Archive for the ‘Healthcare & Pharmaceuticals’ Category.

Southwest Synthetic Pharmaceutical mulls RMB 230 mln share placement

Editor: evewen
6 Nov 2008 01:49:31 GMT

Nov. 5, 2008 (China Knowledge) - Southwest Synthetic Pharmaceutical Corp<000788> plans to sell 42.87 million outstanding shares to Peking University International Hospital I & M Co. Ltd. (PKUIHIM) in a private placement, sources reported.

According to the statement filed with the Shenzhen Stock Exchange today, the shares will be sold at RMB 5.36 apiece, and the proceeds will be used to fund its acquisition of 90.63% stake in Chongqing Daxin Pharmaceutical Co. Ltd.

However, the acquisition deal, which involves investment of RMB 230 million, is still subject to regulatory approval.

After the transaction, Peking University International’s shareholding in Southwest Synthetic Pharmaceutical will be raised to 50.86% from 41.16%.

Southwest Synthetic Pharmaceutical estimates that its net profit for 2008 will surge 212% year-on-year, with earnings per share of RMB 0.11 and RMB 0.13 for this year and 2009, respectively, if the deal proceeds smoothly.

UPDATE 1-Takeda H1 profit down on acquisitions, cuts forecast

Editor: Bruce Meng
4 Nov 2008 10:42:40 GMT

TOKYO, Nov 4 - Japan’s largest drugmaker, Takeda
Pharmaceutical Co, reported a 70 percent fall in first-half
profit and trimmed its full-year forecast, weighed down by
acquisition costs.

But Takeda raised its dividend forecast for the year to March
by 6 yen to 176 yen, and its shares were up 5.2 percent after the
results.

Many Japanese drugmakers expect profit declines this year on
the back of hefty acquisition and expansion costs, investments
they have made to ensure long-term survival amid a series of U.S.
patent expiries on key drugs and stagnant growth in Japan.

Eager to beef up its pipeline ahead of patent expiries for
its Actos diabetes drug and Prevacid ulcer drug in 2011, Takeda
bought Millenninum Pharmaceuticals, a U.S. cancer specialist, for
$8.9 billion in May and absorbed its part of a U.S. joint venture
this year.

Takeda reported a recurring profit, which is before tax and
exceptional items, of 100.98 billion yen ($1.02 billion) for the
six months ended on Sept. 30, down from 333.7 billion yen in the
same period a year ago but better than its own forecast for 65
billion yen.

Takeda cut its full-year recurring profit forecast to 290
billion yen from 300 billion yen. That compares with a mean
forecast of 311 billion yen in a poll of 15 analysts by Reuters
Estimates.

Shares of Takeda were up 5.2 percent at 5,080 yen after the
announcement. The stock lost 36 percent in the year to Friday,
outperforming a 44 percent drop in the benchmark Nikkei average.

US top court weighs drugmaker liability for harm

Editor: Bruce Meng
4 Nov 2008 03:20:45 GMT

WASHINGTON, Nov 3 - Pharmaceutical companies should not be liable for harm from medicines which carry warnings approved by federal regulators, lawyers for drugmaker Wyeth and the Bush administration told the U.S. Supreme Court on Monday.

The court is considering a case that could sharply limit lawsuits against drugmakers if the justices decided Food and Drug Administration approval shielded companies from liability claims under state law.

Wyeth is battling a guitarist, Diana Levine, who lost part of an arm after she was improperly injected with an anti-nausea drug made by the company as part of treatment for a migraine.

The prescribing instructions for the drug, Phenergan, "plainly comprehended and warned about the specific risks" of giving the drug in the way Levine received it, attorney Seth Waxman, arguing for Wyeth, told the court.

The company was required to use the FDA-approved warnings and could not have changed them without the agency’s permission, Waxman said.

But Levine’s lawyer said Wyeth knew the injection method used for Levine was dangerous and the company should have put a stronger warning on the drug.

"These kinds of risks come to light frequently with drugs that are on the market, and the need to revise these labels is the duty of the manufacturer," attorney David Frederick said.

Justice Antonin Scalia appeared to back Wyeth’s position.

"If you’re telling me the FDA acted irresponsibly, then sue the FDA," Scalia said. But holding the company liable could lead to manufacturers overwarning about beneficial drugs just to avoid lawsuits, he said.

"It would not promote public safety if you believe that the name of this game is balancing benefits and costs," Scalia said.

The justices are weighing whether FDA approval preempts state laws and protects companies from legal damages. In Levine’s case, a Vermont jury awarded her $7 million.

