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•BTK 3,203.94 •NBI 2,966.25
October 23, 2014 | Issue No. 789
Since Last Issue:
BTK: 5.2%; NBI: 5.4%; Model Portfolio: 9.8%; Trader’s Portfolio: 15.4 %
This Issue: Despite Extreme Volatility, Staying the Course
UPDATES: ALKS, CELG, ISIS, MDCO,
NVAX, PCRX, PCYC, SGMO
Biotech Sector Analysis
SENTIMENT– The market took any and every
reason to sell stocks in the beginning of October
– the EU slowdown, US interest rates concerns,
World Bank lowering global GDP forecasts,
Urkaine/Russia, China, ISIS, technical violations and
of course, Ebola. The bottom line may have been as
simple as this – larger stocks, dominating the market
in 2014, were due for a correction and smaller stocks
appear to have bottomed in the meanwhile. As we
mentioned a few times recently, fund managers get
paid for performance on December 31. The market
often gives us opportunities and this month was a
classic example. Not to completely ignore the
negative worldwide events, savvy investors with cash
on the sidelines took advantage of attractive levels to
add to or initiate positions during the recent market
collapse. With the abatement of some of the above
issues, all of a sudden the sentiment is not so bad if
Chart A
not positive once more (e.g., the spike and return of
the VIX, see Chart A). Our last two Issues repeated
the same message “Pick Your Spot” and there were
plenty of them since then.
Technically IBB At Highs Once More – Thanks to a
bounce back in the smaller caps followed by another
resurgence by the leaders (e.g., AMGN, CELG,
REGN, GILD, see Chart B), the IBB touched its longterm support levels (i.e., the 200-day MA) and now is
once more at the highs for the year (whew that was
fast). It will be interesting to see if the momentum is
maintained (e.g., will investors chase performance)
or the trading range activity returns (e.g., one more
pullback?). While the end of the year is still a bit
away, the October damage was rather severe and
may have signaled the bottom for the remainder of
2014. The sector does not seem to be in overbought
territory, although short covering is likely to have
played a role in the snapback as well.
Chart B
©Piedmont Venture Group (2014). Address: P.O. Box 40460, Berkeley, CA 94706. Telephone: (510) 843-1857. Fax: (510) 843-0901. Website: http://www.bioinvest.com. Email: [email protected].
Published 24 times a year. Email subscription rates: 1 year - $399, 2 years - $678, 3 years - $898. You may cancel at any time for a prorated refund. The information and opinions contained herein have
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purchases or sales of, securities mentioned herein. We cannot guarantee and you should not assume that future recommendations will equal the performance of past recommendations or be profitable.
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
Leaders Keep Leading – BIIB announced a
disappointing quarter and the first Tecfidera patient
with PML, but it’s the only Big Bio that has not had
good news of late. AMGN, with a pipeline
resurgence, has been approached by activist fund
Third Point, to split up the company. That comment
sent the shares to new highs. CELG’s GED-301 hit
the mark and investors were very pleased with its
Q3:15 quarterly call. GILD received Harvoni approval
(see below), ALXN beat and raised again, and
REGN delivered further encouraging Eylea DME
results. Hence, the new highs for the IBB.
I/O Corner – PCYC’s Imbruvica Enters Red Hot
Immune Oncology With BMY’s Optivo –
PCYC/Janssen struck an IO collaboration with
Bristol-Myers Squibb to test Imbruvica in combination
with Optivo (nivolumab, anti-PD-1).
The new IO
combination will initially focus on diffuse large B-cell
lymphoma (DLBCL), follicular lymphoma (FL) and
chronic lymphocytic leukemia (CLL) with Janssen
conducting the studies. Imbruviva has some very
positive characteristics that would make it an ideal
component of an IO combo as it is both safe and
delivered orally for ease of use. Safety is always
paramount in drug development and even more so
when combining drugs.
Imbruvica’s Truly Novel Mechanism of Action –
Imbruvica's primary activity is against malignant B
cells via BTK (Bruton's tyrosine kinase) inhibition. In
addition, Imbruvica has potent off-target activity
against ITK (interleukin-2 inducible kinase), which
results in improved T cell immunity that, in theory,
could enhance the response to a PD-1 inhibitor such
as Opdivo. In a paper that appeared last year in the
scientific journal, Blood, Imbruvica was shown to be
the first clinically viable ITK inhibitor, with “clinically
relevant and physiologically potent activity that could
lead to broad therapeutic utility". It was shown that
Imbruvica inhibits the differentiation and activation of
T helper 2 (Th2) T cells and skews development in
favor of Th1-based immune responses. The
accompanying editorial stated that "this bias toward
Th1 cells promotes a more effective antitumor
immune response." In malignancies, the balance
between Th1 and Th2 T cells is commonly disturbed
and results in compromised ability of the immune
system to eradicate the tumor. Therefore, in addition
to a specific inhibition and down-regulation of BCR
that directly inhibits the proliferation and survival of
the malignant B cell, Imbruvica's inhibition of ITK
leads to a “dramatic” change in the tumor
microenvironment. This promotes a Th1 response
that helps immune regulation that inhibits malignant
cell growth. Importantly, the activity of Imbruvica
beyond BTK inhibition, which to date has been
viewed as a potential liability, could extend its utility
to solid tumors as part of an immuno-oncology (IO)
combo paradigm. PCYC will most likely form
additional future solid tumor collaborations with other
I/O players.
BMS formed another I/O joint venture, this time with
Novartis, to test Opdivo in combination with three
NVS experimental cancer drugs. One study will
evaluate Opdivo with Zykadia, which was approved
by the FDA in April as a treatment for late-stage nonsmall cell lung cancer. The second study will test
Opdivo with two investigational drugs, INC280 and
EGF816. INC280 is INCY’s C-met inhibitor that is
partnered with Novartis. NVS is also developing
Chimeric Antigen Receptor T-cell, or CAR-T,
immunotherapies, which involves engineering a
patient's own T-cells to identify proteins on cancer
cells.
The company also acquired CoStim
Pharmaceuticals earlier this year as they play catch
up in the red hot IO space.
Regulatory – FDA Rolling Along – Gilead has won
FDA approval to begin selling Harvoni (a.k.a, the son
of Solvaldi), the first pill that cures most hepatitis C
(HCV) patients without requiring other medicines. Its
near $100,000 cost will likely further inflame the
national debate between drug companies and health
insurers over spiraling prices. Harvoni combines
Sovaldi with another agent into a single pill that
needs to be taken just once a day to cure most
>
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
patients. The cost is $94,500 for most patients, who
will be treated for 12 weeks.
