19 februari 2007, 21:37
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#1
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HaarWeb lid
Geregistreerd: 9 april 2004
Berichten: 5.706
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Prx0002
Iets om de komende jaren af en toe nog eens met een schuin oogje naar te kijken, een Japans middel in ontwikkeling (op de website een 'immunomodulator' genoemd): http://www.polarisrx.com/products.html (incl. scammy foto's)
Persbericht:
Citaat:
Breaking into the Japanese Pharmaceutical Market: PolarisRx Corp. in-licenses potential medicine to treat post-menopausal balding in women
(PRLEAP.COM) February 16 2007 — PolarisRx Corporation (“PRX”), www.polarisrx.com , announces that it has signed an exclusive license agreement with an Israeli bioventure for a compound (PRX0002) that treats male and female balding (Alopecia, Androgenetic Alopecia and Chemotherapy induced Alopecia) for the territories of Japan, New Zealand, and Australia.
When PRX0002 was administrated I.V. concurrently with a chemotherapy treatment in a US FDA approved Phase 2 study, a "side-effect" was noticed: hair loss was prevented or significantly reduced for many of the patients treated. In a 3 pilot case-report study PRX0002 was shown to have hair growth potential in humans. In humans, PRX0002 induced hair growth in adolescents who remained affected with alopecia long after cessation of chemotherapy. It is hoped that orphan status will be granted for the small number of children that can never grow back their hair after chemotherapy.
Licensor is conducting a Phase 2, double blind, placebo controlled trial in 3 dose ranging groups for patients with alopecia due to chemotherapy, natural causes ( androgenetic ), and post-menopausal symptoms. No product has ever been able to show clinical efficacy in patients receiving chemotherapy and this will differentiate PRX0002 from all the other products on the market.
In total, an estimated $900 million is spent each year on efforts to regrow hair. Clearly, a large population of men and women eagerly awaits remedies for male and female pattern baldness. In Japan, on average 40% of patients may experience alopecia from chemotherapy which translates into 50,000 patients with chemotherapy induced alopecia. In Japan, 30% of the male population experiences balding, usually later in life after 45 years of age. This translates into about 18 million men. As many as 13% of premenopausal women reportedly have some evidence of androgenetic alopecia. However, the incidence increases greatly in women following menopause, and it may affect 75% of women older than 65 years, but in Japan this number is much less. The market for hair growth products for women in Japan is small; it is only approximately 5 billion yen but quickly growing.
PRX will oversee all regulatory and clinical development activities up until a pharmaceutical company with an appropriate sales force joins the team. The terms of the license include IPR and Know-how transfer from Licensor to PRX. PRX will be contributing all funds required to establish the business and meet the key objectives. Key milestones have been agreed upon that include substantial upfront and milestone payments from PRX to Licensor.
PRX0002 sales are expected in Japan no later than 2012 which will follow after US FDA approval. Milestones received up to 2012 are expected in the multi-million dollar range as well as multi-million dollar royalty payments after market approval for each indication.
Joe Baxter, Senior Vice President, PolarisRx commented:
"We believe that the Licensor’s expertise in this field combined with PolarisRx’s business and clinical development capabilities in Japan will create tremendous new opportunities in the well established balding market for men and women. For alopecia treatment, no company has ever developed a compound to prevent balding in chemotherapy patients and only one clinical product is available for treating post-menopausal women for this embarrassing disease."
PRX was established in 2006 by CEO, Yasuhiro Endo, DVM, PhD, a pharmaceutical industry veteran of 10+ years who served as a Head of Strategic Drug Development at Bayer-Japan where he was responsible for overall Japan development strategies and company-wide development portfolio. Other founders include CFO, Yukoto Motomatsu, who was the first person in Japan to make a JV deal with American Home Products and Joe Garrett Baxter, MSc., who worked for 4 years at an institutional investment company, ITX International Holdings, where he completed and directed 5 investments into US bioventures and medical device companies.
The value system of PRX is threefold: helping patients, creating value, and adhering to highest ethical and work standards.
PRX expects operating expenses to remain stable for the next 4 years with estimates of 750 million yen and revenue of 575 millionyen in 2007 growing to 1.55 billion yen in 2010 with break even target reached in 2008. PRX is planning IPO in Japan in 1H 2009.
PRX is currently conducting Series A investment round.
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