Pfizer keeps pushing its inflammation pipeline

 The longevity of Pfizer’s Covid-related revenues was the hottest topic at the group’s earnings yesterday, but pipeline progress elsewhere is equally important, and several updates in the inflammation and immunology space caught the eye. This is a big area for Pfizer, with etrasimod, recently acquired from Arena, star of the show. Failure overnight with a rival S1P agent from Connect adds weight to Pfizer’s claim of having a best-in-class agent; a pivotal trial in atopic dermatitis will start later this year, it was announced yesterday. The Jak3/Tec inhibitor ritlecitinib is also primed for further phase 3 studies, while executives described data on the group's TL1A MAb as “very strong”, particularly in a biomarker-selected group. Data due on that asset later this year are keenly awaited, particularly for those with similar assets such as Prometheus, whose stock jumped 11% yesterday on those comments. Less encouraging was Pfizer’s discontinuation of its Irak-4 inhibitor in a rare skin condition, a move that knocked shares in a small rival. With a couple more assets added to Pfizer’s inflammation and immunology pipeline, and several others being advanced, progress here will be closely watched – and this space remains likely to see further dealmaking.

Pfizer's inflammation and immunology pipeline: progress and setbacks
Project	Mechanism	Settings
>Etrasimod (from Arena)	S1P inhibitor	Ph3: ulcerative colitis, atopic dermatitis to start Q4; ph2b: Crohn's disease; ph2: eosinophilic esophagitis, alopecia areata.
Ritlecitinib (PF-06651600)	Jak3/Tec Inhibitor	Ph3: alopecia areata; ph2: ulcerative colitis, Crohn's disease, vitiligo
PF-06650833	Irak4 inhibitor	Ph2: hidradenitis suppurativa abandoned; project continues only in an RA combination trial
PF-06480605	TL1A MAb	Ph2: ulcerative colitis
PF-06823859	IFNB1 antagonist	Ph2: dermatomyositis
PF-07038124	Topical PDE4 inhibitor	Ph2: atopic dermatitis and psoriasis
>RIST4721 (option from Aristea)	CXCR2 antagonist	Ph2: palmoplantar pustulosis
Dekavil (from Philogen)	F8 MAb-IL-10 fusion product	Ph2: rheumatoid arthritis
>PF-06835375	Anti-CXCR5	Ph2: immune thrombocytopenic purpura; ph1: lupus
PF-07054894	CCR6 Antagonist	Ph1: inflammatory bowel disease (trial in healthy volunteers)
PF-07242813	CD1a inhibitor	Ph1: atopic dermatitis
PF-07295324* plus PF-07259955	Topical Soft Jak Inhibitors	Ph1: atopic dermatitis (trial in healthy volunteers)
>Advanced to next phase; *new to pipeline. Source: company communication.  https://www.evaluate.com/vantage/articles/news/trial-results-snippets/pfizer-keeps-pushing-its-inflammation-pipeline

US FDA approval tracker: April

 Last month the US regulator tightened its grip over PI3K inhibitors by calling for randomised data instead of single-arm clinical studies. Ahead of an advisory committee meeting on the subject, TG Therapeutics pulled its own PI3K asset Ukoniq from sale and withdrew the filing of its combination product, U2. Elsewhere both Alnylam and Merck had Pdufa dates extended. For the latter, its 15-valent pneumococcal vaccine Vaxneuvance was heading for a decision in infants and children, a larger market than its already approved adult label. Despite the three-month delay Merck is still ahead of Pfizer in the younger age group, with that group's follow-on project, Prevnar 20, due to yield phase 3 in the second half of the year. Lastly Bristol Myers Squibb finally received the green light for mavacamten, now called Camzyos, in obstructive hypertrophic cardiomyopathy. The cardiac myosin inhibitor not only comes with a REMS and a black boxed warning, but a higher than expected price tag. With a list price of $89,500 a year it is well above the $15,000 figure ICER said would meet traditional thresholds of cost-effectiveness. Bristol has its work cut out to meet its $4bn-plus peak sales target, and justifying the $13.1bn it spent on Myokardia.

