Tag: USFDA

The Suboxone opportunity for Dr Reddy’s

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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It has been a great week for pharma stocks. After Sun Pharma received the US FDA clearance to restart supplies from its Halol facility, Dr Reddy’s has also received approval for the generic version of the opioid addiction drug Suboxone.

The news on both these developments was expected, but for it to finally happen after several false starts was the major highlight.

Now, a little more Dr Reddy’s. To understand the opportunity from Suboxone, it is first important to understand the opioid market itself.

Opioids are described as a class of drugs that include powerful pain relievers that contain codeine, morphine and are available legally via prescription. While the drugs are prescribed to patients suffering from pain, regular use, or misuse can lead to a dependency on the drug.

Opioids also consist of illegal drugs such as heroin. The US, as described by the US FDA, is facing a “public health crisis of staggering human and economic proportion,” due to opioid abuse.

Of the total deaths in the US caused by drug overdose in 2015, 63% were caused by the use of an opioid. President Donald Trump in October 2017 declared the opioid crisis a public health emergency.

So, how does Suboxone fit in? It is an anti-opioid addiction drug, the innovator drug of the UK-based pharma company, Indivior Plc. An innovator drug is the first drug containing its specific active ingredients to receive approval for use from the US FDA.

The drug essentially mimics the effect of an opiate and reduces the withdrawal symptoms in the patient during the de-addiction process.

The market size of this drug is currently about $750 million in the US and despite competition from other de-addiction drugs, Suboxone averaged a market share of 58% in 2017.

A generic version of Suboxone is one of the eight drugs that Dr Reddy’s acquired from Teva in 2016 for a total of $350 million.

The FDA had asked Dr Reddy’s for  details on the drug in January 2018, and the company has now received approval for the launch.

While Dr Reddy’s has said they will launch the generic version of the drug in the US, it faces multiple ongoing issues that could hurt its prospects.

First, Dr Reddy’s will launch the drug “at-risk,” meaning drug will be launched in the US while it is fighting a patent litigation battle with Indivior.

There are a total of seven patents which were being litigated. Of these, Dr Reddy’s got a verdict in its favour for four of these patents.

Some of these verdicts have been challenged by Indivior in an appeals court, and the remaining three patents of the seven are currently under litigation.

If Dr Reddy’s loses a verdict on any of these litigations, then there is a chance the company will have to pay damages.

It is likely the damages could amount the loss of sales by the innovator and possible withdrawal of it from the market as well.

But, it is important to note, as Nomura points out, that two of the three patents being litigated seem to be an extension of the old patents that Dr Reddy’s already won. And the company already has a favourable verdict on the 4 patents, which is currently in appeals.

The other major issue Dr Reddy’s faces is competition. There are five known generic filers for this drug including Dr Reddy’s. The others include Teva, Mylan, Endo and Actavis. Both Mylan and Endo have settled with Indivior.

Endo as per the terms of the settlement will launch its generic drug in January, 2023. The terms of Mylan’s agreement, that was approved on Friday by the US FDA, are not disclosed.

That leaves Actavis with the possibility of approval in the US and Teva, that is also awaiting final US approval.

The factors that could affect Dr Reddy’s also include Indivior launching an authorised generic, where the innovator manufactures the drug but is  marketed by another company, immediately.

The opportunity for Dr Reddy’s financials depends on this competitive scenario. The range for a best case varies from Rs 25 to Rs 30 all the way to Rs 60 in a no competition scenario.

Some analysts are projecting an average $80-85 million worth of sales in the first year.  The conservative estimates include Nomura, which is pencilling in Rs 10 in FY18 per-share profit and Rs 12 in FY20.

The other factor to watch is competition from another drug, Sublocade, also launched by Indivior.

The company launched this drug in the first quarter of calendar year 2018. The difference is that Sublocase is a long acting drug, the injection just needs to be taken once a month versus Suboxone that is a daily dose.

The combination of these factors indicate that while the approval for Dr Reddy’s is no doubt a positive, it is still a story that is unfolding.

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Biocon an important strategic partner, says Mylan

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Mylan president Rajiv Malik said Biocon was an important strategic partner and that the company would look to expand the portfolio of the partnership, after the US Food and Drug Administration approved Mylan’s cancer treating biosimilar Fulphila co-developed with Biocon.

Malik said both the companies have already expanded the partnership recently to add two more products.

“Its huge moment for Mylan-Biocon partnership, because it validates our commitment to affordability and accessibility. Very excited to get another first in US market after the approval for our biosimilar Herceptin,” Malik said.

However, he clarified that there are no talks of buying any stake in Bengaluru-based Biocon.

Watch Here: No talks of buying any stake in Biocon, says Mylan after USFDA nod to cancer drug Neulasta

Edited Excerpt:

Q: What is the size of the market you are expecting to garner in 2018 and 2019 and when is the launch?

