Velcade

ASCO already churning out news

Tracy Staton — Fri, 30 May 2008 11:06:50 -0400

Today marks the start of the annual American Society of Clinical Oncology meeting, always a big news generator in the pharma biz. We'll let our sister pub FierceBiotech keep you up to date on the in-development drugs, while we look at studies of existing meds--and so far, we've picked up a few interesting tidbits:

Analysts are hyped about Celgene, whose Revlimid blood cancer drug performed well as a first-line treatment for multiple myeloma in combo with Millennium's Velcade. Data on Revlimid as a non-Hodgkin's lymphoma treatment looks promising, too, one Wall Street type says.
New data on Avastin, Genentech's multitalented cancer drug, is expected at the conference, including results from a late-stage trial in breast cancer, for which the drug was approved in February. (One closely watched stat is sure to be dosing levels; we'll be looking to see whether low doses work as well as higher ones, because if they do, that could pressure Avastin sales.) Data on the drug as an add-on in early colon cancer is also expected. A third Avastin study on the docket: a mid-stagter in glioblastoma multiforme, the type of advanced brain cancer recently identified in Sen. Edward Kennedy.
Roche is already touting data on Herceptin, saying that two new studies show women with breast cancer should start with the drug and stay with it -- provided they test positive for a protein known as HER-2
In the anxiously awaited category: Lung cancer survival improvement data on Erbitux, the ImClone/Merck KGaA/Bristol-Myers Squibb med that's said to have met the main goal of a big trial, though no specific data has yet been released.

There's sure to be more as the weekend progresses, so check in Monday for an update.

- see the Associated Press ASCO round-up
- find the advance info from CNN Money
- read the Herceptin story at MarketWatch

Takeda risks short-term pain in buyout

Fri, 25 Apr 2008 06:59:57 -0400

You can't say Takeda Pharmaceutical is unwilling to take risks. The Japanese drugmaker went out on an $8.8 billion limb in bidding for the U.S. biotech Millennium Pharmaceuticals. Investors weren't impressed; they dragged share prices down by 8 percent almost immediately. Analysts say that, if the deal goes through, profits are likely to fall over the next fiscal year--by a whopping 55 percent. Plus, some think the buyout offer is way too rich.

But the short-term pain may equal long-term gain. Revenue from Millennium's best-selling blood cancer med Velcade could shore up eroding profits at Takeda, as two of Takeda's best sellers see their patents expire in 2009 and 2011. The smaller company's pipeline offers promise for the future, analysts told the Wall Street Journal. The deal would put "the company in a position to move ahead of the field in anticancer-drug strategies," one said, rating the shares a "buy." We'll see what shareholders think when the tender offer expires next month.

- see the story in the Wall Street Journal

Takeda offers $8.8B for Millennium

Thu, 10 Apr 2008 06:59:58 -0400

Takeda Pharmaceutical is placing an $8.8 billion bet on cancer meds. The Japanese drugmaker has offered $25 per share for Millennium Pharmaceuticals, which not only makes the lucrative blood-cancer med Velcade, but boasts a pipeline of up-and-coming cancer therapies, too.

Analysts see the deal as "a positive move." Takeda has had a $10 billion war chest ready for dealmaking, and it's been needing some way to offset the looming loss of exclusivity on its blockbuster diabetes med Actos, whose U.S. patent expires in 2011. The offering price for Millennium amounts to a 53 percent premium over market.

- see the press release from Takeda
- read the story from the Financial Times

Related Articles:
Millennium chief scientist takes offbeat approach
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Cell Genesys scores $320M blockbuster deal with Takeda

ALSO NOTED: Takeda prevails in Actos patent suit; Analyst gets peek at Biovail founder's laptop;

Fri, 04 Apr 2008 07:59:50 -0400

> The U.S. Supreme court refused to reconsider an appeals court ruling that upheld Takeda's patent on its diabetes treatment Actos, a decision that keeps Alphapharm from launching a generic version until 2011. Report

> A former Bank of America analyst who's suing Biovail for defamation is getting access to founder Eugene Melnyk's computer to search for deleted emails. Report

> Taro Pharmaceutical got the tentative nod from the FDA for its copycat form of GlaxoSmithKline's Lamictal (generically lamotrigine), an anti-seizure med also used as a mood stabilizer. Release

> Sinclair Pharma disclosed that non-executive director JeanCharles Tschudin bought 55,000 shares on top of the 20,000 he purchased last week. Report

> Amgen got a badly needed boost with its announcement that its most promising experimental therapy, denosumab, significantly increased bone mineral density in a Phase III trial. Report

> A new report out says that the clinical trial process routinely ignores women, the elderly, minorities, the disabled and people living in rural America. Report

> The Scientist profiles Millennium Pharmaceuticals CSO Joe Bolen, whose team has been advancing a new therapy that targets molecules "upstream" from Velcade. Report

