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Clinuvel gets orphan status for Scenesse in HHD
By Dylan Bushell-Embling | Posted in Pharma & biopharma on 19 May, 2014
Clinuvel Pharmaceuticals (ASX:CUV) has been awarded orphan drug designation from the European Medicines Agency for Scenesse in the rare skin disorder Hailey-Hailey Disease (HHD).
Clinuvel is currently trialling Scenesse in HHD through a phase II trial in Italy, based on evidence that alpha-melanocyte stimulating hormone has protective and antioxidative effects in cutaneous cells. The active ingredient of Scenesse, afamelanotide, is an analogue of this hormone.
Orphan status will entitle Clinuvel to potential fee reductions, protocol and scientific assistance and - most importantly - 10 years of marketing exclusivity if Scenesse is approved.
HHD is an inherited, lifelong disorder characterised by plaque-like lesions, blisters and ulcerations on skin folds.
Clinuvel is also developing Scenesse as a treatment for erythropoietic protoporphyria (EPP), a disorder causing severe light intolerance, and is waiting the completion of an EMA review into the treatment.
In an announcement designed to address questions from shareholders about why the review process has taken so long, chairman Stan McLiesh and CEO Dr Philippe Wolgen said three factors are responsible.
First, no other melanocortin has ever been submitted to European regulatory bodies, they said. Second, this is the first time evaluation of light exposure is needed to be assessed in a submission.
Third, the EMA has to review safety data for afamelanotide for the last 20 years in general, and nine years in EPP.
The current EMA review is expected to be complete between July and October, but further reviews may be needed. EMA approval for Scenesse would trigger Clinuvel’s New Drug Application with the US FDA.
Vitiligo treatment holds promise for restoring skin pigmentation
This image shows the effects of the combination treatment on skin repigmentation, from top to bottom, at baseline, at 66 days and at 140 days of the study. Credit: Henry Ford Hospital
A treatment regimen is safe and effective for restoring skin pigmentation in vitiligo patients, according to a Henry Ford Hospital study.
"Our findings offer patients with vitiligo worldwide a renewed hope for a bright future in the treatment of this disfiguring disease," says Henry Lim, M.D., chair of Dermatology at Henry Ford and the study's lead author. "Patients with lesions on their face and arms could have a more rapid response to the combination treatment."
Henry Ford dermatologists described the repigmentation results as "superior," and said the treatment combination holds promise as a future therapy for the more than 50 million people worldwide living with vitiligo. It affects about one in every 100 people in the United States.
The study will be published online Wednesday in the Journal of the American Medical Association-Dermatology.
In a multi-center study led by Henry Ford, dermatologists sought to evaluate the safety and effectiveness of a treatment combination of afamelanotide, a drug that induces skin pigmentation, and phototherapy using narrowband ultraviolet-B rays (NB UVB). Phototherapy, or ultraviolet light therapy, is the treatment of choice for many patients with widespread vitiligo. It has been shown to be effective, though the degree of repigmentation varies.
Dr. Lim, an international vitiligo expert, says afamelanotide "enhances the ability of the UVB to induce repigmentation of the skin."
Patients were randomly divided into two study groups: Group A received the combination therapy; Group B received only NB UVB treatment.
Key findings:
Repigmentation occurred faster in patients who received the combination treatment compared to patients who received NB UVB.
Patients who received the combination treatment achieved appearance of pigment on their face and arms after 40 days compared to 60 days for patients who received NB UVB.
In dark-skinned patients, repigmentation occurred faster in the combination group compared to the NB UVB group.
Henry Lim, M.D., chair of Dermatology, Henry Ford Hospital, highlights the study. Credit: Henry Ford Hospital
Afamelanotide is in the process of being submitted for approval from the U.S. Food and Drug Administration for use in treating vitiligo.
Vitiligo is a skin disease that causes the skin to lose color and develop white patches that vary in size and location. It develops when cells called melanocytes are killed by the body's immune system, causing the area of skin to turn white because the cells no longer make pigment. Vitiligo is more noticeable in individuals with darker skin tones, but it affects all races and ethnicities.
