Zydus completes phase 2 clinical trial in Covid patients with bio-therapy

 Drug firm Zydus Cadila on Thursday said

it has successfully completed a phase 2 clinical trial In COVID-19 patients with its biological therapy, 'PegiHep', and it will now begin phase 3 clinical trial.

In a regulatory filing, Zydus Cadila said "it has successfully completed a phase 2 clinical trial in COVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHep'... Based upon the results from its Phase 2 study, Zydus Cadila now plans to conduct a phase 3 clinical trial in India".

Zydus Cadila, whichis a part of the Cadila Healthcare group,said Pegylated Interferon alpha 2b significantly increased viral reduction and reduced the need for supplemental oxygen in moderate COVID-19 patients.

"We continue to look at possible treatment options that are safe and efficacious in the treatment and management of COVID-19. Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we will like to explore this biological option further. We are hopeful of reinforcing our treatment options to fight COVID-19," Sharvil Patel, Managing Director, Cadila Healthcare Ltd said.

Pegylated Interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in WHO's Essential Medicines List.

Zydus Cadila said its Pegylated Interferon alpha-2b, PegiHep, was originally approved for Hepatitis C and was launched in the Indian market in 2011.

Since then safe and efficacious drug use for this product has been demonstrated in thousands of patients, the company added.

Zydus Cadila said it had conducted this study on the approval from the Drugs Controller General of India (DCGI) to investigate the role of Pegylated Interferon alpha-2b for COVID 19. The company is also conducting a similar phase 2 trial in Mexico.

The company is also working with the US Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the US.

Zydus Cadila gets USFDA nod for overactive bladder treatment drug

 

Drug firm Zydus Cadila on Tuesday said it has received final approval from the US health regulator to market Solifenacin Succinate tablets, used for treatment of overactive bladder.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market Solifenacin Succinate tablets, in the strengths of 5 mg and 10 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.

Solifenacin Succinate is a symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

The company said the newly-approved medication will be manufactured at the group's formulation manufacturing facility at the special economic zone, Ahmedabad.

The group now has 309 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in financial year 2003-04.

Shares of Cadila Healthcare were trading 0.01 per cent higher at Rs 422.55 on BSE.

Zydus Cadila gets USFDA nod to market Verapamil Hydrochloride Injection

 Drug firm Zydus Cadila on Friday said it has received final approval from the US health regulator to market Fingolimod capsules and Verapamil Hydrochloride Injection.

Fingolimod capsules is indicated for the treatment of patients with relapsing forms of multiple sclerosis. While, Verapamil Hydrochloride Injection, is used to rapidly/temporarily restore normal heartbeats in people with certain heart rhythm disorders.

Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to marketFingolimod capsules, (Gilenya)in the strengths of 0.5 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing.

The company said the drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

"The company has also received the final approval from the USFDA to market Verapamil Hydrochloride Injection USP, 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL), single dose vials (Isoptin Injection)," Zydus Cadila said.

The injections will be manufactured at the company's manufacturing facility at Jarod, near Vadodara.

The group now has 305 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in 2003-04.

Shares of Cadila Healthcare were trading 2.85 per cent higher at Rs 427.45 apiece on BSE.

Zydus Cadila gets tentative USFDA approval to market arthritis drug

Drug firm Zydus Cadila on Saturday said it has received a tentative approval from the US health regulator to market generic Apremilast tablets.

The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 10 mg, 20 mg, and 30 mg, Zydus Cadila said in a filing to BSE.

This medication is used to treat psoriatic arthritis and moderate to severe plaque psoriasis. It is also used to treat mouth sores in people who have Behcet's disease, it added.

The tablets will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.

The group now has 276 approvals and has so far filed over 360 ANDAs since the commencement of its filing process, it added.

Zydus Cadila gets US FDA approval for generic muscle relaxing injection

Cadila Healthcare on Tuesday said group firm Zydus Cadila has received final approval from the US health regulator for its generic version of muscle relaxant Cisatracurium Besylate Injection given before general anaesthesia.

The approval by the US Food and Drug Administration is for single dose vials of Cisatracurium Besylate Injection USP with strengths of 10 mg/5 ml and 200 mg/20 ml.

This medication is used to relax the muscles. It works by blocking the signals between nerves and muscles and is given before general anaesthesia in preparing for surgery, the company said in a regulatory filing.

The injection will be manufactured at Liva Pharmaceuticals, a wholly-owned subsidiary of Cadila, it added.