Federal preemption has been a goal of the pharmaceutical industry for years and has been supported by the Republican George W. Bush administration. The court’s ruling in the Wyeth case also could affect millions of other businesses, the U.S. Chamber of Commerce has said.

Justice Ruth Bader Ginsburg seemed concerned that the FDA does not always make the right decision about whether a medicine is too dangerous or has proper warnings, a position argued by Levine’s lawyers.

"Considering the huge number of drugs, is the FDA really monitoring every one of these?" Ginsburg asked.

With Phenergan, "the risk of gangrene and amputation is there. No matter what benefit there was, how could the benefit outweigh that substantial risk?" she added.

A decision is expected by the end of June.

The Supreme Court ruled in favor of federal preemption earlier this year. In February, the justices sided 8-1 with medical device maker Medtronic Inc after it was sued by a man harmed by a catheter during an artery-clearing procedure.

If the court ruled strongly in favor of preemption again, Democrats in Congress have pledged they would push legislation to preserve a patient’s right to sue under state law.

The pending case is Wyeth v. Levine.

Drug firms agree to invest more in AIDS research-UN

Editor: Bruce Meng
10 Oct 2008 01:56:44 GMT

UNITED NATIONS, Oct 9 - U.N. Secretary-General
Ban Ki-moon said on Thursday that major pharmaceutical firms
promised to invest more on researching treatments for the AIDS
virus and diagnostic procedures for poorer regions.

The companies also agreed to invest more in prevention,
including vaccines and pre- and post-exposure prophylaxis, Ban
said in a statement issued after he met with top executives at
pharmaceutical and diagnostic firms working on AIDS and HIV,
the virus that causes it.

“We noted that despite the gains, the epidemic continues to
outstrip our best efforts. Only one-third of those who need
antiretroviral treatment in low-and middle-income countries are
getting it,” he said.

“Each day, for every two people who are placed on
antiretroviral treatment, five more are infected. Collectively,
we still have more work to do.”

The senior executives Ban and other U.N. officials met with
were from 17 companies, including Abbott Labs <ABT.N>,
Boehringer Ingelheim, GlaxoSmithKline <GSK.L>, Pfizer <PFE.N>
and other top industry players.

Ban said the companies agreed to “invest further in
research and development of new HIV-related medicines adapted
to resource-limited settings to be used safely in children,
adolescents, adults and pregnant women” — in other words, to
try to make drugs available to people in poor environments.

“All participants agreed that increasing access to
vaccines, diagnostics and medicines is essential in scaling up
prevention and treatment efforts,” Ban said.

One of the U.N. millennium development goals aimed at
halving poverty by 2015 is to achieve universal access for HIV
and AIDS treatment by 2010.

Some 33 million people were living with immunodeficiency
virus infections in 2007, most of them in Africa, according to
the latest U.N. reports on the AIDS epidemic. The disease has
killed an estimated 25 million people since it was identified
in the 1980s.

Waters faces challenge as Big Pharma shrinks

Editor: Bruce Meng
17 Oct 2008 01:22:51 GMT

BANGALORE, Oct 16 - Lower research and development spending by drugmakers involved in high-profile mergers will hit the pharmaceutical business of analytical-tools maker Waters, but it may yet find comfort in the food-safety testing market.

If Eli Lilly and Co closes its $6.5 billion takeover of Imclone Systems Inc, and Roche succeeds in its bid to buy Genentech, the newly merged firms may lay off overlapping research programs, combine facilities and outsource drug discovery work.

"Into 2009, pressure on those research and development budgets increase as these companies get swallowed up," Leerink Swann analyst Isaac Ro said.

This could hurt companies such as Waters Corp, which makes instruments that are used in drug research.

"Most believe that the environment will continue to be difficult in terms of trying to sell instruments to pharmaceutical companies," Cowen and Co analyst Doug Schenkel said.

Big Pharma is increasingly turning to mergers to bolster weak drug pipelines that are unable to replace blockuster drugs that go off patent in the next few years.

Lipitor, Pfizer Inc biggest selling product, loses its U.S. patent protection in 2011, and Eli Lilly’s main cancer drug, Gemzar, loses patent protection in 2012.

Historically, demand slows in the immediate aftermath of a merger, but a resonable growth rate returns within a couple of quarters, Gene Cassis, Waters’ Corporate Vice President of Worldwide Business Development, said.

Large drugmakers used to contribute about a quarter of Waters’ sales in prior years, but their share has since reduced to about 15 percent, Cowen’s Schenkel said.

Rivals such as Thermo Fisher Scientific Inc and Applied Biosystems Group are not as exposed to big drug companies as Waters.

