DUBLIN, Dec. 6, 2016 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the
"Company") today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to
velusetrag (TD-5108) for the treatment of symptoms associated with
idiopathic and diabetic gastroparesis. Velusetrag is an oral
investigational drug in development for the treatment of patients
with gastroparesis, and is currently being studied in a large,
multinational Phase 2b study in patients with confirmed
gastroparesis of either diabetic or idiopathic origin.
Gastroparesis represents a significant unmet medical need with
no approved treatment options for patients with idiopathic
gastroparesis and only one FDA-approved product for diabetic
gastroparesis. The condition is characterized by delayed
gastric emptying of food and associated with nausea, vomiting,
early satiety, postprandial fullness and upper abdominal
pain. In the United States,
it is estimated to affect approximately six million individuals and
includes two major sub-classes: those with diabetic gastroparesis
(29% of the overall gastroparesis population) and those with
idiopathic gastroparesis (36%).1
FDA's Fast Track program was established to facilitate the
development and expedite the review of drugs with the potential to
treat serious conditions and address an unmet medical need.
Companies that receive Fast Track designation are provided the
opportunity for more frequent interactions with FDA during clinical
development and are eligible for accelerated approval and/or
priority review, if relevant criteria are met. Additionally,
companies that receive Fast Track designation are allowed to submit
completed sections of their New Drug Application for the drug on a
rolling basis, resulting in the potential for an expedited FDA
review process.
"We are pleased to receive Fast Track designation for the
velusetrag development program in gastroparesis, given its
potential to treat patients with this serious medical condition.
Velusetrag represents a uniquely positioned asset as the only
investigational drug to be examined in a study enrolling both
idiopathic and diabetic gastroparesis patients," said Brett Haumann, MD, Chief Medical Officer
at Theravance Biopharma. "The valuable development and
regulatory opportunities provided to the velusetrag program by Fast
Track designation will augment our efforts to bring this important
therapy to patients who currently have very few effective treatment
options. We look forward to results from our Phase 2b study
in mid-2017."
Velusetrag is being developed by Theravance Biopharma in
collaboration with Alfa Wassermann (S.p.A.) ("Alfa
Wassermann"). Under the terms of the agreement, Alfa
Wassermann pays for the majority of the Phase 2 clinical costs and
has an exclusive option to develop and commercialize velusetrag in
the European Union, Russia,
China, Mexico and certain other countries, while
Theravance Biopharma retains full rights to velusetrag in
the United States, Canada, Japan
and certain other countries.
About Gastroparesis
Gastroparesis is a disorder characterized by delayed gastric
emptying and symptoms of gastric retention in the absence of
mechanical obstruction. The prevalence of gastroparesis in
the United States is estimated at
approximately six million, or 1.8% of the population.
Symptoms of gastroparesis are variable but typically include
nausea, vomiting, early satiety, postprandial bloating/fullness or
upper abdominal discomfort. In two case series, nausea was
reported by more than 90% of patients with gastroparesis, vomiting
by 68%-84% and bloating by 75%. Severe cases may also suffer
from dehydration, electrolyte disturbances, weight loss and
malnutrition. There is also a correlation between severity of
symptoms and impairment of quality of life.2
About Velusetrag
Velusetrag is an oral, once-daily investigational medicine
discovered internally and developed for gastrointestinal motility
disorders. It is a highly selective agonist with high
intrinsic activity at the human 5-HT4 receptor.
5-hydroxytryptamine receptor 4 (5-HT4) agonists are
established as gastrointestinal (GI) prokinetic agents for the
treatment of GI tract dysfunction, such as chronic constipation.
Velusetrag (or TD-5108) is a 5-HT4 receptor agonist that
demonstrates high in vitro intrinsic activity and
selectivity for the 5-HT4 receptor and has no
significant affinity for all other receptor types, ion channels, or
enzymes tested.
The ongoing Phase 2b study (study 0099) of velusetrag is a
multicenter, double-blind, randomized, placebo-controlled,
parallel-group trial that explores the efficacy and safety of
velusetrag in patients with diabetic (n=100) or idiopathic (n=100)
gastroparesis. Three doses of velusetrag (5, 15, and 30 mg
once daily for 12 weeks) are being evaluated. The primary endpoint
is the effect of velusetrag on symptoms in subjects with
gastroparesis. The study also evaluates the effect of velusetrag on
gastric emptying, and patient-reported outcome (PRO) measures.
The study is being conducted in the
United States and Europe.
A previous Phase 2 trial of velusetrag showed that all three
doses of velusetrag (5, 15 and 30 mg) reduced gastric emptying time
(GE t1/2) compared to placebo in patients with either
diabetic or idiopathic gastroparesis. The completed Phase 2
trial was the first study to evaluate gastric emptying, a
diagnostic criterion for gastroparesis, in a patient population
including both diabetic and idiopathic gastroparesis patients.
Comparable studies of other investigational medicines have
focused only on the diabetic population.
In addition, velusetrag has completed a 400-patient Phase 2
proof-of-concept study in chronic idiopathic constipation,
demonstrating statistically significant prokinetic activity at all
three doses tested.
