Drugmaker Actavis agrees debt refinancing deal

July 22 (Reuters) – Icelandic generic drugmaker Actavis has agreed a debt refinancing deal with its lenders to slash its multi-billion-euro debt load, the company said.

The group did not give details in a brief statement but said the agreement positioned it with the flexibility to continue to grow, especially in southern Europe, Japan, the Middle East and northern Africa, and increase market share in current markets.

Sources familiar with the matter had told Reuters earlier this month that key lender Deutsche Bank (DBKGn.DE) was close to a deal with Bjorgolfur Thor Bjorgolfsson, the Icelandic tycoon who owns Actavis, to refinance the company. [ID:nLDE6661A3]

Deutsche financed Bjorgolfsson’s 4.7 billion euro ($6 billion) leveraged buyout (LBO) of Actavis, one of the world’s biggest makers of copycat drugs, in 2007. ($1=.7836 Euro) (Reporting by Ben Hirschler; Editing by Hans Peters)

UPDATE 1-Astra loses Canada court case over generic Nexium

LONDON, June 17 (Reuters) – Generic competition to AstraZeneca’s (AZN.L) top-selling acid reflux drug Nexium moved a step closer in Canada, after a court rejected the drugmaker’s bid to stop a copycat version from entering the market.

The Anglo-Swedish group said on Thursday the Federal Court of Canada had dismissed its request to prohibit the country’s minister of health from issuing local manufacturer Apotex with a notice of compliance (NOC) for generic Nexium.

Under the Canadian system, makers of branded medicines can request that the minister does not approve a generic drug by applying to block an NOC.

The move paves the way for generic copies of the popular heartburn and stomach ulcer drug to enter the market before the expiry of AstraZeneca’s Canadian patents, the first of which runs out in 2013.

Nexium is one of the world’s biggest-selling drugs, with sales last year of $5 billion. But Canadian sales last year were a relatively modest $217 million and AstraZeneca said it did not expect to alter its 2010 earnings outlook if a generic went on sale there in the near term.

AstraZeneca said it was evaluating its options and could still initiate a comprehensive patent infringement action against Apotex.

The setback in Canada contrasts with recent success by the company is seeing off generic threats to Nexium in the United States, the world’s biggest market, where it has struck settlement deals with several makers of generic drugs. [ID:nLDE60607R] (Reporting by Ben Hirschler; Editing by Hans Peters)

UPDATE 1-Roche wins wider EU label for arthritis drug

June 8 (Reuters) – Roche (ROG.VX) said on Tuesday the European Commission had extended the label for its drug Roactemra to reduce the rate of progression of joint damage and improve physical function in patients with rheumatoid arthritis, when given in combination with the older drug methotrexate.

The move had been expected following a positive recommendation from the European Medicines Agency in April.

The drug, which is known as Actemra in the United States, is currently approved for use in combination with methotrexate to treat adults with moderate to severe rheumatoid arthritis who respond inadequately to other treatments.

The new label extension is a recognition that Roactemra can also inhibit structural damage to joints, reinforcing its effectiveness.

(Writing by Ben Hirschler)

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)

Defensive pharma promises solid Q1 results

By Ben Hirschler and Lewis Krauskopf

LONDON/NEW YORK (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 and Abbott Laboratories — 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 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, 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 and Merck and Co Inc — two companies facing the biggest earnings crunch — are spending a combined $110 billion to buy Wyeth and Schering-Plough Corp 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)