Are there penems are difficult to make is there any entry (technology / molecule ) barrier ? We hear this word most of the times in Gland call and recently I heard the same in Gufic call also.
A good summary of various drug administration
Could you please enlighten us more about Penems ?
Thanks
Hi, first of all sorry to jump in the line.
But penems are kind higher antibiotics which are given intra-venously most of the times.
These are mainly used in very tough infections in ICU settings.
They are kind of last resort or highest antibiotics available against many resistant bacteria.
Google search will help in this regard.
The other company which is big in penems is Kopran.
My source is from this video.
Watch from 27 minutes onwards for details on Kopran.
Do check Kopran investor presentations for more info.
Mr. Sujal Kapoor has not mentioned Gufic Bio in his presentation as far as I remember.
But this is GREAT video to understand the whole of API & Pharma space.
Hope this helps.
Regards,
Dr. Vikas
Don’t know much about the complexity in the commercial manufacturing of Carbapenems. Kopran is the one who specialise in Carbapenem APIs and they don’t do concalls. So don’t know about the complexity in manufacturing. However let’s analyse some data.
Carbapenem-----------API suppliers-----US DMF holders
Imipenem---------------16-----------------------10
Meropenem -----------39-----------------------17
Ertapenem--------------19------------------------8
Faropenem---------------5------------------------1
Doripenem---------------15-----------------------5
Biapenem ----------------5-------------------------1
Tebipenem ---------------1------------------------1
From the data, you can clearly see that few API players have US DMF for carbapenems and fewer indian players have that.
1.Most of the Carbapenems are intravenous drugs. That means, those drugs should be sterile and sterile manufacturing facilities are essential. Maintaining regulatory compliance of sterile products are very very hard and not too many can do that.
Quoting main points from the report,
"Non-penicillin beta-lactam drugs also may
be sensitizing agents and cross-contamination with non-penicillin beta-lactam drugs can initiate
the same types of drug-induced hypersensitivity reactions that penicillins can trigger, including
life-threatening allergic reactions. Therefore, manufacturers of non-penicillin beta-lactam drugs
should employ similar control strategies to prevent cross-contamination, thereby reducing the
potential for drug-induced, life-threatening allergic reactions.
FDA recommends that the area in which any class of sensitizing beta-lactam is manufactured be
separated from areas in which any other products are manufactured, and have an independent air
handling system.
As with penicillin, the section of a facility dedicated to manufacturing a sensitizing non-
penicillin beta-lactam should be isolated (i.e., completely and comprehensively separated) from
areas in the facility in which other products are manufactured.
Accordingly, firms that manufacture
beta-lactam intermediates or receive them for further processing, as well as firms whose
manufacturing processes result in beta-lactam derivatives, should evaluate their manufacturing
operations for the possibility of cross-contamination and implement appropriate controls to
reduce or mitigate the potential for cross contamination."
You can see this hidden information in Kopran’s Investor presentation too. They have mentioned in the presentation that they have dedicated manufacturing facilities for Beta lactam antibiotics (cephalosporins, penicillins, carbapenems) and other drugs.
General information about carbapenems
Carbapenems comes under the group of antibiotics called as beta lactam antibiotics. (named so because of their 4 membered lactam ring) Beta lactam antibiotics are,
1.Penicillins (Penicillin G,V, Ampicillin, Amoxicillin, Oxacillin, Piperacillin etc)
Cephalosporins (Ceftriaxone, Cefotaxime, Cefepime etc)
Carbapenems (Meropenem,Imipenem,Ertapenem,Doripenem etc)
Monobactams (Aztreonam)
Among these drugs, Penicillins and Cephalosporins are the most commonly & routinely used drugs in hospitals as well as in out-patients. (Oral and intravenous preperations are available)
Carbapenems are reserved for the treatment of multi-drug-resistant (MDR)bacterial infections and often called as “last line antibiotics” or “antibiotics of last resort”. So Carbapenems are only used judiciously against MDR strains in hospital and ICU settings, as most of them are intravenous drugs and can’t be given oral. So it can’t be given to out-patients.
Advantages
Broad spectrum activity against most of gram positive and gram negative bacterias. (Inactive against only few bacterias)
Carbapenems are also the treatment of choice for serious infections caused by extended-
spectrum β-lactamase-producing Gram-negative bacteria (ESBL-gram negative bacterias are resistant to cephalosporins and penicillins)
3.Fewer side effects.
Drawbacks
Almost all Carbapenems are intravenous drugs. So it can’t be given orally.
Resistance against Carbapenems are also rising and bacterias are becoming more smarter in evading carbapenems too.
(Carbapenem resistant enterobacteriacae CRE)
However development of resistance against carbapenems is not as faster as development of resistance with other antibiotics.
Novel carbapenems with improved antibacterial activity against resistant bacterias and oral carbapenems are on development.
In general, there is a decline in the development & approval of newer antibiotics with improved antibacterial activity.
But one thing we need to understand is Bacteriae are not slowing from evolving into smarter strains which evade current antibiotics. Subsequently there is heavy rise of multi drug resistant organisms (superbugs) in the last decades and death due to antimicrobial resistance is also rising.
Carbapenems are like our ‘magic bullets’ and one of the last resort options. We will need more magic bullets in the near future and we can hope that development of more antibacterials with improved activity against these superbugs will emerge in this decade.
Received this attached deck and to my surprise it is Botox product ( I am just guessing it is a cosmetic product and the name it self is Botom in bottle )
Prettyandco_Deck.pdf (3.5 MB)
If anyone of you have anything to share related to this, please share!
