Monday, January 19, 2015

Macro Events - End of January

Extremely important news is set to hit the last two weeks of January, that could play significantly on the capital markets not only in the short, but also long term.

A)  European Central Bank (ECB) will hold it's latest monetary policy meeting this Thursday the 22nd, to discuss current policy issues.  The expectation is that the ECB will announce some sort of quantitative easing program (QE) similar to what the U.S. Federal Reserve, and Japan has recently done for many years now.  If QE is coming from the ECB, what kind of magnitude can we expect to see.  Perhaps $500 - $700 million over the next 12 months?  We'll know on Thursday.

B)  Greek elections are set to vote and potentially put a new government in place.  If a victory by leftwing party Syriza in the election, the leader of the party Alexis Tsipras may elect to abandon the Euro Zone.  If so, could this be the first step toward European Monetary Union demise.  What could the effects of a Greek departure from the Eurozone do to confidence moving forward, and could Spain and Italy decide the same.

C)  The Federal Reserve (FOMC) has scheduled their Monetary Policy meeting on January 28th, and the main topic of interest will be the raising of interest rates, and how soon that will get implemented. Will it occur later in 2015, or get pushed out to 2016. The current expectations are for sometime in 2015, starting from April outward.

Bottom Line:  An extremely important two weeks ahead for the markets worldwide, starting with the ECB this Thursday, the Greek elections on the 25th, and the FOMC meeting on the 28th.  Markets may display volatility, depending on the outcome of these three events. Thank you for reading.

Saturday, January 17, 2015

"The Waiting"

I titled this post after a popular song created by musician Tom Petty.  The correlations between good investing and patience is high, and the waiting can truly become the hardest part.  As investors, we search for a well run company, with a product that fills an unmet medical (or other) need.  Then create a picture of the potential future success this drug (or other) could become to society, and extrapolate that potential into monetary terms.  After we believe we have found this future successful potential, we sit, wait, and try not to screw it up.  Screwing it up can take many forms. To shifting investment capital to other high flying stocks that we know little of, but everyone is talking about, (known as herd following), because the stock we originally found, has not advanced in price as quick......impatience.  Or worse yet, dip into investment capital to fund other silly lifestyle ventures, that gives us short term gratification, and creates nothing of value for others.
Good investing can, and in most cases be boring.  Most investments take at minimum, three to five years of good patience until the underlying value becomes apparent to the masses, and only then, may the value of the asset rise in price as it fulfills an unmet societal need.  That does not imply that a change within the company, product, or competition, could have a material impact on future prospects of the asset, and force us to reexamine our initial investment thesis.  That can happen, but is much different than falling prey to herd following (comfort in numbers), impatience, or pulling investment funds for short term lifestyle gratification.  Good investing involves patience, and the discipline to believe what we have found (after hundreds of hours of research) will materialize into the future potential we originally judged it to be......The Waiting is the hardest part.  Thank you for reading.

Wednesday, January 14, 2015

Acadia - JP Morgan Healthcare Conference ($33.76)

Acadia (ACAD) presented yesterday at the annual JP Morgan Healthcare Conference.  Not much new information was presented, just a reiteration of timelines, and current, and future clinical trials.  The breakout session afterwards yielded a few questions regarding their phase 2 ADP (Alzheimer's Disease Psychosis) trial.  
  • At six weeks into the trial, they will measure psychosis and agitation, using the NPI-NH (Neuropsychiatric Inventory-Nursing Home) and the CMAI (Cohen Mansfield Agitation Inventory) respectively.  
  • At 12 weeks, they will measure cognition using the ADAS-cog (Alzheimer's Disease Assessment Scale Cognitive Subscale).
Bottom Line:  Management did another fine job explaining the science, clinical trial updates, and timelines for 2015.  Thank you for reading.