SAFETY IN FOOD

One way that Waters — a bellwether of the research-tools industry — is trying to offset some of this lost pharmaceutical potential is by increasing its market share in the food-safety market.

Apart from their use in drug discovery and development, Waters’ liquid-chromatography and mass-spectrometry devices are used to identify, separate and measure the composition of chemicals during food-safety and quality-control testing.

This market uses about half of the company’s installed mass-spectrometry devices, Cowen’s Schenkel said.

"They are certainly still exposed to the slowdown in pharmaceutical companies but I would say that they are less exposed than they have been in the past," the analyst said.

Waters’ Cassis said while growth from large pharmaceutical companies was flat last year, the company recorded overall growth of 8 percent.

During the first quarter, Waters’ industrial and food-safety sales grew 28 percent, while global sales to pharmaceutical customers grew just 4 percent.

Emerging markets such as Asia also seem to help. Waters’ first-quarter sales in Asia rose 18 percent.

Strong demand from developing markets, continued expansion of the industrial businesses and sales in the instruments division were cited as key second-quarter growth drivers by Chief Financial Officer John Ornell in a July conference call.

Barclays Capital analyst Anthony Butler said, "As long as standards in emerging markets are moving towards western standards, those markets are growing at the highest rates."

Bayer boss says firm will stay in China

Editor: Sharon Li
20 Oct 2008 02:34:09 GMT

GERMANY’S Bayer MaterialScience said there will be no change to its China investment plans despite the current global financial woes, as it opened one major plant and broke ground for another in Shanghai yesterday.

Chairman Patrick Thomas said plans to invest 2.1 billion euros (US$2.8 billion) until 2012 to its Shanghai integrated base remain unchanged as China is fundamental to its strategy, while noting it is looking at putting on hold certain activities in America and Europe amid global worries over recession.

Thomas said the company’s growth rate in China may drop a bit but the base remains huge. China sales stood at 1.3 billion euros in 2007, having been growing at a double-digit rate over the past 10 years, doubling the pace of China’s economic growth.

“The risk of not being in China is much greater than the risk of being in.”

The firm started production at its new 350,000-ton-a-year diphenylmethane diisocyanate (MDI) plant and broke ground for a 250,000-ton-a-year facility for toluene diisocyanate (TDI) at its integrated site at the Shanghai Chemical Industry Park.

Largest market

MDI is a raw material used primarily for the production of polyurethane rigid foams, whose main applications are in refrigeration and as thermal insulation in the building industry. TDI is used in the production of flexible polyurethane foam for upholstered furniture, mattresses and car seats. China is expected to become the largest country market for polyurethanes by 2015.

The TDI facility, to be completed in 2010 with gas phase phosgenation technology, features energy-efficient and clean production. It could enable energy saving of up to 60 percent compared to conventional plants of the same size. The technology could also save 80 percent in solvent use, and cut investment costs by around 20 percent.

Thomas said globally the major concern out of the ongoing credit crunch for Bayer MaterialScience is the limited lending access for its customer base, among which 80 percent are small and medium-sized companies. He added that one effect he has seen is destocking by customers.

However he said Bayer MaterialScience itself is comfortable without financing, although if it had to get bank loans, things are harder.

Pfizer cuts US$894m settlement deal

Editor: Sharon Li
20 Oct 2008 02:13:33 GMT

DRUG giant Pfizer Inc has reached a US$894-million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market.

The world’s biggest drug maker said yesterday it has agreements in principle to end more than 90 percent of personal injury lawsuits brought by people claiming the pills caused heart attacks, strokes or other harm.

Pfizer hopes to settle those suits, which cover up to 92 percent of plaintiffs, by year’s end. It also hopes to include many of the remaining claimants in the settlement and will fight any remaining personal injury suits with court motions or at trial, General Counsel Amy Schulman said.

“I don’t think either side has an interest in protracting this,” Schulman said in an interview.

She said the deal comes after two important court rulings - one by a New York state judge overseeing many of the state-level personal injury cases and the other by a federal judge in San Francisco coordinating pretrial steps in federal lawsuits over the drugs.

“We teed up some pretrial motions for a court ruling on whether there was significantly reliable evidence that would allow an expert to testify as to whether there was an increased risk of heart attack and stroke at the most common dose,” 200 milligrams, Schulman said. Both judges ruled that was not the case, she said.

The proposed deal also would end suits by insurers and patients seeking to recover what they spent on Bextra and Celebrex, as well as claims by 33 states and the District of Columbia that Pfizer improperly promoted Bextra.

