Meeting the Demand for Pediatric
Halo Pharma’s chief executive talks about the growing industry trend and the company’s newly
established Pediatric Center of Excellence.
Halo Pharma recently launched its Pediatric Center
of Excellence to support the development and manufacture
of dosage forms tailored for pediatric indications. The con-
tract development and manufacturing organization (CDMO)
has been working closely with pharmaceutical companies to
apply its expertise in formulation sciences and its integrated
manufacturing capabilities across a broad range of scales
and dosage forms to overcome the challenges in develop-
ing pediatric dosage forms (PDFs) of already
approved adult dosage forms. Contract
Pharma had the chance to sit down with
Halo’s chief executive officer, Lee Karras, to
talk PDFs and Halo’s unique position in this
niche market space. —TW
Contract Pharma: What is driving the demand for pediatric dosage forms (PDFs)?
Lee Karras: I don’t know when it first
started but I know for a long time physicians have been using adult doses for pediatric indications and the FDA said we
don’t understand the safety profile of pediatrics so we need to make sure that the
pharma companies are developing dosage
forms that are not toxic for kids. Limiting
off-label use in pediatric patients is certainly something that is a very common
mandate by FDA.
Pharmaceutical companies are often
asked by FDA to conduct clinical trials
for pediatric indications of adult dosage
forms. The Agency has created exclusivity
around pediatric dosage forms to create
an incentive for companies to make the
investment in clinical studies for pediatric
patients to meet the pediatric safety profile and get the right dose to the patient.
Sustaining revenue growth through
pediatric exclusivity typically adds 180
days of intellectual property protection—
almost 6 additional months of branded
drug sales—which in some cases could
translate to billions of dollars of revenue.
If a patent is going to run out they can ac-
tually sell the product for six more months
in the adult dosage form and the pediat-
ric dosage form. One company we work
with has a product worth $5 billion a year
in sales. Do the math. An additional six-
months of exclusivity is worth $2.5 billion
in sales for the adult dosage form. So, pre-
venting the generic from coming out dur-
ing that time is a big deal.
CP: How active has Halo been in the PDF area?
LK: We’ve partnered with several pharmaceutical companies already to develop commercially viable PDFs that have received
both U.S. and international regulatory approvals. In addition, the company currently
has multiple clinical and commercial PDF
programs underway. In support of our Pediatric Center of Excellence, we’ve developed
the infrastructure, process trains and equipment needed for efficient, cost-effective, and
rapid production of small- to medium-scale
cGMP clinical drug products that are used
in pediatric clinical studies. We provide technical expertise needed to modify adult dosage forms for pediatric use. This may include
reformulation to enable a lower strength or
making changes to the adult dosage form to
improve patient compliance by making the
medication easier to take and/or taste better.
CP: What are common indications for PDFs?
LK: Everything Halo is involved with is in
the prescription field and we’re typically
focused on a couple key areas. Anti-infec-
tives are a big one along with central ner-
vous system (CNS) disorders, including
ADHD and depression. We make PDFs a
little bit in the pain management area and
for some specialty indications like cystic
fibrosis. We’re making one product right
now for cystic fribrosis typically given to
patients between 6 and 25 years old. It’s a
chronic disease so patients take the drug
every day or else they could die. You don’t
see a lot of PDFs in cardiac care just be-
cause kids don’t generally have cardiac is-
sues. There also are not a lot of oncology
pediatric products out there.
CP: What types of services does Halo offer?
LK: Our formulation development and
clinical manufacturing capabilities can
support a variety of oral solid and liquid
dosage forms suitable for pediatric applications, such as granules produced using
fluid bed technology and mini-tablets that
can be packaged into stick packs, powder in bottles for reconstitution, and our
liquid products, which are typically oral
solutions and suspensions that can also
be time release-based. We offer our customers over 40 years of commercial drug
manufacturing experience and a proven
track record of approvals with regulatory
agencies around the world.
CP: What are the challenges when developing PDFs?
LK: There are a number of challenges.
Scale is one. PDFs are generally not made
in the same scale as their adult counterparts because you’re dealing with a