Ex-Shire CEO Ornskov emerges as Galderma CEO after $10B Nestlé spinout

As Takeda folds in Shire, two of the Irish rare disease specialist’s former top leaders have found themselves a new home at Nestlé skin health spinoff Galderma.

 

Flemming Ornskov, Shire’s most recent CEO before the Takeda buyout, has taken the reins as Galderma CEO. And Shire’s former finance overseer, Thomas Dittrich, will work alongside him as CFO of Galderma, a company that now holds the title of the world’s largest independent dermatology-focused drugmaker.
Prior to Shire, Ornskov had plenty of experience from his work at Bayer, Bausch & Lomb and Novartis. Dittrich was only Shire’s CFO for a year, but he’s not so new to pharma, either, having previously served a stint at Amgen.

 

 

Meanwhile, Thomas Ebeling, former CEO of Novartis Pharma and Novartis Consumer Health, has become Galderma Chairman, and Sheri McCoy, former Johnson & Johnson vice chair responsible for the pharma and consumer divisions, has also joined as a director. Stuart Raetzman, Nestlé Skin Health's CEO since 2016, has transitioned to a director role.
Consumer giant Nestlé in May confirmed the CHF 10.2 ($10.2 billion) skin health spinoff to a consortium of private investment organizations including EQT Partners, Abu Dhabi Investment Authority’s Luxinva, and PSP Investments, among others.

Ornskov is credited for growing Shire from a relatively small, $4 billion business into one of biopharma’s most prominent rare disease players with $15 billion in revenue in just five years.
He orchestrated Shire’s eventful $32 billion takeover of Baxalta in 2016, which is still one of the biggest pharma M&A transactions in history. And about four years after AbbVie walked out of a $55 billion acquisition deal, Ornskov successfully sold the company to expansion-hungry Takeda for an even larger $62 billion.
Both the Baxalta tie-up and Takeda’s subsequent Shire deal have been challenged by investors, what with the heated competition and risk to Baxalta’s hemophilia business, which previously made up 20% of Shire’s revenue. As Roche’s antibody hemophilia A drug Hemlibra continues its land-grab, and as gene therapies lurk around the corner, other firms’ hemophilia franchises will only be under more pressure.
But that’s not Ornskov’s concern anymore. The new Galderma operates in three business units: aesthetics, prescription and consumer care, with combined revenues of CHF 2.8 billion ($2.81 billion) and about 5,000 employees. In a statement on Oct. 2, the company said it would maintain its current course focused on the “highly attractive” dermatology sector, continue to build its presence in the U.S. and China, and launch new products with an eye on global expansion.
First up, the company on Friday said it had snagged an FDA green light for Aklief, a topical retinoid cream for acne. Its active ingredient, trifarotene, is the first new FDA-approved retinoid molecule in over 20 years, Galderma said. It also stands as the first topical treatment that's been specifically studied and shown efficacy in both facial and truncal acne.
The new cream will add to Galderma’s existing acne solutions, including Epiduo and Differin, both of which contain retinoid drug adapalene. The now-independent Fortworth, Texas-based company said it will launch Aklief in November, and it’s “working closely with payers, provider and pharmacy benefit managers to ensure” its access.
https://www.fiercepharma.com/pharma/ex-shire-ceo-flemming-ornskov-emerges-as-galderma-ceo-after-10b-nestle-spinout

Medtronic Gets FDA Breakthrough Tag for Valiant TAAA Stent Graft System

Medtronic PLC (MDT) said Tuesday it received Breakthrough Device designation from the U.S. Food and Drug Administration for its Valiant TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm.
A TAAA is a complex condition causing a bulging of the aorta, which extends from the chest down into to the abdomen.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies, the company said. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

https://www.marketscreener.com/MEDTRONIC-PLC-20661655/news/Medtronic-Gets-FDA-Breakthrough-Device-Designation-for-Valiant-TAAA-Stent-Graft-System-29350567/

