FierceBiotech

ChemGenex shares dive on FDA's leukemia drug critique

John Carroll — Tue, 09 Feb 2010 12:25:58 -0500

With the FDA's oncology experts preparing to gather to consider the fate of ChemGenex Pharmaceuticals' experimental leukemia drug Omapro, FDA staffers are questioning the clinical significance of the therapy. And their skeptical stance triggered a steep dive in the Australian developer's share price.

Staffers noted that data from only 66 of the 100 patients with the T315I mutation who planned to enroll in the study were submitted, with 15 percent responding to therapy. The average benefit was 7.7 months, according to Bloomberg, and the company didn't detail how it determined if patients had the genetic mutation that spurs resistance to Gleevec.

"The company is aware of the questions posed by the FDA and we are confident in our ability to answer these questions during the ODAC meeting," ChemGenex notes in a statement. But Shane Storey, an analyst with Wilson HTM Investment Group, wasn't so sure.

Storey told investors that the staffers' objections were "disconcerting" but added that they were hardly the final word on the drug. ChemGenex shares plunged 20 percent, sliding to 68 Australian cents.

- here's the story from Bloomberg

Medivation's Dimebon turns in promising results for Huntington's

Maureen Martino — Tue, 09 Feb 2010 11:59:11 -0500

The drug Dimebon, which has shown some significant promise for Alzheimer's, has now registered positive results in a trial designed to test the therapy's ability to improve thinking, learning and memory skills for people who suffer from Huntington's. Dr. Karl Kieburtz of the University of Rochester in New York says that the drug also appears to be safe and well tolerated. Article

Crucell plots major boost in R&D spending

Maureen Martino — Tue, 09 Feb 2010 11:45:44 -0500

In the course of reporting its fourth quarter earnings, Dutch biotech Crucell said that it plans to boost R&D spending by a third in 2010. That's following a big year in 2009, during which the company landed a $70 million contract with NIAID/NIH to develop infectious disease vaccines. That deal was followed up in September of 2009 with Johnson & Johnson's purchase of an 18 percent stake in Crucell for $443.5 million.

Crucell, which hired 120 people last year, said it's using the J&J funding to significantly up its R&D spending, which amounted to spent €70.2 million last year. That additional cash will go to advancing its clinical product pipeline. Additionally, the company's strong cash position has led to speculation that Crucell will make acquisitions to keep pace with rivals like Sanofi's Shantha Biotech and Panacea Biotech. "If we would make an acquisition, it would be of a profitable product or products that are very close to being launched on the market rather than a pipeline product," Crucell CEO Ronald Brus told reporters, according to Reuters.

- here's Crucell's release
- check out this Reuters article for more

Amgen: Denosumab demonstrates superiority over Zometa

Liz Jones — Tue, 09 Feb 2010 11:17:54 -0500

Amgen's denosumab was more effective than Novartis' Zometa (zoledronic acid) in delaying fractures in men with advanced prostate cancer, according to results of 1,901-patient Phase III trial. In fact, denosumab outperformed Zometa by 18 percent in delaying the time before patients suffered a fracture or needed surgery or radiation treatment to ease bone pain, Bloomberg reports.

The results "demonstrate the ability of denosumab to delay bony complications in patients suffering from metastatic prostate cancer," Roger Perlmutter, executive vice president of R&D at Amgen, says in statement. "Denosumab has shown remarkable consistency in reducing the serious complications of bone metastases. [The] results greatly enhance our understanding of the efficacy of denosumab in multiple different tumor types."

This study is the final of three pivotal trials in more than 5,700 advanced cancer patients investigating the potential of denosumab to treat bone metastases. Results from the previous two trials were presented in last September. These three studies will form the basis of the clinical evidence package for denosumab in advanced cancer, which will be submitted to regulatory authorities later this year.

Amgen rose $2.42, or 4.2 percent, to $59.88, Bloomberg reports.

- check out the Amgen release
- read the Bloomberg coverage

Editor's Note: The original article incorrectly named Roche as the maker of Zometa. It has been corrected to read Novartis' Zometa. We regret this error.

Glaxo lays plans to pink-slip R&D workers

John Carroll — Tue, 09 Feb 2010 10:49:24 -0500

GlaxoSmithKline is beginning to detail plans to cut as many as 380 jobs at its R&D complex in Harlow, England. According to a Press Association report out this morning, GSK has begun a 90-day consultation process at the site, which employs 1,150 people.

Last week a spokesperson for GlaxoSmithKline said that the Harlow site and another R&D center in Verona, Italy faced the biggest job cuts as the pharma giant dropped its work on depression and pain. A smaller R&D center in Tonbridge is slated for closure with additional cuts planned in Zagreb Croatia, Poznan in Poland, and Mississauga in Canada.

Glaxo CEO Andrew Witty has been hammering away at the company's pipeline to make it more productive. He told investors last week that between 1998 and 2007 the £3 billion spent on research each year delivered no new molecular entities to the market.

- here's the story from the Press Association

Novartis licenses hep C drug from Debiopharm

Maureen Martino — Tue, 09 Feb 2010 10:22:44 -0500

Novartis has signed a deal with Switzerland's Debiopharm to develop and market Debio 025 (alisporivir), an antiviral agent for hepatitis C. Debio 025, which is currently in Phase II, is the first in a new class of drugs called cyclophilin inhibitors, which target host proteins that are involved in the growth of the hepatitis C virus. Financial details were not disclosed, but Novartis gets worldwide rights (outside Japan). Debiopharm is getting compensation upfront, along with milestone payments and royalties.

A Phase IIb study of the drug is underway to assess the efficacy and safety of Debio 025 in combination with peginterferon alfa-2a plus ribavirin, the current standard of care. It's being studied in patients who haven't previously received treatment for hep C.

