Cancer Drugs: November 2006 Archives

Nov 27 (Reuters) - Cytokinetics Inc. (CYTK.O: Quote, Profile, Research) said it will be responsible for the costs and activities of further development of two cancer drug candidates following an amendment of a collaboration agreement with GlaxoSmithKline plc (GSK.N: Quote, Profile, Research).

The company also lowered its 2006 revenue outlook to $3 million to $4 million, with research and development expense of $52 million to $56 million. Analysts on average were expecting the company to report revenue of $3.8 million, according to Reuters Estimates. (Reporting by Hari Kumar in Bangalore)

© Reuters 2006.

Canadian biotech drug maker AEterna Zentaris Inc. said Monday that women enrolled in an early stage clinical trial were able to tolerate its experimental cancer treatment.

In the study, 17 women with gynecological and breast cancers were given increasing doses of AN-152, and tolerated the maximum dose of the treatment well, according to the company.

AEterna Zentaris also said that results hinted at effectiveness of the treatment.

Biotech drug developer Introgen Therapeutics Inc. on Tuesday said the European Patent Office issued a patent covering the company's platform for killing cancer cells.

The patent, which is one of a family of patents issued to University of Texas and licensed to Introgen exclusively, covers one or more of 40 tumor suppressor genes for inducing programmed cell death in cancer cells.

The company seeks to use synthetic nanoparticles to deliver the genes to cancer cells, and shows promise in treating lung cancers that have spread.

Introgen shares rose a penny to $4.74 in afternoon trading on the Nasdaq.

source - BusinessWeek 

The German drugs giant Merck is seeking help from the world of traditional Chinese medicine to find a cure for cancer. The Chinese medicine company spun out of Hong Kong's Hutchison Whampoa, Chi-Med, will today unveil a potentially lucrative deal to research oncology on behalf of the German group.

Merck will pay Chi-Med to raid centuries of Chinese medical knowhow in search of a natural cancer-fighting product that it can turn into a marketable Western drug.

The financial terms of the deal were not disclosed, but Chi-Med stands to reap tens of millions of pounds from the partnership if it comes up with a drug that is suitable to be put into trial.

TRIALS of a potential new cancer treatment made from a noxious weed have been halted after concerns were raised by the drug regulator.

Australian manufacturer Solbec Pharmaceuticals has suspended testing of its developmental drug Coramsine, designed to work alongside chemotherapy to treat advanced cancers.

The company was about to enlist up to 120 skin cancer and kidney cancer patients for trials at 16 hospitals nationwide.

However, concerns raised by the Therapeutic Goods Administration (TGA) have put the studies on hold.

The hardest thing to do for any biopharmaceutical company is obviously just bringing a drug to market. Drug makers though, can make this process easier or harder on themselves by trying to get their drugs approved with a broader label for more indications or to be used sooner in a disease's progression. Because of the conservative nature of the U.S. Food and Drug Administration (FDA) it's usually a smart idea just to bring a drug to market with one label, and then if additional clinical studies suggest it will be useful in other indications, then patient demand and awareness will drive off-label usage of the drug until it receives a broader label.

Drug developer Genentech has pursued this strategy for most of its top drugs, and it has paid off greatly for it. Today, Genentech finally received formal approval to market its breast cancer therapy Herceptin for the early stages of breast cancer before the disease has spread to other parts of the body in the 30% or so of sufferers of the disease that the drug is effective in.

While this formal approval to use Herceptin earlier in the disease's progression will most likely spur higher sales, sales of the drug have been gaining rapidly since the interim results of the trial that brought about this label expansion were announced in April of last year.

Biotech drug developer Exelixis Inc. said Thursday its licensee, Helsinn Healthcare SA, discontinued a late-stage cancer drug clinical trial when it was found that chemotherapy was more effective.

Helsinn discontinued enrollment of new patients in the becatecarin (XL119) Phase III clinical trial. The anticancer compound targets tumors of the biliary tract, which helps connect the liver to the small intestine.

Helsinn reported that preliminary analysis of the Phase III data by an independent data monitoring committee indicated that patients treated with chemotherapy demonstrated greater-than-expected survival rates by comparison.

Data on Veridex LLC's lab test to quickly detect breast cancer that has spread to lymph nodes lacks long-term information on survival, U.S. regulatory staff said in documents released on Wednesday.

Veridex, a Johnson & Johnson company, is seeking Food and Drug Administration approval of its GeneSearch Breast Lymph Node Assay to find cancerous growths in lymph node tissue that has been removed from breast cancer patients.

An FDA advisory panel is scheduled to review the test on Thursday and make a recommendation on whether it is safe and effective enough to be marketed. The agency usually follows the recommendations of its outside advisers.

GlaxoSmithKline Plc's new breast cancer pill Tykerb will receive a priority review from U.S. regulators in a move that should speed its path onto the world's biggest drugs market next year, it said on Thursday.

Priority review designation requires the U.S. Food and Drug Administration to decide on a drug application six months after submission. Tykerb was filed for U.S. approval on Sept. 18.

The oral cancer treatment is a potential rival to the blockbuster Herceptin, which is given by injection, and is a key new medicine for Europe's biggest drugmaker. Glaxo hopes it will confirm its arrival as a major force in oncology.

Pharmion Corp. on Wednesday said it acquired Cabrellis Pharmaceuticals for an initial cash payment of $59 million to expand its portfolio with a cancer drug candidate currently in mid-stage trials.

Pharmion said it will make two additional payments of $12.5 million each if the small cell lung cancer drug, amrubicin, gets U.S. and EU approval.

