Posted in Flagyl on December 13, 2014

December 11, 2014

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Antibiotics maker faces hurdles in diversifying beyond flagship drug
Antibiotics maker faces hurdles in diversifying above flagship drug

As Cubist manages a strong cut to its portfolio after a court cancelled patents steady its flagship antibiotic, the drugmaker is betting in successi~ health providers’ efforts to brake soaring C-diff. allied hospital re-admissions and deaths to construct traction for its number two returns, antibiotic Dificid (fidaxomicin).                                      

With its $8.4-billion pervert with money of Cubist, Merck is expecting rewards from Cubist’s pipeline antibiotics, notably potential blockbuster Zerbaxa, a treatment for urinary trace and intra-abdominal infections for what one. Cubist expects FDA approval this month. The procedure is expected to close in the first quarter of next year, when Merck give by ~ take the reins on Dificid.

As Cubist’s abet-best-selling-product, Dificid’s revenues are dwarfed ~ the agency of Cubicin’s $1.2 billion in occurring once a year sales. The firm’s flagship antibiotic treats pelt and other infections. Dificid, for the contagium Clostridium difficile, is showing promise because a revenue generator after Cubist re-launched the harvest in February.

The drug posted 10% district-over-quarter volume growth in the July-September determination, and year-on-year revenue bourgeoning of 14% vs. Q3 of latest year. Nine-month sales came in at $47.7 the multitude.

That follows several lackluster years. Dificid get annual sales totaled $51 million in the primary year after its launch in the US in July 2011 ~ the agency of Optimer, acquired by Cubist in 2013.

C. diff. is an infection that usually affects older patients and can cause symptoms ranging from diarrhea to potentially life-commination inflammation of the colon.

In a third part-quarter call with analysts last month, Cubist president and COO Bob Perez reported the Dificid re-launch involves three initiatives: targeting Dificid during the term of patients at the highest risk of resort, and those most impacted by the consequences of ~y extended bout of CDAD (clostridium difficile-associated diarrhea); erection relationships with key opinion leaders and targeting a subset of gastroenterologists exterior of hospitals that see a portion of CDAD cases; and improving contented access through the Dificid access program.

More than 700,000 CDAD cases are seen yearly in the US with high resort rates of 20%-30%. According to the US Centers against Disease Control and Prevention, the infirmity is estimated to be responsible in quest of approximately 14,000 deaths per year in the US.

Yet the deaden with narcotics faces an uphill climb due to a well-entrenched generic, the widely-used off-patent drug vancomycin. In one study comparing the brace, Dificid compared favorably, showing superiority to vancomycin in sustained clinical response through 25 days beyond the cessation of treatment, and proved non-less good to the older drug, dosed four periods daily, after 10 days of usage.

Given the availability of the much cheaper generic, Dificid’s growth may be pendent on its ability to price the physic competitively.

Another recent study suggests the physic can also have a sizable pack close on health system costs. The require to be paid-effectiveness study, which took place in the UK in which place fidaxomicin is sold by Astellas with less than the brand name Dificlir, demonstrated that elementary-line use of the antibiotic was effective in reducing recurrence rates and threatening mortality.

Researchers reported that the certain-world study concurred with clinical attempt data in showing a 74% connection reduction in recurrence, compared with the streamer of care: vancomycin and metronidazole.

“This analytics supports a growing consensus that fidaxomicin should subsist used first-line in all patients diagnosed with CDI to address recurrence, improve submissive outcomes, and ultimately save valuable NHS available means,” stated Dr Simon Goldenberg, consultant microbiologist and bane control doctor, Guy’s and St. Thomas’ NHS Foundation charge.

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