An FDA panel voted unanimously to approve
Novartis’ secukinumab for moderate-to-severe
plaque psoriasis. The agency’s Dermatologic and
Ophthalmic Drugs Advisory Committee voted 7-0 in
favor of secukinumab, a selective interleukin-17A
inhibitor, based on 10 Phase II/III clinical trials that
included nearly 4,000 patients. The new drug could
be very competitive as it has shown superiority to
AMGN’s Enbrel, an anti-TNF drug, which represents
the current standard of care.
BMS announced that they were withdrawing their US
application for asunaprevir and daclatasvir, eight
months after the HCV combination received
'Breakthrough Therapy Designation’ from the FDA.
The decision due to the “rapidly evolving” HCV
treatment landscape in the US, which means that
GILD, ABBV and JNJ will have one less competitor
in the extremely lucrative U.S. HCV market.
The U.K.’s National Institute for Health and Care
Excellence (NICE) published draft guidance that
recommended Novartis’ Gleevec for up to three
years in patients who have had a gastrointestinal
stromal tumor (GIST) and are at high risk of
recurrence. The U.K.’s NICE has also decided that
Dendreon’s Provenge is too expensive to be used as
a treatment for prostate cancer.
InterMune/Roche and Boehringer both were granted
FDA approval for their fibrosis drugs. The two
treatments were designated "Breakthrough" and are
designed to treat the often-fatal idiopathic pulmonary
fibrosis (IPF), a lung-scarring disease that inhibits
oxygen absorption and hampers pulmonary function.
InterMune/Roche's drug, perfenidone, will be
branded Esbriet, the same as it does in Europe,
while Boehringer's nintedanib will be called Ofev.
Until now, there were no FDA-approved treatments
for IPF, which kills about 40,000 people a year.
AMGN has filed for an early FDA approval for its
leukemia drug candidate blinatumomab based on
promising Phase II data. The compound is an
antibody developed through Amgen's bispecific T cell
engager (BiTE) system, which they acquired in 2012
when they bought Micromet. Amgen has moved
quickly with blinatumomab, which is also in
development as a treatment for CLL, B-cell
lymphoma and other blood cancers. Pfizer’s potential
breast-cancer treatment, palbociclib, was granted
Priority Review by the FDA, potentially speeding the
approval process by up to four months. The FDA
designated an adult stem cell treatment from
BrainStorm Cell Therapeutics as a fast-track product
for treating amyotrophic lateral sclerosis, or ALS.
Daily Ebola News Affects Markets, Some Bios –
Ebola headlines were the icing on the market’s
decline (once the virus arrived in the U.S.), and its
abatement (for now) has led to the market’s rebound
(once all quarantined people were released without a
new infection being reported). NLNK started a Phase
I trial of an experimental Ebola vaccine at Walter
Reed. GSK has also provided an update on their
Ebola vaccine saying that initial Phase I data will be
available by year end which would allow them to
begin testing the vaccine in healthcare workers going
to Africa as soon as early next year. JNJ announced
that it would deliver 250,000 doses by May of a novel
Ebola vaccine developed with Denmark’s Bavarian
Nordic. Other biotech-related Ebola stocks and their
wild rides include TKMR, BRCX, CERS and CHRX.
Although Ebola will continue to make noise until a
bonafide treatment and/or vaccine exists, the most
urgent virus causing hospitalization in infants/adults
remains
the
flu/RSV
(hence,
our
NVAX
recommendation).
More Partnerships – In the midst of all of their Ebola
catalysts, NewLink made headlines once again when
they inked an attractive partnership with
Genentech/Roche for the development of NLG919,
an IDO pathway inhibitor. NLNK will receive an
upfront payment of $150 million and may receive in
excess of $1 billion in milestone payments plus
escalating double-digit royalties. The company has
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
discovered novel tryptophan-2,3-dioxygenase (TDO)
specific inhibitors that are potential anti-cancer
compounds which could function individually or in
combination with IDO inhibition and were included in
this deal. As a reminder, MTSL Recommendation
INCY is the faraway leader in the IDO race.
M&A – ABBV/SHPG Break-Up & More Deals –
With the collapse of the AbbVie/Shire merger, SHPG
walks away with a $1.6 billion break-up fee. As a
result, small/mid-cap biotechs have emerged as
targets for Shire to spend its newfound money on.
Speculation targets include CBST, NPSP, BMRN,
DVAX and SGMO. In the meantime, more deals are
being struck. Actavis is buying Durata (DRTX), a
specialty drug maker – for $675 million plus more on
sales milestones – which is expected to strengthen
its business that focuses on infectious diseases. In
our view, this bodes well for MTSL Recommendation
MDCO (see below). Endo is buying Auxilum,
boosting its offer to $2.6 billion. The Auxilium
acquisition is the latest of several deals for Endo,
which pulled off a tax-cutting inversion earlier this
year with its purchase of Paladin Labs.
Data – Good and Bad Remind Us It’s A Stock
Picker’s Market – ALNY’s stock rose sharply after
the Company released positive Phase II data for
patisiran, for the treatment of transthyretin-mediated
amyloidosis (ATTR) in patients with familial
amyloidotic polyneuropathy, a rare genetic defect
that affects roughly 10,000 people. MTSL Rec ISIS
is also developing a drug candidate for this indication
that is currently in Phase III.
Regulus’ stock doubled when it announced positive
Phase I data for HCV. In 14 patients with hepatitis C,
a single injection of RG-101 yielded an average viral
load reduction of 4.1 log at 29 days. While very early
data, a four log reduction from a single injection
could compete with the new HCV combo pills.
Regulus was formed by a joint venture between
ALNY and MTSL Recommendation ISIS.
SNSS stock was crushed after vosaroxin missed
Phase III trial endpoints for acute myeloid leukemia.
The stock plunged ~70% on the news that the
compound failed to significantly improve survival
rates compared to a placebo.
Alcobra is attempting to tout the benefits of a failed
Phase II trial for its ADHD treatment, MDX. Wall
Street clearly understood the data, sending the
shares down nearly >50% on the clinical trial.
