Anemia drugs

PBMs making big bucks off specialty drugs

Tue, 22 Apr 2008 06:59:54 -0400

Drugmakers aren't the only ones making money off the specialty drug trend. Specialty drugs, many of which are biologics, are used to treat a range of rare or difficult diseases, including various cancers, MS, rheumatoid arthritis, anemia and hepatitis. And pharmacy benefit managers (PBMs), which distribute these drugs to patients, are realizing a growing profit from high-priced products.

Take the case of Questcor's H.P. Athcar Gel. Last year patients and payors were shocked when the price of Questocor's epilepsy treatment increased from $1,600 a vial to $23,000. The decision was made after Questcor did market research and determined that its drug would sell at the higher price (incidentally, Questcor landed in the number one spot of FiercePharma's best stocks of 2007 list). To curb costs, pharmacy benefits managers are designed to enforce rules on drug selection, usage, and dosage. But as the New York Times observes, this specialty drug trend is "seemingly at odds with that best-price mission." The paper notes paper that Express Scripts, CVS Caremark and Medco Health Solutions have been making increasingly large profits off the specialty drugs they sell, particularly when they sign contract to be exclusive or semi-exclusive distributors of rare drugs.

"We are headed right down into conflict alley with these exclusive arrangements," Gerry Purcell, an Atlanta-based health benefits consultant, told the Times. The exclusive licensing agreements between drugmakers and distributors mean PBMs "can raise the prices at will, and the employer will have little chance but to pay the bill."

- read the story in the New York Times

Troubled Amgen pays CEO $13.2M in compensation

Wed, 02 Apr 2008 07:59:56 -0400

With its shares plunging and regulators threatening its blockbuster anemia franchise, Amgen CEO Kevin Sharer (photo) nevertheless garnered $13.2 million in compensation last year, according to the AP. Sharer's fortunes waned by a hefty 29 percent, dropping from $18.6 million taken in the halcyon days of 2006. Sharer took home $1.5 million in pay last year (up), $1.5 million in bonuses (down) and stock and options valued at $9.3 million when they were offered (also down). The perks of the job may have softened the blow, though. Sharer's use of a company plane, Amgen car and driver and tax and financial planning services were worth a collective $900,000. Amgen shareholders did a little worse than the CEO. Company shares plunged 35 percent last year.

- read the AFX story

Related Articles:
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Amgen CEO touts blockbuster potential of D-mab. Report
Amgen discusses the future with analysts. Report
Amgen in crisis? Not us, says CEO Sharer. Report

Safety, efficacy problems sink Takeda drug

Fri, 28 Mar 2008 07:59:58 -0400

Japan's Takeda has walked away from development of its once-promising cholesterol drug TAK-475. The first sign of trouble came late in October, when the FDA recommended Takeda stop trials using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. Takeda discontinued TAK-475 development because, according to a release, the drug's profile was not superior to existing marketed drugs from both efficacy and safety standpoints. TAK-475 is a squalene synthase inhibitor which, had it been successful, would have been the first drug of its kind on the market. Takeda badly needs another blockbuster in its pipeline to make up for the loss of Actos patent protection in 2011.

In order to fill the gap, Takeda said it will aim for the "earliest possible launch of SYR-322 and TAK-390MR of which NDAs are now under review by the FDA, and for earliest possible NDA submission of the development projects in the late stage such as Hematide, a treatment for chronic kidney disease related anemia and cancer related anemia, and Lu AA21004, a treatment for mood and anxiety disorders."

- see Takeda's statement

Related Articles:
Safety questions cloud future of Takeda's TAK-475. Report
Takeda expands R&D budget, may look for buyout. Report
Takeda scraps licensing deals, inks $100M pact. Report

SPOTLIGHT: Amgen dodges a bullet

Fri, 14 Mar 2008 07:59:53 -0400

Look on the bright side: It could have been worse. An FDA advisory panel voted to keep Amgen and Johnson & Johnson's anemia remedies on the market for cancer patients. So the drugs appear to have dodged the feared silver bullet, an outright revocation of that indication. FDA generally follows its panels' advice, but isn't required to. FiercePharma

Amgen forecast darkens as FDA review looms

Thu, 13 Mar 2008 07:59:58 -0400

The FDA couldn't have scheduled today's meeting on the risks posed by Amgen's anemia drugs at a worse time. With the market opening to a new raft of chilly economic reports, analysts covering Amgen were in a particularly dour mood about Amgen's chances. Christopher Raymond at Robert W. Baird predicted more restrictions on the use of its multibillion-dollar drugs, which would further eat into the biotech company's revenue. And FBR Capital's Jim Reddoch wouldn't even rule out a vote to remove Aranesp from the market--a worst-case scenario that would inflict major damage at a company that has been working to build up a pipeline of new therapies needed to rescue its bottom line.