While vitiligo is neither contagious nor life-threatening, there is no cure. However, it causes low self-esteem and depression for those living with the disease.
The Henry Ford study represents its latest research into investigating new treatment options for vitiligo. In a 2012 study published in the Journal of the American Academy of Dermatology, Henry Ford dermatologists showed the benefits of skin cell transplant surgery, called melanocyte-keratinocyte transplantation or MKTP. Henry Ford has since performed more than 190 MKTP procedures on patients from Michigan, 23 other U.S. states and Canada.
For this new study, 55 patients were enrolled at four sites – Henry Ford, Icahn School of Medicine at Mount Sinai in New York and Vitiligo and Pigmentation Institute of Southern California and University of California Davis' Department of Dermatology.
In the two study groups, 28 patients were enrolled in Group A and 27 patients in Group B. Both groups received phototherapy two to three times a week for six months for a total of 72 treatments. In addition to phototherapy, patients in Group A received a dose of 16 mg of afamelanotide in four monthly treatments. Afamelanotide, about the size of a grain of rice, was implanted just under the skin.
Two common vitiligo assessment scoring systems – Vitiligo Area Scoring Index and Vitiligo European Task Force – were used to evaluate the repigmentation response.
While patients in both groups showed repigmentation, the response in Group A was superior to Group B by the 56th day of treatment and even better by the 168th day of treatment. The most common side effect was redness of the skin.
Explore further: Study examines vitiligo, alopecia areata and chronic graft vs. host disease
More information: JAMA Dermatology. Published online September 17, 2014. DOI: 10.1001/jamadermatol.2014.1875
Journal reference: JAMA Dermatology search and more info website
This post is a copy / paste from the Clinuvel Google Group. Florian Homm, a controversial former hedge fund manager who invested in Clinuvel in the early days, gave his view on where Clinuvel is headed:
Dear Uhohinc,
your research is amazingly in depth. You even quoted my book, Rogue Financier. That is thorough stuff.. I am leaving this little post with you. On November 5th I will hold a speech at a University in Erding, Bavaria, north of Munich before a few hundred students and about a dozen people from the media. Clinuvel will feature quite prominently in this speech as the investment, providing me with great emotional gratification especially after the EMA approval. I was fortunate to finance this company. Quite frankly, our funding prevented this jewel from going bust and we actively searched the market for credible, science oriented management. I leave this little commentary with you to make available to others on share scene and other boards. I have followed Clinuvel very closely for years even during my 15 months in prison fighting extradition to America. I will touch on a few issues (not just these very narrow financial concerns) that may be of interest to you and others:
Valuation:
In the absence of serious research the shares are absurdly misplaced. During my illustrious career I received numerous investment awards (european hedge fund manager of the year, top us specialty fund manager, number one germany fund, European pension fund, blah blah blah). I have written over 500 research reports for the likes of Fidelity, Merrill Lynch, tweedy Browne, VMR AG, ACMH Group etc etc... I have a reasonable idea of this business. Here we go:
Revenues of USD 40 to 70 Million for EPP is realistic. But get to the pretax or net profit figures! On EPP alone, Clinuvel may trade at only 5 times 2016 or 2017 earnings. I have not the slightest doubt that EPP alone is worth AUD 5-7 per share right now. You have to look at Vitiligo separately! This a sum of the parts evaluation. I was the original proponent to encourage CUV to consider Vitiligo, but Dr. Wolgen took it the critical step further: not as a stand-alone treatment but as a combination therapy. Here are some facts which will blow your mind: there are no less than 1.2 million vitiligo treatments per year. Some world class sources say the number may be between 1.5 and 1.8 Million. I love using lowish numbers in my models. If the low balling works and I do not have to twist the math - so much the better. It is utterly realistic that CUV may get USD 5K to 7K per vitiligo treatment. It is increasingly evident, that the combination therapy is so much more effective it will over a few years largely wipe out the traditional treatments. I would be very surprised if CUV does not reach