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FDA backs Cubist's antibiotic Zerbaxa

Combination cephalosporin and beta lactamase inhibitor wins US approval

Cubist PharmaceuticalsCubist Pharmaceuticals has rounded off a busy few months with its second approval for a new antibiotic, this time getting FDA approval for combination cephalosporin and beta lactamase inhibitor Zerbaxa.

The brace of product approvals in 2014 comes as the company is in the process of being acquired by Merck & Co under the terms of an $8.4bn deal signed earlier this month.

Zerbaxa (ceftolozane/tazobactam) has been approved in the US to treat adults with complicated intra-abdominal infections (cIAI) in combination with metronidazole, as well as complicated urinary tract infections (cUTI) such as pyelonephritis.

The drug was filed in Europe for the same indications in the third quarter of this year and Cubist is hoping for EU approval in the first half of 2015.

Zerbaxa was granted a priority review by the FDA under its Qualified Infectious Disease Product (QIDP) programme, which is designed to accelerate the development and approval of new antibiotics to help fight the rising threat of antibiotic resistance. In addition to quicker review times, QIDP status also gives an extra five years of patent life for the antibiotic product.

The approval of Zerbaxa adds to Cubist's stable of antibiotics, which include $1bn-a-year blockbuster Cubicin (daptomycin) as well as recently-approved Sivextro (tedizolid phosphate) for acute bacterial skin and skin structure infections.

One the acquisition goes through Merck will have two new growth products to add to its portfolio, although Cubist suffered a setback for Cubicin earlier this month after it lost a patent challenge filed in a US court by generic drugmaker Hospira.

The ruling opened the door for generic competition to Cubicin in 2016 rather than 2018, which according to analysts could cost the company up to $2bn in lost sales.

Both Cubist and Merck moved swiftly to quash any suggestions that the ruling could scupper the acquisition, and analyst projections that Zerbaxa could achieve peak sales of $1bn or more have no doubt helped keep the transaction on track.

The Zerbaxa approval brings the number of novel antibiotics approved by the FDA in 2014 to four. In addition to Sivextro, the agency also gave a green light this year to Durata Therapeutics' Dalvance (dalbavancin) - recently acquired by Actavis - and The Medicines Company's Orbactiv (oritavancin).

Other new antibiotics coming through the pipeline that will compete with Zerbaxa include AstraZeneca (AZ) and Actavis' ceftazidime/avibactam - under regulatory review at the FDA - as well as Tetraphase Pharmaceuticals' eravacycline which reported positive phase III results in cIAI earlier this month.

Article by
Phil Taylor

23rd December 2014

From: Sales

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