leukemia

Antisoma buys Xanthus for $52M

Fri, 16 May 2008 06:59:56 -0400

Looking to boost its pipeline, the U.K.'s Antisoma is paying $52 million for Boston oncology company Xanthus Pharmaceutical. Antisoma gains three drug candidates:

Xanafide, which is in Phase III trial in secondary acute myeloid leukemia,
Oral fludarabine, which has been submitted to the FDA for marketing approval for the second-line treatment of chronic lymphocytic leukemia, and
the Flt3 program, which is in preclinical testing for non-oncology indications. Antisoma says it may out-license this drug.

The deal lessens Antisoma's dependence on ASA404, a non-small cell lung cancer treatment. Last year the company announced it would pit the drug against Roche and Genentech's Avastin in a late-stage trial. Glyn Edwards, CEO of Antisoma, said: "This is a transforming deal. Combining Antisoma and Xanthus produces a company with the critical mass and mature pipeline needed to become a major player in oncology."

- here's the release on the deal
- read the MarketWatch article for more

EUSA Pharma spins off assets as it narrows focus

Thu, 01 May 2008 06:59:56 -0400

The transatlantic EUSA Pharma has spun off its monoclonal antibody research operation along with a development program for leukemia as it narrows its focus to late-stage drug development and marketing. France's International Drug Development snared the antibody operation while the Alize Pharma Group snagged the recombinant L-asparaginase therapeutic research program for acute lymphoblastic leukemia. EUSA's antibody research business is based in Dardilly, France, and includes a library of approximately 600 murine antibodies.

Bryan Morton, chief executive of EUSA Pharma said: "As we continue to rapidly build our business around our commercial infrastructure in the US and Europe, we are creating the opportunity to compete effectively with major players as an attractive partner for companies seeking specialist transatlantic commercialization and late-stage development expertise in the oncology, pain control and critical care areas."

- read EUSA's release for more information

Aldagen gets $18.4M in fourth round

Fri, 25 Apr 2008 06:59:56 -0400

With the help of Intersouth Partners, Tullis-Dickerson, Harbert Venture Partners and The Aurora Funds, stem cell technology company Aldagen has closed an $18.4 million fourth round of funding. The company plans to use the funding to to advance four clinical-stage product candidates and for general corporate purposes. Durham, NC-based Aldagen has been developing adult stem cell therapies for leukemia, damaged heart muscles and other ailments.

- check out Aldagen's release
- read this report for more

ALSO: Malvern, PA-based CRO Frontage Laboratories has raised $10 million in growth equity funding. Release

SPOTLIGHT: Genta restructures

Wed, 02 Apr 2008 07:59:53 -0400

restructures
With the FDA unwilling to budge on its decision to demand more data before it approves the leukemia drug Genasense, Genta announced plans to cut 16 employees--about 30 percent of its workforce--as it restructures to conserve cash. Release

Cephalon, investors await FDA Treanda decision

Wed, 19 Mar 2008 07:59:54 -0400

After seeing its stock price shed about a third of its value since last summer, Cephalon is keeping its fingers crossed that tomorrow's scheduled regulatory decision on its cancer drug Treanda can turn things around. At least that's what the analysts are seeing. Some expect a sharp upturn if the agency approves Treanda for chronic lymphocytic leukemia.

"This is the first big step. It will be the foundation for our oncology business," Liz Barrett, vice president of Cephalon's oncology unit, told the Wall Street Journal. Analysts peg its potential in the neighborhood of $250 million a year. But Cephalon is also looking for additional approvals, including using the therapy as an add-on to Rituxan, which could make it a seven-figure market blockbuster.

