Pharma News – 2 July 2020

Sun Pharma launches Ilumya in the Japanese market

Sun Pharma had announced the launch of its psoriasis drug, Ilumya, in the Japanese market on 29 June 2020. Ilumya is an innovative product of Sun Pharma that is used for plaque psoriasis.
The drug firm has stated that one of its wholly-owned subsidiaries in Japan had received the approval from the MHLW[1]. Ilumya (tildrakizumab) is approved for use in adults suffering from plaque psoriasis. It was permitted to be used in patients on whom conventional therapies remained ineffective. Currently, around 430,000 people are suffering from psoriasis in Japan.

The company also claimed that Ilumya was comprehensively tested in Japanese patients to validate its safety. This was a part of the Ilumnya’s global clinical development program.
The advantage of Ilumya is that it only needs to be injected once every 12 weeks for patients suffering from chronic plaque psoriasis. The efficacy of this drug was sustained and lasted up to 4 years. Ilumya’s safety profile was also over 4 years, as there were no signs of malignancies or infections during this period.
Ilumya is already approved in the US[2] and EU[3] markets. Its sale in these markets summed up to around $94 million in the first year of commercialization itself.

In 2019, Sun Pharma acquired Pola Pharma in Japan. The company has been keen to expand its dermatology portfolio in Japan. The launch of Ilumya is expected to strengthen this endeavor of Sun Pharma. At present, Sun Pharma has around nine specialty products, namely Ilumnya, Absorica, Xelpros, Yonsa, Cequa, among others. The company has not yet launched all these products in the Japanese market.
Some analysts believe that this move of Sun Pharma is quite risky. This is because the prices of generic drugs in Japan get revised twice a year.
Other main reasons are price erosion of the dermatology segment and the competition from other psoriasis drugs in the market.
Sun Pharma had entered the Japanese market in 2016. During this period, it had acquired 14 prescription brands from Novartis. Other Indian drug firms have already called it quits owing to the price competitiveness in Japan. The latest one to drop out of the Japanese market was Lupin. In 2019, Lupin sold its Japanese subsidiary to the indigenous brand Kyowa. However, Sun Pharma remains optimistic about its venture into the Japanese market. The drug firm has invested around $2 billion in its specialty products.

Psoriasis is a chronic, immune disease that has affected around 125 million people globally. It is primarily manifested in the skin as red skin with white, thick, flaky scales that are itchy and painful. These regions may crack and bleed. The most common type is plaque psoriasis, as around 80-90% of the people are affected by it.

Abbreviation: 1. Ministry of Health, Labour and Welfare

1. United States
2. European Union

2.US court has accused Glenmark of price-fixing of Pravastatin:

The US Department of Justice had charged Glenmark Pharmaceuticals Inc, USA, with price-fixing conspiracies on 30 June 2020. 

Glenmark was alleged to have partnered up with other generic drug firms like Apotex Corp to increase the price of certain medicines. The drugs that were price-fixed were Pravastatin, cholesterol medication, and other generic prescriptions.

Glenmark is vehemently denying these claims and has stated that it will prove its innocence on this matter.

This conspiracy was alleged to have occurred from 2013 to 2015. As per estimates, this conspiracy has caused a loss of around $200 million with regard to the victims.

In May 2020, the allegation against Apotex was resolved by a deferred prosecution agreement as the company agreed to pay $24 million as compensation. 

The stocks of Glenmark pharma dropped by 4.66% and traded at Rs.429.20 at 12.20 pm on 1 July 2020. This was a repercussion of the charge that was filed in the US District Court in Philadelphia, Pennsylvania. 

The Antitrust Division has clearly stated that strict actions would be taken on drug companies for price-fixing.

Currently, four senior executives have been charged with this conspiracy. Three of the four have pleaded guilty while the fourth one is waiting for the trial.

3.Pfizer’s Covid-19 vaccine shows potential in early-stage clinical trials:

Pfizer and BioNTech have collaborated to develop a Covid-19 vaccine. The early-stage human trials of this vaccine were successful, and this was announced on 1 July 2020.

This drug is one of the 17 drugs that Pfizer is currently testing on humans. Pfizer has also collaborated with Moderna, CanSino Biologics, and Inovio Pharmaceuticals for testing these products.

The German biotech firm, BioNTech, witnessed a surge in its shares to 8%, and this went on rising to 19%. Pfizer, too, seen a gain in its stocks from 4.4% to $34.13.  

BioNTech stated that two doses of its BNT162b1 drug were administered to 24 healthy volunteers. After 28 days, these individuals showed higher levels of Covid-19 antibodies.

The second dose was injected 13 weeks after the injection of the first dose. Following the two injections, a shorty fever was observed in around 3 out of the 4 participants. A third dose was injected into a separate group, which had higher concentration. It was not injected after the first shot due to injection pain.

The drug firm further added that more extensive trials were underway. These trials would help to identify if the robust immune response produced can be used effectively against Covid-19.

Currently, there are no Covid-19 vaccines in the market. An analysis by the Massachusetts Institute of Technology in 2019 revealed insight into this matter. It claimed that one in every three vaccines that are undergoing clinical trials will most likely get approved.

BioNTech claimed that BNT162b1 was well tolerated and produce minimal side effects. This drug firm, together with Pfizer, is planning to conduct trials on four of its most promising vaccines. This trial will include 30,000 health volunteers from the United States and Europe. It is expected to begin in late July 2020 after receiving the proper approvals from the regulatory body.

Both companies are optimistic about the vaccine and hope that the vaccine gets a regulatory green signal. They are currently gearing up to manufacture 100 million doses by the end of 2020. Another 2.1 billion doses of the vaccine will be produced by the end of 2021. This vaccine is being manufactured in Germany and the United States. 

Translate Bio and its partner Sanofi are also currently working on a 

A COVID-19 vaccine that works on the messenger RNA.

Reference:

[1] – Sun Pharma launches Ilumya in the Japanese market: Business Standard – 29 June 2020

[2] – US court has accused Glenmark of price-fixing of Pravastatin: Live mint – 1 July 2020

[3] – Pfizer’s Covid-19 vaccine shows potential in early-stage clinical trials: India Today -2 July 2020