→ Revance feels like it has a competitive advantage over AbbVie’s blockbuster Botox with only biannual injections of its freshly approved Daxxify, as opposed to the injections every three or four months that Botox requires. But you come at the king, you best not miss, and as Daxxify hits the market, Revance has now tapped David Hollander as CMO. Hollander was previously the chief R&D officer at Aerie Pharmaceuticals, which was sold to Alcon a couple months ago in a $770 million deal, and he has familiarity with the Botox developer through his 10 years at Allergan. From 2011-16, he was Allergan’s VP, global therapeutic area head in clinical development for anterior segment and consumer eye care. The Nashville biotech is also testing DaxibotulinumtoxinA in patients with cervical dystonia, among other conditions.
→ Now under the leadership of ex-Intercept CEO Mark Pruzanski and part of this year’s Endpoints 11 class, obesity startup Versanis Bio has welcomed Kenneth Attie as CMO and Aditya Venugopal as SVP, corporate development and strategic planning. Attie was one of the staffers left out in the cold at Imara as it whittled down to a six-person company in April but turned around its fortunes by reverse merging with Enliven Therapeutics last week. Before he was Imara’s medical chief, Attie spent 11 years at Acceleron as VP, medical research. In a mini-reunion, Venugopal worked for Pruzanski at Intercept as head of strategic planning, and since 2020 he had been VP of business development for Luca Santarelli at VectivBio.
→ Wholesale changes are being made at Scynexis, and not just with a slimmed-down pipeline as it shops around for a commercialization partner with Brexafemme. CEO Marco Taglietti will retire on Dec. 31, setting up CMO David Angulo to replace him as we ring in 2023. Ex-Eisai and Athersys finance chief Ivor Macleod’s first day as CFO will be Oct. 24, while chief commercial officer Christine Coyne’s job has been phased out. Scynexis will also be making more cuts to a staff that stood at 56 employees as of March 1, but the exact number wasn’t revealed. Kyle LaHucik has more on a company in flux.
→ Lyn Baranowski has taken over for Bruce Montgomery as CEO of Seattle-based pulmonary disease outfit Avalyn Pharma, once known as Genoa Pharmaceuticals. Since 2018, Baranowski knows the pulmonary space well from her four years as operations chief at Altavant, and from 2013-18, the Novartis alum was SVP of corporate development & strategy with Melinta Therapeutics. Avalyn’s lead program is an inhaled version of pirfenidone named AP01 for idiopathic pulmonary fibrosis.
→ The CEO situation has taken a turn at Maravai LifeSciences, where former Danaher SVP Trey Martin had succeeded Carl Hull earlier this month — or so we thought. Three Danaher subsidiaries have a bone to pick with the appointment, suing Martin and Maravai, and “alleging that Martin is in breach of a noncompetition agreement.” With a temporary restraining order in place, Hull didn’t hide his displeasure as he retakes his old position. “We have complete confidence in Trey and are appalled that Danaher would seek to leverage a noncompetition agreement to prevent Trey from advancing his career,” Hull said in a statement.
→ Alice Zhang’s AI drug discovery shop Verge Genomics has installed 14-year Biogen vet John Applegate as CFO. Formerly the VP of finance & accounting with Valo Health, Applegate closed out his Biogen career in 2019 as head of R&D finance. Zhang just contributed to Ochre Bio’s $30 million Series A, while Verge’s latest round of funding totaled $98 million in December 2021. In another Biogen connection, ex-R&D chief and current Voyager CEO Al Sandrock joined the board of directors at Verge in February.
→ Zentalis Pharmaceuticals has been relentless with its leadership moves since the Kim Blackwell era began in May with a $200 million cash infusion, promoting co-founders Cam Gallagher and Kevin Bunker while picking up a CMO and general counsel in that span. This week Zentalis returns to Peer Review with Mark Lackner as chief translational officer, head of biomarker strategy. Before he was head of biology and translational sciences for Ideaya Biosciences, Lackner led the oncology early-stage biomarker group as part of his 13 years at Genentech.
