Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts

Friday, May 11, 2012

Diet Pill Maker Arena Pharmaceuticals (Nasdaq: ARNA) Wins Backing of FDA Advisers

Diet Pill Maker Arena Pharmaceuticals (Nasdaq: ARNA) Wins Backing of FDA AdvisersOrlando, FL 5/11/12 (StreetBeat) -- In a stunning turn of events in less than two years, diet pill maker Arena Pharmaceuticals (Nasdaq: ARNA) won the backing of a panel of government advisers to sell what may be the first new weight-loss treatment in the US in more than a decade. The company’s shares rose 80% in early trading Friday after advisers voted 18-4 in favor of approving Arena’s drug, lorcaserin.

Arena is the second company to win such an endorsement for a diet drug this year after Vivus (Nasdaq: VVUS) was recommended by Food and Drug Administration advisers in February. The FDA delayed a decision on Vivus’ Qnexa, moving a potential approval date later than one set for Arena. If the FDA doesn’t adjust its dates, it will decide on Arena’s drug, lorcaserin, by June 27, and on Vivus’ Qnexa by July 17.

After a pair of overwhelmingly positive panel recommendations from advisers, it’s beginning to look like there may be two near-term approvals for diet drugs. That seemed unthinkable a little more than a year ago after Orexigen Therapeutics (Nasdaq: OREX) followed Arena and Vivus in being rejected by the US agency because of safety concerns.

Shares of Arena rose to $6.59 in morning trading. Vivus was up 4% to $23.57 and Orexigen, which is the farthest away from any potential approval, jumped 7% to $3.57.

Safety has been the killer for these new diet pills. The FDA is very cautious about approving another product that could pose health risks to people taking them. Abbott Laboratories (NYSE: ABT) withdrew its drug Meridia from the market in 2010 after fears of heart attack and stroke. The drug cocktail fen phen was withdrawn from the market in 1997 after evidence of heart valve damage. Those drugs were sold by American Home Products, which was later renamed Wyeth and is now part of Pfizer (NYSE: PFE).

In April, Vivus said the FDA was extending its deadline for an approval ruling on Qnexa because the agency needed more time to review a company plan on mitigating risks for patients. Arena, which is partnered with Japanese drug maker Eisai to sell lorcaserin, has responded to FDA worries about safety, including heart valve problems. However, Arena hasn’t yet discussed a risk plan -- a so-called a risk evaluation and mitigation strategy -- or a post-approval safety study with the FDA, company executives said on a conference call Friday. Eisai would pay 90% of any post-approval safety analysis. No decision has been made yet on a price for the pill.

Arena, Vivus and Orexigen argue that obesity is an epidemic in the US, leading to health problems such as heart disease, diabetes and other conditions.

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Wednesday, May 2, 2012

Pfizer (NYSE: PFE) Races to Reinvent Itself

Pfizer (NYSE: PFE) Races to Reinvent ItselfOrlando, FL 5/2/12 (StreetBeat) -- For years, drug companies have known that their days of plenty were numbered, that the moment would arrive when the best-selling drugs that had driven two decades’ worth of profits would lose their patent protection and succumb to competition from generic alternatives. Without new blockbusters to replace them, profits would tumble.

For Pfizer, that day has arrived. Pfizer (NYSE: PFE) profited from hits like Lipitor and Viagra, and swallowed up smaller companies from the 1990s onward.

But it has no immediate successor to Lipitor, the best-selling drug in history, which lost patent protection last fall. The problem was punctuated on Tuesday when the company said that profit declined 19 percent last quarter, largely because of declines in Lipitor sales.

Pfizer — once the Big in Big Pharma — is making a radical shift, one being watched closely by the rest of the industry. It is getting smaller.

Last week the company announced it was selling its infant nutrition business to Nestlé for $11.85 billion, and it is expected to divest its profitable animal health business by next year. At the same time, the company is slashing as much as 30 percent of its research budget as part of a plan to focus on only the most promising areas, like cancer and Alzheimer’s disease.

