why it is important for investors to know about patent but not for trial participant risking his life for drug that will never be marketable drug? Because Galmed is public company listed on NASDAQ stock exchange in USA. Securities Exchange Commission (SEC) requires Galmed to disclose all important information to investors. Food & Drug Administration (FDA) does not require any such disclosure to trial participants. Is it because trial participants second class citizens? I hope anyone reading this will post comments below. I think reason is rich people invest in stocks and participants of clinical trials according to statistics I read are mostly poor and uneducated. So why would anyone care about Guinea pigs? Is it even possible for Galmed CEO with annual compensation of $1,269,700, company that employs 19 people treat trial participants as human beings? In my opinion Allen Baharaff does not care.
I thought long and hard why Baharaff failed to show any humanity towards me, unpaid volunteer who trusted him for 66% chance I will get aramchol which was promised to me as safest NASH experimental drug. What would be Baharaff getting out of it if aramchol was approved by FDA? As CEO who owns 20% of Galmed, Baharaff may get few hundred million dollars. But Baharaff has no respect for people who endanger their lives to make him that obscene amount of money. He treated me like garbage and here are my thoughts why it is not possible for Baharaff to act like human being expected to act. As I read about him, Baharaff and his wife Roni Gilat-Baharaff part of Tel Aviv super rich elite. Articles written how he is fighting liver disease but in in my opinion the only thing he is fighting is his bottom line. I doubt Baharaff can understand that ordinary people like myself actually have feelings and care that I was possibly hurt by his investigational drug. She is managing director of famous Christie auction house, he is on board of art museum and member of Israel bar association. He is elite snob and you just Guinea pig and he does not give a damn about you.
Galmed filed annual report around the same time Informed Consent for Phase 3 trial was prepared.
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“The composition of matter patents directed to Aramchol expired on March 25, 2019 worldwide. We will not be able to submit an NDA seeking approval of Aramchol (free acid) prior to the composition of matter patents’ expiration date. However, because Aramchol is regarded as a new chemical entity, or NCE, following approval of an NDA, if we are the first applicant to obtain NDA approval, we may be entitled to up to five years of patent term extension in the United States with respect to such NCE, and provided that the use patent with respect to Aramchol in the treatment of fatty liver will still be in force when the approval of the NDA is received from the FDA. The non-extended patent term for such use patent, is due to expire on April 15, 2022 worldwide and on April 17, 2021 in Israel. The U.S. patent was extended by a patent term adjustment of 567 days, resulting in an effective expiration date in the U.S. of November 3, 2023. In addition, a term of data exclusivity of up to 5 years will be available for the first approved clinical use of this NCE in the U.S., if Aramchol receives regulatory approval. Although we believe that we may be able to protect our exclusivity in our field of activity through such use patent portfolio and such period of exclusivity, the lack of composition of matter patent protection may diminish our ability to maintain a proprietary position for its intended uses of Aramchol. Moreover, we cannot be certain that we will be the first applicant to obtain an FDA approval for any indication of Aramchol and we cannot be certain that we will be entitled to NCE exclusivity.”
Galmed talked about uncertainty of continuing with new compound Aramchol salts with investors but not with trial participants. Even if FDA grants galmed right to substitute aramchol acid with aramchol salt in phase 3 trial, would you as trial participant want to know if aramchol salt went thru the same phases as aramchol acid? Will it be in informed consent? I doubt it.
“Our potential development of Aramchol salts may not result in improved bioavailability compared to the existing form of Aramchol. Furthermore, although we have submitted patent applications for our Aramchol salts in development, there is no assurance that we will receive any patents for them, and even if we receive one or more patents for our Aramchol salts in development, they may be of little or no commercial value.
As part of our research and development studies, we have confirmed that several Aramchol salts have improved solubility as compared to the existing form of Aramchol acid. In 2014, we submitted new patent applications to protect such salts and we will need to conduct an appropriate bioequivalence study, or studies, of the biological equivalence of two proprietary preparations of a drug.