Payout time

Out of the total settlement, US$745 million will go to settle personal injury cases, US$60 million will cover settlements with attorneys general in the 33 states and Washington, DC, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs. Two additional states, Louisiana and Mississippi, still have pending cases regarding Pfizer’s promotion of the drugs.

New York-based Pfizer withdrew Bextra from the market in 2005, a year after Merck & Co withdrew its Vioxx, a similar drug.

The Vioxx withdrawal, which triggered an avalanche of lawsuits against Merck, also raised concerns about the safety of other medicines in the same class, called Cox-2 inhibitors.

They were touted by their makers as superior to traditional nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, because they block an enzyme involved in promoting inflammation but - unlike NSAIDs - don’t block an enzyme that protects the stomach from bleeding and other side effects. Other NSAIDs, such as ibuprofen and naproxen, have also been linked to increased heart risks.

Nikkei up 2.0 pct as Panasonic jumps, soft yen helps

Editor: Bruce Meng
20 Oct 2008 01:55:31 GMT

TOKYO, Oct 20 - The Nikkei average rose 2.0 percent on Monday, buoyed by Panasonic after a report that the electronics maker was likely to beat its profit forecast, while a softer yen helped recently battered shares of exporters.

Shares of Nippon Steel Corp and JFE Holdings Inc shot up after the Nikkei business daily said Japan’s top two steelmakers were likely to raise their annual profit forecasts due to lower costs and price hikes.

"The firm dollar is leading investors to pick up cyclical stocks that were sold off last week," said Takahiko Murai, general manager of equities at Nozomi Securities.

"But the gains probably won’t last. The deterioration of the real economy is happening much faster than expected. We need comprehensive counter-measures, rather than just those only for the financial system."

As of 0104 GMT, the Nikkei added 175.00 points to 8,868.82. It rose 2.8 percent on Friday and ended the week up 5 percent.

The broader Topix climbed 2.1 percent to 913.30.

The dollar was trading around 101.65 yen by midmorning Investors welcome a softer yen as it helps boost exporters’ overseas profits when they are brought back home.

U.S. stocks fell on Friday, with Caterpillar and United Technologies leading the Dow lower, after a report that U.S. housing starts fell to their lowest in 17-½ years last month, adding to recession fears.

Shares of Panasonic jumped 6.9 percent to 1,603 yen after the Nikkei business daily reported that the electronics maker, which had predicted a drop in operating profit for the first half, is now seen beating its forecast by more than 20 billion yen ($196.9 million).

Nippon Steel advanced 5.1 percent to 332 yen and JFE Holdings surged 7.4 percent to 2,390 yen.

The weaker yen helped exporters climb, with Toyota Motor Corp rising 4.7 percent to 3,580 yen and Sony Corp gaining 4.9 percent to 2,560 yen.

Still, so-called defensive stocks such as drugmakers continued to be popular amid worries about the global economy. Takeda Pharmaceutical Co added 1.8 percent to 4,570 yen and Astellas Pharma Inc gained 3.4 percent to 3,990 yen.

Daiichi Sankyo buys 20 percent stake in Ranbaxy

Editor: Bruce Meng
17 Oct 2008 07:26:06 GMT

TOKYO, Oct 17 - Japan’s Daiichi Sankyo Co said on Friday it had completed the purchase of 20 percent in India’s Ranbaxy Laboratories, part of its plan to obtain a majority holding in the generic drugmaker.

Japan’s third-largest drugmaker also sought to reassure investors about the status of prasugrel, a closely-watched drug it has developed with Eli Lilly and Co, saying it had not been notified of any action by U.S. regulators.

The Food and Drug Administration failed in September to finish its review of prasugrel, the second time it has missed a deadline after failing to meet one in June.

The companies submitted their application in late December and the drug was given priority review status, which normally means a six-month review period.

Daiichi’s payment for the 20 percent stake it obtained from the market had been postponed due to a delay in approval by Indian authorities.

As part of the deal to acquire a stake of at least 50.1 percent and estimated at $4.6 billion, it also plans to buy an 34.8 percent holding from Ranbaxy’s founding family, as well as new shares.

It paid a total 68.2 billion Indian rupee ($1.4 billion), or 737 rupee per share, for the 20 percent holding plus interest amounting nearly 1 billion yen due to the payment delay.

Daiichi Sankyo warned earlier this month it could book a valuation loss on its holding of Ranbaxy shares in the year to March.

Ranbaxy shares have lost more than half of their value since June amid a data falsification scandal in the United States. They finished trading on Thursday at 266.35 rupees.

Ranbaxy’s chief executive Malvinder Singh said on Tuesday the Indian firm expects to close the takeover deal by Daiichi Sankyo by the end of December.