Glaxo Links Up with US Biotech to Target Solid Tumors with Cell Therapy

GlaxoSmithKline PLC (GSK.LN) said Tuesday that it has partnered with San Francisco-based biotechnology company Lyell Immunopharma to develop its cell therapy pipeline, with a special focus on solid tumors.
The five-year collaboration aims at using Lyell’s technology to strengthen the efficacy of its existing cell therapy program, the FTSE 100 drugmaker said.
Glaxo said that it hopes that using Lyell’s technology, it can improve the fitness of T cells, a type of white blood cell.
Unlike other medicines, cell therapies use living cells that are extracted and modified to fight disease. Existing cell therapies on the market, Kymriah and Yescarta, are only approved for blood cancers.
The British company said that so far, T cell exhaustion has posed an obstacle to adapting to cell therapies to solid tumors.
“Lyell is exploring several approaches to improving T cell function and increasing T cell ‘fitness’ to enhance initial response rates in solid tumour cancers and to prevent relapses due to loss of T cell functionality,” said Glaxo’s chief scientific officer and president of research, Hal Barron.
In March 2018, the company sold its gene-therapy division Strimvelis to Orchard Therapeutics PLC. However it retained its cell therapy research program, which was largely based around a collaboration with Adaptimmune Therapeutics PLC which began in 2014.
The lead asset to emerge from the program was GSK3377794, a T-cell therapy currently in phase 2 clinical trial as a potential treatment for relapsed or refractory synovial sarcoma. Glaxo said the asset is also under investigation for a range of other cancers, including non-small cell lung cancer and multiple myeloma.

https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/Glaxo-Links-Up-with-US-Biotech-to-Target-Solid-Tumors-with-Cell-Therapy-29350616/

Humira, Rituxan top list of U.S. drugs with biggest price increases

AbbVie Inc’s arthritis drug Humira and Roche Holding AG’s cancer drug Rituxan topped a list of seven treatments whose combined 2017 and 2018 price hikes accounted for a $5.1 billion increase in U.S. spending, a report released on Tuesday showed.

The price hikes were more than twice the rate of medical inflation and were not supported by any new clinical evidence, the Institute for Clinical and Economic Review (ICER) said in the analysis.
It was the first such annual report by the Boston-based research group, which assesses the cost-effectiveness of drugs.
Other top treatments by spending that were called out included Pfizer Inc’s pain drug Lyrica, Gilead Sciences Inc’s HIV drug Truvada, Amgen Inc’s cancer drug Neulasta, Eli Lilly & Co’s erectile dysfunction drug Cialis and Biogen Inc’s multiple sclerosis treatment Tecfidera.

U.S. drug prices are tough to pin down. Companies may provide list prices, but they also negotiate discounts and after-market rebates with purchasers and their representatives such as pharmacy benefit managers, health insurers, employers, and government and state health coverage programs.
ICER evaluated the pricing in partnerships with SSR Health Inc, a research firm, which calculated the increases excluding discounts and after-market rebates.
Gilead spokesman Ryan McKeel disagreed with ICER’s conclusion, saying it left out real-world and economic evidence. Biogen spokeswoman Nina Varghese said ICER’s methodology was flawed and did not consider evidence it submitted such as observational studies.
Lilly spokesman Mark Taylor also questioned the methodology for the report and said that generic versions of Cialis were on the market for less than 90% of the retail price.

Pfizer spokesman Steve Danahy said the analysis did not include external factors that affect drug prices or take into account what an appropriate value-based price should be.
Roche spokeswoman Emmy Wang said that in pricing drugs, the company strived for the right balance between patient access and investing for breakthroughs in medicine.
Amgen and AbbVie did not have an immediate comment.
ICER acknowledged it was difficult to determine the actual increase in spending on the drugs, but said it was confident that the seven drugs cost a lot more.
Pricing drugs based on new benefits could help slow cost hikes, ICER Chief Medical Officer David Rind said.

