#BioPharma Snapshot; New Growth Strategies Continue for the
Industry - (TSXV: $ICO.V) (OTCQB: $ICOTF) (NASDAQ: $ALXN) (NASDAQ: $BIIB)
(NASDAQ: $ACHN) (NASDAQ: $PRVB)
Point Roberts WA,
Delta, BC – October 29, 2019 - Investorideas.com, a leading investor news resource covering
pharmaceutical and biotech stocks releases a sector snapshot reporting on the
growth of the global monoclonal antibody market and how this is affecting
industry decisions moving forward.
Read
this in full at https://www.investorideas.com/news/2019/biotech/10291BioPharma-GrowthStrategies.asp
Why is this a sector to pay attention to? According to
recent industry
reports,“ The Monoclonal Antibodies market worldwide
is projected to grow by US$47.6 Billion, driven by a compounded growth of 6%..
Poised to reach over US$44.3 Billion by the year 2025, Inflammatory Disease
will bring in healthy gains adding significant momentum to global growth.”
As this segment of bio/pharma grows in size and scale, we
are seeing it become a more prominent focus for many companies in the industry.
At present, the global Monoclonal Antibody Based Products market is chiefly
driven by a number of outstanding firms and the major market players are
beginning to execute different growth strategies including new product
launches, strategic partnerships & collaborations, operational &
geographical expansions, joint ventures, mergers & acquisitions and sales
to grab a superior business position. Key players include Abbott Diagnostics,
Inc., Amgen, Inc., AstraZeneca PLC, Bristol-Myers Squibb Company and Eli Lilly
and Company.
Is there room for smaller players?
iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) thinks so. The
Company, which identifies existing development stage assets for use in
underserved ocular and infectious diseases, recently announced several corporate
developments related to their monoclonal antibody product, Bertilimumab.
iCo has been
monitoring a current US court-mandated auction process, with respect to
systemic uses of Bertilimumab, previously sublicensed to Immune
Pharmaceuticals. On October 21, 2019, the bankruptcy court in New Jersey
approved a sale order relating to the assignment of the sublicense of iCo's
assets to Alexion Pharmaceuticals (NASDAQ: ALXN) . With respect to
the court approved assignment to Alexion, iCo did not object and their rights
as the sub-licensor will continue under the sublicense agreement if Alexion
acquires the asset in accordance with terms submitted to the bankruptcy court.
Further approval by Israeli courts will be required. The company expects in the
coming weeks to comment on outcomes, a potential new partnership and next steps
for this asset.
Bertilimumab is a
fully human monoclonal antibody with specificity for human eotaxin-1 and
inhibits its function.
Favorable results
from pre-clinical assessments resulted in three clinical studies of
Bertilimumab conducted in the EU (a total of 126 patients – healthy
individuals, patients with a history of seasonal allergic rhinitis and
individuals with a history of seasonal allergic conjunctivitis) provided evidence
of good safety and tolerability of Bertilimumab when administered by the
intravenous (IV) or intranasal route as well as topical application to the eye.
More recently,
Bertilimumab has been investigated in two Phase 2 trials. The first trial
targeted patients with a skin condition called bullous pemphigoid and revealed
good safety and efficacy results. A second trial has been carried out in
patients with an inflammatory bowel disease called ulcerative colitis. Results
from this trial are still pending. A Phase 2 clinical trial for patients with
vernal keratoconjunctivitis and/or atopic keratoconjunctivitis (involving
cornea and conjunctiva) is in preparation. A number of other indications have
also been considered.
Therapy with
Bertilimumab could be useful in treatments of a number of diseases where
steroids and immune-suppressants or other drugs may need to be prescribed
chronically (a number of these diseases appear to be seasonal), often resulting
in adverse reactions that may become serious over time.
Separately, iCo has
also solicited bids from CROs for assistance with iCo's wholly-owned ocular
Bertilimumab asset. Currently the company expects to engage the Food and Drug
Administration regarding an additional Phase 2 study in ophthalmology, to be run
by the Company and/or prospective partners.
Biogen Inc. (NASDAQ: BIIB) and Eisai, Co., Ltd. recently announced that, after
consulting with the US FDA, Biogen plans to pursue regulatory approval for
Aducanumab, an investigational treatment for early Alzheimer’s disease (AD). Aducanumab is a monoclonal
antibody that is supposed to prevent or slow down neurodegeneration by removing
toxic beta-amyloid plaques from the brain in the early stages of this
condition.
The Phase 3 EMERGE
Study met its primary endpoint showing a significant reduction in clinical
decline, and Biogen believes that results from a subset of patients in the
Phase 3 ENGAGE Study who received sufficient exposure to high dose Aducanumab
support the findings from EMERGE. Patients who received Aducanumab experienced
significant benefits on measures of cognition and function such as memory,
orientation, and language. Patients also experienced benefits on activities of
daily living including conducting personal finances, performing household
chores such as cleaning, shopping, and doing laundry, and independently
traveling out of the home. If approved, Aducanumab would become the first
therapy to reduce the clinical decline of Alzheimer’s disease and would also be
the first therapy to demonstrate that removing amyloid beta resulted in better
clinical outcomes.
