Vi­cal finds way out of R&D woes via re­verse merg­er with der­ma­tol­ogy biotech Brick­ell

Months af­ter bury­ing its third and fi­nal clin­i­cal pro­gram, Vi­cal has turned to a re­verse merg­er with Brick­ell Biotech to put an end to its mis­ery.

Robert Brown Brick­ell

The new com­pa­ny — in which Vi­cal in­vestors will re­tain a 40% own­er­ship — will op­er­ate un­der Brick­ell’s name and agen­da, fo­cus­ing on se­ri­ous der­ma­to­log­ic dis­or­ders like hy­per­hidro­sis, cu­ta­neous T-cell lym­phoma and pso­ri­a­sis. Fol­low­ing the all-stock trans­ac­tion, No­vaQue­st Cap­i­tal Man­age­ment has pledged $25 mil­lion to fund near-term R&D, adding to the $35 mil­lion in cash re­serve that Vi­cal brings.

For Vi­cal in­vestors, CEO Vi­jay Samant says, the deal gives them a stake in a po­ten­tial best-in-class ther­a­py for ax­il­lary hy­per­hidro­sis or ex­ces­sive sweat­ing. A top­i­cal soft an­ti­cholin­er­gic, sof­piro­ni­um bro­mide is now on the cusp of a Phase III af­ter Brick­ell’s de­vel­op­ment part­ner Kak­en re­port­ed pos­i­tive late-stage re­sults in Japan.

Brick­ell CEO Robert Brown, who jumped from Eli Lil­ly late last year, said to ex­pect topline da­ta for sof­piro­ni­um bro­mide in Q4 2020 while his team fur­ther de­vel­ops the pipeline of skin dis­ease treat­ments.

Vi­jay Samant Vi­cal

Samant him­self hasn’t had a great track record pre­dict­ing suc­cess for drug de­vel­op­ment pro­grams — con­sid­er­ing he’s axed three clin­i­cal-stage pro­grams in less than two years, ac­com­pa­nied with a cou­ple of rounds of lay­offs — but he added that Brick­ell’s ex­ec team brings ex­pe­ri­ence launch­ing drugs for oth­er com­pa­nies.

The dis­as­trous streak be­gan last Jan­u­ary with a Phase III cy­tomegalovirus vac­cine part­nered with Astel­las, which had al­ready failed a her­pes study in 2016. Then Vi­cal scrapped an­oth­er Phase II bi­va­lent vac­cine can­di­date for her­pes sim­plex virus type 2, turn­ing to an an­ti­fun­gal li­censed from Astel­las, on­ly to give up this Feb­ru­ary and go through a fi­nal re­struc­tur­ing.

Dur­ing this time, the biotech saw val­ue steadi­ly leak from its stock, hov­er­ing just above $1 (in con­trast with a high of $14.8 in 2015). Shares $VI­CL lift­ed 31.3% for a fi­nal ral­ly pre-mar­ket, though that on­ly trans­lat­ed to $1.51 in dol­lar terms.

The val­u­a­tion for Vi­cal was $40 mil­lion, a pre­mi­um over its 30-day vol­ume weight­ed av­er­age share price as well as its mar­ket cap of $26.25 mil­lion.

Brick­ell, which was val­ued at $60 mil­lion in the deal, has yet to pick out a new tick­er on the Nas­daq.


Im­age: Shut­ter­stock

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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