lung cancer

BMS swallows Canada's Erbitux price

Tue, 29 Apr 2008 06:59:54 -0400

Call it a new pricing strategy. Bristol-Myers Squibb is preparing to launch the cancer treatment Erbitux in Canada after a two-year wrangle over cost. Approved by Health Canada in September 2005, Erbitux never went on sale because Bristol-Myers and the Patented Medicines Prices Review Board couldn't agree. Now, the drugmaker has acceded to the price the board set. "We think [the price] did not recognize the value of innovation that Erbitux represents," BMS's Marc Osborne said, "but with the overall survival data, we decided it's time to market this drug."

Next, the government has to check out the drug's manufacturing process, and once that's approved, the provinces will decide whether to cover Erbitux. Ontario looks like a safe bet: It currently sends patients to the U.S. for treatment.

- read the story from CBC

SPOTLIGHT: NICE rejects Roche drug as too costly

Fri, 25 Apr 2008 06:59:52 -0400

Roche's lung cancer med Tarceva got the goodbye gong from the U.K.'s National Institute for Clinical Excellence, which ruled that the drug wasn't a cost-effective option for treating non-small cell lung cancer. Roche said it would appeal as patient advocacy groups assailed NICE's decision. Report

Stanley: Erbitux outperformed Avastin

Mon, 21 Apr 2008 06:59:57 -0400

Morgan Stanley got a juicy scoop on the Avastin versus Erbitux boxing match: Genentech's Avastin faces news that as-yet-unpublished data shows Erbitux delivering an "unexpected survival benefit" against metastatic lung cancer. Perhaps not coincidentally, the news comes as Genentech announced that a new trial showed Avastin improving progression-free survival in non-small cell lung cancer but didn't prolong life.

According to CNBC, this scores the match at two Phase III survival benefits for Erbitux, compared with only one for Avastin. Erbitux, as you know, is sold in Europe by Merck KGaA and in the U.S. by Bristol-Myers Squibb; Avastin is marketed by Roche and Genentech.

Morgan Stanley says it won't change its official sales estimates for either drug until it sees this mystery data (which, incidentally, the companies declined to confirm). But the brokerage did make a breathless estimate of €400 million in additional revenue if the rumor proved true.

- see the CNBC story
- get more from Pharmalot

Related Articles:
Erbitux clears late-stage hurdle for lung cancer. Report
FDA approves Avastin for lung cancer. Report

Roche, Cipla trade jabs on Tarceva

Mon, 21 Apr 2008 06:59:55 -0400

We turn to India for updates on another cancer-drug battle, this one between Roche's brand-name Tarceva and Cipla's copycat version, Erlocip. A Roche distributor tattled to India's Drug Controller General, accusing Cipla of promoting its version for an unapproved use. Taksal Pharma alleged that Cipla is touting Erlocip for head and neck cancer and colorectal cancer, as well as for the approved uses in non small-cell lung cancer and pancreatic cancer. One source close to the situation said, "They are selling it for uses that even the innovator hasn't discovered."

This is just the latest skirmish between Roche and Cipla. The two companies have been wrangling over Tarceva's patent for some time now: Cipla launched a generic even though Roche had a patent on the med, so Roche sued to keep Cipla's drug off the market. Then Cipla countersued, alleging that Tarceva didn't deserve a patent anyway because it's a tweaked version of an older med. Delhi high court denied Roche's injunction, saying that it's in patients' best interest to have Cipla's cheaper version available. Roche appealed. And the beat goes on: hearings are continuing in the patent revocation case. Stay tuned.

- see the item at Pharmalot
- check out LiveMint's coverage

Related Articles:
European committee gives negative ruling on Tarceva. Tarceva report
FDA panel endorses Tarceva for pancreatic cancer. FDA report
The specter of generic competition grows. Report

What Exubera says about safety

Thu, 10 Apr 2008 06:59:54 -0400

When Pfizer announced yesterday that the inhaled insulin product it spiked last fall may have triggered lung cancer in a few patients, pundits immediately pronounced the death of all insulin inhalers, may they rest in peace. Pfizer's partner on Exubera, Nektar Therapeutics, has been looking for another parter to relaunch the product--but not anymore. The damage may even spill over onto inhaled forms of other meds.

All most likely true. But the Exubera fallout may be instructive for all drugs, actually. It shows the impossibility of guaranteeing perfect safety for prescription meds. As In the Pipeline points out today, Exubera was tested for years and years, and insulin itself has been on the market for decades. The FDA's stamp of approval couldn't guarantee that this drug--or any drug--wouldn't cause injury or death at some doses or in some people.

- see the item at In the Pipeline

Related Articles:
Inhaled insulin lung cancer warning riles investors
Pfizer gives Nektar $135M for Exubera settlement
Pfizer kills off Exubera, hunts for deals
Exubera becoming a big disappointment for Pfizer
UK: Exubera not worth the price.
MannKind bets the farm on inhaled insulin

Court sends Mircera case to ITC

Thu, 20 Mar 2008 07:59:55 -0400

Another chapter in what's becoming a long Mircera saga: A federal appeals court ruled that Roche could import the anemia drug so long as it wasn't for sale--but sent the case back to the International Trade Commission for its opinion. Previously, the ITC had said that it couldn't rule on whether importing the med in itself would infringe on Amgen's patents. The appeals court says it can.

