GlaxoSmithKline (GSK) and Denmark-based Genmab received some good news with the US Food and Drug Administration’s (FDA) approval for Arzerra (ofatumumab), a monoclonal antibody for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.  Arzerra is approved for cancer patients who are no longer responding to the current available treatment options using fludarabine and alemtuzumab. Following the approval, Genmab has become eligible to receive a milestone payment of DKK 116 million (approximately $23 million) from Glaxo.  Earlier, in May 2009, Arzerra had received a positive recommendation from the FDA's Oncologic Drugs Advisory Committee (ODAC) in which the panel had voted 10-3 in favor of the drug. They had found that Arzerra provided some clinical benefit to patients with CLL whose disease was refractory to fludarabine and alemtuzumab.  Arzerra has been approved by the FDA under the accelerated approval process ...

Last week, Keryx Biopharmaceuticals, Inc. (KERX) announced that its renal cancer drug KRX-0401 (perifosine) met both primary and secondary endpoints in a mid-stage trial. KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) in the US, Canada and Mexico. The data was presented at the eighth International Kidney Cancer Symposium in Chicago. The candidate demonstrated efficacy, safety and tolerability in metastatic renal cell carcinoma (RCC) patients whose disease progressed after failing treatment with both a VEGF (vascular endothelial growth factor) receptor inhibitor and an mTOR (mammalian target of rapamycin) inhibitor. Even though the drug was well-tolerated, the most common adverse events were gastrointestinal discomfort and fatigue. RCC is the most common of all kidney tumors, accounting for 85% of the cases. The advanced form of the disease is resistant to standard therapies such as radiation and chemotherapy. The initial treatment in most cases ...

Last week, Keryx Biopharmaceuticals, Inc. (KERX) announced that its renal cancer drug KRX-0401 (perifosine) met both primary and secondary endpoints in a mid-stage trial. KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) in the US, Canada and Mexico. The data was presented at the eighth International Kidney Cancer Symposium in Chicago. The candidate demonstrated efficacy, safety and tolerability in metastatic renal cell carcinoma (RCC) patients whose disease progressed after failing treatment with both a VEGF (vascular endothelial growth factor) receptor inhibitor and an mTOR (mammalian target of rapamycin) inhibitor. Even though the drug was well-tolerated, the most common adverse events were gastrointestinal discomfort and fatigue. RCC is the most common of all kidney tumors, accounting for 85% of the cases. The advanced form of the disease is resistant to standard therapies such as radiation and chemotherapy. The initial treatment in most cases ...

Cephalon, Inc. (CEPH) recently received priority review from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Nuvigil. The company had filed the sNDA in June 2009, seeking to expand Nuvigil’s label as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. Priority review status means that a response from the agency will be out in six months instead of the usual 10-12 month review period. As such, a response from the FDA should be out by December 29, 2009. Nuvigil is Cephalon’s follow-on sleep franchise product which received FDA approval in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). Cephalon launched Nuvigil in June 2009 and is promoting the product aggressively. The company has ...

Yesterday, the U.S. Food and Drug Administration (FDA) approved a more flexible design of Hologic Inc.’s (HOLX) MammoSite system, which provides radiation seeds to prevent recurrences of breast cancer. The company intends to launch the radiation therapy system, designed to treat early-stage breast cancer, in the first quarter of fiscal 2010. The MammoSite ML (multi-lumen) radiation therapy system allows physicians to target radiation to areas which are most likely to be affected by cancer and shift the dose away from areas that do not need it. MammoSite devices include balloon catheters that are inserted into the body after the removal of a tumor. A pellet of radioactive material is inside the catheter. The radiation treatment is completed in just five days. The therapy aims to prevent recurrence without affecting healthy tissues. Side effects like skin discoloration, fatigue, etc. are minimized by this therapy. Additionally, the ...

Bristol Myers Squibb Co. (BMY) yesterday announced the approval of a broader label for its rheumatoid arthritis drug Orencia by the U.S. Food and Drug Administration (FDA).   The agency approved an addition to the label that supports the use of Orencia (abatacept) in patients suffering from moderate to severe rheumatoid arthritis, duration of which is less than or equal to two years. The drug that recorded global sales of $129 million in 2008 is designed to reduce symptoms of rheumatoid arthritis. However, it should not be administered along with tumor necrosis factor (TNF) antagonists and is not recommended for use in tandem with other biologic rheumatoid arthritis therapies.   As a reminder, the drug was initially approved by the FDA in late 2005 and made commercially available in the U.S. in February 2006. At that time its label indicated the usage of the drug for patients with ...

Headquartered in Woonsocket, Rhode Island, MultiCell Technologies, Inc. is an integrated biopharmaceutical company. Trading on the OTCBB, their commitment is to the development of breakthrough therapeutics based on a portfolio of therapeutic candidates and patented drug development technologies. The company plans to pursue strategic alliances to better penetrate the various markets for their therapeutics.

The company’s drug development program focuses on the modulation of the immune system. Their lead drug candidates include drugs to treat multiple sclerosis (MS)-related chronic fatigue, relapsing-remitting MS, type-1 diabetes, and infectious disease. MultiCell Technologies, Inc.’s therapeutic pipeline includes MCT-125, which is directed at treating chronic fatigue in MS patients. MCT-125 completed a 138 patient Phase II clinical trial and demonstrated strong efficacy in reducing fatigue in MS patients.

The company also has their MCT-175, a targeting relapse-remitting MS. MCT-175 targets disease specific autoaggressive T-cells that destroy the myelin sheath of nerve cells. It is in preclinical

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On July 24, New York-based biopharmaceutical company Regeneron Pharmaceuticals Inc. (REGN) announced that its once-weekly injection Arcalyst (Rilonacept) received a positive response from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The drug is used for treating Cryopyrin-Associated Periodic Syndromes (CAPS), a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue.

CHMP has recommended that rilonacept, an interleukin-1 blocker, be granted marketing authorization under exceptional circumstances. Such authorizations are granted to products on which comprehensive data cannot be provided by the company, which may happen due to the the rarity of the condition. The agency also asked Regeneron to  provide new information, if available, pertaining to the drug every year for review.

The company submitted a Marketing Authorization Application (MAA) with the EMEA for Arcalyst for the treatment of CAPS in the European

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The Cheshire based Alexion Pharma (ALXN) reported second quarter earnings better than our estimates on strong sales of Soliris. The company reported GAAP net income from operations of $16.8 million ($0.19 per share) for the quarter compared to $2.4 million ($0.03 per share) in the year-ago period. The net income would have been on the higher side, but for the $3.4 million charge associated with the exchange of convertible notes during the quarter.  Revenue from operations increased 55% year on year and 14% sequentially to $92.3 million. Alexion Pharma derives its revenue from the sale of its only marketed product Soliris. Total operating expenses increased 23% to $61million primarily due to the 30% rise in SG&A expenses. The increase in SG&A expenses reflects the increased costs associated with the expansion of operations related to the launch of Soliris. The 9% increase in R&D expenses is due to ...

HGSI’s Benlysta meets its endpoints in Bliss-52 phase III trial for lupus Earlier today, Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline PLC (GSK) announced that Benlysta met the primary endpoint in BLISS-52, the first of two pivotal phase III trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52 compared with standard of care alone. Study results also showed that Benlysta was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. As a reminder, HGSI and GSK is co-developing Benlysta as a potential treatment for SLE. Benlysta is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein discovered ...