abut half of the market in annual vitiligo treatments, certainly no less than 500,000 treatments a year as the market will quickly learn about CUV's vastly superior product. USD 3.5 Billion in sales. What do you thing the bit margins are on this product? It is not unrealistic that CUV generates USD 1 Billion or more in net profit by 2018/2019. Some of the things you say make serious sense as well. How about off-label use for extreme vitiligo cases? Or how about the hundreds of thousands who get skin cancer after organ transplants. Would CUV work there. Worth a try certainly. Always better than the risk of malignant, at times deadly skin cancer. Or how about those extreme Fitzgerald 1 types ultra prone to get skin cancer even with only modest sun exposure. What is beautiful about the modeling now is that with EMA approval and 95 percent likelihood of FDA approval the shares have basically done nothing. There is not a single first rate research report on CUV! That is incredible and difficult to fathom. It is also a once in a lifetime investment opportunity. Do not get lost in all the blah-bla micro details in these posts. Buy, put away and then cash out of your ten, twenty, thirty or forty bagger. Yes, that is possible and probable. There is no chance this undervaluation persists for more than 6 to 12 months. None. Vitiligo is progressing quite quickly, quarterly EPP profit figures will show exponential growth and patient numbers in the US and Europe may even surprise on the upside. For a proper valuation you need to strip out all R&D, OH and simply take COGS and Marketing/Sales. Vitiligo, the same but get ready for USD 50 Million to get to full FDA approval. If I use 50 million shares outstanding (conservative) CUV is worth 12 to 15 AUD per share at this very moment. 300 for EPP and 450 for Vitiligo. In an organized auction process, CUV would easily get USD 10 per share. Cash!
Threats:
There are three: A takeover. CUV, at this price is a sitting duck. It needs to be on NASDAQ asap. Top senior management (mostly Dr. Wolgen) needs to stay for at least the next 5 years and he needs to upgrade his team for a rather demanding Vitiligo approval process. Unless you have been in this space for a few decades (I have) you do not appreciate obtaining regulatory approval for a treatment which simply does not fit into the classical approval methodology (placebo or double blind design was absolutely not possible). The Scenesse approval by the EMA was the first ever, which integrated patient/doctor groups in the decision making process. That is a monumental achievement. The product pricing is amazingly good and much better than I ever imagined when I got involved about a decade ago. I see shareholders moaning about compensation levels. That is beyond absurd. This company is already global, operating in Europe, Australia, Singapore and the US. Compared to those companies compensation levels are well below average and what I view as a serious risk - management only has a tiny stake in this company. Their interest are not properly aligned with shareholders. It is always the same risk. A well payed manager may sell out a company well below price if his personal stake is small. He may opt for a fat golden parachute instead. CUV top management owns about 4 percent of the company. Get real. 10 percent, some for EPP and milestones like NASDAQ and the mother of all approvals vitiligo. This is a serious risk. Of course an opportunistic takeover at AUD 7, 10, 20 or even 30 is another heavy risk. You are sitting on a potentially huge gold mine and someone literally steals it from under you. The third serious risk is execution. Dr. Wolgen is key and few very focused members of senior management. Retain, retain, retain and motivate. So simple. Upgrade that board and senior management for NSDAQ because this is no longer the Queensland Cup. There are so many clowns running around (an Australian dentist (madman on share scene), Retrophin under Shkreli, some suspect, "concert party" hedge funds) who have no idea what has been achieved and what remains to be done. This stuff is micro-management, persistence requiring the highest possible degree of credibility and operational focus. Regulators hate disruptions. Management disruptions, and all too frequent board shuffles are toxic and at best delay regulatory procedures. At worst they can derail them entirely. I have hired and fired hundreds of senior executives. Those wannabe entrepreneurs offer nothing but populistic generic hogwash. Madman has a sharp mind, but stick to the research Mr. Jones. I like what I read from you and Poontz as well, but get the big picture....grasp the complexity.
