Amylin

Byetta uptick, Icahn news boost Amylin

Tracy Staton — Tue, 18 Nov 2008 09:48:30 -0500

Maybe Amylin Pharmaceuticals isn't so bad off after all. With Carl Icahn boosting his stake in the company and Byetta sales reversing their downward slide, industry observers are taking another look at the embattled company.

Byetta's fourth quarter sales are still down 9 percent year-over-year, but the diabetes med boosted scrips by 3.9 percent during the first week of this month, IMS Health data shows. As you know, Byetta has been beset by doubts since August, when the FDA flagged cases of pancreatitis in patients who used the drug, including six deaths. There's no proof that Byetta caused the problem, but scrips numbers deteriorated anyway. Until now.

And as Byetta sales are ticking upward, Carl Icahn has been snapping up Amylin stock. At less than $7 a share these days, it's a lot cheaper than it was just three months ago, when it was trading at almost $30. Just since June 30, Icahn has added some 4 million shares to his Amylin stake, bringing it to a total of 10.7 million.

Other investors are apparently following along: Amylin was up 8 percent Monday to $6.91.

- get the Associated Press news
- check out Mike Huckman's take at Seeking Alpha
- read The Street's coverage

Amylin lays off 340 as Byetta flags

Tracy Staton — Tue, 11 Nov 2008 10:04:02 -0500

The layoff pain in pharma isn't limited to the big guns. Amylin Pharmaceuticals yesterday cut 340 staffers--some 25 percent of its workforce--to save $100 million a year. The San Diego drugmaker will be left with 1,800 workers.

Disappointing sales of Amylin's diabetes med, Byetta, prompted the staffing cuts, which will include positions in administration, operations and R&D, CEO Daniel Bradbury told the San Diego Union-Tribune. "The purpose of the reorganization is to really put us in a stronger position as a company to execute our business plan and become cash flow positive by 2010," Bradbury said.

As you know, Byetta ran into a big of a snag in August, when the FDA reported that six patients using the drug had died of pancreatitis. The agency hasn't fingered Byetta as the cause of those deaths, but the med's warning label is in the process of being updated to reflect the new info. Byetta sales dipped in response, though Bradbury said he expects the med to recover soon. Meanwhile, Amylin is negotiating that label update with the FDA, hoping that it doesn't include a "black box" warning.

Amylin sells Byetta in partnership with Eli Lilly, and the two companies are working together to push a new once-weekly version of the med through the FDA approvals process. The two companies recently struck a deal allowing Amylin to borrow up to $165 million from the larger drugmaker provided the new med gets the FDA nod.

- read Amylin's release
- check out the news from San Diego's KRON
- see the Union-Tribune story

Icahn boosts stake in Amylin

Tracy Staton — Mon, 15 Sep 2008 10:51:32 -0400

Guess who's knocking at Amylin Pharmaceuticals' door? None other than activist investor Carl Icahn, who boosted his stake in the company to 10.1 million shares, or 7.3 percent. Known for rattling the doors of executive suites--and pushing for M&A deals--Icahn could already be eyeing his next biopharma project.

Icahn owns a chunk of Biogen Idec, the company he pushed onto the sales block last year. Though that bidding process failed to turn up a buyer, Icahn is still pressing Biogen to make a deal, saying it didn't try hard enough the first time around. Meanwhile, as chairman of ImClone, Icahn is in a contest of wills with Bristol-Myers Squibb CEO Jim Cornelius, who offered $60 a share for the company. Icahn says he has a $70-per-share buyer in the wings, but with that bid contingent on due diligence, he and Cornelius have been trading accusations via letter.

What's Icahn's interest in Amylin? The company sells the diabetes med Byetta in partnership with Eli Lilly, and as you know, the drug came in for some controversy last week when the FDA announced several severe cases of pancreatitis among Byetta patients. But its follow-up med, a once-weekly version, won some research kudos for controlling blood sugar better than Merck's Januvia.

And that controversy may be the simple reason: Amylin stock plummeted on the news, so Icahn had a chance to buy low. Still, the move shows a confidence in Amylin that investors haven't exactly shared recently. Will the market now follow Icahn? We'll have to wait and see.

