FiercePharmaManufacturing

Providing insight into pharmaceutical manufacturing requires conversation

Eric Palmer — Tue, 07 Feb 2012 09:55:18 -0500

Take a look at a recent graph of health spending in the U.S., and you may see a visual metaphor for what faces drug manufacturing. It looks like a series of precipitous peaks, each smaller than the one before.

Spending in 2010 increased 3.9%, the slowest rate in 50 years. Retail spending on prescriptions grew just 1.2% in 2010, to $259 billion, also the slowest rate in half a century.

The snapshot report comes from the Office of the Actuary, Centers for Medicare and Medicaid Services at the Department of Health and Human Services, and is published in Health Affairs. It says the declines can be chalked up to a wavering economy and an onslaught of generic drugs, factors that drug manufacturers still face.

Those pressures come as the FDA and regulators in other parts of the world are likely to be cautious about approving drugs and devices. We know there are shortages and manufacturing quality issues for some companies to address and trade secrets and deliveries to protect.

But one company's challenge is another's opportunity. There are growing markets in places like Asia and India. There are constant innovations in IT and manufacturing that can cut costs and improve quality along the entire supply, manufacturing and delivery chain.
But to snatch an opportunity, you need insight into your markets, into what is happening and likely to happen. The common threads through all of this is information and data.

We at Fierce are all about giving you that information. And as the new editor of FiercePharmaManufacturing, I intend to bring my three decades of experience as a business journalist to bear so you know who in the industry is winning--as well as who is losing--and why.

To do the job you need, you and I need to have a conversation. So let me know what is important to you. Email me at epalmer@fiercemarkets.com or talk with me on Twitter at @EricPFierce.

AstraZeneca faces resistance to job cuts on home turf

Eric Palmer — Mon, 06 Feb 2012 23:17:55 -0500

With expiring patents undercutting revenues, the pharmaceutical industry has shed hundreds of thousands of jobs worldwide. And while it is always an unpleasant process, it is probably hardest when a company has to cut jobs on its home turf.

In the case of London-based AstraZeneca, ($AZN), which last week announced plans to eliminate 7,300 jobs while increasing its dividend to shareholders, resistance is brewing at R&D and manufacturing facilities in the U.K. Citing the damage the jobs losses will have to the U.K. economy, union leaders have vowed to resist cuts there.

"If the company can afford a 10 percent hike in its dividends, then it can afford to retain these roles," Linda McCulloch, a national labor leader, told the Manchester Evening News. The newspaper said between 250 and 350 jobs reportedly would be lost from the R&D department at Alderley Park, as much as 10% of the workforce of 3,500. There has been no announcement regarding Macclesfield, the group's second-largest manufacturing site with around 2,600 staff.

AstraZeneca said it will cut about 3,750 sales, general and administrative jobs, 2,200 positions in R&D, and another 1,350 in operations worldwide. These come on top of 24,000 job cuts globally by the company since 2009. The cuts are to take place over three years. The company also reported that it would increase its dividend 10%, amounting to an additional £2.9 billion to shareholders in 2012 on top of the £6 billion last year.

AstraZeneca has 8 facilities and about 8,000 employees in the U.K., including its London headquarters, according to Thomas Hushen, a spokesman for the company, told FiercePharmaManufacturing in an email. It has manufacturing facilities in Avlon, Speke and Macclesfield, which also includes information services and R&D. It has R&D facilities in Alderley Park and Cambridge, environmental research at Brixham and sales and marketing operations in Luton.

Hushen did not say what impact the labor resistance might have or if saving jobs in one area would mean deeper cuts in another location. "It is important to note that all of the estimated numbers provided last Thursday are subject to the requisite consultation process before they can be finalized, and that process is under way," he explained. "These are tough decisions. The changes we are making will help us to safeguard our long-term competitiveness and improve productivity."

The cuts come at a tough time for the U.K. pharmaceutical industry. Blogger Rowan Gardner recently said the country has gone from 26 major pharmaceutical and 6 agrochemical R&D facilities in 1985 employing 35,000 to two major pharmaceutical R&D facilities employing 5,500.

