Is Gilead's Anti- Viral the Best solution

Covid 19 the pandemic,  Gilead started Remdesivir phase 3 trials in US, the drug was first developed for the treatment of EBOLA , but its now opted as investigational drug for Covid 19 treatment. Remdesivir  phase 3 trials in US has shown 50 % recovery in patients according to some articles  the drug has shown improvement in the recovery rates in patient who were admitted with symptoms of less than 10 days , the patients recovery time has reduced to  5 days compared to recovery duration of 10 days. And  those patients with symptoms more than 10 days incubation the recovery duration was 10 days as compared  to 15 days. Another report suggests that the  trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID), the patients who received remdesivir have a 31% faster recovery time as compared to those who received placebo

The data coming out of China for Remdesivir, where 237 patients were randomly assigned to treatment group. 158 to Remdesivir and 79 to placebo. The study enrolled patients with symptoms of not more than 12 days . The phase 3 study data did not produce statistically significant clinical benefits, but it showed reduction in recovery time compared to Placebo.
Overall faster the symptoms are diagnosed, and treated with Remdesivir,  the drug will help in recovery time. the US govt is pushing Remedesivir as a treatment option for Mild Covid 19 cases, but more such study results are needed, since the aforementioned trials were conducted in less than 1500 patients across the globe....

For Remedesivir more broader horizon trials should be conducted before giving it a positive nod. Question which comes to my mind is, Will Gilead collaborate with Dr Reddys , Cipla or Bicon for drug production in India, as they have the infrastructure for large scale production.

Curious case of Covid19

Its been 4 years that i have written anything in my blog. but this lockdown has made me come back. Covid 19 has become a pandemic all over the world and will it be a blessing in disguise for Pharma n medical diagnostic companies based out of india , as every where globally countries are finding issues with diagnostics purchased from china.

Elctronic companies based out of south korea and japan are moving their manufacturing out of china, so will this be applicable for Pharma API for which china was the first in terms of production of major API's all across globe, will the big Pharma giants shift their APIs production from china to india ??????

The good part is the drug manufactured for treatment of malaria in the developing nations is one of the key element in covid treatment in the western world, i am talking about hydrochloroquin which is used in combination with broad spectrum antibiotic azithromycin, which i will cover in details in later blogs

Indian generics like Cipla n others would like to work on remdesivir, a orphan status drug which was developed for treatment of Ebola, which till yesterday didnt show any significant effect in severe Covid 19 patients in Phase III clinical trials but they still hope that it may have some effect on moderate Covid 19 patients in P3 trialsa, results are awaited by may first or 2nd week, then indian companies may proceed for the copycat

Another Oxford UK based vaccine trial for Covid 19 has started yesterday and they have collaborated all across globe for clinical trials and have collaborated with Serum institute of india, lets wait for teh results .....

More in the next blog .....happy weekend 

Race for Gland Pharma

Gland Pharma, a Hyderabad based company which some years back had started its biosimilar portfolio development in terms of small proteins and mAb initial developments is up for sale. Though the company started developing R&D in terms of small protein development but due to financial constraints had to stop biosimilar process development in between.

The recent news is both Baxter, Torrent Pharma (India) and Fosun Pharma (China) have proposed for its acquisition. The interesting part is both Torrent and Fosun are focusing on biosimilar development, Torrent recently launched its Adalimumab Biosimilar under the name of "Adfrar' and Fosun is developing Herceptin Biosimilar which it is planning to launch in 2018. Who ever acquires gland pharma whether its Torrent or Fosun will already have process in place for small molecule Biosimilar development.

Both Torrent and Fosun have sufficient cash in place, but we need to see if any one of them will be able to close the deal.

Oncobiologics

I admire OncoBiologics, though the company is a very late entrant in the biosimilar race but they developed a good portfolio in a span of just 4 years.

