UPDATED: Arena Pharma's weight drug wins the day, shares soar.

Arena Pharmaceuticals' closely watched diet pill won over FDA advisers today. A committee of non-agency advisers backed approval of the weight drug, lorcaserin, which went down in flames when last in front of the same panel in 2010.

The turnaround for the program marks a victory for San Diego-based Arena ($ARNA) and its partner for U.S. marketing, Eisai. The FDA will consider the panel's 18-4 vote in favor of approval in the agency's decision on whether to green-light the drug. As Bloomberg notes, the agency hasn't approved a weight loss drug in 13 years. Vivus ($VVUS) and Orexigen ($OREX) are also in the hunt to advance new drugs to combat obesity, which affects more than a third of the U.S. population.

The FDA has taken a tough stance on the safety of obesity meds, and Arena's lorcaserin has been no exception. Arena faced numerous questions about potential side effects of the drug such as malignancies, heart valve damage and psychological problems. And critics of the program point out the modest efficacy data on the drug. Yet the company made a compelling enough case during Thursday's advisory committee session in Silver Spring, MD, to come away with a win.

After the panel meeting closed, shares of Arena skyrocketed. The stock more than doubled at points early in the morning and traded at $7.16, up from the May 9 close of $3.66 as of 8:55 a.m. ET.

Yet worries linger about the effects of the drug on the heart. An FDA briefing and panel members were satisfied with data Arena provided to show that the risk of cancer to patients who take lorcaserin appears remote. However, there was less certainty about the long-term impact of the drug on patients' hearts, Bloomberg reported. And any unresolved safety issues threaten the timely approval of the drug.  

"We expect lorcaserin to be approved; now the question is when," J.P. Morgan analyst Cory Kasimov said in a note to investors this morning. "It's now certainly feasible that the drug is approved at that time. However, a number of panelists mentioned their desire for a Risk Evaluation and Mitigation Strategy and a post-approval [cardiovascular] outcomes trial."

The FDA has set an action date of June 27 for its decision on approval of lorcaserin.

Fox Foundation partners with Sanofi on Parkinson's study

The Michael J. Fox Foundation has signed on to sponsor an early-stage study of a Parkinson's drug candidate in Sanofi's ($SNY) pipeline. In the pact, the foundation will own the data and results from the Phase Ib study of AVE 8112, a PDE4 inhibitor. And the two groups can decide how to proceed once they get the results in hand. For the foundation, it's a chance to push a new therapy up the pipeline. For Sanofi, it's a chance to gain some help from a partner, a major focus right now. Release

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Google's Brin allies with Pfizer and GSK in war on Parkinson's

Google co-founder Sergey Brin has been betting on some of the titans of the biopharma world to advance new treatments against Parkinson's disease. And Brin, who carries a gene for the disease, is willing to spend a considerable amount of his multibillion-dollar fortune for a cure.

"If I felt it was guaranteed to cure Parkinson's disease a check for a billion dollars would be the easiest one I have written," Brin told Bloomberg's Robert Langreth. "Pretty much everybody in the world has or will have some serious condition. How much is it worth to you to have that condition be potentially curable?"

Brin has put some serious dollars behind the R&D efforts, spending $132 million so far to fund programs through the Michael J. Fox Foundation for Parkinson's Research and discovery work at pharma giants Pfizer ($PFE) and GlaxoSmithKline ($GSK), Bloomberg reports. Brin and his mother carry a gene linked to 1-2% of cases of Parkinson's, a poorly understood neurological disorder that leads to shaking and early death, and which affects about 1 million Americans.

Brin has channeled significant resources into work on drugs that could target the specific Parkinson's gene LLRK2, which is associated with a brain cell-killing protein. Through his investment in a vast database of genetic profiles on Parkinson's patients housed at the personal genomics outfit 23andMe, which his wife Anne Wojcicki runs, Brin's dollars could spur sharing of genetic information to benefit patients with many of the known triggers of the disease.

