Will a new FDA warning on Plavix help the personalized-medicine cause, or will it just confuse people? That’s the question the Wall Street Journal Health Blog asks today. A new “black box” warning has been added to Bristol-Myers Squibb/Sanofi-Aventis’ anti-clotting medicine Plavix, which is poorly metabolized by up to 14 percent of patients who use it. Those patients, who have a particular genetic variant, could do better on another anticoagulant or on higher Plavix doses, the warning states.

Perhaps the FDA envisions that doctors will now be more likely to follow its recommendation to test patients for that variant before prescribing Plavix. But do enough doctors have access to the tests? Will they have time to wait for the results? Before such an approach grows common, cardiology associations will have to develop treatment protocols, experts tell the WSJ. Meanwhile, says one Harvard Medical School associate prof, “I expect mass confusion in response to this FDA warning.”

This could be an opportunity for upstart Plavix competitor Effient, from Eli Lilly and Daiichi Sankyo, but that drug carries an increased bleeding risk. Or it could be an opportunity for Medco Health Solutions, which last week said it was expanding its personalized-medicine programming–and planned to extend that program to Plavix at some point. Maybe that point has arrived.

Source: FiercePharma

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Eli Lilly’s Effient hasn’t exactly hit the ground running. The new blood thinner racked up $22 million in sales during its first quarter on the market, the New York Times reports, but sales in the next quarter dropped to $3.8 million. Now, analysts say they’re no longer expecting the drug to be a blockbuster. ”Even if the company isn’t ready to give up on Effient, we are,” a Goldman Sachs analyst writes to clients (as quoted by the Times).

Effient won a limited approval–for certain patients who are undergoing angioplasty–and hit the market with a black-box warning of bleeding risks. The pharmacy benefits manager Medco announced that it would run its own head-to-head trial comparing Effient with Plavix, the big-selling clot-buster that’s not only cheaper than Effient now, but is also set to go off patent soon, when it will be cheaper still.

So far, doctors aren’t convinced that Effient is superior, the Times reports. Plavix works, and it’s been on the market for years now, they say. Even Lilly execs say it’s tough to sway doctors: “It’s a challenge to sell to doctors satisfied with Plavix,” VP Javan Collins tells the newspaper.

CEO John Lechleiter says the drop in sales was just a blip, caused by hospitals and pharmacies stocking up on the drug during its first quarter on the market, leaving inventory to be absorbed during the next quarter. So, what will the next quarter bring?

Source: FiercePharma

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Eli Lilly executives said there’s every reason to be optimistic about future sales of Effient, the blood thinner launched last summer with expectations of perhaps growing to become a billion-dollar seller one day. The only worry seems to be early sales of the drug are headed in the wrong direction.

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Reporting its fourth-quarter results, Lilly said that sales of Effient, which the company co-markets with Japan’s Daiichi Sankyo, slid to a tiny $3.8 million world-wide in the fourth quarter. In the third quarter following the drug’s August launch, world-wide sales totaled $22.6 million.

On the conference call with analysts, Lilly execs said they were undeterred about Effient’s prospects, offering comments like “we feel just as good about Effient today as we did when we launched the product.” CEO John Lechleiter explained it was still early days in the roll-out and noted there was an initial jump in third-quarter sales because wholesalers were stocking up on the drug.

Lilly has long had high hopes for Effient to help replace the revenue from drugs that are losing patent protection in the next few years. But Effient also is in a tough market, competing against Plavix whose fourth-quarter sales rose 10% to $1.6 billion, Bristol-Myers reported today.

There was some better fourth-quarter numbers in Lilly’s results today and Lilly and Bristol-Myers also announced a settlement in a fight stemming from Lilly purchase of Imclone in 2008. Here’s the Dow Jones Newswires report with more details.

Source: The Wall Street Journal

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The FDA approved 26 new drugs last year, edging out the 25 approvals for first-of-a-kind therapies in 2008, according to analysts at Washington Analysis. But biotechnology emerges as the real winner in the annual statistical review. Of the 26 new drug approvals in 2009, seven were for biotech therapies. That compares to four new biotech drugs in 2008 and two new sanctions in 2007.

