Hovione Announces Successful End-of-phase 2 Meeting With the FDA and Outlines Phase 3 Program for Minocycline Topical Gel

Cork, Ireland (ots/PRNewswire) - Hovione announced details of its
planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3
development program for the treatment of moderate to severe
inflammatory rosacea. At a recent End-of-Phase 2 meeting with the
U.S. Food and Drug Administration (FDA), Hovione received guidance
for the design and clinical endpoints for HY01, topical minocycline
gel 3%.

Based on the review of the Phase 2 clinical trial which enrolled
270 subjects across 3 treatment arms (HY01 Gel, 1%, HY01 Gel, 3%, and
vehicle), FDA has supported advancement to Phase 3. The two, US
based, pivotal studies will enroll 750 subjects each with the primary
endpoints of absolute reduction in inflammatory lesions at week 12
compared to baseline and the achievement of "clear" or "almost clear"
and a 2-grade reduction on the Investigator Global Assessment.
Additionally, Hovione will complete a maximal use study in subjects
with papulopustular rosacea. Assuming replication of the clinically
significant improvements in subjects with moderate to severe
papulopustular rosacea observed in Phase 2, Minocycline Topical Gel
may offer a safer alternative to modified-release doxycycline, which
is the only tetracycline approved for the treatment of inflammatory
lesions of rosacea1. If approved, Minocycline Topical Gel will
provide an important alternative treatment option targeted to the
site of action and as thus avoiding the systemic side effects of oral
doxycycline.

Hovione's topical minocycline is the only program under
development that uses a proprietary, crystalline form of the drug as
minocycline base, conferring differentiated properties of potentially
lower skin irritability based on its lower acidity and superior
stability, as compared to its generic alternative. Hovione has
secured patents for both the drug substance and the drug product
globally with exclusivity through 2033. Hovione's topical minocycline
uses a novel proprietary excipient that reduces Trans-Epidermal Water
Loss (TEWL) and provides a moisturizing, skin-barrier effect,
potentially conferring relief to dry cracked skin of some rosacea
patients. Minocycline is proven to have a potent anti-inflammatory
effect,2 potentially superior to other tetracyclines.

Guy Webster, M.D. Ph.D., dermatologist at the Sidney Kimmel School
of Medicine of Thomas Jefferson University stated: "Approximately
two-thirds of oral antibiotic prescriptions written by dermatologists
are for doxycycline and minocycline for either acne or rosacea. Both
compounds are only available for oral delivery and carry a risk of
side effects. Hovione's topical minocycline has a systemic exposure
1000 times lower than oral minocycline and provides a topical
alternative with a moisturizing formulation."

Hovione anticipates initiating the Phase 3 trial subject to
entering into a strategic collaboration with a commercial partner, by
fourth quarter of 2019, aiming at filing the NDA during 2021.

About Rosacea

Papulopustular Rosacea (PPR) is a chronic facial skin disease
presenting most commonly in adulthood, with an estimated 16 million
patients in the United States. PPR is characterized by inflammatory
lesions (papules, pustules) on the nose, cheeks, chin and forehead.
PPR has been shown to have a negative impact on quality of life.
Surveys conducted by the National Rosacea Society have shown that
approximately 70% of rosacea patients experience lower
self-confidence and lower self-esteem. Forty-one percent stated they
avoid public contact and cancel social engagements during an
exacerbation2.

Strategic Partnership

Hovione is seeking strategic partners with proven regional or
global commercial expertise in dermatology capable of maximizing the
value of the First Topical Minocycline Gel for Rosacea.

About Hovione

Hovione (http://www.hovione.com/) is an international company with
60 years of experience as a Contract Development and Manufacturing
Organization (CDMO) and is currently a fully integrated supplier
offering services for drug substance, drug product intermediate and
drug product. With four FDA inspected sites in the USA, China,
Ireland and Portugal and development laboratories in Lisbon, Portugal
and New Jersey, USA, the company provides branded pharmaceutical
customers services for the development and cGMP-compliant manufacture
of innovative drugs including highly potent compounds. For generic
pharmaceutical customers the company offers niche API products.
Hovione also provides proprietary product development and licensing
opportunities (http://www.hovione.com/products-and-services/proprieta
ry-product-licensing/partnering-opportunities) for drug products. In
the inhalation area, Hovione is the only independent company offering
a complete range of services. Please visit www.hovione.com

1. Two randomized phase III clinical trials evaluating
anti-inflammatory dose doxycycline (40-mg doxycycline, USP
capsules) administered once daily for treatment of rosacea Del
Rosso, James Q. et al. Journal of the American Academy of
Dermatology, Volume 56, Issue 5, 791 - 802
2. 2. Minocycline: far beyond an antibiotic. Garrido-Mesa N. et al.
British Journal of Pharmacology. 2013;169(2):337-352.
doi:10.1111/bph.12139

Contact
Isabel Pina, Director Corporate Communications
Tel.: 0035121-982-9362 - ipina@hovione.com

Business Development
Courtney Smith, Director of Business Development & Licensing
Tel.: +1-609-271-9569 - csmith@hovione.com

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