OBR Radar

FDA action date is Dec. 16 for the company's experimental drug for stem-cell transplantation in blood cancer patients, which has been granted priority review; if the drug is approved, Genzyme anticipates a U.S. launch during 1Q2009

FDA Oncologic Drugs Advisory Committee (ODAC) Meeting to discuss biologics license application (BLA) for Erbitux and BLA for Vectibix in the context of K-ras as a predictive and/or prognostic biomarker in oncology drug development

Pre-NDA meeting with the FDA scheduled for December 22; the company is seeking approval for co-administration of Davanat (a galactomannan) with 5-FU for intravenous injection for the treatment of advanced colorectal cancer

Novartis announced on Nov. 19 that the FDA had requested additional details on the advanced kidney cancer drug and the action date had been extended by three months, but that no additional studies were required; Afinitor was accepted for priority review in mid-2008 based on results of the RECORD-1 trials showing that it more than doubled the time without tumor growth in patients with advanced kidney cancer after failure of standard treatment; the company also said that clinical trials were continuing in other cancers, including an ongoing trial in pancreatic neuroendocrine tumors (pNET)

The company announces on Oct. 19 that the Phase 3 NSABP C-08 study of Avastin plus chemotherapy in adjuvant early-stage colon cancer will continue after independent experts back its safety record; investors are watching the study closely since it might open up a major new market for Avastin and the news may strengthen Genentech's clout in negotiating a higher bid from Roche, seeking to buy the company; the planned interim analysis was not expected until the end of November but Genentech says it had nothing to do with the announcement's earlier timing; interim safety data was presented earlier this year and showed side effects occurring more often in patients on Avastin than those on chemo alone; full results from the final-stage trial are expected in mid-2009

On July 21, Roche offers $89 per share in cash ($43.7 billion) for the 44% of Genentech it doesn't already own; Genentech responds to Roche's bid in August, saying that it "substantially undervalues the company" and leaving the door open to a better offer; Wall Street speculates that Roche timed its offer to get Genentech on-the-cheap before promising final data on Avastin in colon cancer is reported in 2009, adding millions to the drug's market value and forcing Roche to make a better offer; while Genentech trades at a hefty premium in the weeks after Roche's initial offer, it slides well below $89 in September and October as U.S. financial markets turmoil stoke uncertainty about Roche's ability to finance the deal; when Roche releases its 3rd quarter earnings on October 21, it says it is still committed to securing the deal, which is estimated to close in Q2 '09

Following an FDA meeting on Nov. 17, BDSI anticipates a resubmission containing the Risk Evaluation and Mitigation Strategy (REMS) for Onsolis, its lead product for "breakthrough" pain in opioid tolerant patients with cancer, to the FDA in December; the company received a Complete Response letter regarding the drug's NDA in August 2008 and anticipates final FDA approval of Onsolis in the first half of 2009

Genta receives a complete response letter from the FDA requesting an additional clinical study regarding the company's amended New Drug Application (NDA) for the use of Genasense(R) plus chemotherapy in patients with chronic lymphocytic leukemia (CLL); the FDA says they cannot approve the NDA in its present form

On Oct. 6, Eli Lilly (the previously unidentified large Pharma that beat-out Bristol Myers-Squibb's final offer of $62 a share for ImClone) announces that it will purchase the Ertibux-maker in an all-cash deal valued at $6.5B ($70 a share); Lilly successfully complete its previously announced tender offer for ImClone, which was set to expire on November 20, and the acquisition is finalized, through a short-term merger, on November 24

GSK's oral drug for short-term use in patients with chronic immune thrombocytopenic purpura (ITP) was granted accelerated approval by the FDA on Nov. 20 after several delays in the agency's announcing a decision to clear the drug; in May, ODAC unanimously recommended approving the drug; Glaxo discovered the drug in partnership with Ligand and views Promacta as a potential blockbuster; Amgen's Nplate, a weekly injection for the same blood disorder and a competing treatment, was approved earlier on August 22