About Theravance Biopharma
Theravance Biopharma is a diversified biopharmaceutical company
with the core purpose of creating medicines that make a difference
in the lives of patients suffering from serious illness. Our
pipeline of internally discovered product candidates includes
potential best-in-class medicines to address the unmet needs of
patients being treated for serious conditions primarily in the
acute care setting. VIBATIV® (telavancin), our first
commercial product, is a once-daily dual-mechanism antibiotic
approved in the United States,
Europe and certain other countries
for certain difficult-to-treat infections. Revefenacin
(TD-4208) is a long-acting muscarinic antagonist (LAMA) being
developed as a potential once-daily, nebulized treatment for
chronic obstructive pulmonary disease (COPD). Our neprilysin
(NEP) inhibitor program is designed to develop selective NEP
inhibitors for the treatment of a range of major cardiovascular and
renal diseases, including acute and chronic heart failure,
hypertension and chronic kidney diseases such as diabetic
nephropathy. Our research efforts are focused in the areas of
inflammation and immunology, with the goal of designing medicines
that provide targeted drug delivery to tissues in the lung and
gastrointestinal tract in order to maximize patient benefit and
minimize risk. The first program to emerge from this research
is designed to develop GI-targeted pan-Janus kinase (JAK)
inhibitors for the treatment of a range of inflammatory intestinal
diseases.
In addition, we have an economic interest in future payments
that may be made by Glaxo Group Limited or one of its affiliates
pursuant to its agreements with Innoviva, Inc. relating to certain
drug development programs, including the Closed Triple (the
combination of fluticasone furoate, umeclidinium, and vilanterol),
currently in development for the treatment of COPD and asthma.
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, MEDICINES THAT MAKE
A DIFFERENCE® and VIBATIV® are registered
trademarks of the Theravance Biopharma group of companies.
About Alfa Wassermann
Alfa Wassermann is a private pharmaceutical company wholly owned
by and subject to the direction and coordination of Alfasigma
S.p.A. Alfa Wassermann has its headquarters in Bologna,
Italy with its own R&D and
Manufacturing facilities. In 2015, Alfa Wassermann net sales were
€429 million and the company employs over 1,500 people. It has a
growing number of affiliate companies in both Europe as well as in emerging markets such as
Russia, China and Mexico. Its main product rifaximin-α is a
gut-selective antibiotic marketed under the trade names of
NORMIX®, XIFAXAN® and others, in 47
countries, including the USA. Alfa
Wassermann has also developed other important products: sulodexide
(VESSEL®) and parnaparin (FLUXUM®). For more
information, please visit www.alfawassermann.com
ALFA WASSERMANN®, the ALFA WASSERMANN logo,
ALFASIGMA® , NORMIX®, XIFAXAN®,
VESSEL® and FLUXUM® are registered trademarks
of Alfa Wassermann group of companies.
This press release contains certain "forward-looking"
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995 regarding, among other things,
statements relating to goals, plans, objectives, expectations and
future events. Theravance Biopharma intends such forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 21E of the
Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Examples of such statements include
statements relating to: the Company's strategies, plans and
objectives, the Company's regulatory strategies and timing and
results of clinical studies, the potential benefits and mechanisms
of action of the Company's product and product candidates and the
Company's expectations for product candidates through development,
potential regulatory approval and commercialization. These
statements are based on the current estimates and assumptions of
the management of Theravance Biopharma as of the date of the press
release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Theravance Biopharma to be materially different
from those reflected in the forward-looking statements. Important
factors that could cause actual results to differ materially from
those indicated by such forward-looking statements include, among
others, risks related to: delays or difficulties in commencing or
completing clinical studies, the potential that results from
clinical or non-clinical studies indicate the Company's product
candidates are unsafe or ineffective, the feasibility of
undertaking future clinical trials for our product candidates based
on FDA policies and feedback, dependence on third parties to
conduct clinical studies, delays or failure to achieve and maintain
regulatory approvals for product candidates, risks of collaborating
with or relying on third parties to discover, develop and
commercialize products, risks associated with establishing and
maintaining sales, marketing and distribution capabilities with
appropriate technical expertise and supporting infrastructure.
Other risks affecting Theravance Biopharma are described under the
heading "Risk Factors" contained in Theravance Biopharma's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 9,
2016. In addition to the risks described above and in
Theravance Biopharma's other filings with the SEC, other unknown or
unpredictable factors also could affect Theravance Biopharma's
results. No forward-looking statements can be guaranteed and actual
results may differ materially from such statements. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Theravance Biopharma assumes no
obligation to update its forward-looking statements on account of
new information, future events or otherwise, except as required by
law.
References:
1 American Gastroenterological Association.
"Technical Review on the Diagnosis and Treatment of Gastroparesis."
http://www.gastrojournal.org/article/S0016-5085(04)01634-8/fulltext.
Published online July 27, 2005.
2 Journal of Neurogastroenterology and Motility.
"Prevalence of Hidden Gastroparesis in the Community: The
Gastroparesis 'Iceberg'."
http://www.jnmjournal.org/journal/view.html?doi=10.5056/jnm.2012.18.1.34.
Published online January 16,
2012.
Contact Information:
Renee Gala Chief Financial
Officer
650-808-4045
investor.relations@theravance.com
Tim Brons
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com
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