Occurrence of serious procedure- or treatment-related
side effects could impede clinical study enrollment and receipt of marketing approval from the FDA, the EMA and comparable foreign
regulatory authorities. Adverse events could also adversely affect physician or patient acceptance of our product candidates.
Additionally if one or more of our product
candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number
of potentially significant negative consequences could result, including:
||regulatory authorities may withdraw approvals of such product and require us to take any approved products off the market;|
||regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies;|
||we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;|
||we may be required to change the way the product is administered, conduct additional studies or change the labeling of the product;|
||we may be subject to limitations in how we promote the product;|
||sales of the product may decrease significantly;|
||we could be sued and held liable for harm caused to patients; and|
||our reputation and physician or patient acceptance of our products may suffer.|
Any of these events could prevent us from
achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business,
results of operations and prospects.
We operate in highly competitive and rapidly
changing industries, which may result in others discovering, developing or commercializing competing products before or more successfully
than we do.
The biopharmaceutical and pharmaceutical
industries are highly competitive and subject to significant and rapid technological change. Our success is highly dependent on
our ability to discover, develop and obtain marketing approval for new and innovative products on a cost-effective basis and to
market them successfully. In doing so, we face and will continue to face intense competition from a variety of businesses, including
large, fully integrated pharmaceutical companies, specialty pharmaceutical companies and biopharmaceutical companies, academic
institutions, government agencies and other private and public research institutions in Europe, the United States and other jurisdictions.
Many of our potential competitors, alone or with their strategic partners, have substantially greater financial, technical and
human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining
FDA and other regulatory approvals of treatments and the commercialization of those treatments. Mergers and acquisitions in the
biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our
competitors. The commercial opportunity for our products could be reduced or eliminated if our competitors develop and commercialize
products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than
any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly
than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are
able to enter the market.
We believe that our key competitor product
candidates are (i) aducanumab (Biogen), gantenerumab (Roche) and BAN2401 (Eisai/Biogen) for crenezumab; (ii) CAD-106 (Novartis),
UB-311 (United Neuroscience) and ABvac 40 (Araclon Biotech) for ACI-24; (iii) AADVAC1 (Axon Neurosciences) for ACI-35; BIIB092
(Biogen), ABBV-8E12 (Abbvie) and LY-3303560 for anti-Tau antibody and (iv) Flortaucipir (Eli Lilly) and MK-6240 (Cerveau/Merck)
for Tau-PET imaging tracer, as described under “Item 4. Information on the Company – B. Business Overview – Competition”