The Human Dimension:
I do not own a single share. I will not own a single share. I used to serve Mammon. I have zero motivation to pump CUV. I want millions to be treated and cured. I want people to be hopeful. My masters are God, Jesus and Mary. I am so grateful Scenesse was approved. I wish all of you great fortunes with CUV, but give some back to great causes when you cash in that CUV check. On a fifteen year viewpoint, Scenesse may even succeed to help those most likely to contract skin cancer. Vitiligo is very damaging emotionally. EPP suicide rates are very, very high. At least half of those obtaining organ transplants get skin cancer. Hundreds of thousands of lives may be saved, millions will improve. Many of these folks have been without hope. That is what pleases me most. CUV gives hope, not just superior investment returns. It gives me a kick, that between all the raids, dozens of IPOs, short sales, VC deals and so forth there is this one company which makes me happy to bee associated with: Clinuvel. How often in life can you invest and reap a serious fortune and do something really good at the same time? Well? I have done hundreds of deals in a thirty year career. Such a benign and virtuous mix is incredibly rare: once in a lifetime for me. So you intense investors.....do not forget the human dimension and consider if CUV becomes this multi-bagger as I am predicting (anybody who had bought Rogue Financier and bought CUV shares would have made more than 300 percent), give to those in need and those who are less fortunate than you.
Viel Glück
Florian
Skin Disease Drug Finally Wins Approval
By Sara Hammond, UA Cancer Center | November 5, 2014
Robert Dorr, leader of the UA Cancer Center's therapeutic development scientific program and professor of medical pharmacology in the UA College of Medicine-Tucson, was involved in the work on the synthetic hormone.
Robert Dorr, leader of the UA Cancer Center's therapeutic development scientific program and professor of medical pharmacology in the UA College of Medicine-Tucson, was involved in the work on the synthetic hormone.
A synthetic hormone developed years ago at the UA can now be marketed in Europe, and U.S. approval will be sought next.
A synthetic hormone developed more than two decades ago by faculty at the University of Arizona Cancer Center and the UA’s Colleges of Medicine and Science, shown to offer relief for a rare skin disease, has been approved for patients in Europe.
Clinuvel Pharmaceuticals Ltd. of Melbourne, Australia, received permission in October from the European Medicines Agency to market the drug, whose trade name is Scenesse. The company says it plans to seek approval for Scenesse from the U.S. Food and Drug Administration and also for patients in the Asia-Pacific region.
The molecule was developed, patented and initially tested at the UA under the name afamelanotide by Regents' Professor Emeritus of Chemistry and Biochemistry Victor Hruby; Robert Dorr, leader of the UACC’s therapeutic development scientific program and professor of medical pharmacology in the UA’s College of Medicine-Tucson; and the late Mac Hadley, a cell biology and anatomy professor. The UA licensed the molecule to a predecessor company, Melanotan Inc., in 1995.
Hruby said the process "involved the very close collaboration of chemists, biologists and medical doctors who brought similar excitement and creativity to the problem but from different perspectives." Dorr said this is the first approval of a pure melanotropin, which is a hormone that causes dispersion of melanin and results in darkening of the skin.
Scenesse has been demonstrated to reduce and prevent painful reactions to sunlight experienced by people with erythropoietic protoporphyria, or EPP, after trials in Europe, Australia and the U.S. EPP is a rare genetic disease found mainly in those with fair skin, characterized by intolerance to light and resulting in pain, swelling, burning and scarring of sun-exposed areas of skin. Those with this condition often must remain indoors during daylight hours.
As many as 10,000 suffer from EPP worldwide, with approximately 45 percent of them in Europe. EPP is considered the most common form of skin disorder in children.
Afamelanotide, formerly known as Melanotan I, is a superpotent form of the naturally occurring alpha-Melanocyte Stimulating Hormone, which stimulates melanin production. Melanin is known for its photoprotective effect on the skin. Initial proof-of-principle clinical trials were conducted at the UA Cancer Center under the Chemoprevention of Skin Cancer program project grant, led by Dr. David S. Alberts. Initial study results were published in the Journal of the American Medical Association in 1991.