With genetic data from Parkinson's patients, drug developers aim to provide a host of new targeted treatments that can begin to impede progression of the disease, which leads to the death of dopamine-producing cells that play a role in regulating movement. There's a lot of research and discovery work to be done before such treatments become available, and Brin's role as financier could be crucial during the risky period when some pharma groups blanche.

Developing countries warn against unethical drug trials

The growing number of clinical drug trials in developing countries is associated with a well-known list of attributes. Drug companies hope to do studies for less money, gaining a big population of treatment naïve patients to choose from. Developing countries hope for better access to meds and a shot at gaining some cutting-edge technologies for their economies.

But a recent gathering of science journalists in Qatar was also treated to a look at the dark side of the trend: A loose regard for ethics and a chance at spinning the data by overlooking side effects. The Guardian was there to report on it.

"Less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation make carrying out research in the developing world less demanding," said Ames Dhai, director of the Steve Biko Centre for Bioethics at the University of Witwatersrand, South Africa.

India has been debating the issue and is working on a new streamlined approach to overseeing clinical trials in the subcontinent. One new bill is expected to identify one government agency to handle the monitoring work.

"We can even think of making it necessary for volunteers for human clinical trials to register with a government body first. This way we can make sure that their interests are protected when clinical trials are conducted on them," said Indian Council of Medical Research (ICMR) director-general V M Katoch.

FDA review questions long-term use of bone-building drugs.

The FDA is giving women a lot to chew on with a new analysis of long-term use of drugs for osteoporosis because they can, although rarely, have a debilitating effect.

The review was published Wednesday online in The New England Journal of Medicine, reports The New York Times. The review says there is limited, if any, benefit from the drugs after three to 5 years of use.

The drugs are taken by millions of women who have come to believe that they are their best defense against bone loss. And, of course, the pharmaceutical industry has come to believe that women will continue to buy large quantities of the drugs. So, if the pattern changes, it could have implications for drugs like Fosamax from Merck ($MRK) and Roche's ($RHHBY) Boniva, as well as for some genericsmakers. It also may create a moment of reflection for those companies still developing osteoporosis treatments.

The agency in March said that it requested data from drugmakers in 2008 after reports of femur fractures in women using bisphosphonates. The drugs have been linked to osteonecrosis of the jaw (Merck is fighting lawsuits over Fosamax's association with the bone-death syndrome) and severe musculoskeletal pain. In addition, the FDA also looked at a potential association with femur fractures.

The review does not address whether women at risk should be prescribed the drugs in the first place, and because the repercussions from long-term uses are so rare, many doctors believe that the benefits for women at high risk for spinal fractures far outweigh the risks.

But for women with only marginal risk, the review may serve as a turning point in popular practice.

"I think a lot of people are going to come off this drug," Dr. Clifford J. Rosen, an endocrinologist and researcher at the Maine Medical Center Research Institute, told The Times.

Daiichi sends in posse to keep Ranbaxy plant in line

Daiichi Sankyo isn't taking chances on Ranbaxy Laboratories' ability to keep turning out FDA-compliant drugs. The Japanese drugmaker, which owns the controlling interest in the Indian company, has dispatched two executives to the Punjab facility to keep a close eye on operations there, The Economic Times says. Report

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Ranbaxy faces 'groundbreaking' oversight with DoJ settlement

The Ranbaxy Laboratories regulatory saga is nearing an end. The Justice Department announced a "groundbreaking" consent decree that requires the Indian drugmaker to make "fundamental changes" to plants in the U.S. and India. The company won't be allowed to sell products made at certain facilities until problems there are corrected. It has to give up its sought-after 180-day exclusivity on three drugs--their identities filed under seal--and perhaps relinquish those rights on three more if it doesn't meet certain milestones.