→ Co-founded and chaired by Tillman Gerngross, oncology outfit Ankyra Therapeutics has recruited Joseph Elassal as CMO. Elassal has two stints at Regeneron on his résumé: one from 2012-18, and the other as senior medical director, global medical affairs, oncology since 2020. In between, he was a deputy VP at PhRMA and a senior medical director for Replimune. Ankyra bagged a $45 million Series B in November 2021 with the help of Polaris, GV and a number of other investors.
→ Another Gerngross company, Invivyd, came out swinging when it was known as Adagio, with big aspirations for its Covid-19 monoclonal antibody along with bigger bucks. But the drug struck out against Omicron, and Gerngross was gone as CEO within a couple months. The name changed to Invivyd a few weeks ago, but the unease remains the same, as CFO/CBO Jane Henderson and chief commercial officer Eric Kimble have packed their bags. Fred Driscoll, a CFO with Renovacor, Flexion Therapeutics and Novavax, will bridge the gap as interim finance chief as Invivyd also says goodbye to an unspecified number of staffers.
→ Pittsburgh’s NeuBase Therapeutics has also been beset by layoffs, dismissing 60% of its employees this week while pivoting to gene editing. Sandra Rojas-Caro, NeuBase’s CMO since May 2021 who also began another role as head of R&D this past April, handed in her resignation.
→ As George Church’s Colossal Biosciences continues its quest to bring back the woolly mammoth, its computational biology spinout Form Bio has locked in Mark Swendsen as chief revenue officer. Swendsen held the same position at DNAnexus before coming to Form Bio, which christened the boat with a $30 million Series A round in late September.
→ Flagship’s Alltrna has dipped into the talent pool of the incubator’s most famous creation to find its VP, discovery platform. Caroline Köhrer comes to the tRNA player after more than two years as Moderna’s director of RNA science — a key cog in the development of its Covid-19 vaccine — and five years overall. Alltrna chief Michelle Werner was part of Flagship’s rapid-fire CEO-partner appointments in April that included Margo Georgiadis and former AbbVie president Michael Severino.
→ While we have Flagship companies on our mind, Senda Biosciences has pulled in two new execs with the appointments of Lori Rudolph-Owen as COO and Barbara Bispham as general counsel. Rudolph-Owen hails from Goldfinch Bio, where she most recently served as chief development officer. Prior to that, Rudolph-Owen held a number of roles at Pfizer, AMAG Pharmaceuticals, MGI Pharma, Vertex and Millennium Pharmaceuticals. Bispham joins Senda from BridgeBio, where she was VP, head of legal. Prior to that, Bispham was with Goodwin Procter, Cooley and Reed Smith.
→ Not to be confused with the great basketball Hall of Famer Bob Pettit, Robert Petit has become the head of early clinical development at Orionis Biosciences, a cancer biotech that racked up $55 million in financing this week. Petit chairs the scientific advisory board and is the ex-CSO of Advaxis, which happened to make news the same day as Orionis’ raise by merging with Ayala Pharmaceuticals. One more thing about Orionis: Cormorant Asset Management founder and chief executive Bihua Chen is now a member of the board.
→ Nigel Horscroft has settled in as CSO of German antiviral biotech Atriva Therapeutics, replacing current scientific advisory board chairman Oliver Planz. Horscroft brings Big Pharma credentials with him from Pfizer, and during his time at CureVac from 2012-20, he was promoted to area head, molecular therapy. Atriva has also picked up two other clinical execs this year: Stephan Witte (VP, clinical science and operations) in January and Tim Overend (VP, clinical development and regulatory) in July.
→ Staying in Germany, Boehringer Ingelheim and GSK alum Thomas Bogenrieder has joined adenovirus-based cancer biotech Abalos Therapeutics as CMO. Bogenrieder had held the role of chief clinical officer at Swiss-based AMAL Therapeutics since July 2020 and is the ex-medical chief of Evaxion Biotech. A year ago around this time, Abalos topped off its Series A with $37.6 million in additional funding.
→ In September 2021, we told you about Roche vet Anja Harmeier taking the CEO job at Belgian remyelination biotech Rewind Therapeutics. Fast forward to this week, where Rewind has selected Irene Knuesel as CSO. Knuesel has Roche ties herself, closing out her six-year tenure in 2019 as the pharma giant’s head of the neuroimmunology and neurodegeneration section. Incidentally, Roche is under the microscope again in the Alzheimer’s space as we await data for its resuscitated drug gantenerumab.
