Velcade

Global demographic trends threaten drug industry

Wed, 14 May 2008 06:59:54 -0400

You can file the following under the category of really, really bleak forecasts:

The rising cost of healthcare in the developing world matched by an aging population is creating a perfect storm for drug developers that threaten their entire industry, according to an upcoming report by AT Kearney. We are moving from a world in which six or seven workers support one person in retirement to a ration of three to one, warns the report, and that will force healthcare services all over the world to restrict their support to essential services. Expensive biologics aimed at extending the lives of patients won't be included. There will also be much greater pressure on developers to match a recent agreement Johnson & Johnson made with the National Health Service in the UK to reimburse the NHS for each patient who doesn't respond to Velcade. And as developing countries grow their populations will demand new therapies that target diseases like malaria, tuberculosis and HIV.

- read the story from Dow Jones

Takeda makes $8.8B bid for Millennium

John Carroll — Thu, 10 Apr 2008 08:51:20 -0400

Looking to expand out of a budget-bound Japanese market, Takeda is taking a big chunk of its $10 billion war chest and offering $8.8 billion in cash for U.S.-based Millennium Pharmaceuticals. The $25 per share offer is a 65 percent premium over Wednesday's close. Millennium is best known for the cancer drug Velcade, which Takeda is looking to turn into a global blockbuster. That would go a long way toward overcoming the looming patent expirations for Actos and Prevacid.

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the 14th largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology.

"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda Pharmaceutical Company Limited.

- here's the release
- see this article from Forbes

Millinneum News:
Millennium chief scientist takes offbeat approach
Millennium spent $1.3M on lobbying
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster

Takeda News:
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Safety, efficacy problems sink Takeda drug
Cell Genesys scores $320M blockbuster deal with Takeda

Takeda makes $8.8B bid for Millennium

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

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the fourteenth largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology. "Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda.

- here's the release
- check out the report from Forbes

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

Millennium chief scientist takes offbeat approach

Thu, 03 Apr 2008 07:59:55 -0400

The Scientist profiles Millennium Pharmaceuticals CSO Joe Bolen, whose team has been advancing a new therapy that targets molecules "upstream" from Velcade. The data will be released at the American Association of Cancer Research meeting. "We'll be the belles of the ball at AACR with this one," says Bolen, whose scientific journey started at the University of Nebraska and wound through 10 years of work at the NIH, where he won the institute's Meritorious Research for his work on protein tyrosine kinase oncogenes.

- read the profile in The Scientist

Related Articles:
Millennium spent $1.3M on lobbying. Report
Positive Velcade data fuels stock rise. Report
Millennium to buy AnorMed for $515M. Report

ALSO NOTED: Genentech options Exelixis inhibitor; Millennium reports positive data for cancer cocktail; Immtech CEO takes a pay

Fri, 14 Mar 2008 07:59:50 -0400

> Exelixis announced that Genentech has exercised an option to develop Exelixis' XL518, a selective inhibitor of MEK which is currently in a Phase I clinical trial. Exelixis earns $3 million on the option. Release

> Millennium Pharmaceuticals has posted positive data in a study of a drug cocktail that includes its cancer drug Velcade. The combo was being tested on patients with multiple myeloma who were ineligible for stem-cell transplantation. Report

> Immtech CEO Eric L. Sorkin has volunteered to take a pay cut during this fiscal year. Release

> AVI BioPharma has acquired all the outstanding shares of Ercole Biotech it didn't already own. Ercole has been working on alternative RNA splicing technology. Report

> Calando Pharmaceuticals, a subsidiary of Arrowhead Research, has asked the FDA for a green light to begin an early-stage trial of a cancer therapy. Report

> For the first time, federal authorities are conceding a link between vaccines and autistic symptoms--just not the link activists thought. Report

> The venture capital group Perseus has pumped $10 million dollars into NanoBio, bringing its total investment in the University of Michigan spin-off to $30 million. Report

Most popular this week: Breakthrough reported in flu vaccine research. Report

And Finally...New Jersey, an aggressive suitor of biotech companies, is offering ImClone $32 million in tax rebates to woo it to the Garden State. Report

Europe moves to reclaim center stage

Fri, 21 Dec 2007 06:59:55 -0500

In Europe, venture money is typically harder to come by than in the U.S., but the continent still has some of the best scientific talent on the planet, often working at academic institutions that make groundbreaking discoveries a routine performance.

