Drug Maker Teva Growing in Ireland

DUBLIN, Ireland -

Teva Pharmaceutical Industries Ltd., a world-leading maker of generic drugs, announced Monday it is expanding its operations in Ireland to counter growing global competition.

The Irish government provided a confidential level of aid to secure the 65 million euros ($98.6 million) investment in Teva's facilities in Waterford, southeast Ireland.

Teva, an Israeli company with plants worldwide, said it planned to boost its current 650-strong work force in Waterford to 815 within the next five years.

The announcement follows a string of job cuts in Waterford, most notably in the city's flagship crystal plant, which is cutting its Irish work force nearly in half.

Jacob Winter, Teva's vice president for global generic resources, said the Waterford expansion "will allow us to protect our products' leading market shares, add new capability and broaden our geographical reach and impact."

"We face intense competition in the generic drug market from other generic drug manufacturers, brand-name drug companies through authorized generics, manufacturers of branded drugs that continue to produce those drugs after patent expirations, and manufacturers of therapeutically similar drugs," Winter said.

The Waterford facility is operated by Teva's subsidiary IVAX, a previously Miami-based competitor that Teva acquired in January 2006. It includes three production plants and a research and development lab that specializes in combating respiratory ailments.

Tom McCabe, general manager of the Waterford operation, said the expansion was "akin to building a new factory" and would allow Teva to "more than double" its current production of medicines in inhalers and tablet form. The facility is already Teva's No. 1 site worldwide for producing products that relieve and prevent asthma.

Ireland is a major European hub for drug development and production. Most of the world's biggest drug companies have manufacturing and R&D operations here, and about 25,000 people are employed in pharmaceuticals in the country of 4.2 million

Thai Drug Administration Chief Resigns

BANGKOK, Thailand -

The recently appointed head of Thailand's Food and Drug Administration resigned Monday amid controversy over the new government's plan to review a policy of overriding patents on several expensive cancer-fighting drugs.

Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.

Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and groundless," without elaborating.

Chatree's predecessor, Siriwat Thiptharadon, was transferred to an inactive post last Tuesday by the new government of Prime Minister Samak Sundaravej. Siriwat called his transfer unfair, charging it was because he supported compulsory licensing of drug patents.

Compulsory licensing is intended to make some drugs more affordable by taking away the patent holder's ability to control the drug's price, a benefit of being a drug's exclusive supplier. International trade rules allow a government to issue a compulsory license to manufacture a generic version of a drug only in case of a national public health emergency.

Siriwat was the architect of the government's policy leading to the issuing of compulsory licenses on Jan. 4 for four cancer-fighting drugs.

In the past two years, the Thai government has also issued compulsory licenses for several drugs used to treat AIDS and heart disease, drawing criticism from companies holding patents on the drugs.

The drug companies dispute whether the circumstances in Thailand qualify for such licenses.

Newly appointed Public Health Minister Chaiya Sasomsup said Monday the ministry will review the licensing policy on the cancer-fighting drugs, while ensuring patients have affordable access to the medicines.

He said that if negotiations fail to get drug companies to lower their prices, compulsory licensing would be maintained.

Chaiya earlier said the government planned to review the drug licensing policy because U.S. drug manufacturers might ask Washington to apply trade sanctions against Thailand.

The four drugs issued compulsory licenses on Jan. 4 are Novartis (nyse: NVS - news - people )' Imatinib and Letrozole, Sanofi-Aventis (nyse: SNY - news - people )' Docetaxel, and Roche (other-otc: RHHBY.PK - news - people )'s Erlotinib.

Novartis AG and Roche Holding (other-otc: RHHBY.PK - news - people ) AG are Swiss, and Sanofi-Aventis SA is French.

Pfizer Buying Biotech Company

NEW YORK -

Drug developer Pfizer Inc. said Monday it will buy privately-held biotechnology company Serenex Inc. for an undisclosed amount.

