Tag: Mylan

Pfizer declares interim dividend of Rs 30 per share after sale of Upjohn business

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

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The US-based pharma major Pfizer Ltd on Tuesday said it has declared an interim special dividend of Rs 30 per equity share for the financial year ending March 31, 2023.

In a regulatory filing, the company said, “The Board of Directors at its meeting held today, i.e., September 6, 2022, has declared an Interim (Special) Dividend of Rs. 30/- per equity share of Rs. 10/- each (300%) for the financial year ending March 31, 2023, in view of the gain on account of sale of Upjohn Business to Mylan Pharmaceuticals Private Ltd.”

This is the first interim dividend the company has announced for this fiscal. September 20, 2022, has been the record date for the purpose of payment of dividends.

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Back in 2021, Pfizer had entered into an agreement with Mylan Pharmaceuticals to sell its Upjohn business for Rs 180.48 crore.

“The Upjohn business comprises six brands which include Lyrica, Viagra, Celebrex, Amlogard, Daxid and Dilantin. These along with related business assets and liabilities will transition to Mylan,” the filing said.

The rationale for the transaction is that Pfizer Inc, USA, on July 29, 2019, announced that it had entered into a definitive agreement to combine its Upjohn business — which consists of off-patented branded and generic established medicines — with Mylan N.V., thereby creating a new global pharmaceutical company, Viatris Inc.

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Under the global transaction, six brands currently marketed by Pfizer Ltd in India, viz., Lyrica, Viagra, Celebrex, Amlogard, Daxid and Dilantin, will transition to Mylan Pharmaceuticals.

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

Remdesivir shortage: Cipla, Cadila ramping-up production

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

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There are around 6-7 companies that are licensed to sell Remdesivir in India. It includes Cadila, Cipla, Mylan, Hetero, Jubilant Lifesciences and Dr Reddy’s Laboratories (DRL).

CNBC-TV18 has learnt that Remdesivir is witnessing a shortage across major states and that is because of a sudden spurt in demand that has been seen.

Now, because of the surge that has been seen in the COVID-19 cases, all of the companies have had to ramp up demand quite substantially. The shortage is because Remdesivir takes a longer time to ramp up production.

Watch the accompanying video of CNBC-TV18’s Ekta Batra for more details.

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

USFDA informs Biocon Biologics, Mylan of deferred action on Avastin biosimilar license application

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

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Biotechnology major Biocon on Friday said its arm, Biocon Biologics, and Mylan have been informed by the US health regulator of a deferred action on the biologics license application (BLA) for a biosimilar to drug Avastin, used to treat various types of cancers.

Biocon Biologics Ltd and Mylan, a subsidiary of Viatris Inc, have been informed by the US Food and Drug Administration (USFDA) of a deferred action on the BLA for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), Biocon said in a regulatory filing.

”To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard review process. However, due to restrictions on travel related to COVID-19, the agency is unable to conduct an inspection during the current review cycle. We await the dates for the inspection,” it added.

”There are no additional observations related to the application,” Biocon Biologics spokesperson said.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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

Biocon, Mylan’s diabetic drug receives positive opinion from European Medicines Agency committee

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

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Biotechnology firm Biocon on Monday said its subsidiary Biocon Biologics and Mylan have received a positive opinion from the European Medicines Agency’s committee for medicinal products for human use (CHMP) recommending approval of the market authorisation of their product ’Kixelle’ use for the treatment of type 1 and 2 diabetes.

”Biocon Biologics and Mylan (a subsidiary of Viatris Inc.) have received a positive opinion from the European Medicines Agency’s committee for medicinal products for human use (CHMP) recommending approval of the market authorisation of Kixelle, a biosimilar Insulin Aspart, which is a rapid acting insulin for the treatment of type 1 and 2 diabetes,” Biocon said in a regulatory filing.

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Biocon said the CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected early next year. Christiane Hamacher, CEO, Biocon Biologics, said the company will look forward to a final decision from the European Commission approving Insulin Aspart ”which will enable us to expand our offering to people with diabetes to include a rapid-acting insulin analog along with a long-acting insulin glargine”. Shares of Biocon were trading 0.58 percent lower at Rs 452.25 apiece on BSE.