→ Targeting solid tumors, Immuneering — one of many biotechs that took the Nasdaq plunge at the zenith of IPOs in 2021 — has brought in Leah Neufeld as chief people officer. Neufeld has worked in human resources for companies of all sizes, with J&J, Daiichi Sankyo and Prevail packing her résumé. The one-time head of HR at Intercept was recently the chief human resources officer for Jiangsu Hengrui subsidiary Luzsana Biotechnology.
→ Ashvattha Therapeutics, a hydroxyl dendrimer (HD) biotech based in the Bay Area, has pegged Steve Maricich as CMO. Maricich recently held the CMO post at Scripps’ Calibr, and he’s been the medical chief at Allievex, the developer of a drug for Sanfilippo syndrome type B that was once in BioMarin’s hands.
→ Jessica Atkinson has been appointed CBO of ImmuneID, a biotech out of Stephen Elledge’s lab at Harvard that’s zeroing in on antibodies with its AI platform, called aiSPIRE. Atkinson rose to VP, business development at Foundation Medicine in 2019 after Roche’s $2.4 billion takeover, and she just had a brief run as SVP, business development of Glympse Bio.
→ Plainly-named IO Biotech, a Nasdaq newcomer in 2021 that’s going after IDO and PD-L1 with its cancer drugs IO102 and IO103, has enlisted Amy Sullivan as CFO. Sullivan had a seat at the negotiating table as chief strategy officer of Kiadis when it was purchased by Sanofi for $358 million. The ex-SVP of corporate affairs at Keryx Biopharmaceuticals was also VP, investor relations and corporate communications with AMAG Pharmaceuticals.
→ Belgian biotech Bioxodes is changing up the top exec seat with the appointment of Marc Dechamps as CEO. Dechamps takes over the reins from company founder Edmond Godfroid, who is transitioning into the roles of COO and CSO. Dechamps brings with him experience from his times at GSK and ViiV Healthcare to the new role.
→ San Diego RNA editing biotech ADARx Pharmaceuticals is a busy bee in Peer Review too, naming Feriandas Greblikas as VP of clinical development after hiring CFO Chris Prentiss and CMC VP Christopher Claeboe this year. A veteran of Novo Nordisk, Biogen and Baxter, Greblikas comes to ADARx from Travere Therapeutics, where he was a senior medical director and clinical development lead. And in a previous gig, he worked for JJ Bienaimé as BioMarin’s medical director of phenylketonuria clinical trials.
→ Coming up on a year since its $60 million Series A, STAT3- and STAT6-focused Recludix Pharma is back in Peer Review with Paul Smith as SVP of biology. Smith, the ex-global research lead for Gilenya with Novartis, has also been senior director of inflammation and autoimmunity at Incyte. He held the role of VP, discovery biology at Connect Biopharma before pivoting to Recludix, a company out of San Diego that introduced CBO Matthew Caldemeyer in late September.
→ Transpacific oncology biotech AnHeart Therapeutics, which secured a $61 million Series B round last year, has welcomed aboard Heinrich Farin as senior medical director, clinical research and Michael Humphries as VP, head of US medical affairs. Farin hails from Mirati, where he served as senior medical director and has a prior stint as global senior medical director, clinical research and development at BeiGene. Earlier in his career, Farin had roles at Ariad Pharmaceuticals and Baxalta. Meanwhile, Humphries brings expertise from his time at Takeda Oncology, where he served as senior scientific director of global medical affairs. Prior to Takeda, Humphries had gigs at Bayer Healthcare Pharmaceuticals and Array Biopharma.
→ Swiss LILRB (leukocyte immunoglobulin-like receptor subfamily B) biotech ImmunOs Therapeutics has pegged Hilmar Ebersbach as VP, antibody development and protein engineering. Ebersbach had spent the last 15 years in biotherapeutic engineering and gene therapy at the Novartis Institutes for BioMedical Research.