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The Wall Street Journal asked Ira Loss, a senior health policy analyst at Washington Analysis, whether the spike represents a watershed of sorts for biotech drugs versus the small-molecule drug field. But he was a tad skeptical.

“I think it has the potential to be a breakout,” he responded, “but I am not prepared to say so based on one year. If there is a repeat performance in 2010 then I would be prepared to say the long awaited breakthrough in therapeutic biotech approvals may in fact be here. But not yet!”

The slow pace of drug approvals overall has bedeviled the biopharma industry for years. But with the Obama administration dedicating more money to the FDA, it’s quite possible that the routine breach of PDUFA deadlines can be rectified. With fewer regulatory delays at the agency, more approvals are almost a sure thing. That would be a big boon for biotech drugs and small-molecule therapies alike.

Among the potential blockbusters approved by the FDA last year: Eli Lilly’s and Daiichi Sankyo’s blood thinner Effient and Sanofi-Aventis’ Multaq. Amgen’s D-mab and Liraglutide from Novo Nordisk, meanwhile, are still on hold long after approvals were expected.

Source: FierceBiotech

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Earnings forecast is lower than expected, sending shares down 4%

Can Eli Lilly and Co. keep its sales and profits from plunging off the edge of a cliff in two years? Wall Street apparently doesn’t think so.

Investors dumped 21.2 million shares of the Indianapolis drug maker’s stock Monday, the highest amount in more than two years, after the company suggested that earnings could dip after its biggest products lose patent protection starting in 2011.

That sell-off pushed the stock price down 4 percent, to $35.02 a share, even as the broader markets rose slightly.

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Lilly executives took pains to say the company’s pipeline is full and could produce two new medicines a year, beginning in 2013. But investors have heard similar reassurances before and seemed to be running out of patience.

And some said that even if Lilly achieves its goal, the new medicines will not make up for a wave of drugs whose patents will expire before then.

“Although Lilly had a growing midstage pipeline, these assets remain several years away from the market,” said Chris Schott, a drug industry analyst at JP Morgan in New York, in a research note. He predicted that Lilly’s profits will fall by a “meaningful” degree from 2012 to 2015.

Lilly has been struggling to develop new medicines lately, launching just one in the past four years — the blood thinner Effient, and that is off to a slow start.

The company’s late-stage pipeline includes new medicines for cancer, Alzheimer’s disease and diabetes. The company also hopes to launch a long-acting version of Byetta for diabetes.

Analysts are not sold that Lilly can suddenly begin to launch new products after such a long dry spell, or that new products will make a big difference.

“Effient’s launch has been relatively unimpressive,” Seamus Fernandez, a drug analyst at Leerink Swann in Boston, said in a research note. He added he remains cautious on prospects for speedy government approval of long-acting Byetta.

In recent years, Lilly has been stung by one disappointment after another in its laboratories. Late-stage, experimental drugs for brain cancer, multiple sclerosis, osteoporosis and other ailments have failed to live up to expectations and ended up on the scrap heap.

Now, Lilly’s top-selling drugs, including the antipsychotic Zyprexa, antidepressant Cymbalta and cancer drug Gemzar, will lose patent protection in a wave between 2011 and 2014, allowing competitors to offer low-cost generic alternatives. Lilly must quickly find a way to replace those products, which account for more than 60 percent of revenues.

John Lechleiter, president and chief executive of Lilly, said the company has cut costs, become more productive, speeded up its business model and invested heavily in research and development.

In September, the company said it would cut 5,500 jobs, or 13.6 percent of its worldwide work force, by the end of 2011. On Thursday, the company said it has cut about 25 percent of its sales force this year.

Lechleiter again ruled out a large-scale merger or acquisition as a solution, saying Lilly could compete while remaining independent.

“We’re betting on our scientists and our scientific leaders and the deep insights and advanced technologies increasingly at their disposal,” he told analysts during the company’s annual investor conference in New York City.

