pharma News July 2021

Monthly Update- pharma News July 2021

pharma News July 2021: Let us know what’s happening around the globe and the Indian Pharma Industry.

Three-dose ZyCoV-D vaccine could be just two doses, says pharma firm Zydus Cadila

pharma News July 2021: 1 July 2021

Zydus has announced that the immunogenicity produced by the two-dose regimen of ZyCoV – D vaccine (3 mg per visit) is equivalent to the three-dose regimen. This data has been submitted to the government and the company awaits the final decision pertaining to the regulatory approval of this vaccine. Per sources, the two doses must be taken 28 days apart and the company plans to produce over 1 crore doses per month, most likely from August 2021.

By the end of 2021, the company plans to supply over 5 crore shots. It also aims to annually produce over 12 crore vaccines. 1

Alembic Pharma gets USFDA nod for generic Nitrofurantoin capsules

1 July 2021

Alembic Pharma has received the USFDA’s approval for its generic nitrofurantoin capsules. This tablet is indicated for treating urinary tract infections. The FDA has granted the approval for the ANDA application of nitrofurantoin capsules USP, 25 mg, 50 mg, and 100 mg. This tablet is the generic version of Alvogen Malta Operations Ltd’s Macrodantin capsules in the same strength. The estimated market size for this product is around USD 23 million for a period of 12 months ending March 2021. 2

J&J’s single-dose COVID-19 vaccine shows promising signs against Delta variant

pharma News July 2021: 2 July 2021

A small-scale laboratory study has revealed that Johnson & Johnson’s single-dose COVID-19 vaccine is effective against the Delta strain of the virus. Per this, the shot generated a strong and persistent immune response that lasted for over 8 months. J&J further added that the neutralizing antibody activity against the Delta variant was more than that observed with the Beta (B.1.351) variant in South Africa. This shot is around 85 % effective against severe/ critical disease and offers protection against hospitalization and death. It was granted Emergency use authorization (EUA) by the USFDA on 27 February 2021 and Conditional Marketing Authorization (CMA) by the European Commission on 11 March 2021. 3

Philip Morris International Announces Agreement to Acquire Fertin Pharma

2 July 2021

Philip Morris International Inc. (PMC), a leading tobacco company, has entered into an agreement to acquire Fertin Pharma for around DKK 5.1 million (approx. USD 820 million). PMC plans to use Fertin’s technologies to scale up its production to generate over 50 % of its net revenue from smoke-free products and at least USD 1 billion from products other than nicotine by 2025. Fertin is a Denmark – based pharma company that specializes in the research, development, and production of gums, pouches, other solid dosage forms, and is the leading producer of Nicotine Replacement Therapy (NRT) solutions.

This transaction is a multiple of around 15 times Fertin’s 2020 revenue which was revealed to be DKK 1.1 billion (approx. USD 160 million). PMI has decided to fund this transaction with the existing cash and close it by the fourth quarter of 2021 after getting approval from the respective regulatory authorities. 4

US FDA authorizes additional batch of J&J jabs produced at Baltimore factory

3 July 2021

The USFDA has authorized the use of an additional batch of J&J’s single-dose COVID – 19 vaccines that are being manufactured at the Baltimore factory of Emergent BioSolutions Inc. Over four batches that have been manufactured in this factory have received the FDA’s approval. According to a trusted source, this could account for about 15 million doses of J&J’s vaccine.

The regulatory body is, however, yet to approve this unit as an authorized manufacturing facility owing to a long list of sanitary problems and bad manufacturing practices that were discovered during the FDA inspection. The production of the J&J vaccine was halted at this unit in April 2021 due to contamination of this shot with the ingredients of AstraZeneca’s vaccine. 5

NPPA allows 50% price hike for ibuprofen, ranitidine, carbamazepine

3 July 2021

The NPPA has allowed for a one-time 50 % price hike for three key drugs, namely ibuprofen (analgesic), carbamazepine(anti-epilepsy), and ranitidine (antacid). The price of carbamazepine would rise from INR 1 to INR 4.61 per tablet, while that of ranitidine would be in the range of INR 1 to 2.43 per tablet or ml of liquid. For ibuprofen tablets, the price hike is about INR 59 paise to INR 1.04 per tablet. Top pharma companies like Torrent Pharma, Cadila Pharma, Zydus Cadila, and JB Chemicals are more likely to benefit from this as they are the top-selling ranitidine brands of India.

