Johnson & Johnson sued over pediatric drug recall

CHICAGO, July 10 (Reuters) – Johnson & Johnson (JNJ.N), the U.S. drugmaker forced to recall children’s Tylenol and other over-the-counter pediatric medicines, has been sued in federal court here by consumers unhappy with the company’s plan to offer coupons or replacement products to those who bought the affected drugs.

In five complaints filed this week in U.S. District Court for Northern Illinois, six consumers accuse J&J of fraud and racketeering for not recalling all of its children’s drugs and for not offering consumers an opportunity to fully recover their out-of-pocket payments.

The suits, all filed against J&J’s McNeil Consumer Healthcare unit, seek class-action status.

J&J took more than 40 nonprescription products off store shelves in late April, including Children’s Tylenol, in what the Food and Drug Administration has characterized as the largest recall of children’s medicine in the agency’s history.

The recalls came after FDA inspectors found multiple problems at the company’s Fort Washington, Pennsylvania, plant, including bacterial contamination of ingredients and filthy equipment.

The inspectors also found that some medications made at the plant were overly concentrated and had, in the words of congressional staffers, “the potential to be superpotent.”

The case numbers are 10cv4252 through 10cv4256.

(Reporting by James B. Kelleher, editing by Vicki Allen)

UPDATE 1-Crucell starts work on RSV vaccine

AMSTERDAM, June 24 (Reuters) – Dutch biotech Crucell (CRCL.AS) (CRXL.O) said on Thursday it would start the development of a universal respiratory syncytial virus (RSV) vaccine as part of its collaboration with Johnson & Johnson.

Crucell sold an 18 percent stake to U.S. diversified health care company J&J (JNJ.N) for 302 million euros last September as part of a flu vaccine development deal and in February said it will boost R&D funding by more than a third.

On Thursday, the company said it would start a discovery programme aimed at the development of an RSV vaccine to prevent severe infections with the most common RSV strains in infants and the elderly.

“We expect that an RSV vaccine will be the next frontier in children’s vaccines for inclusion in the routine immunisation of newborns,” Chief Executive Ronald Brus said in a statement.

While the partnership with J&J focuses on the development of and commercialisation of a universal influenza vaccine, it also included innovation programmes directed against three other disease targets.

The universal RSV vaccine has now been selected as one of the innovation programmes, while selection of the other two targets is ongoing, Crucell said.

Crucell said RSV is the most important cause of viral lower respiratory illness in infants and children and that RSV-induced disease is the last of the major paediatric diseases for which no preventive vaccine is available. (Reporting by Aaron Gray-Block; Editing by David Cowell)

J&J called uncooperative in Tylenol probe-NYT

June 11 (Reuters) – A lawmaker investigating a recent recall of Johnson & Johnson’s (JNJ.N) children’s medicine has accused the company of stymieing the inquiry, the New York Times reported.

Stocks | Global Markets | Healthcare

U.S. Rep. Edolphus Towns, a New York Democrat who is the chairman of the House Committee on Oversight and Government Reform, said J&J had used delaying tactics in its dealings with the committee and in some instances had provided misinformation, the paper reported for its Friday editions.

J&J denied the accusations, the paper said.

The conduct may compel the committee to take more aggressive action as it looks into drug quality and safety issues raised by the recall, Towns said, according to the report.

“We are not getting the kind of information and cooperation” that he would like, the paper quoted Towns as saying in an interview.

J&J spokeswoman Bonnie Jacobs told the paper that the company had been “very cooperative with the committee.” J&J has provided the committee with about 20,000 pages of documents, made its executives available for interviews and answered queries in a timely manner, she said, according to the report.

Reached for comment, Jacobs said she was quoted accurately in the story. A spokeswoman for the committee did not immediately return a call for comment placed before regular business hours. (Reporting by Lewis Krauskopf; Editing by Lisa Von Ahn)

GlaxoSmithKline nears $3 bln deal for Stiefel-WSJ

(Adds details, background)

NEW YORK, April 19 (Reuters) – GlaxoSmithKline PLC (GSK.L) is close to a deal to buy U.S. skincare specialist Stiefel Laboratories for about $3 billion, the Wall Street Journal said on its website on Sunday, citing unnamed sources.

The deal for Stiefel, which is partly owned by private equity firm Blackstone Group (BX.N), is expected to be announced on Monday, the report said, adding there is still a chance it could fall apart.

A person familiar with the matter told Reuters a month ago that Stiefel was considering selling itself and had asked Blackstone to seek offers for the business.

Stiefel is the world’s largest independent dermatology company and is viewed as a potentially attractive asset for major drugmakers, industry experts have said.

