FDA Orphan Product Status Approval for Regenicin’s Burns Treatment

Shares of Regenicin are expected to continue to increase as the micro-cap business plans to start the commercialisation of the US Food and Drug Administration (FDA) approved orphan product skin substitute for burn victims.

Shareholders pushed the shares 76.47% higher from $0.13 a share to $0.27 on Tuesday and increased even more after hours, after a late afternoon announcement that the company had been approved orphan product status by the FDA.

In excess of 4 million shares of the stock traded within a couple of hours, compared to a day-to-day average of 136K, after the organisation’s tissue replacement treatment, which creates a substitute skin to treat catastrophic burn victims using the patients’ own skin cells received the orphan product designation which shareholders had been waiting for.

Although Regenicin owns the license for the skin treatment, Swiss biopharmaceutical organisation Lonza Group holds the exclusive manufacturing rights for PermaDerm. Analysts see this as a treatment which could transform the way wounded soldiers and civilians recover from major burns and wounds.

Shares could increase considerably in the next few days as the corporation anticipates fetching as much as $300k per treatment for pediatric patients and near $600k per treatment of each adult patient.

While these prices may appear high, industry observers note that the therapy could save healthcare costs by decreasing the requirement for multiple surgeries, reducing the threat of infection and decreasing the time patients spend in intensive care units. The orphan status also provides the business with up to seven years of market exclusivity for treating up to 4,000 patients each year. The status also provides tax relief and numerous exclusions from certain fees.

PermaDerm is the only tissue-engineered skin prepared from autologous (patient’s own) skin cells from both the epidermal and dermal skin layers.  A small sample of the patient’s skin can be expanded in the laboratory to cover a wound site that extends over 50% of the patient’s body. These self-to-self skin grafts are intended to form permanent wound closure that is not rejected by the patient’s immune system, a critical possibility in porcine or cadaver skin grafts used today.

In November 2010, Lonza announced over $18 million in US defence funding to develop their skin substitute grown from the patient’s own cells. Soon after, in early January last year, Regenicin’s CEO, noted that that the burns treatment market in the US represents a $3 Billion dollar opportunity for the organisation.

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