Leading carbamazepine selling brands like Abbott, Intas, Torrent Pharma, and Sun Pharma, as well as the popular ibuprofen brands Cipla and Abbott also stand to benefit from this move. Apart from this hike, the NPPA had also increased the price of antibiotics and other essential drugs like paracetamol in the past few months, although this has been revealed to be steeper when compared to the pre – COVID prices of December 2019 by around 140 %. 6

Panacea Biotec gets regulator’s nod to produce Sputnik V jabs

5 July 2021

The Drugs Controller General of India has granted the license to Panacea Biotech for manufacturing Sputnik V in India. This move has come into effect after the company’s first batch of COVID -19 vaccine cleared all the quality control tests at the Gamelya Center, Russia. The first batch of vaccines was manufactured at the company’s Baddi facility in Himachal Pradesh and has also passed the quality control checks at the Central Drugs Laboratory, Kasauli. Sputnik V received emergency use authorization in India on 12 April 2021 and was first launched in India by Dr. Reddy’s in May 2021. This vaccine is based on human adenoviral vectors and costs around INR 1,145 per dose at the paid vaccination centers. 7

Cadila Healthcare arm recalls 21,240 bottles of diabetes drug in US

pharma News July 2021: 5 July 2021

Viona Pharmaceuticals has initiated a nationwide voluntary class II recall of over 21,240 bottles of Metformin hydrochloride extended-release tablets, USP 750 mg in the United States. This drug firm is a wholly-owned indirect subsidiary of Cadila and the lot being recalled has been manufactured at the Ahmedabad – based facility of Cadila Healthcare. The ongoing recall was initiated due to the cGMP deviations and presence of an excess of probable human carcinogen, N – nitrosodimethylamine (NMDA) in the product as per FDA analysis. Metformin hydrochloride tablets are used as an adjunct to controlling type 2 diabetes along with dietary changes and exercise. Class II recalls are typically initiated when the exposure to the violative product produces a temporary or medicinally reversible adverse effect that is usually not so serious. 8

Moderna mRNA COVID-19 vaccine likely to arrive in India this week

5 July 2021

Moderna’s mRNA vaccine is most likely to reach hospitals by 15 July 2021 for inoculating the people against the novel coronavirus. The company had received the emergency use authorization for its mRNA – based COVID – 19 vaccine from the DCGI on 29 June 2021, making it the fourth COVID – 19 vaccine to be available in India. Drugmaker Cipla has been granted approval for importing this vaccine to India. The DCGI has, however, stated that this permission is for restricted use in emergency situations in the public interest.

According to the approval order, the drug firm is expected to submit the 7 days’ safety assessment of the vaccine to the first 100 beneficiaries before proceeding with the immunization program in the country. Moderna’s mRNA vaccine is given in two doses and is currently being widely used in the USA and Europe. 9

Govt asks Pfizer to expedite COVID-19 vaccine application process

6 July 2021

The DCGI has recently asked the US-based pharma company, Pfizer, to file the application papers for bringing its COVID – 19 vaccine to India at the earliest. This request has been put forth to hasten the vaccination drive in the country. The drug regulator had reportedly written to Pfizer about this matter twice. Despite the company’s reaffirmation to support the Indian government in this ongoing pandemic, the vaccine is yet to be available in the country owing to the ongoing talks with the government over indemnity against legal proceedings.

In June 2021, Pfizer’s CEO claimed that the vaccine was in the final stages of approval in India and once approved will be available to the Indian population at less than $10 per dose (approx INR 730). The company had also added that it would only directly deal with the Government of India (GoI) and that the GoI would have to make the payment to Pfizer India. 10

Bharat Biotech-Brazil row: Covaxin nod under controlled conditions

pharma News July 2021: 6 July 2021

Brazilian health regulator, ANVISA, has not yet granted Bharat Biotech’s COVID – 19 vaccine, Covaxin, emergency use authorization. However, on 4 June 2021, it was revealed that the regulatory agency has authorized the “exceptional import of Covaxin by the health ministry for distribution and use under controlled conditions”. Due to the missing data from the vaccine’s clinical trials, the deadline for evaluating the application for the emergency use of Covaxin has been suspended by ANVISA.