- here's Cephalon's release
- read the report in the Wall Street Journal

Related Articles:
Cephalon, NitroMed make cuts jobs. Report
Positive Phase III results for Cephalon's Treanda. Report
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

Rumors of buyout interest heat GenMab stock

Mon, 28 Jan 2008 06:59:58 -0500

There's been some heated speculation that Biogen Idec--the jilted biotech turned avid suitor--is taking a close look at GenMab, a Danish company in trials for HuMax, a new leukemia therapy. HuMax, though, has been partnered with GlaxoSmithKline, which may want to counterbid against any takeover move. Glaxo already owns 10 percent of GenMab's shares. Novo Nordisk has also been listed as a potential suitor. GenMab shares were up 5.62 percent in a stormy European market

Late-stage data on HuMax is due in the late spring, analysts noted, adding that any takeover at this stage would include some dramatic risks. That might suit Biogen Idec, though. Its CEO was scornful that big pharma companies were unwilling to offer what he thought the company was worth, and then set out to do his own deal for up to $10 billion.

- read the report from Trading Markets
- and here's the report from The Times

ALSO: ImClone Chairman Carl Icahn has three people he'd like on Biogen's board, including ImClone board member Alexander Denner. Report

Related Articles:
Biogen CEO spells out interest in biotech buyout. Report
Biogen CEO: Pharma too wimpy to deal. Report
Biogen shares deflate as it gives up on sale. Report
Glaxo forges $2.1B deal for HuMax-CD20. Report

Biogen CEO spells out interest in biotech buyout

Tue, 22 Jan 2008 06:59:55 -0500

Just days after scornfully assessing a field of weak-kneed pharma companies that were too timid to see the real value in Biogen Idec, the CEO says he may be in the market for a $10 billion acquisition himself. And in an interview with MergerMarkets he said that any takeover target would not have to have late-stage therapies in the pipeline. A bullish-sounding Jim Mullen also told the publication that he expects to see two new therapies launched this year from a pipeline with 15 compounds in Phase II or beyond. Mullen said Biogen Idec will focus on rheumatoid arthritis, lupus and leukemia.

- read the report from the Financial Times

Related Articles:
Biogen CEO: Pharma too wimpy to deal. Report
Biogen shares deflate as it gives up on sale. Report
Is Big Pharma souring on Biogen deal? Report
Sources: Biogen gets bidders, with Pfizer in lead. Report

FDA extends review time for Genta's appeal

Mon, 14 Jan 2008 06:59:54 -0500

Genta is going to have to wait a little longer before it gets final word on its appeal of the FDA's rejection of Genasense. The feds were supposed to act by the end of last year, but Genta says now that a decision won't be made until sometime in the current quarter. Genta had filed for approval to use Genasense with chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

- check out the release on the appeal

Related Articles:
FDA rejects Genasense. Report
Advisory committee rejects Genta cancer drug. Report
Genasense hits primary endpoint in late-stage cancer trial. Report

FDA removes hold on Vion's late-stage cancer trial

Tue, 08 Jan 2008 06:59:55 -0500

Vion Pharmaceuticals has received a green light from the FDA to resume studying the cancer drug Cloretazine as regulators removed a clinical hold on a Phase III trial of the therapy. The late stage study of Cloretazine in combination with cytarabine for acute relapsed myeloid leukemia was put on hold after researchers raised concerns over an increase of death relative to the control arm of the trial matching cytarabine and a placebo. But a review found no reason to believe there was any unexpected toxicity playing a role in the deaths.

- read this release for more
- here's the report from Thomson Financial

Related Article:
Vion shares dive after Phase III trial is suspended. Report

Novacea slows down development program for AQ4N

Thu, 03 Jan 2008 06:59:55 -0500

Novacea, which is burning through $17 million to $19 million this year, says it will scale back on the development of AQ4N, shelving a clinical trial in acute lymphoblastic leukemia and delaying a clinical trial in B-cell lymphoma. The news was included in a strategic review of its plans for 2008. An ongoing Phase Ib/IIa clinical trial of AQ4N in patients with glioblastoma multiforme will continue.

"Since we terminated the ASCENT-2 trial in advanced prostate cancer, managing our capital resources, which totaled approximately $110 million in cash and receivables at the end of the third quarter of 2007, is a top priority as we seek to maximize the strategic options available to the company," says Novacea CEO John Walker.

