UnitedHealth 1Q Revenue, Profit Grow as Membership Expands

 UnitedHealth Group Inc. on Thursday posted a larger profit and stronger revenue year over year in the first quarter, as growth in the Medicare and Medicaid businesses contributed to overall expansion of the company's membership base.

The Minnetonka, Minn.-based health insurer logged earnings per share attributable to common shareholders of $5.08, up from $3.52 in the year-ago quarter. Overall net earnings were $4.86 billion, up from $3.38 billion a year earlier.

On an adjusted basis, the company's first-quarter earnings were $5.31 a share. Analysts surveyed by FactSet had forecast adjusted earnings of $4.39 a share.

Revenue was $70.2 billion, an improvement from $64.42 billion in last year's first quarter. Analysts had forecast revenue of $69.07 billion.

The number of people served by the company's plans grew by more than 1 million to 49.5 million, UnitedHealth said. Strong Medicare Advantage membership growth during the annual enrollment period helped drive the company's growth, along with other Medicare and Medicaid program expansions and growth in speciality products, such as dental and vision benefits, UnitedHealth said.

Revenue for UnitedHealth's Optum business grew nearly 11% to $36.4 billion.

https://www.marketscreener.com/quote/stock/UNITEDHEALTH-GROUP-INCORP-14750/news/UnitedHealth-1Q-Revenue-Profit-Grow-as-Membership-Expands-32975050/

Thermo Fisher Scientific to Buy PPD for $17.4 Billion in Cash

 Thermo Fisher Scientific Inc. said it has agreed to buy pharmaceutical-testing company PPD Inc. for $17.4 billion in cash, the latest tie-up among companies that run clinical trials and provide other services for drugmakers.

On top of paying $47.50 a share in cash, Thermo Fisher said it will also assume about $3.5 billion in net debt, the companies said Thursday.

The deal value reflects a premium of about 24% of PPD's closing price on Tuesday, before The Wall Street Journal on Wednesday reported that the two companies were nearing a deal.

PPD has more than 26,000 employees in nearly 50 countries. It generated revenue of $4.7 billion in 2020, up 16% from the prior year.

PPD, based in Wilmington, N.C., is a so-called contract-research organization, a type of company that runs the studies testing experimental drugs developed by pharmaceutical companies. PPD also provides laboratory services.

Thermo Fisher, of Waltham, Mass., sells lab equipment, chemicals and tests, among other life-sciences services and products. It had $32 billion in sales last year, a 26% increase.

The deal could add $1.40 a share to Thermo Fisher's adjusted earnings in the first 12 months after closing, which is expected by the end of the year, the companies said. Thermo Fisher said it expects about $75 million in cost savings and roughly $50 million in adjusted operating income benefit by the third year after close.

https://www.marketscreener.com/quote/stock/THERMO-FISHER-SCIENTIFIC-14623/news/Thermo-Fisher-Scientific-to-Buy-PPD-for-17-4-Billion-in-Cash-32975984/

FibroGen Gets Rare Pediatric Disease Tag for Duchenne Med

 FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD). Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration and is currently being evaluated in two Phase 3 trials for the treatment of DMD.  

https://www.globenewswire.com/news-release/2021/04/15/2210640/33525/en/FibroGen-Receives-Rare-Pediatric-Disease-Designation-from-the-U-S-FDA-for-Pamrevlumab-for-the-Treatment-of-Duchenne-Muscular-Dystrophy.html

GSK discontinues two feladilimab trials in head and neck cancer

 British drugmaker GlaxoSmithKline (GSK) has announced that it will discontinue two phase 2 trials evaluating its investigational inducible T cell co-stimulatory (ICOS) agonist feladilimab.

In a statement issued today, GSK said that following a recommendation by the Independent Data Monitoring Committee, it will stop enrolling patients in the phase 2 INDUCE-3 trial – including discontinuing treatment with the ICOS agonist.

The mid-stage study is evaluating feladilimab – GSK3359609 – plus Merck & Co’s Keytruda (pembrolizumab) compared with placebo plus Keytruda for the potential treatment of patients with PD-L1 positive advanced or metastatic head and neck squamous cell carcinoma (HNSCC).

In addition, GSK has also halted another mid-stage trial – INDUCE-4 – which is investigating feladilimab plus Keytruda and chemotherapy compared to placebo in combination with Keytruda and chemotherapy.

GSK did not say exactly why it was stopping the two mid-stage studies, but it is likely that the ICOS agonist did not yield the results that the British drugmaker was hoping for.

‘The totality of the data will be evaluated to assess the impact on the overall clinical development programme,’ commented GSK.

In the early-stage INDUCE-1 trial results, which included 34 evaluable patients who received feladilimab plus Keytruda, the overall response rate (ORR) was 24%, with responses in this cohort being durable and lasting for six months or longer.

The median progression-free survival (PFS) for the combination cohort was also found to be 5.6 months.

Based on these results, GSK initiated the INDUCE-3 trial to investigate the potential survival benefit for feladilimab with Keytruda in advanced or metastatic HNSCC patients who are PD-L1 positive.