Afamelanotide originally was developed by UA scientists as a defense against skin cancer, Dorr said. Stimulating a person’s natural photoprotective skin pigmentation, melanin, would create tanned skin prior to sun exposure, protecting the person from harmful UV rays.
Clinuvel also is testing Scenesse as a treatment for several other skin conditions.
Hey Jest. Shoot me an email please: farmazutical(a)gmail.com
If you really need to stir up sentiments and get emotional about your investment ask yourself, did you really do your homework before investing ?
Why on Earth would you create a storm around a rock solid emerging company with great long term perspectives just to create a platform for shortsighted instant gratification ? Let it go. It's not worth it.
Thanks a lot ! I think that's why the market isn't reacting big time yet. Even though there is a big possibility that P53 is activated and that the P21 biomarker is a direct consequence of that we still don't know. The day when Leo can write a PR saying that P53 is undeniably activated the pps will surge. I'm pretty sure this will happen. Until then: Patience.
Do we know for a fact that the P21 expression in cohort 8 is a direct consequence of P53 activation ? If yes, a new PR is needed to let the World know. If the data does not yet confirm that the P21 expression is linked to P53 activation (p21 can be expressed also without p53 activation) then we will have to wait for more data before expecting any kind of hype.
Anyone ?
One of the things that might be the answer to why the market hasn't appreciated the scientific results could be the P21 expression mentioned in the latest PR. I simply don't know from the PR whether the p21 expression in 50 % of the subjects are directly linked to activation of p53. It doesn't say clearly. If you study the relationship between P21 and p53 you know that p21 expression can also occur without p53 being activated.
But in this case it seems very obvious that p21 is expressed as a direct consequence of p53 activation considering the the fact that it was achieved as a consequence of dose escalation to cohort 8.
Now, do we know for a fact that the p21 expression that was observed in cohort 8 is directly related to p53 being activated? Do we know for a fact that p53 was activated in 50 % of the subjects ? Because if that is a scientific fact I think this is key to getting the word out about CTIX and boosting the pps. The PR wasn't very clear about this.
Leo doesn't nessecarily know the date yet. They probably asked for a type B meeting with the FDA which has to be granted within 60 days. He knows that the meeting will take place but he might not know the exact date yet.
How about compassionate use ? Wouldn't it be unethical to not give Kevetrin to terminal ill cancer patients if there is a proven likelyhood that it works ?
I've been a critic of Leo's PR's before but not this time. I think it was well written, adequate and to the point. Very exciting. Hopefully, we will soon see some numbers as well.
What makes me pretty sure about CTIX is the fact that Leo might have used big words in pretty much all PR's to date. But when you go back and re-read (which I have done) what he has written and said over the past few years he has never lied nor promised too much. They actually seem to deliver and that's being trustworthy in my book. If this continues I can't really imagine where the pps will go. And how many patients will benefit. Impressive.
What news, Jest ?
I have to admit that this is astonishing. If anyone has followed Puma Biopharmas development over the past two years you probably agree that CTIX has the same or an even greater potential. Puma has only one drug that completed ph2 with good results. It's a breast cancer compound. CTIX has so much more.
Puma has a market cap of app 7 bn today which would mean a pps of app 50 for CTIX. Puma's market cap is solely based on one drug about to enter ph3. I think CTIX could very well be headed towards a similar market cap or more within few years.
Leo should sign up for this:
http://www.longitudeprize.org
I don't have the private post option here on iHub. I would be very wary of Palatin. The AEs are many and management seems flawed to say the least. I could be wrong but I'm not placing any money there. Good luck too all here.
Scenssse activates p-53. Nobody talks about it, though. I wonder if a combination of Kevetrin and Scenesse will be a power cocktail.
An I've been saying it for years You too, probably. The Clinuvel Google Group is one of the best informed boards ever - along with the CTIX here on Ihub. At some point people will also come to this board.