At present they are looking for a IPO where in the price ranges will be for USD 11- 13, which is to be listed in NASDAQ by the symbol ONS and i am sure that once their biosimilar products are launched all across globe their share may give around 3-4 times profit in next 6-7 years. I shall hold this company as a long term investor. 

Their most advanced candidates are ONS - 3010, which is a Humira Biosimilar and ONS- 1045 which is Avastin Biosimilar , these products yet to see Phase III. The company at one hand is promoting itself as a cost effective biosimilar  producer company and at the other hand its promoting its state of the art manufacturing process "Biosymphony model".

Why IPO at this point??????

The company was planning to start the PIII trial for ONS 3010 and ONS 1045 in last quarter of 2015 but due to huge cash burn in 2015 at the rate of -292.9%,they went ahead with the IPO so that they can probably go ahead and start their PIII trials latest by Q2 or Q3 2016, and perhaps this year they would start with other products PI trial (I can pull up the information, if required), Thus this IPO will define their path going forward 

The company already have investors and collaborators funding them in different stages for their Biosymphony model  and advising them with regulatory aspects of launching their products in the regulated marker and already partnerships placed all across the globe for their Biosimilar products manufacturing, marketing and sales.

In future i shall not be surprised that this company will be acquisition target for companies like TEVA ....

Roche.....

The Swiss giant has become one of the pioneers in the Biopharma segment.

Companies like Roche have a strong active pipeline in their Phase I/II and the company is constantly exploring the LCM (Life cycle management) of its existing several product franchise (> than $1Bn). The second wave of Biosimilars may effect its immunology portfolio and the third wave its Oncology portfolio, But company has already taken several measure to cope up with the stiff competition from Biosimilars

• If you look at the process development of Biopharmaceutical in terms of mAb development, Roche is continuously evolving its process development of its existing innovative portfolio.
• The company is one of the top companies in terms of R&D investments and at every steps from Drug designing to development and preclinical its increasing its operational efficiency, in terms of better cloning, better per batch yield in terms of pilot scales and production scales and Clinical studies approach 
•  Roche is providing its oncology/immunology products at 35-40% discounted rate in the emerging countries compared to the original price in the developed nations.

So i assume that though Biosimilar developers are developing the mAb's at 40-45% less than the originators price, but innovators like Roche will come up with strategy to manufacture the innovative mAb's at half price compared to the current price of the said innovative mAb manufacturing then i don't think that in future there will be much difference in the pricing of innovator drugs compared to Biosimilar's. Also Physicians all across the globe will still prescribe the innovative drug as they know about their for their long terms benefits, so Biosimilar companies will have hard time to influence the Medicare 

The game is going to be tough for the Biosimilars 

Challenges for Biosimilar Producers in India

Companies in the emerging nations like India were the front runners in the Biosimilar development in terms of small protein molecule development over the last decade. I being a molecular biologist was working on E.coli and Yeast and and i could say cloning of small molecule is much more simple work compared to complex molecules rituximab and infliximab and now the third wave which are one step more complex to develop and produce.

The issues companies in India are facing is that pilot scale production for the mAb sometime cannot be copied the same way in large scale production cycle with various factors taken into consideration, and the complexity in production increases when you move from bacteria, yeast to cell lines, then the per batch yield is also a big hurdle, also the regulatory issues related to the upstream and downstream production in regulated market such as EU and US, thus these companies are first launching their product in semi regulated and non regulated market and then looking for partners or collaborators to design PIII trials in regulated market and further launches

The article which i was reading today they mentioned that companies need to understand the MOA of cell lines, Sometime after understanding how the cell line behaves companies still face issues related to per batch production yield.

And i believe that the approval for the second and third wave of Biosimilars is still going to be difficult as regulators are still developing their understanding of the complexity of these molecules and further their safety and efficacy.

