Am­gen goes back to Rhode Is­land to build its first next-gen man­u­fac­tur­ing site in the US

In a bid to lead the way in de­vel­op­ing a new gen­er­a­tion of more ef­fi­cient bi­o­log­ics man­u­fac­tur­ing fa­cil­i­ties, Am­gen $AMGN is in­vest­ing $160 mil­lion in a new plant to be con­struct­ed on its Rhode Is­land base.

The phar­ma gi­ant $AMGN — head­quar­tered in Thou­sand Oaks, CA — has had a long his­to­ry with the 75-acre cam­pus in West Green­wich, RI, since in­her­it­ing it in the Im­munex ac­qui­si­tion in 2001. With the new op­er­a­tion, it plans to add around 150 man­u­fac­tur­ing po­si­tions to the 625-strong team. The state gov­ern­ment was hap­py to hear about that job cre­ation, in ad­di­tion to 200 tem­po­rary con­struc­tion and val­i­da­tion jobs, and has promised $9.5 mil­lion in tax cred­its to move things along.

Bob Brad­way

Flex­i­bil­i­ty is a hall­mark of this new de­sign, Am­gen says, which would al­low the com­pa­ny to re­spond to new de­mands more quick­ly and at low­er cost. The mod­u­lar de­sign means the equip­ment in­side the fa­cil­i­ty would be portable and dis­pos­able. One such plant has al­ready been up and run­ning in Sin­ga­pore since 2014.

Af­ter eval­u­at­ing glob­al lo­ca­tions for the project, Am­gen — led by CEO Bob Brad­way — fi­nal­ly de­cid­ed to dou­ble down on the re­sources it’s al­ready poured in­to the Rhode Is­land site, cit­ing the work­force, the qual­i­ty of liv­ing and the po­ten­tial to grow. While cost was not men­tioned, the cur­rent num­bers — both in cap­i­tal and hir­ing — is al­most half of what the com­pa­ny out­lined in Feb­ru­ary, when it an­nounced it would spend up to $300 mil­lion and hire up to 300 em­ploy­ees for a new fa­cil­i­ty.

Es­te­ban San­tos

“Am­gen has three decades of ex­pe­ri­ence in bi­o­log­ics man­u­fac­tur­ing, and we are proud of our track record of pro­vid­ing a re­li­able sup­ply of high-qual­i­ty med­i­cines for pa­tients around the world,” said Es­te­ban San­tos, ex­ec­u­tive vice pres­i­dent of op­er­a­tions.

The com­pa­ny al­so at­trib­uted the de­ci­sion to build the new plant on US soil to the fed­er­al tax re­form that, ac­cord­ing to an ear­li­er End­points analy­sis, re­duced its tax rate by 20-plus per­cent.

It is yet un­clear when the plant, which Am­gen says would take half the con­struc­tion time to build com­pared to a tra­di­tion­al one, will open. Mean­while, Am­gen is tout­ing its low op­er­at­ing cost and en­vi­ron­men­tal ben­e­fits, in­clud­ing re­duced wa­ter and en­er­gy con­sump­tions.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.