Part of the reason for such a sweeping decree is Ranbaxy violated one major no-no in drugmaking: It falsified data submitted to the FDA. As part of the deal, Ranbaxy has to set up internal safeguards to make sure fake data doesn't make its way into company filings again. It also has to go back and audit any FDA applications produced by the suspect facilities. If auditors find false data, then those applications must be withdrawn.

The company's quality-control problems were serious, too. The Justice Department cites a lack of proper procedures to prevent contamination of sterile drugs and to keep penicillin meds from contaminating non-penicillin drugs. Ranbaxy also didn't adequately test for drugs' potency or investigate evidence that some drugs didn't meet specifications, the agency said.

Submitting false data to the FDA in drug applications will not be tolerated," Assistant Attorney General Tony West said in a statement. "The Department of Justice, in partnership with the FDA, will use all available tools, including civil injunction actions and consent decrees, to ensure the integrity of drug applications, and to ensure that all drugs sold in the U.S. meet U.S. standards."

The decree ends more than three years of wrangling over Ranbaxy's manufacturing violations. The FDA announced in December 2008 that U.S. Marshals had seized Ranbaxy shipments and 30 of the company's drugs would be barred from the country. Since then, Ranbaxy has been negotiating with the FDA--and the DoJ has been investigating--in a process that caused considerable nail-biting at Daiichi Sankyo, which bought controlling interest in the Indian drugmaker a short time before the regulatory snafu.

The drama continued as the expiration date on Pfizer's ($PFE) Lipitor patent neared. Ranbaxy had 180-day exclusivity for its version of the drug, but whether it could get FDA approval remained an open question. Rumors flew until the company announced Dec. 1 it had launched its copycat version. The decree won't affect Ranbaxy's Lipitor marketing, officials say. Which is a good thing, considering the company had to set aside $500 million to cover its government settlements.

'Dateline' exposé snares Indian CROs in an ethics 'sting'

When Chris Hansen of "Dateline" shows up at the door, you know some predator is about to get very publicly busted. So when he and his team journeyed to India to expose CROs for preying on the poor and operating without any ethical considerations or concern for people's health, you know that somebody is going to wind up running from a camera.

In this case, Hansen nabbed two Indian CROs--Lambda Therapeutic Research and Synchron Research Services--willing to test a copy of Vioxx, the once promising treatment linked to heart attacks and thousands of deaths. And they found that both were more than happy to start testing the drug--identified by its old generic name MK-0966--in Indian patients who would be paid a fraction of what trial subjects earn in the U.S. or Europe. One CRO executive bluntly told them that Indian patients would take whatever a doctor prescribed. "Doctor is god," he told Hansen, "So if I go to him, I will blindly follow what he says."

The FDA, of course, rarely tries to police the overseas CROs. That's a big concern for bioethicists. "We have no idea what's going on in these clinical trials," Dr. Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota, tells Hansen.

The Association of Clinical Research Organizations was not amused by the report. In fact, it found some aspects blown out of proportion. Lambda and Synchron, said the group, are not prominent CROs, as "Dateline" depicted. And they dismissed the implication that an Indian study could substitute for a large U.S. clinical trial for a drug like Vioxx. Nevertheless, the report tarnishes Indian CROs just as more and more developers are looking overseas for CROs who can do the work more efficiently. And India isn't the only country where money can attract fly-by-night clinical research groups.

India introduces new rules on device manufacturing

New guidelines for the import and manufacture of medical devices in India have now come into effect, aimed at increasing world confidence in medical devices made in the region.

Set by India's Central Drugs Standard Control Organization (CDSCO), the new guidelines will regulate the import, manufacture and sale of all sterile devices in India, including cardiac stents, drug eluting stents, catheters, and orthopedic implants.

The rules were recently clarified by the CDSCO after numerous requests both from inside and outside India and finally came into effect on 29 June 2006.

 "From a situation where regulations were lacking, India has progressed and the new guidelines are set to bring additional discipline to the medical devices sector," said Dr Umakanta Sahoo, director of Chiltern International, Mumbai.

