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Mezzion hires Pol Pharma and Halo Pharma and accuses Dr Reddy's of fraud

By Gareth MacDonald+

01-Feb-2017
Last updated on 01-Feb-2017 at 20:22 GMT2017-02-01T20:22:46Z

Pol Pharma API facility in Starogard Gdański, Poland (source Google maps)
Pol Pharma API facility in Starogard Gdański, Poland (source Google maps)

Mezzion has hired Pol Pharma and Halo Pharma and accused former CMO Dr Reddy’s of hiding manufacturing problems that cost its erectile dysfunction candidate, udenafil, US approval.

The Seoul, Korea-based firm announced the contracts last week (here in Korean ) explaining that Pol will be responsible for active pharmaceutical ingredient (API) production and Halo will take charge of formulation.

A Pol Pharma spokeswoman confirmed the deal, telling us: “We have started our co-operation with Mezzion.”

Lawsuit

Mezzion announced it had sued Dr. Reddy’s in a press release issued on January 24.

The Korean firm accused the Indian CMO of hiding “significant deficiencies in its US Food and Drug Administration (FDA) cGMP practices, and misrepresenting its compliance.”

The Korean firm cited a 2015 warning letter detailing deficiencies at Dr. Reddy’s plants to support its claim, arguing that the problems were the only reason the US FDA refused to approve udenafil.

Mezzion said: “Dr. Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations, and that it hid its misconduct from Mezzion. 

Dr. Reddy's misconduct was the sole reason given by the FDA to deny approval of Mezzion's new drug application (NDA) for udenafil for the treatment of erectile dysfunction (ED) and for FDA's refusal to grant marketing approval of Mezzion's udenafil finished drug product.”

Dr. Reddy's told us "The Company has not been officially served with any legal papers or process in the matter referred to in Mezzion’s press release.

"Nevertheless, the Company is aware of Mezzion’s claims and intends to deny any wrongdoing and to vigorously defend against the claims."

Replacement contractors

Mezzion - which is seeking millions of dollars in damages - said it had been forced to seek replacement contractors and is working to resubmit udenafil.

The US FDA originally accepted udenafil for review in 2015 . Mezzion has not disclosed when the US regulator rejected the product and has not responded to a request for comment.

US Federal law prevents the FDA from discussing existing or potential applications, which includes information about complete response letters (CRLs) issued to developers of rejected products.

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