Nutrition segment
Our Nutrition segment sells lipid compositions and bioactive ingredients as
ingredients for infant formula, adult nutrition products and dietary supplements,
which we tailor to the special needs of the nutrition industry. These ingredients
are sold by us to three types of customers: (i) companies that manufacture the
end-product themselves; (ii) companies that outsource manufacturing of the end
product; and (iii) outsourced manufacturers of the end product.
InFat®
Soy-PS
K•REAL®, our
krill oil
PS Line of
Products
GPC Line of
Products
• A clinically-proven fat ingredient for infant formula that more closely
resembles the composition and properties of human breast milk fat.
• Offered by AL.
• A nutritional ingredient to improve cognitive and mental performance.
• Pure K•REAL®
• High Potency K•REAL®
• Custom made K•REAL®
• Sharp PS®
• Sharp PS® SILVER
• Sharp PS GOLD
• Sharp PS GREEN
• Sharp GPC
• Sharp GPC ACTIVE
InFat® — InFat is a clinically-tested lipid ingredient for infant
formula that enables infant formulas to more closely resemble the composition
and properties of human breast milk fat. The product was originally developed
by us and its initial sales, from 2004 to 2006, were made directly by us. In
2007, we entered into a joint venture with AAK relating to the production, marketing,
sale and distribution of InFat. As a result, all sales of the product are now
made through AL, the joint venture company. See “— Joint Venture
with AAK” below.
Human breast milk is considered the optimum nutrition for infants, as it provides
the perfect balanced diet to meet the needs of the growing child. Accordingly,
the ultimate goal for every infant formula producer is to offer a product as
similar as possible in its functional and nutritional benefits to human breast
milk. The special fat structure in human breast milk, which is known as sn-2
palmitate, is found in all women and offers clinically proven benefits for infant
development. Through the use of our proprietary technologies, we have developed
an enzymatic process to restructure vegetable oils into a sn-2 palmitate enriched
fat, the InFat ingredient for infant formula, which more closely resembles the
fat composition and properties of human breast milk fat.
Our published peer reviewed clinical studies demonstrate that formula containing
InFat provides infants with unique benefits, such as stronger bones, improved
intestinal flora and reduced crying, in addition to reduced constipation, improved
calcium absorption and more efficient energy intake.
The InFat ingredient sold by AL is customized according to customers’
requirements, ranging from a concentrate form of InFat to complete blends of
InFat with various additional vegetable oils for use by infant nutrition manufacturers.
Soy-PS® — Our Soy-PS product is a lipid ingredient. Our Soy-PS formulation
is derived from soybean lecithin and is designed to improve cognitive and mental
performance.
Krill Oil — We are a leading manufacturer of krill oil, a premium omega-3
bound to phospholipids. Our product, K•REAL®, previously known as
Krill Oil+, which was first commercialized in 2006, is manufactured by us according
to rigorous quality and freshness standards. Krill oil offers advantages over
competing products, such as fish oil, due to the bio-availability of krill oil
and the ease with which the omega-3 fatty acids are absorbed into the bloodstream.
Our krill oil also offers the additional benefits such as low smell and oxidation-resistant
krill oil compared to our competitors.
We offer the following krill oil products:
Pure K•REAL®, characterized by its purity, freshness, high stability
and low viscosity;
High Potency K•REAL®, which contains enriched levels of omega-3 fatty
acids, without dilution of the level of phospholipids found in pure krill oil;
and
Custom made K•REAL®, suited for specific customer needs, including
different grades of K•REAL®, more cost-effective K•REAL®
through the reduction of phospholipid levels, and the inclusion of higher levels
of certain ingredients as compared to our other K•REAL products.