"This will fuel confidence in the suppliers and manufacturers in India."

 Companies now have 60 days to obtain a license for the medical devices they manufacture in India.

 From now on device manufacturers will have to pay a registration fee of $1,500 (€1,173) per manufacturing premise and a fee of $1,000 per single medical device.

 

For each additional type of device, firms will need to pay an extra fee of $1000, unless the medical device only varies in size or shape without any change in the material or method of use.

 Devices which are currently in use will be permitted to be sold for the time being up to a period of six months, until an application is approved or rejected.

 From now on if a company intends to make a device in India that has not been manufactured in the country before, they would not be allowed to begin manufacturing without the regulatory approval.

 The rules also specify that the importers, stockists and retail sellers of medical devices must obtain appropriate sale licenses from the State Licensing Authorities for the medical devices they are dealing in, within the next three months.

 These new guidelines are the latest in a number of regulatory reforms aimed at putting India's pharmaceutical industry standards on par with the west, as more and more international pharma firms look to use the country as a low cost research and manufacturing destination.

 India's regulatory framework is now compliant to international standards in areas such as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and the 2005 amendment to the schedule Y of the Drugs & Cosmetics Act has been moving India towards the acceptance of International Conference on Harmonisation (ICH) guidelines for clinical research. The implementation of the product patent act has also confirmed the country's willingness to accept global confidentiality and data security.

 However, medical devices have been neglected in these reforms - until now.

Pfizer, Lilly, AstraZeneca giving NIH abandoned drugs

Three of the world's largest drug manufacturers are going to empty out their closets and turn over research on unsuccessful drugs to the National Institutes of Health. The idea is that federally funded researchers can take what's there and perhaps find another ailment the drug will work on.

Pfizer ($PFE), Eli Lilly ($LLY) and AstraZeneca ($AZN) will release more research on more than 20 drugs to NIH, which will turn it over to researchers at universities and hospitals.

NIH Director Francis S. Collins points out that AIDS treatment AZT began as a cancer drug, while Raloxifene was developed for treating osteoporosis but ended up as a breast cancer drug.

The agency has $20 million to jump-start the project, which is set to begin in October. Nobody is saying what abandoned drugs are being exchanged, but officials see great promise in the project.

Lilly's executive vice president for science and technology, Jan M. Lundberg, tells The Wall Street Journal that the company is releasing drugs on which there has already been significant work. "If you compare this to a relay, you are starting as person three out of four," she said.

The NIH expects others will follow the lead of Pfizer, Lilly and AstraZeneca. And as Health and Human Services Secretary Kathleen Sebelius said to The Associated Press, the effort is to "see whether we can teach old drugs new tricks."

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Drug shortages have fallen dramatically, FDA says

Drug shortages in the U.S. have dropped significantly, and more than 125 shortages have been averted in recent weeks, says the FDA.

Since Jan. 1, there have been 42 shortage reports made, compared with 90 a year ago, the FDA reports. There are currently about 120 drugs considered in short supply.

In the kind of logic that federal agencies often use in election years, the FDA is giving an executive order by President Barack Obama credit for cutting drug shortages in half. In October, he ordered drug companies to report any potential for shortages to the FDA quickly so that the agency could take steps to help stave off shortages. In February, for example, the FDA agreed to temporarily allow Sun Pharma to import Lipodox from India to substitute for a shortage of the cancer drug Doxil.

"I am both amazed and delighted to see the progress that's been made," FDA Commissioner Margaret Hamburg said in a blog post. "Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts."

Of course, there are many factors that contribute to drug shortages, including how stringent FDA regulators are about problems they observe in manufacturing sites. Manufacturing problems led to 43% of the supply problems reported to the FDA, Bloomberg reports.