Serenex has one drug candidate in early-stage studies, called SNX-5422, focusing on cancer. Its other compounds are in still in preclinical development and could help treat a range of conditions from cancer to inflammatory and neurodegenerative diseases, Pfizer (nyse: PFE - news - people ) said.

The buyout is expected to close in the second quarter.

Pfizer and several other large pharmaceutical companies have seen several blockbuster drugs lose patent protection recently, with the trend expected to continue. The company is attempting to rebuild its development pipeline and in August said it plans to triple its number of late-stage development products by 2009.

Shares of Pfizer fell 5 cents to $22.23 in morning trading.

FDA to Speed Ligand, Glaxo Application

NEW YORK -

Drug developers Ligand Pharmaceuticals Inc. and GlaxoSmithKline PLC said Monday the Food and Drug Administration will give their blood-disorder drug Promacta priority review, accelerating its path toward approval.

The drug is aimed at treating chronic short-term idiopathic thrombocytopenic purpura, a condition which causes increased risk of bruising and bleeding. The companies said there are about 60,000 people in the U.S. with the condition.

When the FDA designates a priority review, it attempts to make a decision on the drug candidate within six months instead of the normal 10 to 12 months.

GlaxoSmithKline (nyse: GSK - news - people ) and Ligand have been partners since 1997. Glaxo will be responsible for worldwide marketing of the drug, which would be the first treatment approved for the blood condition. It also plans on asking for European regulatory approval in 2008.

Shares of San Diego-based Ligand rose 31 cents, or 9 percent, to $3.70 in morning trading. The stock has traded between $3.31 and $11.45 over the last 52 weeks. Shares of U.K.-based Glaxo rose 58 cents to $44.49

Top Drugs' Strange Side Effects

Ever experience a sudden, strong desire to gamble , or a funny feeling that you've been driving in your sleep?

It could be nothing. Or maybe it's time to finally read the warnings that came with that bottle of over-the-counter or prescription drugs you're taking. Strange as it may sound, compulsive gambling and sleep-driving are two real side effects that have been reported by patients or drug manufacturers in recent years.

In recent months, popular new anti-smoking treatment Chantix has made headlines for its array of potential side effects, which include insomnia and nightmares. In February, the U.S. Food and Drug Administration announced that Pfizer (nyse: PFE - news - people ), the manufacturer of Chantix, had updated the drug's prescribing information to include additional warnings about the possibility of severe changes in mood and behavior in patients taking it.

In Depth: Drugs' Strangest Side Effects

Last year, over-the-counter diet drug Alli made waves. Late-night talk show hosts in particular had a field day joking about the product's warning label, which included a recommendation to wear dark pants and bring a change of clothes to work until users had a sense for the drug's gastrointestinal effects.

Even though drugs must pass through three phases of clinical studies before getting FDA approval, new side effects often emerge only once a medicine reaches the broader population, says Cynthia Reilly, director of clinical standards and quality for the American Society of Health-System Pharmacists.

FDA officials confirmed last week that the agency is launching a plan to strengthen oversight of prescription drugs after they are approved, including a new database of medications' possible side effects, and timelines for following up on those concerns.

But in the meantime, how much attention should consumers pay to news of strange side effects?

The answer, experts say, is plenty. "People really need to be aware of all [a drug's] side effects, strange or not," says Reilly.

That means actually reading the drug's label, as well as those papers that come stapled to your prescription bag at the pharmacy. No one--not your family members, not your assistant, not even your doctor, is going to recognize changes in your health as quickly as you can. And left ignored, some side effects can cause permanent damage.

Pharmacy handouts and data cribbed from vetted Internet sources may be your best bets for getting more information about side effects, since TV drug ads don't devote much time to them. A new University of Georgia study found that the average 60-second prescription drug ad aired on broadcast and cable television contained less than eight seconds of side effect disclaimers, and the average 30-second ad had less than 4.4 seconds. Most 15-second ads studied devoted no time at all.