Raising a stink about job cuts in the home country actually resulted in a decision by Swiss drugmaker Novartis ($NVS) to save a plant and 320 jobs in Vaud and ease back on cuts in Basel, Pharmalot pointed out.

"Overall, Novartis firmly believes that the agreements now reached in Nyon are of great importance not only for the company, but also for Switzerland as a whole," making the country more attractive for international investment, Novartis said in a statement sent to FPM on Monday.

The Novartis statement also noted that the company expects to increase employment in Switzerland by 2,000 positions in coming years. The salvaging of jobs in Switzerland will not mean deeper cuts elsewhere; however, "across the Novartis Group, we are constantly looking for ways to reduce costs, improve productivity and absorb pricing pressures."

- check out the Manchester Evening News story
- see Pharmalot's insight
- get the Bloomberg story

Special Report: AstraZeneca - Top 10 pharma layoffs of 2011

FDA report shows deep problems at closed Novartis Consumer Health plant

Eric Palmer — Mon, 06 Feb 2012 22:58:59 -0500

With the completion of inspections Jan. 20, Novartis Consumer Health ($NVS) set about reviewing the 483 FDA observations of its idled plant in Lincoln, NE.

The plant was voluntarily closed Dec. 19 to address a multitude of problems that have led to several recalls of Novartis over-the-counter products, including the entire Excedrin line. The plant also made pain killers for Endo Pharmaceuticals ($ENDP), which has been affected by the closure.

In a statement Monday, Novartis officials said "maintenance and improvements at the Lincoln site, where we voluntarily suspended production on December 19, 2011, to strengthen standards" are ongoing. The officials said the company was "committed to ensuring the highest standard for consumers who rely on our products, and will continue to work with the FDA to fully address their concerns." Novartis has set aside $120 million to address shortcomings at the plant and CEO Joseph Jimenez (photo) has told the investment community he is confident the plant will reopen mid-year.

But a deep dive into the latest inspection report indicates just how serious the FDA believed problems at the plant were, as well as the level to which standards will have to be raised to meet agency expectations. According to the FDA report, the plant was lax about maintenance, short on staff and training and complacent about some aspects of quality control that on many occasions led to the wrong drug showing up in containers. Among others, there were reports of Excedrin Migraine tablets also containing Excedrin caplets and regular-strength aspirin in an Excedrin Migraine geltabs carton.

The report said that as of Dec. 12, there were 1,360 unresolved consumer complaints, 1,332 major and 31 critical, and the backlog had been more than 1,000 since Aug. 30. The complaints included "foreign products in container, suspected tampering, foreign object, missing label, discolored product, partial tablet, chipped/cracked and crumbled product." The report said Novartis had to bring in outside consultants to help review complaints.

The FDA said line clearance practices didn't consistently remove all the tablets and capsules from packaging lines, and there were reports of various products found after a major clean in such areas as the "base of a filler dust collector, capper base, oil catch under capper, electrical cable tray, tray below the tiller, underneath electrical box," etc.

It said Excedrin tablets, as well as 28 assorted tablets, were found in troughs for Oxycodone ER, Percocet and others. It said the company failed to explain how the 28 various tablets, including Gas X, Soft Gels and others that were not even packaged in that room could have gotten there. The FDA said the company blamed it on "Human Error" and "Failure to Follow Procedure," without documenting who could have brought in the tablets and what procedure was not followed.

The FDA repeatedly found there were problems, including hundreds of consumer complaints dating to 2009, of chipped or cracked products, but corrections were not executed until this year. And it said investigations into complaints of the wrong drug found in a package were often closed with citations of mix-ups at the distribution or consumer level as likely causes, but with no evidence to support those contentions.

In its statement Monday, Novartis said the FDA's concerns are being addressed. The company "is committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these standards are implemented across our entire network."

However, the FDA says so far the Novartis "Quality Unit has failed in the responsibility and authority to monitor Quality systems designed to assure the quality of drug products manufactured and packaged at [the] firm."

