analysts

Lilly sees pipeline hope in MS drug

Mon, 11 Feb 2008 06:59:54 -0500

An article in the Indianapolis Star details Lilly's development program for MBP9289, a multiple sclerosis drug offering hope to both patients and a drug developer that hasn't launched a new drug for humans since 2005. MBP9289 is currently in Phase II and III trials and has shown promise in delaying progression and worsening of MS. The opportunity here for Lilly is huge--roughly 2.5 million people worldwide have the disease, and MS-related drugs did $6 billion in sales last year. Moreover, those who treat the MS say the disease is under-served by current treatments.

"Given Lilly's prominence in neurosciences, an expansion into multiple sclerosis makes strategic sense," said Linda Bannister, a drug analyst at Edward Jones in St. Louis. "But whether this compound is the answer, it's too soon to say."

- read this IndyStar article

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

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Novartis, MorphoSys ink $1B antibody deal

Mon, 03 Dec 2007 06:59:58 -0500

There's fresh evidence this morning that antibodies remain one of the hottest commodities in biotechnology. Novartis has extended its antibody development deal with Germany's MorphoSys, agreeing to pay $60 million a year in R&D support along with technology access fees and up to $400 million in milestone payments. Investors loved the major league endorsement of MorphoSys, sending its shares up 32 percent. Novartis gains access to MorphoSys' library of antibodies, expanding a pact that was originally signed three years ago. The pharma giant also gains an option to extend the deal by another two years. Analysts applauded the deal and seemed particularly enthusiastic about the length of Novartis' commitment.

- see the release on the deal
- check out the AFX report for more

ALSO: MorphoSys used the attention garnered by the announcement to say that much of the money it gains from Novartis will go into developing its own pipeline. Report

PLUS: Read more about Novartis' pipeline. Report

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Organon experiences Schering's research 'religion'

Mon, 26 Nov 2007 06:59:57 -0500

The Star-Ledger sat down with Tom Koestler, the research chief for Schering-Plough, to review its progress developing new therapies and integrating the R&D section of Organon. Koestler and CEO Fred Hassan (photo) have been lauded for their work turning the company around. Analysts now generally give the company top marks for creating a promising pipeline. And while some have questioned the $14.4 billion price tag for Organon, there are five other late-stage products offering some major earnings potential. The combined R&D operations includes 7,000 employees working in 42 sites. It's all built around the working philosophy of "customer-focused product flow," where reps from research, manufacturing and marketing all have a hand in guiding the research. "That's kind of like a religion we follow at Schering-Plough," Koestler told the Star-Ledger. "You can't just rely on the scientists to develop a compound."

- check out the report from the Star-Ledger

ALSO: Schering-Plough says the FDA has accepted its NDA for asenapine, a tablet for schizophrenia and bipolar disorder. Release

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Schering-Plough CEO applauded for turnaround. Report
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Investors fret over Lilly's pipeline, Prasugel data

Wed, 21 Nov 2007 06:59:55 -0500

Barron's concludes that Eli Lilly's anti-clotting drug Prasrugel will probably make it to the market, but recent safety data is likely to prevent it from becoming the kind of blockbuster the drug company badly needs. How badly? A series of upcoming patent expirations will potentially trim up to 60 percent of its revenue. Other big competitor drugs are going to go generic relatively soon. And if physicians are scared away from preferring Prasrugel to Plavix, that's one more big gap to fill on Lilly's financial horizon. Even more worrisome, analysts can't find any other potential blockbusters in the Lilly pipeline. It all spells trouble for the company's stock price, which has shrunk considerably since it issued its latest batch of Prasrugel data.

