Ap­proval in sight, Per­cep­tive, Or­biMed dou­ble down on Foamix's an­tibi­ot­ic foam to the tune of $64M

In an­tic­i­pa­tion of a long-await­ed — and some­what de­layed — date with the FDA on its top­i­cal der­ma­tol­ogy drugs, Foamix has re­turned to its biggest share­hold­ers to stack up re­sources for the com­mer­cial stretch ahead.

David Domzal­s­ki

The $64 mil­lion fi­nanc­ing in­vest­ment from Per­cep­tive Ad­vi­sors and Or­biMed break down to two main parts. A cred­it agree­ment cov­ers up to $50 mil­lion in term loans, $15 mil­lion of which would be pro­vid­ed at clos­ing; the oth­er $20 mil­lion and $15 mil­lion are con­tin­gent on reg­u­la­to­ry and rev­enue mile­stones, re­spec­tive­ly. Per­cep­tive has al­so signed up to pur­chase $14 mil­lion worth of Foamix’s shares, which is list­ed on the Nas­daq cur­rent­ly at $2.14 a pop.

“As we man­age the tran­si­tion of Foamix to be­com­ing a ful­ly in­te­grat­ed com­mer­cial or­ga­ni­za­tion it is im­por­tant that the Com­pa­ny is fi­nanced ap­pro­pri­ate­ly,” CEO David Domzal­s­ki said in a state­ment. “Com­bined with our cur­rent cash po­si­tion, we be­lieve these ini­tial in­vest­ments, along with fu­ture ac­cess to cap­i­tal which this trans­ac­tion pro­vides, will al­low us to fund the com­mer­cial launch­es for FMX101 and FMX103, pend­ing FDA ap­proval.”

FMX101 and FMX103 are both foam for­mu­la­tions of the an­tibi­ot­ic minocy­cline but con­coct­ed at dif­fer­ent con­cen­tra­tions for ac­ne and rosacea, re­spec­tive­ly.

The Is­raeli biotech had orig­i­nal­ly lined up two Phase III stud­ies for the lead drug, FMX101, back in 2017, but end­ed up with mixed re­sults that forced a third late-stage tri­al. The drug cleared that test on in­flam­ma­to­ry le­sion re­duc­tion and IGA treat­ment suc­cess, se­cur­ing for Foamix a PDU­FA date of Oc­to­ber 20.

The NDA sub­mis­sion for FMX103, which hit the co-pri­ma­ry end­points in both tri­als, is in the “fi­nal stages of prepa­ra­tion.”

At the end of last quar­ter, Foamix re­port­ed that it ex­pect­ed to last through mid-2020 with its cash and cash equiv­a­lents of $82.9 mil­lion. The new fund­ing should ex­tend the run­way for some time to come.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Anthony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Gilead-part­nered Goldfinch Bio lands $100M as it piv­ots to clin­i­cal stage biotech

A year after landing $109 million in cash for an early-stage discovery deal with Gilead, Goldfinch Bio has scored a similar bounty from investors, raising $100 million in the biotech’s first financing round since its 2016 launch.

The new round, led by Eventide Asset Management and joined by 8 other firms, confirms that last year’s Gilead deal began a new, busier, more vocal era for the company. After launching out of Third Rock with $55 million and a plan to tackle kidney disease, they focused on preclinical research and made few material announcements. But the latest press release is full of plans, including their first Phase II study and a new therapy scheduled to enter the clinic next year.