Merck Experiments On 900 Women With Untested Breast Cancer Vaccine - Investors Concerned

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http://www.bloomberg.com/apps/news?pid=20601202 & sid=aD2rO8iba81UBreast Cancer Vaccine Tests German Merck’s $1 Billion StrategyBy Naomi KresgeNov. 4 (Bloomberg) -- Merck KGaA of Germany is gambling an unproven therapy that spurs the immune system to attack cancer cells will increase its share of a $48 billion oncology market.Merck is enrolling more than 900 women globally in an experiment of a so-called cancer vaccine to treat breast tumors even before having evidence from smaller studies that the product works. Merck plans to seek approval for the treatment, known as Stimuvax, for lung cancer in 2012 based on studies in that disease begun in 2007, said Wolfgang Wein, head of the company’s oncology business.While Chief Executive Officer Karl-Ludwig Kley said in September 2008 that Stimuvax has the potential to generate $1 billion a year, Odile Rundquist, an analyst for Helvea SA in Zurich, is more cautious, estimating 180 million euros in annual sales by 2014. Merck needs new drugs to help it weather competition to its best-seller, Rebif, when the multiple sclerosis treatment loses patent protection in 2012, Rundquist said.“Stimuvax is a high-risk, high-reward asset,” said Rundquist. She estimates sales from the product may rise to 350 million euros by 2017. The calculation is “very conservative. It could be more,” she said.The expansion of the Stimuvax trials against breast tumors comes as Merck’s only marketed cancer drug, Erbitux, was unexpectedly denied approval for use in lung malignancies in July. Darmstadt-based Merck’s stock has fallen 14 percent since the decision, which the company is appealing.Lagging SharesRundquist said the Stimuvax project is worth about 4 percent of her 74-euro share price target for Merck, which has lagged the Bloomberg Europe Pharmaceutical Index this year as a result of the Erbitux setback.A surge in drug development spending including clinical trial expenses contributed to a 28 percent decline in Merck’s third-quarter earnings, reported on Oct. 26. The breast cancer study alone may cost the company about 100 million euros ($146 million), according to Commerzbank AG analyst Daniel Wendorff.The German company, which isn’t related to U.S. drugmaker Merck & Co., lowered its 2009 profit margin forecast for its drugs unit on the day of the earnings report, and said higher- than-usual spending on drug development will continue through 2010. Merck declined to comment on the cost of Stimuvax trials.Merck is taking nothing but “completely normal risks” on a product that could be the first of its kind, Kley said at a press conference to discuss the quarterly results.Investor ConcernsThe company may broaden the Stimuvax studies to include still more tumor types, said Oliver Kisker, head of cancer clinical development.The breast cancer project has stirred investor concerns, said Cornelia Thomas, a London-based analyst for WestLB AG. Merck could have waited for final-stage results in lung cancer before starting new tests, she said.Merck is testing the product for use as a potential first- line treatment for women with inoperable cancer, recurring tumors or metastases.Stimuvax belongs to a class of cancer drugs known as therapeutic vaccines. The approach involves injecting molecules that are unique to or found in abundance on tumor cells into the body to provoke an immune response, potentially offering a way to attack the tumor cells without harming healthy tissue, a drawback of traditional cancer therapies.Hurdles include experimenting on patients whose immune systems have been weakened by their disease or damaged by radio or chemotherapy.Attempting to spur the body’s natural defenses to kill tumor cells is a field scientists have probed for decades, and one that has been dogged by setbacks, WestLB’s Thomas said.Cancer VaccinesThe only therapeutic cancer vaccine to make it to market is Antigenics Inc.’s Vitespen, which was approved in Russia for kidney cancer last year after being rebuffed in the U.S., according to Thomas.Still, more companies are entering the field. Twelve of the 50 cancer therapies in late-stage clinical trials as of last year were therapeutic vaccines, according to research firm IMS Health Inc.Drugmakers including Pfizer Inc. are migrating to the cancer market, which