- get the inspection reports

Related Articles:
Novartis says Nebraska plant to reopen midyear
FDA: Novartis plant shows patterns of problems

Merck's manufacturing information not trade secrets, court rules

Eric Palmer — Mon, 06 Feb 2012 14:41:01 -0500

Merck Frosst Canada ($MRK) has reached the end of the legal line in its fight over whether manufacturing and clinical study information the company gave Health Canada were trade secrets protected from release to competitors under Canada's access-to-information law. Merck provided the information on Singulair, an asthma drug that it ultimately removed from the market, as part of the compliance process with the government's Food and Drug Regulations. When competitors asked for the information, and Health Canada agreed to provide it, Merck cried foul. It sued claiming competitors could piece together enough from the data to gain a competitive advantage. The Supreme Court upheld a lower court's ruling that the information was not protected. News | Pharmalot's take

Dishman set to bail on API manufacturing in once-promising China

Eric Palmer — Sun, 05 Feb 2012 18:06:59 -0500

Dishman Pharmaceuticals & Chemicals ($DISHMAN.NS) appears poised to give up on manufacturing for now in China, which it believed held great promise when it first bought land there in 2005.

But having already invested $20 million in an API plant that may still be years away from approval, the company is looking instead at selling the site to pay down debt. Otherwise the company will use the plant to produce Category III HAPI.

Dishman is in advanced negotiations with prospective buyers and expected to get $25 million for the facility near the Shanghai Pudong International Airport, Dow Jones reported recently. CFO V.V.S. Murthy told Dow Jones that Dishman hoped to close a deal by June and would use the money to pay down debt.

On Monday, Dishman spokesman Christian Dowdeswell told FiercePharmaManufacturing in an email that having been unable to get Chinese Food and Drug Administration (SFDA) approval as expected, selling the plant was one of a couple of options.

"It is estimated that it will take up to three years for the SFDA to grant GMP status," he said. "The first option is to retain the Shanghai plant for the production of Category III HAPI (Safebridge Category III) and the second option would be to divest the Shanghai plant and focus on API manufacture in India."

Like many other pharmaceutical companies, Dishman had great expectations for what it could achieve in a market with less expensive labor and utility costs. Dishman initially planned to buy a 20,000-square-meter parcel but opted on one four times that size because of the potential of the market. The plant was built to produce pharmaceutical intermediates and active pharmaceutical ingredients for its U.S. and European clients.

Construction began in 2006 on the facility, which includes a production plant, a warehouse, dedicated on-site utilities and administrative/quality control offices. The facility's large-scale capacity (10 reactors with total capacity from 2,500 L to 8,000 L) is designed to produce multiton quantities. Dishman completed the trial production of its new China facility in May 2010, PharmTech.com reported.

Dishman expected to have it approved and operating by September 2008. But three and a half years later, it still does not have local regulatory approvals and so the facility at the Shanghai Chemical Industry Park is up for sale.

- get the Dow Jones story
- see the in-Pharmatechnologist.com piece
- read the PharmTech.com report

ALSO: Check out our new ebook: Including China in Drug Development Programs: Opportunities & Challenges

Smith & Nephew eliminating 800 jobs, restructuring already felt in Memphis

Eric Palmer — Sun, 05 Feb 2012 11:53:06 -0500

It has been a tough few days for medical device manufacturer Smith & Nephew ($SNN) and particularly for its Memphis, TN-based division.

The company announced Monday that it would pay the U.S. $22.2 million in fines and profit disgorgement to settle claims that it won business in Greece by bribing doctors in that country's public health service. Its U.S. subsidiary, Smith & Nephew Inc., based in Memphis, is shouldering $16.8 million of the settlement with the Justice Department.

The settlement came days after the company announced that it would cut about 800 jobs from its orthopedics unit and place emphasis on emerging markets and research and development.

The bribery charges date to 2007 when an investigation found that the company, with the help of a distributor, paid $9 million in bribes to Greek doctors. The company agreed to maintain an enhanced compliance program to be reviewed by an outside monitor for 18 months.