GW Pharmaceuticals' potential treatment for
ulcerative colitis missed its primary endpoint in a
Phase II trial and was not well-tolerated, a setback
for the U.K. drugmaker and its pipeline of
cannabinoid treatments.
IPO – Forward Goes Backward – One of the more
widely anticipated debuts, Danish drug developer
Forward Pharma (FWP) priced its IPO at $21 which
was above the initial range. Unfortunately, timing
was poor and the deal quickly traded down to ~$16.
Forward's lead treatment is FP187, a compound in
Phase III trials for MS that uses a proprietary
formulation of dimethyl fumarate (DMF), the same
active ingredient in Biogen's Tecfidera. Forward will
likely face Biogen in court as an IP battle is about to
be waged. At the time of publication, the stock has
recovered although still sits below the IPO price.
The Netherlands' Forbion Capital Partners has
raised $120 million with plans to stake a new
generation of biotech companies. Forbion expects to
raise up to $250 million in this third fund of theirs,
enough to support 12 to 15 investments in
therapeutics, devices and diagnostics. Among the
group's recent exits are Santaris Pharma, sold to
Roche for $450 million; Bluebird, which pulled off a
$116 million IPO last year; and BioVex, which
Amgen acquired for up to $1 billion.
Focus On MTSL News Now and Future – This
Issue will focus on the plethora of news flow in our
Universe, keeping subscribers well informed and
ahead of the curve. With the recent sharp pullback
most of the companies continue to trade below our >
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
BUY LIMITS. Although we believe they are still
undervalued, the majority of our companies have
bounced off their recent lows by 10-20%. In our view,
however, the market has given us a tremendous
opportunity in MDCO and SGMO shares at current
levels. Except for CELG and SGMO, the remainder
of our universe will be reporting Q3:14 earnings and
holding conference calls between now and the next
Issue.
CLINICAL TRIALS WATCH – Relevant New
Studies or Changes Posted on ClinicalTrials.gov
for our MTSL Portfolio and/or Related Companies
since last Issue:
ABBV – Study Evaluating ABT-199 in Subjects With
Relapsed or Refractory Non-hodgkin Lymphoma or
Multiple Myeloma
ALKS – A Drug-Drug Interaction Study of ALKS
5461 in Healthy Volunteers
CELG – Pharmacokinetic and Safety Study of Nab®Paclitaxel (ABI-007) Plus Gemcitabine in Subjects
With Advanced Pancreatic Cancer Who Have
Cholestatic Hyperbilirubenemia
CELG – Efficacy and Safety of Intramuscular PDA002 in Subjects Who Have Diabetic Foot Ulcer With
Peripheral Arterial Disease
CELG – The Efficacy and Safety of Nab-paclitaxel in
Pretreated Patients With Extensive Disease of Small
Cell Lung Cancer
GILD
–
Safety,
Pharmacodynamics,
Pharmacokinetics, and Efficacy of GS-9901 in Adults
With Relapsed Follicular Lymphoma, Chronic
Lymphocytic
Lymphoma
Leukemia,
or
Small
Lymphocytic
INCY – Study of INCB039110 in Combination With
Docetaxel in Subjects With Non-Small Cell Lung
Cancer
INCY – Study of INCB039110 in Combination With
Docetaxel in Subjects With Non-Small Cell Lung
Cancer
INCY – An Open-Label Study of a Novel JAKinhibitor, INCB052793, Given to Patients With
Advanced MalignanciesCombination With Docetaxel
in Subjects With Non-Small Cell Lung Cancer
INCY – Ruxolitinib and Pracinostat Combination
Therapy for Patients With Myelofibrosis (MF)
NVAX – Placebo-Controlled Study to Evaluate the
Safety and Immunogenicity of the RSV-F Vaccine in
Elderly Adults
NVAX – RSV F Vaccine Maternal Immunization
Study in Healthy Third-trimester Pregnant Women
PCRX - The Transversus Abdominis Plane Block: A
Prospective Randomized Clinical Trial Using
EXPAREL.
PCYC – A Multi-Center Study of Ibrutinib in
Combination
With
Obinutuzumab
Versus
Chlorambucil in Combination With Obinutuzumab in
Patients With Treatment naïve CLL or SLL
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
PCYC – Tissue Collection for Biomarkers
Determining Resistance to Ibrutinib (CLARITY)
PCYC – A Study to Evaluate the Effects of Ibrutinib
on Cardiac Repolarization in Healthy Participants
PCYC – A Phase II Study of Ibrutinib Plus FCR in
Previously Untreated, Younger Patients With Chronic
Lymphocytic Leukemia (iFCR)
PCYC – Ibrutinib Post Stem Cell Transplantation
(SCT) in Double-Hit B-Cell Lymphoma
REGN – Study of REGN1500 in Patients With
Homozygous Familial Hypercholesterolemia (HoFH)
TGTX/PCYC – A Phase I/Ib Safety and Efficacy
Study of the PI3k Delta Inhibitor TGR-1202 and
Ibrutinib in Patients With Select B-Cell Malignancies
Company Updates
ALKS, CELG, ISIS, MDCO, NVAX,
PCRX, PCYC, SGMO
ALKS – FDA Accepts AL Filing, Getting Closer To
The Transformation – The clock is now set for
August 22, 2015 for the once-monthly schizophrenia
drug. The approval will be marketed directly by
Alkermes, which is establishing a premier antipsychotic franchise. The NDA filing includes the
positive results from the registration Phase III study
in which aripiprazole lauroxil demonstrated
significant
improvements
in
schizophrenia
symptoms, compared to placebo. The randomized,
multicenter, double-blind, placebo-controlled study
was successful at both doses tested – 441 mg and
882 mg – administered once monthly and met the
primary endpoint with statistically significant and
clinically meaningful reductions in Positive and
Negative Syndrome Scale (PANSS) scores. In
addition, AL met all secondary endpoints and
demonstratedXXXsignificantXXimprovementsXXXin
schizophrenia
symptoms
versus
placebo.
Aripiprazole lauroxil was generally well tolerated with
the safety profile was similar to that reported with oral
aripiprazole. The most common adverse events in
the study were insomnia, akathisia and headache.
ALKS continues to move aggressively forward with a
broad current, near-term long-term portfolio of valueadded compounds. Another clinical trial was just
posted on Clinicaltrials.gov (see above) for ALKS5461, another major growth driver being developed
for major depressive disorder. ALKS is BUY under
55 with a TARGET PRICE of 75.