Interesting dated article on how gufic is fighting botox by Allergan
An excerpt on what got the CEO interested in botulinum toxin
Allergan botox costs 14000/unit
If anyone has friends in derma doctor fraternity & can help us figure out Gufic’s stunnox pricing that would be very helpful @Dr.Midhun in case you might be able to help.
katalystweath has initiated coverage
https://katalystwealth.com/2021/11/30/gufic-biosciences-nse-guficbio-nov21-alpha-alpha-plus-stock/
STUNNOX which is the brand of botulinum toxin of Gufic biosciences is being sold to doctors ( mostly Dermatologists and ophthalmologists) at a price around 8500 to 9000 Rs per vial. The pricing is aggressive in comparison to BOTOX, but a couple of Korean brands (SIAX etc), which are well established now are being sold at similar rates too.
The brand STUNNOX, almost 1.5 year old now is slowly gaining popularity among Dermatologists. The volumes are still not huge, although I am sure, the margins for the company in this product would be good. Most patients, who generally belong to ‘upper strata’ of the society ( being a cosmetic procedure) are net savy and don’t mind paying extra for the ‘Original’ product (read BOTOX).
Their Dermatology division products, other than STUNNOX, haven’t picked up yet. Their entire focus is on building the STUNNOX brand. The sales team is also small and will take a long time to establish itself.
Importantly, they do not yet ( to the best of my knowledge) have the license to export this product to other countries. Will take more long term studies for that to happen. So, do not expect a sudden blockbuster growth in this product. It is more of gradual build up. The use of botulinum toxin is majorly restricted to tier 1 cities in India still.
Regards.
Dr Ankur Talwar
Dermatologist - Lucknow.
Thanks for sharing the scuttlebutt Dr ankur. This is exactly the kind of feedback that we were seeking.
I was reading that there are some sub standard botox branda cheap ones from Korea & china which do not work very well :
I am wondering whether you might have some first or second hand experience regarding either the quality of stunnox or the quality of these Korean or Chinese brands. Can we say that stunnox works well ? Because the biggest worry for anyone buying a 9000 vial is whether it will work well specially since it is a challenger/disruptor to the botox original brand.
Would be very helpful if you could add some feedback regarding the quality of stunnox, Chinese/Korean brands & botox (how the 3 rank against each other).
Botox is a toxin. Second part, allergic reaction can happen to anybody, even with paracetamol. People can develop allergic reaction to even Allergan’s Botox.
If Chinese or Korean is substandard then Allergan would have gotten them banned in India.
This comment is particularly on this news.article which looks like one sided and only mentions views of Allergan
I do not know about quality of Chinese or Korean Botox.
Disc: Not invested.
Have been using STUNNOX regularly for over 5 months now. The results are quite predictable and consistent. I would raise my neck out and say that the efficacy is at par with Botox.
But the problem is not the efficacy. Most ‘hi - fi’ patients have a deep rooted notion that BOTOX is the BEST brand - A concept that has been nurtured very very smartly by ALLERGAN over the years. Most people do not know the actual composition which is Botulinum toxin but just know that they want botox treatment ( just like a JCB is synonymous with backhoe loader). So difficult to change that mindset of people.
Korean brands (SIAX, NABOTA) available in the market are good and have a decent market share. It is this share of the pie that Gufic wants to dig into. I am not aware of any Chinese brands and not sure that any Dermatologist is using it either.
How is Stunnox price compared to these 2 ?
Pricing of STUNNOX is more or less at par with SIAX which is an often used brand. The other one ( NABOTA) is substantially higher, and it’s usage is not very frequent in dermatology fraternity
Any view on how the present volatility in the price of raw materials will affect the company?
Immuno-oncology has very high potential to become mainstay treatment option in cancer treatment. Most of the big pharma are now focusing more on newer modalities like Immuno-oncology, Antibody-drug conjugate treatment (ADC), Multi specific antibodies, Autologous & allogenic cell therapy, oncolytic virus therapy etc for cancer treatment.
IMHO, in the coming decade we may see major shifts in the treatment algorithm & regime of cancer treatment with newer modalities providing more specific and precise treatment options with better treatment outcome and prognosis and lesser adverse effects replacing the current chemotherapy options. Chemotherapy drugs with severe adverse effects which targets whole body (non-specific) may get replaced with newer modalities.
But one thing to note is, very few preclinical drug trials have the potential to reach commercial stage (10-15%). All others will fail and cause huge R&D expense for the innovator.
Selvax immuno-oncology therapy is still in Preclinical stage. It has showed some good clinical success in animal studies (Preclinical stage) and is now preparing for human trials (Phase 1).
R&D costs of Immuno-oncology drugs can be higher than ₹20,000 Cr. And Selvax has earlier stated that they don’t want to pursue high cost R&D on their own and will prefer early stage partnering for the drug development.
Now the Gufic announcement also points the same. It is a drug development partnership and Gufic has to bear high costs for the drug development.(Risk?)
Gufic can get huge benefit only if the drug reaches commercial stage and gets into mainstay treatment options. I should mention that, the competition is super huge in this immuno-oncology treatment area. Also only 10-15% reaches commercial stage from the preclinical stage.
So one should weigh the risk vs benefit. Ofcourse opportunity size is huge, but don’t forget the risk is also huge.
I agree.
Immunotherapy and biologicals are money guzzlers when it comes to product development.
This needs very deep pockets and there is high risk of it not falling through.
Less than 15% of the products in pipeline actually see the light of the day.
This is also a reason why many big players do not bother to enter this complicated domain of larger molecules and biologicals.