And oh, that's 10 bn in potential market cap only for Vitiligo of course. Low ball. 100 PPS. And that could very well happen within 3-5 years. Then add EPP, HHD and possibly some off label for other indications once approved in the US. 150 USD is not unrealistic within 5 years. That's a 40-50 bagger from current levels. And a lot of good for millions of patients.
CLVLY is one of the most undervalued stocks right now and it won't last for many months. Many investors have been in Clinuvel for 5-10 years and the recent EMA approval of Scenesse was a historic event. But this is merely the start. The World hasn't yet recognized the potential Afamelanotide holds. EPP is only a proof of concept and many indications will follow soon. Today, the PPS ought to be app. 10 USD based in a very conservative valuation. Europe has around 4500 EPP patients. Let's assume 50 % turn to Scenesse. That's extremely conservative given the huge support the patients have shown. Actually, they were instrumental in getting the implant approved by the CHMP. Cost per year is up to 28.000 USD. That's 63 million in revenues. Conservatively. Clinuvel is going to self distribute so let's say 60 million after marketing expenses. A p/s ratio of 5 (very conservative) and we arrive at a PPS of app. 7 USD. (60 m x 5 / 42 m s.o.) That's without FDA approval which is 98 % sure. Then add at least 50 % of the European revenues and we arrive at 10 USD PPS.
Now, EPP is only a foot in the door. Clinuvel will be dominating the World market for photoprotection within few years. Imagine all the conditions that will benefit from UV protection. PMLE, SU etc. HHD is already in Phase 2b and has shown remarkable results. And then there is the big one: Vitiligo.
Clinuvel is conducting its phase 2b in Singapore right now and there is huge academic support for that indication as well. Potential revenues (conservatively) could very well exceed 1 bn per year after expenses. That's a market cap of 5 bn for Vitiligo alone with a p/s ratio of 5. But when the World realizes that there is a melanocirtin implant on the market that gives you a healthy tan and that it can cure and treat a huge number of dermatological conditions emotions will also drive this stock higher. After all, this is historic. Never before has Afamelanotide been approved by regulators and only a very naive person can't see the potential. Eventually, this is the perfect protectant against skin cancer. A healthy tan without having been exposed to UV. Revolutionary.
Then there is the potent antiinflammatory effect Scenesse has.
Add Acne, Psoreasis, Rossacea and the market cap will be + 10 bn. Probably way more.
Very few stocks offers the potential Clinuvel does. Longs have known that for a decade and I invite you to visit ShareScene or our CUV Google Group.
When the World wakes up and sees the potential in this remarkable company this group will also get going. But it will probably take some months. Until then, if you read this you are one of the very lucky few to begin your DD before the big run.
Go to the CUV Google Group or ShareScene. That's where the action is.
I wasn't actually thinking about dogs and cats although that might be a little franchise as well. Many countries and among those the U.S. pump their livestock full of antibiotics and that is partly why us humans develop resistance. Not only do we pump ourselves but we also eat pigs and cows that are given tons of antibiotics for various reasons. In Europe they have begun cutting back a little but not much. Here in the US app. 70 % of the antibiotics produced are given to animals. Now, will B be able to take over that market ?
http://www.thedoctorwillseeyounow.com/content/infections/art3435.html
Have you ever calculated the potential value of B in animals ? Is that something we could expect the company to focus on later ? Animals need safe and efficient antibiotics just as much as humans.
C'mon. Rude ? Why can't I be a happy share holder and bullish about CTIX and still have issues with parts of the business ? This is not a sect, right ? I own a lot of shares and I think CTIX will be successful eventually. But it's always good to spare some dry powder if you are going to war. And the battle aint over yet.
There are many ways to convey a message. I just think Leo is undermining his position by using too many big words too often. That's not being rude. That's making a point.
Miles, I'm with you on that. Totally. My only point is the language. I think Leo could get the same message out there with much weight behind it without using superlatives all the time. Of course it's a good thing to get exposure.
That's a great come back Thumbs up.
CTIX to the Pope: We can save the World.