K•REAL® is processed only from Antarctic krill, which we source from
vessels and facilities approved for food handling and storage by the appropriate
national food safety authorities. These vessels and facilities are also approved
by members of the Commission for the Conservation of Antarctic Marine Living
Resources, an international commission with responsibility for the conservation
of Antarctic marine ecosystems. We have conducted comprehensive safety evaluations
of K•REAL® krill ingredients and have determined them to be “Generally
Recognized as Safe” (GRAS) for certain food uses. We notified the FDA
of our GRAS determinations and the FDA issued a “no questions” response
letter advising us that the FDA accepts our conclusion that our K•REAL®
krill ingredients are GRAS. Further, as of 2015, the Novel Food status of K-REAL®
krill oil has been expanded to cover additional grades of the product.
PS line of products — This consists of a range of food supplements, containing
Phosphatidylserine, or PS, a phospholipid component of cell membranes and a
building block of the human brain. Research has indicated that PS has a role
in the proper signal processing and cell-to-cell communication functions of
nerve cells. These products are sold by us as a powder (generally for use in
tablets, capsules and functional foods) and as a liquid or dispersion (generally
for use in soft gels). This line of products includes the following:
Sharp PS® — Is a soybean-derived PS brain nutrient, introduced in
2003. It is a nutritional supplement for adults, intended to improve cognitive
capabilities, such as memory. Sharp PS is also shown to benefit other populations,
such as young persons, by improving memory, learning abilities and concentration.
Sharp PS SILVER® — Is a blend of two different active ingredients,
PS and omega-3, derived from soybean and fish oils, introduced in 2008. It is
intended to improve mental and cognitive abilities.
Sharp PS GOLD — This patented compound nutrient, introduced in 2006, offers
high potency PS together with targeted deliveries of DHA to the brain. It mimics
human PS found in the brain. Two versions of this product are available, one
derived from fish oil and the other from krill oil. Clinical trials have shown
that Sharp PS GOLD is effective in improving memory in elderly persons suffering
from age-associated memory decline.
Sharp PS GREEN — Is a soy-free PS food supplement, derived from sunflowers,
introduced in 2010, aimed at the large and growing market of health conscious
and environmentally-concerned consumers who demand clean, pure, soy allergen-free
and non-GMO (genetically modified organisms) ingredients. Sharp PS GREEN is
also offered in a special gummy-bears application intended for children under
our trade name SharpKidz.
GPC line of products — Consist of a range of food supplements, containing
L-Alpha Glycerylphosphorylcholine, or alpha GPC, a natural choline compound
found in the brain. Alpha GPC is the simplest phospholipid, and a key metabolite
in choline metabolism signaling. In addition, alpha GPC serves as an organic
osmolyte and assists in proper kidney function and may play a role in sperm
motility. Alpha GPC is naturally occurring in certain foods, such as milk, eggs
and meat, in low amounts. Alpha GPC is sold in the United States as a dietary
supplement and in Europe and South America as a drug for patients suffering
from dementia related to Alzheimer’s disease or cerebrovascular conditions,
such as strokes.
Our GPC products are sold by us as a powder (generally for use in tablets and
capsules) and as a liquid (generally for use in soft gels and drops).
This line of products includes the following:
Sharp GPC — This product, derived from soybeans and introduced in 2011,
is used for improving cognitive functions for different age populations. It
is also suitable for use by aging persons facing the deterioration of their
cognitive functioning. Sharp GPC is available in various forms, including a
powder (with 99% maximum purity) and a liquid (with 85% maximum purity) for
different applications.
Sharp GPC ACTIVE — This product, derived from soybeans and introduced
in 2011, is an alpha-GPC-based complex (comprised of 45% alpha-GPC), which has
the known beneficial value of GPC on human health, especially on cognitive function
and additional important biological activity, resulting from the presence of
other naturally occurring, lecithin-derived compounds. Sharp GPC ACTIVE is a
naturally-sweet, water-based platform, which is compatible with a wide range
of nutrients and does not require special preservatives.
