Amylin Looks Ahead To Bydureon Launch

The company plans to respond to a second FDA "complete response" letter for the GLP-1 analog by "next week," management says.

Amylin Pharmaceuticals Inc. is again ramping up for the launch of the once-weekly GLP-1 analog Bydureon (exenatide) for type 2 diabetes after what will be close to a two-year delay.

During a second quarter sales and earnings call July 26, CEO Daniel Bradbury said the company will respond to a second FDA "complete response" letter "next week" and anticipates a six-month review, positioning the drug for a potential launch in early 2012.

FDA has twice held up the drug, which Amylin partners with Eli Lilly & Co., The most recent delay, in October 2010, gave rival Novo Nordisk AS valuable time to secure a foothold in the market for its once-daily GLP-1 analog Victoza (liraglutide). Victoza, which launched in early 2010, has proven to be a tough challenger to Amylin/Lilly's currently marketed twice-daily form of exenatide, Byetta. Despite the setback, Bydureon now appears on track to secure FDA approval after a QT study evaluating the drug for cardiovascular risk met the primary endpoint (Also see "Amylin's Once-Weekly Bydureon Clears Major Cardiac Safety Hurdle" - Pink Sheet, 7 Jul, 2011.).

A launch is expected "weeks, rather than days" after FDA approval, Chief Commercial Officer Vincent Mihalik commented, with the timing contingent largely on the final labeling and any updates that may be required to the packaging. In the meantime, Amylin will "dust off" the manufacturing and begin commercial preparations in the second half of the year, he said. The company's current sales team will support the launch of Bydureon, and Amylin stands to earn a $40 million milestone from Lilly upon U.S. launch, which will offset the increased costs.

Bydureon was approved in June in Europe, where Lilly markets it and has launched it in the U.K. (Also see "EMA Gives Nod To Bydureon, Approves Additional Indication For Pradaxa" - Pink Sheet, 15 Apr, 2011.).

On the development front, the company is now turning its attention to lifecycle management plans for the franchise. Those include a more convenient pen device for Bydureon, which is expected to launch by the end of 2012/early 2013, Bradbury said, and a once-monthly injectable suspension formulation of exenatide. Amylin is awaiting discussions with FDA on the monthly formula - expected to take place by the end of the year - before formalizing the pivotal program.

Management kept mum on the ongoing lawsuit with its partner Lilly. The company filed suit against Lilly in May, claiming that Lilly's diabetes pact with Boehringer Ingelheim GmbH for the DPP-4 inhibitor Tradjenta (linagliptin) was anti-competitive. The court immediately blocked Lilly from selling the drug, but lifted the temporary restraining order in June (Also see "Lilly Sales Reps Resume Launch Of BI's Tradjenta; Judge Says FDA Regs Protect Byetta" - Pink Sheet, 9 Jun, 2011.).

Amylin said it is planning to appeal that decision while its lawsuit moves forward. "We intend to work with our partner Eli Lilly in the meantime to ensure that we successfully launch Bydureon together," Bradbury assured investors.

Amylin certainly needs a successful launch to get its business back on track. Sales of Byetta, the company's top-seller, have faltered since the launch of Victoza. The second quarter results told the story. Amylin reported $129 million in Byetta sales, down 8.3% compared to the second quarter 2010, taking into account price hikes. Net product sales of $154.8 million declined 4.7%. The company reported a net loss of $31.4 million, compared to a loss of $44.2 million in the year-ago period, as it sought to reign in expenses. SG&A expenses decreased to $65.2 million from $71 million last year, reflecting lower sales force spending, lower expenses associated with Bydureon pre-launch spending and efforts to drive efficiencies, the company reported.

- Jessica Merrill ([email protected])