Notable first-time US approval decisions in April
Project	Company	Indication(s)	2026e sales by indication (SBI) ($m)	Outcome
Vutrisiran	Alnylam	Polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis	1,828*	Delayed to July 14 (review of new information related to the secondary packaging and labelling facility)
Camzyos (mavacamten)	Bristol Myers Squibb	Obstructive hypertrophic cardiomyopathy	1,672	Approved
Bimzelx	UCB	Plaque psoriasis	953	Pending (H1)
Igalmi (dexmedetomidine/ BXCL501)	Bioxcel	Agitation associated with schizophrenia and bipolar disorders I and II	378	Approved
Sulanda (surufatinib)	Hutchmed	Pancreatic and non-pancreatic neuroendocrine tumors	362	CRL (multi-regional clinical trial needed)
FT218	Avadel	Narcolepsy	321	Pending
AXS-07	Axsome	Acute treatment of migraine	128	CRL (CMC issues)
Epsolay cream	Sol-Gel/ Galderma	Papulopustular rosacea	-	Approved
Vivjoa (oteseconazole)	Mycovia	Recurrent vulvovaginal candidiasis	-	Approved
Cuvrior (Cuprior)	Orphalan	Adult patients with stable Wilson’s disease	-	Approved
Tuoyi (toripalimab)	Coherus/ Shanghai Junshi	1st-line chemo combo & 3rd-line monoRx nasopharyngeal carcinoma	-	CRL (quality process change required)
Tapinarof	Dermavant	Plaque psoriasis	-	Pending (Q2)
Annik (penpulimab)	Akeso/Sino	3L nasopharyngeal carcinoma	-	Pending (H1)
SH-111	Shorla Oncology (private)	T-cell leukaemia	-	Pending
*SBI as amyloidosis. Source: company statements, Evaluate Pharma

 

Advisory committee meetings in April
Project	Company	Indication	Outcome
Covid-19 vaccination	N/A	Covid-19 prevention	Agency will reconvene its booster discussion on June 28
PI3K inhibitor class	N/A	Haematologic malignancies	16-0, future approvals of PI3K inhibitors should be supported by randomized data
U2, Ukoniq	TG Therapeutics	Haematologic malignancies	Prior to ad com U2 application withdrawn and Ukoniq pulled
Source: FDA ad com calendar, Evaluate Pharma

 

Supplementary and other notable approval decisions in April
Product	Company	Indication (clinical trial)	Outcome
Vaxneuvance	Merck	Prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age (15-valent conjugate vaccine, PNEU-PED)	Delayed to July 1 (additional analyses of data from the paediatric studies)
REgen-Cov (Ronapreve)	Regeneron	Treat Covid-19 in non-hospitalised patients and as prophylaxis in certain individuals	Delayed to July 13 (already has EUA)
Yescarta	Gilead	2L relapsed/refractory large B-cell lymphoma (Zuma-7)	Approved
Qelbree	Supernus	ADHD in adults (P306)	Approved
Ultomiris	Astrazeneca	Adults with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive (NCT03920293)	Approved
Rinvoq	Abbvie	Ankylosing spondylitis (Select-Axis 2, Select-Axis 1)	Approved
Vijoice (alpelisib, marketed as Piqray in breast cancer)	Novartis	Adult and paediatric patients 2 years of age and older with PIK3CA-related overgrowth spectrum (EPIK-P1)	Approved
Cysteine hydrochloride (Elcys generic)	Eton	Additive to amino acid solutions to meet the nutritional requirements of newborn infants	Approved
Alymsys (Avastin biosimilar)	Amneal/ mAbxience	Metastatic colorectal cancer, 1L NSCLC, recurrent glioblastoma, met renal cancer, met cervical cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer	Approved
Veklury	Gilead	Paediatric patients under 12 years old hospitalised with Covid-19 or have mild-to-moderate Covid-19 at high risk of progression to severe Covid-19	Approved
Caplyta	Intra-cellular	New dosage strengths for schizophrenia and bipolar depression	Approved
Olumiant	Lilly	Atopic dermatitis (Breeze-AD programme)	CRL
TV-46000/mdc-IRM (risperidone extended-release)	Teva/ MedinCell	Schizophrenia (Rise, Shine)	CRL
Enhertu	Astra/Daiichi	Unresectable/metastatic Her2 +ve breast cancer pts who have received a prior anti-Her2-based regimen (Destiny-Breast 03)	Pending (Q2)
Olumiant	Lilly	Treatment of certain hospitalised patients with Covid-19	Pending (Q2)
Kymriah	Novartis	r/r FL after two prior lines of treatment (Ph2 Elara)	Pending
Source: company statements, Evaluate Pharma

 

FDA Covid-19 EUAs
Product	Company	Outcome
Xevudy (sotrovimab)	GSK/Vir	No longer authorised to treat Covid-19 in any US region as Xevudy is unlikely to be effective against the BA.2 sub-variant (gained EUA in May 2021)
Source: company releases https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-tracker-april

Parents in no rush on COVID vaccines for young children: KFF poll

 A survey out Wednesday shows parents of young children have some hesitation in terms of vaccinating their children for COVID-19 as the Food and Drug Administration prepares to consider authorizing shots for children under 5 this summer.