And the FDA is not saying that lifesaving drugs are no longer in short supply. The commissioner says the FDA is still working to resolve shortages of such drugs as childhood leukemia treatment leucovorin and the anesthesia fentanyl, Reuters reports. And she notes that her agency is working with Congress on bipartisan legislation to address the ongoing shortage concern.

- here's the Reuters story
- read more from Bloomberg
- FDA blog post

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GSK's Witty has no interest in buying AstraZeneca

Thanks but no thanks. That was GlaxoSmithKline ($GSK) CEO Andrew Witty's comeback to the suggestion that maybe GSK should buy AstraZeneca ($AZN).

They are both based in the U.K., and AstraZeneca is thought to be vulnerable, what with its earnings down and its future in question now that the board recently invited CEO David Brennan to make an early exit. Might there not be significant cost savings, suggested an investor at GSK's shareholder meeting, Reuters reports.

But Witty said that kind of a deal would be a distraction at a time when GSK feels good about the prospects of its pipeline of drugs. That reasoning doesn't completely square with GSK's recent $2.6 billion offer for Human Genome Sciences ($HGSI), particularly given that HGS told GSK thanks but no thanks. There may very well be distractions if GSK gets involved in a proxy fight.

And all is not rosy for GSK. This week, German regulators rejected its big-time hope, Benlysta, saying the lupus treatment was too pricey.

And there is always the question of whether megamergers pay off, given the difficulties of braiding together different cultures, workforces and assets. Just the other day, Pfizer ($PFE) CEO Ian Read acknowledged to The New York Times that the company's decade of buying up company after company may not have been the best strategy. It is now trying to get smaller and more focused by selling its animal health and nutrition businesses.

Of course, every company has its own strategy, and Witty in the past has said he does not favor large acquisitions, reminds Reuters.

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Feds nab suspects in $70M Lilly heist

For several years now, a trail of large pharmaceutical cargo theft led to south Florida. Authorities have now arrested nearly two dozen suspects, many from Miami, including two Cuban brothers tied to the heist of more than $70 million worth of drugs from an Eli Lilly ($LLY) warehouse in Connecticut.

The feds say the 23 suspects are tied to pharmaceutical cargo losses worth tens of millions of dollars throughout the country, Reuters reports. According to a statement from Lilly, most of the drugs stolen from its warehouse have been recovered, although safety concerns and FDA rules about how the drugs have been stored since the theft will dictate what happens to them now.

The drugs were taken two years ago in a daring heist, the details of which were like something out of Ocean's Eleven--a dismantled alarm, burglars rappelling through a skylight and the use of a forklift to load pallets of drugs onto a semi. Drugs taken included Lilly's schizophrenia drug Zyprexa, its anti-depressant Prozac and the cancer drug Gemzar.

In fact, Charles Forsaith, coordinator of the Pharmaceutical Cargo Security Coalition, said it seemed a few years ago that there was a very organized gang working out of south Florida "that would literally have a shopping list, and they would target a particular company or a particular site."

Forsaith, whose day job is director of supply chain security for Purdue Pharma Technologies, says the Eli Lilly burglary and several others at the time served as a wake-up call to the industry. He credits the coalition--whose mission it is to combat this type of crime--with helping the industry shake a certain naiveté that had allowed criminals to take advantage of vulnerabilities.

Not only did pharma companies start using certain technology, like hiding GPS devices in cargo loads; they started using common sense. For instance, making sure that transport companies used two-person driving teams so a rig was never left unattended.

The result has been a dramatic decrease in pharmaceutical cargo theft. Last year, according to coalition statistics, there were only 5 stolen shipments with a value that topped $500,000, and only three over $1 million. In 2009, there were 15 in the $500,000-plus category, 11 of which topped $1 million.

Along the way, the group also collected data and information that may very well have helped authorities track down the alleged cargo theft gang. And as a result of the investigations, U.S. Attorney David Fein in Connecticut says, "we believe that a prolific cargo theft ring has been dismantled." 