Update on Samsung's Benepali

Samsung Bioepsis and Biogen's Benepali (Enbrel Biosimilar) received approval by EMA on Jan 2016.  Samsung has already launched the European production in UK and the drug has already been launched in  UK, Norway, Germany, and Netherlands. Today Benepali got approval by Danish regulatory authorities and the collaboration expects to capture 50% of the originator market as local hospitals and doctors favor prescribing drugs selected by the procurement agency. Benapali is been sold at 40 to 50% less price compared to the originator.

The collaboration is actively promoting the uptake of Biosimilar all over EU market. Both Samsung Bioepsis and Biogen are enjoying the first mover advantage before the the upcoming European approval for Sandoz Enbrel Biosimilar. 

Samsung Bioepis has gained approval of its biosimilars for Remicade and in future will try to get approval for Roche’s Herceptin, and AbbVie’s Humira Biosimilar. The company has a Phase I clinical trial underway for its Avastin Biosimilar, currently, Bioepis has been  valued at $8 Bn and is trying to be listed on the Nasdaq. Samsung Bioepis has set a target revenue of $872 Mn by 2020.

After Sandoz , we have Daiichi and Coherus Biosciences Enbrel Biosimilar study going on which has met primary end point for PIII trial in Jan 2016 and now regulatory submission has to start. Rest around 8 companies are working on Enbrel Biosmilar, some have received approval in the semi regulated market and we have to see if the approved product in the non regulated and semi regulated market will be going ahead and be part of the second wave of Biosimilars 

The originators meanwhile are reducing Enbrel price at their end and probably will be using their age old bundling approach for drug uptake

Amgen.......ABP 501- More update

Sometime back i had posted about submission for ABP 501. Recently Amgen presented data from a Phase III trial comparing the biologic Humira to its biosimilar ABP 501 at the American Academy of Dermatology meeting in Washington, D.C.

The trial had in total 152 patients on ABP 501 and 79 on Humira,  and they compared the effectiveness of the two drugs for a year. According to the data, results were similar for both the drugs. Comparable numbers of patients had improvement, with about 85% of patients in both groups had experienced a 75% improvement in their psoriasis, and about 40% becoming completely clear.

According to researchers side effects were similar for the two groups too,. About 86% of patients on the biosimilar, and about 79% of patients on the biologic.The most common side effects in both groups included headache, upper respiratory tract infection and the common cold.

What will be Pfizer's next move?????

Last week US treasury Department made a rule change that appeared to be aimed specifically at the transaction of Pfizer and allergan $ 160 Bn deal, stripping Pfizer of its benefits. 

With this deal Pfizer’s would have had relocated its headquarters to Ireland and shaved billions off its tax bill. Pfizer CEO Ian Read said in a brief statement: "We plan to make a decision about whether to pursue a potential separation of our innovative and established businesses by no later than the end of 2016.....

In terms of Biosimilars the question which comes in my mind is that will Pfizer keep the Biosimilar assets of the ongoing program of Allergan and Amgen ABP 215 (avastin Biosmilar) for NSCLC and ABP 980 (Transtuzumab biosimilar) into its own portfolio as its own pipeline PIII studies will be concluded in the later part. 

Also analyst belief that Pfizer will be in acquisition spree again and the target will be companies with attractive assets which may include Shire, Biogen, Regeneron and AbbVie. I believe that Pfizer may go ahead at the earliest for Biogen or Regeneron. In terms of biopharma/biosimilar prescriptive Biogen may be the next best deal for the company. 

After Remicade Biosimilars........the next ones are Adalimumab Biosimilars

Three years back Remicade Biosimiliar was released in EU and this quarter the same Celltrion Biosimilar got approved in US. Now its the turn for Biosimilars for Adalimumab.

As of now Amgen's ABP 501 Phase III trials  are going on  in the European Union and for US positive results for it's phase III trial in arthritis were announced in February 2015. The company has submitted application for approval in  US FDA on November 2015 and to the EMA on December 2015. 