S&N, Europe's largest artificial knee and hip maker by sales, also will take a $200 million hit related to the job reductions but expects to save $150 million annually. The reduction amounts to 7% of its 11,000 global workforce.

The company announced in November that it would reduce its workforce but only outlined the cuts during a conference call Thursday. The company reported a fourth quarter profit of $279 million--compared with $278 million a year earlier--and said orthopedic sales lagged areas like wound care.

The company has already eliminated 220 of the 800 positions to be cut. Olivier Bohuon (photo), CEO of the London-based medical device company, did not give details, but said much of the restructuring would come from consolidating back office work.

The Daily News has already reported 80 positions were lost in Memphis, TN, where S&N employs about 2,000. The cuts were part of a restructuring when S&N's Memphis-based orthopedic reconstruction and trauma division was merged with its Andover, MA-based endoscopy division to form the advanced surgical devices division.

While Johnson & Johnson ($JNJ) has said it expects spending on orthopedics to grow this year, S&N does not. Bohuon said the company would make acquisitions and invest savings in emerging markets like India, Brazil and Russia. The company on Jan. 30 reported its purchase of Aderma Dermal Pads Products from Focus Product Development to expand its wound-care business.

- read the AP story
- here's The Daily News story
- read Bloomberg's take
- get more from the Financial Times

Special Report: Top 10 medical device deals of 2011

Related Articles:
UPDATED: Smith & Nephew settles with gov't over bribery allegations, impresses with earnings announcement
S&N spins off drug unit into private-equity JV
Report: S&N to raise R&D budget

Executive suite not spared in J&J reorg tied to quality concerns

Eric Palmer — Thu, 02 Feb 2012 09:07:11 -0500

Management at the factory level feel the heat under any FDA consent decree, but a shake-up at Johnson & Johnson ($JNJ) this week showed that the pressure can extend into the executive suite.

Two J&J group chairmen and long-term executives left this week, presumably because of ongoing difficulties in the company's consumer health business, The Wall Street Journal reports. The departures come less than a year after manufacturing problems sparked a revamp that gave them new authority in consumer health.

Patrick Mutchler, who was put in charge of overseeing the McNeil Consumer Healthcare unit in April, is retiring after 35 years at the company. The company also confirmed that Pericles Stamatiades, a 28-year J&J veteran, is also leaving. He was named strategist for consumer businesses in the same April reorganization. Mutchler's duties will be taken over by Roberto Marques, who heads J&J's consumer businesses in North America. Stamatiades' responsibilities are being parsed out among other management.

A string of recalls of J&J products began in late 2009 affecting products including Tylenol, Benadryl, Motrin and Zyrtec, prompting FDA intervention and congressional hearings. McNeil Consumer Healthcare immediately closed its Fort Washington, PA, plant after an April 2010 recall of more than 136 million children's and infants' products.

McNeil entered into a consent decree with the FDA in March covering plants in Lancaster, PA, and Las Piedras, Puerto Rico, in addition to the Fort Washington facility, which is undergoing a $100 million renovation.

Johnson & Johnson moved some of the affected products to other plants but problems have persisted. Just in August the company yanked another 2.5 million units of Tylenol.

U.S. sales at McNeil fell to $1.4 billion last year, from a peak of $3.1 billion in 2008, WSJ notes, citing Fargo Securities.

Suggesting, however, that the quality control issues CEO William Weldon wants addressed extend beyond McNeil, Johnson & Johnson said day-to-day operations at McNeil Consumer Healthcare will continue to be led by the executive named in April to oversee the unit.

In a statement sent to FiercePharmaManufacturing, the company said: "The U.S. OTC business will continue to be operated as a separate, integrated business in order to maintain its focus on quality and compliance, and on the successful reintroduction of OTC medicines in the U.S. market. The business will continue to be led by U.S. OTC President Denice Torres."

- here's the WSJ story

Pfizer suspects 30 packs of contraceptives mispackaged; pulls 1 million just in case

Eric Palmer — Thu, 02 Feb 2012 06:53:35 -0500

Workers at a Pfizer ($PFE) plant in upstate New York that makes birth control pills are learning that if you mispackage pills, it can create unwanted problems.