CELG – Celgene’s GED-0301 Delivers Positive
Phase II Crohn’s Data; Strong Q3:14 Financials &
Otezla Gains Psoriasis FDA Label – Celgene
released positive Phase II results for their potential
blockbuster drug candidate, GED-0301, for the
treatment of Crohn’s disease patients who are
steroid-resistant or refractory.
In a 166-patient
Phase II study, GED-0301 met the primary endpoint
of statistically significant remission rates at four
weeks of therapy. The high dose (160mg) reported a
65% remission rate. The middle dose (40mg)
demonstrated a 58% remission rate and the low dose
(10mg) reported a 12.2% remission rate which was
not statistically significant. Placebo patients had only
a 9.5% remission rate.
Most importantly, the positive results seem durable
and showed at 12 weeks GED-0301 continued to
demonstrate statistically significant, better remission
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
rates. The high dose (160mg) reported 67%
remission rate. The middle dose (40mg) 63% and the
low dose (10mg) 29%. The placebo rate was low at
21%. Questions still remain regarding long-term
efficacy and side effects, and those will be answered
in the Phase III studies. Partially supporting this is
the fact that in the trial patients still did well 10 weeks
after stopping the drug, hinting at its efficacy long
after stopping treatment. Recruitment for Phase III
studies is expected to begin by the end of the 2014,
and one-year maintenance duration trial is planned,
which would lead to a launch ~2018.
GED-301 appears rather competitive when
compared to the blockbuster anti- TNF drugs. The
data for GED-0301 at the 40/60mg dose level (2
week & 4 week) showed superior remission rates of
55%/65% vs. Remicade and Humira (4 weeks only)
of 48% and 12% respectively. The drug candidate is
oral, has few side effects and greater ease of
administration than the injectable anti-TNFs. These
novel drug profiles have the potential to cause a
revolution within a given therapeutic area, which was
discussed last year in MTSL Issue entitled “Oral
Arguments,” as new targeted therapies replace
current injectable or intravenous market leaders.
Q314 Financials – CELG beat Wall Street estimates
this week when they reported an EPS of $0.97
versus consensus EPS of $0.95 on revenues of
$1.98 billion versus a consensus estimate of $1.96
billion. The primary driver for the company is
Revlimid which came in at $1.3 billion slightly above
consensus estimate of $1.26 billion, and represents
a 7% increase quarter-to-quarter. CELG has also
raised 2014 revenue guidance to “exceed” $7.6
billion versus their previous guidance of “exactly”
$7.6 billion. The pipeline remains unprecedented
with the number of projects under development at all
stages of development.
Also since the last Issue, Otezla received it psoriasis
label from the FDA on target – significantly
expanding the drug’s patient population. While the
quarterly sales were below consensus, the new label
will lead to greater usage right away.
Expectations were very high for GED-301, and the
presentation in Vienna was well attended and well
received. Registration studies are still required, but
analysts are now beginning to discount ’301 in their
mid-term CELG models. The diversified pipeline is
hitting pay dirt. CELG is a BUY under 90 with a
TARGET PRICE of 115.
ISIS – Delivers Positive Phase II SMN Data in
Both SMA Infants & Children at WMS – ISIS
released anticipated incremental data for SMN-Rx in
infants and children with spinal muscular atrophy
(SMA) at the World Muscle Society (WMS)
Congress. The update represents an additional five
months of data since last reported at the American
Society of Neurology (ASN). Overall, 20 infants have
been dosed as of the 9/2 cutoff date, including 4
patients in the 6mg cohort (unchanged) and 16
patients in the 12mg cohort (up from 11). Patients
who have completed the 3-dose induction regimen
(per protocol efficacy population) include the four
6mg pts and twelve 12mg pts. In the 6mg cohort, the
median event-free survival (EFS) is up to 16.3
months, and is 13.8 months in the 12mg cohort.
While we are cautious when using historical control
comparisons, in our view, this data is quite
encouraging when compared to the ~10.3 month
EFS seen in Dr. Finkle's recently published natural
history study. Additionally, infants in the 12mg cohort
showed a mean 11.7 point increase in CHOPINTEND (vs. an average 1.27 point/year decline in
the natural history study). Lastly, the data is
supported by spinal cord tissue samples from SMA
infants that shows increases in SMN protein in ISISSMN-treated infants, suggesting that ISIS-SMN is
acting by the mechanism of action through which it
was designed to act.
In the ongoing, open-label study in children with SMA
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
increases in muscle function scores, as measured by
the Hammersmith Functional Motor Scale-Expanded
(HFMSE), were observed in children treated with
multiple doses of ISIS-SMN. As previously reported
at ASN in April 2014, children in the 3 mg, 6 mg and
9 mg cohorts achieved mean increases from
baseline
of
1.5,
2.3
and
3.7
points,
respectively. Further evaluation of these children
showed that the previously observed mean increases
in muscle function scores continued to show
increases from baseline for an extended period after
their last dose with mean increases from baseline of
1.7, 3.2 and 2.3, respectively. There has been some
criticism that the data lost its dose response with the
6mg dose now stronger than the 9mg dose. This
ignores the fact that these patients are all showing
increases in HFMSE, a major victory with a
degenerative disease. Even if ISIS-SMN was just
maintaining muscle function as measured by HFMSE
it would still be an intriguing drug candidate for the
infants and children facing death or severe lifelong
disability. In our view, ISIS-SMN’s ability to improve
HFMSE scores is clinical proof that it could be a very
real drug for SMA patients.
SMN-Rx Continues To Be Well-Tolerated – At the
WMS, 20 infants have been exposed to 6mg or 12mg
SMN for a total of 67 intrathecal injections. As of the
same time point, 56 children have been exposed to
doses ranging from 1mg to 12mg of SMN for a total
of 183 doses. The lumbar puncture procedure
continues to be well tolerated for both infants and
children. Importantly, there continues to be no drug
related serious adverse events.
Phase III Development – ISIS is now recruiting
~110 SMA infants for the Phase III trial (ENDEAR),
with the goal of testing how well SMN can improve
survival and forestall the need for ventilation. The
company is also on schedule to launch a second
pivotal trial (CHERISH) later this year in children with
SMA.