Amgen will have the first mover advantage to market the Biosimilar in both US and EU market, Amgen already has a strong hold in the biological space in both the continents and has been in the part of the lobby which is promoting Biosimilars uptake and approval in the US market for long, so i assume that it will have a better uptake in the US market by 2020 

After Amgen it will be Sandoz and  Boehringer Ingelheim (BI), Germany which will have the second and third mover advantage. Now Abbvie, which has been boasting all about its Humira franchise will not have much affect in its revenue till Q3- Q4 2017 from the First wave of Biosimilars. But from Q2- Q3, 2018 onwards it may feel the heat

And by the time second wave of Biosimilar happens i am sure that Amgen and Sandoz together will capture around as much as 30-35% of the market and BI will have to make its presence felt in the Biosimilar space as it has no credibility till date in Biosimilars

The advantage for both Amgen and Sandoz are that they veterans in the Biologic & Biosimilar space and they are a strong brand themselves and by 2020 they shall have more Biosimilars approved and more Phase 4 study data for their Biosimilars application in various indications , so i assume that Amgen and Sandoz  will be able to capture around 30 to 35% of market..

For BI we have to see how its promoting its Biosimilars by 2020. Also by 2020, we will have more players like Pfizer, Oncobiologics, Fuji (Emerging Markets) coming up as part of second wave for Biosimilar. 

India perspective   we have the Biosimilar for Adalimumab launched in India and i shall capture it in the later parts 

Note:The reason i have provided the ranges between 30- 35% is as per the survey data for Remicade Biosimilar uptake in EU (Data can be skewed thus taken a conservative estimation)

Another Milestone For Emerging Biosimilar Companies

Celltrion received Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of: -Adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; -Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; -Patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; -Patients with active ankylosing spondylitis (arthritis of the spine); -Patients with active psoriatic arthritis;adult patients with chronic severe plaque psoriasis. After Positive node from FDA for its safety and efficacy, we were expecting an approval by Q3 2016. This was a pretty fast approval from FDA's end. Also Celltrion is coming up with more Phase 4 data, which i shall be collating in my next update As i track the generic companies in India, i have observed that FDA's has fasten its process both the generic and other approval. Also to note is that Samsung Bioepis (South Korea) has also received recommendation from EMA for its in-development biosimilars: Flixabi, a biosimilar of Janssen’s blockbuster Remicade for Inflammatory diseases.

CMO to Biosimilar developer journey

What is common between Celltrion, Samsung Bioepsis, Biocon and Oncobiologics ??????

All these companies are actively promoting themselves as one of the leading contract manufacturing companies for both Biopharmaceuticals and Biopahrma production and have formed alliances with major companies in the regulated market during Biosimilar drug development process. The first three already have marketed products in regulated market and Oncobiologics which was formed in year 2011 has already finished P1 clinical studies for ONS -3010 (Humira Biosimilar) and ONS- 1045 (Avastin Biosimilar and i assume the said mAb's to enter P3 clinical studies by early 2016

In the span of less than 10 years these companies have evolved as a major biosimilar developer in their specific countries...its a great achievement till now....

Now we need to see how the generic players who have already marketed products  and are developing their Biosimilar portfolio will be evolving as a third party vendor in the developing world for the major Pharma's. Let see how the landscape evolve in the coming years.....

Biocon the game changer for Biosimilar’s from India

Biocon for past sometime is developing its biosimilar portfolio with state of the art Biopharma production unit in India and in Malaysia. Biocon-Mylan Biosimilar’s partnership is progressing well as company is planning to file upto 5 biosimilars in EU and US. In 2014, the company became the first biosimilar company to launch Roche’s Herceptin copycat “Canmab” in India but now it is planning to launch this product along with four other biosimilars which are in development phase.