Bayer Healthcare posts big growth in Asia Pacific

Bayer Healthcare is on a roll in Asia. The German company toted up a 9.4% increase in Asia Pacific sales last year, for a regional total of 3.6 billion euros, or $4.8 billion. And it has even bigger ambitions: The company said it expects Asia sales to grow to 11 billion euros by 2015, with 6 billion of that coming from the China region.

"We are confident about our growth prospects in the region based on the dynamic development of the economy and the innovative potential of the pipeline," regional chief Alok Kanti told Reuters. One of the best new performers is the clot-fighter Xarelto, which grew 109% in the region last year in the hip-and-knee surgery market. With anticipated approvals for stroke prevention, Xarelto growth there is expected to accelerate.

As Kanti notes, most drugmakers are now focused on emerging markets, given that developing countries are posting double-digit growth figures, compared with lagging growth in the U.S. and Europe. Bayer already sources almost one-third of its global sales in emerging countries.

Which countries are turning in the biggest numbers for Bayer? Sales growth leaders for the company were Singapore, Vietnam, and Pakistan, all with 26% and higher growth. The company didn't break out its China figures, Reuters said.

- read the Reuters news

ALSO: Bayer AG put in a preliminary bid for Pfizer's ($PFE) animal health unit, Dow Jones reports, citing the Financial Times Deutschland. Pfizer is expected to offer an update on the potential deal by early April, the FT's sources said. Report

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Indian government forces Bayer to accept generic Nexavar competition

India has invoked its compulsory licensing rules for the first time, allowing the domestic drugmaker Natco Pharma to make and sell a version of Bayer's cancer drug Nexavar--despite the fact that Nexavar is still on patent. Natco will pay a 6% royalty, but given the fact that it's going to be selling Nexavar at a substantial discount, that payment probably won't be very significant.

It's the patent board's ruling that's significant. Now that the Indian government has granted one license, more generic drugmakers are expected to petition for their own.

Compulsory licensing is a contentious affair; globally, it's uncommonly used. The idea is that, in a public health crisis, generic drugmakers should be able to sell lower-cost versions of branded drugs, so that more patients can get access to treatment. Some multinational companies have granted their own licenses to low-cost drugmakers for public health (and public relations) reasons, particularly on AIDS drugs for sale in Africa. Government compulsion is a different story; branded drugmakers view that approach as an assault on their intellectual property rights.

Bayer has been fighting Natco's petition for a compulsory license for years, but government officials finally ruled in the domestic company's favor. Under the license, Natco can sell its version of the drug until 2021 at a price no higher than 8,880 rupees, or about $178, per month, Dow Jones reports. Natco says that Bayer sells the branded version for 284,428 rupees a months, or $5,690.

Now, the German drugmaker tells Dow Jones that it is disappointed in the government ruling and plans to "evaluate our options to further defend our intellectual property rights in India." For its part, Natco "opines that this opens up [a] new avenue of availability of life-saving drugs at an affordable price to the suffering masses." Natco expects to reap annual sales of up to $6 million from its Nexavar version, CFO Bhaskar Naranaya told India's CNBC-TV18.

India's Cipla puts fire-sale prices on cancer drugs

In what appears as a full-on assault on the pricing structure of Western drugmakers, Indian genericsmaker Cipla will sell its copies of cancer drugs for a fraction of their branded counterparts.

Cipla is discounting its version of Bayer's Nexavar from about $525 for a month's supply to about $128, The Wall Street Journal reports. That compares to Bayer's price tag of about $5,235. Cipla also will slash the cost of AstraZeneca's ($AZN) cancer drug temozolomide by 75%.

Western drugmakers of course believe there could be great financial rewards for selling branded drugs to India's 1.2 billion people. But they were already getting nervous when the government a few weeks ago ordered Bayer to issue a compulsory license for Nexavar on the grounds that it was badly needed but too expensive for the country's very poor population.