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The company said it has 62 compounds in development, including 25 in midstage and late-stage clinical testing. Dr. Steven Paul, Lilly’s top research executive, said the company now has “the strongest pipeline in our history.”

The company said it moved into ninth place worldwide for pharmaceutical sales in the 12 months that ended in June, according to data from IMS Health.

The company said it expects annual revenue of at least $20 billion in the years 2012 to 2014 and beyond. Wall Street has been expecting company revenue in 2011 of about $22.9 billion, Reuters reported. Lilly had revenue of $20.4 billion last year.

Lilly expects to earn $4.65 to $4.85 per share next year, excluding the potential impact of health-care reform. That range represents growth of 6 percent to 13 percent, compared to the company’s profit guidance for this year. Analysts were expecting earnings of $4.74 per share for 2010.

Source: Indystar.com

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It’s not revolutionary to suggest that the blockbuster drug model is passé. Industry watchers have been theorizing for some time that specialty drugs are where it’s at, that personalized healthcare is the future, that all the easy disease targets have already been hit. Pharma can no longer expect–or even hope–that new blockbusters will save them from mega-patent expirations.

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But In Vivo has taken a detailed look at a quite different pressure on the blockbuster model: the payer. Exhibit A is the current head-to-head battle between the old standby clotbuster Plavix, set to go off patent soon, and Eli Lilly’s brand-spanking-new Effient.

The stepped-up FDA warning of interactions between Plavix and popular heartburn meds was initially set off not by the agency itself, but by data from insurer Aetna and pharmacy benefits manager Medco Health Solutions. That data could boost Effient in the short run. But Medco now is taking the unusual step of conducting its own head-to-head study of the two blood thinners–the idea being that if it can prove Plavix works as well as Effient, it can save lots of money for clients once Plavix goes off patent.

To that end, Medco will be screening patients for a genetic marker that identifies those who properly metabolize the drug. That’s designed to help Plavix, because the drug just doesn’t work in some one-third of patients without the marker. Medco will then compare Plavix’s efficacy in 14,000 of those selected patients to Effient in 14,000 other Medco members to see if there’s a difference in outcomes.

This study won’t cost Medco that much because it already collects outcomes data, In Vivo reports. Compared with what Lilly spent to study Effient, the expense is probably pretty trivial. And if Medco is prepared to do this sort of work on Plavix, it no doubt would do the same to push other soon-to-go-off-patent meds over newly approved branded drugs.

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Should pharma-watchers be worried about Eli Lilly and Bristol-Myers Squibb? After all, they both launched blockbuster hopefuls–the clot-buster Effient for Lilly, the diabetes remedy Onglyza for Bristol–but haven’t racked up the kind of early numbers that the drugs-that-would-be-blockbusters did in the past.

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But as In Vivo points out, times are changing. With insurers steering patients toward generics, patients worrying about drug risks, and these particular drugs facing some heavy-hitting competition, the quick uptake once expected of blockbuster meds may not be in the cards for most drugs, no matter how successful they may be in the long term

Effient is covered by a risk-management plan, which effectively slows down any launch, In Vivo says. Plus, it’s chasing Plavix, the world’s No. 2 drug. Onglyza enters a diabetes drug market shaken by Avandia safety concerns. Its marketing materials still aren’t FDA-approved, which has got to slow down sales efforts. And Onglyza will be competing against Januvia and Janumet, which have been romping and stomping for Merck.

So maybe the sales model should be like Prozac, which built sales slowly, then became a breakout success. In Vivo argues that regulators want new meds like Effient and Onglyza to be slow out of the gate. After all, some fast-growing meds proved not so safe when administered to thousands of new patients not hand-picked by clinical trial committee. What do you think?

Source: FiercePharma

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Now that the cardiovascular drug market has a couple of new entries, analysts are applying their skills. Their take: Eli Lilly’s clot-buster Effient has been “sluggish” out of the gate, while Sanofi-Aventis’ atrial fibrillation drug Multaq has hit the ground running. But even Multaq hasn’t made huge advances.