Sunday, January 11, 2015

Lundbeck Clinical Trials - Update

Lundbeck and their marketing partner Otsuka (the manufacturer of the #1 selling drug Abilify) are major players in the central nervous system (CNS) space.  An update on new phase 3 trial data for depression and schizophrenia are listed below.  The links are below.

12-10-2014
Brexipiprazole Phase 3 Major Depressive Disorder Results
Trial: (NCT01360645) Phase 3
Brexpiprazole as adjunct for Major Depressive Disorder (MDD)
Study 1 (2mg + ADT (N=175): -3.21, p=0.0002)  MADRS

12-11-2014
Brexpiprazole Phase 3 Acute Schizophrenia Results
Trial: (NCT01396421) Phase 3
Brexpiprazole as mono-therapy for adults with Acute Schizophrenia.
Total Score (4mg: -19.65, p=0.0006) PANSS

Both studies achieved significant efficacy results, which may lead to approval from the FDA mid 2015.

Saturday, December 27, 2014

"Anecdotal Reports"

Is what Acadia Pharmaceutical CEO Uli Hacksell said he was receiving from the current phase 2 ADP (Alzheimer's Disease Psychosis) trial, during the recent Oppenheimer Healthcare conference on December 10th.  So what was the CEO eluding to when he made that statement...

Friday, December 19, 2014

Acadia Pharma 2015 Event Sheet

Here are some interesting events, with timelines to remember for 2015.

1. Filing of the NDA in the first quarter of 2015.
2. 60 days for the FDA to accept the application.
3. Upon potential acceptance, FDA could also grant priority review. 
4. With priority review, six months PDUFA date, without, 10 months.
5. Sleep disturbance trial for PDP patients first half of 2015.
6. EU filing 6- 9 months post FDA filing, so around 3rd quarter. 
7. Potential top line ADP in fourth quarter of 2015 or around end of 2015. 
8. Schizo maintenance trial to commence 2nd half of 2015. 
9. More information on Pima for Autism 2015.

Sunday, December 14, 2014

A Technical Look at Acadia Pharma ($32.53)

Some charts of Acadia as the stock is now making new highs on a weekly basis.
Above daily chart is a nice looking breakout to new highs.  Even though overbought somewhat on the daily, the chart can stay overbought for much longer on a technical basis.  
On a comparative basis, ACAD has outperformed the XBI biotech sector and the S&P 500 the last three days, as the market has sold off.  Thank you for reading.  We hold ACAD as a long term investment.  

Monday, December 8, 2014

MEI Pharma: ASH and Investor Conference Update

MEIP just finished with their annual investor / analyst conference this evening and ASH on Saturday. There are a few issues at hand that have left me to believe that Pracinostat / Vidaza combination for Newly Diagnosed Elderly Patients with AML, may not be the combo that achieves a significant improvement over existing therapy for these patients.  At least as far as overall survival may be concerned.  The company has released positive interim CR (complete remission) data throughout the phase 2 AML trial.  What we did not hear, up until the investor conference is below.

1. Six patients out of 41 had to have dose reduction.  First Vidaza then Pracinostat reduced, with the majority being Vidaza reduced out of six.
2. The company is planning a phase 3 AML trial in June 2015, with a planned primary end point being (CR) or complete response, with overall survival as a secondary endpoint.  But the company said that discussion with the FDA is still ongoing, and will have to see if the CR is a valid endpoint for the filing of an NDA.
3. The age group for this AML phase 3 trial in elderly population is planning on being lowered from greater or equal to 65 years, down to greater or equal to 60 years of age.

The reason that the company is planning a phase 3 trial using CR as the endpoint could be because of the lowering of dose in the current trial. Patients may be exhibiting greater side effects than initially thought.  If that is the case, the lowering of the dose could impact overall survival, and may be the reason that they are planning a phase 3 trial using CR as the primary endpoint rather than OS.  There has to be a trade off between receiving enough of the drug for efficacy and the safety profile for the elderly population.  In this case, with six patients, the lowering of the dosage of Vidaza to keep patients on therapy was the step taken.  The inclusion criteria for the planned phase 3 trial of 60 years of age rather than the current trial design of 65 years, is another reason to believe that the combination may be too adverse for patients 65 years and older, and that an extra five year reduction could make the drug combination more tolerable.  

