Regulators

Sanofi: Acomplia demonstrates better glucose control

John Carroll — Tue, 10 Jun 2008 11:56:48 -0400

Sanofi-Aventis said that a trial of Acomplia showed a significant improvement in glucose control in comparison to insulin among patients with type 2 diabetes. Glucose control was three times more pronounced among the Acomplia group compared to volunteers who received insulin and lifestyle advice.

The drug has been approved in Europe but faces a lengthy delay in the U.S. as regulators shift through data that the drug may raise the risk of depression. In the trial, 14 percent of the Acomplia drug reported symptoms of anxiety compared to five percent in the control group and 14 percent reported symptoms of depression compared to 7.5 percent in the control arm.

- check out the AFX report

Committee votes to back GSK/Ligand's Promacta

Mon, 02 Jun 2008 06:59:57 -0400

GlaxoSmithKline and Ligand Pharmaceuticals won a key endorsement for Promacta for the short-term treatment of people with chronic immune thrombocytopenic purpura, or ITP. An FDA expert committee voted unanimously to back the drug and a formal decision is expected June 19. The news on Friday provided a big boost to Ligand shares, which shot up almost 50 percent. The rise came after a big loss last week after FDA staffers raised doubts about the drug's ability to significantly lower bleeding.

The decision in favor of the drug came despite concerns that the developers have yet to produce a significant amount of data on the effects of the drug over a long period of use. That's likely to be a key concern for regulators, as ITP is a chronic condition. Glaxo, though, said it has more studies in the works and plans to file additional data later this year.

- here's the release
- read the Wall Street Journal's report
- check out the AP story

Canadian biotech may face funding crisis

Tue, 20 May 2008 06:59:57 -0400

Every country's biotech industry is different. And E&Y's report notes that Canada in particular is "facing a real funding crisis," says Rod Budd, Ernst & Young's Canadian biotech industry leader.

"In Canada, the industry market cap dropped 26 percent in 2007, funding to public companies dropped by almost US$900 million and the number of companies shrunk by 14 percent reflecting the long-awaited consolidation. It's getting harder and harder to attract investors to this area," says Budd.

- check out the Canadian release

Novartis restructures its development strategy

Tue, 20 May 2008 06:59:56 -0400

Novartis CEO Daniel Vasella (photo) tells the Wall Street Journal that he knew Novartis had become too big and too bureaucratic when one of the company's top scientists expressed delight at finally meeting him. So he's set out to reconstruct the drug giant he built, with a particular emphasis on drug discovery.

At the top of the pipeline: two meningitis vaccines that could become blockbusters. And the new pharma chief--Joe Jimenez--is breaking up investigators into small teams so they can go one on one with regulators to see if they should move ahead with a development program.

- read the article from the Wall Street Journal

FDA's delay of Geron ESC trial raises concerns

Thu, 15 May 2008 06:59:57 -0400

Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Geron, which has been racing to become the first biotech with a hESC therapy in clinical trials, says it was given verbal notice that regulators are putting a hold on the planned trial. The company's shares plunged 20 percent on the news.

No details were offered on the reasons for the delay, though Geron's Dr. Thomas Okarma noted that "we are disappointed with this action given the interactions we had with the FDA." Analysts also note that FDA delays can be routine and of short duration.

Advanced Cell Technology has also been in the running to launch an ESC trial, which they hope to get approval for this year.

- check out Geron's release
- read the report from the San Jose Mercury News

Intercell snaps up Iomai in $189M deal

Tue, 13 May 2008 06:59:57 -0400

The little Maryland-based vaccine developer Iomai, which has posted some impressive data on a new therapy for traveler's diarrhea as well as an adjuvant for bird flu vaccines, is being bought out by Intercell for about $189 million. Intercell gains a mid-to-late-stage product in the needle-free diarrhea program, adding it to a Japanese encephalitis vaccine it has in development. The diarrhea patch is scheduled to enter Phase III in the first half of 2009. Intercell is looking for approvals of its vaccine by regulators around the globe this year.

In the deal, Iomai's public investors get cash for their shares while a group of large stakeholders will exchange their Iomai shares for shares in Intercell. Iomai was featured as one of FierceBiotech's emerging drug developers.

- here's the release
- read the AP story

SPOTLIGHT: Silver lining to Big Pharma's cloud?

Fri, 09 May 2008 06:59:53 -0400

Some people see the Big Pharma glass as half-full instead of the alternative. In an investor's-eye look at the industry, Kiplinger ticks off the usual criticisms: patent expirations, tough generics competitors, skyrocketing R&D costs, picky regulators, and election-year political pitfalls. But it also says that beaten-down pharma stocks are so cheap, for some there's no way to go but up. Pharma report

Eisai wins expert panel's approval for new sedative

Thu, 08 May 2008 06:59:57 -0400

Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, including colonoscopies. Data for the therapy suggests that the drug produces a slow onset of sedation, helping avoid potentially dangerous cases of sudden general anesthesia, which can trigger breathing difficulties.

The sedative is for patients with a minimum to moderate need of sedation. And the experts said that the drug could help fill a gap in hospitals and clinics that may be shorthanded in people trained in general anesthetics. Panel members asked Eisai, which acquired the drug with its buyout of MGI Pharma, for more studies on the sedative's impact on the elderly and obese.

- see Eisai's release
- read the report in the Wall Street Journal

Astellas faces new delay for Advagraf approval

Wed, 07 May 2008 06:59:54 -0400

Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised questions about the safety and efficacy of the drug for use in liver transplants. Last March the FDA issued an action letter regarding Advagraf for kidney transplants. The agency's action letters typically mean at least a six month delay before regulators will approve it.

Advagraf is already approved in Europe. Prograf earned $2 billion in sales last year.

- read the story in Yahoo News

FDA staffers say that Eisai sedative appears safe

Mon, 05 May 2008 06:59:54 -0400

FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in general anesthetics. Eisai gained rights to fospropofol disodium with its acquisition of Minneapolis-based MGI Pharma. And an FDA expert committee is scheduled to meet on Wednesday to consider Eisai's application for marketing approval. The sedative is designed for use during a number of procedures, including colonoscopies. Researchers say the sedative has a safer profile than existing meds.

- read the report in the Wall Street Journal