Novartis AG’s cancer drug Afinitor has been rejected for patients with kidney cancer by Britain’s health costs watchdog, which says it is too pricey for the country’s taxpayer-funded National Health Service (NHS).

The drug, known generically as everolimus, was being considered for the second line treatment of advanced renal cell carcinoma, but the National Institute for Health and Clinical Excellence (NICE) said it did not provide enough benefit to patients to justify its high cost.

“We are disappointed not to be able to recommend everolimus as a second line treatment option,” NICE chief executive Andrew Dillon said in a statement. “However, we have to ensure that the money available to the NHS is used to best effect, particularly when NHS funds, like the rest of the public sector, is under considerable financial pressure.”

The decision was criticised by advocacy groups, who said it was “another disappointing blow” after NICE last year rebuffed three other drugs for kidney cancer patients.

“Once again NICE has disappointed the thousands of kidney cancer sufferers in the UK by not approving everolimus, a drug which gives terminal kidney cancer patients and their families some hope,” said Nick Turkentine of the James Whale Fund for Kidney Cancer.

NICE has ruled that only Pfizer’s cancer drug Sutent will be reimbursed for kidney cancer patients on the NHS, with Roche’s Avastin, Bayer’s Nexavar and Pfizer’s Torisel also rejected as not cost-effective.

Source: Reuters

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With late-stage data on an experimental blood thinner with blockbuster potential due next year and ambitious plans to push revenue, Daiichi Sankyo’s European chief tells Bloomberg that the Japanese pharma company would like to do some more deals along the lines of its $235 million buyout of Germany’s U3 Pharma AG.

Reinhard Bauer made it clear that he’s not on the lookout for any generic drugs or meds already approved for use. U3, which Daiichi Sankyo bought two years ago, provided the pharma company with antibodies for breast, colon and lung cancers. And the blood thinner edoxaban could gin more than a billion dollars a year in new revenue. Edoxaban would also offer new competition to Bayer and Boehringer Ingelheim.

“We’re still looking energetically for venture capital companies and biotechnology companies that could lead to acquisitions or partnerships,” Bauer told the business news wire.

U3 Pharma was founded by Professor Axel Ullrich of the Max Planck Institute of Biochemistry, whose gene technology and oncology research helped lead to the development of Herceptin and Sutent.

Source: FierceBiotech

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Who is doing the most to get medicines to the developing world? GlaxoSmithKline, at least according to this year’s Access to Medicines Index, with Merck, Novartis, Gilead Sciences and Sanofi-Aventis rounding out the top five.

This year’s access index–which looks at pricing policies, R&D efforts, patents, access and more–includes six European companies in the top 10, with the remaining four from the U.S. Produced by a Dutch foundation and backed by institutional investors and funds that manage $3.1 trillion in assets–as Reuters notes–the index is designed to help investors compare drugmakers’ social responsibility.

Access to drugs in emerging markets isn’t only a social issue for drugmakers these days, but a key business strategy. Companies such as GSK and Sanofi have cut their prices in the developing world to help spur volume sales. Big Pharma has been buying up and partnering with drugmakers in Africa, India, China and Latin America.

As emerging markets continue to deliver the biggest growth prospects on the globe, no doubt access to Big Pharma drugs will continue to grow. ”[E]merging markets are where the larger growth is,” My-Linh Ngo, associate director of sustainable investments at Henderson, told the Financial Times. “Better access to medicines helps position them.”

Looking at this year’s top 10, we have Roche, AstraZeneca, Novo Nordisk, Johnson & Johnson, and Abbott Laboratories in sixth through tenth place. Among the rest are Pfizer, Bayer, Eli Lilly, and Boehringer Ingelheim. According to the foundation, Bayer, Bristol-Myers Squibb, Merck KGaA and Novo Nordisk dropped in this year’s rankings, while Gilead and Pfizer moved up.

Source: FiercePharma

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Waiting in the wings for his role as Bayer CEO, Marijn Dekkers is promising to focus on sales growth rather than profit margins when he takes the stage. At least that’s the word from Financial Times Deutschland (via Bloomberg), which reported the news based on talks between Dekker and JP Morgan stock analysts.

Scheduled to replace current chief Werner Wenning in October, Dekkers is said to be preparing to scout for acquisitions to beef up Bayer’s healthcare division, JP Morgan told investors in a research note. To push the growth-over-margins strategy further, FT reports, pay incentives for management will be adjusted accordingly.

The company’s margins have improved over the last five years and is “now looking to increase absolute sales and profits, with less of a focus on margin expansion,” the firm wrote (as quoted by Reuters). Margins are now 23.1 percent, as of the first quarter of this year, up from 21.1 percent for all of 2009, the news service notes.

