Eli Lilly is looking to its pipeline to fill the gaps left by a number of high-profile drugs comping off patent. In October 2011, blockbuster Zyprexa will fall to generic competition; additionally, about three-quarters of Lilly’s current revenue comes from eight drugs that will lose patent protection between now and 2017. ”We have the challenge of replenishing our product portfolio from our pipeline,” says CEO John Lechleiter in a USA Today interview. “Fortunately, we have the most exciting pipeline today in our history.”

The CEO notes that Lilly has about 70 molecules in clinical development, giving the drug giants multiple shots on goal. He adds the company is ”confident that while not all those will make it, many of them will.” Late-stage programs include enzastaurin (cancer), IMC 11F8 (non-small cell lung cancer), IMC-1121B (breast and gastric cancer), tasisulam (melanoma), teplizumab (diabetes), GLP-1 Fc (diabetes), semagacestat (Alzheimer’s) and solanezumab (Alzheimer’s), according to the company’s website. Three additional drugs are under FDA review. Lechleiter adds that aside from the Prozac expiration in 2001, Eli Lilly has gone almost 20 years without a major patent expiration. ”I think that makes the nature of the challenge more acutely felt for us.”

ALSO: Lilly has completed its acquisition of Alnara Pharmaceuticals, which is developing protein therapeutics for the treatment of metabolic diseases. The financial details were not release when the deal was first announced, but Lilly has revealed that it is paying $180 million up front and up to $380 million for the developer.

Source: FierceBiotech

Popularity: 2% [?]

In the second off-label marketing settlement this week, two Johnson & Johnson subsidiaries have agreed to pay $81 million to wrap up a probe of their Topamax promotions. The deal involves a $6.1 million criminal fine for Ortho-McNeil Pharmaceutical, stemming form a single misdemeanor violation, NPR reports.

The settlement stems from whistleblower lawsuits that alleged J&J had promoted Topamax–approved for treatment of epilepsy and migraine prevention–for a variety of psychiatric uses. According to the government, Ortho-McNeil paid doctors to come with sales reps on detailing calls and suggest unapproved uses for the drug. Doctors also were allegedly hired to speak at meetings and dinners about off-label Topamax use.

There has been a string of off-label marketing settlements over the last couple of years. Given the huge size of some of them–think Eli Lilly’s $1.4 billion Zyprexa settlement or Pfizer’s $2 billion-plus Bextra deal–this $81 million payment seems fairly small. But it does emphasize the government’s drive to combat off-label marketing, and there’s no sign that drive will end any time soon.

“Working with our federal and state partners, we will take action against pharmaceutical companies that promote their drugs for off-label uses,” Assistant AG Tony West promises in a statement. “This type of unlawful marketing undermines the FDA’s important role in deciding which drugs are safe and effective for consumers and costs the taxpayers billions of dollars each year.”

Source: FiercePharma

Popularity: 2% [?]

The U.S. government is on the cusp of announcing that Seroquel-marketing settlement with AstraZeneca, the New York Times reports. The drugmaker will pay $520 million and sign a corporate integrity agreement to settle probes into its marketing of the antipsychotic drug, sources told the newspaper. The company won’t face criminal charges.

As you know, AstraZeneca has been working on a settlement deal for some time; it came to a tentative agreement with the U.S. attorney’s office in Philadelphia last fall. And it has earmarked $520 million for the purpose.

According to the Times, the final arrangement will wrap up two federal investigations: one related to doctors who participated in clinical trials of the drug and another the involved the company’s sales organization. The company allegedly misled doctors and patients about the drug’s safety, downplaying known risks of weight gain and diabetes; AstraZeneca has repeatedly denied any wrongdoing.

This is the third Big Pharma marketing settlement of late and the second involving marketing of an atypical antipsychotic. Eli Lilly agreed to pay $1.4 billion to settle probes into its promotion of its antipsychotic Zyprexa, including a $515 million criminal fine. And Pfizer agreed to pay $2.3 billion, including a $1.3 billion criminal fine, the biggest in U.S. history.

Source: FiercePharma

Popularity: 2% [?]

The debate over patents in India continues. India has been struggling to bring its intellectual property laws up to a standard that will invite multinational companies to do business there. But public opinion is strongly in favor of domestic companies, putting Big Pharma in a tough spot. Drugmakers want to sell their branded drugs at a branded drug price–which might be lower in India than in, say, the U.S. But thanks to a strong local drugs business, Indians have enjoyed cheap meds for years.

