Today's Top Stories We've been talking a lot about drug sales in the developing world lately, as Big Pharma eyes markets such as Brazil, China and India--the so-called BRIC countries--to make up for stalling sales in the U.S. This week's Economist comes to the party, taking a look at America's declining contribution to pharma profits, and just how developing countries might help take up the slack. As the magazine rightly notes, pharma's a bit late. Other industries started targeting the growing markets in Asia and Latin America years ago. While consumer brands and high-tech companies poured billions into those countries, drugmakers sniffed about weak intellectual property laws and low per-capita incomes. Now, however, that's changed, partly because other countries have started to beef up IP protections and partly because incomes have been growing. But at least half the reason is that China, India, et al, are among the only countries pharma hasn't fully tapped. Consider a new report from Decision Resources, which predicts that China's market for antidepressants will triple by 2012 to $226 million. The research firm expects SSRI sales to post continuing double-digit growth there. Plus, Chinese docs and patients consider Western-made antidepressants to be better-quality than those made domestically. The roll call of companies looking eastward and southward includes GlaxoSmithKline and Pfizer, which just announced that it would put emerging markets on its priority list. And then there's Abbott Laboratories, which has quietly been building up its Chinese business and now ranks as that countries' No. 1 outside pharma firm. Plus, news is just now breaking that AstraZeneca is building up a supply hub in China that's aimed at helping the company not only build its "In China for China" manufacturing strategy, but also its "In China for Global" business. Meanwhile, look no further than the FDA, which is cutting ribbons at three new offices in China this week: Beijing, Guangzhou and Shanghai. "Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries," HHS Secretary Michael Leavitt said in a statement. So pharma appears to be meeting itself coming and going, from developed nations to developing countries and back again. And the FDA won't be the only ones watching. - read the story in The Economist
- see the AstraZeneca news at Supply Chainer
- check out the release on China's antidepressant market
- see the AP article about new FDA offices Related Articles:
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Are you ready for an erectile dysfunction drug revamped to treat high blood pressure? Eli Lilly and United Therapeutics are betting big on it. The two companies have inked a deal to commercialize the active ingredient in Cialis--tadalafil--for pulmonary arterial hypertension. That indication is currently under review by watchdogs in the U.S., Canada, Mexico, Japan, and the E.U. Under the deal, United Therapeutics will pony up $150 million for exclusive rights to tadalafil for the hypertension use in the U.S. The company will also get a manufacturing-and-supply deal for its money: Lilly will make the drug for United Therapeutics and will handle all the regulatory and patent details. In return, Lilly will take a $150 million stake in United Therapeutics. "United Therapeutics brings substantial expertise and passion to the treatment of patients with PAH and will be an excellent partner for this product," Lilly's Dr. Gwen G. Krivi said in a statement. "Their experience in this field will greatly enhance the ability to provide tadalafil for PAH, if approved, as a new therapeutic option for this very serious disease." United Therapeutics' stock slumped on the deal, which investors appeared to consider too expensive for the smaller company. - see the Lilly release
- check out the story at MarketWatch Related Articles:
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Can it be that Merck is going out looking for unexpected cardiovascular side effects? The drugmaker is preparing to launch a massive trial of its diabetes med Januvia, specifically to check for potential heart problems. The 14,000-patient study, helmed by Duke University, aims to gauge the safety of long-term use of the drug--which is logical, considering diabetes is a chronic, lifelong illness. It makes sense, but it's not necessarily every drugmaker's practice to seek out data on the long-term safety of meds for chronic maladies. Think Zyprexa, the Eli Lilly antipsychotic that's been shown to boost the risk of weight gain and diabetes, or Avandia, the GlaxoSmithKline diabetes drug that's been linked with cardiac problems. Or, closer to home for Merck, there's Vioxx, the arthritis painkiller pulled from the market after a plethora of serious adverse events such as heart attack and stroke. Barbara Ryan, the Deutsche Bank analyst who dug up info on the new trial, said in an investor note (and we're quoting CNBC's Mike Huckman here), "MRK appears to have taken a proactive approach for Januvia in this regard, which is a positive in our view, as it will have such data well ahead of its competitors (though not till the end of 2014), which should help it to maintain a dominant position in the...market." The news of the study comes on the heels of an FDA advisory committee vote in favor of heart side-effect studies on new diabetes meds. Just for the record, Januvia posted third-quarter sales double the same period last year. - read Huckman's column at Seeking Alpha ALSO: We heard from Merck about our story last week on CVS's doctor letter in support of Januvia use. The drugmaker wanted to point out that the letter advocated adding Januvia to drug regimens that weren't currently working, rather than a complete drug switcheroo. Plus, as we noted in our piece, CVS wrote and sent the letter, and Merck didn't get ahold of any private patient info. Related Articles:
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Indian drugmakers are feeling a bit paranoid these days. Big Brother, a.k.a. the FDA, is looking over their shoulders, and they're not happy about it. There appears to be reason to fear, Pharmalot reports: Three major Indian pharma companies have felt the long arm of the law in recent months. First, the FDA banned 30 Ranbaxy Laboratories drugs because of manufacturing irregularities at two of its Indian plants. Then the agency nixed drugs made at Sun Pharma's Detroit plant. And last week, FDA warned Lupin about 15 manufacturing problems at a plant in Madhya Pradesh. Some Indian pharma types are even wondering whether the regulatory scrutiny amounts to a sort of trade barrier. "[T]here may be an attempt by global innovator majors to question the standards of Indian drugs and stop their entry," Daara Patel, chief of India's pharma trade association, told the Economic Times. But others say Indian generics makers just need to toughen up. The companies have an edge in the copycat-med market, and with the U.S. government and other payers looking to control healthcare costs, Indian drugmakers can certainly benefit. One expert told the Times, "The three companies who have come under (the FDA) scanner should be ready for any test conducted by any regulator, anytime." Hear, hear. - check out the Economic Times story
- see the Pharmalot post
- get the Lupin news from NDTV Related Articles:
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Well, it's not good news for those long-suffering cholesterol meds Vytorin and Zetia--but at least it's not more bad news. The two drugs, which have seen new scrips fall and fall again since less-than-stellar research news first hit in January, may finally be bottoming out. The latest sales report from Schering-Plough shows that prescriptions for the two meds actually took a tiny tick upward to $2.19 million in October from $2.17 million in September. That's way down from the $3 million-plus posted back in January, but the numbers could definitely be worse. As you know, Schering and Merck together sell Vytorin, a combo of the Merck statin Zocor (generic simvastatin) and Zetia, another cholesterol fighter that works via a different mechanism. Since January, the Vytorin/Zetia franchise has sustained a series of blows, starting with the Enhance study, which suggested that Vytorin doesn't slow heart disease any better than Zocor would on its own. Another study suggested that Vytorin and Zetia might boost the risk of cancer, and though that data has been called anomalous by various experts, the continuing debate hasn't helped sales. As the Wall Street Journal Health Blog notes, next month's scrip figures could be telling: If the numbers continue to hold their own, Vytorin and Zetia may finally have hit bottom. - read the Health Blog post Related Articles:
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