→ Believe it or not, Daniel Ripley has ventured off to HighTide Therapeutics as SVP, business development. Ripley is an Ionis BD vet who led global business development for the last two years at Alpha Biopharma, and as the brave souls of HighTide give NASH a whirl with its lead program HTD1801, he also has experience in the space as SVP of business development, program and alliance management at Conatus Pharmaceuticals, a Novartis partner plagued by NASH failures that merged with Histogen in 2020.
→ GSK India has named Bhushan Akshikar as managing director, succeeding Sridhar Venkatesh, who is transitioning to a senior role within the GSK Group. Akshikar joined GSK India in September 2011. Prior to GSK, Akshikar had a 15-year stint at J&J’s Janssen.
→ Ex-AMAG Pharmaceuticals CEO Brian Pereira has been named chairman at KalVista following the resignation of Martin Edwards and a resounding trial failure. Earlier this month, KalVista had to stop a Phase II trial of its hereditary angioedema drug KVD824 after issues with liver enzymes were detected throughout all three treatment groups. Pereira has been president and CEO of Otsuka sub Visterra since 2013.
→ Proteomics biotech SomaLogic, which reverse-merged onto Nasdaq with Eli Casdin’s SPAC with a $1.2 billion valuation last April, has tapped Troy Cox as executive chair of the board of directors, taking over from Chuck Lillis, who will remain on the board. Cox formerly served as president and CEO of Foundation Medicine and was SVP and officer at Genentech and held roles at UCB, Sanofi-Aventis and Schering-Plough.
→ Rocket Pharmaceuticals chief Gaurav Shah is now chairman of the board at Swiss gene therapy developer Anjarium Biosciences, which unveiled a $61 million launch round in September 2021 thanks to such big-name investors as Pfizer and Abingworth. And after joining the board at Oncorus in June, ex-Dicerna CEO Doug Fambrough also has a place in Anjarium’s boardroom.
→ Cell processing shop Curate Biosciences has reserved space for Shah’s chief technical officer at Rocket, Mayo Pujols, on the board of directors. Pujols was in charge of global manufacturing for liso-cel (now Breyanzi) as Celgene’s VP of global CAR-T operations and technology.
→ Belgian infectious disease biotech ExeVir has appointed Jeanne Bolger to chair the board of directors. After 13 years at GSK, Bolger switched to another pharma giant as VP of scientific licensing at J&J, later becoming the VP of venture investing at Johnson & Johnson Innovation (JJDC).
→ Theseus Pharmaceuticals — a TKI player from OrbiMed whose stock $THRX recently hit its nadir practically a year to the day that it joined Nasdaq in a none-too-shocking development in this market — has added Incyte CMO Steven Stein to the board of directors. Stein is a former clinical development exec with GSK and Novartis Oncology.
→ Geron’s EVP, corporate strategy and chief commercial officer Anil Kapur is making his way to the board of directors at Verastem Oncology. Kapur is the former head of early assets, biomarkers and external innovation for worldwide oncology commercialization for Bristol Myers Squibb and the ex-CCO at Actinium.
→ China-based Hangzhou Qihan Biotech has brought on Tony Ho to its board of directors. Ho joins after a four-year stint at CRISPR Therapeutics, where he most recently served as EVP and head of research & development. Ho’s prior experience includes roles as SVP and head of oncology integration and innovation at AstraZeneca, head of neurology and ophthalmology at Merck and co-founder and CSO at Neuronyx.
→ Following a recent Series C financing round, Inversago Pharma has reeled in Ed Mathers and Nanna Lüneborg to its board of directors. Mathers is a general partner at New Enterprise Associates and has previously served as EVP, corporate development and venture at MedImmune. Mathers currently serves as a director to a host of companies, including Rhythm Pharmaceuticals, Synlogic, Senti Bio, Inozyme, Akouos and Affinia. Meanwhile, Lüneborg is a general partner at Forbion and formerly served a decade-long stint as a partner at Novo Ventures.
→ The Illinois Biotechnology Innovation Organization (iBIO) has added three new faces to its board of directors with the appointments of: Rahul Jerath (senior director, head of oncology business development & acquisitions at AbbVie), Phil Tennant (SVP and head of oncology business unit at Astellas), and Joe Whalen (SVP, alliances & international business development at Horizon Therapeutics).