- read the report on Lilly from Smart Money

Related Articles:
Doubters see big obstacles for Lilly's Prasrugel. Report
Lilly drug outperforms Plavix, but there's a catch. Report
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Antisoma shares tank on bold new trial strategy

Tue, 20 Nov 2007 06:59:58 -0500

Shares of Antisoma took a dive this morning after researchers announced that they would pit ASA404 against Roche and Genentech's Avastin in a late-stage trial. And investors were further unnerved by the announcement that AS1411 will not begin a mid-stage study early next year, as had been planned. Antisoma shares slid 13 percent on the news, with analysts fretting over the decision to pit the cancer therapy against Avastin. Originally, Antisoma and its partner Novartis had planned to only go after squamous cancers, leaving Avastin's non-squamous patients out of the mix. By switching strategies and going after both cancers, investors appeared worried that researchers would find it difficult to attract enough patients away from Avastin to complete the trial in a timely fashion. On the up side, a successful pivotal trial for squamous and non-squamous cancers would double the potential market for the drug.

- see this release
- check out the MarketWatch report on the trial strategy fallout

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Doubters see big obstacles for Lilly's Prasrugel

Mon, 19 Nov 2007 06:59:56 -0500

The news that Eli Lilly's experimental anti-clotting drug Prasrugel was linked with a higher risk of fatal bleeding has converted a large group of analysts into disbelievers in the company's stock price. Specifically, Barron's is quoting a slate of analysts skeptical that the drug can be approved as is and worried by the absence of any other potential blockbuster in the Lilly pipeline. Lilly has maintained a much more optimistic attitude, noting that its recent crop of data indicates that the drug demonstrated efficacy in reducing heart attacks and strokes with fewer major incidents than Plavix. The analysts are betting that the FDA will want more studies--and that will take considerably more time than planned.

- read the report from Barron's

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report
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SPOTLIGHT: Analyst: AZ "worst performer" in pharma

Wed, 14 Nov 2007 06:59:53 -0500

So, Dresdner Kleinwort, tell us how you really feel about AstraZeneca. The investment bank, which just started covering AstraZeneca's stock, minced no words in its first report. The company's in "serious trouble," the analysts said, and quite possibly will be the worst performer in Big Pharma for the next eight years. Report

Novartis faces delay rolling out Galvus

Tue, 06 Nov 2007 06:59:55 -0500

Novartis is staring at some serious problems rolling out its diabetes drug Galvus. New data showing patients taking higher doses of the drug--100 mg--demonstrated more frequent enzyme elevation levels prompted Novartis to seek a revision in prescribing recommendations before the drug is marketed in Europe. The company plans to recommend once or twice daily dosing of 50 mg. That move raised analysts' concerns that Galvus will be less competitive than expected against Merck's once daily Januvia. Novartis had been planning to resubmit Galvus for U.S. approval in 2009. The FDA issued an approvable letter for Galvus earlier this year, outlining a request for additional information.

- see the release from Novartis
- read the report from in-Pharma Technologist

Related Articles:
Galvus delay raises questions about drug class. Report
FDA expected to approve Januvia soon. Report
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SPOTLIGHT: FDA rejects Glaxo depression drug

Mon, 05 Nov 2007 06:59:53 -0500

The FDA has turned thumbs down on GlaxoSmithKline's gepirone ER for major depression. Glaxo had licensed the drug from Fabre-Kramer after Akzo Nobel had bowed out of an earlier partnership. Analysts gave the drug some significant earnings potential, but have been wary of the drug's earlier problems with the FDA. Release

Safety questions cloud future of Takeda's TAK-475

Mon, 29 Oct 2007 07:59:58 -0400

One of Takeda's brightest drug prospects has run into a major stumbling block. The FDA is recommending the company halt clinical trials that are using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. The agency is also looking for additional clinical data ahead of an NDA for the therapy, which is in late-stage studies.

Analysts quickly estimated that the hitch will add at least two years to the development timeline of the drug, which had been tapped as a possible blockbuster able to make up for lost Actos revenue when the diabetes drug loses patent protection in 2011. With the FDA on high alert regarding any safety issues, the potential for liver damage could also be a deal killer for Takeda, which had been expected to file for approval as early as next April. TAK-475 is a "squalene synthase inhibitor" which is being studied to lower levels of bad cholesterol. If it is successful, it would be the first such drug on the market.

- see Takeda's release on the drug
- here's the AFX report for more information

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Takeda expands R&D budget, may look for buyout. Report
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