Following influx of cash, Piramal invests in another Indian CDMO; US inks deal with manufacturer of rapid Covid-19 tests

In­di­an CD­MO Ya­pan Bio has land­ed an in­vest­ment from Pi­ra­mal Phar­ma, the com­pa­ny an­nounced, to help en­hance its man­u­fac­tur­ing arm.

Ya­pan pro­vides bi­o­log­ic and vac­cine scale-up and man­u­fac­tur­ing ser­vices, in­clud­ing RNA, DNA, re­com­bi­nant vac­cines, gene ther­a­pies and mon­o­clon­al an­ti­bod­ies. With the in­vest­ment, Pi­ra­mal takes on a 27.78% stake in the com­pa­ny and will help Ya­pan keep up the quick pace of the rapid­ly ex­pand­ing CD­MO space. It will com­bine its an­ti­body drug con­ju­ga­tion ca­pa­bil­i­ties with Pi­ra­mal’s fill-fin­ish ser­vices.

‘The ex­per­tise found at Ya­pan will help Pi­ra­mal pro­vide ex­ist­ing cus­tomers with wider ca­pa­bil­i­ties for de­vel­op­ing and man­u­fac­tur­ing large mol­e­cules. This in­vest­ment fur­ther sup­ports our growth strat­e­gy for Pi­ra­mal Phar­ma,’ Pi­ra­mal spokesper­son Nan­di­ni Pi­ra­mal said.

Pi­ra­mal made noise this March when it doled out $106 mil­lion plus fu­ture mile­stones for In­di­an pep­tide API mak­er Hem­mo Phar­ma­ceu­ti­cals. The CD­MO called Hem­mo ‘one of the few pure-play syn­thet­ic pep­tide API man­u­fac­tur­ers in the glob­al mar­ket­place’ af­ter it made the move, and con­sid­ered it a part of a larg­er push in­to con­tract work in on­col­o­gy and meta­bol­ic ther­a­pies. The in­vest­ment comes with a man­u­fac­tur­ing fa­cil­i­ty in Turb­he that can pro­duce more than 30 APIs and an R&D fa­cil­i­ty in Thane.

Pi­ra­mal’s par­ent com­pa­ny of­fered up 20% of the phar­ma busi­ness as a part of a stake sale in 2020, giv­ing the CD­MO $490 mil­lion cash. As a re­sult, Pi­ra­mal con­sol­i­dat­ed all of its phar­ma units un­der one Pi­ra­mal Phar­ma um­brel­la, and put $32 mil­lion in­to its Riverview, MI API plant, which boasts 25,000 square feet.

US inks deal with man­u­fac­tur­er of rapid Covid-19 tests

A unit of Ger­many’s Mer­ck KGaA is set to land a $137 mil­lion con­tract to up its pro­duc­tion of a key com­po­nent of rapid Covid-19 tests, Pres­i­dent Joe Biden tweet­ed Wednes­day.

The con­tract will al­low Mil­li­pore Sig­ma to build a new fa­cil­i­ty to pro­duce ni­tro­cel­lu­lose mem­branes, the pa­per that shows the test re­sults. Its She­boy­gan, WI plant will now al­low for an­oth­er 85 mil­lion tests a month, though Reuters said it was un­clear when ex­act­ly the fa­cil­i­ty will ramp-up to full pro­duc­tion.

To­day, I com­mit­ted $137 mil­lion to ex­pand­ing the pro­duc­tion of COVID-19 at-home tests us­ing our mil­i­tary au­thor­i­ty in or­der to meet de­mand. https://t.co/eN­mA4CCk­kR

— Pres­i­dent Biden (@PO­TUS) De­cem­ber 30, 2021 The ef­fort was fund­ed through the Amer­i­can Res­cue Plan Act, es­tab­lished to sup­port do­mes­tic ex­pan­sion for crit­i­cal med­ical re­sources.

Mil­li­pore Sig­ma is a sup­pli­er to many ma­jor US anti­gen test man­u­fac­tur­ers, a source told Reuters. ‘It’s prob­a­bly the most con­strained piece of tech­nol­o­gy in ex­pand­ing ca­pac­i­ty, in mak­ing more of these over-the-counter or point-of-care tests,’ the of­fi­cial told the pub­li­ca­tion.

Biden an­nounced plans to dis­trib­ute 500 mil­lion at-home tests through­out the coun­try to help ad­dress the uptick in pos­i­tive cas­es, due to the Omi­cron vari­ant, ear­li­er in De­cem­ber.

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Michel Vounatsos, Biogen CEO

A Korean business publication reported Wednesday that Samsung is in the process of making a buyout bid for Biogen, raising equal parts skepticism and anticipation around a possible deal.

The report from the Korea Economic Daily says that the Samsung Group – which has a long-term biosimilar partnership with Biogen – has offered to acquire Biogen for some $42 billion, a 20% improvement over the $35 billion recorded ahead of the report. That’s far less than what Biogen was trading for when hopes of a major windfall from their controversial Alzheimer’s drug Aduhelm still percolated.

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Five years after little Leo Pharma put up its dukes and $115 million in cash to acquire and advance tralokinumab for atopic dermatitis, the Danish biotech has crossed the regulatory finish lines with a year-end approval at the FDA.

The drug will be sold as Adbry and there’s no immediate word on pricing.

This is the 50th new drug approval from CDER this year, totting up to 60 for the year if you add 10 major biologic OKs to the mix. That marks a record number of new approvals from the agency, tipping the scales after hitting 59 in 2020 and 2018. And it’s an indication that despite a long litany of setbacks in CMC in other areas, the drumbeat of new approvals continues at chart-topping levels after the long and disastrous dry spell of the early 2000s — despite a global pandemic.

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Patrick Lu, Sirnaomics CEO

A low-profile small interfering RNA player has managed to squeeze in its IPO before the year ends, adding another listing to the Hong Kong stock exchange’s tally.

Sirnaomics is making its HKEX debut with a modest raise of slightly over $50 million, with the potential of adding about $10 million if the over-allotment option is exercised in full.

CEO Patrick Lu founded the biotech all the way back in 2007, setting up an early discovery operation in Gaithersburg, MD after a transition from research at Georgetown into industry — first working for Novartis then co-founding another company called Intradigm. Through it all, he was focused on what he calls nucleic acid drug development.

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BridgeBio CEO Neil Kumar had all but reserved the champagne to celebrate the success of its big Phase III study for acoramidis, designed to stabilize transthyretin and slow or halt the progression of TTR amyloidosis. They had bought out full rights to the drug in late 2020 and borrowed the first $450 million of a $750 million loan, adding to a hefty debt load while confidently predicting a straight march to the FDA in 2022.

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Matthew Gantz, Castle Creek CEO

Close to 6 months after it initially posted its S-1 in what was still a thriving biotech IPO market, Castle Creek Biosciences has now yanked the offering as new deals fade against the background of a hard, year-end appraisal for drug stocks.

In its filing with the SEC, Castle Creek CEO Matthew Gantz merely states that the biotech is no longer pursuing an IPO. He had initially penciled in a $100 million raise last summer.

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The FDA on Thursday authorized another new pill to treat the Omicron variant, this time from Merck.

While Pfizer’s antiviral may prove to be more effective, and Merck’s pill has left some scientists questioning the dangers behind its mechanism of action, molnupiravir will be another weapon in the armamentarium of Covid-19 treatments for the US in a time of need, as two mAb treatments from Regeneron and Eli Lilly are no longer effective against Omicron, and as supplies of a third mAb from Vir/GlaxoSmithKline are very limited.

It’s time for our holiday break here at Endpoints News, and like a lot of you, we’ve been prepping for 2022.

Anyone who’s spent some time in industry can tell you the past decade has shoved the drug-hunting field into the forefront of the world’s view of things, garnering tens of billions in investment as new technologies look to change the landscape of R&D. And anyone who qualifies for first-in-class and best-in-class can clean up.

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Khurem Farooq, Gyroscope CEO

Christmas is coming early for Gyroscope.

In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.

Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.

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