The latest skirmish involves 81 drug patents granted over the first four years of India’s new patent laws, 76 of which went to foreign pharma companies. One-third of them were divided among some of the top names in Big Pharma: Novartis, Eli Lilly and Pfizer.

The domestic industry now is questioning the validity of those patents, saying that they were issued in violation of two sections of the new law. These sections would deny patent protection to modified forms of long-ago-patented drugs and to new drugs that aren’t a big leap forward. An industry lobby demanded a review of these patents, and now the drugs in question–and some other related data–have been made public by a government agency.

The disputed patents include one granted to Eli Lilly for a combination of the antipsychotic drug Zyprexa (olanzipine) and the antidepressant Prozac (fluoxetine). Another, given to Novartis, covers a combo of blood pressure meds Norvasc (amlodipine) and Diovan (valsartan), with hydrochlorothiazide, a diuretic.

The industry lobby is fighting hard against these patents, calling for that controversial section of Indian patent law known as 3(d) to be strictly enforced. But others, including the U.S.-India Business Council, are calling for 3(d) to be abolished. It’s a hot-button issue on both sides, and the debate isn’t close to being resolved.

Source: FiercePharma

Popularity: 3% [?]

Two Zyprexa-related events last week underscore the difficulties–and opportunities–Eli Lilly faces with the antipsychotic drug. First, the FDA announced that weight gain and metabolic problems are more prevalent in adolescents taking Zyprexa than they are in adults. The warning comes after a study published last fall showed that children and adolescents who went on Zyprexa gained an average of 17 pounds in 12 weeks, the Los Angeles Times reminds us.

[ad]

Second, the company reported earnings, stating that in 2009 it spent $693 million on costs related to Zyprexa litigation, much of which centers on allegations that it failed to warn patients of the drug’s links to weight gain and, allegedly, diabetes.

This is something of an “it could be worse” story: As BNet Pharma points out, Wall Street looks at that $693 million in legal spending and sees a decrease from $1.9 billion year-over-year. So, Lilly’s shelling out less to defend and/or settle Zyprexa cases than it had been; given the big marketing settlement with the U.S. Justice Department last year, that’s understandable.

And, too, the FDA could have worded its cautionary tale more strongly, issuing a flashing red light rather than a yellow one. “When deciding among the alternative treatments available … clinicians should consider the potential long-term risks,” the agency advises, “… and in many cases this may lead them to consider prescribing other drugs”–i.e., not Zyprexa–”first in adolescents.”

Source: FiercePharma

Popularity: 3% [?]

It’s that time of year again: Earnings season. Over the next several weeks pharma firms big and small will be reporting their performance numbers for last quarter and all of 2009. Today, we see that AstraZeneca boosted profits by 23 percent, but expects 2010 to be an uphill climb. Eli Lilly and Bristol-Myers Squibb were also among today’s announcements. Here’s a roundup.

[ad]

• AstraZeneca reported a 24 percent profit hike to $1.55 billion as sales of its cholesterol drug Crestor and blood-pressure remedy Toprol XL rose and its H1N1 flu vaccine hit the books. Sales grew by 9 percent to $8.95 billion, beating analyst estimates.

• Bristol-Myers Squibb beat analyst estimates with its Q4 earnings of $818 million or 41 cents per share. Sales grew by 11 percent to $5.03 billion, with clotbuster Plavix, antipsychotic Abilify, and AIDS drugs all posting gains.

• Eli Lilly reported Q4 profits of $915.4 million as its bestselling drug Zyprexa gained 19 percent to deliver $1.37 billion in sales alone. The cancer drug Alimta grew by a whopping 64 percent to $523.6 million. Total Lilly revenues for the quarter rose 14 percent to $5.93 billion.

• Celgene posted a fourth-quarter profit of $254 million and higher sales of its cancer drugs Revlimid and Vidaza, compared with a loss a year ago, when it was hurt by acquisition-related costs.

• Diabetes drugmaker Amylin Pharmaceuticals said its fourth-quarter loss narrowed to $50.3 million from $105.2 million, as sales of its drugs held steady and restructuring costs were sharply lower.

Source: FiercePharma

Popularity: 6% [?]