- read the CNBC story

Amylin: Byetta outperforms Januvia

Christe Bruderlin-Nelson — Wed, 10 Sep 2008 03:20:43 -0400

You have to give them credit for trying. Following all the bad news about Byetta possibly leading to severe acute pancreatitis and six resultant deaths, Amylin Pharmaceuticals is looking for something positive to say about the drug. The company yesterday revealed study findings comparing Byetta with Merck's Januvia.

Januvia, Amylin and Eli Lilly claim, is a less potent diabetes medication than Byetta and does not work as well at reducing blood-sugar levels during the two hours following a meal. The study looked at 61 patients who tried each drug for two weeks. Amylin and Lilly together launched Byetta in 2005, and currently nearly three-quarters of a million people take the diabetes medication.

However, at least one analyst seems to think the study was purposed solely to create marketing buzz, since comparing the once-daily pill Januvia with Byetta, a twice-daily injectable in a separate drug class, is an "apples to oranges" comparison.

The companies released the study results in Rome on Tuesday, at the European Association for the Study of Diabetes. Merck was also there presenting positive data on Januvia. Both drugs aim to treat individuals with type 2 diabetes.

The differences between the drugs aren't just in the mode of administration. Primary care physicians are the main prescribers of Januvia and they tend to prescribe it early in the course of the disease, whereas Byetta is typically more of a specialist-prescribed medication used in more advanced diabetes cases.

For its part, Merck responded quickly with some of its own study critiques. Dr. Barry Goldstein, vice president of clinical research at Merck told Forbes.com that the study neglected to note that Januvia has less severe side effects than Byetta and works steadily over a 24-hour period. "The study is really looking at the peak of when Byetta is in the body after it is injected," he said.

Byetta prescriptions have been holding at about 50,000 per week, but Januvia prescriptions are almost double that.

Amylin and Eli Lilly have also collaborated with Alkermes in the development of a long-acting version (a once-weekly injection) of Byetta, but the industry buzz is that the pancreatitis news might affect FDA approval of the new version.

While Merck revealed some good news about Januvia, competitors were hot on the trail with revelations about two new drugs in the same class as Januvia, called alogliptin and saxagliptin. The drugs also help insulin-boosting proteins remain in the blood longer, and are in trials and under consideration with the FDA. Takeda Pharmaceutical Company makes alogliptin, while Bristol Myers Squibb and AstraZeneca together will market saxagliptin as "Onglyza" once it clears FDA hurdles.

- read the story at Business Week
- see more at CNN Money

Can good Byetta news counteract the bad?

Tracy Staton — Mon, 08 Sep 2008 10:34:11 -0400

The Byetta saga continues today: Amylin Pharmaceuticals saw its stock fall Friday after a Citi Investment analyst decreed that the diabetes med causes four times as many cases of pancreatitis as Merck's competitor Januvia. And, the analyst said, Amylin (and partner Eli Lilly, of course) may have a tougher time getting the extended-release version approved if a link between Byetta and pancreatic inflammation bears out.

Then on Sunday, The Lancet published a new study of that extended-release Byetta--a study that showed it controlled blood sugar better than the daily version does. More patients on the weekly version reached the blood sugar goal, the researchers found. The extended-release form also caused fewer side effects, the study authors said.

What's next is anybody's guess. Stay tuned.

- see the Washington Post story
- check out the article in The Telegraph
- get the stock news in Forbes

Lilly, Amylin suffer on Byetta deaths

Christe Bruderlin-Nelson — Wed, 27 Aug 2008 01:51:39 -0400

Eli Lilly and Amylin Pharmaceuticals have reported four more deaths of patients taking the diabetes drug Byetta. This is in addition to the two deaths that made headlines last week.

Both the FDA and the companies were aware of the acute pancreatitis deaths. The two deaths reported last week involved patients with necrotizing pancreatitis. While these four deaths were not due to pancreatitis, all of the patients had experienced the condition at some point.