- see Novacea's release
- read the report from Trading Markets

Related Articles:
Novacea ends Asentar trial, shares plunge. Report
Novacea cheered on decision to expand cancer trial. Report
Novacea stock rockets up on $440M deal. Report
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Santaris grabs $30M in third round venture cash

Tue, 18 Dec 2007 06:59:54 -0500

Denmark's Santaris Pharma has banked $30 million from its latest venture round. Gilde Healthcare Partners put up much of that money with BankInvest, Novo, LD, Forbion Capital Partners, Global Life Science Venture, Sunstone Capital, Seventure, Omega, Innovation Capital and members of the company's board and management joining in.

Santaris has been studying RNA antagonist drug candidates based on its LNA chemistry. In 2008 the company said it expects to advance its SPC2996 compound, an RNA antagonist of Bcl-2, into Phase II clinical trials in chronic lymphocytic leukemia and B-cell lymphoma and initiate phase I volunteer studies of two new RNA antagonists for metabolic disorders.

- check out the release for more info

Related Articles:
Santaris inks $200M collaboration with Enzon. Report
Santaris Pharma pockets $48.3M in VC. Report

China launches drug recall system

Wed, 12 Dec 2007 06:59:54 -0500

Lately, not a week passes without China's trumpeting a new drug-safety initiative, and this week is no exception. Now, the country says it's launching a nationwide drug recall system. The news comes on the heels of a drug-and-device safety pact with the U.S., signed into being just yesterday. The recall plan will force pharma companies to withdraw problem products within 24 hours if they pose major safety concerns. If companies voluntarily recall bad drugs, they may escape fines and other punishments.

Meanwhile, China has also cracked down on the manufacturer of a tainted leukemia drug by pulling its production license. Shanghai Hualian Pharmaceutical also saw revenues from the drug seized, and company officials were taken into custody.

- check out the AP article
- read more on Shanghai Hualian's punishment

Related Articles:
China mulls its first drug-recall system. Report
U.S.-China safety deal goes official soon. Report
Americans distrust drugs from China, India. Report
China to overhaul drug safety regulations. Report
R&D spending going gangbusters in China. Report

BioCryst halts leukemia trial

Fri, 07 Dec 2007 06:59:56 -0500

BioCryst has discontinued a Phase IIb trial of intravenous Forodesine HCl in patients with T-cell acute lymphoblastic leukemia/lymphoma. The decision to discontinue the trial was based on a number of issues. There were delays associated with addressing a previously announced stability problem, a limited number of patients were eligible to be enrolled in the trial and, to cap it all off, there was a lower-than-expected response rate observed in an earlier trial. BioCryst made sure to point out that other clinical trials, which are using the oral capsule formulation of forodesine HCl, are still ongoing.

- see BioCryst's release for more

Related Articles:
BioCryst trial scuttled by short needles, fat arms. Report
Stonehouse tapped to run BioCryst. Report

ChemGenex restructures, focuses on cancer drugs

Mon, 29 Oct 2007 07:59:54 -0400

ChemGenex Pharmaceuticals, which recently reported positive data on the experimental leukemia therapy Ceflatonin, says it is restructuring the company so it can focus on its cancer therapies. The company's wholly-owned Autogen Research, which holds its metabolic disease assets, is being renamed Verva Pharmaceuticals. Verva will be demerged from ChemGenex and merged with Adipogen Pharmaceuticals in a stock deal. Following a capital raising, Verva Pharmaceuticals will seek a listing on the ASX in early 2008.

