Onyx pharmaceuticals is a biopharm company which makes products that deal with the molecular mechanisms which cause cancer.  They are most well known for the  kidney and liver cancer drug Nexavar.  The company acquired carfilzomib last year when it bought Proteolix Inc.

-Michael B. Sauter

Abraxis BioScience, Inc., a biotechnology company, engages in the discovery, development, and delivery of next-generation therapeutics and core technologies that offer treatments for cancer and other critical illnesses.

-Michael B. Sauter

Novelos Therapeutics, Inc. (OTC-BB: NVLT) is a biotechnology firm which has suffered a form of its own private Idaho before.  News out of the company this morning has rekindled at least some interest in a name that we had all but written off for dead.

Novelos saw shares imploded earlier this year after its promising lung cancer drug development program for NOV-002 failed in a late stage trial against lung cancer.  In fact, this was a $2.00 stock at the start of this year and had drifted down to $1.65 before the news implosion came out.  Shares then fell to about $0.30 overnight and then eventually slid to the recent levels around $0.10.

This morning the company announced positive phase 2 results for NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with certain types of breast cancer (stage IIB-IIIC HER-2/neu negative invasive breast cancer).  Same drug candidate, different indication.

The company said that its criterion of 12 pathologic complete responses has been met prior to all patients completing the trial. Results from this study now has 39 breast cancer patients who have been enrolled from three different hospitals, and the company noted that it has its 12 confirmed pathologic complete responses out of 31 patients who have undergone surgery.  This is higher than what had been previously been reported with preoperative chemotherapy. ”

The goal is to show that the addition of NOV-002 doubles the complete response rate for breast cancer patients taking three other chemo drugs.  The number of successful PCRs may also rise as some of these 39 patients already in the study are still being treated and will need to be evaluated for scores.

This was a single-arm study, so it did not have a side-group of patients that were receiving placebo. That may make any ultimate FDA action down the road more challenging, but that is also something that may be months or years down the road.  The company said it does plan to seek FDA guidance on designing a larger placebo-controlled study.

Today’s news is merely a rekindled “proof of concept” rather than an outright win or anything that would signal an assured FDA approval.  Still, this brings NOV-002 back from what investors and the public had written off as a dead issue.

Shares are up over 10%, on a rounded basis and the stock is still only listed as being at $0.13 on the OTC-BB.  The 52-week range was $0.09 to $3.05, meaning the expectations here were slim or none.  The market cap is a mare $11.5 million after the pop.

While it had $5.612 million in cash and equivalents on its books at the end of last quarter, the company also listed $5.866 million as its accounts payable and listed another $392,000 in its deferred long term liability charges on the books.

Novelos is probably far from coming back to life with a vengeance, but it may have just gotten one foot out of the grave.

JON C. OGG

Abraxis BioScience, Inc. is a biotechnology company that deals in the development and sales of treatments for cancer and other illnessesses.  The company’s main product is Abraxane, a form of chemotherapy used in the treatment of breast cancer.

EpiCept Corporation, a specialty pharmaceutical company, focuses on the development and commercialization of pharmaceutical products for the treatment of cancer and pain in the United States and Germany.

Molecular Insight Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, engages in the discovery, development, and commercialization of targeted therapeutic and imaging radiopharmaceuticals for use in oncology.

Jevtana is a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer.  The release from the FDA noted that Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

The approval came after a priority drug review and before the September 30, 2010 deadline.

Jevtana’s safety and effectiveness was established in a 755-patient study and all had previously received docetaxel. The study was designed to measure overall survival in men who received Jevtana in combination with prednisone compared with those who received the chemotherapy drug, mitoxantrone, in combination with prednisone. The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen.  You can see the updated Dendreon survival data on PROVENGE here.

PROVENGE from Dendreon is designed to stimulate a patient’s immune system, using a patient’s immune cells to a protein that functions as a prostate cancer-associated antigen, to target prostate cancer cells.

The thing to consider here is rather simple for now.  Dendreon’s PROVENGE is not as simple (none really are) but the demand is far greater for PROVENGE today than what can be delivered.  The centers who participated in the Dendreon studies are getting first call for this, and based upon two separate discussions with personal contacts with family members who have prostate cancer it is being issued effectively on a lottery basis right now.  Dendreon is in the process of manufacturing more facilities and it has secured more supplies to assist it in making more and more PROVENGE treatments.

Dendreon closed at $40.59 earlier this week and the shares were at $39.57 the day before this Jevtana was approved.  Dendreon closed at $38.46 yesterday and shares are down less than 0.2% today at $38.40.  Is this competition in the classical sense of competition?  Yes, of course?  Will it likely have any impact at all on any demand for PROVENGE over the ramp-up time of the next 18 to 24 months?  Absolutely not.  Even if some decide to go for Javtana right now and pull their name from the PROVENGE waiting list, there are many many patients who will step in to fill their slot.

JON C. OGG

Curis, Inc. is a drug discovery and development company which focuses primarily on cancer treatments.

Denosumab is a subcutaneous RANK Ligand inhibitor and the aim here is to slow or stop he spread of tumors into the skeleton.   Bone metastasesis a serious concern for many patients with advanced cancer.

If cancer reaches into the bone structure, the growing cancer cells weaken and destroy the bone around the tumor.  After that occurs, patients can end up with easy fractures, spinal cord compression, and/or the need to receive radiation or surgery to bone.

The RANK/RANKL pathway is believed to play a central role in cancer-induced bone destruction, regardless of cancer type. Denosumab is the first therapy to target this important pathway.

Amgen said that it intends to submit marketing applications in the European Union, Switzerland, Canada and Australia, and also in Japan, all in a short period of time, with its licensing partner, Daiichi-Sankyo, under a collaboration and license agreement for the development and commercialization of denosumab in Japan.

This BLA represents the second marketing application for denosumab that has been submitted to FDA; denosumab is currently being reviewed under the trade name Prolia™ for conditions related to bone loss. For that application, the FDA has set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.

Roger M. Perlmutter, M.D., Ph.D., EVP ofR&D said, “We believe that denosumab will offer substantial benefit to cancer patients suffering from bony metastases.  Denosumab, administered monthly as a 120 mg dose subcutaneously, demonstrated consistently similar or greater efficacy in clinical trials when compared to zolendronic acid, offering the potential to improve on the current standard of care. One potential advantage of denosumab is that dose adjustments resulting from declining renal function are not necessary.”

Amgen shares closed down 2.25% at $54.63 (unofficial closing bell price) on only about 4.8 million shares.

JON C. OGG