“It’s not necessarily smaller per se, it’s focused,” Ian C. Read, Pfizer’s chief executive, said in an interview Tuesday. “We are at our heart a biopharmaceutical company focused on applying science to improving people’s quality of life. That is what our core is. That is what will determine our success.”

Pfizer is one of many pharmaceutical companies racing to reinvent itself. This year alone, at least 19 drugs — including the antistroke drug Plavix — are scheduled to lose patent protection, a potential $38.5 billion in lost sales, according to an analysis by Barclays (NYSE: BCS).

Drug executives are asking themselves: “What is it that we now face, given that in the past decade — when everything was going right — we didn’t build with this future in mind?” said Jeremy Levin, who oversaw a similar reorganization of Bristol-Myers Squibb and is about to take over as chief executive at Teva Pharmaceuticals.

At Pfizer, skeptics have questioned the decision to shed some of its most profitable units in favor of doubling down on the risky pharmaceutical business. Pfizer’s nutrition unit grew by 15 percent and animal health by 17 percent in 2011, while its pharmaceutical sales dipped by 1 percent. And Pfizer has suffered some notable flops over the last several years, including the failure of an experimental cholesterol treatment that was seen as a potential successor to Lipitor and poor sales of an inhaled insulin drug that the company eventually abandoned.

“It’s a high-risk plan,” said Erik M. Gordon, who teaches business at the University of Michigan. “They’re focusing on what they don’t have the best track record in and they’re spinning off things that are doing pretty well.”

Pfizer spent the last decade buying other big companies. In 2000, it acquired Warner Lambert and with it the rights to Lipitor, which Pfizer had been co-marketing with the company. In 2003, it merged with Pharmacia and added the painkiller Celebrex to its lineup. It acquired Wyeth in 2009 in a $68 billion deal that brought a portfolio of biologic drugs. Last year, Pfizer bought King Pharmaceuticals, a maker of pain drugs.

The acquisitions, some said, turned Pfizer into a Frankenstein’s monster — a giant stitched together from the scraps of smaller companies that lurched forward with little purpose.

“I think the company sort of lost their way in the years before the Wyeth acquisition,” said Catherine J. Arnold, an analyst for Credit Suisse (NYSE: CS).

Mr. Read said he agreed. “I think it was broken — I think we were spending huge amounts of money,” said Mr. Read, who took over as chief executive in late 2010 after Jeffrey B. Kindler resigned abruptly. “We weren’t producing the drugs we needed and frankly that was seen in the marketplace.”

Analysts said Pfizer’s nutrition deal and the divestiture of the animal health business is a way to tide over shareholders while it undertakes more substantial changes to its business model. The company has said it plans to use most of the cash from the deals to buy back stock, though studies have repeatedly cast doubt on the efficacy of such moves by corporations.

Pfizer said Tuesday that it had repurchased $1.7 billion in stock in the first quarter, and expects to buy back about $5 billion by the end of the year. The company reported earnings of $1.79 billion last quarter, or 24 cents a share, compared to $2.22 billion, or 28 cents a share over the same period last year.

Investors seem to be buying into the company’s strategy so far: Pfizer stock has risen nearly 8 percent over the last year. Pfizer’s stock closed at $22.78 on Tuesday, down 12 cents, or less than 1 percent.

Even so, the company’s decision to cut research budgets as it is planning to recommit to its pharmaceutical core struck some as risky. Mr. Gordon, the Michigan business professor, called it a “magic trick.”

It’s a magic trick, however, that most major pharmaceutical companies are also trying. “The question is how do you remain successful and sustain your operations if you’re investing less and less in R&D?” said Kenneth I. Kaitin, a professor and director of Tufts University’s Center for the Study of Drug Development. “The answer to that is to try to find a new way and a more efficient mechanism for discovering and developing drugs.”

Pfizer plans to reduce its research budget from $9.4 billion in 2010 to $6.5 billion to $7 billion this year. It closed a research center in Britain and has been trimming its facility in Groton, Conn., and moving resources to areas closer to universities in Boston and Cambridge, England.

