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Athenex seeking meeting with FDA

Athenex officials are working to have a follow-up meeting with federal regulators within a month.

Company officials announced this week the U.S. Food and Drug Administration’s view that its new drug application for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer is not ready for approval in its present form. The FDA recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S.

In addition to its research, Athenex has spent the past five years building a state-of-the-art plant in Dunkirk with help from $200 million in state funding. While the process has been a slow one, company officials said in a conference call with investors on Monday that the Dunkirk facility is nearly complete. The local plant will serve Athenex’ specialty pharmaceutical business and ultimately proprietary products. A portion of the facility is expected to be used later this year making 503B products, large batches of opioids with or without prescriptions to be sold to healthcare facilities for office use only. Pharmacies are allowed to use larger batches to lower their manufacturing costs, passing the savings onto consumers.

The FDA’s news sent Athenex stock prices tumbling from more than $12 a share to just over $4 by Friday, but Johnson Lau, Athenex CEO, said the FDA’s decision may not be costly to Athenex. The company will know more once it meets with FDA officials.

“Now if it’s a small study, we’ll be in a position to support it,” Lau said. “But certainly, if it’s a big study … we’ll have to reconsider with regard to how big the study, the financial implications, the time involved and also the competing nature of our other programs as well as the compressive landscape before we can make a firm decision. So I apologize, I’m giving you a long answer, but there are many factors to consider, in particular, the response from the FDA before we can have some clarity after our analysis with regard to how to sort of push this program forward.”

FDA officials determined additional risk mitigation strategies to improve toxicity, which may involve dose optimization and/or exclusion of patients deemed to be at higher risk of toxicity, are required before the FDA can support Athenex’ proposed breast cancer treatment. There is no firm timeline when Athenex can meet with the FDA, but Lau said it could happen within as soon as 30 days if things go well.

“We’ll we try our best to provide data to FDA as soon as possible,” Johnson said. “The other aspects are already addressed. So therefore, the review process by FDA may be exercised. Now with regard to time line for our submission to FDA and then ask for a Type A meeting, obviously, we need to submit a package before we have a time line. And Dr. (Rudolf) Kwan (chief medical officer) is working very hard, and we are trying to prepare the package as soon as possible, hopefully within a couple of weeks and then followed by a request to FDA. And we sincerely hope that FDA will run us the meeting as soon as possible. But the usual time line expecting — at the meeting will be occurring within 30 days. So we’re looking into a couple of weeks together with the time line that the FDA would want to submit the meeting. And I think we will have some clarity very soon.”

Among FDA’s concerns, according to Kwan, is the lack of a U.S. location in the study; pacilitaxel’s myelotoxicity among some patients and concerns over the radiological reviews of Athenex’ work. Kwan said the myletoxicity risks could be handled with labeling guidelines. The FDA’s concerns over the independent radiological review is something Kwan said the company hopes to speak to the FDA.

“We use industry standard, blinded independent center review which is completely independent and totally, the readers are totally blinded and the process are well-documented,” Kwan said during Monday’s conference call. “And it’s frustrating for us to hear that they are concerned about the process, especially having witnessed them, all our process, including process in this aspect, having all put to the clinical sites conducting the study and having all the bioimaging lab that conduct this independent blinded process and still feels that they are unmeasured bias that they cannot articulate clearly. So, clearly, we have to clarify with the agency what constitute unmeasured bias after a total rigorous inspection of the process and the independency of the read.”

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