The pharmaceutical industry points to the billions it has to pour into R&D to develop and get approval for all of these life-saving treatments, but that argument hasn't worked so well in India, which has spurned patents before.

Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, tells WSJ that there has to be a better way to get cheaper treatments to the poor than forcing drug companies to license their drugs to genericsmakers before they have a chance to recoup their investments.

But Cipla became heroic in Africa when it began selling cheap versions of cancer drugs a decade ago, and its managing director is casting this move in that light.

"We had taken the lead to provide affordable medicine for AIDS, and I think the time has now come--10 years later--when we do a similar thing for cancer," Y. K. Hamied tells WSJ

Bupivacaine Hydrochloride Injection Shortages

Company/Products	Reason	Related Information	Date Updated
APP 1-888-386-1300	Increased demand	APP has Sensorcaine (with & without Epinephrine) on intermittent back-order and the company is releasing product as it becomes available. Check Wholesaler Inventory.	Revised4/24/2012
Hospira, Inc. Customer Service 1-877-946-7747   0.25%; 30 mL amp (NDC 0409-1158-01) 0.25%; 10 mL vial (NDC 0409-1159-01) 0.25%; 30 mL vial (NDC 0409-1159-02) 0.25%; 50 mL vial (NDC 0409-1160-01) 0.5%; 10 mL vial (NDC 0409-1162-01) 0.5%; 30 mL vial (NDC 0409-1162-02) 0.75%; 10 mL vial (NDC 0409-1165-01)   0.75%; 30 mL vial (NDC 0409-1165-02) 0.25% w/epi 1:200,000; 10 mL vial (NDC 0409-9042-01) 0.25% w/epi 1:200,000; 30 mL vial (NDC 0409-9042-17) 0.25% w/epi 1:200,000; 50 mL  (NDC 0409-9043-01) 0.5% w/epi 1:200,000; 10 mL vial (NDC 0409-9045-01) 0.5% w/epi 1:200,000; 30 mL vial (NDC 0409-9045-17) 0.5% w/epi 1:200,000; 50 mL vial (NDC 0409-9046-01)   50 mg/20 mL Sterile pack amp (NDC 0409-4272-01)	Manufacturing delays	Product 0.25%; 30 mL amp (NDC 0409-1158-01): ample supplies available. Product 0.25%; 10 mL vial (NDC 0409-1159-01): next delivery April. Product 0.25%; 30 mL vial (NDC 0409-1159-02): next delivery April. Product 0.25%; 50 mL vial (NDC 0409-1160-01): next delivery April. Product 0.5%; 30mL amp (NDC 0409-1161-01): next delivery May. Product 0.5%; 10 mL vial (NDC 0409-1162-01): next delivery April. Product 0.5%; 30 mL vial (NDC 0409-1162-02): next delivery April. Product 0.5%; 50 mL vial (NDC 0409-1163-01): next delivery April. Product 0.75%; 10 mL vial (NDC 0409-1165-01): next delivery April. Product 0.75%; 30 mL vial (NDC 0409-1165-02): next delivery March. Products 0.75% w/ dextrose 8.25%; 2 mL ampule (NDC 0409-3613-01): next delivery April. Product 0.25% w/epi 1:200,000; 10 mL vial (NDC 0409-9042-01): next delivery May. Product 0.25% w/epi 1:200,000; 30 mL vial (NDC 0409-9042-17): next delivery April. Product 0.25% w/epi 1:200,000; 50 mL vial (NDC 0409-9043-01): next delivery April. Product 0.5% w/epi 1:200,000; 10 mL vial (NDC 0409-9045-01): next delivery April. Product 0.5% w/epi 1:200,000; 30 mL vial (NDC 0409-9045-17): next delivery April. Product 0.5% w/epi 1:200,000; 50 mL vial (NDC 0409-9046-01): next delivery April. Product 50 mg/20 mL Sterile pack amp (NDC 0409-4272-01) next delivery June. Product 0.25%; 20 mL amp (NDC 0409-5622-01): next delivery April. Product 0.5%; 20 mL Sterile pack amp (NDC 0409-4273-01): next delivery April. Please check with your wholesaler for available inventory.	Revised 4/12/2012

Nestle near buying Pfizer's baby formula

Nestle , the world's biggest food group, is closing in on a deal to buy Pfizer's infant nutrition business for up to USD 10 billion to boost its business in China and extend its lead in the world of formula milk for babies, sources familiar with the matter said on Wednesday.