In sum, we are encouraged by the combination of
infant event-free survival compared to the natural
history and the improvements in muscle function
delivered by SMN in Phase II to date. In our view,
the mechanism of action data is also pointing in the
right direction. SMA represents a multi-billion dollar
opportunity with market estimates showing that SMA
effects approximately 30,000-35,000 patients in the
US, EU and Japan, and that one in every 10,000
children born will have SMA. ISIS also has an
excellent partner for SMN in BIIB and is in line to
receive escalating high, double-digit royalties. ISIS
is a BUY under 55 with a TARGET PRICE of 70.
MDCO – Q3 Results Highlight Underappreciated
Pipeline; Actavis Purchase of DRTX Underscores
New Antibiotics Market Potential; Orbactiv
Studies Published; Co. To Host NYC Analyst
Meeting On 11/5 – While third quarter results
included slightly below consensus Angiomax sales
(mostly due to inventory build in Q2 vs. Q3, and
weak EU markets), to us the pipeline continues to
progress, as the Company adds another novel new
compound to the long-term outlook. As a reminder,
Angiomax is not a growth driver and not a reason to
own MDCO. In our view, the stock reflects a
complete loss of Angiomax patent protection by next
year or so (instead of 2019 which the company
continues to defend its position). The near-term
pipeline includes 7 NDA or EMA decisions within the
next year for cangrelor, Orbactiv, Ionsys and Replixa.
Orbactiv was launched domestically two weeks ago,
and has meaningful competitive advantages (see
below). Minocin IV was also launched just in the
hospital as well. The company is confident that it has
successfully answered the four FDA issues from
negative advisory panel earlier this year. A resubmission is due shortly and a six-month review is
expected. An EU submission is due by year-end,
with a Q1:15 opinion and potential approval 76 days
after that. Nonetheless, expectations for cagrelor
remain low. Ionsys has an April 15th PDUFA date.
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
Replixa, a unique powder for hemostasis, has been
filed in the U.S. and overseas. Hence, the near-term
pipeline will result in a number of catalysts and 4-5
global launches by next year.
The most exciting and yet underappreciated chapter
of the MDCO investment thesis is the long-term
pipeline. Four major compounds include a)
carbavance (antibiotic resistance); b) PCSK-9 RNAi;
c) APO-A1 and d) ABP700, a new short-acting
anesthetic with similar properties to propofol but with
a much cleaner side effect profile. Either one of
these compounds has blockbuster potential – and
may participate in major drug and biopharmaceutical
markets. PCSK-9 compounds – the new class of
super LDL cholesterol drugs (AMGN and
REGN/SNY) – are led by monoclonal antibodies with
impressive profiles and are about to be
commercialized. The MDCO/ALNY version, in early
studies, appears to have an even wider therapeutic
window and easier administration. APO-A1, the
major subject of a NY Times/NEJM paper in June
showing key cardiovascular benefits (e.g., ISIS has a
novel APO compound in the clinic), will present new
data at next month’s AHA meeting. Finally, ABP700
has impressed management enough that it will
exercise its option to acquire the company where it
came from, Annovation Biopharma, in H1:15. While
investors
remain
focused
on
Angiomax
predominantly, we remain steadfast that this pipeline
will eventually be reflected in MDCO’s valuation.
On October 6, Actavis purchased antibiotic small cap
maker DRTX for $675 million in cash (plus another
potential 20% based on sales milestones). The
acquisition is based solely on the recent approval of
Dalvance, a novel gram-positive antiobiotic that will
compete
directly
with
MDCO’s
Orbactiv.
Subsequently, two registrational trials of Orbactic
(oritavancin) were published in the recent Journal of
Clinical Infectious Diseases. The SOLO II clinical trial
studied Orbactiv (oritavancin) as a single dose
treatment of acute bacterial skin and skin structure
(ABSSS) infections caused by gram-positive
bacteria,XXXincludingXXXmethicillinXXXXresistant
staphylococcus aureus (MRSA). MRSA remains a
major epidemic in hospitals, the key target market for
MDCO’s salesforce. In addition, with its single dose
profile (vs. 2x per day for Dalvance), we believe
Orbactiv is in excellent competitive shape.
MDCO is shockingly undervalued to us. As of this
writing MDCO’s market cap is $1.3 billion. Excluding
Orbaciv, total revenues for 2014 which will be
approximately $750 million. Including the earlier
compounds, MDCO may introduce possibly ten new
products over the next several years. Also as of this
writing, Bridger Management, one of the most
sophisticated and value-oriented health care
investors, filed a passive 5.1% stake in MDCO. The
Company will hold an Investor & Analyst Day in NYC
on November 5. MDCO is a BUY under 42 with a
TARGET PRICE of 60.
NVAX – RSV Vaccine Begins Key Elderly Trial;
RSV Trial Published & Data will be Presented at
Important Vaccine Conference; SNY Inferior
Pandemic Vaccine Trials Published; Some
Insider Buying – The elderly study will be the
fastest path to market for the RSV vaccine. The
longer-term data from the previous trial in this
population is the basis for this next study and the
follow on offering in June. The Phase II trial is a
traditional design with a solid sample size – a
randomized, observer-blinded, placebo-controlled
study in 1,600 elderly subjects (>60 years of age) –
at ten sites in the United States. The trial will
evaluate the incidence of all respiratory illnesses due
to RSV, including medically-attended respiratory
illnesses due to RSV, and hospitalizations for
respiratory illness NVAX will also evaluate the safety
and immunogenicity of a 135ug dose of the RSV F
Vaccine compared with placebo. The trial will also
estimate the efficacy of the RSV F Vaccine in
reducing the incidence of respiratory illnesses due to
RSV. Results will be due after the RSV/flu season
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
most likely in Q2/Q3:15. After the pregnancy study
announced last month, it is the second RSV trial
starting this Fall; a third one in pediatrics is also due
to begin shortly.
For some time we had expected NVAX to publish
data on its RSV vaccine. On October 15, the gold
standard paper for vaccines, ironically called
Vaccines, delivered the first printed preclinical results
entitled, “An insect cell derived respiratory syncytial
virus (RSV) F nanoparticle vaccine induces antigenic
site II antibodies and protects against RSV challenge
in cotton rats by active and passive immunization.
Highlights include the following:
• RSV F nanoparticle vaccine induced palivizumab
competing antibodies (PCA)
• PCA is in excess of serum protective levels than IM
injected palivizumab
• Live virus infection induces little or no PCA
• Passively administered RSV F antibodies protects
cotton rats against RSV virus
• RSV F vaccine does not induce disease
enhancement in comparison to Lot 100 FI-RSV.