Tuesday, December 2, 2014

MEIP: Completes Enrollment Front Line AML

Today MEI Pharma announced that enrollment for their phase 2 trial for patients who are elderly, newly diagnosed with AML (acute myeloid leukemia) is complete.  This trial enrolled 50 patients extremely fast since August 1st, when they only had 14 total enrollments.  Since then, the company announced that they achieved 8 (CR) complete remissions, or 57% in November with no progressions...

Avanir Pharmaceuticals: Buy Out

A busy day as one of the stocks we hold received a buyout offer from Otsuka Pharmaceuticals (the maker of Abilify) for $3.54 billion or $17.00 per share, in a stock transaction. My initial impression is that Otsuka received a good deal, as they will get a nice pipeline including indications such as agitation / aggression in Alzheimer's patients (phase 3 2015), along with Major Depressive Disorder or (MDD), which is in the early stages of a phase 2 trial.  AVNR patents extend out to 2030.  

Monday, November 24, 2014

Acadia Pharma: New High ($29.53)

Acadia has closed at a new all-time high on a inter-weekly basis.  The stock finished the day strong, on above average volume.  Below is a weekly chart of ACAD.
Bottom Line:  Even though the company announced a short delay for filing their new drug application for Nuplazid, the stock held up well, and has actually advanced higher.  Last week, the analyst house Cowen Group, provided coverage on ACAD with a buy rating, and a $46.00 price target on the stock. Perhaps that, and a strong biotech sector has contributed to the new high.  Thank you for reading.  We currently hold ACAD, and AVNR.  

Thursday, November 20, 2014

MEI Pharma: AML Trial Update ($6.90)

Trial updates are coming in quite fast now, as companies seeing positive results want to bring that information to the public as soon as possible. Many are scheduled to appear at the ASH Conference on December 6th. MEI Pharma just updated investors on their AML phase 2 trial using Pracinostat (an HDACi) in combination with Vidaza for elderly newly diagnosed patients...

Thursday, November 13, 2014

MDS & AML: Assessing the Landscape

There has not been an effective, and safe, FDA approved drug for MDS (myelodysplastic syndrome) or AML (acute myeloid leukemia) since Vidaza in 2004 and Dacogen in 2006.  This post will examine the competitive landscape of companies with the hope of meeting the unmet need for MDS and AML patients...

Monday, November 10, 2014

ACAD: Third Quarter Conference Call ($28.21)

There was good and somewhat bad news that ACAD announced today. First the somewhat bad news. The company is delaying the filing of their new drug application with the FDA to the first quarter of 2015, from previously the end of 2014.  They stressed that the delay is not an FDA issue, but more an internal issue of gathering all the pieces, for a well planned filing.  So the company is losing about three months by delaying this filing, not a big picture game changer...

The new information that we have not heard before, was the marketing research the company has been working on over the last year.  The research is below.
  • 11,000 U.S. PDP treating physicians, mostly Neurologist
  • 1 million Parkinson's Disease patients
  • 400,000 thousand patients with PDP
  • 50% have disruptive disturbances, (think sleep, or agitation/aggression (my notes)
  • Reimbursement Payee is positive on the drug, (commercial, medicaid)
  • Pricing of Nuplazid similar to Abilify 20 mg at $13,000 / Wholesale Acquisition Cost (WAC) annually.
 Thank you for reading.

Thursday, November 6, 2014

MEI Pharma: ($7.87)

MEI Pharma (MEIP), updated investors this morning on the phase 2 trial of Pracinostat / Vidaza combo for elderly patients with AML.  The trial is about 50% complete, with a total of 14 patients currently evaluated.  The update is positive with (8) or 57% of AML patients achieving a CR + CRi response...
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