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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s an­oth­er day of haul­ing cash in the bio­phar­ma world as four more IPOs priced Fri­day and a fifth filed its ini­tial pa­per­work.

The biggest of­fer­ing comes from PMV Phar­ma, an on­col­o­gy biotech fo­cus­ing on p53 mu­ta­tions, which raised $211.8 mil­lion af­ter pric­ing shares at $18 apiece. Pre­lude Ther­a­peu­tics, de­vel­op­ing PRMT5 in­hibitors for rare can­cers, was next with a $158 mil­lion raise, pric­ing shares at $19 each. Gray­bug Vi­sion raised $90 mil­lion af­ter pric­ing at $16 per share for its wet AMD can­di­dates, and breast can­cer biotech Green­wich Life­sciences brought up the rear with a small, $7 mil­lion raise af­ter pric­ing shares at $5.75.

Opthea, a South Yarra, Aus­tralia-based biotech al­so sub­mit­ted its F-1 pa­per­work, es­ti­mat­ing a raise of up to $150 mil­lion.

Through late Au­gust, the biotech in­dus­try had raised a com­bined $11 bil­lion-plus in four dozen IPOs per in­de­pen­dent an­a­lyst Brad Lon­car, sur­pass­ing the amount from all of 2019.

Jor­dan Saxe

Fri­day’s pric­ings move the 2020 to­tal to 56 to­tal pub­lic of­fer­ings in the in­dus­try, ac­cord­ing to Nas­daq head of health­care list­ings Jor­dan Saxe. Nas­daq has count­ed $11.3 bil­lion raised for the 56 biotechs through Fri­day.

Saxe’s tal­ly al­so match­es Lon­car’s to­tal from 2018, which makes 2020 tied for the most biotech IPOs seen in any of the last four years. The boom this year is be­ing dri­ven by sev­er­al fac­tors, Saxe said, in­clud­ing the Covid-19 pan­dem­ic high­light­ing the al­ready-im­pres­sive amount of in­no­va­tion in the field, a steady in­crease of crossover in­vestors from the last few years and the fact that biotechs can pro­vide longer-term in­vest­ments than com­pa­nies re­liant on quar­ter-to-quar­ter sales num­bers.

“All of those fac­tors com­bined have added up and cre­at­ed this per­fect storm,” Saxe told End­points News. 

PMV’s move to go pub­lic comes a lit­tle over a month af­ter pulling in a $70 mil­lion Se­ries D round and hir­ing long­time biotech en­tre­pre­neur Rich Hey­man as chair­man of the board of di­rec­tors. Hey­man no­tably found­ed the biotechs Aragon and Ser­agon, each of which sold for more than $1 bil­lion in the span of 12 months back in 2013 and 2014.

Per its S-1, PMV will pri­mar­i­ly use the IPO funds to help push its lead can­di­date, PC14586, in­to a Phase I/II tri­al tar­get­ing cer­tain p53 mu­ta­tions ag­nos­tic to the tu­mor. P53 pro­teins play a piv­otal role in the body’s nat­ur­al de­fense mech­a­nism against can­cer, and PMV hopes its pro­grams can help re­store some of the func­tion lost when they mu­tate.

Pre­lude pro­vid­ed a de­tailed break­down in its fil­ing, show­ing just how they ex­pect to divvy up the IPO funds to fur­ther de­vel­op­ment. The com­pa­ny is plan­ning to spend be­tween $15 mil­lion to $20 mil­lion on each of its three lead pro­grams, in­clud­ing com­plet­ing Phase I tri­als in sol­id tu­mors, hema­to­log­i­cal ma­lig­nan­cies and some re­lapsed/re­frac­to­ry high risk can­cers. An­oth­er $30 mil­lion to $40 mil­lion will go to­ward its pre­clin­i­cal stud­ies of pro­grams com­ing up the pipeline.

Gray­bug al­so spec­i­fied how they’d use the IPO mon­ey, in­di­cat­ing about $17 mil­lion would fund tri­als for its lead pro­gram, cur­rent­ly in a Phase IIb for wet AMD. Some of the mon­ey is planned for the com­ple­tion of that tri­al, as well as start­ing up a par­al­lel Phase IIb in DME and the wet AMD Phase III should the ear­li­er study prove suc­cess­ful.

In its own fil­ing, Green­wich said that rough­ly $3 mil­lion of its raise will help com­plete man­u­fac­tur­ing of its GP2 prod­uct and en­roll the first 50 to 100 pa­tients in a Phase III tri­al. Opthea aims to be­gin two Phase III tri­als in wet AMD and ad­vance non-clin­i­cal stud­ies for a po­ten­tial com­bi­na­tion ther­a­py.

With a full quar­ter left in the year, Saxe said he doesn’t ex­pect the biotech train to slow down any­time soon. He pegged a “con­ser­v­a­tive” es­ti­mate of 65-70 biotech IPOs by New Year’s.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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