Amgen officials, though, will fight this battle over the $6 billion market to the bitter finish.

"ESAs provide an unequivocal treatment benefit for cancer patients undergoing chemotherapy by reducing the need for blood transfusions," said Roger M. Perlmutter, Amgen's executive vice president of research and development.

- see Amgen's release
- read the story from CNN
- and check out the Dow Jones report

Related Articles:
Epogen/Aranesp--Top 10 Warnings and Recalls. Report
FDA's worst-case anemia scenario. Report
Do anemia warnings signal new limits? Report
Study: Anemia meds hike death risk 10%. Report
FDA: More risks from anemia drugs. Report

Experts to weigh in on Amgen's Nplate

Wed, 12 Mar 2008 07:59:55 -0400

Amgen is going before the FDA's Oncologic Drugs Advisory Committee (ODAC) in order to discuss its BLA for Nplate (romiplostim). The drug is a treatment for thrombocytopenia, a disorder that causes the body to attack its own blood clotting cells. The FDA is concerned about adverse reactions noted in clinical trials. These include significantly higher platelet levels, dangerous blood clots, bone marrow growth and malignant tumors in those taking the drug. The experts will advise the FDA whether Nplate's benefits outweigh the risks, and whether it should be given a limited approval.

- check out this release
- and read the AP article for more

ALSO: Here's a peek into the FDA playbook for tomorrow's advisory panel on Amgen and Johnson & Johnson's anemia drugs. According to documents posted on the agency's website, those expert advisors will be asked to consider several limitations on the meds, which have been linked to increased tumor growth and reduced survival among some cancer patients. And the options include yanking FDA approval for that use. Report

Related Article:
Amgen platelet therapy hits endpoint in Phase III. Report

GSK scraps malaria drug on anemia concerns

Fri, 29 Feb 2008 06:59:55 -0500

GlaxoSmithKline is halting work on Dacart after a Phase III trial showed the malaria drug causes anemia in some patients. The trial, which GSK was conducting with Medicines for Malaria Venture (MMV), showed that Dacart caused anemia in subjects with G6PD deficiency. G6PD deficiency is a hereditary enzyme disorder which is estimated to affect 10 to 25 percent of sub-Saharan Africans. GSK observed similar problems with Lapdap, another malaria drug, and has started the recall process at the pharmacy level in Kenya.

- here's GSK's release

ALSO: GSK is cutting about 70 jobs at its plant in Zebulon, NC. Report

Related Articles:
Has the Gates Foundation created a malaria 'cartel'? Report
Genome map completed on malaria parasite. Report

ALSO NOTED: Novartis faces development bottleneck; Bayer lowers 2008 expectations;and much more...

Fri, 29 Feb 2008 06:59:50 -0500

> Five years ago Novartis set out to speed drug development, hoping to quickly advance discoveries in the lab to approval. Now the project has been so successful that the company now has a Phase II/III bottleneck. Blog

> Call it Bad News Bayer. The German company reported a whopping 78 percent drop in profits for the fourth quarter and forecast 2008 sales growth at its lowest level in years. Though 2007 full-year results were actually quite good--sales grew 11.8 percent--shares are down 15 percent since January 1 on a series of disappointing news. Report

> It's a grim trifecta of heparin news today. Regulators say they've now found 21 deaths that may be linked to Baxter's recalled blood thinner. FDA inspectors uncovered quality-control problems at the Chinese plant where crude heparin was processed for Baxter's supplier. And Baxter widened its recall to include not just its multidose heparin vials but single-dose packaging and diluted heparin. Report

> The FDA's pleas for more money are gaining attention in Congress. Report

> Victory for Amgen--and maybe for Roche, too. The California drug maker persuaded a judge to temporarily ban Roche's competing anemia drug Mircera in the U.S. Report

And Finally... A CDC study confirms what many of us already know: American's aren't getting enough sleep. Report

ALSO NOTED: Ardana looks to sale or merger; Oxigene inks $40M capital deal; and much more...