From a drug developer's perspective, Europe's single-payer systems have cast a constant shadow over earnings potential. But the pall hasn't stopped the industry in its tracks. If anything, the market obstacles have been spurring innovators to become more creative. That could be seen in the recent deal by Johnson & Johnson to guarantee the effectiveness of Velcade. And more recently there was a pact to include cost effectiveness in a late-stage trial for UK regulators. Given the focus on value-based medicine, where payers on both sides of the Atlantic are stepping up their demands on these expensive new therapies, this is one trend that won't be going away anytime soon. In fact, you can expect payers in the U.S. to pay particularly close attention and start issuing their own demands.

Anxious to revive drug development work in the continent, the industry has successfully pushed through one of the largest public/private initiatives the world has seen in drug discovery. Europeans are on the verge of authorizing a €2 billion partnership with pharma designed to fuel academic and industry research over the next seven years. The Innovative Medicines Initiative is expected to speed testing on safety and efficacy, the Holy Grail of goals among developers. This partnership could help open the tap of funds that would fuel the swift advance of the European biotechnology industry.

Related Articles:
Europe readies revolutionary drug discovery pact. Report
Group: EU should double research spending. Report
The trouble with Europe. Editorial

ALSO NOTED: Solvay drug 'approvable'; ChemGenex touts trial results: Asuragen raises $18.5M in venture cash; and much more...

Mon, 10 Dec 2007 06:59:50 -0500

> FDA staffers say that Solvay's experimental therapy for atrial fibrillation is approvable--with conditions. Report

> Shares of ChemGenex, a biotech with facilities in the U.S. and Australia, were boosted on the news that its experimental therapy for chronic myeloid leukemia showed promise in a clinical trial. Speaking at ASH, researchers said that omacetaxine triggered a response in 91 percent of the 21 patients taking the drug. The patients were selected after the T3151 mutation made them resistant to existing therapies. Release

> Austin-based Asuragen, a molecular diagnostics company and molecular biology service provider, has raised $18.5 million in Series B financing. Release

> Fundamental Applied Biology has completed a $21 million Series B financing. Release

> ZymoGenetics is touting positive early stage data on its cancer therapy IL-21. The drug may boost the effectiveness of Rituximab in killing cancer cells. Report

> The Jordanian pharma company Arab Pharmaceutical Manufacturing has accepted a $163 million cash offer from Hikma. Report

> Acura Pharmaceuticals has received a $30 million cash payment from King Pharmaceuticals Research and Development. Release

> GE Healthcare and Novavax have agreed to collaborate on the development of a manufacturing process for a pandemic influenza vaccine. Release

> The rise of generic drugs has been bad news for Big Pharma, but not so bad for copycat makers like Mylan. Report

> Third time's the charm? Merck is going to the FDA again, hat in hand, asking for approval to sell the statin drug Mevacor over the counter. Report

> News flash: Experts are using the words "Velcade" and "blockbuster" in the same sentence. Report

And Finally… Scattered in the American Southeast, you'll find pockets of some of the country's highest mortality rates. Release

ALSO NOTED: GSK cuts 5,000 jobs; Codexis opens Singapore lab; Reliant sets IPO terms;and much more...

Thu, 25 Oct 2007 06:59:50 -0400

> The closure of a GlaxoSmithKline's Puerto Rican plant has kicked off the plan to cut 5,000 jobs. Report

> Codexis has opened a laboratory in Singapore, its first research facility in Asia. Release

> Reliant Pharmaceuticals has set its IPO terms at $25 to $27 a share. The company has raised more than $500 million from investors. Report

> Pharmion Corporation and MethylGene have reported preliminary clinical data from the Companies' MGCD0103 Phase I/II combination trial with Gemzar. Release

> It's official: the UK's National Health Service will start using Johnson & Johnson's Velcade under an unprecedented money-back-guarantee program. Report

> Bristol-Myers Squibb's third-quarter results show what one big drug can do. Net income more than doubled to $858 million on revenues of $5.1 billion--and Plavix was the biggest reason. Report

> The European Union backed a trade protocol that will give poor countries better access to cheap generics in the event of an epidemic. Report

> The FDA slapped a new warning on Provigil, a drug for narcolepsy and other sleeping disorders made by Cephalon. Report

And Finally… Most people believe their sleep meds work better than the drugs actually do. Article

ALSO NOTED: Cosmo inks deal; GenMab expands cancer program; OPKO acquires rights Phase III drug; and much more...

