Despite safety board’s recommendation to continue a study comparing Merck’s Vytorin versus Zocor, at least one analyst is predicting that Vytorin’s sales will keeping falling with increased competition from brand and generic rivals. The news initially sent Merck’s stock down Friday. But the drugmaker broke into positive territory later in the day, ONN.tv notes.

Bernstein Research analyst Tim Anderson gave his assessment after Merck provided an interim analysis halfway through the IMPROVE-IT trial comparing Vytorin with the cheaper Zocor. Some had feared that the study results would further harm Vytorin, but Anderson sees this as “highly unlikely.” Instead, generics and cheaper brand drugs will likely eat into Vytorin sales. As BNET’s Jim Edwards points out, Pfizer’s mega-blockbuster Lipitor goes generic in 2011–before the Vytorin results come out in 2013.

Vytorin had been battered after a 2008 study found the drug worked no better than much lower-priced cholesterol medicines, the Star Ledger notes. Sales of Vytorin and Zetia, which formed the center of a cardiovascular drug partnership between Merck and Schering-Plough, declined. Merck now owns Schering-Plough.

The interim efficacy analysis was conducted by the data safety monitoring board after the trial had reached approximately 50 percent of the 5,250 pre-specified clinical endpoints called for in the study design. Merck remains blinded to the actual results of the interim analysis and other IMPROVE-IT data, the drugmaker says in a brief statement.

Source: FiercePharma

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Are low interest rates prompting the big interest in Ratiopharm? That’s one explanation analysts have hit on in trying to explain Pfizer’s newfound zeal at the prospect of buying the German generics maker–and Teva’s, too. “[Cash] is making 0.5 percent interest in the bank,” says Ronny Gal, an analyst at Sanford Bernstein. “Why not buy generics?”

The pharma world is closely watching the Ratiopharm auction, reported to be narrowed to three bidders: Pfizer, Teva and Iceland’s Actavis. Analysts and others have been advancing various rationales for the sudden popularity of Ratiopharm, the second-largest generics company in Germany.

Pfizer might want it so that it can funnel its soon-to-be-off-patent drugs like Lipitor into Ratiopharm’s global generics network. Teva might be enthused because of its goal to be among the top three generics makers in every country.  Right now, it’s in the top three in every European country–except Germany. Maybe Pfizer is trying to “stick it to Teva,” making sure that the Israeli generics giant doesn’t get a bargain price.

Meanwhile, talk is already turning to which generics company is likely to be snapped up next, the New York Times reports. Might one of the losing Ratiopharm bidders try to buy out Stada, third in line for the German generics crown?

Source: FiercePharma

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Canada’s Resverlogix is in mid-stage trials for its experimental drug RVX-208. The company, which has no marketed products, is hoping it can achieve the Holy Grail of heart disease drug development: Finding a product that can raise “good” HDL cholesterol.

It’s a tree that Pfizer has been barking up for years, but without success. In 2004, the pharma giant spent $1.3 billion purchasing Esperion Therapeutics, and with it the rights to ApoA-1 Milano. The drug, heralded as “Drano for the heart,” looked promising. But Pfizer abandoned development after it determined producing the therapy would be too expensive. It eventually sold the ApoA-1 Milano rights to the Medicines Company.

And then, of course, was the now-legendary failure of the CETP inhibitor torcetrapib, which was once projected to bring in $13 billion in annual sales. The day after Pfizer announced the late-stage failure of the drug, its stock dropped 11 percent, taking with it $21 billion in market value. The company would go on to cut almost all its early-stage heart disease work–as well as 10,000 jobs.

Bloomberg notes that after pouring $2 billion into developing a “good” cholesterol drug, Pfizer is still facing the loss of Lipitor patent protection and doesn’t have a new heart drug to take its place.

Cleveland Clinic cardiologist Steve Nissen was the lead investigator for both Pfizer drugs, and he’s also the lead for RVX-208. He points out that the drug works differently than other drugs by activating a protein that causes the production of HDL. The drug is currently in Phase II testing. Not surprisingly, there’s been a lot of interest from Big Pharma; if the drug works, it could be as big as Lipitor. But there are hurdles left yet to overcome. Nissen isn’t giving up, though. “Hope springs eternal,” he tells Bloomberg. “We need to keep trying to find an HDL-raising strategy that works.”

Source: FierceBiotech

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It seemed like only a question of time, but Bristol-Myers Squibb said this afternoon that Lamberto Andreotti, its president and chief operating officer since last March, would succeed James M. Cornelius as CEO.

