Some good news on the TPM injectable front.
To recap, last December a US district court ruled that four of the five patents protecting Merck’s antibiotic Cubicin were invalid. Cubicin (daptomycin) is an injectable only antibiotic used for difficult-to-treat skin and bloodstream infections.The remaining patent which was ruled as valid is set to expire in June 2016. Unfortunately for Merck, the adverse ruling came on the very same day it announced that it had paid $9.5 billion to acquire the drug as a part of its buyout of Cubist.
As previously noted, Merck chose to appeal the decision. Last Thursday a federal appeals court affirmed the original ruling.
This potentially paves the way for launch of Cubicin generics from next June. However it is still possible that Merck will appeal the decision in the US Supreme Court. It is also possible that Merck will apply for and win paediatric exclusivity, a commonly-used tactic that allows extension of patent exclusivity for a further six months.
In its recent investor presentation, POH highlighted some of the advantages of its TPM injectable antibiotic formulation over the existing product. At the request of licensee Mylan, the identity of the antibiotic is not revealed, but all the evidence points to Cubicin.
TPM is said to transform an opaque emulsion to a transparent microemulsion. Reconstitution time is more than halved and shelf life at room temperature is doubled, potentially transforming the present single use product into a world first, multi-use product. TPM is said to also replace harsh co-solvents known to be irritating and excipients known to cause anaphylaxis.
Mylan announced acquisition of Agila in February 2013. In August 2013 Agila filed a patent for an improved daptomycin injectable formulation incorporating TPM. Two months later it filed an application to the FDA to market a generic version of Cubicin but this application has been subject to an automatically stay pending the outcome of Cubist/Merck’s patent infringement lawsuit.
In the meantime, Cubicin sales have continued to grow - $325 million revenue was generated for Merck in the third quarter of this year.
http://www.fiercepharma.com/story/m...n-losing-fight-protect-cubicin-pat/2015-11-13
https://anewmerckreviewed.files.wordpress.com/2015/11/mrk-cubist-hosp-11-13-2015.pdf
https://www.sec.gov/Archives/edgar/data/310158/000031015815000058/mrk0930201510q.htm
http://www.google.com/patents/WO2014045296A2?cl=en
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