“If manufacturers weren’t raising prices if they haven’t shown a new important benefit, I think that would help,” he said.
Celgene’s Revlimid and Gilead’s Genovya were also large contributors to spending but were excluded from the list because of their clinical advancements, ICER said.
Humira’s net price increase over 2017 and 2018 added $1.8 billion in spending while Rituxan added $806 million, the report said.
https://www.reuters.com/article/us-usa-healthcare-drugpricing/humira-rituxan-top-list-of-u-s-drugs-with-biggest-price-increases-report-idUSKBN1WN1BE

Clovis continues selloff, down after Goldman cuts target

Buyers in Clovis Oncology (CLVS -9.2%) are a scarce commodity. Shares are down on below-average volume in early trade after Goldman Sachs cut its fair value target to $3 (from $13).

The stock has been in a steady down trend since early March, shedding almost 90% of its value along the way.

Per a presentation at ESMO last week, the company says it expects to file a U.S. marketing application this quarter for Rubraca (rucaparib) for BRCA-mutant prostate cancer, a subset of metastatic castration-resistant prostate cancer patients representing ~12% of total cases. The overall response rate (ORR) in these patients in the Phase 2 TRITON2 study was 43.9% (n=25/57).

https://seekingalpha.com/news/3504470-clovis-continues-selloff-9-percent-goldman-cuts-target

AMAG Pharma settles issues with activist investor

AMAG Pharmaceuticals (NASDAQ:AMAG) has settled matters with activist investor Caligan Partners LP who had filed a preliminary consent statement aimed at replacing four board members with candidates who, it believed, would be change agents.

Under the terms of the agreement, the company has added former Boehringer Ingelheim USA CEO Paul Fonteyne and Caligan Partner and co-Founder David Johnson to the board, temporarily expanding membership to 11 prior to the 2020 Annual Meeting. After the shareholder vote, membership will revert back to nine directors. Caligan has withdrawn its consent solicitation.

https://seekingalpha.com/news/3504428-amag-pharma-settles-issues-activist-investor

BioNTech IPO: What You Need To Know

An oncology biotech that promises individualized immunotherapies is part of the slate for the week.

The IPO Terms

Germany-based BioNTech SE is proposing to offer 13.2 million ADSs, each ADS representing an ordinary share, in an IPO, according to a F-1/A filing. The company expects to price the offering between $18 and $20 per ADS.
At the midpoint of the estimated price range, the size of the offering is likely to be $250.8 million.
The company has applied for listing its shares on the Nasdaq under the ticker symbol “BNTX.”
JPMorgan, Bank of America Merrill Lynch, UBS and SVB Leerink are the lead managers for the offering, while Canaccord Genuity, Bryan, Garnier & Co, and Berenberg are serving as co-managers.

The Company

Founded in 2008, BioNTech uses a combination of immunology, cutting-edge therapeutics platforms and a suite of patient profiling and bioinformatic tools to develop individualized immunotherapies for cancer as well as other diseases.
Its product candidates are developed using numerous immunotherapeutic platforms across four drug classes, namely mRNA therapeutics, engineered cell therapies, antibodies and small molecule immunomodulators.
The company has established relationships with seven biopharma companies, including Roche Holdings AG Basel ADR RHHBY‘s Genentech, Sanofi SA SNY, GENMAB A/S/S ADR GMAB, Genevant Sciences, Eli Lilly And Co LLY, Bayer AG BAYRY and Pfizer Inc. PFE, which provide with R&D assistance and non-dilutive capital.

The Finances

BioNTech reported revenues from contracts of 127.58 million euros in 2018, up about 107% year-over-year. The loss for the year narrowed from 85.65 million euros to 48.02 million euros.
For the six months ended June 30, revenues from contracts rose roughly 20% to 51.94 million euros but the loss widened from 23.24 million euros in 2018 to 90.73 million in 2019.
https://www.benzinga.com/news/19/10/14555357/biontech-ipo-what-you-need-to-know