Long time holder and very bullish about CTIX. But seriously, the PRs coming from Leo are just silly. By exaggerating he is making it increasingly difficult to make the market believe him. People who have to trow around superlatives all the time often run out of means to make people listen. At some point you're just fed up with how super duper fantastic wonderful even the smallest thing or event is. What's left in the linguistic tool box if all the superlatives have been used not once or twice but all the time ?
Actually, I think Leo could have had much more impact with all his PRs by methodically and pragmatically stating the obvious: CTIX is on the right path and on the cusp of brining some very interesting products to market. Sometimes, understating is much more powerful that shouting.
I know 98 % of you guys probably don't agree with me on this, but rest assured that we share a common goal and vision: CTIX bringing live saving drugs to market while making shareholders very wealthy.
But as we get closer to maybe Nasdaq or an other major exchange I think Leo ought to start talking like a large cap CEO and not the little boy jumping up and down in the corner. GLTA.
Hi guys and thank you for a high quality board. I've been a silent listener for a very long time and I have a small position in CTIX. Hopefully, I will be buying more when time comes (or just before time comes).
A question:
I'm very excited about the outlook for Kevetrin but I haven't been able to find anything that indicates, that the drug leads to real apoptosis of tumor stem cells. Is that the case ?
All best,
Farma
He is the PR from Trimel:
TORONTO, ONTARIO--(Marketwired - Jan. 23, 2014) - Trimel Pharmaceuticals Corporation (TSX:TRL) is pleased to announce the appointment of Dr. Nathan Bryson to the position of Vice President, Scientific Affairs. Dr. Bryson will replace Mr. Wayne Kreppner who has elected to pursue other opportunities. Dr. Bryson will be responsible for all areas of the Company's research and development activities as well as leading the clinical, regulatory affairs, and manufacturing functions.
Dr. Bryson joins Trimel from Cynapsus Therapeutics where he served as Chief Scientific Officer. He brings more than 20 years of experience in pharmaceutical development, having held scientific and executive management level positions at several pharmaceutical companies including Flamel Technologies SA, Bionisis SA, and Matregen Corporation. Dr. Bryson holds a BSc in Chemistry from Auburn University and a PhD in Radiopharmaceutical Chemistry from the Massachusetts Institute of Technology ("MIT"). He performed post-doctoral research under two well-esteemed chemists, the late Dr. J. Osborn at the University Louis Pasteur (Strasbourg, France) and Dr. D. Seyfeth at MIT.
"We are thrilled to welcome Dr. Bryson to the Company and to the executive team," stated Tom Rossi, President and Chief Executive Officer. "With his impressive academic credentials that complement his extensive experience in the pharmaceutical industry, we believe he is ideally suited to oversee our ongoing drug development opportunities as we work to further the growth of Trimel. I would also like to thank Mr. Kreppner for his many contributions over the last five years and wish him good luck with his future endeavours."
About CompleoTRTâ„¢
Trimel's most advanced product candidate, CompleoTRTâ„¢, is a bioadhesive intranasal gel formulation of testosterone. CompleoTRTâ„¢ is designed with a view to providing hypogonadal patients with superior safety and enhanced convenience over currently available treatment options.
Hi guys,
I'm an investor in Trimel Pharma and yesterday we got the news that Mr.
Bryson will be our new VP and head of Scientific operations. Our former CSO apparently wanted to resign - or he was canned. We don't really know.
But it seems Mr. Bryson was head hunted and that Cynapsus wasn't prepared for his resignation, right ?
Do you know what could make him leave ? To me it seems that Cynapsus is doing great and that your prospects are very promising.
We Trimel investors wonder about why our now former CSO leaves very close to PDUFA for Trimel's lead drug, Compleo. PDUFA is May 28th. I think he might be canned because I can't find any announcement from any company about him being hired. He's just out.
I would like to hear your take on what could make Mr. Bryson leave ? Any controversy with management ? Is Trimel just a better job for him at this stage ? Personal reasons ?
Good luck with your investment. It seems very interesting. I might look into it my self later.
Kind regards,
Farma