Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Green­Light li­cens­es mR­NA shin­gles vac­cine to Serum In­sti­tute fol­low­ing a $10M in­vest­ment

Green­Light Bio­sciences has come a long way from try­ing to shake up the pes­ti­cides mar­ket.

The Med­ford, MA biotech signed a deal Mon­day with the Serum In­sti­tute of In­dia to de­sign three mR­NA prod­ucts, in­clud­ing a shin­gles vac­cine, for de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion in a num­ber of mar­kets around the world.

Green­Light will re­tain the rights to North Amer­i­ca, Eu­rope, Aus­tralia, New Zealand, Chi­na, Japan and South Ko­rea, while SII will get a tech trans­fer to work in Africa, Latin Amer­i­ca, the Mid­dle East and much of Asia. The deal pig­gy­backs off of a $10 mil­lion in­vest­ment made by Serum Life Sci­ences in No­vem­ber 2021.

Green­Light will re­ceive up­front pay­ments and is el­i­gi­ble for ex­clu­siv­i­ty, de­vel­op­ment mile­stones, and man­u­fac­tur­ing tech­nol­o­gy trans­fer pay­ments. Mean­while, SII will pay for the de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion for each emerg­ing mar­ket, as Green­Light will re­tain a per­cent­age of those prof­its.

“Green­Light’s ap­proach res­onates with our mis­sion to make health­care eq­ui­table for all,” SII CEO Adar Poon­awal­la said in a state­ment. “Mes­sen­ger RNA tech­nol­o­gy will play a key role in re­duc­ing the bur­den of hu­man suf­fer­ing caused by vac­cine-pre­ventable dis­eases across LMICs.”

There is an op­tion to ex­pand the li­cense to two ad­di­tion­al vac­cines or ther­a­pies to be named lat­er, Green­Light said in a re­lease, and the shin­gles vac­cine man­u­fac­tur­ing process will be trans­ferred to the SII fa­cil­i­ty in Pune, In­dia.

The com­pa­ny was found­ed in 2008 to use its mR­NA tech­nol­o­gy most­ly on agri­cul­ture, in­clud­ing hon­ey­bees and crops. Since an Au­gust re­verse-merg­er, the com­pa­ny has been work­ing on a vac­cine for sea­son­al flu and a treat­ment for sick­le cell dis­ease.

It al­so land­ed a $1.5 bil­lion val­u­a­tion, and has pro­posed build­ing sev­en new mR­NA man­u­fac­tur­ing fa­cil­i­ties to bring glob­al ca­pa­bil­i­ties up to snuff. Green­Light’s plat­form com­bines two mR­NA ap­proach­es — one that in­volves fer­men­ta­tion-based process­es and an­oth­er uti­lized by high-pro­file com­pa­nies like Mod­er­na and BioN­Tech in­volv­ing tran­scrip­tion, and that helps pro­duce prod­ucts at a high­er scale in a more af­ford­able man­ner.

In De­cem­ber, Green­Light inked a deal with Sam­sung Bi­o­log­ics to man­u­fac­ture its mR­NA Covid-19 vac­cine com­mer­cial­ly. Right around that same time, SII an­nounced that it would waive its pro­tec­tion from le­gal li­a­bil­i­ties for any As­traZeneca-Ox­ford dos­es it pro­vid­ed to CO­V­AX, in an ef­fort to pro­vide mil­lions of mi­grants with ac­cess to the Covid-19 jab.

Many man­u­fac­tur­ers re­quire pro­tec­tion from any side ef­fects. That is not able to be guar­an­teed if there is no gov­ern­ment, as in a sit­u­a­tion with a non­prof­it al­liance such as Gavi. Asy­lum seek­ers, refugees, de­tainees, and peo­ple who are state­less are all el­i­gi­ble.

SII was found­ed in 1966 with the goal of mak­ing life­sav­ing drugs across the world, and ben­e­fit­ing glob­al health as well.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

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.

Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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