offers bigger profit margins than primary care medicines and a higher barrier for generic rivals because the biotechnology drugs are harder to copy. IMS estimates that sales from oncology treatments will soar to $75 billion worldwide in 2012 from $48 billion now.Dendreon Corp. said in September it expects to begin selling a vaccine known as Provenge to fight prostate cancer by the middle of next year. Provenge is the only therapeutic vaccine to be proven to prolong patients’ lives, said Karen Anderson, an oncologist at the Cancer Vaccine Center at the Dana-Farber Cancer Institute in Boston, Massachusetts.Gold StandardTwo other therapeutic vaccines also seemed to help patients in recent studies, though neither met the clinical gold standard of prolonging lives, according to test results in May.One, an experimental treatment from Tampa, Florida-based Accentia Biopharmaceuticals Inc., kept lymphoma, a cancer of immune cells, at bay for more than a year among patients who achieved remission after chemotherapy, data presented at the American Society of Clinical Oncology in Orlando, Florida, in May showed. In a second study, twice as many patients with severe, late-stage melanoma, a skin cancer, saw their tumors shrink after treatment with a vaccine developed at the U.S. National Cancer Institute based in Bethesda, Maryland.GlaxoSmithKline Plc of London is also working on a lung cancer vaccine. The U.K. drugmaker began recruiting patients for a final-stage trial of its MAGE-A3 vaccine in October 2007. By May, more than 3,000 patients had been screened and 433 enrolled, spokeswoman Bernadette Murdoch said. Glaxo expects to recruit the 2,270 patients it needs by 2011, she said.More StudiesStimuvax targets cells with an antigen known as MUC-1, which is present in more than 90 percent of breast tumors, Kisker said. Merck is considering more clinical studies in other types of cancer because overactive MUC-1 is common in many kinds of malignancy, the executive said. The German drugmaker bought rights to the vaccine from Seattle-based biotechnology company Oncothyreon Inc. in 2001.Researchers have been looking at MUC-1 for two decades in the hunt for a “fundamentally different” approach to fighting cancer, said Anderson of the Dana-Farber Cancer Institute. Merck’s vaccine should work the same way in breast cancer as it does in lung tumors, though it’s uncertain whether the strength of the effect will be the same, Anderson said.“What we know is that the basic immunological mechanism should be similar,” she said. Anderson wasn’t involved with the MUC-1 research that led to Stimuvax and hasn’t consulted with Merck, Oncothyreon or its predecessor Biomira.Mixed ResultsResults on Stimuvax so far have been mixed. A smaller lung- cancer trial in 2004 showed the vaccine failed to help patients with advanced tumors live longer than those who just got standard care. A follow-up survey of the same trial found that one group of patients who received Stimuvax lived for 31 months, compared with 13 months for those who got standard care, though there weren’t enough patients in that group for the results to be statistically significant, Merck said.Sixteen patients in the 2004 trial were still alive in April after being treated from two to eight years. Eight of the living patients were still taking Stimuvax, Merck said in May.Merck was counting on growth from Erbitux before the lung cancer rejection, which denies the company an additional 252 million euros in sales by 2015, according to Alexandra Hauber, a JP Morgan analyst in London.Erbitux, approved for bowel tumors and head and neck cancer, was dealt an additional blow on Sept. 23 when an independent U.K. study showed it failed to lengthen colon cancer patients’ lives or keep their disease from getting worse.To reach $1 billion annual sales with Stimuvax, Merck will probably need to get the vaccine approved for more than just lung cancer, WestLB’s Thomas said.Merck has little to lose with investors by trying, said Commerzbank’s Wendorff.“It’s not good for Merck if it fails,” Wendorff said. “But the market doesn’t expect it to succeed.”To contact the reporter on this story: Naomi Kresge in Zurich at nkresgeLast Updated: November 4, 2009 00:00 EST =====«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»§ - PULSE ON 21st CENTURY ALTERNATIVE MEDICINE! §Subscribe send email to: - «¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»