Thursday, March 31, 2016

Nuplazid: FDA Briefing Documents

Acadia Pharmaceuticals drug Nuplazid, for Parkinson's Disease Psychosis (PDP) should get FDA approval by May 1st.  The link to the documents are here FDA AdvisoryCommitteeThe Advisory Committee (ADCOM) will meet on Tuesday to give their opinion on the efficacy and safety of the drug.  Nuplazid will be the only drug approved to treat the disease, and will have patent protection to 2028, prior to any Hatch-Waxman additions.  The labeling for the drug will be revealed upon approval.  I am expecting a black-box label at that time.  Thank you for reading.

Saturday, March 19, 2016

Otsuka's Commitment to AVP-786

Otsuka a focused CNS company, and the producer of Abilify, purchased drug AVP-786 for $3.5 billion through their acquisition with Avanir on November 13, 2014.  To get a sense of just how committed the company is to AVP-786, we have to look at the clinical trials that have started since the acquisition, and compare that to the number of clinical trials the company has started with another Otsuka drug Brexpiprazole, deemed the second generation drug of Abilify, that would compete in the indications similar to AVP-786.

Clinical Trials Started Since Acquisition
(3)  Alzheimer's Agitation - U.S.        phase 3
(1)  Residual Schizophrenia                phase 2
(1)  Disinhibition                                   phase 2
(1)  Alzheimer's Agitation - Japan     phase 3

Ongoing Trials With AVP-786
(1)  Treatment Resistant Major Depression Disorder  phase 2

New Otsuka Clinical Trials with Brexpiprazole
(0)
The company was previously in clinical trials prior to the acquisition of AVP-786, for Alzheimer's Agitation, MDD, and Schizophrenia as co- partner with Lundbeck.  But has not initiated anything new since agreeing to acquire AVP-786 from Avanir late 2014.  

Bottom Line:  Some significance into the timing of initiating clinical trials, may help us identify a companies priority in their clinical pipeline.  Thank you for reading.
 

Saturday, March 12, 2016

N91115 CFTR Stabilizer

Nivalis Therapeutics (NVLS) is a clinical stage company that specializes in treatments for Cystic Fibrosis, with it's lead candidate stabilizer N91115.  N91115 is the only clinical stage candidate designed to stabilize CFTR (Cystic Fibrosis Transmembrane Conductance) inside the cell and at the cell surface.  The company expects N91115 to be complimentary to existing and future CFTR modulators, and is currently in a phase 2 clinical trial with approved drug Orkambi for people with the F508del mutation.  The trial is designed to see what effect N91115 may have as addition to what Orkambi achieves.  Below is the clinical trial and efficacy goals the company expects from this trial.

N91115 in Patients With CF Homozygous for the F508del-CFTR Mutation.
- The company is targeting a 5% improvement, up and over Orkambi's 3% range in ppFEV1.
- Readout of data will be 2nd half 2016.
- First readout for a triple with three distinct therapies, for F508del homozygous patients.
- Have received Orphan and Fast Track designations from FDA in 2016.
- The patent for N91115 runs until 2031 at the very earliest.

The company plans to couple N91115 with leading potentiator's to potentially increase efficacy for combo therapy.  Either Kalydeco, CTP-656 or GLPG1837 are the current group of potentiator's that hold the most promise to date.  Thank you for reading.

Sunday, March 6, 2016

QBW251 Clinical Trial Terminated

Novartis was in a phase 2 for healthy and Cystic Fibrosis patients since 2014, and in February terminated the trial prior to completion, and readout.  The link is NCT02190604. QBW251 was one of a few potentiators that are being tested for efficacy. Perhaps Novartis may see some value in potentiator CTP-656, once the company completes their phase 2 clinical trial sometime in 2017.  Thank you for reading.