If we commence animal PK studies and formulation development in order to test the bioavailability of the Aramchol salt compounds, the results might not support the claims sought by us. Success in our earlier pre-formulation studies does not ensure that later studies will be successful, and the results of later studies may not replicate the results of our prior pre-formation studies. Furthermore, either or both of the animal PK and formulation development studies may fail to demonstrate that the Aramchol salts result in an improvement in solubility and bioavailability. Any such failure may cause us to abandon the Aramchol salt compounds and may delay development of other product candidates. If the animal PK studies do not support our claims, the completion of development of such potential product candidates may be significantly delayed or abandoned, which will significantly impair our ability to generate revenues and will materially adversely affect our results of operations.
There can be no assurance that the U.S. Patent and Trademark Office, or the USPTO, will issue any patents based on the patent applications that we submitted to protect our Aramchol salts, nor, should the USPTO issue any patents to us with respect to the Aramchol salts, that we will be provided with adequate protection against potentially competitive products. Furthermore, if the USPTO issues us one or more patents for the Aramchol salts, there can be no assurance that the issued patents will be of any commercial value, or that private parties or competitors will not successfully challenge these patents or circumvent these patents in the United States or their counterparts abroad. In the absence of adequate patent protection, our business may be adversely affected by competitors who develop “comparable technology or products”.
When a company in S.E.C. filing talks about materially adverse effect, what they say to investors we are unlikely to remain as a business entity and our stock will become worthless. What Informed Consent should be saying is that the trial will be stopped if such materially adverse effect takes place.
New patent was given to Galmed on 12/1/2020 long after I signed informed consent. Galmed initially filed for patent in 2014 and said above there is no guarantee US Patent office will grant such application. Why trial participants not entitled to know this? Because Galmed will do the absolute minimum that is required by law. I saw other biotech companies clearly showing patent expiration on their website. This kind of disclosure shows respect for patients and investors.
Even if patent granted it is still unknown if FDA will allow Glamed to substitute Aramchol acid with Aramchol salt. Aramchol Meglumine is salt version of Aramchol and considered to be NCE (New Chemical Entity) and was granted patent.
And if you don’t want to read company reports provided to investors here is clinicaltrials.gov, primary source to find trials
https://www.clinicaltrials.gov/ct2/show/NCT04104321?term=galmed&cond=nash&draw=2&rank=1#contacts. Double blind study expected to complete in 2024 after Galmed lost or will lose patent protection. While Galmed does not refer here if participants will receive patent losing Aramchol acid or unapproved Armachol salt with patent to 2035, how you person considering trial will know what you are going to be on for duration of the trial expected to complete in 2027. If you go on assumption FDA will do right thing and do not allow substitution unless Aramchol salt is safe to substitute, I wish you luck. By definition there is no such thing as safe investigational drug. Right thing for patients for FDA to do is to require Galmed to go back to Phase 2 with Aramchol salts with the same number of people as initial Phase 2 people (247) and don’t allow Galmed jump line because it will cost Galmed lots of money. FDA has responsibility to give 2000 future Phase 3 double blind trial priority over Galmed money and schedule to get to NDA.
And lastly note Galmed added open label trial to Phase 3 double blind trial I was kicked out from with no explanation. If you considering it ask some independent party what is the purpose of doing this? How would FDA actually know at the end of the trial if participant got better by itself or on Aramchol? This is why double blind placebo controlled trials are done. The only sense I got out of one researcher about open label trials, they done for very sick group of patients. Expanding trial to participants with F1 fibrosis (less sick than Galmed double blind trial) makes no sense.
I had many conversations with investigators at different locations in US.
- When you hear person breathing heavily and says ” to be honest it is been very difficult trial ….”. it tells you there are some people where honesty comes before Galmed money
- Investigator with many trials including Galmed told me in email “I am not fan of Galmed trial”
You may want to call investigators who participated in Phase 2 and not doing open label or Phase 3 double blind or open label and ask them why not. May be they tell you more than standard “difficult to recruit”.
NASH Patients Clinical Trial Exchange 