Mylan launches copy of Copaxone 40 mg even as patent litigation is on

Moneycontrol News
Mylan on Thursday said it has launched the generic version of Israel-based Teva multiple sclerosis (MS) drug Copaxone 40 mg/mL for 3-times-a-week injection in US market.

The launch comes as analysts were debating whether Mylan should wait for the outcome on the pending patent ligation or it will go ahead and launch “at risk”.

Mylan will have to pay millions of dollars in damages to Teva if it fails to invalidate the remaining patents held by the Israeli drug maker.

Teva has already warned Mylan of “significant damages” if it goes ahead and launches the generic version of Copaxone 40mg/ml prior to the resolution of the pending patent litigation.

Teva said it will be appealing against the earlier orders by Patent Trial Appeal Board and US District Court for the District of Delaware that came against at least four patent claims. The Israeli drug maker also brought a suit against five Abbreviated New Drug Application (ANDA) filers, including Mylan, for infringement of a patent covering a manufacturing process for glatiramer acetate product.

Analysts said Mylan has taken a gamble.

“Mylan has taken a calculated risk,” said Afzaal Mohammed, pharma analyst tracking Natco at Karvy Stock Broking said. "Teva may have difficulty in defending its remaining patents," Mohammed added.

Mylan on Wednesday announced that it had received US FDA approval for the generic version of Israel-based Teva’s top-selling multiple sclerosis (MS) drug Copaxone 20 and 40 mg/mL dosage forms.

While Mylan doesn’t face any problems for the generic version of Copaxone 20 mg/ml as the patents have ended, the patent litigation for Copaxone 40 mg/ml version is still on.

Mylan partnered with Indian drug maker Natco Pharma. As per the agreement Natco will supply the drug, while Mylan takes care of litigation and marketing strategy in the US.

Natco will receive 30 percent profit share from Mylan for the 20 mg product and 50 percent share for the 40 mg product.

With Copaxone 40 mg/ml version hitting the US market Mohammed of Karvy said he would expect the company to make a profit of Rs 700-Rs 1000 crore from this drug alone in the next two quarters.

"It all depends on the acceptability of doctors and patients and the extent of price erosion," Mohammed said. Copaxone is the most prescribed MS treatment for relapsing forms of MS (Multiple sclerosis) in the United States with brand sales for the 20 mg/mL dose of approximately USD 700 million and for the 40 mg/mL dose of approximately USD 3.64 billion for the 12 months ending July 31, 2017, according to QuintilesIMS.

Copaxone alone contributed a fifth of Teva's USD 21 billion sales in 2016 and nearly half of company’s profits. Shares of Natco Pharma rose 4.39 percent and were trading at Rs 996.25 on BSE at 12.17 pm, while the benchmark Sensex declined 0.14 percent and was trading at 31,622.05 points.

THe ADR's of Teva were down 14.56 percent on NYSE to close at USD 16.08 on Wednesday, while shares zoomed 16.20 percent on Nasdaq to end at USD 37.80.