Archive for the ‘Roche’ Category

May
17

GSK lands one-two punch in melanoma trial

Posted under ASCO, Blog, BRAF inhibitor, Companies, dabrafenib, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Melanoma, personalized medicine, Pharmaceuticals, R&D, Roche, skin cancer, Startups, targeted therapies, trametinib, Universities, Videos, Zelboraf by rmcbride

GlaxoSmithKline ($GSK) is rushing to start a late-stage trial of an experimental cocktail therapy against deadly skin cancer after a mid-stage study produced impressive results. And data from the small trial provide early evidence that GSK's two-drug combo could have an edge over Roche's ($RHHBY) approved melanoma drug Zelboraf.

In the 77-patient study, those who took the combo of GSK's BRAF inhibitor dabrafenib and MEK-targeting agent trametinib lived for 7.4 months without their melanoma getting worse. Also, there were data to support that the combo could reduce a patient's risk of developing a separate cancer known as squamous-cell carcinoma while taking BRAF blockers, which are linked to growth of the tumors, Bloomberg reported.

Roche's Zelboraf is the first BRAF inhibitor approved for treating melanoma. GSK aims to stymie mutated forms of BRAF with dabrafenib, and pack the added punch of the MET-blocking trametinib to close an escape route that melanomas travel to skirt attacks from BRAF inhibitors. And despite the advance in care that Zelboraf has provided, about a third of patients on the drug develop cutaneous squamous-cell carcinoma and most patients' tumors eventually build up resistance to the targeted drug, Reuters reported.

"We know that cancers are smart," said ASCO president-elect Dr. Sandra Swain, as quoted by Reuters. "They find work-around pathways. We are seeing a very innovative approach that ostensibly blocks off some of this pathway."

The results of GSK's study were revealed Wednesday as part of an avalanche of cancer trial news tied to next month's ASCO meeting, where the London-based drug giant will present the study and feed a frenzy in the oncology world for targeted treatments that are tailored for cancer patients based on the specific molecular drivers of their tumors.

Not surprisingly, GSK's combo is already drawing comparisons to Zelboraf. And Bloomberg noted that, while the London-based giant's study showed that its two-drug combo provided longer profession-free survival than Roche's BRAF inhibitor in similar studies, Roche pointed out to the news service that such comparisons are premature.

- check out Bloomberg's article
- see Reuters' report

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May
16

Cancer drug experts brace for ASCO abstract dump tonight

Posted under ASCO, Blog, Bristol-Myers Squibb, Companies, dabrafenib, Diagnostics, Funding, GlaxoSmithKline, Johnson & Johnson, Medical Devices, Medical Supply, personalized medicine, Pfizer, Pharmaceuticals, Pipeline, Roche, Startups, trametinib, Universities, Videos, Xalkori, Zytiga by john

Tonight's the big night for cancer drug watchers. ASCO is releasing a mountain of data on cancer studies, and some of the biggest names in the business will be angling for star billing on some closely watched therapies.

Peter Loftus at Dow Jones lists Pfizer ($PFE), GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ) among the big names that will be featured tonight. But Bristol-Myers Squibb ($BMY) and Roche (T-DM1) plan to hold back on the headlines until the confab in Chicago gets under way.

For GSK, dabrafenib and trametinib are slated for top billing. Together, the two therapies could earn more than $700 million a year, Cowen reports. Pfizer, meanwhile, will be looking to make a case to expand the approval for Xalkori while J&J will make a case for Zytiga.

As Loftus notes in his report, one of the big themes this year will be the continued focus on personalized medicine, as investigators look for better results from cancer therapies targeted to specific patient populations.

- here's the story from Dow Jones

Special Report: Top 10 Late-Stage Cancer Drugs – 2012

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May
15

Buzz: Big Pharma suitors line up for a look at Amylin’s books

Posted under Amylin pharmaceuticals, AstraZeneca, Blog, Bristol-Myers Squibb, Carl Icahn, Companies, Diagnostics, Funding, M&A, Medical Devices, Medical Supply, Pharmaceuticals, Roche, Sanofi, Startups, Universities, Videos by john

One of the cardinal rules involved in deal-making focuses on the need to get as many buyers to the negotiating table as possible. The next big rule: Make sure everyone knows who's interested in bidding.

Amylin--while maintaining a strict no comment policy ever since initial reports appeared the Bristol-Myers Squibb ($BMY) had made an offer--has scored on both points with a Bloomberg report out this morning assessing the line of potential bidders queuing up to take a confidential look at the books. By the business news service's count, fed by an inside source, Pfizer ($PFE), AstraZeneca ($AZN) and Sanofi ($SNY) have all signed confidentiality agreements, joining Merck ($MRK), Takeda, Roche ($RHHBY) and Bristol-Myers Squibb at the auction block.