But according to a trusted source, over 4 million shots of Covaxin would be imported and used in Brazil under the specific conditions determined by the Brazilian government. This news has been disclosed in the midst of the $324 million deal controversy that Brazil is alleged to have made with Covaxin makers for the supply of over 20 million shots. Bharat Biotech had, however, refuted this claim on 30 June 2021 in a press statement. 11

NEUWAY Pharma Announces Formation of Scientific Advisory Board

6 July 2021

NEUWAY Pharma has recently announced the formation of a Scientific Advisory Board ( SAB) to provide guidance and advice for its preclinical and clinical strategies. These strategies will be used for its proprietary EnPC protein capsule delivery approach. This technology is being utilized for transporting a variety of therapeutic loads across the blood-brain barrier to deliver therapies to the brain. The SAB includes leading drug delivery and development experts such as Hans Grünhagen, Olaf Ritzeler, and Georg Terstappen. 12

Big global worry! Pfizer vaccine less effective against Delta variant

6 July 2021

The Pfizer vaccine has revealed a significant drop in its efficacy in recent times, especially in Israel. While the vaccine has shown the efficacy of about 94 % between 6 June 2021 and early July 2021, it has now dropped to around 64 %. The fall in the vaccine’s effectiveness is associated with the spread of the Delta variant of the virus across the country and with the lifting of the restrictions in the country.

The Israel Health Ministry has, however, stated that the vaccine offers strong protection against severe COVID – 19 and is effective at preventing hospitalization from severe illness by about 93 %. Pfizer’s spokesperson has also added that the vaccine offers protection against the new variants of the virus, but this could be in a slightly reduced capacity in some variants. Pfizer further revealed that the third dose of the vaccine is more likely to be given within 12 months of being fully vaccinated. 13

India’s Morepen Labs begin manufacturing test batches of Sputnik V

7 July 2021

Morepen Laboratories has begun to manufacture test batches of the Russian COVID – 19 vaccine, Sputnik V, with the aim to enhance production capacity within the country. The pharma major together with RDIF had made this announcement and added that the production was being carried out at an exclusive facility in Himachal Pradesh. The company had signed a cooperation agreement with RDIF in June 2021 and the technology transfer is now being actively implemented. The first batch of vaccines produced at this site will be shipped to the Gamelya Center for quality control tests. Sputnik V was granted emergency use authorization by the Indian government on 12 April 2021. 14

Novartis to make Leqvio for the U.S. in Austria to overcome FDA delay

7 July 2021

Novartis will manufacture its anti-cholesterol drug, Levqio, in its manufacturing plant situated at Schaftenau, Austria. The pharma major had acquired this drug via its 2019 acquisition which cost around $10 billion. It has been approved by the European regulatory authority but is being stalled by the FDA due to ” unresolved facility inspection – related conditions” at the Italian plant of Novartis supplier, Corden Pharma. Novartis has resubmitted the complete response letter to FDA citing its manufacturing plant in Austria for the production of the final finished product. It further added that while Corden will continue to supply this drug to the markets outside the US, the US market will receive the drug manufactured at the Austrian facility. The generic name of this drug is inclisiran. 15

India expects 3-4 mln Pfizer, Moderna vaccine doses through COVAX by August: Sources

pharma News July 2021: 7 July 2021

Over 3 to 4 million doses of Pfizer and Moderna COVID -19 shots are likely to reach India by August 2021 via the COVAX facility. A trusted source is also anticipating the arrival of the US-made vaccines to India as early as July 2021. The concerned parties have, however, remained silent over this matter and have not yet made any official statement. While India mainly depends on AstraZeneca’s shot for its vaccination drive, it is now courting Pfizer, Moderna, and Johnson & Johnson for vaccine supplies. J&J has entered into a manufacturing agreement with Biological E to supply the vaccine to India but the production is yet to start. The company has claimed that it is looking to expedite the vaccine supplies to the country. 16

US FDA narrows patient group for Biogen’s Alzheimer’s drug after sharp criticism

8 July 2021

Biogen has announced that the USFDA has narrowed down the group of patients that can use its Alzheimer’s disease drug, Aduhelm. Per the FDA, this drug is permitted for use only in patients with mild cognitive impairment or mild dementia stage of the disease, as this was the population in which the treatment was studied in the clinical trials. The FDA has made this move after receiving sharp criticism over the effectiveness of this drug in June 2021. It must also be noted that around three experts had resigned from the FDA committee over the approval of this drug as it only slowed the mental decline in one study and was marred by hard-to-interpret results. Aduhelm is the first Alzheimer’s disease drug that has been approved by the USFDA in around 20 years. 17

Mankind Pharma gets DRDO nod to manufacture, market Covid drug 2-DG

9 July 2021

Mankind Pharma has received the license for the manufacturing and marketing of DRDO’s oral 2 – deoxy – D – glucose (2 – DG) in India. This oral drug is used for the treatment of COVID – 19 and was developed by the Defence Research and Development Establishment (DRDE), Gwalior. The clinical trials of this drug were carried out in a lab of DRDO in association with Dr. Reddy’s Laboratories. Per sources, this drug will be manufactured in Mankind Pharma’s manufacturing facility situated at Himachal Pradesh and Vishakapatnam. 2 – DG is found to help hospitalized COVID – 19 patients recover faster and also reduce supplemental oxygen dependency among these patients. 18