Wed, 20 Feb 2008 06:59:50 -0500

> Edinburgh-based Ardana's CEO, says the biotech is looking for a sale or merger. Report

> Oxigene has inked a deal with Kingsbridge Capital for $40 million in capital over three years. Release

> Oxford Biomedica has completed a late-stage trial of its cancer therapy TroVax, triggering a €10 million milestone payment. Release

> Scientists in the U.K. have identified a molecule that they say plays a critical role in the development of allergies. Report

> A growing demand for new biotech and lab space is forcing up rents in the Washington DC area as vacancies decline. Report

> There's a new target for drug developers focused on multiple sclerosis--and a pair of approved drugs that may already work against the disease. Report

> Some biotechs are eager for the FDA approval of biogeneric drugs. Report

> A new survey has concluded that specialists feel Medicare's new anemia drug payment limits are hurting cancer patients. Report

> Various agencies are taking aim at pro quo deals between brand-name drug makers and generics firms. Report

> Amgen harshly rejected a royalty offer from Roche, which wants to sell an anemia drug that would compete against Amgen's signature blockbusters. Report

And Finally... A 20-year effort to find a microbicide that protects women from HIV ended in another bitter setback for researchers who reported that a late-stage trial of a new gel has failed. Report

Amgen, Takeda ink massive development deals

Mon, 04 Feb 2008 06:59:58 -0500

Struggling under the weight of falling anemia drug sales, Amgen is selling the Japanese rights to a slate of some 13 experimental therapies to Takeda in a deal that may be worth more than $1 billion. For Takeda, which is putting up $200 million upfront and $340 million in worldwide research costs, the pact marks a major lunge into the biologics market.

The deal includes $362 million in milestones payments and a deal to to acquire Amgen KK, Amgen's Japanese subsidiary. And in a separate deal, Takeda has signed on to partner with Amgen on the cancer drug motesanib. Takeda will play $100 million up front and $175 million in a schedule of milestone paydays. Amgen announced plans to out-license some of its drugs last summer, when weakening sales forced the company to launch its first-ever cost-cutting move. "We have more assets in our pipeline than we can develop ourselves," said Amgen CEO Kevin W. Sharer recently.

- see this release
- here's the article from The New York Times

ALSO: Take a look at Amgen's pipeline. Report

Related Articles:
Amgen - Top 5 layoffs of 2007. Report
Amgen makes big workforce, budget cuts. Report
Amgen income hammered as anemia drug use drops. Report
Takeda expands R&D budget, may look for buyout. Report

ESA troubles sink Neose anemia drug program

Wed, 30 Jan 2008 06:59:58 -0500

With red alerts flying over risk factors posed by erythropoiesis-stimulating agents (ESAs), Neose has decided to shelve further development of its experimental anemia drug and hand out pink slips to 27 workers, roughly a third of its work force.

"Since commencing development of NE-180, we have intended to partner the compound during phase-II clinical trials due to the significant funding that would be required to conduct a phase-III program and launch a new ESA," said George J. Vergis, president and CEO of Neose. "We have concluded that the safety concerns expressed in recent quarters about marketed ESAs have not only impacted the market potential for new ESAs, but also made it unlikely that a collaborative relationship could be formed for the future development of NE-180 in a reasonable time frame."

- see this release
- check out the report from the Philadelphia Business Journal

Related Articles:
Amgen in new talks over ESA safety. Report
Neose shares sink on new trial delay. Report
FDA puts Neose anemia trial on hold. Report

Deal-making hits a faster pace in '07

Fri, 21 Dec 2007 06:59:57 -0500

New licensing deals and big venture rounds remained a staple of our coverage right through the end of the year, and will remain that way in 2008. For PricewaterhouseCoopers, which just did its big annual review of healthcare trends, the surge in deal-making between Big Pharma and biotechnology was unmistakable.

"In the first quarter of 2007," reports PwC, "life sciences firms recorded the most deal activity and the highest dollar amounts for mergers and acquisition deals than any quarter in their history. With these collaborations, life sciences companies are now driving the industry whereas big pharmaceutical companies once had a significant advantage. To fill the pipeline and accelerate innovation, look for greater collaboration between pharmaceutical and life sciences companies through mergers, collaborative risk-sharing, joint ventures and other co-development and co-promotion arrangements."

Big Biotech--a select group of companies--was clearly just as interested as Big Pharma in new collaborations. You could see that in evidence at Amgen as well as Genentech, which both signed up with smaller outfits advancing new technologies. For Amgen, the focus is on staunching an open sore as its anemia drugs take a hit. For Genentech, partnerships are a way to keep the music playing for its hit parade.