- here's Novartis' release

BIO chief maps salvage plan for the 12-year umbrella

John Carroll — Tue, 09 Feb 2010 08:18:39 -0500

Just a few weeks ago, 2010 was shaping up as the year that the biotech industry would be handed one of the biggest legislative trophies buried inside the healthcare reform bill. Even with a key House leader--Henry Waxman--and President Obama voicing objections at the end of the long wrangle, the votes in the House and Senate were solidly in support.

But that was before the Scott Brown election in Massachusetts turned the heat up in Washington and healthcare reform became a political hot potato.

The optimist in Jim Greenwood, the president and CEO of the Biotechnology Industry Organization, still sees a path to approval, but it gets narrower with every passing day. It is, he tells me at the BIO CEO & Investor conference in New York, "increasingly difficult politically to get it done." But that doesn't mean that Greenwood, a former Congressman with considerable legislative skills and certainly the industry's leading lobbyist, is going to stand aside as the prize slips away from his grasp at the 11^th hour. So he sat down on the first day of the conference and offered FierceBiotech readers some ideas on the way forward.

The healthcare reform bill isn't going to get through the Senate unless it goes through the reconciliation process, he says. And the House would have to craft a new bill that 'fixes' some of the problems that can't pass the public smell test: The Nebraska Medicaid payoff and Cadillac health plan tax being the two most prominent examples. But that path gets narrower with every passing day, and there's a good chance that supporters won't be able to thread the needle.

A separate, stand-alone bill that carves out the data exclusivity issue from healthcare reform would likely get stymied by key committee leaders in the House and Senate who opposed the 12-year umbrella plan. "I think we have the political support we need in the House and Senate," says Greenwood. And attaching the initiative to a bill that has broader support could well prove to be the industry's best hope for getting what most developers want and most lawmakers are willing to back.

That's the same path that could be used to gain approval for another big prize: A tax credit allowing developers to deduct half the cost of discovery, with the refunds converted into a grant if the biotech company don't have any taxes to refund. Any bill that offers that kind of financial support would likely be greeted with big smiles by most developers.

BIO's legislative champions, like California Congresswoman Anna Eshoo, who was the chief protagonist in favor of 12 years of data exclusivity, still have a chance to prevail with members of the Obama administration, who may no longer have a big appetite for squabbling over this particular issue. - John (twitter | email)

Novavax, ROVI end talks over flu vax

Maureen Martino — Mon, 08 Feb 2010 11:32:11 -0500

In a terse statement, Novavax said today that it's halted negotiations in its pursuit of the previously announced collaboration with ROVI Pharmaceuticals to develop Novavax's virus-like-particle (VLP)-based vaccines against influenza in Spain. Novavax said the two companies are unable to agree on acceptable terms of the proposed collaboration and to obtain the necessary funding commitments for the program.

Novavax and ROVI announced in June a deal through which ROVI would license Novavax's technology for use in Spain. And Spanish officials committed €60 million to develop vaccines and establish the country's first vaccine plant, along with the funding needed to get the vaccines through the regulatory process. Apparently, that money hasn't materialized. Novavax says it's now on the hunt for a new partner for its pandemic and seasonal influenza vaccine efforts in Europe.

- check out the release from Novavax

Senate provision could benefit biotech industry

Liz Jones — Mon, 08 Feb 2010 11:09:28 -0500

As the tough economy forces biotechs to halt projects or declare bankruptcy, the industry is looking to a provision in the Senate's version of the healthcare reform bill to keep research going.

The so-called Therapeutic Tax Credit, backed by Sen. Robert Menendez (D-NJ), is intended to help companies with fewer than 250 employees pay the salaries of their scientists, continue research and even hire workers to help the companies develop new medicines, according to the Star Ledger.

The program would require companies to compete for money by submitting research projects to the federal Treasury Department. The companies would have to show how their projects lower healthcare costs or meet an unmet medical need. Tax credits will cover as much as 50 percent of the R&D expenses generated by the submitted project. The program is capped at $1 billion for the two-year period, according to the Ledger article.

The Biotechnology Industry Organization already has praised the amendment. "Emerging research-intensive biotech companies have to raise hundreds of millions of dollars during a decade-long period to bring new treatments to the market for H1N1 (swine flu), cancer, Alzheimer's, and many other unmet medical needs," BIO President and CEO Jim Greenwood said last year. "Senator Menendez's amendment will advance the key goal of healthcare reform: that all Americans have access to quality healthcare, including innovative, high-quality therapies."

Menendez has said the provision also could be added to the Senate jobs bill, which President Obama urged lawmakers to pass during his State of the Union speech.

- check out the Ledger's coverage

FDA questions Cell Therapeutics' pixantrone

Maureen Martino — Mon, 08 Feb 2010 10:56:34 -0500

Ahead of Wednesday's advisory committee meeting, FDA staffers have raised questions about Cell Therapeutics' lymphoma drug pixantrone. The developer is hoping to market the therapy, also known as Pixuvri, as a treatment for patients with non-Hodgkin's lymphoma that hasn't responded to other treatments.

The agency has concerns about both the drug's effectiveness as well as its safety profile. Difficulty recruiting patients led Cell Therapeutics (CTIC) to halted trial enrollment with only 40 percent of the patients originally planned for the trial. That's caused doubts about "the level of evidence necessary to draw conclusions from this Phase III study and the reliability of these conclusions," according to the agency's documents. The FDA also cited concerns about "substantial hematologic and cardiac toxicity" associated with pixantrone.

An expert panel will weigh the drug's effectiveness against its side effects, and a full decision is expected by April 23. Cell Therapeutics stock was down 36 percent this morning on the FDA's comments.

- here's TheStreet report
- read the Reuters article for more