Mylan Shareholders To Vote On Viatris
Almost 11 months to the day since the deal was first announced, Mylan shareholders are to meet to vote on matters related to the company’s proposed combination with Pfizer‘s off-patent and mature brands division, Upjohn.
Originally scheduled for 27 April, the extraordinary general meeting was pushed back to 30 June “due to the unprecedented circumstances surrounding the COVID-19 pandemic,” Mylan announced in late March. The new date aligns with Mylan’s annual general meeting of shareholders.
Pfizer’s shareholders are not required to vote on the deal.
While the transaction had previously been due to close by midway through 2020, Mylan and Upjohn have confirmed that the deal – which is to result in a combined company called Viatris – will now happen no sooner than 1 October. (Also see "Mylan And Pfizer Announce Key Date For Viatris Merger" - Generics Bulletin, 3 June, 2020.)
Both companies are still busy behind the scenes preparing for the deal, recently unveiling pricing details around its debt financing. Upjohn is on the hook to pay parent Pfizer $12bn upon its separation and under terms of the deal agreed to issue that amount in debt. (Also see "Mylan And Upjohn Put A Price On $11.5bn Viatris Debt" - Generics Bulletin, 19 June, 2020.)
Sandoz And Biosimilar Players Kick Off Q2 Results
It’s a truth universally acknowledged in the industry that Big Pharma precedes generics and biosimilars for the announcement of quarterly results. As such, it’s no surprise that Sandoz, by way of parent Novartis, will release second-quarter earnings to the world only three weeks after the close of the quarter on 21 July.
Also, this month, several Big Pharma with burgeoning biosimilars presences will unveil results. These includes the likes of Amgen (22 July), Biogen (28 July), and Pfizer (28 July), which have begun to split-out biosimilar results for closer scrutiny as these businesses mushroom into hundreds of millions of dollars in sales.
While very much not in the biosimilars space, Roche (23 July) will also make for interesting reading given its continued exposure to biosimilar competition for its multi-billion-dollar biologic brands across the globe, notably Avastin (bevacizumab), Herceptin (trastuzumab) and MabThera/Rituxan (rituximab).
US Court Of Appeals May Decide On Enbrel
Biosimilar approval for Amgen’s Enbrel (etanercept) has been held in the US by Sandoz’ Erelzi (etanercept-szzs) for nearly four years – but glaringly a launch is yet to materialize.
The firms remain locked in an intellectual property fight that, due to an injunction agreed between the parties pertaining to two patents expiring in 2028 and 2029, prevents Sandoz from moving on a US launch for the $5bn brand.
In August last year, Sandoz emerged with total defeat at the district court level, having conceded infringement over alleged claims in US patents 8,063,182 and 8,163,522 ahead of trial and failing to leave a dent with invalidity arguments. (Also see "Sandoz Will Appeal Against US Enbrel Patent Setback" - Generics Bulletin, 12 August, 2019.)
Recently, Japan’s Mizuho Securities forecasted that Sandoz’ appeal may be decided early in July, coming four months after the court heard oral arguments from the pair, consistent with other high-profile appeals. (Also see "Industry Awaits US Appeal Ruling On Sandoz’ Enbrel Biosimilar" - Generics Bulletin, 24 June, 2020.)
The eyes of the world will be on the decision – in particular, Samsung Bioepis, which holds approval for its Eticovo (etanercept-ykro) rival and has agreed to stay its own infringement case in agreement with Amgen.
Defeat for Sandoz sets the stage for a 30-year monopoly in the Enbrel market for Amgen following the autoimmune diseases treatment’s US market debut for rheumatoid arthritis in 1998.
Sanofi Set To Gain First Insulin Aspart Biosimilar – Ever
While its head of research and development may feel biosimilars are an “enormous distraction” for a company focused on novel medicines (Also see "Sanofi Labels Biosimilars ‘Enormous Distraction’" - Generics Bulletin, 25 June, 2020.), Sanofi is this month set to become the first mover on a biosimilar to rival Novo Nordisk’s NovoRapid/NovoLog (insulin aspart) in Europe – and also possibly the world.
Following its monthly meeting in April, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for the French originator’s application, observing its “comparable quality, safety and efficacy to NovoRapid.” (Also see "Sanofi’s Insulin Aspart Biosimilar Gets European Nod" - Generics Bulletin, 4 May, 2020.)
Typically, the European Commission acts on the CHMP’s opinion within 67 days, meaning a decision is due any day now.
Filed with the EMA in May last year, Sanofi’s proposed biosimilar product was the first to be filed in the EU and was also thought to be the first submission worldwide.
Nevertheless, Sanofi has underlined its desire to keep research and development dollars away from any biosimilar development in favor of novel research in oncology, immuno-inflammation and rare diseases.
Zydus Cadila Aims To Move On Remdesivir
Having initially not been a part of Gilead Sciences’ licensing arrangement for remdesivir, Zydus Cadila is aiming to introduce its version of the investigational treatment option for COVID-19 by the end of this month.
The Indian firm is aiming to follow in the steps of local players Cipla and Hetero Drugs with a launch by securing marketing approval for its brand of remdesivir by the middle of July. (Also see "Zydus Cadila Plans Indian Remdesivir Entry In July" - Generics Bulletin, 26 June, 2020.)
“Remdesivir has been launched in the Indian market as an injectable to be administered in a hospital setting, a route that Cadila is also likely to take,” Scrip’s Vibha Ravi wrote at the end of June. “Meanwhile, Gilead plans to begin testing an inhaled version of the product, hoping that ease of administration will drive increased usage.”
Zydus Cadila was among the second wave of companies to obtain a licensing agreement with Gilead for remdesivir, joining Dr Reddy’s and Syngene International following initial deals between Gilead and five companies: Cipla, Hetero, Jubilant Life Sciences, Mylan and Ferozsons Laboratories. (Also see "Remdesivir Rivals Hit Indian Market" - Generics Bulletin, 25 June, 2020.)