The KFF COVID-19 Vaccine Monitor survey showed that just 18 percent of parents with children under 5 are eager to get their children vaccinated for COVID-19 right away, while 38 percent of parents say they plan to wait to see how the vaccine is working for others. 

Twenty-seven percent of parents said they would definitely not get their child vaccinated and 11 percent said they would but only if the shot is mandated. 

More than half of the parents with children under age 5 said they did not have enough information about the safety and effectiveness of the vaccine for children in that age group.

Among parents with children between ages 12 and 17, 56 percent had already gotten their child vaccinated, and 31 percent said they would “definitely not.” 

For those with children between ages 5 and 11, 39 percent of parents said their child had received the shot and 32 percent said they would not. Thirteen percent of parents with children in that age group said they would pursue the wait and see approach. 

In terms of safety from exposure, 84 percent of parents said they think their child is at least “somewhat safe” from COVID-19 at school.

Divided by race, 33 percent of Black or Hispanic parents said they felt their child is “very safe” compared to 52 percent of white parents.

The poll was conducted April 13-26. It has a margin of sampling error of 3 percentage points and included 1,889 adults.

It comes as the FDA last week released tentative June dates for its advisory committee to meet to discuss authorizing COVID-19 vaccines for young children, suggesting that authorization could come this summer.

https://thehill.com/policy/healthcare/3476712-parents-in-no-rush-on-covid-vaccines-for-young-children-poll/

Avanos Medical Q1 Results, Outlook

  Avanos Medical, Inc. (NYSE: AVNS) today reported first quarter 2022 financial results.

"Coming off last year's solid finish, we maintained our momentum through the first quarter while adding OrthogenRx to our portfolio," stated Joe Woody, Avanos' chief executive officer. Woody continued, "I am very pleased with our first quarter results despite persistent global economic headwinds. We met our customers' orders and meaningfully improved our gross margins in the face of inflationary pressures and a difficult supply chain environment, and we remain confident in our ability to continue to do so through the back half of the year. Additionally, the OrthogenRx business performed as expected, confirming our belief that our acquisition strategy, combined with solid organic execution, positions us to meet our longer-term financial goals."

First Quarter 2022 Financial Highlights

• Net sales totaled $197 million, a 9 percent increase from the comparable prior year period.
• Net income for the quarter was $6 million, compared to net loss of $8 million a year ago.
• Adjusted net income totaled $12 million, compared to $11 million a year ago.
• Diluted earnings per share was $0.12, compared to $0.16 diluted loss per share a year ago.
• Adjusted diluted earnings per share was $0.26, compared to $0.23 in the prior year.

Operational and Business Highlights

• On January 20, 2022, we completed the acquisition of OrthogenRx, Inc. ("OrthogenRx"), a leader in viscosupplementation therapies for the treatment of knee osteoarthritis ("OA") knee pain. The acquisition was based on a purchase price of $130 million plus up to an additional $30 million in contingent cash consideration.
• During January, we repurchased 588,293 shares of our Common Stock for $19.3 million, completing our repurchases under a board-authorized $30 million repurchase program.
• A lead investigator on one of our clinical studies presented data at the North American Neuromodulation Society's annual meeting that provided a combined analysis of subjects across two randomized clinical studies that demonstrated remarkable consistency of COOLIEF for treating knee OA pain.
• Pre-clinical data exploring in-vivo tissue response following a COOLIEF procedure was recently published in the Journal of Pain Research.
• We are seeing significant engagement with state-level pain societies in issuing statements in support of reimbursement coverage for genicular radio-frequency pain therapies.

2022 Outlook

The company affirms previous guidance for 2022 net sales of between $830 million to $850 million, which assumes organic growth between 3 percent to 6 percent. Additionally, we anticipate gross profit margins to be between 55 percent to 57 percent with adjusted diluted earnings per share between $1.55 to $1.75.

