Byetta

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

FDA seeks tougher labeling for Byetta after deaths

Christe Bruderlin-Nelson — Tue, 19 Aug 2008 03:37:00 -0400

They warned you once and they'll warn you again. FDA is upping the label ante on Byetta, the diabetes drug that Eli Lilly and Amylin Pharmaceuticals developed and market, following reports of deaths in patients taking the drug. Greater than 700,000 patients have used the medication since 2005, bringing the companies nearly $700 million in sales.

Patients taking the twice-daily injectable drug Byetta are at increased risk of acute pancreatitis, a dangerous form of pancreatitis that comes on suddenly and can be rapidly fatal, even with treatment. The FDA is warning patients on Byetta to stop taking the medication immediately if they develop symptoms of acute pancreatitis, including abdominal pain, nausea, vomiting, diarrhea, fever and chills.

The two drug companies say the reports of complicated or fatal pancreatitis are "very rare," and that diabetes patients already have an increased risk of pancreatitis.

The medication already had warnings following about 30 reports of nonfatal pancreas concerns in Byetta patients, but now the FDA has received at least six new reports of patients taking Byetta coming down with an aggressive type of pancreatitis. Of these, two have died.

For their parts, Lilly and Amylin are in the process of developing a once-a-week version of the medication that had piqued some investor interest despite recent lackluster sales, but this news has some analysts raising a red flag about investing, saying that it will likely influence how the FDA will view the new version. Not surprisingly, shares in both companies saw a dip in price on Monday.

--see the release
--read the story in the New York Times
--see more at ABC News
--find the Pharmalot blog post

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

ALSO NOTED: Bayer sues Watson over Yasmin; Zimmer weeds out doc conflicts

Mon, 21 Apr 2008 06:59:50 -0400

> Open another chapter in the Bayer fight to protect Yasmin patents: Watson Pharmaceuticals filed for FDA approval for its copycat version of the birth control pill, and Bayer sued to keep the drug off the market. Release

> Device maker Zimmer is working to cut "potential or perceived conflicts of interest" in any consulting deals with docs, by banning all gifts to healthcare professionals, pulling back on sponsoring doctor presentations at conferences, and reviewing royalty deals for potential conflicts--and in some cases, suspending payments. Report

> Alabama's Supreme Court ruled that GlaxoSmithKline and Novartis will have to face claims that they inflated Medicaid drug prices--together. The drugmakers had argued for separate trials. Report

> Shire has seen its share price drop by 22 percent over the past six months as investors worry that patients aren't switching to the ADHD treatment Vyvanse, its lead drug. Report

> India's Dabur Pharma said longtime shareholders the Burman family would sell its entire 65 percent stake in the company to a unit of Germany's Fresenius. Report

> Amylin Pharmaceuticals posted a larger first-quarter loss on higher marketing costs for diabetes meds Byetta and Symlin; the company lost $68.8 million last quarter versus $49.4 million during the same period last year. Report

> QLT said that its Visudyne eye treatment marketed by Novartis posted first-quarter sales of $36.5 million, a decline of 40 percent from first quarter of last year, because of increased competition from new macular degeneration meds. Report

> BrainCells is moving its lead program into a Phase IIa trial after boosting its second venture round with a second tranche. Report

> The FDA is prepared to back a new safety standard on preclinical drugs that could--at some point--significantly reduce the time and expense of testing a new therapy. Report

> The war between Biogen Idec and Wall Street raider Carl Icahn is heating up. Report

> Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Report

> The U.K.'s Renovo has seen shares bounce back on the news that two more mid-stage studies have produced positive results. Report

And Finally... With a new safety threat reported almost every day, is this becoming the United States of Anxiety? Report

Lilly declares a truce in diabetes rep war

Fri, 07 Dec 2007 06:59:54 -0500

For a while there it looked like Eli Lilly and Novo Nordisk were competing to see who could deploy the biggest army of diabetes reps in the U.S. While most pharma companies were chopping sales forces, Lilly swelled its contingent in the diabetes field by 40 percent, only to see Novo Nordisk recruit 700 new diabetes reps in the U.S. But Lilly's president John Lechleiter used yesterday's analyst day to call a truce on hiring. "We're not in this to see who can add more salespeople," he told Dow Jones. Not that sales are all they could be, he added, voicing some disappointment at Lilly's sales of Humalog and Byetta.

- read the report from The Wall Street Journal

Related Articles:
Top Lilly exec plays secret sales agent. Report
Lilly predicts double-digit earnings growth. Report
Novo: no pancreatitis risk linked to Liraglutide. Report
Lilly diabetes med linked to pancreatitis. Report

Lilly predicts double-digit earnings growth

Thu, 06 Dec 2007 06:59:54 -0500

Here's one bright spot today: Eli Lilly predicts a big year in 2008, with 14 percent growth in net profits and seven billion-dollar-plus products. Higher sales of drugs for depression (Cymbalta), diabetes (Byetta and Humalog), cancer (Alimta), and ED (tadalafil) will account for much of that growth. Lilly also says it's hoping to launch pasugrel, its anti-clotting drug candidate designed to prevent recurrent heart attacks and strokes, in 2008.

In its latest forecast, the company also affirmed its 2007 expectations of $3.50 to $3.55 in earnings per share, excluding special charges. For 2008? It's predicting $3.85 to $4 per share, above analysts' previous expectations of $3.81 per share. The dark cloud in all this news, at least for Lilly's workforce, is that the earnings growth depends in part on increased productivity--and that includes an unspecified number job cuts.

- check out the release from Eli Lilly
- read the report from Dow Jones

ALSO: Take a look at Lilly's pipeline. Report

Related Articles:
Doubters see big obstacles for Lilly's Prasrugel. Report
In speech, Lilly CEO calls for drug monitoring. Report
Lilly CEO: Use IT to boost drug safety. Report