The source had told Reuters that Blackstone and the company’s family owners were seeking a speedy sale.

The Wall Street Journal, which had first reported news of the possible sale last month, said the business had drawn interest from a number of major drug companies, including Johnson and Johnson (JNJ.N) and Novartis AG (NOVN.VX). (Reporting by Jui Chakravorty Das; Editing by Jan Paschal)

GlaxoSmithKline nears $3 billion deal for Stiefel: report

NEW YORK (Reuters) – GlaxoSmithKline PLC (GSK.L) is close to a deal to buy U.S. skincare specialist Stiefel Laboratories for about $3 billion, the Wall Street Journal said on its website on Sunday, citing unnamed sources.

The deal for Stiefel, which is partly owned by private equity firm Blackstone Group (BX.N), is expected to be announced on Monday, the report said, adding there is still a chance it could fall apart.

A person familiar with the matter told Reuters a month ago that Stiefel was considering selling itself and had asked Blackstone to seek offers for the business.

Stiefel is the world’s largest independent dermatology company and is viewed as a potentially attractive asset for major drugmakers, industry experts have said.

The source had told Reuters that Blackstone and the company’s family owners were seeking a speedy sale.

The Wall Street Journal, which had first reported news of the possible sale last month, said the business had drawn interest from a number of major drug companies, including Johnson and Johnson (JNJ.N) and Novartis AG (NOVN.VX).

(Reporting by Jui Chakravorty Das; Editing by Jan Paschal)

SNAPSHOT – Financial Crisis – 2255 GMT

Obama says economic measures starting to work, but “not

out of the woods yet”

– Obama says taking over banks would be costlier

– Recovery in U.S. GDP seen delayed to Oct -EIA

– Intel beats earnings forecasts, says thinks Q1 computer

sales hit bottom, but no Q2 revenue outlook sent shares

down 4.6 percent after-hours

– UBS (UBSN.VX)(UBS.N) client to plead guilty in U.S. tax

case as Swiss bank set to cut thousands more jobs

– U.S. retail sales fell sharply by 1.1 pct in March after

two months of gains

– U.S. March producer prices unexpectedly slip 1.2 pct

– Poland to ask IMF fpr $20.5 bln standby credit line

– Goldman Sachs (GS.N) sells $5 billion in stock, aims to

repay TARP funds early

– Philips (PHG.AS) posts disappointing earnings

– Russian finance minister says Moscow may borrow abroad
next year for the first time in a decade

– Singapore devalues currency after record GDP fall

– U.S. job losses, falling GDP ahead – White House adviser

– World 2009 oil demand seen 180,000 bpd less – EIA

– Germany’s Merkel summons experts to assess downturn

– ECB’s Orphanides says deflation risk has grown

– UAE economic growth to slow to 3.3 pct in 2009 – IMF

– South Korea’s central bank to inject $2 bln into banks

– Indonesia finance minister sees 2010 GDP growth at 5 pct

– Australia business conditions better but jobs go

– J and J (JNJ.N) profit beats forecast, shares jump

MARKETS

– Wall Street shares close down on U.S. sales data and
drops in financial stocks. The Dow Jones Industrial Average
.DJI lost 137.63 points, or 1.71 percent, to close
unofficially at 7,920.18. The Standard and Poor’s 500 Index lost
17.22 points, or 2.01 percent, to 841.51. The Nasdaq Composite
Index dropped 27.59 points, or 1.67 percent, to 1,625.72.

– Oil CLc1 was down 1.1 percent to around $49.50 a barrel
on forecasts for softer 2009 global petroleum demand and for a
weekly build in U.S. crude supplies

– The dollar and yen both gained after disappointing
retail sales and uncertainty about corporate earnings boosted
safe-haven flows

– Goldman Sachs shares dropped 11.6 percent to $115.11

QUOTES

“I want to update you on the progress we’ve made, and to be
honest about the pitfalls that may lie ahead. But from where we
stand, for the very first time, we are beginning to see
glimmers of hope.” … “There is no doubt that times are still
tough. By no means are we out of the woods yet.” – U.S.
President Barack Obama

“A leveling out of economic activity is the first step
toward recovery.” – Federal Reserve Chairman Ben Bernanke said
in remarks prepared for a speech, referring to hopeful signs
that include the latest data on home sales, homebuilding and
consumer spending.

“We know the economy’s still sick. We know we’ve got
several more months of job loss, for example. We know that the
numbers on GDP are almost surely going to be very bad for this
quarter and next.” – White House economic adviser Christina
Romer/

“This morning’s U.S. data came well below expectations and
doused the positive sentiment in the markets in the past couple
of weeks. The data shows that expectations that the U.S.
economy has bottomed were overdone.” – Omer Esiner, U.S. market
analyst, Ruesch International, Washington.

