Sandoz Inc. and partner Momenta Pharmaceuticals Inc. have won the long and closely watched race for FDA approval of the first generic version of Teva Pharmaceutical Industries Ltd.’s blockbuster multiple sclerosis drug Copaxone (glatiramer), but the timing of generic launch remains hazy due to underlying patent litigation.

FDA approved Sandoz’s ANDA for 20 mg/mL once-daily glatiramer injection April 16. In an unusual move for a generic, the drug will carry a brand name, Glatopa. [See Deal]

Concurrent with the approval, FDA also denied Teva’s most recent citizen petition seeking to block approvals of glatiramer ANDAs until certain conditions are met.

In securing the first generic approval, Sandoz/Momenta beat several other competitors to the approval line, including Mylan NV. However, other near-term approvals are not out of the question, as Sandoz/Momenta did not receive 180 days of generic marketing exclusivity.

Because there are no remaining unexpired patents listed in the Orange Book covering the 20 mg formulation, generic marketing exclusivity is not available, FDA said.

During a same-day conference call to discuss the approval, Momenta CEO Craig Wheeler said Sandoz’s parent company, Novartis AG, stands ready to help promote Glatopa with its existing MS product sales force, if needed.

Wheeler declined to discuss the timing of launch, citing competitive reasons. However, he walked analysts through recent events in Copaxone patent litigation with Teva that seem likely to guide Sandoz’s decisions around launch timing.

Waiting On The Federal Circuit

In January, the U.S. Supreme Court ordered the Federal Circuit Court of Appeals to reconsider the validity of Teva’s manufacturing process patent for Copaxone.

That patent, No. 5,800,808, expires on Sept. 1. As a manufacturing process patent, the ‘808 is not listed in the Orange Book. The other Copaxone patents that originally were part of litigation brought by Teva have expired.

A district court had determined that glatiramer ANDA filers had infringed the ‘808 patent, but the Federal Circuit reversed that finding, ruling that the term “average molecular weight” was indefinite, rendering the patent invalid.

However, the Supreme Court ruled that an appeals court can only review a district court’s decision on the meaning of patent terms when there is a question of “clear error” by the lower court judge. The high court vacated the appellate ruling of invalidity and sent the case back to the Federal Circuit for further review ([A#14150120005]).

The parties in the case submitted new briefs with the Federal Circuit in March; the appeals court could decide to schedule a hearing in the case, or it could issue a decision at any time without holding a hearing, Wheeler said.

“We believe the appellate court’s action invalidating the patent was correct, and we have a strong chance of ultimately prevailing in the case,” Wheeler said.

“We have informed the court of the FDA approval and requested an expedited decision with an opinion to follow to facilitate competitive access to a generic version of Copaxone,” he said.

Commercialization prior to a Federal Circuit ruling seems highly unlikely given that such a launch would come in the face of decisions by the district court and Supreme Court that favored Teva.

Responding to FDA’s approval of the Sandoz/Momenta generic, Teva said: “We cannot speculate on availability of Momenta’s generic version of Copaxone. However, given the pending decision from the U.S. Court of Appeals for the Federal Circuit, any companies that launch a generic version of Copaxone would do so at risk.”

Successful Conversion Strategy

Teva has been preparing for generic competition to Copaxone and has worked hard to convert patients from the 20 mg once-daily formulation to a newer 40 mg, three-times-weekly formulation ahead of generic competition.

“Teva has acknowledged for some time that a generic version of our Copaxone 20 mg/mL could enter the market and we have planned for it,” the company said. “We continue to be pleased with strong demand and uptake by both patients and physicians of three-times-a-week Copaxone. … The data through April 3, 2015 shows the conversion rate of 66.8%.”

During Teva’s Feb. 5 earnings call, Robert Koremans, president and CEO of Global Specialty Medicines, noted the 40 mg formulation has access to about 90% of patients in the U.S. and contracts have been secured for 2015 and, in some cases, even longer.

Copaxone sales were $4.24 billion in 2014, accounting for 49.5% of Teva’s specialty drug sales and 21% of the firm’s total sales of $20.27 billion.

In commenting on the generic approval, Teva noted the 40 mg formulation requires 60% fewer injections compared to the 20 mg daily regimen. “We expect three-times-a-week Copaxone 40 mg/mL will continue to be an attractive option for patients currently on daily Copaxone, as well as new patient starts and patients that fail on other disease-modifying therapies,” the company said.

However, Momenta also sees market share opportunities in these same areas, including the more than 30% of Copaxone users who are still taking the 20 mg daily dose.

For those patients who already have switched to Copaxone 40 mg, “I think you’re less likely here to see a lot of patients that are comfortably on three times a week switching back, unless they’re in a high-control [health insurance] plan which is really looking to manage costs,” Wheeler said. He noted, however, that co-pay shifts potentially could help drive some patients back to the 20 mg dose on their own.

In addition, there remains an opportunity to grow the glatiramer market overall.

“Now, with a lower-cost product on the marketplace, you almost certainly will get most of the new starts and so you’ll see doctors having more restricted choices when they have a lower-cost generic alternative of starting patients, particularly when the only differences are dosing frequency,” Wheeler said.

“We see those three areas: capturing some of the 20 mg perhaps with some high-control plans switching back, getting new patients, and then potentially beginning to grow Copaxone opportunities versus other therapies,” Wheeler said.

Backed By The Power Of Novartis

Wheeler did not discuss pricing on the call except to confirm that Sandoz is responsible for setting the price.

The Glatopa launch will be coordinated by Sandoz, which is “putting their full capabilities to use,” he said.

The generic’s commercialization “will be supported as needed by the full MS infrastructure of Novartis,” Wheeler said. “We at Momenta believe that the commitment Sandoz and Novartis have made to this product will drive commercial success.”

Novartis’ branded MS products include the oral drug Gilenya (fingolimod) and the injectable agent Extavia (interferon beta-1b).

Under the terms of its collaboration agreement with Sandoz, Momenta will receive a $10 million milestone payment upon ANDA approval and another $10 million payment upon first commercial sale. Momenta also is entitled to a 50% share of contractual profits on Glatopa sales.

Sandoz/Momenta’s Copaxone Generic Clears FDA, But Court Action May Guide Launch Timing

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