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GlaxoSmithKline’s bargaining on Tyverb has failed. The U.K.’s cost-effectiveness watchdog nixed the breast-cancer pill once again–despite the company’s offer to pay for the first three months of treatment.

The National Institute for Health and Clinical Excellence said the drug wasn’t a good value when compared with treatment alternatives. “[E]vidence suggest that it extends life by a small amount of time–around 10 weeks or 2.4 months–and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication,” NICE chief Andrew Dillon said in a statement (as quoted by Dow Jones).

NICE has been fairly skeptical of pricey cancer treatments, and, in spite of new “end-of-life” calculations for drugs for terminal illnesses, remains difficult–but not impossible–to convince. In recent weeks it has rejected one kidney cancer treatment–Bayer’s Nexavar –while accepting AstraZeneca’s lung cancer pill Iressa.

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Bayer once again lost its bid to persuade the U.K.’s cost-effectiveness watchdog that Nexavar is worth the price as a liver cancer treatment. The National Institute for Health and Clinical Excellence says its decision is final.

Nexavar’s rejection for use by Britain’s National Health Service came even under a new NICE model for evaluating treatments that could possibly extend the lives of patients, NICE chief Andrew Dillon said. “[T]he price is simply too high to justify using NHS money,” Dillon said (as quoted by Bloomberg). The cost of Nexavar “couldn’t be justified by its marginal benefit,” NICE says in a statement.

Just what cost-benefit info was NICE considering? The agency says that Nexavar extended the lives of liver cancer patients by an average of 2.8 months at a cost of £27,000 ($38,850). To sweeten the deal, Bayer had offered a buy-three-get-one-free deal, but that wasn’t enough to sway the agency. Bayer co-markets the drug with Onyx Pharmaceuticals.

The cost and availability of cancer drugs has been an ongoing issue in the U.K. (and in the U.S., for that matter). NICE has rejected some drugs to public outcry, and in response the agency promised to reconsider the cost and benefits of drugs for terminally ill patients. And in some cases, drugmakers have offered risk-sharing deals through which the NHS pays for a drug only if it works, as well as other creative arrangements to mitigate the costs. In some cases, that strategy has worked. But in Nexavar’s case, it didn’t.

Source: FiercePharma

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Big Pharma has been jostling for market share in China. Now, the likes of Pfizer and Bayer will have still more competition in that fast-growing market in the form of Japan’s Astellas Pharma.

In its annual report on strategy, Astellas unveiled plans to hire at least 300 sales folks in China, aiming to double its sales there by March 2015. And that push into China will be key, because the company is depending on it to help meet some ambitious sales-growth goals. Namely, 17 percent growth in five years.

Astellas is aiming for global revenue of $12 billion (1.1 trillion yen) by 2015, up from $10.5 billion (940 billion yen) this year. It’s aiming for operating profits of $2.68 billion (240 billion yen), up from $1.7 billion (152 billion yen) for the current fiscal year. (This year’s profits happened to be 19 percent off last year’s results, by the way.)

Other critical elements to its “mid-term management plan” include a strong effort to grow sales of its transplant-rejection drug Prograf in Asian markets, including Japan, to help offset sales erosion from generic competition in the U.S. And then there’s its acquisition of OSI Pharmaceuticals: Revenue from the cancer drug Tarceva is expected to boost Astellas once the deal closes, but pipeline meds aren’t factored into this five-year business plan.

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A U.S. appeals court has affirmed a so-called “pay-for-delay” patent settlement between Bayer and Teva Pharmaceutical Industries, citing legal precedent. But the three-judge panel says applicable law might need to be revisited. It invited the original plaintiffs in the case–which include drug purchasers such as CVS Caremark–to ask for a rehearing by the entire Second Circuit Court, thus opening the door to a new legal approach.

U.S. and European officials have been dogging these patent settlements, in which a branded drugmaker pays a generics firm to keep cheap copycat meds off the market. European antitrust regulators have been investigating an array of patent settlements among such drugmakers as GlaxoSmithKline and Sanofi-Aventis on one side and Teva and its ilk on the other. On this side of the Atlantic, the FTC has been challenging the deals at every opportunity, saying that they cost taxpayers billions every year.

In the appeals panel’s view, a previous case involving the drug Tamoxifen puts the law in drugmakers’ favor. So, the purchasers that brought this suit against Bayer and Teva can’t advance their claims. But perhaps the precedent needs reconsideration, the panel acknowledged. “We believe there are compelling reasons to revisit Tamoxifen with the benefit of the full court’s consideration of the difficult questions at issue and the important interests at stake,” the ruling states.