Thu, 11 Oct 2007 06:59:50 -0400

> Italy's Cosmo Pharmaceuticals will pick up a €2 million upfront fee after inking a global licensing deal with Ferring for a reformulated budesonide product. Cosmo also could receive up to €58 million in scheduled milestone payments. Release

> Denmark's GenMab is expanding its development program for HuMax CD4 to include patients with Sezary syndrome. Release

> Miami-based OPKO Health has acquired the rights to the ophthalmic indications for a late-stage therapy being developed to treat dry eye. Release

> CRO PPD has made two new hires to help bolster its in late-stage trials and advance its work overseas. Release

> J&J has made a money-back guarantee to the UK's NHS for the cancer drug Velcade. Report

> It's day three of the Pfizer-Sanofi merger watch. Now experts are saying that a Sanofi acquisition wouldn't be prudent for Pfizer--but a partnership would. Report

> Several drug makers are recalling cold medicines for kids under two years. Johnson & Johnson, Novartis, and Wyeth are among those pulling products from store shelves. Report

And Finally… As if Big Pharma didn't have enough challenges. Moody's Investors Services has downgraded the entire industry's credit rating, cutting its 12-month outlook to "Negative" from "Stable." Report

SPOTLIGHT: Positive Velcade data fuels stock rise

Tue, 18 Sep 2007 06:59:53 -0400

Shares of Millennium Pharmaceuticals shot up this morning after the company announced that a late-stage trial of Velcade proved effective against multiple myeloma. Researchers stopped the trial so that all the participants could receive the drug, which is also being developed for non-Hodgkin's lymphoma. Release

ALSO NOTED: Titan discontinues Phase II; Poniard lines up $15M; and much more...

Wed, 25 Oct 2006 20:01:30 -0400

> Titan Pharmaceuticals announced it was launching a Phase III trial for opioid independence but discontinued a Phase II trial of an experimental therapy for CHF without explanation. Report

> South San Francisco-based Poniard has secured a $15 million loan. Release

> Bilcare has acquired DHP, a UK-based clinical trials service provider. Report

> Insert Therapeutics has completed a $10 million private placement. Release

> Evolutec has raised 2.8 million stg in a private placement. Report

> Millennium Pharmaceuticals discussed plans to focus on Velcade and pipeline development in its latest quarterly report. Report

> The FDA has signed off on Human Genome Sciences Phase III trial of LymphoStat-B. Report

And Finally... Researchers are studying the use of fat stem cells for breast reconstruction. Release

Velcade wins priority review from FDA

Tue, 08 Aug 2006 20:01:36 -0400

The FDA has granted a priority review for Millennium's Velcade for relapsed mantle cell lymphoma. Velcade is currently approved for patients with multiple myeloma who have failed at least one standard therapy. "Receiving priority review is a significant step forward in accelerating and expanding the potential of Velcade in cancers beyond multiple myeloma," said Deborah Dunsire, Millennium's president and CEO.

- here's the UPI report on Velcade

ALSO NOTED: Allos gains orphan status for cancer therapy; NICE recommends against Velcade; and much more...

Tue, 25 Jul 2006 20:00:50 -0400

> Allos Therapeutics has gained orphan drug status for an experimental cancer therapy. Report

> The U.K.'s drug watchdog, the National Institute for Health and Clinical Excellence, has recommended against covering Velcade, saying its effectiveness against myeloma is unclear. Report

> NICE, however, decided to back Enbrel and Raptiva for severe psoriasis. Report

> The National Cancer Institute has begun a late-stage trial of Cytogen's Quadramet in combination with Zometa as a therapy for lung, breast and prostate cancer that has spread to the bone. Release

> Acambis said that its revenues this year would likely suffer from changes in a U.S. government contract for smallpox vaccine. Article

> Avalon Pharmaceuticals and ChemDiv have inked a collaboration for the discovery and development of small molecule oncology therapeutics. Release

> Iconix Pharmaceuticals announced a services agreement with Merck KGaA in which Iconix scientists will compare several of Merck's compounds with compounds from similar classes of molecules and with marketed products to gain insight into the safety of new drug candidates. Release

> Dainippon Sumitomo Pharma and Bristol-Myers K.K. have concluded an agreement on the marketing rights of anti-hypertension and hepatocellular cancer drug. Release

And Finally… South Korean scientist Hwang Woo-suk, the man at the center of an international scandal over faked stem cell research, explained that some of the research money that investigators went looking for was spent on a failed effort to clone an extinct mammoth. He is on trial for embezzling funds. Article

ALSO NOTED: FDA fast tracks Nexavar; ImClone, Merck KGaA amend pact; and much more...

