Acorda Therapeutics has suffered its second setback this week, acknowledging that the FDA has extended by three months the PDUFA target decision date for its NDA of its Parkinson’s disease OFF-symptoms candidate Inbrija™ (levodopa inhalation powder)—three days after Acorda lost its appeal of a court decision invalidating four of its five patents for its top-selling drug.

The PDUFA or Prescription Drug User Fee Act date for Inbrija has been extended from October 5, 2018 to January 5, 2019, Acorda said. The extension followed submissions Acorda made in response to FDA requests for “additional information on chemistry, manufacturing, and controls (CMC),” the company said.

“FDA determined that these submissions constitute a major amendment and will take additional time to review,” Acorda stated.

Acorda’s NDA for Inbrija has been pending since the FDA accepted it for review in February. The FDA refused to file Acorda’s initial NDA for Inbrija last year, saying it didn’t know when the manufacturing site would be ready for inspection, and had an additional unspecified question about the submission of the drug master production record, the company disclosed last year.

Inbrija is a self-administered, orally inhaled levodopa (L-dopa) therapy indicated for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Applying Acorda’s investigational ARCUS® platform for inhaled therapeutics, Inbrija is designed to deliver a precise dose of a dry powder formulation of L-dopa through the lung.

FDA approval and the planned launch of Inbrija was “our primary focus now,” Acorda president and CEO Ron Cohen, M.D., stated in the company’s August 2 announcement of its second-quarter results.

“We believe that there would be strong demand and market receptivity to Inbrija,” Dr. Cohen told analysts on the company’s quarterly earnings call on August 2, according to a transcript published by Seeking Alpha.

He cited a survey conducted for Acorda among 226 neurologists, 175 primary care physicians, and 150 people with Parkinson's disease. The survey showed that physicians are frustrated by the lack of options, specifically indicated to address OFF periods, and despite their best efforts to optimize daily drug regimens, their patients still experience OFF periods.

Of the physicians surveyed, Dr. Cohen said, 71% agreed that OFF periods are the greatest unmet need in Parkinson's disease and 81% agree that therapies are needed specifically for OFF periods. All of the people with Parkinson’s who were surveyed agreed that nearly half of OFF periods were “very bothersome.”

$800M Peak Sales Projection

“Approximately 350,000 people with Parkinson's in the U.S. who are taking levodopa still experience OFF periods. Based on our market research, we believe that peak sales for Inbrija would be greater than $800 million,” Dr. Cohen added.

Acorda is counting on Inbrija approval to enhance its portfolio focused on treatments for CNS disorders—a portfolio that has helped make the company “an attractive takeover target in 2018,” according to Informa Pharma Intelligence and some other market observers, including Jefferies analyst Steven DeSanctis.

Acorda is among 10 Takeover Targets to Watch This Fall that were highlighted by GEN on Monday. The list cited unnamed-source news reports earlier this year that had Acorda either exploring a possible sale (The Wall Street Journal) or the subject of potential bids by Biogen and UCB (Bloomberg).

Also on Monday, the U.S. Court of Appeals for the Federal Circuit on Monday rejected Acorda’s appeal of a U.S. District Court for the District of Delaware decision invalidating four of the five patents protecting the company’s top-selling drug, the multiple sclerosis treatment Ampyra® (dalfampridine).

Judge Leonard Stark of the U.S. District Court for the District of Delaware last year cited obviousness in invalidating U.S. Patent Nos. 8,663,685, 8,007,826, 8,440,703, and 8,354,437 covering Ampyra®. He upheld the validity of the fifth patent, No. 5,540,938, which was originally granted to Elan and covers the formulation of Ampyra Extended Release Tablets, 10 mg. That patent expired in July, compared with between 2025 and 2027 for the four invalidated patents.

Acorda eliminated 20% of its workforce in a restructuring that followed the March 31, 2017, district court decision—a victory for companies seeking to market generic versions of the MS drug, which include Mylan, Roxane Laboratories, and Teva Pharmaceutical Industries.

In July of this year, the Federal Circuit denied Acorda’s motion for a preliminary injunction to prevent entities of Teva Pharmaceutical Industries, Mylan, and Hikma Pharmaceuticals from launching generic versions of Ampyra pending the appellate court decision.

Last month, Acorda settled with Mylan, allowing it to market a generic Ampyra in the U.S. in 2025, “or earlier under certain circumstances,” and reached interim agreements with Teva and Hikma.

Ampyra accounted for nearly 98% of Acorda’s total $259.467 million in total revenues for the first six months of 2018, a figure that rose 3.3% from $258.824 million in January-June 2017. Ampyra generated revenue of $253.1 million, up 3% from the first half of last year—of which $150.3 million was garnered during the second quarter, up 13% from Q2 2017.

Acorda last month maintained its guidance to investors that Ampyra would finish 2018 with net sales of between $330 million and $350 million.

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