According to the company latest update  

1.       Insulin Glargine global Phase III trials were completed in the first quarter of this fiscal,

2.       Patient recruitment for multi-centric global Phase III for Pegfilgrastim and Trastuzumab are nearing to their completion while the global Phase III clinical trial for

3.       Adalimumab PIII trial is in progress across multiple sites.

4.       Bevacizumab PI PK studies is approaching completion while the ROW focused Phase III trial is advancing as per plan

Today the company announced that Japanese Ministry of Health, Labour and Welfare (MHLW) has given approval to its insulin Glargine Biosimilar. This approval will give Biocon and its partner, FUJIFILM Pharma, opportunity to bring quality and affordable medicines for diabetes patients in Japan

What surprises me is that Biocon is the late entrant in the Biosimilar space, Dr Reddy’s, Intas and Wockhardt were already in the space last decade in terms of small molecules and mAb’s. What is taking these companies so much time to go ahead for their products launches from semi- regulated to regulated market. 

In 2013 Dr Reddy’s said that it is planning to launch its Bioismilar products in EU in next 5 years. 3 years are already over but it has not yet started PIII clinical trials for the same in the regulated market, what is it doing??

Celltrion's Remsima.......

I have been working in the field of Biosimilars for past 10 years. First in the process of cloning to pilot scale purification process, then later moved into IP and then CI projects for Biosimilars. I am enjoying the way the scenario is changing for the biosimilar in terms of manufacturing, planning of clinical trials and then the over all customer engagement initiatives happening at different company level.

Yesterday FDA's independent committee of 24 members, 21 in favour and 3 in opposition offered opinion on the quality, safety and cost effectiveness of Celltrion’s Remsima Biosimilar. This committee's view will not determine the approval but its opinions will largely influence FDA's decision. Remsima will be used for treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, psoriasis and psoriatic arthritis.

Some analysts expect Remsima to be introduced in the United States by 2018 but I assume that Remsima will be approved by Q3, 2016 and slow uptake will start happening from Q4 2015 to Q1 2016 onwards. Celltrion has not disclosed what they might charge for Remsima, but a substantial discount is expected. What’s there after Q2, 2017 is to watch for?????

RNAi Technology - The charm is it existing or fading away.......

New job as a sales person is completely different and every place has a different way of working, suddenly out of blue my hubby (A computer geek) asked me about RNA and then the difference from DNA, so i started explaining to him the difference between the both and how in last decade the hype of treating with RNA came into existence .....i some how feel that the charm of developing RNA therapies has gone to back shelf , and new technologies like ADC's are taking their place with much better results.

In late 2000's did some consulting projects for a company, which later went ahead with acquisition of one small innovative company based out of US. I have been tracking the companies update but now not much buzz is happening from their end......

Hope to see traction in the segment going ahead!

2013 Update...

After a long hiatus, i am back with a bang....life was becoming pretty hectic as i was required to change job, city and home....so after long time i am blogging something.....

Pharma industry there were acquisitions happening, but not like the big ones which happened last decade. Valeant was in a spree for deal, like wise Bayer moving ahead with its M&A deal. Pfizer was playing safe. Like Abbott last year split its division into two, like wise Pfizer and Eli lilly decided to move ahead with split and consolidation of some of its BU units.

Medical devices industry there were lot of M&A activity and approvals, but we have more to look forward in this year from the emerging markets

Biosimilars were creating lot of noise, with the first biosimilar in immunology approved in EU, this year we need to look at the market. Both physician's and patients response to the drug in terms of its safety and efficacy.

Companies in 2014 to watch : Celltrion, the biggest CMO for biologics/Biosimilars. Is it really there for sale?
Roche is continuously bolstering its Oncology portfolio.

More to come in Next article......

Novartis will it go Pfizer and Abbott way!

