Genentech Upside Confirmed after FDA Avastin decision

As anticipated by Biobusinessblog.com on January 1 (Genentech: Biotech Stock of 2008) and February 10 ( will the FDA approve Avastin for Breast Cancer), the FDA has put Genentech and Roche’s Avastin on accelerated approval track pending the results of breast cancer study RIBBON 1 later this year confirming the favorable data of AVADO already shared with the agency. It is anticipated that the FDA will focus on Progression Free Survival with a positive trend for Overall Survival.

The Breast Cancer labelling has the potential to add $2-3 billion to the yearly sales of Avastin. Genentech (NYSE:DNA) closed at $71.60 on Friday, gaining $ 5.80 in after hour trading to $ 77.40. We expect that DNA will move rapidly over       $ 80 a share supported the Breast Cancer indication for Avastin and future upside with Avastin in Colon Cancer and Rituxan in Lupus and Multiple Sclerosis.

Cancer-Sensing MicroChip to help Real Time Treatment Decisions

 

Circulating tumor cells (CTCs) are cells from solid tumors that circulate in the bloodstream at a rate of approximately one in a billion.  As such, these cells are extremely hard to acquire and require large quantities of blood.  A new microchip technology, relying on a novel geometric shape at the nano-scale, is able to detect, capture and analyze CTCs with a 99% rate and using less than one-thousandth the volume of blood.  This test is invaluable for providing real-time information for treatment decisions, assessing treatment response, identifying risk factors and early detection of cancers.  As of yet this chip has successfully isolated CTCs from lung, colorectal, pancreatic, breast, prostate and esophageal cancers. Find more in Mass General’s press release.

Posted by Milly Ray, PhD candidate, Harvard Medical School

Will Genentech’s Avastin be approved on February 23, 2008 by the FDA for Metastatic Breast Cancer ?

While the FDA Advisory Committee voted 5-4 last December, against approval of Avastin in Metastatic Breast Cancer, one of the committee members may have changed his vote, leading to a 5-4 in favor of approval, according to a recent Conference Call of Roche. Roche is the parent company of Genentech (NASDAQ:DNA) and the marketer of Avastin in Europe. The European Regulatory Agency, EMEA, has expressed a favorable opinion. The FDA Approval decision is expected on February 23. If there is any doubt, the AVADO study, to be released by mid-2008, should demonstrate progression-free survival and convince the skeptics. Breast Cancer labeling is worth $ 1 billion in Avastin sales.

Genentech’s stock is trading at below $ 70 a share, assuming the worst scenario. The good news on February 23 as weel as other developments such as  adjuvant treatment of Colon Cancer with Avastin and Lupus and Multiple Sclerosis with Rituxan, should support a ride upwards for DNA.

JP Morgan Update:Can Celgene become a “Niche Buster” Factory?

Sol Barer, PhD, CEO of Celgene (NASDAQ:CELG) announced at the JP Morgan Conference in San Francisco, exciting developments in in label expanding clinical trials for Revlimid including in the treatment of newly diagnosed multiple myeloma patients. Along with oral TNFalpha inhibitor for the treatment of psoriasis in the research pipeline, Celgene is demonstrating its ability to create and develop more drugs in the immunology/oncoloy sector. Dr Barer announced the goal for Celgene to become a major pharmaceutical company. Hopefully, Celgene will remain nimble, delivering multiple ”niche busters’ , just like Genentech has done, rather than grow into a Big Pharma with a mediocre R&D productivity.

In the mean time, Celgene is trading at around $ 50 a share, 33% below its peak level in 2007. 2008 will a transition year with the digestion of the $ 2.9 billion Pharmion acquisition and continued pressure to grow Revlimid sales over 30 % in face of competition from Millenium’s Velcade.

Amgen and J&J under Pressure on New Risks Associated with Aranesp and Procrit

The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn’t receive the anemia drug.

“This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

“FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients.”

Amgen (NASDAQ:AMGN) and Johnson & Johnson (NYSE:JNJ) continue to experience a rapid sales slide for their blockbuster anemia drugs, as the FDA and payors are attempting to promote more cautious use of ESAs.

Clinical Cancer Advances 2007

The American Society of Clinical Oncology (ASCO) conducted its annual independant review and published it in the December 17 issue of the Journal of Clinical Oncology.

The following are listed as major advances:

• Magnetic resonance imaging for breast cancer screening.
• The role of human papilloma virus in head and neck cancers.
• Decreasing use of hormone replacement therapy linked to declines in breast cancer cases.
• Preventive radiation therapy improves survival and decreases brain metastases in patients with advanced small-cell lung cancer.
• Sorafenib (Nexavar, Onyx/Bayer) improves survival in liver cancer.
• Bevacizumab (Avastin, Genentech/Roche) improves treatment of advanced kidney cancer. The report notes that in recent years, 3 new agents have been approved for kidney cancer — sorafenib, sunitinib (Sutent, Pfizer), and temsirolimus (Torisel, Wyeth) — and future trials will need to compare bevacizumab with these agents and explore combinations.

The following are considered to be “notable” advances:

• Arsenic trioxide (Trisenox, Cell Therapeutics Inc) improves leukemia survival.
• Dasatinib (Sprycel, Bristol-Myers Squibb) active as first-line treatment for chronic myelogenous leukemia.
• Lenalidomide (Revlimid, Celgene Corp) and bortezomib (Velcade, Ortho-Biotech) more effective together for myeloma.
• Hypofractionated radiation (fewer but larger doses) appears to be as effective as standard-dose radiation in early-stage breast cancer.
• Bevacizumab with irinotecan (Camptosar, Pfizer) effective against gliomas.
• Radiotherapy improves survival of elderly patients with glioblastomas.
• Cetuximab (Erbitux, ImClone Systems) improves outcomes in colon cancer when added onto the FOLFIRI regimen (fluorouracil, irinotecan, and leucovorin).
• High-fat diets linked to recurrence of colon cancer.
• External-beam radiation does not improve outcomes in endometrial cancer.
• Cetuximab with chemotherapy as first-line treatment prolongs survival in head and neck cancers.
• Investigational drug axitinib (under development by Pfizer) shows activity against advanced thyroid cancer.
• Less intense treatment for children with neuroblastoma achieves high survival rates.
• Small investments can improve childhood cancer treatment in low- and middle-income countries.
• Imatinib (Gleevec, Novartis) increases recurrence-free survival in patients with gastrointestinal stromal tumors.
• Aspirin use promising for prevention of colorectal cancer.
• Long-term health problems in survivors of childhood cancers.
• Survivors of childhood leukemia and brain tumors have elevated stroke risk.
• Most survivors of childhood cancer do not get recommended follow-up care.