Not surprisingly, the FTC said it welcomed the ruling: “This is further evidence that courts are rethinking their approach to pay-for-delay settlements,” Chairman Jon Leibowitz said in a statement. Whether that rethinking ends up going in the FTC’s favor, however, is still an open question.

Source: FiercePharma

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It’s a banner day for earnings reports, with Bristol-Myers Squibb posting double-digit increases in sales and profits and AstraZeneca hiking its 2010 earnings forecast. Sanofi-Aventis recorded profits growth as well. Bayer, UCB and a gaggle of smaller companies also reported. Here are the highlights.

• Bristol-Myers Squibb’s Q1 profit leapt by 16 percent, beating analyst expectations, on an 11 percent rise in sales to $4.81 billion. Strong performers: The blood thinner Plavix, which posted a 16 percent increase in sales despite a new FDA boxed warning; bone drug Orencia, which grew by 36 percent; antiviral Baraclude, which posted 42 percent growth; and atypical antipsychotic Abilify, which grew by 4.8 percent. Bristol did cut its EPS forecast by 5 cents, citing U.S. healthcare reform costs.

• AstraZeneca actually raised its 2010 earnings forecast, for the second time this year, despite expectations of $300 million in healthcare reform costs. First-quarter earnings, excluding items, grew to $2.03 per share, well beating analyst expectations of $1.72; net income amounted to $2.7 billion, up from $2.15 billion year over year.

• Sanofi-Aventis posted an 8.6 percent rise in fourth-quarter net profit to $2.26 billion, lifted by its diabetes drug Lantus, acquisitions and a boost from sales of H1N1 flu vaccines. The French drugmaker said it is on track to meet its full-year targets, with earnings growth of 2 percent to 5 percent. An analyst noted “solid numbers,” but “no fireworks here.”

• Bayer raised its 2010 earnings growth forecast and posted first-quarter profits growth of 63 percent, but these figures came despite weakness in its healthcare unit in general and drugs business in specific. Pharma sales managed 0.7 percent growth, suffering from a 10 percent decline in revenues from the Yaz family of contraceptive pills.

• Belgian pharma UCB repeated its outlook for 2010 as growth in new drugs helped absorb declines by its leading product, epilepsy treatment Keppra, which faces generic rivals in the United States.

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Pfizer Inc. has halted another late-stage drug trial, this time announcing that its near-blockbuster therapy Sutent had failed because of a high rate of serious events in liver-cancer patients taking doses of the medicine.

“The disappointing outcome of this trial challenges all of us to work harder to understand the complex biology of this disease,” Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit, said in a statement.

The drug-trial failure comes at a critical time for Pfizer, as several of its leading drugs, including cholesterol treatment Lipitor, near the end of their patent protection over the next two years. The potential loss in revenue would be more than $15 billion without new drugs to take their place, according to industry figures.

Sutent, which recorded nearly $1 billion in sales last year, has received FDA approval for use in people with advanced kidney and stomach cancer, and Pfizer continues testing the drug on a variety of other cancers.

Just last month, Pfizer stopped two late-stage studies of Sutent, known generically as sunitinib malate, saying it did not help patients with advanced breast cancer. At the same time, it ended a cancer trial involving the monoclonal antibody figitumamab, saying it had proved ineffective.

Previously, a late-stage trial of the potential Alzheimer’s blockbuster Dimebon had crashed and burned.

The most recent Sutent trial stoppage occurred after an independent Data Monitoring Committee determined the drug led to an increase in serious adverse events when compared to standard liver-cancer therapy using Bayer’s Nexavar treatment. In addition, Sutent did not demonstrate any significant difference in overall survival rates compared with Nexavar, according to a statement from Pfizer.

Although Pfizer’s largest research-and-development contingent is in Groton and New London, its cancer research is based in California.

Rothenberg said Sutent’s disappointing results in helping liver-cancer patients do not diminish Pfizer’s confidence that the drug is still effective in renal cell cancer and for gastrointestinal stromal tumors.

In addition, he said Pfizer will continue looking at how Sutent can help patients with hepatocellular carcinoma, the most common form of liver cancer, as well as advanced non-small cell lung cancer and advanced castration-resistant prostate cancer.

It is also being studied as an add-on therapy for renal cell carcinoma.
“We are committed to patient safety and are working with investigators to better understand these trial results and their implications for clinical practice,” Rothenberg said.

By Lee Howard Day Staff Writer

Source: theday.com

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