With a market cap of $4 billion, Amylin ($AMLN) can be bought for a reasonable enough sum, offering up product revenue and a background in diabetes development that would complement quite a few potential acquirers. Amylin spent $162 million last year on R&D. But its newly approved Bydureon could prove a much tougher sale than some would like to take on.

"Diabetes is an area companies either want a position in or want a stronger position in," Deutsche Bank analyst Mark Clark tells Bloomberg. "Amylin is not a massive financial stretch so it comes down to what companies' alternatives are, whether there are other synergies involved and who it makes the most sense to. Some companies are more desperate for revenue sources than others."

That last point on desperation indicates that AstraZeneca, at least, may be more willing than the others to pay a premium for Amylin. Sanofi, meanwhile, is reportedly undeterred that its experimental lixisenatide would compete with Amylin's drug roster. And that could leave Amylin--along with its advisers from Credit Suisse and Goldman Sachs--right where it wants to be: At the center of a bidding war. Even Carl Icahn would have to admire that strategy.

- here's the story from Bloomberg

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May
14

Cancer drug developers angling for center stage at ASCO

Posted under Ariad Pharmaceuticals, ArQule, Array BioPharma, ASCO, axitinib, Blog, breast cancer, cabozantinib, Cancer, Cancer Drugs, Companies, Diagnostics, Eli Lilly, Exelixis, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pipeline, renal cell carcinoma, Roche, Startups, Universities, Videos by john

Later this week the cancer drug research crowd will examine a tsunami of abstracts filed ahead of the ASCO meeting in early June in the hopes of finding a few new gems in the mountain of data being readied for the confab. ASCO is the place where anyone who's doing anything in cancer tries to make a splash in the spotlight. And with close to a thousand cancer drugs in the pipeline, that's no easy task.

Pfizer ($PFE) and Eli Lilly ($LLY) were both out bright and early this morning touting their work in the cancer arena. Pfizer's best hope at drawing attention lies in updating the data on axitinib, its recently approved treatment for renal cell carcinoma. And Lilly clearly hopes to impress analysts with ramucirumab, which is in 6 late-stage cancer studies.

Digging deeper, Executive Editor Ryan McBride's recent take on the top 10 cancer drugs in late-stage studies includes some of the closest watched therapies likely to elbow their way to center stage. Aveo ($AVEO) will be working hard to distinguish tivozanib--its kidney cancer drug with so-so head-to-head data with Nexavar--as it takes a monumentally important run at an approval later this year. Anything new on Roche's ($RHHBY) T-DM1 for breast cancer, which has racked up positive late-stage data on breast cancer on its way to an odds-on approval at the FDA, will be studied closely. Onyx ($ONXX) has the promising carfilzomib to tout, which is already at the FDA for review, while regorafenib (majority-owned by Bayer) is also in the media mix.

Today in Xconomy, the savvy biotech scribe Luke Timmerman assesses 8 drugs likely to make it into the center ring at ASCO. In addition to the drugs already mentioned, Timmerman includes abiraterone (Zytiga) from J&J ($JNJ) and Exelixis's ($EXEL) cabozantinib, a promising cancer drug that has earned Exelixis CEO Mike Morrissey both acclaim and exceptionally harsh criticism. The development program for cabo has been raked over the coals by a number of analysts. Medivation's enzalutamide (MDV3100), meanwhile, could wind up stealing the thunder for prostate cancer. And there's follow-up data from Ariad ($ARIA) on ponatinib.

Back in mid-March Adam Feuerstein at TheStreet got the first crack at an ASCO preview, listing prospects from Celldex, ArQule, Array BioPharma and Oncothyreon among the more frequently mentioned drug developers. But Celldex's ($CLDX) CDX-011 presentation was scrapped due to a clerical error. Now Celldex is planning a preemptive strike, with plans to hold a press conference of its own on May 23.

If you can't join them at ASCO, you can always try to beat them to the punch.

- here's the story from Xconomy
- read Adam Feuerstein's piece in TheStreet

Special Report: Top 10 Late-Stage Cancer Drugs - 2012

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Archive for the ‘Roche’ Category

GSK lands one-two punch in melanoma trial

Cancer drug experts brace for ASCO abstract dump tonight

Buzz: Big Pharma suitors line up for a look at Amylin’s books

Cancer drug developers angling for center stage at ASCO