Illustration: Kim Ryu for Endpoints News
Key takeaways:
The data supporting regulatory approval alone are often insufficient for demonstrating the added benefit of a new therapy
Planning in advance to continuously deliver data that illustrate value and post-launch, to not only the regulator, but payers, healthcare professionals, and patients results in more clinically meaningful benefits
By working cross-functionally, biopharmaceutical teams can uncover evidence gaps and better shape registration trials to ensure the needs of as many stakeholders as possible are met
As psychedelic therapies make their way through the clinic, one Seattle doctor is taking his fight to change psilocybin’s status as a Schedule I substance to federal court.
Sunil Aggarwal petitioned the Ninth Circuit Court of Appeals on Thursday to review a decision by the Drug Enforcement Administration in September to leave psilocybin on the Schedule I list under the Controlled Substances Act. Schedule I drugs are considered to have a “high potential for abuse” with “no currently accepted medical use in treatment in the United States,” according to the CSA’s language.
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With public health officials gearing up for a tough flu season, so is GSK consumer spinoff Haleon and its flu brand Theraflu by offering a helping hand to workers who don’t get sick leave.
Now in its second year, “The Right to Rest and Recover” campaign is spreading the word, especially about the inequities around unpaid sick time for Black and Latina mothers. Its research shows those women are putting in twice the work caring for older and younger generations, but often have less access to paid sick leave. One in three Black and Latina women can’t earn sick days in the US, according to Haleon.
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Is pharma advertising recession-resistant? That’s likely to be a popular question in the industry in the coming months, but for now it’s holding steady — and even faring better than most other categories.
Pharma advertising spending rose 12% in September compared year over year to the same month in 2021 and saw the second-biggest jump among 12 categories, according to Standard Media Index’s monthly trend report. Pharma was one of its five categories that increased ad spending, while the other seven dropped year over year.
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Back in 2017, Takeda shelled out more than $5 billion for a smaller company called Ariad Pharmaceuticals, its leukemia drug Iclusig (ponatinib) and its ALK-inhibiting lung cancer drug Alunbrig (brigatinib).
Fast forward five years, and while Iclusig continues to pull in more than $200 million per year for Takeda, the company is now looking to fend off generic competitors, filing suit in New Jersey federal court earlier this week to block a competitor, Canada-based Apotex.
Drug pricing watchdog ICER on Thursday released its final report on drug price increases in California that were unsupported by new clinical evidence, pointing to three outliers — Bristol Myers Squibb’s cancer drugs Revlimid and Sprycel, and Eli Lilly’s migraine drug Emgality.
The report builds on a price transparency law passed in California in 2017, which requires manufacturers to report year-over-year spending increases to prescription drugs’ WAC prices, but does not include net prices, which ICER took issue with.
The Medicines Patent Pool on Thursday unveiled a new voluntary licensing agreement with Novartis to increase access to its patented, second-line chronic myeloid leukemia drug Tasigna (nilotinib) in certain lower-income countries.
The drug, which is on the WHO’s list of essential medicines, will now be made by select generic manufacturers and offered in seven middle-income countries — Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines and Tunisia — where patents on the product are pending or in force.
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Behind Amgen and Mirati are a whole host of players lining up their own KRAS candidates.
Roche is no exception. The Big Pharma already has its own in-house KRAS drug from its subsidiary Genentech that is currently in Phase I studies, but is now expanding its options.
Roche has licensed a preclinical KRAS program from Hookipa Pharma for $25 million upfront, Hookipa announced Thursday morning. Roche also has the option of adding a second immunotherapy candidate for $15 million.
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Less than 2 years after some Oxford grads pieced together a little £6 million seed fund to launch their discovery outfit, the antibody developer has been scooped up by one of the pharma giants scouting the bargain aisle of early-stage drug development.
And the founders did considerably better than the seed round might suggest.
AbbVie is swooping in for the buyout with $255 million in cash for DJS Antibodies, plus some unspecified milestones that could range quite high, given the preclinical nature of the GPCR work involved.
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