Andreotti, a 12-year veteran of the company, is 59 years old and Cornelius is 66. Cornelius was tapped as Bristol-Myers CEO in 2006 (first on an interim basis) and then got the added job as chairman in 2008. Picking a successor was one of his key missions.

Andreotti takes command after Bristol-Myers decided to sit out the wave of multibillion-dollar takeovers that saw big competitors Pfizer, Merck and Lilly get even bigger. Bristol-Myers instead has pursued smaller biotech deals and alliances as well as developing its own pipeline through what it called a “string of pearls” strategy. The company also decided to shrink its non-core units with the split-off of its Mead Johnson baby-formula business.

Looking ahead, Bristol-Myers will have to cope with the loss of patent protection for money spinners like the company’s anticlotting pill Plavix, the world’s second best-selling drug after Pfizer’s Lipitor. The company has cut costs through layoffs, plant closures and wage freezes, Dow Jones Newswires notes.

Cornelius will remain as the drug maker’s chairman when the switch is made May 4. In 2008, his compensation topped $21 million.

Source: The Wall Street Journal

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Suddenly, Pfizer is the belle of the hedge-fund ball. Reuters reports that “some of the savviest” of hedge funds are eyeing the company, now that it has on hand the new drugs and vaccines it bought along with Wyeth. Apparently, these professional investors believe the rationale around that $68 billion deal: That Wyeth’s products will make up for Lipitor’s fall off the patent cliff.

As Reuters notes, it’s something of a change for Pfizer, which hasn’t been on Wall Street’s A-list for some time now. Over the last decade, Pfizer shares have actually lost ground. But with Wyeth in the fold, the company is moving up in the ranks, attracting interest from such well-known hedge-fund managers as John Paulson of Paulson & Co. and David Einhorn of Greenlight Capital. In fact, 11 of the 30 biggest equity-oriented funds bought Pfizer shares in the fourth quarter.

The buys are a vote of confidence for Pfizer’s long-term prospects; with earnings expected to stay relatively flat over the next few years, shares aren’t expected to soar in the short term. But what about down the road? “We’re looking for good results from late-stage trials of new drugs and for earnings growth to kick in in 2013 and 2014,” one asset manager says.

Source: FiercePharma

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Pfizer has won FDA approval of a product developed by Wyeth, which Pfizer bought last year for $68 billion. And it’s a biggie — a updated version of the world’s best-selling vaccine Prevnar.

The new version of the childhood vaccine called Prevnar 13 is intended to fight six more varieties of ear infections, meningitis and pneumonia than the current version of the vaccine. Pfizer says the new vaccine will cover 90% to 95% of the causes of pneumococcal disease in the U.S. Here’s more from the Associated Press.

Prevnar posted sales of $2.7 billion in 2008 and Credit Suisse analyst Catherine Arnold estimates that Prevnar 13 will have $5.9 billion in sales in 2015, more than any other single Pfizer product, according to the WSJ. “We think it is the most important value driver for the future of Pfizer,” she said.

Pfizer has been counting on the addition of Wyeth’s pipeline to help offset patent expirations, including global top-seller Lipitor that loses protection starting late next year. Wyeth has had approval for Prevnar 13 on the horizon for a long time and that was a key reason Pfizer was willing to shell out so many billions for its rival.

In another piece of good news for Pfizer today, a panel of experts from the CDC recommended the vaccine’s routine use for children between two months and 59 months.

Source: The Wall Street Journal

Popularity: 2% [?]

The Associated Press has put out a helpful list of Merck’s top-selling drugs for the fourth quarter, now that it has merged with Schering-Plough. So we thought we’d take a look at the other megamerger–Pfizer and Wyeth–and Merck’s list, too. The names on both lists are familiar, and you’ll notice that each list includes some drugs brought in by the respective mergers. Here’s Pfizer’s list to start:

• Lipitor, cholesterol drug, $3.175 billion, a 1 percent increase over the same period last year;
• Lyrica, for fibromyalgia and nerve pain, $820 million, a 17 percent increase;
• Celebrex, an arthritis pain drug, $669 million, up 1 percent;
• Viagra, erectile dysfunction, $549 million, up 9 percent;
• Xalatan/Xalacom, eye pressure, $499 million, up 10 percent;
• Norvasc, for high blood pressure, $486 million, down 10 percent;
• Zyvox, antibiotic, $330 million, up 16 percent;
• Detrol/Detrol LA, overactive bladder, $309 million, down 1 percent;
• Sutent, cancer treatment, $293 million, up 33 percent; and
• Geodon/Zeldox, antipsychotics, $289 million, up 5 percent.                 Now, here’s the Merck version, from the AP (percentages ours):
• Singulair, Asthma/Allergies, $1.26 billion, up more than 12 percent;
• Cozaar/Hyzaar, high blood pressure, $955 million, up about 8 percent;
• Januvia/Janumet, diabetes, $760 million, up close to 43 percent;
• Remicade, rheumatoid arthritis, $635 million, up about 29 percent;
• Zetia, cholesterol, $614 million, up 10 percent;
• Vytorin, cholesterol, $577 million, up roughly 2 percent;
• Temodar, cancer treatment, $292 million, up close to 21 percent;
• Nasonex, allergies, $286 million, up about 2 percent;
• Fosamax, osteoporosis, $285 million, down 10 percent; and
• Gardasil, HPV vaccine, $277 million, down 3 percent.

Source: FiercePharma

Popularity: 2% [?]

Western Europeans spend an estimated 10.5 billion euros ($14.3 billion) a year on illicitly sourced medicines, many of them counterfeit, according to a Pfizer-sponsored survey published on Tuesday.

Germans and Italians buy the most prescription-only drugs without a prescription, either over the Internet or on overseas trips, in nightclubs, in shops and via friends.

Counterfeit medicines often contain the wrong or even toxic ingredients and are a growing health threat worldwide, especially in poor countries, according to the World Health Organization.

They are also a thorn in the side of companies like Pfizer, the world’s biggest drugmaker, whose impotence pill Viagra and cholesterol drug Lipitor are two of the favorite targets for illegal counterfeiters.

Critics argue that the industry is keen to play up the issue in order to back its demands for tighter controls on medicine supply and packaging, thereby protecting its brands.

But the problem is being taken seriously by European officials. Outgoing European Union industry commissioner Guenter Verheugen said in December he was “extremely worried” about counterfeit medicines after 34 million fake tablets were seized at EU custom points in just two months.

Jim Thomson, chairman of the European Alliance for Access to Safe Medicines, which receives funding from the drug industry, said tests by his group had shown that 62 percent of medicines purchased online were fake or substandard.

“Does industry have a vested interest in this? Absolutely. But I think society should have an even bigger interest in getting this stopped,” he told Reuters.

“Counterfeit medicine is costing the industry a huge amount of money but it’s costing healthcare providers a lot more.”

Overall, 21 percent of 14,000 people surveyed in 14 states said they had bought medicines illicitly, with the rate ranging from 38 and 37 percent in Germany and Italy, respectively, to 12 and 10 percent in Britain and the Netherlands.

Weight-loss medicines accounted for nearly half of all online purchases, followed by prescription treatments for flu, such as Roche’s Tamiflu; pills for erectile dysfunction; quit-smoking drugs; and painkillers.

Source: Reuters

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AstraZeneca’s Crestor has scored. The cholesterol drug can now be marketed as a preventive, not just a treatment. And that’s the FDA approval AstraZeneca needed to help fight rival statins that are going off patent. That includes the great gorilla of statin drugs–indeed of all drugs–Pfizer’s Lipitor.

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AstraZeneca sponsored a huge study–almost 18,000 patients–to see how Crestor worked in people whose cholesterol fell within normal limits but whose C-reactive protein was elevated. CRP is an indicator of inflammation, a sort of precursor to full-blown cardiovascular disease. The JUPITER study showed that patients using Crestor had a significantly lower rate of cardio problems compared with patients on placebo.

So does this mean that doctors will be pulling blood testing and writing Crestor scrips for everyone whose CRP is elevated? The FDA hopes not; an advisory panel that recommended Crestor for the new indication worried that the drug might be used in too many patients at low risk of heart disease. In the JUPITER study, in fact, the drug helped patients with high CRP who also had other risk factors–like high blood pressure or family history–but didn’t help patients without additional risk factors.

Either way, this new indication opens up a huge new market for the drug; some 6 million patients would qualify, the FDA said. Because no other statin is approved for this use, Crestor will be the only one touted as a preventive–and because Crestor still has several years of patent coverage left, AstraZeneca can reap the benefits. No doubt there’s a Crestor ad campaign on its way to a TV or magazine near you.

Source: FiercePharma

Popularity: 1% [?]