RSV Data to be Presented at Important Vaccine
Meeting – Gregory Glenn, M.D., Senior Vice
President, Research and Development at Novavax
will present new immunogenicity data from Novavax'
RSV F-Protein Nanoparticle vaccine candidate (RSV
F vaccine) clinical trials at the 8th Vaccine & ISV
Congress to be held October 26-28, 2014 in
Philadelphia, (http://www.vaccinecongress.com/).
The session presentation title, date and time is listed
below:
The data continues to show that NVAX’s vaccine
candidate is as good if not more protective than
Synagis (palivizumab). For our susbscribers’
information, we covered MedImmune as analysts
during the entire clinical process and launch of
Synagis. That is why we are so confident in the Fprotein vaccine at Novavax. It is relatively easy to
compare what is approved and what trials got it
approved to the NVAX trials. As another reminder,
more than a third of NVAX employees currently are
ex-MEDI employees.
On October 8, Sanofi published results of its H7/N9
vaccine in JAMA. The results portray an inferior
profile to the NVAX vaccine – just 59% of subjects
(n=700) responded with protection and those needed
a high-dose adjuvant (MF59) and no responses were
seen without adjuvant. In the NVAX trial released
last month 89-100% showed seroconversion with a
tiny adjuvant dose (n=610). In our view, NVAX easily
remains the leader in the development of an H7/N9
vaccine.
A few insiders – CFO and SVP manufacturing –
both took advantage of the market’s dislocation and
purchased stock around the $4.15 level. In our view,
it is yet another positive sign of confidence in the
outlook of NVAX. Lastly, with all the Ebola headlines
of late, we have received questions as to whether or
not NVAX is making an Ebola virus vaccine. Frankly,
while we do believe they may be conducting Ebola
virus research (e.g., CEO Erck was quoted as such
in two recent articles), they have yet to announce
anything publicly. We are long-term investors and
believe the entire NVAX portfolio and VLP platform
are quite valuable. NVAX is a BUY under 6 with
TARGET PRICE of 13.
Vaccines against Viral Pathogens
Sunday, October 26, 2014, 3:10 to 3:15 p.m.
Immunogenicity of the RSV nanoparticle vaccine in
humans and the induction of palivizumab competing
antibodies: Review of immunogenicity data from 4
recent clinical trials.
PCRX – EXPAREL Nerve Block Follow On
Suggests Similar Safety Profile As Placebo – The
analysis is based on six clinical trials and were part
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
of an oral presentation at the annual meeting of the
American Society of Anesthesiologists (10/11-15,
New Orleans). The comparative analysis showed all
groups experienced a similar rate of adverse events
(AEs) — 76% for EXPAREL vs 76% for placebo vs
61% for bupivacaine HCl — and that these appeared
to be related to the procedure or opioid rescue rather
than the study medication itself. The most common
events were in the gastrointestinal disorders class,
followed by general disorders/administration site
conditions and nervous system disorders.
This is PCRX’s first comprehensive review of the
peripheral nerve block program and it reinforces the
safety profile of the product. As a result, EXPAREL
may improve patient quality of life by providing
longer-term, safe, postsurgical analgesia while
eliminating pumps and catheters. Furthermore, the
drug will also save money by conserving hospital and
provider resources typically associated with the
placement and management of continuous nerve
blocks. PCRX will report earnings on October 30.
PCRX is a BUY under 75 with a TARGET PRICE
of 105.
PCYC – An Awesome & Busy Period for
Imbruvica – Since the last Issue alone, PCYC has
announced the following:
• Formed a collaboration with Bristol Myers to test
Imbruvica in combination with Opdivo (nivolumab),
BMY’s leading PD-1 inhibitor. It is Imbruvica’s first
foray into immune-oncology (see BSA above).
• Received full European Union approval in R/R
CLL, front line del p17 CLL and R/R MCL via
partner and global powerhouse Janssen (JNJ).
• Formed a collaboration with Roche/Genentech to
test Imbruvica in combination with Gazyva –
probably the leading combo for current patients.
• Filed an sNDA for Imbruvica in Waldenstrom’s
Macroglobulimia (WS) – of which it received BTK
designation last year; hence we expect rapid
FDAXOK.
• Initial full-week October prescriptions have started
off strong, signaling a solid end of year
performance.
• Company raised Imbruvica’s price by 7% in early
September.
• Seven new Imbruvica trials were posted on
Clinicaltrials.gov (see above). There are now 75
trials posted that have either been completed, are
underway and/or about to begin.
Each one of these events is positive, continues to
broaden usage and helps further establish
Imbruvica’s dominant position in oncology.
Furthermore, taken together they tell us that the
drug’s life cycle is in the earliest of the stages – it has
been on the market for less than a year; despite a
relatively narrow initial label, sales are already
annualizing at a ~$600 million run rate; and the exUS markets – where almost every new cancer drug
surpasses its domestic sales – are about to begin
commercialization. It is important to understand that,
with a duration of action that is approaching three+
years, a rising
percentage of 2014 Imbruvica
patients will remain on drug for 2015 as well.
Therefore, we expect year-over-year sales growth
could double when one includes upcoming foreign
launches. As time goes on, healthier patients will
start on Imbruvica and remain on drug even longer
than the initial traunch. Management continues to
execute at a very high level.
PCYC – Meeting With Management Re-Affirms
Top Tier Likelihood – This Tuesday, we had the
opportunity to meet 1-on-1 with PCYC management
in NYC. Included were CEO Bob Duggan, COO
Maky Zanganeh, EVP Corporate Affairs Ramses
Erdtmann, and VP, Head of CLL Program Danelle
James. As true investors, we are less concerned with
quarterly sales forecasts, although we still expect
them to meet or exceed Q3 consensus of $140
million in Imbruvica sales. What intrigues us is the
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
company’s insight regarding their recent foray into
immuno-oncology and the solid tumor clinical
expansion for Imbruvica, plus the inflammation
program as the R&D pipeline is about to expand with
new, optimized BTK compounds. In addition,
witnessing the comraderie amongst the team, in our
view, this is an incredibly exciting (and always busy)
period for PCYC. Taken together with the events of
the past two weeks (see note above), we are more
confident than ever that this company is headed for
the Top Tier of biotechnology valuations.
