Category Archives: Almirall

Polichem, ALM12845, Almirall, P-3074, Topical Finasteride

Polichem Topical Finasteride Phase 3 Results Out

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Update: June 6, 2019: It seems like Polichem’s P-3074 will be called ALM12845 when finally released. Almirall just released its first quarter 2019 filings.

“The top-line Phase III results for ALM12845 (androgenic alopecia) in the EU show statistical significance for the primary end-point (Change of Target Area Hair Count) at week 24. We expect the submission in Europe of ALM12845 in Q4 2019.”

My guess is that a “submission” in Europe means the same as in the US: i.e., the company is filing for approval to sell the new drug after successful Phase 3 trial completion.

Polichem Almirall
Polichem (Almirall).
April 19, 2019

I have covered topical finasteride for hair loss on this blog numerous different times. This despite the fact that I am far more interested in topical dutasteride.

Polichem — Topical Finasteride Phase 3 Trial Results

Earlier today, Switzerland-based Polichem (now owned by Spain’s Almirall) finally released the results of its Phase 3 trials for its eagerly awaited P-3074 topical finasteride product. This came after many months of anticipation.

Edit: It seems like they released results in the EU last month, in a slightly different format to the US ones from today. I never wrote about this important development last month.

From what I can tell, both oral finasteride (105 test patients) and topical finasteride (48 test patients) seem to have given almost the same  results in increase in hair growth after 24 weeks.

Side effects between oral and topical finasteride also seem similar, although they are based on surveys of the patients rather than any scientific methodology.

I suppose many volunteers would drop out if they were asked to come in every couple of months for testing of erectile strength, hormonal blood tests, sperm count and so on. As it is, even in these trials, around 30 percent of subjects dropped out before the 24 weeks were over.

Most studies from the past several decades suggest very limited potential for long-term side effects from oral finasteride. If you do not believe those studies, you could still try out topical finasteride (available at most local compounding pharmacies).

3D Bioprinter, Almirall, Anthony Atala, COL17A1, Replicel, Senescent Cells, Takashi Tsuji, Wake Forest University

Biotechs Target Baldness Market

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Biotechs Target Baldness Market

— The latest issue of Nature Biology has an interesting article titled “Biotechs target stagnant baldness market.” My favorite and at the same time least favorite sentence from the article:  “It’s been 25 years since Propecia (finasteride), from Merck of Kenilworth, New Jersey, was approved by the US Food and Drug Administration (FDA) in 1992.”

— Thanks to commentator “nosyu” from Japan for posting a link with news from today regarding hair and skin focused Japanese company Adjuvant Cosmetics. It is partnering with Dr. Takashi Tsuji (RIKEN Center for Developmental Biology) and Organ Technologies to conduct joint research on product development for hair and scalp problems.

— Of all the researchers and companies involved in the hair loss world, Replicel has provided us with the most regular updates. This past month has been no exception. Here is a new video with Replicel’s CEO Lee Buckler starting his presentation at 16:11. The presentation was part of the Japan External Trade Organization (JETRO)’s “Investing in Japan” conference in Toronto, Canada that took place on January 29th 2016. The focus of the conference was on Japan’s booming regenerative medicine market. Lee also discusses Replicel’s partner Shiseido.

— Study from Japan suggests that COL17A1 (collagen gene) could be a new target for therapy in preventing hair loss.

— Kerastem clinical trial page was updated at the end of January 2016. Go under the locations section of that page to see if there is a clinic near you where you can volunteer. US only for now it seems.

— Excellent new article summarizing latest hair loss treatment options. One of the co-authors is the famous Dr. Antonella Tosti.

— Polichem (which is working on a topical Finasteride product called P-3074) was purchased by Spain’s Almirall. Also see this new positive study from Italy on P-3074.

— Irish men are increasingly opting for hair transplants like Wayne Rooney. Is a reduction in alcohol consumption next?

And now on to medical items of interest:

— Partisanship in the US hurting 21st Century Cures Act. Thank goodness for Japan, Canada, UK and probably some other countries by now.

— I have discussed Dr. Anthony Atala and the Wake Forest Institute for Regenerative Medicine several times on this blog before. This week, both were widely covered by the media due to the completion of their 3D bioprinter that can make bone, cartilage and muscle (a culmination of 10 years of work it seems). Full journal article here. No mention about hair in there, but a Canadian team’s 3D bioprinter related article from 2014 mentions the eventual feasibility of adding hair follicles to the new skin. Some quotes from Dr. Atala here.

— UK scientists get gene editing go ahead. Now western scientists may become less prone to criticize the Chinese too much like they did last year.

— Oldest heart transplant recipient dies 33 years after getting a new heart. Amazing story. In another article I read, his son said that he died from kidney problems and still had no heart problems.

— If you have older family members that you want to live longer, you might want to find a sketchy doctor who can help remove their senescent worn out cells without government approval.

— A major boost for cryonics.

— A major boost for cancer treatment (using immune cells).