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According to data from IMS/Leerink Swann (as quoted by BNet Pharma), Sanofi’s Multaq captured 3,606 scrips over a five-week period. Lilly’s Effient, by contrast, accounted for only 1,823 scrips over the same period. “These IMS data reinforce our view that Effient’s U.S. launch will be muted,” Leerink’s accompanying investor note stated.

There’s a caveat, however. The drugs hit the market in the summer, when folks are vacationing, not going to the doctor to tune up their drug regimens. That’s likely to slow initial uptake. Plus, Effient’s indication for post-procedure use means that it’s started in the hospital, and drug-sales trackers don’t have access to those scrips. So its numbers could see a quick upswing once those hospital scrips move to the pharmacy.

“There will be a delay in prescription data showing up in IMS, given that initial use occurs in the hospital setting,” Lilly CFO Derica Rice told investors at a UBS conference (as quoted by Dow Jones). He added that Lilly has made “positive” progress in persuading health insurers to pay for the drug. We’ll keep an eye on the figures to see if those efforts bear fruit on the scrip side.

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The combined use of proton pump inhibitors (PPIs) with sanofi-aventis and Bristol-Myers Squibb’s Plavix (clopidogrel), or with Eli Lilly and Daiichi Sankyo’s Effient (prasugrel), did not interfere with the clinical benefits of the antiplatelet agents in patients after an acute coronary syndrome (ACS), according to an analysis of study data to be published in The Lancet. Researchers noted that the results contrast with prior findings from other studies, and remarked that these latest data “do not support the need to avoid concomitant use of PPIs…in patients receiving clopidogrel or prasugrel.”

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The analysis was based on data from the randomised TRITON-TIMI 38 trial that enrolled over 13 600 patients who suffered a heart attack or unstable angina, and who were given either Plavix or Effient. The study authors evaluated the effects of PPIs in the trial, and they found that for patients who took these medications in combination with Plavix or Effient there was no increased risk of cardiovascular events, compared with patients who took Plavix or Effient alone.

A previous analysis of medical and pharmacy claims data by Medco indicated that among patients who had undergone a percutaneous coronary intervention, those who were being treated with Plavix plus a PPI had a 50-percent increase in the risk of having a major cardiovascular event, compared with those who took Plavix alone.

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The author of the Medco study, Robert Epstein, explained that the overall health of the patients involved in the studies may have played a role in producing contrasting results. He suggested that the new analysis involved healthier patients who were not in a “real-world setting.” The lead investigator of the latest study, Michelle O’Donoghue, noted that PPIs are often given to more seriously ill patients, which might explain why they experience more adverse events. However, she said such differences were adjusted for in the research. The authors stated that a thorough clinical trial is needed to clearly understand how PPI use affects treatment with antiplatelet drugs.

Source: FirstWord

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With the launch of blood thinner Effient, Eli Lilly has snapped a 4-year dry spell without a new drug.

It was a long time coming — four years, two months and nine days.

During all that time, Eli Lilly and Co. didn’t launch a single new drug, despite its multibillion-dollar research budget and team of thousands of scientists.

While its competitors were launching new drugs for cancer, osteoporosis and other diseases, Lilly ran into problems with one experimental drug after another, forcing the company to scrap or shelve them.

Investors had begun to give up hope. Lilly’s stock sank 41 percent over that rocky period, a sharper dive than the 24 percent drop in the Standard & Poor’s 500 Index.

So finally, nine days ago, when the Food and Drug Administration gave the green light for Lilly to market Effient, a blood thinner it had spent more than a decade developing, the company had reason to celebrate.

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Lilly’s pipeline drought — the longest in decades — had ended.

So is the company now back in the game, ready to launch a string of new medicines and win back skeptical investors?

Not so fast or easy, analysts say.

Lilly still has a big uphill climb. It faces a wave of patent expirations on its blockbuster drugs beginning in 2011 and must find replacements for 70 percent of its revenue in the next seven years.

