News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

An­oth­er phar­ma com­pa­ny is in­tend­ing to use a SPAC to join the Nas­daq.

4D phar­ma, a UK-based biotech, is re­verse-merg­ing with a blank check com­pa­ny in a deal worth up to $37.6 mil­lion. The move will give 4D phar­ma a new Nas­daq tick­er, which will be $LBPS, us­ing the Amer­i­can De­posi­tary Share pro­gram. 4D will con­tin­ue to trade on the Lon­don stock ex­change un­der its pre­vi­ous tick­er.

As a re­sult of the move, 4D phar­ma will gain $14.6 mil­lion in cash held by the blank check com­pa­ny, dubbed Longevi­ty $LOAC. The merg­er is ex­pect­ed to be com­plet­ed in ear­ly 2021, af­ter which shares will be im­me­di­ate­ly trade­able on Nas­daq.

4D’s Lon­don stock is ex­pect­ed to open at about $1.44 per share, rep­re­sent­ing about an 18% pre­mi­um on Wednes­day’s clos­ing price.

The com­pa­ny’s re­search fo­cus­es on har­ness­ing bac­te­ria from the hu­man gut to treat a wide range of dis­eases. Its lead pro­gram is cur­rent­ly in a Phase I/II study in com­bi­na­tion with Keytru­da ex­am­in­ing how it could af­fect sol­id tu­mors. 4D phar­ma al­so has clin­i­cal pro­grams in pan­cre­at­ic can­cer, asth­ma, Covid-19 and ir­ri­ta­ble bow­el syn­drome.

In­dia’s Dr. Red­dy’s the tar­get of an ap­par­ent cy­ber­at­tack

An ap­par­ent cy­ber­at­tack forced In­di­an drug­mak­er Dr. Red­dy’s to shut down all of its glob­al man­u­fac­tur­ing fa­cil­i­ties.

The at­tack oc­curred ear­ly Thurs­day morn­ing lo­cal time, ac­cord­ing to com­pa­ny reg­u­la­to­ry fil­ings. Dr. Red­dy’s in­formed the lo­cal stock ex­change that “in the wake of a de­tect­ed cy­ber-at­tack, we have iso­lat­ed all da­ta cen­ter ser­vices to take re­quired pre­ven­tive ac­tions.”

It was not im­me­di­ate­ly clear what kind of cy­ber­at­tack hit the com­pa­ny, be it ran­somware or some­thing else. CIO Mukesh Rathi said in the fil­ing that he ex­pects the com­pa­ny’s op­er­a­tions to be back up and run­ning at full ca­pac­i­ty with­in 24 hours.

Thurs­day’s at­tack comes less than a week af­ter In­di­an reg­u­la­tors ap­proved a Phase II/III study of Rus­sia’s Covid-19 vac­cine to com­mence in the coun­try.

Haystack Sci­ences ac­quired by in­sitro, bol­ster­ing ma­chine learn­ing ca­pa­bilites

AI and ma­chine learn­ing have long been the­o­rized as one of the next steps in drug R&D evo­lu­tion, and Thurs­day saw a deal aim­ing to cap­i­tal­ize on that front.

The ma­chine learn­ing-dri­ven com­pa­ny in­sitro an­nounced that it is ac­quir­ing Haystack Sci­ences, a pri­vate com­pa­ny de­vel­op­ing its own ma­chine learn­ing plat­form to help en­able drug dis­cov­ery. Fi­nan­cial terms of the deal were not dis­closed.

Haystack’s ap­proach fo­cus­es on syn­the­siz­ing, breed­ing and an­a­lyz­ing di­verse chem­i­cal li­braries en­cod­ed by unique DNA se­quences called DNA-en­cod­ed li­braries, or DELs. The tech can al­so ex­e­cute rapid fol­low-up and pos­sess­es a pro­pri­etary se­mi-quan­ti­ta­tive screen­ing tech­nol­o­gy that gen­er­ates datasets with high­er res­o­lu­tion than con­ven­tion­al “pan­ning” ap­proach­es.

All that goes in­to in­sitro’s ap­proach of gen­er­at­ing pre­dic­tive mod­els that the com­pa­ny us­es to ac­cel­er­ate tar­get se­lec­tion and de­vel­op their ther­a­pies.

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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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.

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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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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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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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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