In 2011, the company ended 91 projects, canceling programs aimed at treating bladder infection, for example, as well as one to treat nasal symptoms from allergies. Company executives have also said they will be on the lookout for smaller acquisitions to fill gaps in their portfolio, and will expand partnerships with academic institutions.

Mr. Read said the cuts would not affect the areas that the company has prioritized. “Most of what I cut had a low probability of success,” he said.

While Pfizer does not have another Lipitor, analysts say several drugs seem promising. On May 9, a Food and Drug Administration advisory panel is to consider recommending approval of an oral pill for rheumatoid arthritis. In June, the agency is expected to weigh approval of Eliquis, an antistroke drug that Pfizer is developing with Bristol-Myers Squibb (NYSE: BMY).

In corporate strategy, Pfizer is following the path of Bristol-Myers, which in 2009 announced plans to spin off the nutrition company Mead Johnson to focus on acquiring small biotech companies. The company has since fared well despite the loss of patent protection for Plavix on May 17. “So long as the blockbuster game was working, people kept playing it,” Mr. Gordon said.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Monday, April 23, 2012

Nestle (Pinksheets: NSRGY) in $11.85 billion deal to acquire Pfizer's (NYSE: PFE) infant-nutrition business

Nestle (Pinksheets: NSRGY) in $11.85 billion deal to acquire Pfizer's (NYSE: PFE) infant-nutrition businessSt. Augustine, FL (StreetBeat) 4/23/12 -- Swiss food and drink giant Nestle SA (Pinksheets: NSRGY) announced a deal Monday to acquire Pfizer Inc.'s (NYSE: PFE) infant-nutrition business for $11.85 billion in a bid to boost sales in emerging markets.

The company based in Vevey, Switzerland said the acquisition would "enhance its position in global infant nutrition" because 85 percent of the Pfizer Nutrition unit's sales is in emerging markets, many of which have large, fast-growing populations.

The deal would particularly help Nestle to boost growth in China and maintain its position as one of the world's largest sellers of infant formula. It is subject to regulatory approval, however, and Nestle, since it already sells so much infant formula, may face some antitrust hurdles to complete the deal.

Nestle's shares fell 3 percent to 55.30 Swiss francs ($60.71) after the Zurich exchange opened.

The maker of Nescafe, Haagen Dazs and Jenny Craig said it estimated that the Pfizer unit's 2012 sales would bring $2.4 billion.

"Infant nutrition has been at the heart of our company since it was founded in 1866," Nestle CEO Paul Bulcke said in a statement. "Pfizer Nutrition is an excellent strategic fit and this acquisition underlines our commitment to be the world's leading nutrition, health and wellness company."

Nestle's offer beat a rival joint bid by Groupe Danone (Pinksheets: DANOY) and Mead Johnson Nutrition Co. (NYSE: MJN) for the infant-nutrition business, which Pfizer had put up for sale last July along with a separate animal-health business unit.

Pfizer, the world's largest drug maker, has been shedding its noncore businesses as it moves to focus on developing new prescription drugs. Last year it suffered the patent expiry of blockbuster drug Lipitor, the cholesterol fighter.

It also sold its business unit that makes drugs in capsule forms to KKR & Co. last August for $2.4 billion.

Nestle forecast Friday that 2012 will be a challenging year but reported that first-quarter sales rose a healthy 5.6 percent from a year earlier, fueled by strong growth in emerging markets and higher retail prices.

"The takeover affirms Nestle's worldwide No. 1 position in one of the most attractive growth markets," said bank analyst Patrik Schwendimann of Zuercher Kantonalbank. "One positive side effect is that speculation about large acquisitions by Nestle will calm down for the foreseeable future."

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Tuesday, January 31, 2012

Vertex Pharmaceutical's (Nasdaq: VRTX) drug approved to treat cystic fibrosis' root cause

Vertex Pharmaceutical's (Nasdaq: VRTX) drug approved to treat cystic fibrosis' root causeNorthern, WI 1/31/12 (StreetBeat) -- The first drug that treats the root cause of cystic fibrosis won approval Tuesday, offering a life-changing treatment for a handful of patients with the deadly illness and broader hope for thousands more patients with the inherited disease.

