Amylin (NASDAQ:AMLN): Comments on Taspo

I don't normally comment on specific news but here is something I think you should be looking at today:

Roche Holding AG delayed development of the experimental diabetes drug taspoglutide by at least 12 to 18 months after more people than expected suffered from side effects such as skin reactions and digestive symptoms.

Reuters.

As many of you probably know, taspoglutide or Taspo has been considered one of the 3 newer glucagon-like peptide-1 (GLP-1) receptor agonist class medications to hit the market in recent years (type 2 diabetes). Taspo is or rather was expected to start competing with Novo-Nordisk's (NYSE:NVO) Victoza and Amylin's (NASDAQ:AMLN) Bydureon.

Now it looks like the drug will see a significant delay or won't be launched at all. That should be a significant positive for both NVO and AMLN.

As AMLN is way more leveraged to Bydureon's success, I think it warrants special attention today.

Note that Piper Jaffray upgraded Amylin (AMLN) to Overweight from Neutral on June 13 after American Diabetes Association abstracts showed that Bydureon had better safety data vs. Taspo.

This is what they had to say:

We are upgrading AMLN to Overweight from Neutral based on valuation and our belief that taspoglutide's profile and development timeline reduces the competitive threat to Bydureon. Since the April 9th highs, AMLN shares have pulled back ~30% (vs. S&P500 -8.6%) ahead of competitive taspo data at the ADA (June 25-29). On Friday, the ADA released abstracts for the Phase III taspoglutide (A1C reduction of 0.8%-1.3% but GI related dropout rate of ~5-14%) and Bydureon Phase III trials (A1C reduction of 1.5-1.9% and nausea and AE related dropout rates of 0.7% and 6%, respectively), which continue to support Bydureon's best in class profile.

Bydureon's profile combined with its two year lead time (taspo launch in 2H12) should offset its need to reconstitute and larger needle size and support peak sales estimates of $2bn. Our estimates for the exenatide franchise do not incorporate sales of once-monthly exenatide, which could launch in 2013.

How does taspoglutide compare to Bydureon? The Phase III taspo abstracts are largely in line with the Phase II results, with a 0.8%-1.3% reduction in A1C and weight loss of 2-4kg at 24 weeks. The A1C reductions are below similarly structured Phase III trials for Bydureon (1.5%-1.9% A1C reduction and 2-4kg weight loss). GI related discontinuation rates are also much higher with taspo, ranging from 5-14% of subjects on drug (vs. <0.7% style="color: rgb(255, 0, 0);">

Notablecalls: My thoughts regarding AMLN are the following:

- The stock went from $15.50 to $18.30 on the worse than expected Taspo data. The ADA abstracts were obviously leaked sometime in the morning of June 11 causing the stock to jump 1.5 pts ahead of the Piper Jaffray upgrade on June 12.

The stock ran another 1+ pt following the Piper upgrade but has given back about 50% of the advance over the past 3-4 days.

- Novo Nordisk (NVO), that has a market cap of around $48 billion is up over 3 pts (3.5%) this morning in reaction Taspo news.

Amylin (AMLN) has a market cap of $2.4 billion and is way more leveraged to Bydureon than Novo is to Victoza.


All in all, I think this sets AMLN for a nice pop. I think it can go to $17.50-18.00 today, if not higher.

Note that there has been some analyst chatter of Bydureon getting an early approval.


One to watch today!