Pfizer announced Wednesday that it is recalling 1 million packets, 14 batches of Lo/Ovral-28 pills and 14 batches of its generic counterparts, norgestrel and ethinyl estradiol tablets. The pills were manufactured and packaged by Pfizer but, Bloomberg says, marketed by Akrimax Rx Products under the Akrimax Pharmaceuticals brand.

Some packets were found with too many active tablets, while others had too few and so the active and inert pills were out of order. Pfizer was notified after an alert customer noticed she had a pink pill where a white one belonged, indicating the active and inert portions of the pack were out of order.

Pfizer told the media there were three ways that on rare occasions the problem could have materialized:

The design of the packaging line could allow for incorrect placement of the pills;

A mechanical system for detecting defective packs could miss one in "very, very infrequent" times; or

Plant workers could also miss problem packs.

Pfizer said it has since fixed the problems. The company said it believes that only 30 packs were mispackaged, but it withdrew an additional 999,970 just to be safe.

- here's the WSJ story
- read Bloomberg's take
- here's the Pfizer statement

Related Article:
Pharma recalls up 54% in Q3

Roche plant spared from sale runs into GMP issues

Eric Palmer — Wed, 01 Feb 2012 21:39:02 -0500

A South Carolina plant Roche ($RHHBY) had on the auction block last year has developed manufacturing issues that have interrupted production of its weight control drug Xenical.

Health officials in the U.S. and Europe have been notified, and the Swiss company is bringing in an expert to help it get a handle on "Good Manufacturing Practice (GMP) deficiencies discovered during an internal audit," the company said in a statement emailed to FiercePharmaManufacturing. No specifics were given.

The Florence, SC, plant manufactures intermediates and active pharmaceutical ingredients (API) used in Tamiflu, Xeloda, Xenical and Valcyte as well as the PEG reagent for Pegasys. The company said "based on the current benefit/risk assessment and high medical need for patients," it continues to release Xeloda, Pegasys, Valcyte, Tamiflu and previously released Xenical material. No recalls have been requested by authorities.

The plant, built in 1992, was one of 6 U.S. facilities targeted in late 2010 when the company announced it would close facilities and layoff 4,800 employees to save $2.4 billion by 2012. That is about half the $5.7 billion it bid last week for gene sequencer Illumina ($ILMN). In its earnings announcement Wednesday, the company reported net income last year rose to 9.5 billion Swiss francs ($10.3 billion) from 8.9 billion francs a year earlier. It said its cost-cutting had saved the company 1.8 billion francs last year and will lead to 2.4 billion francs in savings this year.

Cuts elsewhere apparently were enough to save the Florence plant, at least in the short term. Roche announced in July it would keep the plant open for now.

- get the Bloomberg earnings story

Related Stories:
Roche deals API plants in SC, CO
Roche looks to snatch up Illumina for $5.7B

Medical devicemakers double down on FDA

Eric Palmer — Wed, 01 Feb 2012 17:30:11 -0500

Medical device manufacturers are doubling down on the FDA, agreeing to pay $595 million in fees over 5 years in exchange for promises of more and faster approvals and better communication from the agency. That is about twice what was paid under the program that expires Sept. 30. The FDA said it will hire about 200 people to speed up the process, and an independent consultant to recommend process improvements. Release | Story

Pakistan drug manufacturers make plea for oversight

Eric Palmer — Wed, 01 Feb 2012 16:07:09 -0500

In many countries, asking for more regulation of the pharmaceutical industry would seem like asking for trouble. But not in Pakistan, where a drug manufacturing scandal involving the deaths of more than 130 patients and the sickening of hundreds more has led the industry to ask the government for oversight.

Pharma Bureau, an association of multinational pharmaceutical companies, sent a statement to the government saying an independent Drug Regularity Authority is needed to rebuild public trust and prevent episodes like the one playing out in Lahore. In that case, patients died after being treated at the Punjab Institute of Cardiology, which reportedly gave them drugs received as a donation.

