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Theravance Biopharma (TBPH) Release: New Data For VIBATIV (telavancin) Reported In Presentations At IDWeek 2016



11/1/2016 7:49:43 AM

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DUBLIN, Nov. 1, 2016 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced the presentation of positive new data from several studies of VIBATIV® (telavancin), the Company's proprietary FDA-approved antibiotic.  Results of the studies included reporting of high clinical cure rates in patients with osteomyelitis, greater in vitro potency against challenging MRSA pathogens as compared to other commercialized antibiotics, and similarities in the overall healthcare costs and renal function impact for VIBATIV as compared to vancomycin.  These study findings were presented at IDWeek 2016, which was held in New Orleans, LA on October 26 - 30, 2016. 

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Retrospective Study of Osteomyelitis Patients

Reports from a retrospective chart review of 32 osteomyelitis patients treated with VIBATIV in clinical settings in six U.S. medical centers showed 87.5% of patients were considered cured or improved at the end of treatment (EOT).  At three months following treatment, the percentage of patients considered cured or improved increased to 91.3%.  In this study, Staphylococcus aureus (S. aureus) was the most common pathogen in 18 of those patients (17 methicillin-resistant S. aureus or MRSA and 1 methicillin-susceptible S. aureus or MSSA).  The most common side effect observed in the study was nausea, which was reported in 25% of patients and led to discontinuation of therapy in 9.4% of patients.  Additionally, 6.7% of patients experienced a two-fold serum creatinine increase, which led to treatment discontinuation for two patients.  At EOT, one patient had died due to infection.

"Although osteomyelitis is not currently an approved indication for VIBATIV, these encouraging study results merit further investigation and may suggest that osteomyelitis, particularly when caused by MRSA, is another serious infection type against which VIBATIV appears to have had positive clinical outcomes," stated Jon Bruss, M.D., Vice President Clinical Development & Medical Affairs at Theravance Biopharma.  "These data, along with interim findings from our ongoing TOUR patient registry which were presented at IDWeek, provide interesting insight into clinical results and prescribing patterns for VIBATIV in real-world settings."

Highlights from other VIBATIV data presentations at IDWeek 2016 include:

Findings Related to in vitro Potency

Results of a study showed that VIBATIV possessed significant in vitro activity that was greater than the other antibiotics evaluated in an assessment against difficult-to-treat MRSA pathogens collected from a community hospital in the Mid-Michigan area.  This in vitro potency was seen even though VIBATIV was tested at only 50% of its peak clinical levels, while the other antibiotics were tested at 100% of peak clinical levels.  Even at 50% peak clinical levels, researchers observed VIBATIV to be bactericidal, exhibiting a rapid and prolonged decrease in pathogen levels. The other antibiotics tested were vancomycin, daptomycin, linezolid and ceftaroline. 

Healthcare Cost and Renal Function Impact

Two company-sponsored retrospective analyses of data from the previously completed Phase 3 ATTAIN (Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia) studies were conducted to compare VIBATIV to vancomycin in terms of overall healthcare costs and outcomes, as well as renal function impact.  The ATTAIN studies were registrational trials which supported the regulatory approval of telavancin (marketed as VIBATIV) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

Results from one analysis showed that overall healthcare costs were similar for the population of patients with HABP caused by S. aureus (SA-HABP) that were treated with either VIBATIV or vancomycin.  VIBATIV was associated with higher drug and nephrotoxicity costs, which were offset by lower intensive care unit and ventilator costs.  Overall, the clinical cure rate for VIBATIV-treated patients was 5.9% higher than for vancomycin-treated patients.

For patients with monomicrobial SA-HABP, a population for which VIBATIV has previously demonstrated statistically significant improvements in clinical cure rates as compared to vancomycin, the analysis showed that VIBATIV led to higher clinical cure rates by 10.1% and net cost savings of $1,200 per treated patient.

Results from a second analysis demonstrated that renal shift tables may provide a useful assessment of the timing and magnitude of antibiotic-associated renal function changes. Shift tables were created by grouping patients in the ATTAIN studies based on creatinine clearance levels and researchers evaluated whether patients shifted between these groups (either positively or negatively) at specified treatment time points.

Findings showed that a comparable majority of VIBATIV-treated patients (67%) and vancomycin-treated patients (63%) experienced no categorical shifts in creatinine clearance, suggesting little to no change in their renal function as a result of treatment. Regardless of treatment received, at each time point analyzed approximately 25% of patients had a Grade 1 shift (one category shift in a positive or negative direction) in creatinine clearance.  Negative shifts in creatinine clearance categories during the course of the study were observed in similar proportions for patients treated with VIBATIV (25.1%) and vancomycin (21.2%).

"Interestingly, our retrospective analytical modeling of data from the ATTAIN studies highlights a specific patient population that not only achieved better clinical outcomes with VIBATIV but also incurred lower overall healthcare costs as compared to vancomycin," said Dr. Bruss. "Additionally, the comparable effect of VIBATIV and vancomycin treatment on patients' renal function highlighted by our second analysis may provide further rationale for additional evaluations of the risk of nephrotoxicity associated with VIBATIV treatment.  This builds on and supports similar findings presented earlier this year at ATS 2016 which showed no statistically significant differences in rates of nephrotoxicity for treatment with VIBATIV compared to vancomycin in the ATTAIN trials."

About VIBATIV®(telavancin)

VIBATIV® was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus(S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action that both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date.  Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.  VIBATIV is approved in the U.S. for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

VIBATIV is also approved for marketing in Europe, Canada and Russia.  Theravance Biopharma plans to market VIBATIV outside the U.S. through a network of partners. To date, the company has secured partners for VIBATIV in the following geographies Canada, Middle East, North Africa, Israel, Russia, China and India.

VIBATIV®Important Safety Information

Mortality

Patients with pre-existing moderate/severe renal impairment (CrCl 50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.

Nephrotoxicity

New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.

Fetal Risk

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.

Contraindication

Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.

VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.

Hypersensitivity Reactions

Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.

Geriatric Use

Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

Infusion Related Reactions

VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome" like reactions including: flushing of the upper body, urticaria, pruritus, or rash.

QTc Prolongation

Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.

Most Common Adverse Reactions

The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.

Full Prescribing Information, including Boxed Warning and Medication Guide in the U.S., is available at www.VIBATIV.com.

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 U.S., 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 intestinally restricted 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 (GSK) 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. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

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 of clinical studies, the potential benefits and mechanisms of action of the Company's product and product candidates, the Company's expectations for product candidates through development, potential regulatory approval and commercialization (including their potential as components of combination therapies) and the Company's expectations for product sales. 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 (including when our product candidates are studied in combination with other compounds),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 and risks of developing an institutional customer mix for VIBATIV® (telavancin) that meet the Company's plan for the product. Other risks affecting Theravance Biopharma are described under the heading "Risk Factors" contained in Theravance Biopharma's Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2016and Theravance Biopharma's other filings with the SEC. In addition to the risks described above and in Theravance Biopharma's 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.

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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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-data-for-vibativ-telavancin-reported-in-presentations-at-idweek-2016-300354344.html

SOURCE Theravance Biopharma, Inc.


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