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.