Ranbaxy in technology pact with Pfenex to develop generic biotech drug

Ranbaxy has entered into a technology pact with Pfenex Inc to develop a biosimilar therapeutic.

Pfenex will share its proprietary Pfenex Expression Technology platform, a Pseudomonas-based recombinant protein expression technology, to Ranbaxy to develop the biotech product.

Under the terms of the agreement Pfenex is eligible to receive maintenance fees, milestone payments as well as royalty payments on any product sales derived from the agreement.

The name of the prospective biotherapeutic drug is not disclosed.

Ranbaxy and Pfenex scientists will collaborate on developing the production strains and the process that will be used to produce product in support of clinical development and commercial production of the biosimilar product.

“Within our overall bio-therapeutic plan, the Pfenex technology will enable Ranbaxy to develop a high quality, cost effective product,” said Atul Sobti, CEO & managing director of Ranbaxy.

This collaboration is a great combination of the strength of Pfenex Expression Technology being leveraged for the cost effective production of biosimilars, and Ranbaxy’s proven ability to develop and launch products globally, stated Bertrand C Liang, CEO of Pfenex in a press release.

Headquartered in San Diego, California, Pf?nex Inc. is a biotechnology company focused on recombinant protein expression for a broad range of applications including therapeutic proteins, vaccines, research, reagents and biosimilars.

The company’s core technology, Pf?nex Expression Technology, is a cutting edge protein expression platform that utilizes the BSL-1 microorganism Pseudomonas fluorescens.

Pf?nex Expression Technology combines an extensive toolbox of expression components with a robotically enabled high throughput parallel strain screening technology, delivering unprecedented speed and success in identifying protein production strains expressing high titers of soluble active protein.

Pf?nex currently has three biosimilar molecules at an advanced stage of process development.

Recently, US FDA has denied approval for Daiichi-Ranbaxy’s generic tamsulosin hydrochloride tablets to treat  enlarged prostate due to the ongoing controversy on good manufacturing practice norms violations.

Tamsulosin, which is currently sold under the brand name Flomax was originally developed by Yamanouchi Pharmaceuticals which is now part of Astellas Pharma of Japan.

Tamsulosin is marketed by Boehringer-Ingelheim and CSL under license.Flomax enjoyed a sale of nearly $1.2 bn in US during the year 2009, reports indicate.

Ranbaxy, which is currently owned by Japanese drugmaker Daiichi Sankyo, was scheduled to  launch the generic version of tamsulosin on March 2 in the US.

The Indian generic company could have launched tamsulosin eight weeks before the drug’s patent expiry following an out-of-court settlement in 2007.

Ranbaxy has been denied the approval for tamsulosin generic because of its failure to address the manufacturing violations in some of its facities in India and US.

US FDA has asked Ranbaxy to undertake concrete steps to ensure that all of the company’s facilities involved in manufacturing products to US market confirm with the regulator’s cGMP requirements.

Ranbaxy has been issued warnings for manufacturing violations at least thrice during the last four years by USFDA.

The US drug regulator which hauled up India’s leading generic maker for repeatedly violating manufacturing norms since atleast 2006, found out 1,676 errors in the audit of 15 applications approved for the US market.

Following these findings, the regulator has decided to revoke licences of 25 products made in this factory. The number of application stopped from this facility pending approval included the 6-months’ exclusive marketing rights for Ranbaxy’s version of world’s largest selling anti-obesity drug Lipitor, a worldwide best-seller, which comes off patent in 2011.

Ranbaxy Laboratories Ltd,in which Japan’s Daiichi Sankyo owns about 64 percent, reported net loss of 7.78 billion rupees ($156 million) in its fiscal first quarter ended March 2009, compared with a profit of 1.03 billion rupees in the year-ago quarter, following the US FDA action.

The US market accounted for about a quarter of Ranbaxy’s $1.6-billion revenues for the year ended 2008.