Last year Abbott went ahead with a spin off into two major business units, following that for Pfizer speculation started to surface that it is also going for Split off in early Jan 2013, but yes the decision came in July about splitting of the company. Now it’s turn for Novartis as the CEO announced that he is certainly going to make some changes.....what we have to see if Chiron will still exist in the port folio or they will merge it with Pharma Biological and Vaccine innovation research....time will tell what will be the next steps for Novartis

Pfizer's Next Move.......After RA...its Oncology and Metabolic disorders.............

Pfizer has always been the company which intrigued me in many ways......the company which acted as a massive shark for quite long is being quite mum for a while....In Jan there was a buzz that the company is splitting its business in the similar ground to Abbott but there were no initiation activity from the company end. And then there aggressive movement in the Metabolic and immunology segment (Many of the compounds in Phase I/II) we still need need to check the company strategy going forward.....After its nutrition business sales it has cash in hand....will it go for Onyx deal to expand its portfolio in Oncology, as recently it collaborated for Cytomax for its ADC technology.........Will Oncology be the next game changer for Pfizer growth the way it has been for Roche?????.....Will it be able to displace Roche products in some oncology segments the way it’s trying hard to displace Humira in RA with its expected block buster product???????

Many things to watch from Pfizer's end!

Modern Healthcare touching millions of lives in India

In the last few years India as a favorable destination for medical treatment options as the hospital chains in India has well equipped themselves with facilities second to none. With blooming economy we can boasts of highly qualified doctors with specialization in different branches of medical science. Major advantage of being in India is the cost-effectiveness of treatments. Estimates claim that treatment costs in India start at around a tenth of the price of comparable treatment in developed countries, thus the healthcare system developed in India not only supports Indian patients but treatment spreads to all across globes including America’s and Europe

Major advantages of healthcare treatment options in India include:

ü  Low-cost medical treatment

ü  High-quality medical care

ü  Low TAT (Turn around time)

ü  Places of interest

ü  English-speaking staff

The hospitals chains (Both private, semi government hospitals are promoting themselves by believing in the mission of

·       -  Better Life: Consistently delivering compassionate care to the patients throughout their lives by the value of Seva and “Patient first” approach

·      -   Better Care: All the major hospital have take ISO certification which includes their being protocol driven, reflecting global best practices, and ensure that their patients consistently receive quality care all throughout their lives. 

·       -  Outstanding facility and services: All the facilities have been designed and implemented by international experts to meet the highest international standards of effective medical flows, patient safety, healing and comfort.

·         Innovation: leveraging technology to enhance patient care and outcomes. 

·      -   A legacy of Seva/Care: Hospital chains like Apollo hospital believe in the vision of “Touch a billion lives to create a better world and this is embedded in their genes and their philanthropic endeavors have touched more than 12 million lives till date 

·         -Value and relationship: The values ensure that everyone who enters the front door can count on the highest standards of values and a long-term relationship for rest of their lives

·        - Affordable excellence: Hospitals do understand that modern healthcare is expensive but all the hospitals are focused on being more affordable to their consumers providing them equivalent quality.

We see that all the major hospital chains in India are promoting these values all across the board; I believe that in a decade we will see a healthier India going forward as the legacy of seva, value, relationship and affordable excellence in going to increase day by day  

Biosimilars....

After my M Tech from BITS Pilani, i got placed with biotech pharma R&D where in i was asked to choose my task from being a molecular biologist to fermentation and further downstream processing. I chose to be a molecular biologist, then went ahead for Pharma consulting and the journey still continues. I have been working in the Biosimilar arena for around 8 years with experience in working in R&D to CI in terms of PMR services in terms of development of specific recombinant proteins and Mabs

In the late 2000's some big pharma companies showed a big picture to the world related to their huge investment in this arena and there were some who slowly started developing their pipeline. With the block buster era loosing its glory...biosimilars will mark the difference and emerging markets will be the bait for the big pharma's....in present Europe has been the front runner for biosimilar promotion but we can't negate the emerging markets (China, India and South Korea).....they are the new junctures for growth and promotions of biosimilars and will emerge as destination for biosimilar developments.......