Release date: 2014-12-26
Earlier this month, Merck's $9.5 billion acquisition of antibiotic giant Cubist, the key product of the deal, Zerbaxa, received an FDA approval on Christmas Eve, and the super HPV vaccine Gardasil 9 was approved for listing in the first month of this month. Merck has been a happy event lately. The industry is predicting that Zerbaxa will reach a peak of $1.15 billion in 2023.
Antibiotic giant Cubist recently announced that the FDA has approved the new antibiotic combination Zerbaxa (ceftolozane / tazobactam) for the treatment of complex urinary tract infections (cUTI) and complex intra-abdominal infections caused by susceptible Gram-negative bacteria in adults. (cIAI). The approval of Zerbaxa also marks the second FDA approval that Cubist won in 2014. In June of this year, the FDA approved Cubist's new antibiotic Sivextro (tedizolid phosphate, second-generation oxazolidinone antibiotic) for the treatment of acute bacterial skin caused by Staphylococcus aureus, various Streptococcus and Enterococcus faecalis. Skin tissue infection (ABSSSI).
Zerbaxa is also a key factor in Merck's $9.5 billion acquisition of Cubist. The approval of Zerbaxa is also very important for Cubist. The company's flagship product, Cubicin, has a global sales of more than $1 billion in 2013, but in the first month of this month the FDA federal court ruled that the four patents of Cubicin were invalid. It is also ruling that Hospira will launch Cubicin generics as soon as possible in 2016, two years ahead of the expected patent expiration. In terms of EU regulation, Cubist expects Zerbaxa to be approved for listing in the second half of 2015.
At present, in the face of the increasingly severe "antibacterial" situation, some countries have begun to take incentives to encourage the development of new antibiotics. The United States passed the Encouraging the Development of Antibiotics Act (GAIN) in July 2012. According to the regulations, standards-compliant antibiotics will receive an additional five years of market exclusivity to help developers recover their investments.
Zebraxa is the first new antibiotic product approved for the treatment of Gram-negative bacteria under the Encouragement of Antibiotics Act (GAIN). Under the GAIN Act, the FDA has granted Zerbaxa qualified infectious disease products (QIDP). It is estimated that up to 2 million cases of Gram-negative infections in the United States each year, 23,000 deaths, resulting in direct medical costs of up to 20 billion US dollars.
Zerbaxa is the fourth antibiotic product approved by the FDA in 2014. In May, June, and August of this year, the FDA approved Dalvance of Actavis, Sivextro of Cubist, and Orbactiv of Medicines.
However, Zerbaxa will soon face competition from other rivals, including AstraZeneca and Atvis, which are expected to be approved by the FDA in the first quarter of 2015; in addition, Tetraphase is also working on an antibiotic The product is used in the treatment of cUTI and cIAI. Zerbaxa's approval is based on positive data from two key Phase III clinical studies. One of the studies was conducted in patients with complicated urinary tract infection (cUTI) and the other in patients with complex intra-abdominal infection (cIAI). Both studies reached the primary endpoint.
Source: Bio Valley
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