Daiichi Sankyo shares closed down 4.3 percent at 1,847 yen, underperforming a 3 percent rise in Tokyo’s pharmaceutical subindex.

Drugmakers brace for US Democrats to boost ranks

Editor: Bruce Meng
31 Oct 2008 02:06:57 GMT

* Drugmakers gear up for Democratic gains in US election

* Democrats likely to tackle drug prices, health insurance

* Companies concerned about pricing, reimbursement

By Lisa Richwine and Susan Heavey

WASHINGTON, Oct 30 - Pharmaceutical companies are bracing for a rush of health-care changes if Democrats win big in U.S. elections next week, giving nearly equal campaign contributions to both parties for the first time in recent history.

For years the industry gave most of its campaign cash to Republicans, who tended to back policies favored by drugmakers. But financial alliances began shifting when Democrats took control of the U.S. Congress in 2006.

With polls showing Democrats likely to gain a greater majority in Congress and perhaps capture the White House for the first time in eight years, drugmakers’ funds have followed.

The industry’s political action committees and employees gave 49 percent of their contributions to Democrats ahead of next week’s elections — a 31 percent jump from 2006, according to data from the Center for Responsive Politics, a nonprofit group that tracks campaign contributions.

Drug companies “are looking into the future and seeing that once again their issues are going to be front and center,” said Massie Ritsch, a spokesman for the center.

Among the issues high on the agenda of congressional Democrats are negotiating lower prices in Medicare’s prescription drug program, allowing generic versions of expensive biotechnology drugs and expanding health benefits to uninsured Americans.

Any attempt to expand health insurance coverage could impact prescription drug sales. Use of medications may grow, but companies could face pressure to lower prices often attacked as too high.

The companies are “laying the groundwork to get the access they need to express their points of view,” Ritsch said.

That will be an uphill battle, especially in light of the Wall Street meltdown that has highlighted the excesses of companies in general, said Kim Monk, a health care analyst at Capital Alpha Partners.

“The overarching concern for the industry … is a perception that pharmaceutical companies have nice fat margins and there’s a lot of money there. There’s just not a lot of sympathy toward the industry, even on the Republican side of the aisle and certainly not on the Democratic side,” she said.

Companies like Pfizer are working to change that.

“There has been a lot of criticism,” said Dolly Judge, a Washington-based lobbyist for the world’s largest drugmaker. “I think it’s a big job for (pharmaceutical companies). How do we improve the public’s perception of the industry?”

The industry’s main lobbying group, the Pharmaceutical Research and Manufacturers of America, tapped former Democratic staffer Bryant Hall for its top lobbying job last month.

Democrats currently control the U.S. House of Representatives 235-100, and polls show they could gain upward of 30 House seats. In the Senate, where they have 49 members, the party could win up to 9 seats. Republicans also have 49 Senate seats while two members are independents.

Democrat Barack Obama, the Democratic presidential nominee, leads his Republican opponent John McCain in nationwide opinion polls, but some surveys show the race tightening.

It is unclear who might lead the next president’s health care team. Few names have been floated as possible heads of the Department of Health and Human Services or the U.S. Food and Drug Administration, which decides if new medicines can come to the market.

Drugmakers, meanwhile, have shifted campaign donations.

For the 2008 election cycle, makers of drugs, medical products and dietary supplements gave $11 million to Democratic candidates and $11.4 million to Republicans through mid-October. Obama received nearly $1.2 million of that money while McCain took in nearly $530,000.

Top contributors to federal candidates and parties were Pfizer, Amgen Inc and Johnson & Johnson.

To be sure, McCain is no friend of drugmakers, having attacked them on the campaign trail.

Both Obama and McCain back the idea of letting the Medicare health insurance program negotiate lower prices for medicines, a move the drug industry strongly opposes. The candidates also support greater use of cheaper generic drugs and importation of medicines from other countries.

Democrats in Congress may quickly work to give Medicare the negotiating power, which companies say would lead to government price controls and hurt investment in research for new drugs.

Lawmakers in both parties also are keen to pave the way for approval of cheap, generic copies of expensive biotech drugs, something strongly urged by generic drugmakers.

Widening the pool of Americans who have health insurance — probably the most difficult task — also looms.

While pharmaceutical companies said they are eager to see more patients with access to health care and medications, any move to expand coverage also could pressure companies to lower prices.

Jim Greenwood, head of the Biotechnology Industry Organization, said companies “worry about a short-sighted approach toward cost containment.”

“If new policies restrict the opportunity for new products to be reimbursed, then it will drive away investment dollars,” he said. (Reporting by Lisa Richwine and Susan Heavey)