The deal will result in a $55 million charge in Pharmion's fourth quarter, the biotechnology company said. Cabrellis has $4 million in net cash.

BOSTON (Reuters) - Biotechnology company Genentech Inc.  has raised the price of its cancer drug Tarceva by 8 percent in the United States, according to a regulatory filing.

Genentech raised the wholesale price of Tarceva -- which is approved to treat lung and pancreatic cancer -- to $2,893.86 from $2,679.50 for a 30-day supply of 150 milligram tablets, according to a document filed on Tuesday by Genentech's partner, OSI Pharmaceuticals Inc. with the U.S. Securities and Exchange Commission.

The increase comes amid growing concern among doctors, governments and insurers about the cost to consumers of the newest generation of cancer drugs, which can cost tens of thousands of dollars a year.

Cancer diagnostics and treatment products company North American Scientific Inc. said Tuesday the Food and Drug Administration approved a high-dose radiation version of its breast cancer treatment.

The company received approval for the specific design of ClearPath, its breast brachytherapy, or internal radiation, product. The low-dose rate version was approved in April. Brachytherapy uses radioactive seeds placed through the breast using needles or catheters.

Shares of North American Scientific rose 6 cents, or 5.4 percent, to $1.16 on the Nasdaq in morning trading. The stock has traded between 1 cent and $3 over the last 52 weeks, and is off 49 percent since the start of the year.

source - BusinessWeek 

Specialty drug maker Spectrum Pharmaceuticals Inc. said Monday a midstage study of its developing prostate cancer drug met its primary goal of safety and suppressing testosterone levels.

The drug candidate, called Ozarelix, is aimed at treating prostate cancer, which is the second leading cause of cancer-related deaths in men. In a Phase II clinical trial, a 130-milligram dose given every 4 weeks provided continuous testosterone suppression in patients between day 8 and day 85 of the study. The drug also met a secondary goal, the reduction of a prostate specific antigen.

Spectrum received an exclusive license from AEterna Zentaris in 2004 to develop and market Ozarelix in North America and India. The company will receive half of any payments or profits from sales of the drug in Japan.

The estate of a wealthy New York businessman who died in 1992 is donating $120 million of his real estate fortune to six cancer research organizations, including Dana-Farber Cancer Institute and the Massachusetts Institute of Technology. The six recipients will get $20 million each this year and millions more in future years.

The Ludwig Institute for Cancer Research, which was established by shipping tycoon Daniel K. Ludwig, planned to announce the gift today.

Board members of the nonprofit foundation said they have asked the six institutions to abide by several stipulations, including to collaborate on research projects and to study how cancer spreads in the body. Ninety percent of cancer patients die from metastasis, instead of the original tumor. The foundation's board also urged the researchers to choose daring, high-risk projects that might not win government funding.

A lung cancer drug that has been taken off the shelf in the US market is much more likely to prove effective in some Taiwanese lung cancer patients, according to a local study that was recently published in the journal Lung Cancer.

"We decided to do the study when we realized that Taiwanese patients were doing much better on Gefitinib than studies from abroad would predict," said Huang Hsiu-feng (黃秀芬), the principle investigator of the research into 65 non-small cell lung cancer patients conducted by the National Health Research Institutes.

According to Huang, they found that more than 50 percent of participants responded to the therapy, in contrast to a response rate of around 10 percent found in Western studies.

NEW YORK (Reuters) - Sales of colon cancer drug Erbitux have not been hurt by the launch last month of Amgen Inc.'s rival drug Vectibix, the chief executive of Bristol-Myers Squibb Co. said on Wednesday.

"It is awfully soon, but they launched at a discount, which usually suggests that the product may not be as good as ours or is for a narrower indication," James Cornelius, interim CEO of Bristol-Myers, said at the Reuters Health Summit in New York.

Bristol gets 60 percent of revenue from partner ImClone Systems Inc.'s sales of Erbitux.

Amgen, which priced its drug at $8,000 a month, or a 20 percent discount to the $10,000 a month average cost of Erbitux, is expected a carry out a formidable campaign to dislodge Erbitux as the leading treatment for colon cancer patients who have failed other therapies and said earlier this week the launch of Vectibix is going better than expected.

November 6 (Istanbul) — Cancer patients receiving epoetin to prevent anemia during chemotherapy or radiation treatment fared just as well on once-weekly doses as on the traditional thrice-weekly regimen, but with several advantages. In addition to being far more convenient for patients, the once-weekly regimen had a shorter duration of treatment and less need for dose escalation and probably had a better cost-effectiveness, according to a prize-winning poster presentation at the recent 31st Congress of the European Society of Medical Oncology (ESMO).

These conclusions come from a clinical trial in 409 patients reported by Jose Munoz-Langa, MD, and colleagues, from the Dr Peset University Hospital, in Valencia, Spain. These patients had a variety of solid tumors requiring chemotherapy or radiation and were given epoetin alfa either 40,000 IU once weekly or 10,000 IU 3 times weekly. Two commercial preparations of epoetin alfa are available, Procrit (Johnson & Johnson) and Epogen (Amgen), but the poster did not specify which was used.

DARMSTADT, Germany: Merck KGaA, a German drug and chemical maker, said Monday that test results of its bowel cancer drug Erbitux did not meet its hopes for patient survival rate.

Results from a trial of 1,300 patient did not show a significant difference in prolonging life when comparing Erbitux taken in combination with standard treatment irinotecan and irinotecan alone.

Merck studied the efficacy of Erbitux in combination with irinotecan, a chemotherapy treatment, and found that patients did not survive without progression of the disease as the company hoped.

Still, Erbitux did show positive results in delaying the progress of the disease, the company said in a statement.