I/O Begins - The recent deal with Bristol to test
Imbruvica with Optivo (PD-1 inhibitor) marks the
beginning of another new era of Imbruvica
development. Preclincal and anecdotal evidence
supported by the compound’s effects on the tumor
microenvironment,
coupled
with
ease
of
administration and unique safety profile make this
the ideal combination drug. There will likely be
additional collaborations with immuno-oncology
players (not unlike INCY’s IDO joint ventures). In
fact, the company is receiving almost 40 proposals a
week for combination trials from investigators and
other companies around the world. There are now 75
trials (completed, underway or about to start) with
Imbruvica posted on Clinicaltrials.org.
MM & Immune Function at ASH – We have always
been optimistic for the multiple myeloma potential of
Imbruvica
based
on
its
activity
in
the
mircoenvironment (see chart from Oncotarget, 9/12)
and its encouraging effects on osteoclasts (i.e.,
Blood 8/12). Hence, an update at ASH will finally
reveal if the drug can find a place in this big market –
consensus expectations are almost zero.
entitled “Introducing The AutoImmune Program, The
Next Chapter.” While we may have been a bit early
in our analysis, we expect this to emerge soon and
add yet another major long-term growth driver. The
first compound(s) is currently in an RA trial (US
patent expires in 2035), and the company
(conservatively) expects to report results in H1:15.
However, like the R/R CLL indication, PCYC will take
the lead BTK inhibitor for inflammation into a niche
condition that the company can dominate, enroll key
opinion leaders and (maybe once again) change the
paradigm. Subsequently, various additional studies
will be conducted to broaden clinical (and eventual
commercial) applications. As a reminder, the
company owns full rights to BTK (and Imbruvica) in
inflammation (although JNJ has rights to the GvHD
trial that is underway). In the meanwhile, the
Company continues to be granted U.S. patents on
additional BTK compounds.
Imbruvica Keeps Widening Space Between The
Competition – The recent Roche collaboration
testing Imbruvica with Gazyva is yet another
admission by the majors that Imbruvica is an
important component to the current standard of care.
The fact that doctors are much more familiar with
(and get paid to give) Rituxan makes the joint
venture important for PCYC to gain further inroads
with more oncologists. In addition, PCYC has a trial
underway with Imbruvica vs. Imbruvica + Rituxan >
ONCOTARGET Chart:
In addition, ASH presentations will discuss the recent
T1/T2 impact of ibrutinib that led to the BMY
collaboration.
Inflammation – Mimicking Imbruvica – Back in
February, we published what we believe to be the
most comprehensive inflammation report on PCYC
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Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
Rituxan in CLL, that we believe will be a win-win
regardless of the outcome. Gazyva is Roche’s new
Rituxan, a new anti-CD20 antibody that has some
direct tumor killing ability, but its efficacy will be
enhanced with Imbruvica (early combo studies have
resulted in 100% response rates). Hence, combining
the two newest leaders will, in our view, create the
ultimate new standard of care in CLL. With 75 trials
underway (7 alone posted the past two weeks), the
competition will never be able to catch up and more
likely, fall farther behind. ABT-199, the compound
most touted by PCYC naysayers, is not being heavily
invested in by ABBV besides CLL, notably delp17 (of
which PCYC just received front line approval in the
US and more recently the EU). The shortcomings of
‘199 are becoming increasingly evident by the lack of
an expanding clinical program by ABBV.
Overall, the situation could not be better for
PCYC. With Imbruvica on the market for less than
a year, it already has become the second best
oncology launch ever. The life cycle for such
dominant drugs in biotech is well more than a
decade (US patents expire end of 2028). It was
evident by our meeting with management (which
undertook a Wall Street marketing trip this week
led by JPM, Goldman Sachs and Nomura) – that
they are moving into high gear and steadily
accelerating. PCYC is BUY under 160 with a
TARGET PRICE of 200.
SGMO – Sangamo Provides Optimistic Q3 Update
& Remains Visible at Scientific Forums – SGMO
reported on progress with their HIV program which is
currently enrolling a Phase II trial in ~12 additional
subjects for functional control proof-of-concept.
Enrollment completion is anticipated by year-end,
which should lead to a data readout in 2015. The
company also reiterated timelines for upcoming IND
filings in Beta-thalassemia (partnered with Biogen)
by year end and two lysosomal storage disorders
(wholly owned) and sickle cell anemia (partnered
with Biogen) in 2015. On the Shire partnered
programs, SGMO noted that while timelines remain
uncertain in the wake of the Shire/Abvie breakup,
they are still guiding to IND filings for Hemophilia A,
B, and Huntington's disease in 2015. Importantly, the
company emphasized that from a technical/science
perspective, there are no outstanding issues with
Shire.
While SGMO has near term catalysts
including the Beta Thal IND filing and preclinical data
at ASH, 2015 will also be catalyst rich with the
aforementioned six INDs all on target to be filed next
year.
SGMO will present an overview of the SB-728-T
clinical program at a "bench to bedside" discussion
forum of the annual European Society of Gene and
Cell Therapy ESGCT meeting, October 23-26, which
will be held in The Hague. SGMO’s Dr. Gregory and
Sangamo collaborator Luigi Naldini, M.D., Ph.D.,
Director, San Raffaele Telethon Institute for Gene
Therapy (TIGET) will discuss the larger field of
genome editing, utilizing the company's HIV studies
as a model. They will also be discussing the use of
Sangamo zinc finger nucleases in preclinical and
research studies of SCID-X1, cancer and WiskottAldrich Syndrome.
Last week, SGMO’s Dr. Gregory presented an
overview of the SB-728-T program at the "Strategies
for an HIV Cure 2014" conference organized by the
National Institute for Allergies and Infectious
Diseases at the NIH. Earlier in October, SGMO’s Dr.
Nichol was invited to deliver the Foundation Lecture,
reviewing recent clinical data from the SB-728-T
program at the Autumn Conference of the British HIV
Association which was held in London, UK.