Emerging biotech companies, particularly in the U.S., also continued on a roll through 2007, with venture capital groups anxious to get a piece of equity in new companies with promising technologies and drug candidates. For several years now, venture capital has been edging steadily away from early-stage companies, looking to inoculate itself against risk in one of the riskiest businesses on the planet. That made later stage rounds for biotechs in or through proof-of-concept trials easier to raise, but made life in the A series a little lonelier.

Meanwhile, FierceBiotech has chronicled a number of new companies that are being structured to take advantage of approved therapies for new indications--an innovative twist that can breathe new patent life into a safe, proven product.

But not every funding option had a stellar year. When you talk to the emerging drug developers these days, you're just as likely to hear them talk about a potential buyout as an eventual IPO. The public markets, which bulled their way right to a late-year market correction, remained skittish about biotech public offerings and chilled more than one company's plans to travel the public market route to expansion.

Related Articles:
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M&A activity heats up as biotech IPOs struggle. Report

Amgen reveals promising D-mab data

Mon, 17 Dec 2007 06:59:57 -0500

Amgen's great osteoporosis hope--denosumab, or D-mab--increased bone strength in women receiving hormone replacement therapy for breast cancer. The first complete analysis of late-stage trial data on the drug showed a 5.5 percent increase in bone density among the women. On Friday, researchers for Amgen noted that the drug increased density in the spongy part of the bone. Amgen has great expectations for denosumab, which has the potential to reach blockbuster status with $1 billion to $2 billion in sales.

"In this study, denosumab data looks promising and, as a clinician, I look forward to having a potential alternative to existing therapies," said lead investigator Dr. Georgiana Kehr Ellis, from the oncology division at the University of Washington School of Medicine in Seattle.

- here's Amgen's release
- check out the AFX report for more

ALSO: Oxford Genome Sciences has inked a deal with Amgen to collaborate on new antibodies for treating cancer. Release

Related Articles:
Denosumab: Amgen's salvation? Report
Amgen touts progress in two key programs. Report
Amgen discusses the future with analysts. Report
Analyst: Anemia drug warnings 'not bad'. Report

Denosumab: Amgen's salvation?

Fri, 14 Dec 2007 06:59:54 -0500

2007 has been a rough year for Amgen. The world's largest biotech stumbled as it dealt with fallout from the anemia drug controversy. Safety concerns about the drug led to an FDA warning and caused sales of Amgen's most profitable drug to plummet. Analysts looked at the aging biotech and wondered if Amgen's glory days were over.

Now Amgen is looking to take a bite out of the $7 billion osteoporosis market with denosumab, a fully-human monoclonal antibody currently in Phase III testing. The drug is undergoing trials for bone loss induced by hormone ablation therapy for breast cancer or prostate cancer, prevention of cancer-related bone damage, postmenopausal osteoporosis, and prevention of bone metastases.

According to one analysts, denosumab "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." That would go a long way in turning around the company's fortunes. And denosumab is even more important to the company, as it's the only potential blockbuster nearing FDA approval. Amgen hopes to file an NDA for the drug in 2009.

- see this WSJ article for more

ALSO: Take a look at Amgen's pipeline. Report

Related Articles:
Amgen touts progress in two key programs. Report
Amgen discusses the future with analysts. Report
Analyst: Anemia drug warnings 'not bad'. Report
Amgen income hammered as anemia drug use drops. Report
Top 10 drug warnings and recalls of 2007. Report

Amgen platelet therapy hits endpoint in Phase III

Mon, 10 Dec 2007 06:59:54 -0500

A day after seeing its stock take a nasty dive on more bad news related to Aranesp, Amgen reported on Saturday that a late-stage study of romiplostim for increasing platelet levels in patients with Immune Thrombocytopenic Purpura hit its primary endpoint. In data revealed at the American Society of Hematology's annual meeting, researchers said that 38 percent of patients taking the drug had a sustained platelet response and patients were able to reduce or stop taking other drugs for the condition. More romiplostim data will be released today on another group of patients. Out of the 42 patients taking the therapy 26 percent needed other ITP meds to increase their platelet count compared to 57 percent of the patients taking a placebo.