Wed, 19 Jul 2006 20:00:50 -0400

> U.S. Sen. Charles Grassley (R-IA) has alleged that an FDA official collaborated with Merck to discredit FDA safety expert Dr. David Graham after he publicized health risks linked to Vioxx. Report

> Bayer Pharmaceuticals and Onyx reported that the FDA has provided fast-track status for Nexavar as a therapy for advanced melanoma. Nexavar was approved last year as a therapy for advanced renal-cell carcinoma. Report

> The FDA has approved a generic version of Boehringer Ingelheim's Mobic osteoarthritis therapy. Report

> ImClone Systems and Merck KGaA have amended their '98 development and licensing pact for Erbitux. Report

> Human Genome Sciences has initiated dosing of patients in a randomized Phase II clinical trial of HGS-ETR1--mapatumumab--in combination with bortezomib, Velcade, in advanced multiple myeloma. Release

And Finally... Columbia University Medical Center researchers say they have found an "off switch" for chronic pain. They've applied for a patent to develop a new class of drugs based on their findings. Report

ALSO NOTED: Merck boosts stake in Schering; Lipitor studied for ALS; and much more...

Thu, 08 Jun 2006 20:00:50 -0400

> Merck KGaA has boosted its stake in Schering to more than 10 percent, raising speculation about its possible impact on the planned merger of Bayer and Schering. Report (WSJ sub. req.)

> Lipitor's ability to regulate immune systems has given hope to researchers who believe the cholesterol drug may be an effective weapon in the fights against ALS, amyotrophic lateral sclerosis or Lou Gehrig's disease, as it is best known as. Report

> Hana Biosciences has won orphan drug status for its experimental brain tumor drug Ropidoxuridine. Report

> Millennium Pharmaceuticals has asked the FDA for approval to expand the use of Velcade to include patients with mantle cell lymphoma. Report

> The FDA has approved Merck/Schering-Plough Pharmaceuticals expanded use of the cholesterol drug Zetia. Report

> Trophos plans to launch a Phase II trial for a diabetic neuropathic pain therapy following successful preclinical studies. Release

> Novartis has received FDA approval for two new doses of the antihypertensive drug Lotrel. Report

And Finally… In an editorial, The New York Times cheers on scientists engaged in new embryonic stem cell cloning efforts, despite attempts by the Bush administration to restrict research in the field. Editorial

SPOTLIGHT: Millennium Pharmaceuticals reaches $10M milestone

Wed, 08 Mar 2006 19:01:33 -0500

Millennium Pharmaceuticals has reached a $10 million milestone payment from Johnson & Johnson for sales of Velcade. Release

ALSO NOTED: Researchers announce cancer cases in AIDS research; FDA meets on Cubicin; and much more...

Sun, 05 Mar 2006 19:00:50 -0500

> Schering-Plough announced that five patients taking its experimental AIDS therapy vicriviroc contracted cancer but added that no causal relationship had been established. Report

> Shares of Cubist Pharmaceuticals dropped on Friday as investors braced for an FDA advisory meeting today on whether to expand use of Cubicin antibiotic. Report

> Researchers presented new Phase III data demonstrating the safety and efficacy of Vivaglobin for treating patients with primary immunodeficiency. Release

> Corgentech announced that the lowest dosage of its Avrina eczema therapy proved the most effective. Report

> Millennium Pharmaceuticals and Johnson & Johnson have launched a Phase II trial of Velcade for injection in non small cell lung cancer. Release

> Late last week Kosan Biosciences cut 39 jobs as part of a restructuring. Report

> Mannkind has launched two Phase III trials for Technosphere Insulin in patients with Type 1 and Type 2 Diabetes. Release

> Health Canada has approved Aurobindo Pharma's Citalopram Hydrobromide tablets 20 mg and 40 mg. Release

> China Health Holding has entered into a letter of intent to acquire 51 percent or more of Shaanxi Wanan Pharmaceutical. Release

And Finally... Under pressure, giant retailer Wal-Mart has agreed to carry the controversial Plan B contraceptive. Report

Chutes & Ladders: Levin out, new CEO in at Millennium

Tue, 28 Jun 2005 20:01:37 -0400

The founder and CEO of Millennium, Mark Levin, is expected to announce his departure from the company today. Deborah Dunsire, a senior VP at Novartis, will take over as CEO while Kenneth Weg, a former executive at Bristol-Myers Squibb, will take over as chairman of the board. That transition marks a new phase for the company, says Weg, as Millennium moves from a drug discovery company to a more mature marketing outfit. Millennium has two products in the market: Integrilin, a cardiovascular drug, and Velcade, a cancer drug.

The new CEO will face an enormous task. Millennium lost $252 million on $448 million in revenue last year. It has never turned a profit. Analysts will look for quick evidence that the company can get its revenue growing at a rapid pace.

- read this story in the Boston Globe for more

SPOTLIGHT: Journal posts Velcade data

Tue, 07 Jun 2005 20:01:33 -0400

The British Journal of Haematology has published the results of two phase II studies which showed strong single agent and very high combination response rates in front-line multiple myeloma for Millennium Pharmaceuticals' Velcade. Release