Pfiz­er preps a laun­dry list of drug price hikes for the New Year — let the po­lit­i­cal fire­works be­gin

Pfiz­er is billing this as a re­strained and com­plete­ly rea­son­able move, but the phar­ma gi­ant has just thrown down a gaunt­let beg­ging Pres­i­dent Don­ald Trump to pick it up.

Bioreg­num Opin­ion Col­umn by John Car­roll

On Fri­day af­ter­noon the phar­ma gi­ant $PFE put out a state­ment say­ing that it’s hold­ing the price line on 90% of its drug port­fo­lio come the New Year. But 41 of its drugs have been picked for a price hike on Jan­u­ary 15, av­er­ag­ing 5%. And one of those drugs, which Pfiz­er said has just been ap­proved for 2 new in­di­ca­tions af­ter ex­ten­sive R&D work, is in line for a 9% hike.

Two years ago, that news would have been greet­ed as a sign of re­mark­able mod­er­a­tion. But for ear­ly 2019, af­ter Trump has re­peat­ed­ly ex­co­ri­at­ed the ma­jors for “get­ting away with mur­der” on drug prices, it’s like­ly go­ing to be seen as a call to leg­isla­tive arms.

Just be­fore the elec­tions Trump sug­gest­ed that Medicare Part B move to im­port over­seas drug prices, hop­ing to per­suade com­pa­nies to mus­cle sin­gle pay­er sys­tems to pay more while low­er­ing the cost of ther­a­pies in the US. Ear­li­er, Trump al­so made a high pro­file call to Pfiz­er CEO Ian Read — one of the most re­sis­tant to rein­ing in price hikes — per­suad­ing him to put a planned slate of price in­creas­es on the back burn­er, at least through the end of the year. Oth­er big play­ers al­so quick­ly fol­lowed suit, though Pfiz­er re­cent­ly in­di­cat­ed that they were mov­ing back to busi­ness as usu­al come 2019.

Pfiz­er is al­so promis­ing that con­sumers shouldn’t feel much fi­nan­cial heat. Their state­ment:

These list price in­creas­es are ex­pect­ed to be off­set by high­er re­bates and dis­counts paid to In­sur­ance Com­pa­nies and Phar­ma­cy Ben­e­fit Man­agers and the net ef­fect on rev­enue growth in the U.S. in 2019 is ex­pect­ed to be ze­ro. Giv­en the high­er re­bates and dis­counts, we ex­pect that the health­care sys­tem will share those ben­e­fits with pa­tients so they do not ex­pe­ri­ence high­er costs for their med­i­cines. In 2018 the net im­pact of price in­creas­es on rev­enue growth is pro­ject­ed to be a neg­a­tive 1 per­cent in the U.S com­pared with 2017.

That’s un­like­ly to sat­is­fy the cur­rent res­i­dent in the White House, who is like­ly to view the move as a per­son­al provo­ca­tion.

The Dems, who may wind up as the strangest bed­fel­lows of the Trump ad­min­is­tra­tion on this is­sue, seem to see some op­por­tu­ni­ties here as well.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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