Following a meeting of the Khyber Pakhtunkhwa chapter of the Pakistan Pharmaceutical Manufacturing Association, Riaz Arshad, the former chairman of the PPMA, told a Pakistani newspaper the pharmaceutical industry was the country's most-deregulated sector because there is no authority overseeing its operations.

"A mechanism to regulate drug manufacturing, registration, licensing, pricing, import and export and quality control of drugs is need of the hour, but the matter has remained in limbo," Arshad told The News International.

He said the industry is producing about 90% of the drugs used in Pakistan.

Gulf News said samples of drugs tested in Paris and London were reportedly contaminated with a very high quantity of an anti-malarial chemical. The plant where the drugs were believed to have been manufactured has been sealed.

- read The News International story
- check out the Gulf News story
- here's more

Amylin's OH plant prepped for Bydureon's U.S. debut

Eric Palmer — Wed, 01 Feb 2012 13:16:01 -0500

In anticipation of the U.S. approval of Bydureon, San Diego's Amylin Pharmaceuticals ($AMLN) was already amping up production of the diabetes drug at its West Chester Township, OH, plant where the med was being manufactured for the European market.

The company has been making some parts of the drug and holding it for final packaging, a spokeswoman told the Middleton Journal.
The drug is now being rolled out for delivery to pharmacies this month.

The FDA gave approval of the first once-weekly version of Amylin's diabetes shot last week. It was the third try for the company and its Dublin-based partner Alkermes ($ALKS). The drug uses Alkermes' polymer microsphere technology, manufactured in Wilmington, Ohio, to make it last longer. Alkermes has said it will receive 8% of the drug's net sales and its financial release Thursday it reported it earned $300,000 in the third quarter from sales in the EU.

There are significant expectations for Bydureon, which is intended to replace standard twice-a-day injections, both because of its dosage and the so-called Type 2 diabetes epidemic in the U.S. Most of the estimated 28.5 million people in the country with diabetes have Type 2. The disease costs the nation an estimated $174 billion a year in medical expenses and lost productivity. A federal report in 2010 estimated the disease costing $83 billion annually in hospital fees--23% of total hospital spending.

Deutsche Bank analyst Robyn Karnauskas in New York told Bloomberg Bydureon's U.S. revenue may surpass $1 billion in 2015.

But it is not all upside for the drug. In a head-to-head study with Victoza earlier this year, the rival Novo Nordisk ($NVO) drug had a superior result. Now analysts will be studying whether Amylin's pricing strategy--it intends to charge $323 for a month's supply versus $421 for the high-dose version of Victoza--will help make up the difference.

The Ohio plant, with about 300 employees, started operations in 2009, but approval of Bydureon proved elusive. Amylin's second attempt was thwarted in October 2010, when U.S. regulators expressed concern about irregular heartbeats in patients with impaired kidney functions. It received approval in Europe last June.

- here's the Middleton Journal story
- read the Bloomberg story

Special Report: Bydureon - 15 top blockbuster contenders

Novartis says Nebraska plant to reopen midyear

Eric Palmer — Tue, 31 Jan 2012 08:46:19 -0500

The Novartis ($NVS) Nebraska plant closed in December because a host of over-the-counter products contained stray pieces from other drugs is expected to reopen this summer.

Twice in recent days officials with the Swiss company said manufacturing problems that led to a January recall of Excedrin and other products were being addressed and that the Lincoln plant should reopen midyear.

CEO Joseph Jimenez included sales from the plant in his guidance for 2012 during a conference call with investors, reported In-Pharmatechnologist.com.

"We have people in the site right now working on remediation," he said. "We wanted to put an assumption into our guidance that we felt that we could deliver upon. So I'm fairly confident that we can do this."

Then in a statement emailed to FiercePharmaManufacturing today relating to reports that the company had released, temporary worker's spokeswoman Julie Mascow said: "Novartis Consumer Health is actively working toward a plan to resume manufacturing operations at the site and expects to start shipments midyear."