A: Thank you for the wishes. It is huge moment for Mylan-Biocon partnership because it validates our commitment to affordability and accessibility. We are very excited to get another first in US market after the approval of our biosimilar Herceptin. We are looking forward to bring this product to the market and launch is in following few weeks.

As far as the size is concerned, it is going to be different as compared to the commodity generics where you can convert the market in a matter of couple of weeks, you can get 50-60 percent conversion. It is going to be a slow ramp but we are optimistic of our ability to garner a decent market share and bring affordability and accessibility to this important oncology product to the patients.

Q: You do have litigation which is ongoing for two process patents when it comes to Pegfilgrastim – what can we expect on that? Would this probably be an at-risk launch?

A: Amgen has asserted two process patents in Federal Court in Pittsburg but Mylan is confident on its non-infringement and invalidity defence against these patents. So we will be confidently looking to bring this product to the market at the earliest.

Q: Affordability apart what is the size you are looking at in this calendar 2018-2019 and the launch?

A: The launch will be in coming few weeks. We just got the approval yesterday and we are in the process of preparing the launch quantities and bring the product to the market.  It will be hard to give the market share at this moment because it is going to be little different.

Q: Estimates say that you will make around $100-150 million in terms of joint revenue between you and Biocon from the drug in first year based on the fact that it is a limited competition?

A: Yes, it is not too far from where our estimates will be.

Q: You have long-standing relationship with Biocon for multiple biosimilars and this is the second approval that you have received in the US and you have tie-ups in other countries. Is there a chance that you could look to extend your relationship with Biocon? There have been rumours saying maybe you would even look to buy some stake in Biocon?

A: It has been a great partnership with Kiran Mazumdar Shaw and team, Biocon and the team. It has been almost 9 years of working together on this very hard to market product. We recently, expanded this partnership to add two more products to the basket of co-operation.

Biocon is an important strategic partner and I don’t at the moment want to comment on anything about a stake because there is no truth in the news that we are looking to buy stake in Biocon.

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Biosimilar drug Pegfilgrastim a large opportunity, says Biocon

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

USFDA approves Biocon-Mylan’s first biosimilar of cancer drug Neulasta

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The US Food and Drug Administration (FDA) on Monday approved Biocon-Mylan’s drug Fulphila (Pegfilgrastim) or the biosimilar version of $4 billion drug Neulasta for cancer treatment.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the US (the first being Trastuzumab or biosimilar version of breast cancer drug Herceptin).

Since Biocon-Mylan is expected to be the first company to launch the drug in the US, it will have a first mover advantage.

Biocon expects to launch the drug in FY19. Mylan said they are anticipating a launch in coming weeks.

Mylan and Biocon are in a partnership to develop and commercialise a raft of highly complex biotechnology-based drugs.

Analysts said the opportunity will really come through in FY20. In terms of numbers, the street is excited.

Since, the drug is a biosimilar, it is not interchangeable with the original drug as it is used to reduce the chance of contracting infections due to low white blood cells in patients receiving chemotherapy for certain types of cancer.

Bengaluru-based drug maker Biocon and US-based Mylan is having a profit sharing agreement on all biosimilars and the same applies in the case of Pegfilgrastim.

While the exact profit sharing ratio is not known, based on a limited competition scenario initially, Biocon is expected to make over $50 million revenue from the drug in one year, with some analysts estimating it to 25% of Biocon’s FY20 profit.

On the other front, Mylan is facing a litigation on two process patents, which is currently pending in the US.

If Mylan doesn’t settle on this litigation, then it will be an at-risk launch. It means, Biocon-Mylan launching the drug with an ongoing legal case.

Apart from revenue, profit and litigation this approval should be a feather in not only Biocon’s hat, but one for the Indian pharmaceutical industry.

It also shows the the Biocon’s ability to solve regulatory issues successfully. The USFDA giving approval for the biosimilar means it is not perturbed by the seven observations Biocon received in a pre-approval inspection for Pegfilgrastim that took place at its Bengaluru facility in April.

The approval reinforces the capabilities of Biocon in the biosimilar space and its ability to create a niche in a lucrative market.

It probably gives confidence to the street on upcoming opportunities Biocon has in the biosimilar space – Insulin Glargine for one and the likes of Adalimumab or biosimilar version of Humira to just name a few.

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Biocon: The Pegfilgrastim opportunity

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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June 4 will be another important day for Biocon-Mylan in their biosimilar journey. By that Monday, Biocon-Mylan will get to know what the USFDA thinks of their application for the biosimilar version of the drug Neulasta or Pegfilgrastim (generic name).

Neulasta or Pegfilgrastim is an important drug, and has a  market worth $3.9 billion in the US.

It is used to stimulate growth of white blood cells in the body. White blood cells are used to fight infections. Hence the drug is given to patients who are for example, undergoing chemotherapy and see a drop an overall drop in their cell production, including white blood cells, making them susceptible to infections.

