DNAprint Genomics (DNAG)

[johnnyfiber]

Here's a piece of your Rosetta Stone:

DNAPrint enters neurotherapeutics collaboration
6th March 2006
By Staff Writer
DNAPrint Genomics has revealed that it is to collaborate with the Massachusetts College of Pharmacy and Health Sciences on the potential development of Ritalin-like compounds as possible medications for drug abuse, ADHD and depression.
The compounds are analogs of Novartis' Ritalin, used for treatment of ADHD and designed specifically to take effect slowly but last longer, thus reducing their potential for abuse and a patient's required daily dosage

http://www.pharmaceutical-business-review.com/article_news.asp?guid=B2CB8B6E-04ED-4A76-8B7A-D7DA87C9...


RITALIN® Family of Drugs: We have a major collaboration with Novartis Pharma AG concerning the entire RITALIN® family of drugs. We discovered and developed FOCALIN™ and FOCALIN XR™, using advanced single-isomer technology, which are formulated by isolating the active d-isomer of methylphenidate, providing favorable tolerability and dosing flexibility at only half the dose. On November 15, 2001, FOCALIN™ was approved by the FDA for the treatment of ADHD in children and adolescents. On May 27, 2005, FOCALIN XR™, an extended release version, was approved by the FDA for the treatment of ADHD in adults, adolescents and children.

Celgene licensed the worldwide rights (excluding Canada) to FOCALIN™ and FOCALIN XR™ to Novartis Pharma AG in exchange for milestone payments and royalties on FOCALIN™ and the entire Ritalin family of drugs including Ritalin, Ritalin LA, Ritalin SR and ultimately FOCALIN XR™.

Preclinical and Clinical-Stage Pipeline:

Our preclinical and clinical-stage pipeline of new drug candidates, in addition to our cell therapies, is highlighted by multiple classes of small molecule, orally administered therapeutic agents designed to selectively regulate disease-associated genes and proteins. The drug candidates in our pipeline are at various stages of preclinical and clinical development. Successful results in preclinical or Phase I/II clinical studies may not be an accurate predictor of the ultimate safety or effectiveness of the drug candidate.

Phase I Clinical Trials

If the FDA allows a request to initiate clinical investigations to become effective, Phase I human clinical trials can begin. These tests usually involve between 20 and 80 healthy volunteers or patients. The tests study a drug's safety profile, and may include the safe dosage range. The Phase I clinical studies also determine how a drug is absorbed, distributed, metabolized and excreted by the body, and the duration of its action.


Phase II Clinical Trials

In Phase II clinical trials, controlled studies are conducted on a limited number of patients with the targeted disease. An initial evaluation of the drug's effectiveness on patients is performed and additional information on the drug's safety is obtained.


Phase III Clinical Trials

This phase typically includes multi-center trials and involves a larger patient population. During the Phase III clinical trials, physicians monitor patients to determine efficacy and to gather further information on safety.
IMIDS®: IMiDs® are novel small molecule, orally available compounds that modulate the immune system through multiple mechanisms of action. We have advanced four IMiDs® into development: REVLIMID® (CC-5013), ACTIMID™ (CC-4047) and CC-11006 are being evaluated in human clinical trials and CC-10015 is presently undergoing preclinical evaluation.
Our IMiD® class of drug candidates is covered by an extensive and comprehensive intellectual property estate of U.S. and foreign issued patents and pending patent applications including composition-of-matter and use patents and patent applications.

CC-4047: is one of the most potent IMiDs® that we are developing. CC-4047 is in Phase II trials to determine its potential safety and efficacy as a treatment for multiple myeloma and prostate cancer. CC-4047 and REVLIMID® have different activity profiles which may lead to their evaluation in different diseases or stages of disease.

CC-11006: is a molecule we have identified as a potential treatment for chronic inflammatory diseases, many of which have unmet medical needs. CC-11006 entered Phase I human clinical trials in 2004. Following the completion of Phase I trials, we will evaluate our development options.

TNFa INHIBITORS: Our TNFa, inhibitors potentially provide an oral approach to treat chronic inflammatory diseases. Our lead TNFa inhibitor investigational compound is CC-10004. Data from Phase II proof-of-principal trials support our decision to evaluate CC-10004 in pilot studies based on its TNFa immunobiology in inflammatory diseases with unmet medical needs such as; psoriatic arthritis, rheumatoid arthritis and other immune inflammatory indications. During 2004, CC-10004 entered Phase II clinical trials in exercise-induced asthma and psoriasis after successfully completing Phase I testing in healthy human volunteers. The clinical data demonstrated that CC-10004 is well tolerated with good bioavailability and pharmacokinetics in humans.

BENZOPYRANS: CC-8490, our lead compound in this category, is in Phase I clinical trials for glioblastoma, a form of brain cancer, with investigators at the National Cancer Institute. In Phase I trials in healthy human volunteers, CC-8490 has been shown to be well tolerated. Animal studies have demonstrated that the compound could have an important effect on solid tumors such as non-small cell lung cancer and colon cancer.

KINASE INHIBITORS: We have multiple target and drug discovery projects underway this year in the field of kinase inhibition. Our kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase pathway, or JNK. This pathway has been associated with the regulation of a number of important disease indications. CC-401, our lead JNK inhibitor, successfully completed a Phase I trial in healthy volunteers. We are currently evaluating the clinical potential of CC-401 in acute mylegeneous leukemia (AML), a blood cancer, in a Phase II clinical trial.








FDA Grants Approval to Market FOCALIN XR™ for the Treatment of ADHD in Adults, Adolescents and Children
East Hanover, NJ, May 27, 2005 – Novartis Pharmaceuticals Corporation

http://www.pharma.us.novartis.com/newsroom/pressReleases/releaseDetail.jsp?PRID=1664&usertrack.f...