Closely-held Peritech Pharma of Israel is in discussions with potential marketing partners for a U.S. launch of its once-daily over-the-counter gel, now known as PP-110, for the treatment of hemorrhoids.
“PP-110 contains the same active pharmaceutical ingredients as Pfizer’s Preparation-H cream: pramoxine-HCI 1% and phenylephrine-HCI 0.25%,” Raveh Gill-More, VP of business development, says in an interview with BioTuesdays.com.
“The differentiation with our product is the non-active ingredients, namely our film-forming formulation and slow release mechanism, leading to a long-acting effect,” he adds.
According to Mr. Gill-More, PP-110 gel forms a clear film in the rectal area in less than one minute. It is odorless and does not sting. “The film protects the area much like a Band-Aid and assures the active ingredients remain in contact with the tissue for a long time,” he contends.
PP-110 comes in two dosage forms: a gel in laminated tubes and medicated wipes in aluminum sachets. PP-110 is cleared for sale in the U.S. under the 1990 FDA anal-rectal monograph and is protected by a U.S. patent until 2034, as well as other IP.
Research suggests that 50% of adults will suffer from hemorrhoids at some point in their lives. In the U.S., 3%, or 6.7 million people, will have hemorrhoids on any given day. About 85% of American patients will seek treatment, many of them using Preparation-H, which has an approximate 50% share of the $400-million annual OTC hemorrhoid market in the U.S.
PP-110 is available as a gel in laminated tubes, or as medicated wipes in aluminum sachets.
The annual European market, led by Novartis’ Procto-Glyvenol, is similar in size to the U.S. market, with the annual market in Japan pegged at about $80-million.
Mr. Gill-More points out that Preparation-H has been around for more than 50 years and the only innovation in the sector, including private label competition, has been wrapped medicated wipes. Even though wipes are more expensive than creams, he points out that 50% of people with hemorrhoids prefer them because of their convenience.
In the first half of 2014, seven physicians in Israel recruited 101 patients in a randomized, open-label study that compared the safety and efficacy of PP-110 with Preparation-H Maximum Strength Cream over 14 days.
PP-110 in gel and wipes was provided to some patients once daily, while other patients received Preparation-H three-to-four times a day. Patients collected personal data in a diary for six clinical symptoms: pain, itching, bleeding, discharge, swelling and discomfort.
Patients receiving PP-110 gel reported statistically significant better results in the three most important clinical parameters related to common symptoms of hemorrhoids: pain, bleeding and itching.
“We found that the unique formulation of PP-110 provides a long lasting effect, and were extremely pleased to see that even once-daily application is sufficient, which offers patients a true improvement over current topical treatment,” Mr. Gill-More said. As an added benefit, patients are exposed to a fraction of the amount of active ingredients, compared with competing products.
In 2014, a randomized, open-label study was carried out in Isreal with patients receiving either PP-110 gel or wipes once daily, or Preparation-H three-to-four times a day.
Founded in 2012, Peritech also will be seeking approval to sell PP-110 in Europe, beginning in Germany to be followed by the U.K., France, Italy and Spain.
“In all probability, it appears that no additional clinical data would be needed for European marketing approvals,” Mr. Gill-More said. And regulatory approval in Europe would likely shorten timelines in the rest of the world, he added.
In its pipeline, Peritech also has developed a second OTC product, PP-120, for Pruritus Ani, which is chronic anal itching and affects 1% to 5% of the population.
PP-120 uses the same technology platform as the company’s hemorrhoid treatment, with a different active ingredient: hydrocortisone 1%, which is also found in Anti-Itch Preparation-H.
“Our second product has the potential benefits of once-daily treatment, with higher efficacy,” Mr. Gill-More suggests. It also would follow the same FDA anal-rectal monograph to be sold OTC in the U.S.
The study reported statistically significant better results in patients receiving PP-110 for the three most important clinical parameters related to common symptoms of hemorrhoids: pain, bleeding and itching.
He says the company has completed Phase 1 development of PP-120 and is preparing to submit the protocol for a randomized efficacy study in Israel.
Peritech also has a potential prescription treatment for anal fissures, PP-130, in its pipeline.
Peritech also has initiated development of a prescription product, PP-210, for anal warts, a condition caused by the human papilloma virus, which affects more than three million people in the U.S.
PP-210 is based on the company’s technology platform, containing the approved active ingredient, imiquimod.
Mr. Gill-More points out that there are several approved agents to treat anal warts but they require treatments that can take up to six weeks. The leading brand is Aldera, which costs $1,700 for a treatment course.
“We see the potential for a shorter course of treatment and higher efficacy with our product,” he adds.
Also in the pipeline, but not yet initiated, is a potential prescription treatment, PP-130, for anal fissures, a condition that affects some four million people in the U.S.
Mr. Gill-More says there is an FDA-approved cream, based on nitrates, for anal fissures. However, the active ingredient is absorbed systemically and can cause headaches.
“In our product, based on the company’s technology platform, the dosage would be reduced and we hope to reduce side effects accordingly,” he adds.
