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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Exelixis strikes $251M portfolio pact with Merck

Posted under Blog, Companies, Diagnostics, Exelixis, Funding, George Scangos, Medical Devices, Medical Supply, Merck, Pharmaceuticals, PI3-K, Startups, Universities, Videos, XL499 by John Carroll

Exelixis ($EXEL) is banking a $12 million upfront from Merck ($MRK) under a licensing deal covering its PI3K-delta research work. With the biotech focused squarely on its controversial late-stage development program for cabozantinib, Merck is gaining the full development and commercialization rights to a group of programs, including the preclinical XL499, in a deal that includes $239 million in development and regulatory milestones.

"PI3K-delta is an interesting target with potential utility in a number of therapeutic areas, including inflammation and oncology," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "Our PI3K-delta program builds on our prior interest in the PI3K family, which led to the advancement of pan-PI3K inhibitors into clinical development for cancer. Merck's global presence and significant resources make it the ideal organization to carry the PI3K-delta program forward. At the same time, this agreement provides Exelixis with resources for the continued development and potential commercialization of our lead compound, cabozantinib, which is in late-stage development for medullary thyroid and prostate cancers."

Exelixis could use the added financial support right now. Its shares plunged after the biotech announced that it would forge ahead into Phase III for "cabo" without a special protocol assessment from the FDA, a stamp of approval on trial design and endpoints that can significantly reduce the steep risks inherent in any study. Under Morrissey, who took the helm at Exelixis following George Scangos' departure to Biogen Idec ($BIIB), the company has been downsized and the pipeline slimmed as investigators concentrated on cabozantinib's fate.

- get the press release
- here's the story from Dow Jones

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