The Swiss group had already been seen as favourite for the business, and is now set to seal a deal later this month after outbidding a joint team of Danoneand Mead Johnson in a largely two-horse race.

"Nestle is in the lead position and is closing in on a deal which we expect soon," said one source.

Another source said the business would fetch USD 9-10 billion and expected a deal by the end of the April.

If Danone loses out, analysts say the French group will face a problem of how to expand, with its Chief Executive Franck Riboud saying it did not have the firepower to mount big deals which would seem to rule out an eventual move for Mead Johnson.

The Pfizer unit is a high-growth USD 2.1 billion turnover business with over 70% of sales in emerging markets and a key position in China, and has attracted the attention of the three largest players in the infant milk formula sector.

Pfizer put the business up for sale last July following its USD 68 billion purchase of Wyeth in 2009, while it is also looking to offload its animal health business and says this is more likely to be spun off than sold outright.

A spokesman for Vevey-based Nestle, which holds its annual general meeting in Lausanne on Thursday and releases first-quarter sales figures on Friday, said "we never comment on market rumours".

Analysts said if the deal is concluded it would be positive for Nestle and also may help Danone's shares as there has been concern that the French group might pay a huge price for the business and massively leverage up its balance sheet.

"Overall, this deal makes huge strategic sense for Nestle. It is in the right categories and the right markets and with a reasonable price we would expect a fairly positive response from investors," said analyst Andrew Wood at Bernstein.

Nestle shares were off 0.3% at 56.60 Swiss francs and Danone up 1% at 53.61 euros by 1030 GMT.

Lupin resumes US sales of diabetes drug Fortamet copy

Drug maker Lupin said on Thursday that it has resumed US sales of its copy of Shionogi Inc's Fortamet tablets, a type 2 diabetes treatment drug.

The US Court of Appeals has granted its request to stay preliminary injunction that had earlier barred sales of its generic version of Fortamet, it said.

Lupin had received final approval from US Food and Drugs Administration for its Metformin tablets and launched the product in September last year. In December Shionogi's request for a preliminary injunction had been granted and had blocked Lupin from further sales of its generic product.

US sales for Fortamet were USD 70.2 million in the year ended December 2011, Lupin said citing IMS Health data.

Lupin shares were up 0.5% at Rs 556 on NSE in afternoon trade.

Piramal buys Bayer's potential Alzheimer drug

Drugmaker Piramal Healthcare has agreed to buy a research and development portfolio from Bayer AG, the company said, in a deal that gives Piramal rights to florbetaben, a possible Alzheimer treatment.

Florbetaben, which is in the final stages of clinical trials, works by detecting symptoms in probable sufferers of Alzheimer's, and is expected to allow earlier detection and specific treatment of the disease, Piramal said in a statement.

Florbetaben is racing with similar Alzheimer's imaging agents from global pharmaceutical companies such as Eli Lilly and Co, Pfizer Inc and General Electric Co to enter a global market estimated at anywhere from USD 1 billion to USD 5 billion.

Piramal will acquire intellectual property, worldwide development, marketing and distribution rights of florbetaben and other clinical and pre-clinical assets of Bayer's molecular imaging business in the deal. Financial aspects of the deal were not available.

"We plan to build a promising portfolio in the pharma space, including our newly acquired molecular imaging assets, which will help us create a global branded pharma business," Ajay Piramal, chairman of the Piramal Group, was quoted as saying.