We also have a nutritional ingredient product, InCog, which is an innovative
lipid composition for cognitive functioning. InCog has been approved as a Novel
Food in Europe and its further development is ongoing. We recently completed
a pre-clinical study in pre-term piglets. Pre-term pigs delivered at 92% term
were fed milk replacer supplemented with or without (control) InCog. Term pigs
euthanized at day 0 served as an additional control. Functional and structural
brain development was evaluated following 10 days of supplementation. Results
showed that InCog may enhance functional and structural development of the pre-term
brain, as demonstrated by increased brain and cerebellar growth, higher densities
of granule cells, and reduced N1 amplitude to the second tone measured by event-related
brain potentials (ERP). The results were presented at 30th International Conference
on Nutrition and Growth (Vienna, 2016) and at the Experimental Biology Meeting
(San Diego, 2016).
In 2014, we also began production and sale of Pro•krill, our first product
that is for uses other than human consumption. Pro•krill is an enriched
protein preparation left after the krill oil is extracted, which we are able
to access now that we perform krill oil extraction in-house. It has a unique
composition of amino acids making it a very good source of protein for aqua
culture.
VAYA Pharma segment
Our VAYA Pharma segment is dedicated to the discovery, development, manufacture
and marketing of innovative clinically-tested, effective and safe lipid-based
medical foods for the cardiovascular and neurological markets, as well as for
the pharmaceutical drug markets. Our VAYA Pharma segment currently offers the
following products:
Vayarin
Vayacog
Vayarol
For clinical dietary management of complex lipid imbalances associated with
ADHD in children.
For clinical dietary management of complex lipid imbalances associated with
early memory impairment.
For the clinical dietary management of certain lipid imbalances associated with
hypertriglyceridemia.
In the United States, each of the three products currently offered by our VAYA
Pharma segment is sold as a “medical food,” available only under
the supervision of a physician (either by prescription or acquired directly
from a physician in the context of the physician patient-relationship), meeting
the criteria for medical foods enumerated by the FDA.
Vayarin® — Vayarin® is an orally administered medical food for
the clinical dietary management of complex lipid imbalances associated with
attention deficit-hyperactivity disorder, or ADHD. It is used under the supervision
of physicians. Vayarin is aimed at children and pre-adolescents with ADHD, children
who are reluctant to start drug therapy or are intolerant to stimulant therapy,
or children with a more pronounced hyperactive-impulsive behavior, as well as
mood and behavior dysregulation. Vayarin contains Lipirinen, a proprietary composition
containing phosphatidylserine (PS) conjugated to omega-3 fatty acids enriched
with Eicosapentaenoic acid (EPA). Vayarin was first introduced in Israel in
2010 and in the United States in 2011.
Vayacog® — Vayacog® is an orally administered medical food for
the clinical dietary management of complex lipid imbalances associated with
early memory impairment. It is used under the supervision of physicians. Vayacog
is aimed at people with subjective memory impairment, those suffering from normal
age-associated memory decline and people with mild cognitive impairment (MCI).
Vayacog contains Lipicogen, a proprietary composition containing phosphatidylserine
(PS) conjugated to omega-3 fatty acids enriched with Docosahexaenoic acid (DHA).
Vayacog was first marketed in 2011.
Vayarol® — Vayarol® was initially introduced as a dietary supplement
in the United States in 2007 and as a medical food in 2011. In the United States,
it is now an orally administered medical food for the clinical dietary management
of lipid imbalances associated with hypertriglyceridemia. It is used under physician
supervision. Outside the United States, Vayarol targets those suffering from
hypertriglyceridemia, individuals who are reluctant to start drug therapy for
this condition, or those with borderline to moderate mixed hyperlipidemia. In
the latter case, it is administered to patients with mild elevation of LDL cholesterol
or who are intolerant to statins and other medications. Vayarol contains Lipirolen,
a proprietary composition containing phytosterol esters conjugated to omega-3
fatty acids enriched with Docosahexaenoic acid (DHA) and Eicosapentaenoic acid
(EPA).
While our current focus is to expand our three current products, we also have
a number of VAYA products in various stages of development.