Also, Pegfilgrastim is a biosimilar drug which are different from generic drugs.

A biosimilar drug is the most similar version of an existing drug while a generic drug is an exact copy of an existing drug. A biosimilar is only the closest version of a biologic drug as they are made from living organisms such as yeast or protiens and hence cannot be exactly replicated like the chemical structure of generic drugs.

And because biosimilars are not interchangeable like generic drugs, they require independent approval through clinical trials.

Biosimilars is a big market. About 30% of drug sold globally currently are biopharma drugs. In the US alone, 40% of prescription drugs spending is on biologic drugs.

And approvals for the biosimilar versions of these biologic drugs are only just picking up. As of Jan 2018, Europe had approved around 37 biosimilars while the US had approved 8 with biosimilar drugs for the top three biolgics drugs having been approved – Humira, Remicade and Enbrel.

To give an idea of the potential of the market, it is estimated that with the wave of biosimilar approvals expected in the US, spending on original innovator drugs will reduce by $54 billion in the next 8 years.

And while competition is on the rise, biosimilars are better propostions for companies. For reasons such as higher barriers to entry as it requires clinical trials to prove efficacy of a drug and price erosion not being as steep as the 90-95% for generic drugs.

Now, coming back to Biocon. The USFDA has approved their first biosimilar applications in the US in 2017, Trastuzumab or the biosimilar version of breast cancer drug Herceptin. The launch is likely in Q4FY19. Next in line and the opportunity being discussed is Biocon-Mylan’s application for the biosimilar version of Neulasta or Pegfilgrastim. They had received a queries from the USFDA in October 2017 on the application which Biocon replied too. The target action date for the drug is now on June 4th as mentioned earlier.

While it is difficult to predict what the USFDA might do the likely scenarios include

• Approving the drug – means launch timeline on track, ceteris paribus
• USFDA coming back with a few queries on the application filed
• USFDA awaiting resolution of observations at Bengaluru facility, with or without more queries for scenario 2 & 3, US approval will be delayed to when the observations, qeuries are resolved
  In scenario 3, to recap, the US drug authorities issued seven observations to the company’s Bengaluru facility in a pre-approval inspection (PAI) in April 2018.

A PAI is an inspection conducted by the USFDA to approve the manufacturing process for a specific drug ahead of its approval – in this case it was for Pegfilgrastim.

Biocon has responded to the observations and nalysts are confident. They say the observations appear benign with no data integrity. Mylan also catergorized the observations under ‘continous improvement’ without changing their estimated date of launch for the drug.

And Biocon’s track record provides further assurance. The most recent being solving the eight observations issued by the US in the pre approval inspection for Trastuzumab.

However, while the street is confident the observations won’t create a deterrent, one can’t bet a 100% that the USFDA will give the go ahead, they might just want to see the observations solved before the approval.

But is that the end of the issues?

No, say analysts. Besides the USFDA approval, the launch could also be dependant on resolution of an intellectual property litigation. It has to do two process patents (how a drug is made) and until now only one company, Coherus has been able to obtain a favorable decision on it.

This litigation could entail either a settlement with the innovator – that means a mutually decided date of launch or an at-risk launch –Biocon- Mylan launch the drug despite the litigation being on, even at the risk of losing it. It will be a space to watch.

What is the blue sky scenario?

If all goes well, then as per Mylan’s latest guidance Pegfilgrastim could be launched by second half of 2018 and could very well make it the first biosimilar entrant for Pegfilgrastim in the US. Analysts estimate Biocon can make upto $60-70m profit from the drug in the first year itself. The second year earnings will depend on the competition. Pharma firm Coherus is likely to enter the market in late 2018 with Amneal, Intas and Sandoz lined up.

The larger picture

Biocon is considered the Indian answer to the biosimilar opportunity. It caught the bus early and that is the reason for its outperformance. Besides trastuzumab and pegfilgrastim, some of the other biosimilar opportunities the co has in the US includes its application for insulin glargine (used for diabetes) which under the New Drug Application is under review by the FDA.

While the US is a space to watch, their biosimilar presence in Europe and other countries calls for a whole other write up.​

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

US FDA observations normal & routine, says Galaxy Surfactants

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The US food and drug administration (USFDA) has issued 4 observations for M3 plant and 9 observations for N46 plant in Tarapur of Galaxy Surfactants.

In an interview with CNBC-TV18, U Shekhar, Founder and Managing Director of the company spoke about the latest happenings in his company and sector.

“Though we have been manufacturing and selling these products in the US for the last so many years, this is for the first time that US FDA has come to our premises for an audit. These observations are normal and routine in nature. These do not preclude us from selling our products in the US market at all,” he said.

“We will continue to be selling in US markets, these observations don’t prohibit us or preclude us from selling it in the US market. These are procedural in nature,” he added.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow