That oth­er mes­sen­ger RNA biotech uni­corn is look­ing to jump in­to Wall Street with an IPO that may seek a record $800 mil­lion and a val­u­a­tion of some $4 bil­lion.

Ugur Sahin, CEO, BioN­Tech

Bankers are buzzing that Bank of Amer­i­ca and JP Mor­gan have al­ready been tapped for the IPO on be­half of BioN­Tech, a Ger­man biotech that has at­tract­ed con­sid­er­able at­ten­tion for its role as a leader in the mR­NA field, ac­cord­ing to a re­port in Reuters.

Some­thing is bound to be go­ing on here. Reuters’ re­port comes a few weeks af­ter Bloomberg pub­lished a piece on the prospec­tive IPO for BioN­Tech, cit­ing a pos­si­ble val­u­a­tion of $5 bil­lion.

Mod­er­na blazed the IPO $MR­NA path for mR­NA a lit­tle more than 3 months ago, rais­ing $604 mil­lion in a his­toric of­fer­ing that quick­ly soured as its stock blew south. But that was just tem­po­rary. The stock lat­er climbed back up and now sits at $19.75 with a $6.5 bil­lion mar­ket cap.

Ear­ly this year Sanofi dou­bled down on its al­liance with the biotech, fronting an ex­pand­ed pact with $91 mil­lion in cash for im­munother­a­pies de­signed to go af­ter sol­id tu­mors. Ear­li­er Pfiz­er lined up a siz­able deal to de­vel­op an mR­NA flu vac­cine, of­fer­ing cash for an up­front and eq­ui­ty. And a lit­tle more than a year ago BioN­Tech came up with a $270 mil­lion round, bring­ing its to­tal raise at the time to close to $1 bil­lion.

The ini­tial seed mon­ey was of­fered by the bil­lion­aire Strüng­mann broth­ers, who are the ma­jor­i­ty share­hold­ers.

The IPO win­dow re­mains open for biotechs, but af­ter a big string of new of­fer­ings in 2018, the gen­er­al con­sen­sus is that there will be a de­cline in the num­ber of com­pa­nies mak­ing the leap on­to the pub­lic stage.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).