Feladilimab aims to selectively enhance T cell function by stimulating ICOS, a protein found on the surface of certain T cells often found on a number of solid tumours.

In November 2020, Jounce Therapeutics also announced that it would not expand a phase 2 trial of its own ICOS-targeting monoclonal antibody vopratelimab after revealing less-than-stellar results.

An interim analysis of the EMERGE study found that vopratelimab in combination with Bristol Myers Squibb’s Yervoy (ipilimumab) in non-small cell lung cancer (NSCLC) patients who had previously been treated with a PD-(L)1 inhibitor did not meet the pre-specified criteria for continuation of enrolment.

https://www.pmlive.com/pharma_news/gsk_discontinues_two_feladilimab_trials_in_head_and_neck_cancer_1367078

Novartis agrees to make ingredients Roche’s Actemra for COVID-19 patients

 Swiss drugmaker Novartis has signed a deal to make ingredients for Roche's Actemra treatment that is being repurposed for people with COVID-19, the company said on Thursday.

The arrangement is the third transaction signed by Novartis following agreements with BioNTech and CureVac to make therapies for other firms to help fight the pandemic.

Actemra is a treatment for rheumatoid arthritis which is also being tested in various clinical trials to treat COVID-19 associated pneumonia.

Novartis will make the active pharmaceutical ingredients for the drug at its Singapore site, which will get the necessary technology and expertise during the second quarter of this year.

"Novartis is fully committed to collaborating with Roche in offering our proven biologics production capabilities," said Steffen Lang, Head of Novartis Technical Operations.

"As one of the world's largest producers of medicines, Novartis can mobilize its manufacturing capabilities on multiple fronts."

In March, Novartis signed a deal with CureVac to produce material for its COVID-19 candidate drug at its site in Kundl, Austria. The Swiss company also signed a deal with BioNtech to provide manufacturing capacity for a COVID-19 vaccination at its plant in Stein, Switzerland.

https://whbl.com/2021/04/15/novartis-agrees-to-make-ingredients-roches-actemra-for-covid-19-patients/

agilon health Prices IPO

agilon health, inc. ("agilon health"), which partners with primary care physicians to unlock value-based healthcare delivery, announced the pricing of its initial public offering of 46,600,000 shares of its common stock at a public offering price of $23.00. All of the shares of common stock are being offered by agilon health. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other expenses payable by agilon health, are expected to be approximately $1,072 million. agilon health has granted the underwriters a 30-day option to purchase up to an additional 6,990,000 shares of its common stock at the initial public offering price, less underwriting discounts and commissions.

The shares are expected to begin trading on the New York Stock Exchange on April 15, under the ticker symbol AGL. The offering is expected to close on April 19, 2021, subject to customary closing conditions.

J.P. Morgan, Goldman Sachs & Co. LLC, and BofA Securities are acting as lead book-running managers for the proposed offering. Deutsche Bank Securities, Wells Fargo Securities, William Blair, Truist Securities, and Nomura are acting as additional book-running managers.

https://finance.yahoo.com/news/agilon-health-announces-pricing-initial-220000832.html

Merck ends development of Covid drug acquired from OncoImmune

 Merck announced Thursday it will end the development of its experimental drug for patients hospitalized with severe Covid-19 after the Food and Drug Administration asked the company to provide additional data to support an emergency use authorization.

New Jersey-based Merck acquired the drug, MK-7110, through its $425 million acquisition of privately held biopharmaceutical company OncoImmune late last year.

An interim analysis of clinical trial data suggested the drug improved the chances of recovery for the sickest patients with Covid-19 and reduced the risk of death or respiratory failure.

However, Merck disclosed in February that U.S. regulators had asked for more data on the drug beyond the phase three trial already conducted. At the time, the company said it no longer expected to supply the U.S. with the drug in the first half of 2021.

Now, due to “regulatory uncertainties” and the time and resources needed to provide the additional data, Merck said it decided to discontinue the development of the drug and instead focus its efforts on advancing its other Covid-19 drug as well as accelerating production of the Johnson & Johnson vaccine.

“Based on the additional research that would be required – new clinical trials as well as research related to manufacturing at scale – MK-7110 would not be expected to become available until the first half of 2022,” the company said in a press release.

The announcement marks another disappointment for Merck in efforts to combat the pandemic.

In January, it announced it would end the development of its two Covid-19 vaccines. In early trials, both vaccines generated immune responses that were inferior to those seen in people who had recovered from Covid-19 as well as those reported for other vaccines, according to the company.

While Merck is discontinuing MK-7110, the company said it will move forward with its oral antiviral drug, molnupiravir, in a phase three clinical trial testing non-hospitalized patients with Covid-19.

“We continue to make progress in the clinical development of our antiviral candidate molnupiravir,” Roy Baynes, Merck’s chief medical officer, said in a release. “Data from the dose-finding portion of these studies are consistent with the mechanism of action and provide meaningful evidence for the antiviral potential of the 800 mg dose.”

https://www.cnbc.com/2021/04/15/merck-ends-development-of-covid-drug-it-acquired-from-oncoimmune.html