ADVERTISEMENT

OT: Promising antibiotic for MRSA developed at RU...And great news on the cancer front (Keytruda)

RU848789

Legend
Gold Member
Jul 27, 2001
60,505
39,084
113
Metuchen, NJ
Came across this tonight and thought folks would find this to be interesting: combo of a new FtsZ inhibitor developed at Rutgers with a 20+ year old cephalosporin has great activity against the potentially deadly MRSA (methicillin resistant Staphylococcus aureus) infections in animals. Will start phase I trials next spring, so it has a long way to go, but this is pretty exciting stuff for RU and people, if it pans out, especially since it's an oral antibiotic instead of IV, which most serious last resort antibiotics are. I've worked on a lot of antibiotics in R&D over the years and it's really hard to get one that works well without side effects.

http://www.genengnews.com/gen-news-...thwarted-by-experimental-antibiotic/81252828/
 
If this becomes a successful treatment, does Rutgers profit from it (and if so, how)?
 
If this becomes a successful treatment, does Rutgers profit from it (and if so, how)?

Most small companies and university groups who develop drugs will bring them to an early to maybe mid-stage point in the development process and then sell the molecule (and maybe the whole company) to a big pharma company, reaping the profits. These entities typically don't have the expertise and resources to support large scale clinical trials, intensive process development (to make the active ingredient and the final formulated tablet/capsule/injectable/etc.) and development of manufacturing supply chains. Below is some info that might roughly translate to what the RU drug and other drugs might fetch on the market.

The graphic below shows the valuation (what they might be bought for) for drugs at various stages of development. Keep in mind this is 1997 data, so you'd need to factor in inflation into the valuation prices, but the take home message is that start-ups/universities can fetch modest prices for early stage (preclinical/phase 1 compounds), decent prices for phase 2 molecules and much larger prices as drugs move towards filing/approval by FDA. So if RU sold the drug now, maybe they'd get $50-$100MM, whereas if they wait for phase I results, they might get $200MM and could get much more if they sold after phase II, but they'd also need to invest millions to conduct the larger scale trials and do the other development work.

nbt0602supp-BE36-f2.gif


http://www.nature.com/bioent/2003/030101/full/nbt0602supp-BE36.html

For those unaware, here's a quick overview of clinical development: phase 1 is trials in small numbers (10-20 or so) healthy volunteers simply to assess ADME (absorption, distribution, metabolism and excretion) and phamarcokinetics (is the target receptor being affected?), phase 2 involves clinical trials in patients with some disease/condition to be treated and is looking at both safety and efficacy in modest numbers of patients (maybe 50-100), and phase 3 is the large mega-clinical trials usually conducted in thousands of patients with the target condition to truly determine with high statistical accuracy whether a new drug is safe and effective. These are usually comparing the drug vs. either placebo or vs. a standard of care drug, if one is available and they're usually double-blinded (neither the patient nor the doctor knows who's getting what). Phase 3 data are almost always needed to file for and obtain approval from the FDA and/or health authorities in other countries (there are exceptions in areas like oncology).

As an example, my company (Merck) just bought Afferent for $500MM, mostly for their phase 2 drug in development for chronic cough; this price can also balloon much higher (to over $1 billion), if the drug passes future milestones towards approval. See the link for more. My guess is Rutgers would either sell this very soon or after phase I, at the latest.

https://www.thestreet.com/story/13603293/1/merck-to-bulk-up-with-afferent.html
 
That makes sense, good stuff. Thanks for the explanation.
 
Changed the thread title to include today's news from Merck on Keytruda (trying to keep the # of OT threads reasonable), the breakthrough immunotherapy for a number of cancers. Keytruda results showed superiority to standard chemotherapy in non small cell lung cancer – so much so that they stopped the trial so the chemo patients could be switched to Keytruda. BMS’s Opdivo has been outselling Keytruda (both are humanized antibodies that target the programmed cell death receptor, PD-1), but maybe this study will change that, although BMS has a similar ongoing study. Bottom line is this is great news for cancer patients (including at least one friend of mine, who is not in great shape).

http://www.mercknewsroom.com/news-release/oncology-newsroom/mercks-keytruda%C2%A0pembrolizumab-demonstrates-superior-progression-free-

https://www.thestreet.com/story/136...merck-cramer-says.html?puc=yahoo&cm_ven=YAHOO
 
Numbers, have to keep in mind that BMS positioned Opdivo for solid malignancies regardless of PD-1 levels--Keytruda's indication is based on PD-1 expression as through a test. BMS also has been ahead in terms of label expansion into new cancers, or earlier lines of therapy...both are good, but it will get crowded fast as Genentech/Roche got approval for its PDL-1 for urothelial cancer...
 
  • Like
Reactions: RU848789
Changed the thread title to include today's news from Merck on Keytruda (trying to keep the # of OT threads reasonable), the breakthrough immunotherapy for a number of cancers. Keytruda results showed superiority to standard chemotherapy in non small cell lung cancer – so much so that they stopped the trial so the chemo patients could be switched to Keytruda. BMS’s Opdivo has been outselling Keytruda (both are humanized antibodies that target the programmed cell death receptor, PD-1), but maybe this study will change that, although BMS has a similar ongoing study. Bottom line is this is great news for cancer patients (including at least one friend of mine, who is not in great shape).

http://www.mercknewsroom.com/news-release/oncology-newsroom/mercks-keytruda%C2%A0pembrolizumab-demonstrates-superior-progression-free-

https://www.thestreet.com/story/136...merck-cramer-says.html?puc=yahoo&cm_ven=YAHOO
I'd rather say I went to the school that cured cancer than boast about any Athletic accomplishment.

B1G Cancer Research Consortium

which we are a part of...

Rutgers Cancer Institute of New Jersey
 
ADVERTISEMENT