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Tuesday, October 29, 2019

#BioPharma Snapshot; New Growth Strategies Continue for the Industry - (TSXV: $ICO.V) (OTCQB: $ICOTF) (NASDAQ: $ALXN) (NASDAQ: $BIIB) (NASDAQ: $ACHN) (NASDAQ: $PRVB)

#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 -, 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.

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

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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