Christoph West­phal finds the ex­it at his lat­est biotech cre­ation — af­ter the stock cratered

Christoph West­phal

High-pro­file Boston biotech fi­nancier Christoph West­phal is leav­ing the helm of his lat­est biotech flop.

A lit­tle more than two years af­ter de­but­ing their IPO with a $16 share price, tiny Flex Phar­ma $FLKS an­nounced that se­r­i­al en­tre­pre­neur West­phal is hand­ing the lead role to R&D chief William McVicar, at least on an in­ter­im ba­sis, and stay­ing on as chair­man.

McVicar was re­cruit­ed to Flex two months ago. Its shares closed Mon­day at $3.43, just a shrunk­en re­flec­tion of its one-time high.

West­phal achieved star sta­tus in the big Cam­bridge/Boston hub when he sold Sir­tris to Glax­o­SmithK­line for $720 mil­lion in cash 9 years ago. GSK lat­er laid off the Sir­tris gang and ab­sorbed the re­search work in its US ops, go­ing silent on the work. West­phal briefly ran GSK’s ven­ture group, SR One, then set up Ve­rastem. He is al­so a part­ner at Long­wood Fund, which he co-found­ed.

Ve­rastem’s ear­ly 2012 IPO al­so de­buted high, with a $10 price that helped shine a light on the biotech IPO boom to come. Lat­er he turned the lead role over to Robert For­rester and then left the board a year ago af­ter the biotech ex­pe­ri­enced dev­as­tat­ing clin­i­cal set­backs, leav­ing For­rester work­ing on a turn­around plan.

Among the biotechs West­phal co-found­ed are Al­ny­lam, Con­cert and Ova­Science.

Last fall Flex’s one and on­ly clin­i­cal as­set, FLX-787, failed a study for pre­vent­ing noc­tur­nal leg cramps among a high-risk group, though West­phal’s team in­sist­ed that if you left out one of the three sites with ques­tion­able re­sults the da­ta were good.

Flex is push­ing ahead with with two planned Phase II tri­als.

“On be­half of the Board and the Com­pa­ny, I want to thank Christoph for his vi­sion and en­tre­pre­neur­ial lead­er­ship since the com­pa­ny’s in­cep­tion,” said Dr. Rod MacK­in­non, No­bel lau­re­ate and Flex Phar­ma sci­en­tif­ic co-founder, in a pre­pared state­ment.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.