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

Nektar cut to Sell from Buy by Goldman Sachs

Target to $16 from $54
https://www.benzinga.com/stock/NKTR/ratings

Express Scripts Introduces 2020 Medicare Part D Plan Offerings

$0 Copay for Generic Drugs at Home Delivery (Up to 90-Day Supply) Through the Express Scripts Saver, Value and Choice Plans
Express Scripts announced today its Express Scripts Medicare® prescription drug plan (PDP) offerings for 2020, with three high-value options for coverage and savings – Saver, Value and Choice – including a $0 copay on all Tier 1 drugs via home delivery from Express Scripts Pharmacy^℠.

The company’s low-premium Saver plan will continue to provide affordable access to more than 2,800 commonly used medications, while offering a preferred pharmacy network that includes CVS Pharmacy®, Walmart and the Kroger Family of Pharmacies.
“Savings and meeting seniors’ prescription needs have made our Saver plan so successful,” said Jennie Knisley, Vice President, Medicare Prescription Drug Plans, Express Scripts. “Its affordable monthly premium and preferred pharmacy network provide high value at a low cost. For seniors with more complex medication needs, our Value and Choice plans offer a broader range of coverage options on both generic and brand-name drugs to help Medicare beneficiaries better manage their medication costs.”
The Saver plan offers premiums as low as $18.30 per month¹ with a $0 deductible on Tiers 1 and 2 medications. A 1-month supply of Tier 1 generic medications is approximately $1 and $4 for Tier 2 generic medications when filled at one of more than 16,000 preferred retail pharmacies nationwide.² The copays for a 90-day supply of Tier 1 or Tier 2 generic medications are $0 and $8, respectively, via home delivery from Express Scripts Pharmacy.
New for 2020, the Express Scripts Medicare Choice plan will have a $0 deductible on Tiers 1 and 2 medications, and only a $250 deductible on drugs in Tiers 3 through 5, which is a $100 decrease from 2019 and lower than the Centers for Medicare & Medicaid Services (CMS) standard deductible of $435. Also, the Choice plan offers additional coverage in the Coverage Gap for Tiers 1 and 2 drugs.
Both Express Scripts Medicare Value and Choice plans provide broader medication access with low-cost preferred pharmacy options. Each will deliver a comprehensive formulary with nearly 3,000 medications for the Value plan and 3,200 medications for the Choice plan. You can get plan coverage as high as 75% for specialty medications, after the deductible is met. Further cost savings can be achieved by using the plans’ network of more than 24,000 preferred pharmacies, including Walgreens, the Kroger Family of Pharmacies, and local, independent pharmacies nationwide.
“For more than 15 years, Express Scripts Medicare plans have been caring for millions of beneficiaries nationwide, whether they need occasional medications, or have chronic prescription drug needs,” said Knisley. “With 24/7 access to Express Scripts pharmacists to answer prescription medication questions, and specialist pharmacists and nurses who provide personalized care based on enhanced condition-specific training and experience, we help our enrollees achieve optimal health outcomes.”
Enrollment for the 2020 plan year runs from October 15 through December 7, 2019. Coverage begins on January 1, 2020. The Saver and Value plans are offered in all 50 states, the District of Columbia and Puerto Rico. The Choice plan is offered in all regions except Puerto Rico.
https://www.biospace.com/article/releases/express-scripts-introduces-2020-medicare-part-d-plan-offerings/

Qiagen CEO quits amid genetic sequencing U-turn, shares tumble

Qiagen’s longtime CEO Peer Schatz resigned after the German genetic testing company disclosed a reversal of its genome sequencing strategy and a slump in its Chinese business, sending its shares tumbling 20%.

In a surprise announcement late on Tuesday, the maker of diagnostic kits for cancer and tuberculosis said it would stop developing its next-generation genome sequencing machines and instead collaborate with industry leader Illumina.
For the third quarter, Qiagen cut its forecast for sales growth, adjusted for currency swings, to about 3%, down from a previous outlook of 4%-5%, with its China business turning out significantly weaker than expected.
It expected to report adjusted third-quarter earning-per-share of $0.35-0.36, in line with its previous forecast.
Qiagen plans to take a pre-tax restructuring charge of about $260-$265 million, mainly to write down assets linked to the development of next-generation sequencing (NGS) instruments.
It also cited an overhaul of its global manufacturing network and possible job cuts for the writedown.
The company said Thierry Bernard, the head of the group’s molecular diagnostics business, would now take over as interim boss until a permanent CEO was found.
Shares plunged 20% to 23.47 euros at 0848 GMT, with the group losing close to 1.4 billion euros in market value, after already shedding about 17% over the previous three months.
“The fall from grace of Qiagen shares since June suggests that the market was already positioning for an unfavourable Q3, but the CEO’s departure will come as a surprise,” said Berenberg analyst Scott Bardo, adding the business nevertheless held the promise of attractive underlying growth.
Qiagen’s core work includes making diagnostics kits that test for a single genetic mutation to help decide on treatment. But in recent years the company has developed into a smaller NGS player, where a wider range or all genes are sequenced.
As part of a 15-year collaboration deal with NGS pioneer Illumina, Qiagen will rely on its genetic diagnostic products running on its new partner’s hardware.
Schatz, who will become a special adviser to the supervisory board, had been with the company for 27 years. Since he started as finance chief in 1993, Qiagen has grown from $2 million in annual revenues to $1.5 billion in 2018.

https://www.marketscreener.com/ILLUMINA-INC-9659/news/Qiagen-CEO-quits-amid-genetic-sequencing-U-turn-shares-tumble-29348648/