Alembic Pharmaceuticals gets USFDA nod for anti-depressant drug

pharma News July 2021: 9 July 2021

Alembic Pharma has received the USFDA’s approval for its anti-depressant drug, Desipramine Hydrochloride USP in the strength of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg. This product is therapeutically equivalent to the reference listed drug product, Nopramin tablets of Validus Pharmaceuticals LLC. Per the IQVIA data, the market size for this product is around USD 7 million for twelve months ending in March 2021. 19

Covid vaccine: Pfizer to seek approval for third shot of its vaccine, US agencies say ‘no need now’

9 July 2021

Pfizer company had recently released data which showed that the third dose of its COVID – 19 shot offered the highest level of protection when given 6 to 12onths after the second dose. The USFDA has, however, stated that this is not necessary for completely vaccinated individuals at present. The company claimed that the protection offered by the two-shot regimen declined six months post-vaccination by citing the data released from the Israel Ministry of Health.

It also added that a decline in efficacy against the symptomatic disease is also possible over time due to the continuous emergence of variants. It further revealed that it is planning to seek the FDA’s approval for the booster shot in August 2021 after releasing more data on the efficacy of the third dose of the vaccine. 20

Hetero Labs seeks emergency nod for Covid-19 drug Molnupiravir

9 July 2021

Hetero Labs has sought the local regulatory authority’s emergency use approval for the use of Molnupiravir in the treatment of COVID – 19. The company has made this move after the interim data from the late-stage trial of the drug showed that it reduces hospitalization and sped up the recovery of mild cases of COVID -19. Molnupiravir is an experimental oral drug that has been developed by Merck & Co and Ridgeback Biotherapeutics for the treatment of non – hospitalized COVID- 19 patients. Hetero Labs had started a phase III randomized and multicenter clinical trial on mildly infected cases across India. The interim results were obtained from this trial and it revealed that the patient’s recovered at a faster rate while using this drug as compared to the standard. 21

Alembic Pharma bags USFDA nod on erlotinib tablets

pharma News July 2021: 9 July 2021

The USFDA has approved Alembic Pharma’s Abbreviated new drug application for its Erlotinib tablets,25 mg, 100 mg, and 150 mg. This product is therapeutically equivalent to the reference listed product, Tarceva tablets, 25 mg, 100 mg, and 150 mg that are manufactured by OSI Pharmaceuticals. Erlotinib is indicated for the treatment of metastatic non – small cell lung cancer whose epidermal growth factor receptors have a deletion or substitution mutations. It is specifically permitted for use in patients who are receiving first-line, maintenance, or second, or greater line treatment for cancer that has begun to progress after at least one prior chemotherapy regimen. This tablet in combination with gemcitabine is indicated for the first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer. The estimated market value of the 25 mg, 100 mg, and 150 mg strengths of Erlotinib tablets is around $ 37 million for twelve months ending in March 2021. 22

Zydus seeks emergency approval for ‘needle-free’ three-dose COVID-19 vaccine for children above 12

12 July 2021

Zydus Cadila has sought out the DCGI for the emergency use approval of its COVID – 19 vaccine, ZyCoV – D, in children above 12 years of age. This vaccine has been tested on both adults and children above 12 years of age. This data has been submitted to the Subject Expert Committee (SEC) which will be meeting with the company’s representatives in the third week of July 2021. The pharma major has also revealed that if the SEC finds the phase III trial data and the documents submitted to be satisfactory, then the vaccine will most likely be granted emergency use approval within the third week of July 2021 itself. 23

Israel partners with NRx Pharmaceuticals to commercialize the COVID vaccine

12 July 2021

Israel Institute for Biological Research and NRx Pharmaceuticals has recently partnered up to complete the clinical trials and commercialize the Israeli – developed COVID – 19 vaccine, BriLife. This vaccine has been undergoing early clinical trials in Israel in the past few months and NRs has stated that it has arranged for the rapid Phase 2b/ 3 testing in Israel, Georgia, and Ukraine. Per Israel’s Defense Ministry, tens of thousands of volunteers will be involved in this. The Israeli research institute will provide technical assistance for this vaccine and in turn receive royalty and milestone payments for its intellectual property. NRx, on the other hand, will remain committed to supplying all the required doses of the vaccine to the entire population of Israel. BriLife COVID – 19 vaccine is a self-propagating, live virus vaccine that will be delivered via injection. 24

