Full Press Release Details
Pharmaceuticals, Inc.
210 Main Street West
Pharmaceuticals Announces Commercial Availability of Purified
Cortrophin Gel (Repository Corticotropin Injection USP) for Multiple Chronic
Autoimmune Disorders
Minn., January 24, 2022 - ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI
or the Company) today announced the U.S. commercial availability of Purified Cortrophin Gel (Repository Corticotropin Injection
USP) 80 U/mL. The commercial launch of Cortrophin Gel, an adrenocorticotropic hormone (ACTH), also known as purified corticotropin, is
being led by ANI's recently established rare disease business unit. Cortrophin Gel is indicated for the treatment of certain chronic
autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein
due to nephrotic syndrome. For full list of indications, please see below.
"Patients with certain chronic
autoimmune conditions often need additional treatment options," said Dr. Mary Pao Seideman, Chief Medical Officer of ANI.
"ACTH therapy can be effective across a number of inflammatory diseases. The reintroduction of Cortrophin Gel gives prescribers
another ACTH option, which can mean a greater chance for an effective treatment for some patients."
"Choice in the ACTH category is
long overdue, with only one available treatment option for over two decades. With today's full-scale commercial launch of Cortrophin
Gel, an established treatment, healthcare professionals now have another ACTH therapy option, with U.S.-based development, supply chain
and manufacturing," said Nikhil Lalwani, President and Chief Executive Officer of ANI. "This milestone is the culmination
of six years of hard work and dedication from ANI employees and external partners, building on ANI's long history and mission to
create high-quality medicines for patients in need. I am extremely proud of the high-degree of technical excellence employed by our team
in reintroducing this important treatment to a community long in need of alternatives."
"Our goal from the start has been
to ensure that Cortrophin Gel is available to as many patients who need it as possible," said Christopher Mutz, Head of Rare Disease
for ANI. "As part of our commitment to supporting meaningful access to Cortrophin Gel, we've launched our reimbursement and
access support hub, Cortrophin in Your Corner to provide commercial copay support and other reimbursement assistance
for eligible patients."
Cortrophin Gel is now available to healthcare
providers through a network of specialty pharmacies and distributors. For appropriate patients, physicians can submit a prescription
and initiate access to treatment through a specialty pharmacy by visiting www.cortrophin.com.
ANI is committed to establishing meaningful
access to Cortrophin Gel and has created Cortrophin In Your Corner, a dedicated program for patients and their caregivers
throughout the treatment journey that includes one-on-one access and reimbursement support, financial assistance for eligible patients,
and nurse-provided injection training. Cortrophin In Your Corner also provides access and reimbursement support for healthcare
professionals and their staff. To get started with Cortrophin Gel, call Cortrophin In Your Corner (available Monday-Friday
from 8 AM - 8 PM ET) at 1-800-805-5258.
Important Safety Information
Warnings and Precautions
for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage;
impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; and suppression of growth in children.
These are not all the adverse reactions reported with Cortrophin Gel.
Cortrophin Gel is a prescription medicine
that is injected subcutaneously or intramuscularly. It is indicated for:
Please click here for full prescribing
information for Cortrophin Gel.
About ANI Pharmaceuticals, Inc.
Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high
quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused
on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business
with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities.
For more information, please visit www.anipharmaceuticals.com.
Forward-Looking Statements
the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "anticipates,"
"will," "expects," "plans," "potential," "future," "believes,"
"intends," "continue," other words of similar meaning, derivations of such words, and the use of future dates.
These forward-looking statements include statements regarding the commercial launch of Cortrophin Gel, the potential benefit of Cortrophin
Gel to patients as a new treatment option, and the size of the market opportunity for Cortrophin Gel. Risks and uncertainties that may
cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements
include, but are not limited to, the costs involved in commercializing Cortrophin Gel, the ability to maintain regulatory approval
of the product and maintain sufficiency of the product, the ability to obtain reimbursement from third-party payors for this product,
evolving government legislation, the opinions and views of key opinion leaders and physicians who treat patients with chronic diseases
and who may prescribe Cortrophin Gel, manufacturing difficulties or delays, ANI's
ability to generate projected net product revenue and gain market share on the timeline expected, actions taken by competitors in response
to a new market entrant, ANI's reliance on third parties over which it may not always have full control, costs and regulatory requirements
relating to contract manufacturing arrangements, increased competition and strategies employed by competitors, uncertainties regarding
the COVID-19 pandemic, market trends for our products, regulatory environment and changes, and other risks and uncertainties that
are described in ANI's Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with
the U.S. Securities and Exchanges Commission.
forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current
beliefs, assumptions, and expectations. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or otherwise.
For more details, visit www.cortrophin.com.
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