Media Coverage

Parnell pet division pushes revenue 13%


May 26, 2017 - Animal Pharm

By Sian Lazell
Animal Pharm
May 26, 2017 

US firm Parnell Pharmaceuticals has reported revenue growth of 13% for the first quarter of 2017.

Specifically, the Kansas-headquartered firm said companion animal revenue grew by 13% due to the continued roll out of its FETCH digital application in the US and Australia. This performance backs Parnell's earlier prediction that it would see significant growth in its pet division during 2017.

For Q1, Parnell did not disclose exact figures for its revenues. The firm's production animal segment witnessed growth of 12% in Q1, driven by the continued roll out of its "strategy of clinical science leadership and differentiation through the use of mySYNCH". Parnell's mySYNCH digital technology is designed to help dairy farmers improve profitability.

Contract manufacturing did not generate any revenue in Q1 – in 2016, the segment yielded Aus$3.9 million ($2.9 million). However, Parnell said with the conclusion of negotiations on a new contract manufacturing agreement, its expects single digit millions in revenue beginning in Q2, 2017, and continuing each quarter.

Pipeline progress

In a development update, Parnell said it has completed the re-filing of the chemistry and manufacturing controls section as well as the drug master file for Zydax osteoarthritis treatment for dogs with the US FDA. The company said: "We believe that the time taken to compile these responses, including productive meetings with the Center for Veterinary Medicines, or CVM, section of the US FDA has placed [the firm] in a strong position to have this section of the dossier approved."

Parnell also submitted a full response to the EMA for Zydax for dogs. It explained: "Unlike the US where a phased submission is permitted, all sections of an application dossier must be submitted in Europe simultaneously.

"We anticipate receiving a first response to this refiling from the EMA in mid-July and if successful, [this] could lead to a potential approval in Q4, 2017.

"The re-filing of the full dossier in Europe now allows us to create a common technical dossier for filing in multiple other countries including Canada, China and other potentially large markets for Zydax."

It added: "We have nearly completed a study into the efficacy of Zydax, looking at different end-points that may in turn lead to an enhanced label for Zydax if approved by the FDA. Data from this study is expected to be available in late June 2017 and we expect to refile the efficacy section of the Zydax dossier for dogs with the FDA shortly after that. If successful, this could lead to a potential approval of Zydax late in Q4, 2017."

Looking ahead, Parnell expects to introduce new manufacturing capabilities at its FDA- and EMA- approved facility in Sydney, Australia. It is currently installing 'Single Use' manufacturing technology which it believes "improves [its] sterility assurance (at a time when several other manufacturers are receiving warning letters from the FDA)", as well as increasing operational efficiency.

The firm is also installing equipment that will enable it to manufacture soft-chew dosage forms for dogs and cats.

During 2017, Parnell also expects to: recommence the process of appointing a marketing partner for the commercialization of Zydax in countries outside the US and Australia following the re-filing of Zydax in Europe and the US; progress development of Zydax for cats and the use of the active ingredient in Zydax in humans; progress to pilot studies for PAR121 (a bone healing candidate) and PAR122 (skin healing); enhance the capabilities and operational efficiencies of its manufacturing facility and attract new opportunities for contract manufacturing; and completed negotiations on a contract manufacturing agreement with a major multi-national and progress several other potential contract manufacturing opportunities.

Reprinted with permission of Animal Pharm News

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