When researching potential hazards, be careful not to lose perspective. While it is important to acquaint yourself with all of a drugs' side effects, only some are worth really worrying about, such as an increased likelihood of suicide, says Dr. Darrell Abernethy, chief science officer for the United States Pharmacopeia, a private, non-profit, standards-setting organization that promotes the safe use of medications. Other side effects, like the temporary loss of sense of taste often associated with hypertension treating ACE inhibitors, aren't as big a deal.

Experts suggest making a quick call to your doctor when you hear about side effects associated with a drug you've been taking. That will help you figure out how common the side effects really are, and evaluate alternative treatments.

"People need a medical home," says Dr. Peter Lund, president of the Pennsylvania Medical Society and founder of the organization's Institute For Good Medicine. "They need to have a health care provider or doctor to turn to with those questions."

Just keep in mind that a doctor might weigh a drug's side effects differently than you would. "You have to make your own choice about how you want to proceed," says Abernethy.

Gilead Shares Rise on Drug Sales Outlook

NEW YORK -

Shares of biotechnology company Gilead Sciences Inc. received a boost Friday from a safety board recommendation suggesting some patients should switch to its HIV treatment Truvada.

The stock gained $2.24, or 5 percent, to reach $47.70 in afternoon trading. Shares have traded between $34.15 and $49.05 over the past 52 weeks.

Gilead already has a commanding position in the HIV treatment market, with the three-in-one drug Atripla and Truvada. A National Institutes of Health-sponsored study found that patients with a high viral load were better off taking Truvada than GlaxoSmithKline (nyse: GSK - news - people )'s Epzicom. Several analysts said the results will only help bolster Gilead's position in the market.

"The results provide further proof of something that we already believed, which is that Truvada is the best backbone therapy for HIV," RBC Capital Markets analyst Jason Kantor said in a note to investors.

He reaffirmed a "Outperform" rating, saying the NIH results coupled with other positive study data for Gilead will eventually help it gain 100 percent of the market for new HIV patients.

Goldman Sachs (nyse: GS - news - people ) analyst Meg Malloy, meanwhile, reaffirmed a "Buy" rating for Gilead, citing a series of factors including trends toward earlier treatment and an increase in HIV prevalence.

Citi analyst Dr. Yaron Werber said Gilead could gain 5 cents per share in earnings for every 10 percent market-share gain in the U.S. and 15 percent market-share gain in Europe from patients switching to Truvada. He reaffirmed a "Buy" rating with a $55 price target.

Alnylam Says Drug Study Meets Goal

CAMBRIDGE, Mass. -

Alnylam Pharmaceuticals Inc. reported Friday that its midstage study for experimental drug ALN-RSV01 met its main goal and reduced levels of the respiratory syncytial virus, a highly contagious virus that causes infections in the respiratory tract.

The stock fell, however, as some analysts questioned the drug's true potential effectiveness in a real-world scenario, because patients in the trial took the drug before becoming sick.

ALN-RSV01 is an RNA-interference (RNAi) drug, a class of drugs designed to treat illnesses by shutting off the genes that cause them.

The company claimed ALN-RSV01 is the first RNAi drug to show effectiveness in humans.

The Phase II clinical trial of ALN-RSV01 showed "statistically significant" effectiveness, with about a 40 percent reduction in RSV infection rate. Alnylam also said the drug showed an increase in the number of subjects who remained free of infection.

The drug was safe and well-tolerated, the company said.

In an interview with AP, Needham & Co. analyst Alan Carr highlighted potential challenges for the drug in light of the study's design.

He said that while the results were positive, people in the trial were given the drug before they were infected with the virus, meaning the results fail to show a "real-world" scenario.

The numbers were slightly disappointing with respect to viral load and symptom reduction, said Carr, and left him wondering how the drug would work in patients who don't take the drug before infection.

Caris & Co. analyst Douglas Chow told the AP he viewed the results as positive but said the drug still has a long way to go.

"The company will still need further studies before the drug gets commercialized and there are still many questions that remain unanswered," Chow said.

He said the stock also likely fell because some investors may have expected the company to release more trial data.

Alnylam's stock fell 92 cents, or 3.1 percent, to $29 in midday trading, as the broader market declined Friday.