The group now has 275 approvals and has so far filed over 360 abbreviated new drug applications, since the commencement of the filing process in financial year 2003-04, it added.

Shares of Cadila Healthcare were trading at Rs 241.05 apiece, down 0.17 per cent on the BSE.

Zydus Cadila announces Q1 consolidated net profit of Rs 303.6 crore

Ahmedabad-based drug maker Cadila Healthcare Ltd (Zydus Cadila) in Friday announced a consolidated net profit of Rs 303.6 crore for the quarter ended June 30, 2019 (Q1FY20). As against this, the company's Q1 consolidated net profit for the previous fiscal stood at Rs 460.5 crore.

Led by a 46 per cent growth in its India business, the company saw its consolidated total revenue rise by 17.49 per cent to Rs 3,518.9 crore for the quarter ended June 30, 2019. Last year, the Q1 consolidated total revenue stood at Rs 2,995 crore.

Comprising human formulations, consumer wellness and animal health business, Zydus Cadila's India business saw sales rise to Rs 1,675 crore on a year-on-year basis in Q1FY20. During the quarter, the company entered into a marketing alliance with SIFI, the Italian leader in the development of therapeutic solutions for treating ophthalmic disorders, to market innovative intraocular lenses (IOLs) and surgical products developed in Italy and licensed in India by SIFI.

The company's US business, on the other hand, saw sales rise by 11 per cent to Rs 1,367 crore on a y-o-y basis. During the quarter, the company launched 8 new products in the US, apart from filing four additional abbreviated new drug applications (ANDAs) with the USFDA and receiving 10 ANDA approvals, during the quarter. The company’s business in the emerging markets of Asia, Africa and Latin America grew by 12 per cent, with sales of Rs 220 crore.

For the full year (FY20), the company expects its US generics business to grow in single digits, the management told analysts in an earnings call. The management reiterated that the recent official action indicated (OAI) issued by the USFDA on its Moraiya plant will not have any impact on current supplies or revenues, even as the process of remediation was going on in line with commitments made to the regulator.

Meanwhile, the first quarter saw the company announce phase III trials of Desidustat, an investigational new drug aimed at treating anemia in non-dialysis dependent chronic kidney disease (NDD-CKD) patients as part of its research programme. The company also announced the completion of the enrolment of patients in the Evidences IV Phase 2 Clinical Trial of Saroglitazar magnesium in non-alcoholic steatohepatitis (NASH) across 20 clinical sites in the US.

It is unlikely for Zydus Cadila to repeat US feat this year, say analysts

Analysts doubt if Cadila Healthcare (Zydus Cadila) will be able to replicate the 43 new product launches in the US it did in 2018-19. Also, they think, though high in terms of volume, the new US launches were not big enough to make significant dents in the market.

“It is unlikely for the firm to repeat the feat this year. Last year, the company had said it was going to launch 50 products, against which it launched 43. However, most of these products are smaller ones,” said an analyst, on condition of anonymity.

Cadila’s annual report says FY19 was similar to FY18, which saw 77 new product approvals. The 43 new products in FY19, it had said, was highest number so launched by it in the US in a single year till date.

Analysts doubt if other Indian firms in the segment will do much better in the formulations business in the US. “I do not think FY20 will match expectations of many Indian pharma companies. As far as Cadila Healthcare is concerned, irrespective of the launches, how many of the products will go on to garner market share will be questionable. I don’t think the market is big enough now. Some of the products might turn out to be influential but the rest of them might not,” Surajit Pal, research analyst at brokerage Prabhudas Lilladher, told Business Standard.

Cadila’s US formulations business was the largest contributor at Rs 6,279 crore to its consolidated revenue of 13,166 crore; it grew 8 per cent. The India formulations business, second largest contributor, saw sales of Rs 3,534 crore during the year, up six per cent. It had launched 53 products in this country, including line extensions, of which eight were first-in-India ones.

Analysts are also wary on the company’s Moraiya plant in Ahmedabad that makes drugs for the US market. “The FDA inspected the facility from April 22 to May 3, 2019, and then issued 14 observations. These don’t include any repeat observations or data integrity-related observations. The firm has responded, with the corrective and preventive action plan it proposes to implement to resolve these observations,” the firm stated in its annual report.

“Given the observations Moraiya has received in recent times, these many products getting approved this year is unlikely. There are not many drugs left in formulations in the US that can get revenue. Rather, what are left are in biologics, insulin and gene therapy, among others,” said an analyst.