.
(415) 408-6351
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com
MEDIA CONTACT:
Monica May
Canale Communications
(619) 849-5383
monica@canalecomm.com
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