> Do VC groups love the Web more than biotech? Report

Most popular this week: FDA issues early-warning trifecta. Report

And Finally... Birds do it--select fruits with the highest concentrations of antioxidants, that is. Report

ALSO NOTED: Merck agrees to extended deadline; Millennium disputes IMS data on Velcade;

Wed, 26 Mar 2008 07:59:50 -0400

> Merck agreed to extend the deadline for Vioxx settlement filings to May 1, giving patients who want in on the deal more time to get their paperwork together. Report

> Upset by a report from IMS Health that showed sales of cancer med Velcade dropping, Millennium Pharmaceuticals filed a rejoinder with the Securities and Exchange Commission; at least some analysts were convinced, advising investors to ignore IMS's first-quarter data on the drug. Report

> As expected, California regulators agreed to delay their plans to track all prescription drugs from factory to patient; the deadline for drug makers and pharmacists to comply is now January 2011 instead of January 2009. Report

> Novartis stock gained 3 percent Tuesday on news that Health Canada approved its Diovan drug for congestive heart failure patients who can't take ACE inhibitors. Report

> Big Pharma is spending more on magazine advertising and less on online marketing, according to a report from Neilsen Monitor-Plus. Report

> The German drug maker Ursapharm Arzneimittel announced it would enter the Indian pharma market via a joint venture called Ursapharm India, planning to launch eye drops, ointments, nasal sprays and nasal drops. Report

> Research spending into new drug developments jumped to $58.8 billion last year, according to a new study by PhRMA and Burrill & Co. That represents an increase of $3 billion. Release

> Looks like stressed out doctors might soon have a little less paperwork to worry about. According to the Wall Street Journal, the nonprofit group iHealth Alliance is set to launch an online network "that will email alerts [about warnings and label changes, etc.] to doctors who sign up." Report

> Frustrated by the long years of research needed to prove the effectiveness of a new cancer therapy, British officials have designated a network of 19 hospital units that will be allowed to administer early-stage experimental cancer drugs to terminal patients. Report

> Big Pharma companies are often quick to turn their backs on a drug that doesn't deliver the kind of data needed to win approval as well as big markets. But a series of these failed development programs have been resurrected by scientists who decided to search for the kind of genetic biomarkers that would define a group of patients who would respond positively. Report

> Manipulating insulin levels raises the level of the master gene-regulating protein SKN-1, significantly prolonging the lives of microscopic worms in one study. Report

And Finally... Think your dog has spring fever? It may be Attention Deficit Hyperactivity Doggie Disorder, easily treatable with Fidolin--and you can take it, too! Report

Specialty-drug spending spawns protest

Thu, 20 Mar 2008 07:59:54 -0400

Has spending on specialty drugs hit a wall? Spending on these meds--including those for cancer and multiple sclerosis--is rising at a rapid pace, and that has some payers and watchdogs clamoring for alternatives.

Experts estimate that specialty drug spending could top $99 billion by 2010, nearly double the $54 billion spent in 2006. To curb costs, pharmacy benefits managers already are enforcing rules on drug selection, usage, and dosage. But they fear that's not enough to rein in spending. So they're pushing Congress to make some changes: create a clear pathway for generic biologics, reinforce rules requiring cheaper therapies, and back pay-for-performance projects like the one Johnson & Johnson agreed to in the U.K. to get Velcade on the National Health Service formulary.

- see the item at the WSJ Health Blog
- get more details in the WSJ article

Related Articles:
Can specialty drugs turn pharma tide? Report
Study: Costlier drug worked better. Report
Drug makers jack prices up 7.8%. Report
Specialty drugs emerge as key price driver. Report

ALSO NOTED: Allergan to close Irish plant, lay off 300; FDA grants quick review to Velcade use;

Wed, 30 Jan 2008 06:59:50 -0500

> Allergan plans to shutter its manufacturing facility in Arklow, Ireland, by mid-2009, leaving 300 without jobs; the plant makes breast implants. Another Irish facility in County Mayo won't be affected; that plant makes the wrinkle-reducer Botox. Report

> The FDA will fast-track review of Millennium Pharmaceuticals' application to expand the use of its cancer med Velcade to newly diagnosed multiple myeloma. Release

> Too many similar drug names equals many more medical errors, some of them deadly, according to a new report from Pharmacopeia. Report

> Iroko Pharmaceuticals bought the non-U.S. rights to Merck's Aggrastat heart drug. Report

> Carl Icahn says that Biogen Idec essentially ran a sham when it put itself up for auction recently, putting in place barriers that warded off serious bidding by Big Pharma companies. Now he's made a bid to place three new directors on Biogen's board, and is hoping to gain control of the company. Report

> The rapid move toward offshoring drug trials has sparked controversies over the ethics involved in some of these studies. Report

