In a potential blow to Eli Lilly’s hopes for the new blood thinner Effient, a study has tied the drug to an increased risk of cancer. The researchers analyzed data from a study that was key to FDA approval–Triton-Timi 38, which pitted Effient against its established rival Plavix–and found that the risk of new or worsened solid tumors was 60 percent higher with Effient (prasugrel).

An accompanying editorial calls for curtailed used of the drug, plus a boxed warning for Effient’s label. Dr. Sanjay Kaul–an advisory panel member excluded from the Effient meeting–and Dr. George Diamond, state they “believe that to optimize the benefit-risk balance, prasugrel use should be limited to a duration of weeks rather than months,” until more clinical data are available (as quoted by MedPage Today).

The researchers, Dr. James Floyd of the University of Washington and Dr. Victor Serebruany of Johns Hopkins, posit that as an antiplatelet drug, Effient may promote cancer growth by inhibiting the body’s natural defenses against tumors. Lilly and Daiichi Sankyo pan that argument in a statement, maintaining that the drug isn’t likely to cause cancer and that Serebruany’s hypothesis has been previously presented and published and reviewed by the FDA. Furthermore, the agency “concluded that a causal link was unlikely.”

They add that they continue to monitor worldwide experience in the use of prasugrel and report those findings to appropriate regulatory bodies.

Source: FiercePharma

Popularity: 3% [?]

Novo Nordisk’s new diabetes drug Victoza proved more effective than Merck & Co’s Januvia in a head-to-head study, boosting prospects for a product that has got off to a strong start in key markets.

Daily injections of both high- and low-dose Victoza reduced blood sugar levels by more than a daily tablet of Januvia in people with type 2 diabetes who had not responded adequately to the older drug metformin, researchers said on Friday.

The results may help the Danish drugmaker, which funded the study published in the Lancet journal, to differentiate its medicine in a highly competitive marketplace.

Victoza is Novo’s biggest new drug hope and is expected to generate annual sales of more than $1.4 billion by 2014, according to consensus forecasts compiled by Thomson Reuters.

After a delayed path to market, prescription trends suggest it is now doing well in both Europe and the United States, in contrast to disappointing sales of some other recently launched new drugs, such as Eli Lilly’s bloodthinner Effient.

Mads Krogsgaard Thomsen, Novo’s chief scientific officer, said the results followed other positive comparative studies and would bolster Victoza’s reputation among medical experts.

“The fact that Novo Nordisk has now done most, if not all, of the major comparator studies against different classes of oral and injectable anti-diabetic drugs really shows our commitment to showing comparative efficacy in a serious way,” he said in a telephone interview.

Novo demonstrated two years ago that Victoza controlled blood sugar better than Byetta, a drug from the same class of medicine that is sold by Eli Lilly and Amylin Pharmaceuticals.

PROGRESS REPORT

With investors awaiting a progress report on Victoza’s sales prospects when Novo reports first-quarter results on April 27, Thomsen said demand for the new drug was following the company’s own “optimistic” expectations.

“We have overtaken Byetta in several European markets in the first nine months post launch and in the U.S. we are already seeing, nine weeks into the launch, a rather sizeable uptake,” he said.

In the latest study, 1.8 milligrams of Victoza, or liraglutide, lowered levels of HbA1c — a standard blood measure that is indicative of a patient’s glucose levels — by 1.5 percentage points against 0.9 percent for Januvia, or sitagliptin.

The lower dose of 1.2 mg of Victoza cut HbA1C by 1.2 points in the six-month trial.

Researcher Dr Richard Pratley of the University of Vermont College of Medicine and colleagues said the difference was “clinically relevant,” adding that patients on Victoza, which caused some nausea, also lost more weight.

In an accompanying comment, Dr Andre Scheen and Dr Regis Radermecker of Belgium’s University of Liege said 1.2 mg of Victoza should be considered as a starting dose in most cases, with patients moving up to 1.8 mg if necessary.

On the downside, they noted that Januvia was cheaper, caused fewer gastrointestinal upsets and “one pill of sitagliptin daily might be judged as easier to administer than one subcutaneous injection of liraglutide daily.”

Source: Reuters

Popularity: 5% [?]

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

Popularity: 3% [?]

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

Popularity: 2% [?]

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

Popularity: 5% [?]

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

Popularity: 6% [?]

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

Popularity: 8% [?]

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.

Source: FiercePharma

Popularity: 3% [?]

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

Popularity: 6% [?]

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.

Source: FiercePharma

Popularity: 5% [?]