- see this release on the data
- check out the report from TheStreet

ALSO: Take a look at Amgen's pipeline. Report

Related Articles:
Amgen in new talks over ESA safety. Report
Amgen discusses the future with analysts. Report
Amgen in crisis? Not us, says CEO Sharer. Report
Amgen stock slips as anemia drug concerns rise. Report

SPOTLIGHT: Researchers cure mice of sickle cell

Fri, 07 Dec 2007 06:59:53 -0500

Using a recently-discovered technique that turns normal skin cells into stem cells, scientists at the Whitehead Institute for Biomedical Research have cured mice of sickle cell anemia. Report

Aranesp flunks late-stage trial for breast cancer

Mon, 03 Dec 2007 06:59:55 -0500

Good news is hard to come by at Amgen. The company's slipped on Friday after the biotech giant announced that its fading anemia blockbuster Aranesp failed a late-stage study for breast cancer. Combined with chemotherapy, there was no indication that the combinatorial approach helped shrink tumor sizes in early-stage breast cancer victims. And in the long-term follow-up, researchers said that there were more deaths and tumor progression in the Aranesp group than in the control group. Amgen has been restructuring as it deals with a cutback in the use of anemia drugs.

- see this release
- check out the report on the trial

Related articles:
Amgen touts new Aranesp studies. Report
Amgen in crisis? Not us, says CEO Sharer. Report
Amgen stock slips as anemia drug concerns rise. Report
Amgen makes big workforce, budget cuts. Report

Mircera gets FDA nod, but blocked by patent case

Thu, 15 Nov 2007 06:59:55 -0500

The FDA has approved Roche's anemia drug Mircera, but don't look for any big new product launches soon. Last month Amgen won a patent infringement case on the therapy. And Roche is studying its options--including a possible appeal of the case. In the meantime, Mircera is already available in a long lineup of countries that include Sweden, Germany and the UK.

- see Roche's release
- read the AFX report on Mircera

Related Articles:
Amgen wins patent fight with Roche. Report
Roche: Patent ruling won't stop Mircera. Report
Roche to Launch Mircera in U.K. and Germany. Report
FDA wants more data on new Aranesp doses. Report

The FDA: Caught between a rock and a hard place

Fri, 09 Nov 2007 06:59:54 -0500

What's the FDA to do? The agency has taken no small amount of criticism in recent years for approving drugs with serious and potentially deadly side effects. Vioxx, Avandia, anemia drugs--just to name a few--have surrounded the agency in controversy. And recent news that the FDA can't guarantee the safety of the U.S. drug supply because its oversight of foreign drug manufacturers is horribly lax hasn't helped.

So it's not surprising that the FDA has clamped down on new drug approvals, green-lighting only 15 New Molecular Entities this year. For companies looking to launch drugs for diseases that already have treatment options, the FDA has raised the bar, demanding that the new drugs aren't just safe and effective, but more effective than currently-available treatments. This, of course, hasn't pleased pharma and biotech companies, which have seen their drugs delayed or rejected. Novartis CEO Daniel Vasella (photo), Schering-Plough CEO Fred Hassan and outgoing Wyeth CEO Bob Essner have all spoken out about that slowdown in approvals, with Essner going as far as saying the FDA is creating "drug monopolies" with its new policy.

The FDA maintains that there's been no change in its policy, and blames the lag in approvals on Big Pharma, which has submitted fewer NDAs this year. However, the agency has increased the number of public drug safety warnings and black box warnings. Yet a recent poll found that 84 percent of the public believe Big Pharma still has too much influence over the FDA. "Whatever action we take, someone's going to be unhappy. That's why it takes a special kind of person to work here," says FDA's Janet Woodcock. "A masochist."

- see this Fortune article for more

ALSO NOTED: Merck settles 27,000 Vioxx suits; Amgen, J&J anemia drugs get stronger warnings; and much more...

Fri, 09 Nov 2007 06:59:50 -0500

> Merck's fight-'em-hard strategy for Vioxx lawsuits may have been part of a larger plan to persuade thousands of plaintiffs to make a deal. After winning most of the 20 suits it defended in court, the drug giant now is set to announce that it's settled 27,000 suits covering some 47,000 plaintiffs. Report

> Analyst say the new warnings for Amgen's anemia drugs are 'not bad'. Report

> In the battle of the cholesterol meds, Crestor just got a new weapon. The FDA approved AstraZeneca's application to market the drug not just for lowering cholesterol, but to treat hardening of the arteries, too. It's the first statin to win approval for that indication. Report

> The tidal wave of generics has reached Japan. That country's government has proposed changes to prescription forms that would promote use of cheaper generics. Japanese copycat-drug companies saw their stocks soar on the news. Branded drug makers' shares declined. Report

And Finally... The case of the pain-reliever lollipop is a wrap. Cephalon has agreed to pay $425 million to settle government investigations into its marketing practices. Report