Both companies are seeing stock prices plummet as a result, although the drop is more painful for Amylin, since Byetta is the company's number one product. Amylin shares are down to about $25, while shares of Eli Lilly are just over $46. Some analysts say the reaction is overblown and that it is still safe to hold on to shares of both companies.

The companies maintain that there is no proven causal relationship thus far, but they are working with the FDA to up the warnings on the drug labels. A spokesperson for Lilly said that he believed that the cause of death likely related to something besides the acute pancreatitis in the four patients. No surprise here: a spokesperson for Amylin agreed.

- read the story in the New York Times
- see more at CNN Money
- hear what Pharmalot has to say
- find the Wall Street Journal blog post

Are investors overreacting to Amylin news?

Christe Bruderlin-Nelson — Wed, 20 Aug 2008 10:48:20 -0400

Bad news from the FDA can hurt pharma companies fast and after earlier news this week that Amylin's diabetes drug Byetta was associated with some serious cases of acute pancreatitis, the company's stock began to plummet. Shares were down 13 percent by Monday.

Eli Lilly, which co-markets the drug, isn't receiving equally harsh treatment from investors.

What is interesting is that the there were already 30 reports of pancreas related problems in October. The latest news added six more reports, two of which led to deaths and were quite serious, but was in light of patients with diabetes already being at increased risk of pancreas problems. Later, in an interview with the Diabetic Investor, the FDA said the news was actually about a "rare and uncommon event."

Finance experts say the stock will likely recover and that panic in the industry can provide a great opportunity for investors who want to buy low.

--catch the story at the Motley Fool
--read more at Forbes
--see the latest at Sign on San Diego

Does Lilly's Byetta extend life?

Tracy Staton — Tue, 05 Aug 2008 10:32:26 -0400

Yesterday, we reported a little pooh-poohing of a potential deal between Eli Lilly and Byetta partner Amylin, based on the diabetes drug's flat sales of late. Well, some news today could change that sales trend. (Whether it changes people's minds about a buyout we'll leave to you to speculate.) In a big trial of type 2 diabetes treatments, Byetta patients had a 75 percent lower chance of dying compared with those who took any other drug.

Why haven't Lilly and Amylin trumpeted those numbers? No one is yet sure whether the survival benefit is real or statistical chance, the New York Times reports. The 825 patients--of 10,000 participants--who took Byetta during that trial were likelier to start out healthier, for one thing. The numbers came as a surprise even to the drugmakers. "[M]y jaw just dropped," said Dr. James Malone, global medical director on Byetta for Lilly.

To prove the numbers, the two companies would have to run a head-to-head trial, which would be expensive and time-consuming. And with a reformulated version in the works, they may want to run that sort of study with the new version.

- read the NYT story

Update:
Lilly, Amylin suffer on Byetta deaths
Are investors overreacting to Amylin news?
FDA seeks tougher labeling for Byetta after deaths

Novo drug bests Byetta in ADA study

Tracy Staton — Mon, 09 Jun 2008 11:03:14 -0400

Amylin Pharmaceuticals' stock is suffering from a Novo Nordisk study that showed its experimental diabetes drug liraglutide outperformed Amylin's flagship drug Byetta, co-developed with Eli Lilly; shares dropped more than 8 percent Friday to close at $29.93. Report

Lilly diabetes med linked to pancreatitis

Wed, 17 Oct 2007 06:59:57 -0400

A fast-growing Eli Lilly med may be held back by a new warning linking it to acute pancreatitis. After 30 reports of pancreatitis in patients using the injectable diabetes drug Byetta--five of which led to serious complications such as kidney failure--the FDA has asked Lilly and its partner on the drug, Amylin, to revise its labeling.

With $430.2 million in 2006 sales, Byetta delivered some $219 million in revenues to Lilly. The rest went to Amylin, accounting for 90 percent of that company's sales. Amylin stock fell sharply on the news.

- check out the report from the Indianapolis Star

Related Articles:
In speech, Lilly CEO calls for drug monitoring. Report
Lilly developing biotech drugs the old-fashioned way. Report
Amylin shares shoot up on Phase II Byetta results. Report
Diabetes epidemic triggers soaring drug market. Report

Read more on: Eli Lilly | Diabetes | Amylin