AstraZeneca's stock fell 11% on Nov. 19 in part based on mixed results reported from three late-stage trials of Zactima as a 2nd line treatment in NSCLC; the drug met its primary goal of progression-free survival in combination with Sanofi-Aventis's chemotherapy treatment Taxotere, but not with Eli-Lilly's chemo treatment Alimta, and Zactima did not perform better than Genentech & OSI Pharmaceuticals' Tarceva as a monotherapy; full results from the trials, ZODIAC, ZEAL and ZEST, will be presented at an upcoming medical meeting; the company plans to file a regulatory submission in the first half of 2009

Pixantrone met its main trial goal in CTI's Phase III EXTEND (PIX301) pivotal trial in relapsed, aggressive non-Hodgkin's lymphoma, achieving a high rate of complete remissions in patients compared to the standard chemotherapy, and an independent Data Safety Monitoring Committee said that the study raised no serious safety concerns; the company plans to submit complete study data for presentation at a major scientific conference; pixantrone has received fast track designation for the indication and CTI expects to begin submission of a rolling NDA to the FDA in early 2009

The companies announce that the Phase III SATURN trial, a first-line study of Tarceva in non-small cell lung cancer (NSCLC), had met its primary endpoint and significantly extended the time patients with advanced NSCLC lived without their cancer getting worse, when given immediately after chemotherapy, compared to placebo; in October, results of the Phase III BeTa Lung trial, which combined Tarceva with Genentech's Avastin as a 2nd-line treatment for advanced NSCLC, failed to show an increase in overall survival--the companies said they would further analyze the study results and would submit data for presentation at a mid-November clinical meeting

Treanda gets a second approval in 2008 from the FDA on Oct. 31--this time for relapsed, indolent non-Hodgkins lymphoma (NHL); the drug was approved earlier in the year for CLL

Dendreon's stock soars 92% when interim survival data from Provenge's Phase 3 IMPACT clinical trial in advanced prostate cancer is released finding that the drug reduced the risk of death by 20% compared to placebo; an independent data monitoring committee found no safety concerns and recommended that the study continue to its final analysis; Dendreon says that the study would meet its main goal of overall survival if it shows a 22% reduction in the risk of death at the final analysis; final data is expected in mid-2009

Highly-anticipated data from the Phase 3 FREEDOM trial in post-menopausal osteoporosis shows that D-mab reduces the risk of new spine & hip fractures by 68% and 40%, respectively, compared to placebo; Amgen's stock has risen about 15% since late July when positive top-line results were first reported; the bone drug's ultimate commercial potential rests on how the drug's efficacy and safety compare to currently marketed osteoporosis treatments, including Merck's Fosamax and Novartis' Reclast, which it has not yet been tested against head-to-head; Amgen's stock rises 4% concurrent with the data's release; the company expects to file an NDA with the FDA near the end of 2008, with possible approval in late 2009

After missing an earlier action date of July 18 due to a lack of agency resources, the FDA approves Sancuso, touted by the company as the first and only patch for the prevention of chemotherapy-induced nausea and vomiting (CINV); U.S. product launch anticipated before end of 2008

The FDA issues a "refuse-to-file" letter in response to Introgen's BLA for its gene therapy drug for head & neck cancer, indicating an insufficient or incomplete application for approval, as the stock drops 34.4% to a mere 61 cents; Introgen doesn't publicly disclose the FDA's issues with the drug & says it will appeal the decision; European regulators still plan to review Advexin for approval

Vidaza receives expanded FDA approval reflecting new overall survival data in patients with higher-risk myelodysplastic syndromes (MDS); the expanded indication supplements a prior 2004 U.S. approval as the first therapy for patients with all 5 MDS subtypes

Positive top-line, interim results are reported from a Phase 3 study in CLL with the trial meeting its primary endpoint in both patient populations treated; full data will be presented at an upcoming academic meeting

Pivotal Phase 3 data in non-Hodgkins lymphoma (NHL) shows that Biovax increased median disease-free survival, the study's primary endpoint, by more than a year; Biovest intends to seek accelerated and/or conditional approvals immediately in the US and Europe

Velcade wins FDA approval as an initial treatment for multiple myeloma, widening its use beyond its previous approval for patients who failed other therapies