About 30,000 Americans live with cystic fibrosis, a disease that causes sticky mucus buildup in the lungs and other organs, leading to infections, digestive problems and death in young adulthood. The typical life expectancy is about 37 years, according to the Cystic Fibrosis Foundation.

The Food and Drug approved Vertex Pharmaceuticals Inc.'s (Nasdaq: VRTX) Kalydeco to improve lung function and reduce other symptoms in patients with a rare variant of the disease that affects just 1,200 people in the U.S., about 4 percent of affected population nationwide. These patients have a protein defect that prevents their cells from properly absorbing and excreting salt and water.

"Even though this drug isn't for the majority of people, it proves that you can look at the mistake in the genes and design a drug in a rational way that will fix the problem," said Dr. Drucy Borowitz of the State University of New York at Buffalo, where she directs the cystic fibrosis program.

Kalydeco is among the first drugs designed to a correct a specific genetic defect. Its development characterizes both the promise and challenges of that approach. Scientists first identified the gene that causes cystic fibrosis in 1989, but it took more than two decades and more than $75 million in outside funding to develop a drug to treat the disease.

Borowitz enrolled several of her patients in the key study for Kalydeco, which showed that patients taking the drug increased their lung strength more than 10 percent when compared with patients taking a placebo. Patients also had fewer infections and gained nearly seven pounds on average, a significant amount for patients who typically have trouble retaining weight. All patients in the study continued taking older medications that help loosen mucus.

"Two weeks after using the drug my lung tests were above average for a healthy 15-year-old who didn't have cystic fibrosis," said Nick Mangano, 17, a Borowitz patient who has been taking the drug for two years. Before starting on Kalydeco, Mangano said he was hospitalized for lung infections five times in four years. Now he says he usually recovers from a cold within a week or two.

"I don't really need medicine for it anymore, it's totally different," said Mangano, who is considering leaving Buffalo for college next year — a step he hadn't previously considered because of his dependence on his family and physicians.

Only a few decades ago, children with cystic fibrosis seldom survived elementary school. Today, thanks to earlier diagnosis and new focus on diet and physical therapy, 47 percent live to be 18 or older.

The FDA approved the drug for patients six years old and up, though Vertex is also studying the drug in younger patients. Researchers hope that by using the drug earlier they will be able to prevent permanent lung damage, which is the primary cause of death for cystic fibrosis patients.

Mangano and others with the so-called G551D mutation have a defective protein that fails to balance the flow of chloride and water across the cell wall, leading to the buildup of internal mucus. The vast majority of cystic fibrosis patients have a different genetic defect, in which the protein does not reach the cell wall. Vertex is developing another drug to try and address that problem. Study data for that drug is expected later this year.
Kalydeco is part of a growing number of new medicines that target rare genetic variations found in subgroups of patients. Last year Pfizer (NYSE: PFE) launched a new lung cancer drug called Xalkori, which targets cancer linked to a genetic mutation found in less than 7 percent of patients.

After scientists identified the genetic sequence that causes cystic fibrosis in 1989, many experts hoped the disease could be cured by replacing the gene with a normal one. However, attempts at so-called gene therapy proved unsuccessful, and researchers began looking for ways to correct the genetic defect.

"I think it took the field about a decade to realize we had to look for other options," said Paul Negulescu, vice president of research at Vertex Pharmaceuticals.

In 1998, the Cystic Fibrosis Foundation approached Aurora BioSciences, now part of Vertex, to help screen potential drug candidates for a cystic fibrosis drug. In 2000, the foundation awarded the company more than $45 million to study and commercialize an experimental drug for the disease, the largest grant of its kind by a nonprofit disease group. To date, Vertex has received over $75 million in research and development funding from the Cystic Fibrosis Foundation.

Cambridge, Mass.-based Vertex has only one other drug on the market, the hepatitis C drug Incivek, which launched last May.

The most common side effects with Kalydeco were headache, stomach ache, rash diarrhea and dizziness.

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