IDRA: Idera Pharmaceuticals ($3.04)

Idera Pharmaceuticals is a new holding.  Idera is a clinical stage biotechnology company developing a novel approach to the treatment of autoimmune diseases and certain genetically defined forms of B-cell lymphoma.  Their technology platform is based on nucleic acid therapies to inhibit over-reaction of Toll-like receptors.

Quick Facts:
135 million shares outstanding including warrants
84 million in cash
5M / Q burn rate
810 Million Market Cap
2031 for IMO-8400, 2034 IMO-9200 Patent Expiration

Clinical Trials:
Phase 2 Moderate to Severe Plaque Psoriasis.
Phase 1/2 B-Cell Lymphoma with MYD 88 L265P.

Catalyst:
Phase 2 for Psoriasis top line results in January.
Complete enrollment Phase 1/2 B-Cell Lymphoma?

Bottom Line:  Idera is unique with their technology based around Toll like receptors.  The company is currently working on the dosing for their IMO-8400 and MO-9200 technologies.  They have cash for now that should last until third quarter of 2015, and also patent protection until 2031 and 2034.

ACAD: Acadia Pharmaceuticals ($23.03)

Two companies that we currently hold shares in, Acadia Pharmaceuticals and Omeros, both presented at the 24th annual Oppenheimer Healthcare Conference in New York this week.  From their presentations, I wanted to add any new relevant information for future reference.

ACAD
CEO Uli Hacksell presented on Tuesday.  Some new takeaway's from his presentation are below.
A)  He mentioned that the patent for Pimavanserin expires in 2028, but also mentioned the potential for filing a patent extension after that time period was a possibility.
B)  The other significant new information had to do with side effects and the box labeling for PDP.  He mentioned that under very high dosing (up to 300 mg) nausea was noticed.  Pima will only be prescribed at 40 mg for PDP.  No other side effects were mentioned as he said this is a very unique safe molecule.
C)  All timelines remained the same as far as filing the new drug application for PDP (by end of 2104) and phase 2 ADP data potentially taking up to two years for data.
D)  CEO expects at the very minimum equal pricing to other current atypical anti-psychotic drugs.
Another positive conference for ACAD. The CEO keeps hammering home the safety and efficacy of Pima compared to other Atypical anti-psychotics currently being used, and the potential for premium pricing for the unmet need of PDP and ADP.

OMER
Omeros CEO Greg Demopulos presented on Wednesday, some key information below.
A)  There was much mention regarding partnering for some of their indications, but no concrete details.
B)  The phase 2 Schizo data which was previously thought to be made public in December, now has been pushed back to January.
C)  They have been pursuing hard, getting medical reimbursement for OMS302 or Omidria, which is expected to be approved mid 2014 and launched there after.
D)  Nothing mentioned regarding their cash position.
The phase 2 announcement of OMS824 top line results in January, and the medical reimbursement for Omidria which is expected to launch after approval in mid 2014 are two important events.
Thank you for reading.

TRGT: Targacept ($5.75)

(TRGT) Targacept has developed what they trademark as NNR Therapeutics or neuronal nicotinic receptors. The company is dedicated to the discovery and early development of compounds that interact with nicotine receptors in the human nervous system to treat such diseases as Alzheimer's Disease, Parkinson's Disease, Tourette's Syndrome, schizophrenia and others.

Therapeutic Applications of Nicotine
Nicotine's beneficial effects on learning, memory and other physiological and behavioral endpoints have been well documented in scientific literature.  Some studies reported that smokers had a lower incidence rate of Alzheimer's and Parkinson's Disease.  It was also thought that nicotine could have a beneficial effect on schizophrenia.

Dvelopment of Novel Nicotinic Therapeutics
Companies like Targacept and Forum Pharmaceuticals (previously EnVivo), have worked to discover and develop nicotine-like therapeutic compounds that could be suitable for humans without the side effects of increase in heart rate, blood pressure and nausea.

Current Trials
Targacept  Alzheimer's Phase 2 Trial
- Ongoing with top line results mid 2014.
Targacept  Schizophrenia Phase 2 Trial
- Ongoing with top line results Dec. 13 or Jan. 2014.
Forum Alzheimer's Phase 3 Trial
- Still recruiting

The primary outcome measure in the Alzheimer trials above is the change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item, or (ADAS-Cog-13).  ADAS-Cog-13 helps evaluate cognition and differentiates between normal cognitive functioning and impaired cognitive functioning.

Note that neither company or trial above is seeking a cure for Alzheimer's or Schizophrenia, but trying to improve cognition and dementia with their treatment for a given period of time, above the current standard of care.