Each of these measures is inclusive of the impact of the OrthogenRx acquisition and reflects our expectation that supply chain headwinds related to both product availability and inflation pressures will continue throughout the year.

https://www.biospace.com/article/releases/avanos-medical-inc-announces-first-quarter-2022-results/

Cardiovascular Systems reports 11% sales loss in Q3 results

 Cardiovascular Systems (NSDQ:CSII) this week posted third-quarter results that beat the earnings consensus on Wall Street but missed revenue estimates.

The St. Paul, Minnesota-based heart device company reported losses of $9.7 million, or -25¢ per share, on sales of $56.2 million for the three months ended March 31, for a sales loss of -11.15% compared with Q3 2021.

Earnings per share were 3¢ ahead of The Street, where analysts were looking for sales of $57.38 million.

“Third-quarter results were in line with our expectations. Despite the impact that Omicron had on hospital capacity and procedure volumes in January and into February, our Q3 sales were encouraging as we exited March with momentum. We are seeing staffing shortages slowly improve and we expect the backlog of cases to gradually flow through our accounts in calendar 2022,” CEO Scott Ward said in a news release.

For the fiscal year 2022, Cardiovascular Systems expects revenue to be in the range of $235 million to $240 million with a net loss in the range of 15% to 16% of revenues.

https://www.massdevice.com/cardiovascular-systems-reports-11-sales-loss-in-q3-results/

Regeneron Pharmaceuticals Beat Quarterly Projections Without Leaning On Covid

 Early Wednesday, Regeneron Pharmaceuticals (REGN) reported adjusted income of $11.49 per share on $2.97 billion in first-quarter sales. In response, REGN stock rose moderately.

On average, analysts polled by FactSet expected Regeneron to earn $9.68 per share on $2.69 billion in sales. The company's Covid antibody treatment brought in $635.6 million in sales — all outside the U.S. Excluding that product, Regeneron's total sales popped 25% to $2.75 billion.

In the year-earlier period, Regeneron earned $9.89 a share and reported $2.53 billion in sales.

https://www.investors.com/news/technology/regn-stock-regeneron-earnings-q1-2022/

Why Moderna's Outlook Doesn't Inspire Hope For Covid Vaccine Sales

 Moderna's (MRNA) Covid vaccine obliterated first-quarter views Wednesday, but the company retained its full-year outlook and Moderna stock floundered.

Despite a nearly $2 billion sales beat, Moderna restated its prediction for $21 billion in full-year advance purchase agreements for its two-shot Covid vaccine. The projection was just below Wall Street's call for $22.4 billion in 2022 sales.

The company now is focusing on new projects and hopes to have four drugs in final-phase testing this quarter, including a vaccine that targets Covid's omicron variant. Chief Executive Stephane Bancel says three products could launch over the next two to three years. That would help bolster sales, which are currently expected to peak this year as Covid becomes endemic.

Messenger RNA, the technology behind Moderna's Covid vaccine, "has changed the future of medicine and I look forward to continuing our impact on human health," Bancel said in a written statement. "This is just the beginning."

In morning trading on today's stock market, Moderna stock sank a fraction, near 145.50, reversing a premarket climb.

Moderna Stock: Sales, Earnings Beat

During the first quarter, Moderna earned $8.58 per share on $6.07 billion in sales. Profit surged 202% and easily beat projections for $5.37 per share, according to FactSet. Sales rocketed 213% and crushed analysts' call for $4.2 billion.

The company's Covid vaccine, Spikevax, brought in $5.93 billion in sales. The remainder of Moderna's revenue came from grants and collaboration money.

Next, Moderna hopes to launch its Covid vaccine for children ages 6 months to under 6 years old. In the U.S., Comirnaty, from Pfizer (PFE) and BioNTech (BNTX), is available for children as young as 5. But toddlers and infants remain unprotected.

Moderna is also working on final-phase testing for flu, respiratory syncytial virus and cytomegalovirus, all respiratory ailments. It's also testing a bivalent vaccine, which combines inoculations against the first Covid strain and the omicron variant.

Therapies, Personalized Cancer On Deck

"We also look forward to advancing our therapeutic programs and sharing proof-of-concept readouts on our rare genetic disease programs for propionic acidemia and methylmalonic acidemia, and on our personalized cancer vaccine program this year," CEO Bancel said.

Patients with acidemia are unable to break down certain proteins and fats, leading to a toxic buildup.

https://www.investors.com/news/technology/moderna-stock-moderna-earnings-q1-2022/