Investors like cost-cutting measures as shares outperform S&P 500 index

A year after Pfizer Inc. announced its intention to buy Wyeth Pharmaceuticals, Wall Street is going through a honeymoon phase with the company not seen since the days when Viagra first hit the market.

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Pfizer’s stock, which plunged to a 13-year low of $11.66 last March, has surged recently, hitting a year-to-date high of more than $20 last week, before pulling back to $18.85 by the close of trading Monday. What’s more, the stock has been gradually increasing for nearly 11 months now – a prolonged winning streak not seen for a decade.

“Wall Street is ever the forgiving type,” said Les Funtleyder, a health care strategist for Miller Tabak & Co. in New York City. “The Street is going to give Pfizer the benefit of the doubt for a couple quarters, especially as the overall market remains volatile.”

Analysts point out that Wall Street also is rewarding Pfizer because of a 12.5 percent dividend increase announced late last year. The boost came after Pfizer slashed its dividend in half early last year to help pay for the $67 billion Wyeth deal.

Funtleyder said analysts don’t yet know what to make of the combined Wyeth-Pfizer, but have been impressed by the company’s ability to quickly consolidate R&D sites and take other steps to cut costs. Pfizer’s former worldwide R&D headquarters in New London is one of the research sites to be cut as part of the company’s worldwide consolidation.

So far this year, Pfizer’s stock is up 4 percent, beating all domestic pharmaceutical stocks except for Merck & Co. and far outperforming the Standard & Poor’s index of stocks, which is down 1.5 percent, said Funtleyder. Health care stands as the No. 1 performing sector so far this year, up 2.5 percent, he added.

Pfizer has seen some good upside movement since the Wyeth merger, concluded in October, came to light a year ago today. Even though the overall market gyrated downward over the past week, bringing Pfizer with it, the pharmaceutical giant’s stock still managed a gain of 28 percent – taking into account total return, including dividends – since the Wyeth merger was announced.

“It has outperformed the health care sector, but not the broader market,” said Linda Bannister, a drug firm analyst for Edward Jones in St. Louis who provided the figures.

But Bannister noted that the 28 percent figure might overstate Pfizer’s upside since the merger; the company, she said, is up only 15 percent since the day before the Wyeth announcement, when news of the deal was starting to trickle out, causing nervous investors to sell.

Pfizer’s stock dropped like a rock soon after word about the Wyeth deal leaked out. By March 2, the stock hit a bottom not seen since 1996, two years before Viagra received approval from the Food & Drug Administration.

Pfizer’s stock in the late 1990s was one of the darlings of Wall Street, but it has been in the doldrums for nearly a decade, a long slide precipitated by a dropoff in research-and-development production and exacerbated by such expensive failures as the cholesterol-fighting flop torcetrapib and the inhaled-insulin disaster Exubera.

Adding to Pfizer’s woes is the so-called “patent cliff” coming up in the next two years, highlighted in 2011 by the loss of cholesterol drug Lipitor – the world’s leading medicine – to generic competition.

The Wyeth deal, combined with a host of smaller acquisitions in the past year, has been Pfizer’s answer to the loss of the Lipitor patent. Wyeth has allowed Pfizer to become a more diversified company because of its strength in the emerging field of biologics as well as its consumer-product division, but the jury is still out on whether Wyeth will help Pfizer weather the patent cliff.

“It’s too early to draw any conclusions about the deal,” Funtleyder said. “We may not know until two to three years from now.”

Pfizer does not comment on its stock price or the forces that move investors. A spokeswoman noted that Pfizer will be offering an update on the integration with Wyeth Feb. 3, when the company announces its fourth-quarter and year-end earnings.

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But Wall Street analysts generally like the company’s aggressive stance, with Pfizer chief executive Jeffrey B. Kindler launching the pharmaceutical giant into many different areas – generics, orphan drugs, nutritionals and emerging markets, among them.

“We like the prospects for Pfizer’s more diverse business to deliver sustained cash flows following the introduction of Lipitor generics in ‘11,” said Seamus Fernandez, an analyst for Leerink Swann in Boston, in a recent research note.

Bannister, the Edward Jones analyst, said her company has Pfizer outperforming the market over the next three to five years. She said it’s taken longer than many had hoped for Kindler to turn Pfizer around, but with cost-saving initiatives being implemented, health care reform likely limited and new products to treat Alzheimer’s disease and cancer in the pipeline, she is optimistic.

“Jeff Kindler … has put the structure in place; now it’s all about execution,” she said.

Source: The Day

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