pipeline

Silver lining to Big Pharma's cloud?

Fri, 09 May 2008 06:59:56 -0400

Some people see the Big Pharma glass as half-full instead of the alternative. In an investor's-eye look at the industry, Kiplinger ticks off the usual criticisms: patent expirations, tough generics competitors, skyrocketing R&D costs, picky regulators, and election-year political pitfalls. But it also says that beaten-down pharma stocks are so cheap, for some there's no way to go but up.

Institutional investors tell the magazine that "gloomy" Pfizer can only get better, that Johnson & Johnson has consumer healthcare and devices as hedges, and that Schering-Plough is dirt cheap and, given its comparative lack of copycat exposure, poised to rise. The whole sector has several forces pulling in its favor, too. Strong cash flow that could be even stronger if they'd cut unproductive R&D, there are the undeniable demographics of the baby boom, and Big Pharma possesses the kind of marketing muscle that smaller drugmakers will pay dearly for. Not to mention the propensity for pulling rabbits from empty hats: "It always seems like they have nothing in the pipeline...Then they always come up with something."

- read the Kiplinger article

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

Vasella touts Novartis' diversification

Mon, 14 Apr 2008 06:59:55 -0400

Novartis CEO Daniel Vasella (photo) talked up his company's prospects in an interview with the Swiss weekly Sonntag, saying that it's well on its way to returning to dynamic growth.

Vasella acknowledged that the pharma biz remains difficult, but he praised Novartis' pipeline and cited the new Alcon deal as evidence that the company will be strengthening itself through diversification. Last week, Novartis agreed to buy 25 percent of the eye care company for $11 billion and another big chunk by 2010 for $28 billion, giving it 72 percent controlling interest in the U.S.-based Alcon.

Meanwhile, Alcon announced that it's planning to build a manufacturing facility in Singapore as a beachhead for Asian distribution of its pharmaceutical products. The company plans to break ground in 2009 and have the plant fully operational by 2012.

- find the story in Forbes
- see the Singapore coverage, also in Forbes

ALSO: A new study shows that Novartis' Reclast/Aclasta bone drug outperformed Sanofi-Aventis' Actonel at increasing bone mass in patients whose osteoporosis was caused by steroids. Release | Report

Related Articles:
Novartis taps new U.S. pharma chief. Novartis report
Novartis discovery chief departs in shakeup. Novartis report
CEO: Novartis plans big restructuring. Novartis report
Novartis pledges $39B for Alcon. Novartis report
Cash-rich Novartis CEO mulls biotech buyouts. Report

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

AstraZeneca rivals could launch any day

Mon, 07 Apr 2008 06:59:56 -0400

You can bet the execs at AstraZeneca are biting their nails this week. Next Monday, April 14, marks the end of a 30-month stay on Ranbaxy Laboratories' copycat form of the mega-blockbuster Nexium. And a similar stay against Teva's Seroquel generic ran out March 26. Neither company will say whether they plan to launch the cheaper rivals that are waiting, FDA-approved and ready to go, in the wings.

Lawsuits over the meds' patents still are pending. AstraZeneca says Seroquel is protected till 2011 and Nexium till 2014. But Teva and Ranbaxy could launch at risk if they think their patent challenges will eventually prevail.

- read the article from the Wall Street Journal

ALSO: As part of its global restructuring--prompted in part by generic competition and in part by pipeline troubles--AstraZeneca will cut 132 jobs from its Spanish operations, despite strong growth in the country last year. Report

PLUS: When it comes to drug development, is bigger really better? That is the question Borje Eckholm, president and CEO of Investor AB--and one of AstraZeneca's biggest shareholders--poses in the London Times. Report

Related Articles:
FDA to review Nexium, Prilosec. Report
Canada questions safety of Nexium, Prilosec. Report
Nexium formulation wins FDA approval. Report

FDA: Expect more early warnings

Mon, 03 Mar 2008 06:59:56 -0500

The FDA is warning consumers to expect more communiques about drug side effects. As we noted last week, the number of "early communications" has increased recently, reflecting a new policy of alerting the public to possible problems earlier than in the past. The idea is to air info early, but make clear that any safety problems haven't yet been proven.

FDA deputy commissioner Janet Woodcock said the agency is finding more side effects because last year's FDA reform and funding law gave it the authority and a bit of money to look at after-market drugs. Before that, the agency mainly focused on drugs in the approval pipeline.

If you look at The Wall Street Journal's story on the additional early warnings, though, it seems that the stepped up warning schedule is as much about image as anything. Agency chief Andrew von Eschenbach is quoted saying that data shows an "erosion of trust" among agency observers. "Perhaps because they need to better understand and appreciate what we are doing people's confidence has been eroded." And Woodcock echoed that sentiment: "Consumers will know we are on the case."

- read the story in the Wall Street Journal

Related Articles:
FDA issues more alerts--or does it? Report
Top 10 Drug Warnings and Recalls of 2007. Report
FDA badly needs more money, staff. Report
FDA can't guarantee drug safety. Report

SPOTLIGHT: MabThera aims for new indications

Fri, 25 Jan 2008 06:59:52 -0500

Roche's antibody med MabThera (Rituxan) just aced two trials aimed at expanding uses for the drug: one that pitted MabThera against rheumatoid arthritis and another that used it against adult leukemia. One analyst called the drug "a pipeline in a molecule." Report

ImClone goes long on Erbitux

Tue, 08 Jan 2008 06:59:54 -0500

Is all the Erbitux hype warranted? Some industry analysts say yes, others say they're skeptical. The right answer carries big stakes, because ImClone Systems has all its short-term eggs in that cancer drug's basket.

You'll recall that ImClone is aiming to expand the use of Erbitux beyond its current indications for colorectal cancer and head and neck cancers. The company completed a lung cancer study last year, but so far it's been coy about the results, saying only that they have "positive news." The data is scheduled for release at the June meeting of the American Society of Clinical Oncologists; analysts say the company's recent surge on the stock market has been stoked by anticipation of good news. At least one analyst predicts that Erbitux will hit $4 billion in sales eventually. But others say the company has raised questions by holding back details of that lung cancer study.

Now, Erbitux is ImClone's only product, and it's years away from launching any of its late-stage candidates. Some say that pipeline is strong. For confirmation of that, and for any solid info on the forthcoming data, we'll all have to wait.

- read the report from CNN Money

Related Articles:
Erbitux ok'd as front-line colon cancer drug. Report
Erbitux clears late-stage hurdle for lung cancer. Report
ImClone shares dive after Erbitux fails a Phase III. Report

The top 15 R&D budgets

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

In the world of drug development, you're only as good as your pipeline. As many companies' older blockbuster drugs go off-patent, analysts are looking at pipelines to see who'll have what it takes to survive and grow, and which companies will fall behind in the race to develop new drugs.

A recent EU report ranked the world's largest R&D budgets, and Pfizer took the lead--not just among drug developers but among all industries--with a staggering $8.34 billion budget in 2006. But as this report shows, spending more money doesn't necessarily make for a better pipeline. Take a look at this list of the top 15 pharmaceutical R&D budgets to find out how they're spending all those billions of dollars.

- see this special report for more

SPOTLIGHT: Pfizer snaps up Coley Pharma

Fri, 16 Nov 2007 06:59:52 -0500

Pfizer plans to buy Coley Pharmaceuticals in a $164 million tender offer, hoping to reap new products from Coley's pipeline of vaccine and immunotherapy candidates. Report