> A team of scientists at the University of Buffalo have spun off a company to commercialize a new chemical synthesis that they say can far more efficiently create and manufacture new compounds. Report

> Is synthetic biotechnology the next big thing in drug R&D? Report

And Finally... Even as the demand for new antibiotics grows, new research programs to advance fresh therapies have been drying up fast. Report

ALSO NOTED: Did Merck, Schering withhold Zetia data?;Genentech gives eye docs access to Avastin

Fri, 21 Dec 2007 06:59:50 -0500

> Merck and Schering-Plough research raised questions about potential liver damage from their popular cholesterol med Zetia--but the companies never published those studies. News about this unpublished data comes on the heels of a delay in results from an important new Zetia trial. Report

> Genentech and its eye-doctor critics have buried the hatchet, at least partly. The company will allow ophthalmologists to order its cancer drug Avastin from wholesalers and then send it to compounding pharmacies to be repackaged for use against macular degeneration. Report

> Massachusetts has pledged $40.5 million in incentives to Shire, to persuade the British drug maker to follow through on an expansion project in Lexington that would create hundreds of jobs. Report

> The European Commission is on the verge of handing $2.9 billion to the Innovative Medicines Initiative, which will pair up with academics and pharma industry types to develop new drugs. Release

> Abbott Laboratories got the regulatory nod to sell its psoriasis treatment Humira in Europe. Report

> Millennium Pharmaceuticals filed for FDA approval to market Velcade for previously untreated multiple myeloma. Release

And Finally... Do we need drugs for shyness, or do shy folks just need practice making conversation? Report

Analysts tag Velcade as blockbuster

Mon, 10 Dec 2007 06:59:57 -0500

News flash: Experts are using the words "Velcade" and "blockbuster" in the same sentence. Millennium Pharmaceuticals is reporting stronger-than-expected sales of the cancer drug--which happens to be its only drug on the market. The drug's U.S. take will grow by 20 percent for 2007, to $265 million, and analysts are predicting $420 million by 2009. Globally, they're expecting the drug to bring in $921 million in 2009. Johnson & Johnson has marketing rights to the drug in more than 85 countries outside the U.S.

Docs are using Velcade as an add-on for two blood cancers, multiple myeloma and mantle cell lymphoma. At this week's American Society of Hematology conference in Atlanta, the company will present new studies showing the drug's effectiveness as a first-line treatment for multiple myeloma. The company is also testing the drug against non-Hodgkin's lymphoma and other cancers.

Also at the hematology meeting, Novartis will trumpet new data on Glivec's effectiveness against leukemia. The Swiss drug maker says a new study shows the drug slows the disease's progression. The six-year survival rate on the drug was 88 percent.

- see this release from Millennium
- check out this release on the forthcoming Velcade research
- read the analysis of Velcade's prospects in the Boston Globe
- read the report about Glivec from CNN Money

Related Articles:
Positive Velcade data fuels stock rise. Report
Velcade wins priority review from FDA. Report
Journal posts Velcade data. Report

ALSO NOTED: New drug approval lags in 2007; Velcade boosts Millenium Pharma's outlook;

Fri, 02 Nov 2007 07:59:50 -0400

> The FDA has suffered no small amount of criticism recently, and, according to the Wall Street Journal, the agency's efforts to protect itself from naysayers have contributed significantly to he low number of new drugs approved in 2007. Report

> Strong Velcade sales prompted Millennium Pharmaceuticals to boost its year-end profits forecast to $40 million to $45 million, up from $20 million to $30 million. Report

> The FDA gave a tentative nod to Cipla's generic version of Bristol-Myers Squibb's pediatric HIV drug Zerit. Report

> Maryland-based Vanda Pharmaceuticals said it would two days ago--but now it says it won't offer $100 million in senior notes. Report

> India's Flamingo Pharmaceuticals says it plans to introduce 20 new generics in that country over the next six months, and it's beefing up its distribution network to handle the new business. Report

And Finally... WHO officials are calling on drug companies to help fight a co-epidemic of HIV and drug-resistant TB that's sweeping sub-Saharan Africa. Report

UK accepts J&J's money-back guarantee

Thu, 25 Oct 2007 06:59:57 -0400

It's official: the UK's National Health Service will start using Johnson & Johnson's Velcade, under an unprecedented money-back-guarantee program. Patients who respond to the drug will be fully funded. Patients who respond only minimally or not all all will be taken off Velcade, and J&J will refund the cost to NHS. The guarantee was the only way J&J could persuade the National Institute for Clinical Excellence--the drug gatekeepers for NHS--to reimburse for the drug at all.

- check out the CNN Money report
- read an analysis of the deal in The Telegraph

Related Articles:
J&J drug gets money-back guarantee. Report
Positive Velcade data fuels stock rise. Report
NHS fights expensive Alzheimer's drugs. Report
Metric: Biotech drugs fueling costs. Report