Bharat Biotech says WHO nod to Covaxin for emergency use listing soon

pharma News July 2021: 13 July 2021

Bharat Biotech has submitted the documents required for the Emergency use listing (EUL) for Covaxin to the WHO as of 8 July 2021. The company has also added that WHO is reviewing these documents and expects to receive the EUL from WHO soon. The information was disclosed after WHO chief scientist, Soumya Swaminathan, revealed that the WHO is likely to take a decision on Covaxin’s EUL in the next four to six weeks. Over six vaccines have been approved by the WHO with EUL to date. EUL is a risk-based procedure that is used for the assessment and listing of unlicensed vaccines and therapeutics to expedite the availability of these products to the people affected by a public health emergency. 25

Kintor Pharmaceutical Collaborates with Fosun Pharma Development to Commercialise Proxalutamide for Treatment of COVID-19 in India and Africa

14 July 2021

Kintor Pharma entered into a licensing agreement with Fosun Pharma on 14 July 2021 for the commercialization of ‘proxalutamide’. The main purpose of this collaboration is to secure emergency use authorization of this drug and for the promotion and sales of this drug for the treatment of COVID – 19 indications in India and 28 African countries (the ‘Collaboration Regions’). Per the agreement, Fosun will be granted exclusive rights of registration and commercialization of proxalutamide in the collaboration regions while Kintor will be eligible to receive upfront payments and milestone payments up to RMB 560 billion.

The latter is also allowed to receive about 50 % of the total operating profit in the collaboration regions. Proxalutamide is a newer-generation androgen receptor antagonist that has received the USFDA and ANVISA’s approvals for the ongoing phase III multi-regional clinical trials in the United States, South America, Brazil, the European Union, and Asia. 26

J&J recalls Aveeno, Neutrogena sunscreens after carcinogen found in some sprays

15 July 2021

Johnson & Johnson initiated a voluntary recall of all lots of five Neutrogena and Aveeno brand aerosol sunscreen products due to the presence of a Cancer-causing chemical, benzene, in some samples on 14 July 2021. The recalled products are Neutrogena Beach Defense, Neutrogena Cool Dry Sport, Neutrogena Invisible Daily defense, Neutrogena Ultra Sheer, and Aveeno Protect + Refresh.

The company has stated that although benzene is not an ingredient of the sunscreen product, it was detected in some samples of the finished aerosol sunscreen products. It also added that daily exposure to the levels present in the sunscreen is unlikely to cause any serious adverse effects, but is still taking this move out of caution. J&J has also asked the consumers to stop using and discard this product appropriately and contact their physician especially if they have experienced any problems after using this product. 27

COVID-19 vaccine: Pfizer, Moderna have not submitted applications for EUA, says DCGI

pharma News July 2021: 15 July 2021

The DCGI has yet again appealed to Pfizer to file application papers for bringing their mRNA-based COVID – 19 vaccine to India. This move was taken as the DCGI is yet to receive the applications of the US-based pharma giants, Pfizer and Johnson & Johnson, for the emergency use authorization of their respective COVID – 19 vaccines. Per a trusted source, the Indian government has initiated talks in this regard and is waiting for the pharma giants’ response. Negotiations are being made with a positive mind as the pharma companies have sought legal indemnity in case of any adverse effects of their vaccines. Apart from this, it was also revealed that India is yet to receive Moderna’s 7 million doses of vaccine from the US under the COVAX facility. Cipla was granted permission for importing Moderna’s vaccine but no call has been taken for legal indemnity so far. 28

Fosun-BioNTech COVID-19 vaccine completes China regulator review – media

15 July 2021

Germany’s BioNTech (22UAy.DE) and Fosun Pharma (600196.SS) have collaborated to develop an mRNA – based COVID – 19 vaccine. This shot is in the administration review stage and the Chinese regulators have recently completed an expert review on it. Fosun has stated that the trial production in China will begin by August 2021 and would be used as a booster shot for those who received vaccines using inactivated viruses such as Sinovac’s (SVA.O) COVID – 19 shot. BioNTech’s chief had revealed in April 2021 that he believed this vaccine would receive the Chinese authorities’ approval by June 2021 at the latest. This was probably because China is yet to approve any COVID – 19 vaccines developed overseas but has approved several domestic brands. Over 1.4 billion doses or about two-fifths of the global total of 3.47 billion doses have been administered in China so far and these were done using the indigenously developed COVID – 19 vaccines only. 29

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