Meanwhile, a federal judge is still weighing his opinion in the case. Last month, he told Roche he might let Mircera onto the market in spite of the patent infringement if Roche would meet five conditions. Roche said yes. Amgen said, Not fair. How the judge will respond now is anyone's guess.

- read the update in the Wall Street Journal

ALSO: The shoe's on the other foot for Roche in India. The Delhi High Court ruled that domestic drug maker Cipla could market its copycat version of Roche's lung cancer med Tarceva, pending another hearing in August. The court also accepted a patent challenge to Tarceva from Cipla; Roche has four weeks to respond. Report

Related Articles:
Amgen: Mircera deal would set precedent. Report
Roche accepts judge's deal on Mircera. Report
Mircera gets FDA nod, but blocked by patent case. Report
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

High-priced meds spur dosing debate

Mon, 17 Mar 2008 07:59:54 -0400

What's a drug worth? In the case of Cerezyme, a remedy for a rare inherited enzyme deficiency known as Gaucher disease, the answer is $300,000 a year. But experts are questioning whether lower doses of the med would work as well--besides saving some $200,000 per year per patient.

Pharma companies have faced complaints about prices for years, including accusations that they inflate the required doses to boost sales. When those drugs are super-expensive, like Cerezyme, the debate becomes highly fraught. When a study showed that a half-dose of Genentech's Avastin--which runs $100,000 a year--might be as effective in lung cancer as a full one, some doctors switched. Genentech maintains that doses were set for maximum cancer-fighting.

- read the New York Times article

Related Articles:
Drug makers jack prices up 7.8%. Report
Expensive Herceptin draws fire in UK. Report
Doctors fret about long-term impact of expensive drugs. Report

Bayer loses Yasmin patent fight

Tue, 04 Mar 2008 06:59:57 -0500

Bayer had the Yasmin rug pulled out from under it yesterday. A U.S. court voided the contraceptive's key patent, leading the German conglomerate to revise its 2008 profit expectations downward. Until now, Yasmin and related meds were Bayer's top sellers, just ahead of its MS treatment Betaseron.

The ruling opens the door for Barr Pharmaceuticals to sell a Yasmin copycat in the U.S. The product sold $487 million worth here last year; including other, sister meds such as the lower-dose version Yaz, the franchise is worth about €1 billion, or $1.5 billion. Bayer is mulling an appeal; regardless of the ruling, it holds exclusivity on the drug till 2009.

It's just the latest in a series of blows for Bayer, which last month saw its drug Nexavar fail a lung cancer trial. Last fall, the company suspended sales of its anti-bleeding med Trasylol because of side effects.

- see Barr's release
- read the report from Forbes
- check out the BusinessWeek coverage

Related Articles:
Yasmin sales spur earnings at Bayer. Report
Bayer lower 2008 expectations. Report

Bayer lower 2008 expectations

Fri, 29 Feb 2008 06:59:54 -0500

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.

Kidney cancer drug Nexavar failed to boost survival rates in lung cancer patients; the hoped-for indication would have given the drug its "biggest commercial potential," according to analysts, who called the trial results a serious setback. Novartis and Novo Nordisk sued for patent infringement over the hemophilia drug Kogenate.

Two studies in the New England Journal of Medicine showed that patients given Bayer's anti-bleeding med Trasylol (aprotinin) were more likely to die. Legal experts expect a surge of lawsuits.

What to do? Watch and wait, perhaps. The company has an anti-clotting med on its way that could make a big difference to its fortunes. But as BusinessWeek notes, Bayer is one of the last pharma conglomerates and may lack the pharma focus to compete with the likes of Novartis and Pfizer. And it shows no sign of wanting to change that.

- see Bayer's earnings release
- read the story in Business Week
- see the item at Pharmalot

Related Articles:
Nexavar failure raises questions for developers. Report
Bayer pulls Trasylol at FDA request. Report

ALSO NOTED: MedImmune acquisition could pay dividends; Sun challenges J&J patent;

Thu, 28 Feb 2008 06:59:50 -0500

> Analysts say AstraZeneca's buyout of MedImmune could pay extra dividends as health officials expand their recommendations for an flu jab to all children between the ages of six months and 18. Report

> Sun Pharmaceuticals is challenging Johnson & Johnson's patent on the schizophrenia med Risperdal in the Mumbai, India, patent office. Report

> Pfizer has launched its stop-smoking med in India under the name Champix. Report

> AstraZeneca says it will push ahead with late-stage studies of Recentin for colorectal cancer after shelving plans for a Phase III in non-small cell lung cancer due to toxicity concerns. Report

> The nation's top biotech analysts have looked over the field of presidential candidates and announced a big winner: stem cell companies. Report

> GSK's secret vaccine adjuvant is drawing attention. Report

> Maryland lawmakers are considering a bill that could pump between $5 million and $10 million next year into a program to support the development of nano-biotech companies. Report

> The CDC has greatly expanded the population of people it's recommending for an annual flu shot, saying everyone aged six months to 18 should get the an annual jab. Report

And Finally… An MIT student found a way to make antibiotics more effective, winning a $30,000 prize for his efforts. Report