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

On track for launching Semglee in US in Q2FY21: Biocon’s Kiran Mazumdar Shaw

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

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Biocon and its Mylan today received the US FDA’s approval for their insulin glargine injection Semglee, used for Type 1 and Type 2 diabetes.

The nod comes through soon after the US Patent and Trademark Appeal Board (PTAB) rejected a challenge from Sanofi, which said Semglee infringes upon the patents for its product Lantus, also an insulin glargine injection.

“All the decks are cleared, we have won all the pending litigations. That paves the way for an unencumbered entry into the US market,” Biocon CMD Kiran Mazumdar Shaw told CNBC-TV18. “We already said that we were going to launch in Q2 of this fiscal and we are on track for that,” she further mentioned.

“We have already been approved in Europe but entering the US market was extremely important for Biocon. So we believe that this could now open the way to a very large business opportunity for Biocon in the years ahead,” she said.

Shaw added that glargine was a $8 billion market globally, with the majority of it being in the US.

“We are confident that we will get a very decent double-digit plus market share in the US before long. The US opportunity is about USD 6-7 billion,” she said.

The Biocon chief also talked about the COVID-19 pandemic, saying the government must focus on bringing down the mortality rate.

She added that the economy could not afford another lockdown and it would not help also.

“Implementing a lockdown [now] is like ‘shutting the stable after the horse has bolted,” she said.

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

Biocon and Mylan receive US FDA approval for Semglee

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

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Biocon Ltd and Mylan have received approval from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for Semglee, an insulin glargine injection, in vial and pre-filled pen presentations.

Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications. The drug is used to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes, the company said.

“The global INSTRIDE clinical studies have demonstrated no difference in safety, efficacy and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes. Our goal is to enable access to patients in need of insulins, and we are working towards creating a patient ecosystem that helps in lowering co-morbidities and achieving overall cost savings for the healthcare systems,” said Kiran Mazumdar Shaw, Chairperson, Biocon.

Sanofi’s total IQVIA sales for the 12 months ending April 30, 2020 were approximately $1.68 billion for Lantus 100 units/ml vial and approximately $4.33 billion for Lantus SoloSTAR pen, the company statement added.

Mylan and Biocon Biologics insulin glargine has received regulatory approval in more than 45 countries around the world and is the third product approved by FDA through the Mylan-Biocon Biologics collaboration.

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

Biocon partner Mylan gets favorable ruling in patent case on Insulin Glargine

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

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In a boost to Biocon’s Insulin glargine application in the US, its partner Mylan got a favourable ruling from the US Patent and Trademark Appeal Board (US PTAB) in its case against Sanofi , the innovator of insulin glargine.

The US Patent Office ruled in favour of Mylan for a total of four device patents on Sanofi’s Lantus SoloSTAR. Lantus SoloSTAR is the disposable injection pen version of the drug. The other version by Sanofi—Lantus—is sold in the form of vials.

Biocon and Mylan have a pending application for insulin glargine, which is the biosimilar version of Sanofi’s Lantus with the US Drug Regulator. Biocon’s version of insulin glargine is branded as Semglee. The drug insulin glargine is a long-acting insulin used to manage both Type 1 and Type 2 diabetes.

Biocon and Mylan are currently awaiting the US drug regulator’s final nod for insulin glargine. Biocon expects to launch the drug in the US markets by the middle of this calendar year. According to the CEO and Managing Director of Biocon Biologics, Dr Christiane Hamacher, the ruling ‘further clears the path’ for the launch of insulin glargine in the US.

According to analysts, the market size of insulin glargine is a little over $2 billion for the US. Currently, this market size is split between two companies Sanofi and Eli Lily. Lily’s version of the drug was available in most countries around 5 years ago and is sold under the brand names Basaglar and Abasaglar.

One of the key challenges that Biocon faces on insulin glargine is the lack of an interchangeable status. That means a doctor needs to specifically write a prescription for Semglee and it cannot be sold as a replacement for Lantus or Basaglar. That means Mylan is probably going to have to promote the drug which could even become unviable later on.

As of now, the street will watch if Mylan will be granted interchangeability status. If it does get granted the status for the vial version of Lantus, then Mylan could make around $60 to $80 million in sales from the vial version drug.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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