More proof that FDA warnings make a difference: Alerts about the risks of antipsychotic drugs appear to have depressed sales by some 19 percent, a new Archives of Internal Medicine study finds. “We concluded that it resulted in a modest reduction,” researcher Dr. Ray Dorsey of the University of Rochester Medical Center says. Why modest? In part because antipsychotic scrips still accounted for 9 percent of prescriptions in the elderly in 2008.

[ad]

Studies have shown that atypical antipsychotics–which include such best-selling drugs as Eli Lilly’s Zyprexa and Johnson & Johnson’s Risperdal–carry various safety risks, and the FDA has added strong warnings to the drugs’ labeling. This study looks at a warning that the atypicals boost the risk of death in elderly people with dementia; that “black box” was added to the meds in 2005.

The researchers analyzed data on the use of those drugs from January 2003 to December 2008, finding that 19 percent decline in sales. But the group didn’t have data on how many people might have benefited from the warning, Reuters reports. Nor did the researchers want to characterize the FDA’s warning as a success or failure. “It’s hard to say whether 20 percent is the right number,” Dorsey tells the news service.

A commentary accompanying the study, however, posits that regulatory warnings about the atypical antipsychotics have had little effect on prescription numbers. “There’s a real disconnect between the evidence and the prescribing patterns,” co-author Becky A. Briesacher, associate professor at the University of Massachusetts Medical School in Worcester, tells HealthDay. Some geriatric doctors said that sometimes the benefits outweigh those risks. “The only medications that have been shown to work are antipsychotics, but the problem is they have side effects,” says Dr. Davangere Devanand of the New York State Psychiatric Institute. “It’s a balance.”

Source: FiercePharma

Popularity: 4% [?]

Dainippon Sumitomo has filed for FDA approval of its prospective blockbuster schizophrenia drug lurasidone, beating its own timetable as the Japanese pharma giant stays on course toward an expected 2011 market launch.

[ad]

Dainippon was willing to spend $2.6 billion for Sepracor last fall, at least in part because it plans to deploy its 1,200 sales people in a national campaign to sell the drug. “This NDA marks a significant milestone for our company as we accelerated the global clinical development of lurasidone and achieved an earlier than anticipated submission to the FDA,” said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma.

Analysts expect the drug’s safety profile will allow it to break the billion-dollar barrier in the U.S. if it is approved. But it won’t be easy. The antipsychotic market in the U.S. is intensely competitive. Lurasidone is designed to work much like Zyprexa, Risperdal or Seroquel, without the weight gain that many patients experience. And the Japanese company is also testing the therapy as a treatment for bipolar disorder.

Source: FierceBiotech

Popularity: 4% [?]

Eli Lilly won FDA approval for its long-lasting injectable version of Zyprexa, the blockbuster antipsychotic. Dubbed Zyprexa Relprevv, the injection sustains delivery for up to four weeks, the company said, basing its application for approval on a 2,054-patient study. The drug got FDA’s nod after Lilly developed a risk-management plan. And if all goes well, Relprevv will help counteract the risk of sales lost to generic versions of the regular Zyprexa.

[ad]

It’s a big deal for Lilly, as the Wall Street Journal Health Blog points out, because although the regular Zyprexa goes off patent in 2011, a key patent on the extended-release form doesn’t expire until 2018. If Lilly can sell enough doctors and patients on the long-acting form, it could mitigate the damage from generic competition for regular Zyprexa. BMO Capital Markets analysts predicted that annual sales of the Relprevv form could hit $400 million by 2014 or 2015. That’s not the multibillions brought in by Zyprexa Sr. But it’s not chump change, either.

Selling points that Lilly reps will be hammering home: Long-acting therapy can help prevent relapse, a boon for patients and their families. Lilly research showed that patients using the Relprevv form won’t need to supplement their therapy with oral meds, so no pills to remember. Plus, by prescribing Zyprexa Relprevv, psychiatrists will know which patients have been taking their meds (presumably they’ll collect a fee for injection, too).

“There is a growing recognition among psychiatrists… that non-adherence to medication is an even greater barrier to care for patients with schizophrenia than was previously understood,” Dr. John Hayes, Lilly research VP, said in a statement, “and that long-acting treatments can… [help] patients maintain a stable treatment regimen.” We’ll have to wait and see just how many psychiatrists recognize those benefits enough to prescribe the new drug. Stay tuned.

Source: FiercePharma

Popularity: 3% [?]

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.

[ad]

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.

[ad]

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: 7% [?]