- check out this release for more

Related Articles:
ChemGenex gains orphan status for cancer drug. Report
ChemGenex gains fast track. Report

Aldagen adds $9M in new venture funds

Thu, 13 Sep 2007 06:59:55 -0400

Durham, NC-based Aldagen has added $9 million in new money for its third round, bringing total investment in the Series C to $23 million. That money will be put to use developing new stem cell therapies. Aldagen was founded in 2000 and is developing programs with technology initiated at Duke University. Researchers at the company have been developing adult stem cell therapies for leukemia, damaged heart muscles and more. Its third round is expected to be enough to fund the company until mid-2009. CNF Investments and Tullis-Dickerson are now betting on the company's success.

- see Aldagen's release
- read the report from the Triangle Business Journal

Related Article:
Aldagen gains $17.3M in financing. Report

Sunesis pares staff in cost-cutting move

Wed, 29 Aug 2007 06:59:54 -0400

Sunesis Pharmaceuticals is paring 35 workers, or 25 percent of its staff, in an effort to pare out $10 million in costs. Research and general administrative areas will be cut the most as the developer concentrates on advancing its lead therapy, SNS-595 for leukemia and ovarian cancer. Sunesis had $65.2 million in cash on hand at the end of June.

- see the announcement on the cuts

Cell Therapeutics sees fewer side effects in NHL trial

Wed, 11 Jul 2007 06:59:55 -0400

Seattle-based Cell Therapeutics says that interim data from a Phase II/III trial of pixantrone demonstrated fewer severe side effects than the standard care for non-Hodkin's lymphoma. Compared with a group of patients receiving doxorubicin, researchers say that both arms of the trial achieved similar efficacy results with complete or partial tumor response among virtually all patients.

"We are excited by these results demonstrating that pixantrone is living up to the promise of preventing the severe cardiac damage that accompanies the use of standard doxorubicin treatment while retaining the potent anti-lymphoma activity of this class of drug," said James A. Bianco, M.D., President and CEO of CTI. "Pending results from this and other studies, these findings could have major implications for treating patients with breast cancer, lymphoma, and leukemia, where debilitating cardiac damage from doxorubicin might be prevented."

- read the report for more information

Related Articles:
Cell Therapeutics spins off new protein tech company. Report
Cell Therapeutics inks deal for Xyotax. Report
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SPOTLIGHT: FDA rejects Genasense

Thu, 14 Dec 2006 19:01:33 -0500

Already hammered by poor trial data, Genta announced today that the FDA had formally rejected its leukemia therapy Genasense. Genta's stock dropped more than 20 percent to 54 cents a share. Its stock had already been hurt by the news several days ago that the therapy had failed a trial. "We are keenly disappointed by this decision," Raymond Warrell, Genta's chief executive, said in a statement. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with relapsed and refractory CLL in a carefully designed and executed randomized clinical trial." Release | Report

ALSO NOTED: Pepscan Systems raises $9M in second round; Opexa starts Phase II Tovaxin study; and much more...

Mon, 18 Sep 2006 20:01:30 -0400

> Netherlands-based Pepscan Systems, a peptide based immunotherapy company, announced today that it has raised $9 million in a second financing round by issuance of equity to a group of Dutch investors. Release

> Chutes & Ladders: Dr. Jim A. Wright will step down as the President and CEO of Lorus Therapeutics on September 21st. Report

> Novartis has received additional approvals for Glivec in the EU. The approvals cover a rapidly progressive form of leukemia and a hard-to-treat solid cancer tumor. Report

> Opexa has kicked off a Phase IIb study of Tovaxin for the treatment of multiple sclerosis. Report

And Finally... Pfizer is going to court to try to keep the lid on Dr. Peter Rost's The Whistblower: Confessions of a Healthcare Hitman. Release

Genzyme's Campath performs well in MS study

Wed, 13 Sep 2006 20:01:35 -0400

Genzyme is touting the interim data from a head-to-head study that compares its drug Campath against Serono's Rebif for treating multiple sclerosis. Researchers claim that Campath patients demonstrated a lower rate of relapse and significantly reduced the rate of progression to disability. Campath is currently approved as a therapy for leukemia and Genzyme is pushing to expand its approval to MS. The two-year Phase II trial included 334 patients.

- see the release on the Campath trial