Nexavar

NICE to green-light costly kidney meds

Tracy Staton — Mon, 01 Dec 2008 11:20:07 -0500

A much-lamented ban on new kidney cancer drugs in the U.K. will soon be lifted, the Guardian reports. Of four meds that the National Institute for Health and Clinical Excellence called too expensive for National Health Service use, at least half will be approved--and perhaps all four, the paper writes.

As you know, NICE recently ruled that Pfizer's Sutent, Bayer's Nexavar, Wyeth's Torisel, and Roche's Avastin didn't ace the cost-benefit analysis all NHS drugs are expected to pass. According to NICE's calculations, the drugs were too costly for the additional survival time kidney cancer patients tended to experience when using them. Patient advocates immediately pounced, and a public outcry ensued.

Now, however, sources are telling the Guardian that NICE will OK Sutent next month, when a committee meets to discuss the drugs again. Either Avastin or Nexavar is likely to get the nod, too, the sources said.

This turnabout by NICE follows some pricing negotiations between the agency and drugmakers. The companies have offered some new pricing schemes for the meds, including discounts and risk-sharing.

- read the Guardian story
- see the post at Pharmalot

Bayer: Nexavar study shows survival boost

Tracy Staton — Fri, 31 Oct 2008 11:25:14 -0400

Bayer and Onyx Pharmaceuticals are anticipating the release of two new studies of their liver cancer treatment Nexavar; the studies include evidence of extended survival in more than 40 percent of patients and identification of biomarkers that might predict success with Nexavar therapy. Release

NICE rejects four cancer meds

Tracy Staton — Thu, 07 Aug 2008 10:16:02 -0400

The debate over costly oncology meds rages on in the U.K. as the National Institute for Health and Clinical Excellence rejected four high-tech drugs for advanced kidney cancer treatment: Sutent (Pfizer), Avastin (Roche), Nexavar (Bayer) and Torisel (Wyeth). NICE acknowledged that the drugs do extend life--by up to six months--but concluded that the money would be better spent on other patients.

The decision drew immediate fire, not only from patient advocates, but from cancer researchers and doctors, too. One doctor said there was no point in accepting referrals for advanced kidney cancer patients without those drugs, because most don't respond to the only other alternative, interferon.

The outcry might actually have some effect: NICE initially rejected Herceptin outright for breast cancer treatment, then relented after receiving an outpouring of complaint. The agency's final kidney cancer treatment guidance will come through in January.

- read the story in the Times
- check out the Telegraph's coverage

Alimta, Nexavar look for ASCO boost

Fri, 16 May 2008 06:59:58 -0400

As always, the American Society of Clinical Oncology's annual meeting is spawning tons of drug news. Only this year, the news is coming ahead of the conference itself, because ASCO released all the studies on the program in one fell swoop last night. Wall Street analysts were planning all-night cram sessions to tease the news out of those reams of data. Here are three big items about already-approved drugs:

Eli Lilly's Alimta delayed lung cancer growth when used soon after a first round of chemotherapy. The study could support broader use of Alimta, the Wall Street Journal reports. Currently, patients do a round of chemo, then stop drug therapy until the cancer grows again, then start a second-line drug like Alimta. The new data suggests Alimta could be used right after that first round to keep tumors at bay.
Bayer and Onyx Pharmaceuticals' Nexavar boosted overall survival by 47.3 percent in patients with advanced liver cancer compared with placebo. The study comprised 226 Asian patients who'd never received systemic therapy for their cancer. Overall survival was 6.5 months on Nexavar compared with 4.2 months on placebo.
Combination therapy with Herceptin and Tykerb delayed the worsening of advanced breast cancer in women who'd stopped responding to other treatments. Patients using the combo survived 12 weeks without their cancer advancing, compared with eight weeks on Tykerb alone. Herceptin is marketed by Genentech and Roche, Tykerb by GlaxoSmithKline.

- see the WSJ's Alimta piece
- check out the Nexavar release
- read the Associated Press combo story

Alimta, Nexavar look for ASCO boost

Fri, 16 May 2008 06:59:58 -0400

Eli Lilly's Alimta delayed lung cancer growth when used soon after a first round of chemotherapy. The study could support broader use of Alimta, the Wall Street Journal reports. Currently, patients do a round of chemo, then stop drug therapy until the cancer grows again, then start a second-line drug like Alimta. The new data suggests Alimta could be used right after that first round to keep tumors at bay.
Bayer and Onyx Pharmaceuticals' Nexavar boosted overall survival by 47.3 percent in patients with advanced liver cancer compared with placebo. The study comprised 226 Asian patients who'd never received systemic therapy for their cancer. Overall survival was 6.5 months on Nexavar compared with 4.2 months on placebo.
Combination therapy with Herceptin and Tykerb delayed the worsening of advanced breast cancer in women who'd stopped responding to other treatments. Patients using the combo survived 12 weeks without their cancer advancing, compared with eight weeks on Tykerb alone. Herceptin is marketed by Genentech and Roche, Tykerb by GlaxoSmithKline.

- see the WSJ's Alimta piece
- check out the Nexavar release
- read the Associated Press combo story

ALSO NOTED: China accuses U.S. of obstructing heparin probe; GSK exec charges Mass. with demonizing pharma;

Wed, 07 May 2008 06:59:50 -0400

> China continues to point fingers at the U.S. over the heparin investigation, saying the FDA refused to hand over details about patients who experienced severe allergic reactions to the blood thinner. Report | Report

> GlaxoSmithKline's top U.S. exec, Christopher Viehbacher, harshly criticized Massachusetts' plans to bar drugmakers' gifts to doctors in letters sent to state Senate President Therese Murray, House Speaker Sal DiMasi, and Gov. Deval Patrick. Report

> Discount retailer Target is matching Wal-Mart's recent expansion of its cheap generics program. Report

> Par Pharmaceutical bought Spectrum's interest in the generic versions of GlaxoSmithKline's migraine drug Imitrex, boosting its share of profits to 95 percent from 38 percent once the products are launched late this year or early next. Release

> Lundbeck posted a 40 percent increase in first-quarter profits on a 12 percent growth in revenues, beating market estimates. Report

> OSI Pharmaceuticals saw its first-quarter earnings jump to $29.2 million, or 49 cents per share, from 12 cents per share last year on higher sales of its cancer med Tarceva. Report

> Onyx Pharmaceuticals reported a street-beating first-quarter profit of $15.4 million on fast-growing sales of its cancer med Nexavar. Report

> MAP Pharmaceuticals announced that it secured a $20 million loan for working capital from Oxford Finance and Silicon valley Bank. Release

> Pharma wholesaler McKesson has agreed to pay $13 million in fines for failing to report large and frequent Internet sales of controlled substances. Report

> Shares of France's NicOx tumbled 38 percent after Pfizer announced that it would not advance their experimental therapy for glaucoma into Phase III. NicOx report

> One analyst is predicting a long delay for Merck's Cordaptive. Report

> Two doctors engaged in RNA research became the first women to win the prestigious Albany Medical Center Prize, one of the richest awards available for biomedical research. Report

> Researchers for Purdue Pharma laid out their data for a new, tamper-resistant form of the blockbuster OxyContin to an expert FDA panel, and promptly had their heads handed back to them. Report

And Finally... UK cell biologist Robert Edwards says he can see a time in the not-too-distant future when humans will be able to grow new body parts through the use of stem cell technology. 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