In the news, “Shares of Biogen
surged significantly after it announced new data on Aducanumab in patients with
early Alzheimer’s disease (AD). The company released results from a new
analysis of a larger dataset of the discontinued ENGAGE and EMERGE phase III
studies on Aducanumab in patients with early AD. This analysis was conducted in
consultation with the FDA. Biogen and Japanese partner Eisai had discontinued
ENGAGE and EMERGE studies, following a futility analysis. Nevertheless, the new
data showed that Aducanumab reduced clinical decline of Alzheimer’s disease in
such patients as measured by the pre-specified primary and secondary endpoints.
Based on this data, the company plans to submit a biologics license application
seeking approval of the drug to the FDA in early 2020. The company also
reported better-than-expected results for the third quarter of 2019, driven by
higher sales of key multiple sclerosis drugs and continued global launch of
spinal muscular atrophy drug, Spinraza.”
Based on discussions
with the FDA, the Company plans to file a Biologics License Application (BLA)
in early 2020 and will continue dialogue with regulatory authorities in international
markets including Europe and Japan. The BLA submission will include data from
the Phase 1/1b studies as well as the complete set of data from the Phase 3
studies.
The Company aims to
offer access to Aducanumab to eligible patients previously enrolled in the
Phase 3 studies, the long-term extension study for the Phase 1b PRIME study,
and the EVOLVE safety study. Biogen will work towards this goal with regulatory
authorities and principal investigators with a sense of urgency.
Biogen isn’t the only company to surge on recent
developments, as in recent news, “Shares of Achillion Pharmaceuticals Inc. (NASDAQ: ACHN), rocketed 82% in premarket trading
Wednesday (October 16th), after the biopharmaceutical company agreed to be
acquired by Alexion Pharmaceuticals Inc.
in a cash deal valued at $930 million. Under the terms of the deal, Alexion
will pay $6.30 for each Achillion share outstanding, which is 73% above
Tuesday's closing price of $3.65 and implies a market-capitalization of $880.05
million. The deal also includes potential for an additional payment for
Achillion shares in the form of contingent value rights (CVRs) to be paid if
certain clinical and regulatory milestones are achieved. The CVRs include $1 a
share for U.S. Food and Drug Administration approval of Danicopan and $1 a
share for ACH-5228 phase 3 initiation.”
Danicopan, Achillion's lead drug candidate has received
breakthrough therapy designation for treatment in combination with a C5 monoclonal
antibody for patients with a rare blood disorder, paroxysmal nocturnal
hemoglobinuria (PNH).
Provention Bio, Inc. (NASDAQ: PRVB), a clinical stage
biopharmaceutical company dedicated to intercepting and preventing
immune-mediated diseases, recently announced that the European
Medicines Agency (EMA) has granted PRV-031 (Teplizumab) PRIority MEdicines
(PRIME) designation for the prevention or delay of clinical type 1 diabetes
(T1D) in individuals at-risk of developing the disease.
PRIME designation is
awarded by the EMA to promising medicines that demonstrate the potential to address
substantial unmet medical need based on clinical data. The EMA considers PRIME designations a
priority and provides them with special support, including enhanced
interactions and dialogue, as well as a pathway for accelerated evaluation and
review.
"We are very
pleased the EMA recognizes the transformative potential of PRV-031 and has
granted this groundbreaking therapy PRIME designation", said Ashleigh
Palmerm CEO of Provention Bio.
"Following on the heels of Breakthrough Therapy Designation from the
FDA in August, EMA PRIME further validates the rationale for PRV-031 to prevent
or delay the onset of clinical T1D in at-risk subjects. We are committed to
working closely with both regulatory agencies to bring PRV-031, as quickly as
possible, to the many thousands of T1D at-risk individuals who currently have
no options to prevent or delay this catastrophic disease."
PRV-031's PRIME
designation was based on clinical data from the "At-Risk" Study
conducted by TrialNet, which demonstrated that a single 14-day course of
PRV-031 significantly delayed the onset of T1D, as compared to placebo, by a
clinically-relevant median of at least 2 years in children and adults at high
risk of developing clinical T1D.
PRV-031, also known
as Teplizumab, is an anti-CD3 monoclonal antibody (mAb), which is being
developed for the interception and prevention of type 1 diabetes (T1D). The candidate has been the subject of
multiple clinical studies involving more than 1,000 subjects with more than 800
patients receiving PRV-031 in those studies. In previous studies of newly
diagnosed patients, PRV-031 has consistently demonstrated the capability of
preserving beta cell function and reducing the need for exogenous insulin
usage.
Provention is
currently evaluating PRV-031 in patients newly diagnosed with clinical T1D (the
Phase 3 PROTECT Study). Additional
information on the clinical trial is available at www.clinicaltrials.gov.
As the Monoclonal Antibodies market worldwide is projected
to grow by US$47.6 Billion, driven by a compounded growth of 6% with
inflammatory disease displaying the potential to grow at over 6.4%, the
shifting dynamics supporting this growth make it critical for businesses in
this space to keep abreast of the changing pulse of the market.
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