"We do not expect the temporary suspension in production to impact employees. However, we've had to release some of the temporary workers. Approximately 40 temporary workers are currently being retained to work in manufacturing and packaging," she continued.

Novartis set aside $120 million to address the issues. The shutdown not only cost Novartis time, sales and reputation, it has affected Endo Pharmaceuticals ($ENDP), which had the Opana ER painkiller and other analgesics produced there.

Pharmalot reported today that a new FDA inspection report, which includes inspections from Dec. 14 through Jan. 20, suggested that problems are ongoing. The report also pointed out that Novartis only recently got around to notifying veterinarians that the same potential problems could affect a drug used to treat dogs for separation anxiety.

A Novartis spokesman wrote FiercePharmaManufacturing to say that while there was only a rare chance of a problem, it notified vets out of an abundance of caution.

- get the the In-Pharmatechnologist story
- here's the WOWT.com report
- read the Pharmalot story
- here's the inspection report (.pdf)

Related Article:
FDA: Novartis plant shows patterns of problems

Teva's Cephalon recalls leukemia drug over fragments in vial

Eric Palmer — Mon, 30 Jan 2012 19:18:15 -0500

Teva Pharmaceutical Industries' ($TEVA) Cephalon has recalled one lot of leukemia drug Treanda after glass fragments were found in one of the vials.

FDA-approved labeling for Treanda states that the product, lot TB30111, is manufactured by Teva's Dutch subsidiary, Pharmachemie BV, the Israeli online news service Globes reported. Israel-based Teva acquired Pennsylvania-based Cephalon in October for $6.8 billion.

Wholesalers, distributors, hospitals and providers have been notified. Cephalon has not received reports of an adverse event and a Teva spokeswoman said the company does not believe that much of the lot remains in stock.

The recall was only one of several factors that weighed on the stock price of the world's largest maker of generic pharmaceuticals, Bloomberg Business News reported. Teva shares declined 2.7 percent Jan. 29, the biggest slump since Dec. 29, to the equivalent of $44.84, at the 4:30 p.m. close in Tel Aviv. The U.S.-traded shares closed at $44.91 on Jan. 27. The Tel Aviv shares are up 9.5 percent this year, compared with a 3.2 percent gain for the benchmark TA-25 Index.

Other factors affected the decline in stock as well. Last week, a U.S. federal court ruling cleared the way for competitor Watson Pharmaceuticals ($WPI) to sell a generic version of Sanofi's blood thinner Lovenox, a drug for which Teva also is seeking to market a copy.

Also depressing investor enthusiasm, according to analysts, was a Medicaid rule issued Jan. 27 that will raise the rebates drugmakers pay each time their products are dispensed to Medicaid patients in the U.S. Rebates will rise to 13 percent from 11 percent for generic-drug manufacturers.

- read Globes' story
- here's the FDA recall
- get the Bloomberg story

Pfizer workers at manufacturing hub sue over whiplashed retirement plans

Eric Palmer — Mon, 30 Jan 2012 19:05:11 -0500

Pfizer ($PFE) employees at the company's manufacturing hub in Puerto Rico are not happy with what company shenanigans did to Pfizer's stock price and to their retirement plans.

They allege in a class action lawsuit that the company's controversy over the safety of painkillers Celebrex and Bextra took a toll on their retirement funds, and that the company did not sufficiently manage the funds. Bextra was taken off the market.

Pharmalot reports that the employees claim that the stock also was hurt by sales and marketing practices that eventually resulted in Pfizer paying a $1.2 billion fine and a felony plea to settle an investigation into what the U.S. Department of Justice called fraudulent marketing of several drugs.

The lawsuit says the retirement plans were vulnerable to Pfizer's practice of matching employee contributions with shares. It was filed on behalf of employees who held more than 30% of their assets in Pfizer securities or common stock funds.

A Pfizer spokesman pointed out to The Associated Press that a New York court had rejected similar claims in 2009. But a lawyer for the Pfizer employees claims that tax and retirement plan laws in Puerto Rico make this suit different.

- read the AP story
- here's the Pharmalot article