How will it close that gap? Primarily by developing new drugs. Lilly is testing dozens of new drugs for a wide range of medical conditions, but most of the compounds are still years away from FDA review.

Another option is to buy a biotech company or license its research. But Lilly, fresh off the biggest acquisition in its history, has less cash than many of its competitors, giving it fewer options.

“Lilly is still in a very tight position,” said Seamus Fernandez, a drug analyst at Leerink Swann in Boston, who has an “underperform” rating on the company. “They can’t rest. Their situation continues to be urgent.”

On Wednesday, Lilly will try to win back investors when it releases second-quarter earnings and gives an update on its pipeline.

It won’t be a slam dunk. Of the 21 analysts who follow Lilly, only six have a “buy” recommendation, while 10 have a “hold” and five have a “sell” recommendation.

In the months ahead, Lilly must keep its eye on four key issues, analysts say, if it is to turn its recent victory with Effient into a long-term winning position.

Development of new medicines

Lilly has more than 60 compounds in development, an all-time high, to treat such diseases as cancer, depression, obesity and Alzheimer’s disease. The number and types of compounds under development impress many analysts.

But several say Lilly’s late-stage pipeline — drugs in widespread patient testing — is modest. In a best-case scenario, Lilly is still three or four years away from its next wave of new medicines hitting the market.

That will be too late to make up for the loss of billions in sales when blockbuster drugs lose their patent exclusivity, including antipsychotic Zyprexa (2011), diabetes medication Humalog (2013) and cancer drug Gemzar (2013).

“We continue to believe Lilly’s pipeline remains too early-stage to convince us of its ability to meaningfully offset the loss of key drugs,” J.P. Morgan analyst Chris Schott wrote in a research note.

Lilly acknowledges it will have a revenue fall-off in coming years but says it will be temporary and that it expects to launch 15 to 20 new medicines in the next eight years. The company said it will have 11 drugs in late-stage clinical testing by the end of this year.

“If you adjust for size, I don’t think there’s another (drug) company anywhere that has the number of high-quality molecules in the pipeline, especially in Phase 1 and Phase 2,” said Dr. Steven Paul, Lilly’s executive vice president of science and technology. “We feel very, very good this new wave will break through and get to the market right around 2012, 2013, 2014.”

One thing in Lilly’s favor: More than 40 percent of the compounds in its pipeline are biotech-based. Biotech drugs have a higher success rate for making it through research and development than do traditional chemical drugs. Their protein engineering often leads to better treatments in individual patients, compared with one-size-fits-all drugs.

Already, Lilly is the fifth-largest biotech company in the U.S., based on sales, with such products as Humalog and Byetta for diabetes, Forteo for osteoporosis and Xigris for sepsis.

Acquisitions and partnerships

Last year, with its pipeline still sputtering, Lilly made the largest acquisition in its 130-year history, buying cancer biotech ImClone Systems of New York.

The deal gave Lilly the cancer drug Erbitux, as well as several experimental drugs for its pipeline. But at a cost of $6.5 billion, the deal swallowed much of Lilly’s cash.

Lilly has shown it is willing to pay top dollar for what it wants, outbidding several competitors to win ImClone. In past years, Lilly has closed a raft of smaller deals, such as buying out its partner in the erectile-dysfunction drug Cialis.

But it won’t be so easy to keep up that pace. Analysts say Lilly’s cash flow will peak and decline in the next few years as its blockbusters go off patent. That means Lilly will have less cash to do deals. In the meantime, just about every other big drug maker is also shopping for deals.

“Other drug makers have more cash on their balance sheets than Lilly does, and can pay more for acquisitions,” said Fernandez, the Leerink Swann analyst. “All of these (small biotech companies) are going to be highly competitive.”

So while Lilly needs to do more deals, it will have less flexibility than other companies also shopping, including Johnson & Johnson, Novartis and GlaxoSmithKline, he said.

Some other analysts agree.

“If you’re going to stay competitive, you need to develop new drugs, license them or do acquisitions,” said Les Funtleyder, an analyst at Miller Tabak & Co. in New York. “Can Lilly do many more big acquisitions? The market is skeptical.”