“In the first quarter of 2009 we have seen a significant
further deterioration of our markets.” – Philips’ Chief
Executive Gerard Kleisterlee.

“For us, it will take several years to exit the crisis.” -Russian Finance Minister Alexei Kudrin said.

DIARY

(all times GMT)

WEDNESDAY, April 15

WASHINGTON – Federal Reserve releases Beige Book survey of
U.S. economic conditions

(World Desk, Americas +1 202 898 8482)

PREVIEW-Defensive pharma promises solid Q1 results

First Q1 results from J and J, Abbott, Roche this week

* Solid performance expected but long term problems loom

* Focus on prescribing trends during downturn

* U.S. drugmakers face currency headwind

By Ben Hirschler and Lewis Krauskopf

LONDON/NEW YORK, April 12 (Reuters) – Drugmakers should deliver a solid set of quarterly results but investors will be watching for any signs of recession choking demand for more expensive treatments.

Healthcare is traditionally one of the last areas where consumers cut spending and the sector is faring far better than many downturn-hit industries, despite the long-term problems of multiple patent expiries and excess capacity.

“We’re going to see some pretty good results that will reaffirm the defensive nature of this industry,” said Morningstar analyst Damien Conover.

Currencies, however, will muddy the waters, with a stronger dollar hurting U.S. companies while simultaneously boosting some European rivals.

Two diversified U.S. players — Johnson and Johnson (JNJ.N) and Abbott Laboratories (ABT.N) — kick off the reporting season on April 14 and 15.

J and J warned in January that the weak economy was weighing on parts of its business, although results from unlisted Biomet on April 8 suggest that the orthopedic reconstruction market, at least, is holding up fairly well.

Investors in Abbott, meanwhile, will be closely watching sales of its arthritis drug Humira amid some signs of weakness in prescriptions for such expensive medicines.

“We believe that the economic environment, rising unemployment, and resulting loss of insurance coverage is negatively impacting use of high-priced anti-TNFs,” UBS analyst Bruce Nudell said in a research note, referring to Humira’s class of drugs.

ENLARGED ROCHE

Roche Holding AG (ROG.VX) unveils first-quarter sales on April 16.

The Swiss group, which does not report quarterly profits, said a month ago it had performed strongly in January and February, and analysts are confident its market-leading position in cancer treatment will help keep it on track.

For the quarter, Roche group sales are expected to have grown 5 to 10 percent. Michael Leuchten of Deutsche Bank said there was a chance of a bullish outlook statement.

Importantly, Roche may also give an update on the integration process at Genentech, which is now a wholly owned unit following last month’s $47 billion buyout.

Citigroup estimates Roche will derive 40 percent of its 2009-12 earnings growth from cost savings and reduced financial expensive in the wake of the Genentech deal.

A wild card is the outcome of a keenly awaited clinical trial on cancer drug Avastin that could, if positive, be a major catalyst for Roche shares. Headline results from the so-called C-08 study are also expected in mid-April.

After holding up well last year, drug stocks have lagged recently, with the American Stock Exchange’s pharmaceutical index .DRG, which includes top U.S. and European companies, underperforming the broader market by more than 10 percent since the beginning of March.

“I see them doing pretty well if we’re in a prolonged recession, because I think in time eventually they’re going to get the defensive play,” Morningstar’s Conover said. “Regardless of your outlook on the economy, I think it’s a good spot to be in.”

Indeed, pharmaceuticals usually shine in a recession but their performance in this bear market has been lackluster, reflecting the deep-seated problems facing the sector.

A looming “cliff” of patent expiries, growing political pressure in the United States and elsewhere, and a lack of new drugs coming out of research labs mean drug companies are struggling with over-capacity, just like other industries.

In a bid to tackle the problem, Pfizer Inc (PFE.N) and Merck and Co Inc (MRK.N) — two companies facing the biggest earnings crunch — are spending a combined $110 billion to buy Wyeth (WYE.N) and Schering-Plough Corp (SGP.N) respectively.

Investors will be looking for more information on how both plan to achieve their aggressive cost savings targets when they report quarterly results later in the month.

So far, they have not been followed down the mega-merger path by other Big Pharma groups.

But other drugmakers on both sides of the Atlantic are stepping up drives to diversify and stabilize their businesses by buying promising assets in emerging markets and biotech, albeit on a smaller scale to Roche’s move on Genentech. (Reporting by Ben Hirschler and Lewis Krauskopf; Editing by Gary Hill)