SGMO’s stock has not bounced back in the recent
biotech rally that has lifted many of the smaller cap
biotechs. With the Shire/Abvie merger done, Shire
has received a $1.6 billion breakup fee which could
easily be used for an acquisition. The rumor mill has
already churned out multiple potential targets
including BMRN, NPSP, SRPT, BLUE, ALNY, TKMR
www.bioinvest.com | 13
Medical Technology Stock Letter l Despite Extreme Volatility, Staying the Course
and ISIS. While any of these may make sense, in
our view, SGMO may be the most attractive. Shire
and SGMO already have a strong partnership and
Shire understands the potential of ZFN to be a
disruptive technology. At current prices, SGMO is
significantly undervalued and an acquisition offer
anywhere north of $20 would have to be seriously
considered by the company’s Board. SGMO is a
BUY under 20 with a TARGET PRICE of 30.
www.bioinvest.com | 14
Medical Technology Stock Letter | Despite Extreme Volatility, Staying the Course
“The Back Page”
Price (52-week)
# of
Mkt.
Value
Symbol
Company
Orig.Rec.
Lo
Hi
Current
Target
Shrs.
(m)
($mil.)
Recommendation
ALKS
Alkermes
10.13
34.28
54.25
45.28
75
140.3
6,176.0
BUY under $55
ANTH
Anthera
3.04
1.53
3.79
1.90
20
19.3
57.9
BUY under $6
BMRN
BioMarin
12.68
55.04
84.25
75.01
75
140.8
8,087.6
BUY under $55
CELG
Celgene
24.97
66.85
100.91
100.40
115
817.6
60,849.9
BUY under $90
CNDO
Coronado
6.63
1.25
3.31
1.79
N/A
35.2
61.2
HOLD
FPRX
Five Prime
16.29
8.02
23.33
12.09
32
21.40
275.8
BUY under $22
IMGN
ImmunoGen
4.86
7.70
18.19
9.22
20
86.1
983.3
BUY under $12
INCY
Incyte
5.88
35.21
70.86
54.95
85
170.6
8,692.1
BUY under $68
ISIS
Isis
7.63
22.25
62.66
42.37
70
115.1
2,938.5
BUY under $55
MDCO
Medicines Co.
31.98
19.92
41.28
21.99
60
61.8
1,619.8
BUY under $42
NKTR
Nektar
4.66
8.87
15.34
13.25
20
116.9
1,289.4
BUY under $13
NVAX
Novavax
2.44
2.68
6.95
4.99
13
208.5
871.5
BUY under $6
OGXI
OncoGenex
36.82
2.10
14.25
2.20
N/A
15.4
58.8
HOLD
PCRX
Pacira
15.78
45.68
109.94
104.13
105
33.7
2,534.6
BUY under $75
PCYC
Pharmacyclics
17.00
82.51
154.89
121.32
200
74.8
7,480.0
BUY under $160
SGMO
Sangamo
4.77
8.93
24.69
11.25
30
60.4
796.1
BUY under $20
The Trader’s Portfolio
The Model Portfolio
Company
Shares
Owned
Total Cost
Today’s
Value
LONG positions
Today’s
Value
LONG positions
27,189
90,560
Anthera
1,625
39,057
3,088
Coronado
3,700
24,776
6,623
Five Prime
2,900
40,420
35,061
Incyte
3,139
51,176
172,488
Isis
3,300
53,501
139,821
Medicines Co.
1,250
40,375
27,488
13,194
Nektar
6,000
36,411
79,500
86,125
Novavax
35,965
124,520
Anthera
2,875
68,731
5,463
Coronado
6,000
40,178
10,740
Five Prime
3,700
60,876
44,733
ImmunoGen
2,000
9,938
18,440
Incyte
3,662
42,500
201,227
Isis
4,750
58,333
201,258
600
19,380
6,500
63,277
Novavax
Total Cost
2,000
2,750
Nektar
Shares
Owned
Alkermes
Alkermes
Medicines Co.
Company
25,000
58,025
124,750
OncoGenex
2,000
62,495
4,400
Pacira
1,000
15,938
104,130
30,000
67,670
149,700
OncoGenex
3,000
63,892
6.600
Pacira
1,500
23,907
156,195
Pharmacyclics
1,000
42,804
121,320
Pharmacyclics
1,450
52,892
175,914
Sangamo
5,000
23,250
56,250
Sangamo
5,000
23,250
56,250
23-Oct-14
Equities
Cash
Portfolio
Value
$1,250,358
$61
$1,250,419
Position
Total
Margin
Portfolio
Value
$965,478
-$291,125
$674,353
www.bioinvest.com | 15
Medical Technology Stock Letter | Despite Extreme Volatility, Staying the Course
Benchmarks
NASDAQ
S&P500
Model
Trader’s
Last 3 weeks
0.5%
0.2%
9.8%
15.4%
2014 year-to-date
6.6%
5.5%
5.2%
7.1%
Calendar year 2013
38.3%
29.6%
103.4%
214.7%
Calendar year 2012
13.4%
15.9%
25.7%
68.7%
Calendar year 2011
-1.8%
0.0%
-3.2%
-16.0%
Calendar year 2010
16.9%
12.8%
19.6%
4.3%
Model Portfolio
Contact Info
The Model Portfolio is designed to reflect
specific recommendations. We began the
Model Portfolio on 12/23/83 with $100,000. On
4/13/84, we became fully invested. All profits
are reinvested. Stocks recommended since
then may be equally attractive, but may not be
in the Model Portfolio. Transactions and
positions are valued at closing prices. No
dividends are created, and a 1% commission
is charged. We don’t use margin. Interest
income is credited only on large cash
balances.
Medical Technology Stock Letter
John McCamant, Editor
Jay Silverman, Editor
Jim McCamant, Editor at Large
Mahalet Solomon, Associate
Joan Wallner, Associate
Trader’s Portfolio
The Trader’s Portfolio joined the Model
Portfolio on 1/6/05 with $500,000 and is
designed to take advantage of short-term
opportunities throughout the biotech sector. Te
Trader’s Portfolio will hold both long and short
positions in stocks, trade in options, and use
margin. These strategies increase risk.
Although there is no limit on the time any
purchase can be held, the time frame for most
investments will be weeks to months.
P.O. Box 40460
Berkeley, CA 94704
www.bioinvest.com
Tel.510.843.1857
[email protected]
New Money Buys (when under our limit)
1st Tier: ALKS, BMRN, CELG,INCY, ISIS,
PCYC
nd
2 Tier: IMGN, MDCO, NKTR, NVAX, PCRX,
SGMO
rd
3 Tier: ANTH, FPRX
*Change Recommendation
www.bioinvest.com | 16