NEWS & COMMENTS
PROHOST  FILTER
IN THE
A BLOCKBUSTER DRUG
RITUXAN
How many times we reiterated that Rituxan, developed by Biogen Idec (BIIB) and Genentech (DNA) is candidate for treatment of many malignancies, inflammatory and auto-immune diseases. As a matter of fact, the drug was approved for cancer andc arthritis and used to treat other diseases. Yesterday, though, the developers of the drug announced that the drug has taken the management of arthritis a large step forward, where repairing and avoiding the damage caused by arthritis seems to become feasible with this drug. Biogen Idec said Thursday that new data shows Rituxan arthritis treatment might reduce joint damage in hard-to-treat rheumatoid arthritis patients. The company said the late-stage study data shows that at 56 weeks, Rituxan used with the treatment methotrexate slowed joint erosion and joint space narrowing by more than half in patients with hard-to-treat, moderate-to-severe rheumatoid arthritis compared to patients given methotrexate and a placebo.
The good news for the miracle drug is that the recruited patients were those who have not adequately responded to tumor necrosis factor antagonist (TNF) therapies. (Enbrel for example). It seems that about 30 percent to 40 percent of patients respond inadequately to the TNF modulators according to Genentech.
Rituxan is already approved to reduce signs and symptoms of rheumatoid arthritis. It is not approved to reduce joint erosion.
READ MORE: Analysis of Phase III Study Showed Rituxan(R) Plus Methotrexate Reduced Joint Damage in Rheumatoid Arthritis Patients Who Respond Inadequately to TNF Antagonist Therapies
PREMATURE EJACULATION
INDEVUS PHARMACEUTICALS
Indevus Pharmaceuticals (IDEV) initiated Phase 2 proof of concept trial for its product pagoclone in premature ejaculation. The trial is designed to evaluate the efficacy of various doses of pagoclone versus placebo in delaying the ejaculatory response in male patients with primary premature ejaculation. One hundred patients are expected to enroll at multiple sites in the United States. Patients will be evaluated for a total of 9 weeks including a 4 week screening phase and a 5 week treatment phase. Results of the trial are anticipated to be announced in early calendar 2007
READ MORE: Indevus Announces Initiation of Phase II Trial for Pagoclone in Premature Ejaculation
PATENT UPHELD
GOOD NEWS FOR ALNYLAM
Alnylam Pharmaceuticals (ALNY) announced today that the European Patent Office (EPO) has upheld key features of the company's Kreutzer-Limmer I patent (EP 1144623) with claims covering small interfering RNAs (siRNAs), the molecules that mediate RNAi. This patent was originally granted in Europe on August 28, 2002, but was opposed by several parties, a legal practice that is common for European patents. The amended patent claims cover certain structural requirements for siRNAs that are important for therapeutic activity.
This is very important positrive news for Alnylam. (Read about the RNA group in Prohost N-Letters and E-Letters.)
READ MORE: Alnylam Reports Positive Outcome in European Opposition Proceedings on Kreutzer-Limmer I Patent; Amended Claims Broadly Cover siRNAs with Key Features Critical for RNAi Therapeutics
MESOTHELIOMA
THE STATUS OF ALFACELL’S DRUG ONCONASE
Alfacell Corporation (ACEL) provided an update on the status of the confirmatory Phase 3b registration trial evaluating Onconase® (ranpirnase), for the treatment for unresectable malignant mesothelioma (UMM). Alfacell has completed nearly all of the key requirements of the Chemistry, Manufacturing and Controls (CMC) section of the NDA, and expects to file the CMC submission by the end of the third quarter of 2006. Once accepted by FDA, the CMC section can be used for future ONCONASE filings for major cancer indications.
The company continues to allow access to ONCONASE in key US sites and international sites in the MM program, as a result accrual has been optimized and the required 316 events to initiate the final analysis is projected to occur earlier than previously estimated. Overall, the Company remains on track to file the NDA no later than mid-2007.
READ MORE: Alfacell Provides Update on the ONCONASE Phase IIIb Registration Trial
NEUROCRINE: WHAT”S GOING ON?
Neurocrine Biosciences. (NBIX - news) announced today that the firm and Pfizer have agreed to terminate the collaboration agreement to develop and co-promote indiplon. As a result, Neurocrine will reacquire all worldwide rights for indiplon capsules and tablets and will independently develop indiplon for approval and commercialization. Neurocrine will meet with the Food and Drug Administration (FDA) to finalize development plans for the resubmissions of each indiplon NDA and plans to commercialize indiplon as quickly as possible upon approval. The Company plans to review various business and commercial alternatives to expedite successful commercialization of indiplon. As part of the termination provisions of the agreement, Pfizer will continue to support indiplon for a period of up to 180 days to ensure a smooth transition.
READ MORE: Neurocrine and Pfizer Terminate Collaboration Agreement for Indiplon
Bad news for the stock? Probably yes. However, the bad news might turn in favour of Neurocrine if and when the drug will be approved. Probably it will.
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