Cost control

Lilly already has cut its work force by about 14 percent, or 6,500 people, from a peak in 2004. That leaves it with about 40,000 employees worldwide — and about 12,000 in Indianapolis.

While Lilly has avoided the sweeping job cuts that many of its competitors have made, it plans to continue shedding jobs, mostly through attrition.

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The pressure to contain costs is only going to increase.

Private insurers are stepping up demands that drug makers hold down prices, and the public is increasingly pressuring the government to hold down drug costs. Health-care spending accounted for about 17 percent of the U.S. economy last year. Drug costs have turned into a cornerstone of President Barack Obama’s health-care reform initiative.

That means drug makers have to cut wherever possible. Several months ago, Lilly said it had lowered development costs from an average of $1.2 billion a drug in 2007 to about $1 billion in 2008. It wants to lower them to $800 million by 2010.

That won’t come without aggressively outsourcing more and more functions, from toxicology to information technology. Last year, Lilly sold its Greenfield Laboratories — an early-stage drug development center in Hancock County that it operated for nearly a century — to Covance of Princeton, N.J., for $50 million.

Staying engaged

in health-care reform

With Congress in full swing to overhaul the health-care system, Lilly is not just sitting on the sidelines.

John Lechleiter, Lilly’s chairman and chief executive, has given speeches across the country, written op-eds in national newspapers and hired former Indianapolis Mayor Bart Peterson to oversee the company’s lobbying and communications.

The company’s argument: Putting price caps on drugs or setting up a government-run insurance program could hurt the development of new, lifesaving drugs for such maladies as cancer and Alzheimer’s disease.

Few drug makers have taken as visible a role.

“Lilly is pretty vocal about health-care reform, as anyone who is watching can see right away,” Funtleyder said. “I think they are going to stick to it.”

But Lilly can’t count on even its home state to stand squarely behind it. The Indiana chapter of the AARP is pressing for lower drug prices. The United Auto Workers, which represents 12,000 hourly workers in Indiana, would like to see a national health-care plan that would ease its burden. The UAW recently took over a medical fund for retirees from the Detroit Three automakers.

A few weeks ago, Lilly commissioned Indiana University to study the company’s economic impact in the state.

The study concludes that Lilly contributed $8.03 billion, or approximately 3.3 percent, to Indiana’s gross state product in 2007.

The company immediately took out large newspaper advertisements that touted its economic importance. “So as Indiana’s senators and representatives in Congress debate needed health-care reforms, it is important for them to remember that the decisions they make in Washington impact jobs and the economy here in Indiana,” one ad said.

Getting Effient to market was a big step forward.

Analysts and investors will be watching to see whether Lilly can take other, important steps in the months ahead.

Additional Facts

What’s next out of Lilly’s pipeline?

It’s tough to guess when a new drug will hit the market, but here is a look at several of Lilly’s late-stage drugs that could be the next out of the pipeline.
• Arzoxifene. This is Lilly’s big hope to succeed its blockbuster Evista, an osteoporosis drug that loses patent exclusivity in 2014. Lilly has wrapped up two major trials and expects to file for FDA review by the end of this year for three uses in postmenopausal women: treatment of osteoporosis, prevention of osteoporosis, and reduction of risk of invasive breast cancer.
• Once-weekly exenatide. This is a version of Lilly’s diabetes drug, Byetta, that analysts expect will be more popular than the standard version, which now requires two injections a day. Lilly and its partners (Alkermes and Amylin) said earlier this month that the FDA accepted once-weekly exenatide for review, following an earlier rejection.
• Enzastaurin. This cancer drug has been a long, tough road for Lilly. The company had hoped to use it to treat brain cancer, but scrapped that three years ago after an outside analysis showed the drug probably wouldn’t be more effective than chemotherapy. Lilly continues to test the drug as a maintenance therapy for diffuse large B-cell lymphoma, but tests have taken longer than expected. Lilly hopes to submit the drug for review by 2013.

Source: indystar.com

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