Pharma News August 2021

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GC Pharma and Tottori University Enter Research Collaboration and License Agreement for Development of GM1 Gangliosidosis Chaperone Therapy

GC Pharma and Tottori University have collaborated to accelerate the global development of the chaperone therapy of GM1 gangliosidosis (GM1). Per this agreement, GC Pharma has obtained the exclusive rights to develop and commercialize the therapy worldwide and the responsibility to conduct clinical trials. At the same time, Tottori is entitled to receive an upfront payment, parent for achieving commercial milestones in the future, and royalties based on sales. Under this contract, both the organizations will work together to conduct and complete the derivation of the drug candidates and the non – clinical trials. Tottori University and the National Institutes of Biomedical Innovation, health and Nutrition (NIBIOHN) co-developed the screening technology to identify potential chaperone compounds to treat orphan disorders for more than 20 years. GM1 is an inherited lysosomal storage disease that destroys the nerve cells in the brain and spinal cord. 1

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Pfizer and Moderna raise prices for Covid-19 vaccines sold in Europe.

Per the latest European Union supply contracts, the price of Pfizer and Moderna’s COVID – 19 vaccines that it will sell in Europe have been raised. While the price of the Pfizer shot rose from 15.50 euros to 19.50 euros, the cost of Moderna’s shot is currently about 21.45 euros a dose as opposed to the previously agreed price. An official has also commented on this matter. He has revealed that in the first procurement deal, Moderna’s vaccine was priced at 19 euros per dose and that the current hike in the vaccine’s price is relatively lower than the previously agreed 24 euros as the order has grown. The European Commission recently revealed that the EU is on track to vaccinate at least 70 % of its adult population by the end of summer 2021. Amidst this recent move, the company disclosed that about 170,000 doses of Moderna’s shots are at risk of expiry within the next fortnight. There is an unpredictability of the young teens taking up the vaccine. 2

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Glenmark Pharma signs agreement for nasal spray used for Covid-19 treatment 3

Glenmark Pharma has signed a long-term strategic partnership with SaNOtize Research & Development Corp to manufacture, market, and distribute its breakthrough product, Nitric Oxide Nasal Spray (NONS), in India and other Asian markets. As per the deal with the Canadian biotech firm, NONS will be distributed in Asian markets, including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor – Leste, and Vietnam, for the treatment of COVID – 19. Glenmark had submitted the proposal to the Subject Expert Committee of the CDSCO in early July 2021 for emergency approval to import and market the nasal spray. In response to this, the CDSCO recommended a phase III trial for NONS in Indian patients, which is expected to be completed soon. The company further added that this would be followed by the product’s commercial launch under the brand name, FabiSpray, in India by the fourth quarter of 2021. It also revealed that the clinical trials conducted by SaNOtize in March 2021 showed that NONS reduced the average viral load by around 95 % in the first 24 hours and then by about 99 % within 72 hours. 3

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Novartis to launch new Zolgensma trial after FDA lifts restriction

Novartis has launched a new phase three study to expand the use of Zolgensma after the USFDA allowed the existing trials to proceed and lifted the partial clinical trial hold imposed in October 2019. Zolgensma is the world’s most expensive one-time therapy at $ 2.1 million per patient to treat spinal muscular atrophy (SMA). The ongoing trial is designed to study the use of the drug in patients aged 2 to 18 for SMA treatment. The sales of Zolgensma dropped in 2020 after safety concerns prompted the company to pause the trial to collect more data for the USFDA. The company had also laid off about 400 people and closed a US gene therapy location in March 2021 as the sales momentum of this drug had stalled in 2020. 4

Gilead delivers Amphotericin B
Yuyu Pharma to distribute Novartis Korea’s prescription medicines in Korea.

Korea – based pharma company, Yuyu Pharma and Novartis Korea have agreed to the distribution of Lamisil, Lescol, and Tegretol in Korea. Per this agreement, Yuyu Pharma will have exclusive distribution rights of these prescription medicines in Korea from 1 August 2021. Lamisil tablet contains Terbinafine hydrochloride and is used to treat athlete’s foot, ringworm of the foot, and ringworm of the body. Lescol XL prolonged-release tablets are indicated in the treatment of dyslipidemia and effectively delay the progression of coronary atherosclerosis in patients with primary hypercholesterolemia and coronary artery disease. It contains Fluvastatin sodium as the active ingredient. Tegretol contains carbamazepine and is useful for the treatment of epilepsy, trigeminal neuralgia, and schizophrenia. 5

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Uniza Group ties up with USA Companies for launching innovative products for Indian markets.

Ahmedabad – based pharma company Uniza Group has recently collaborated with Lysulin Inc to launch Lysulin in the Indian market. Lysulin has been patented in the USA for the prevention of protein glycation using Lysine supplements. This has also been approved as a method of diabetes support using a supplement. Uniza had also collaborated with Cymbiotics Biopharma Pvt. Ltd. in 2020 – 21 to introduce Schones hair serum and Keratiza shampoo in India. The company had also revealed that it was looking forward to launching more innovative products for the first time in India, including antifungals, anti-dandruff preparations, moisturizers, oral hypoglycemic agents, Lipid-lowering agents, and iron preparations. 6

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