Drug distributors McKesson (NYSE:MCK), AmerisourceBergen (NYSE:ABC) and Cardinal Health (NYSE:CAH) are up after hours in reaction to the news that
they are in talks to settle over 2,000 lawsuits brought by state and
local governments over their role in the opioid epidemic. The offer
allegedly on the table is $18B over 18 years.
https://seekingalpha.com/news/3505955-drug-wholesalers-perk-talks-settle-opioid-suits-18b
Tuesday, October 15, 2019
Akebia sues feds over dropped Auryxia coverage
Akebia Therapeutics (NASDAQ:AKBA) has filed a complaint in
a district court against the U.S. Department of Medicare & Medicaid
Services (CMS) and the U.S. Department of Health and Human Services
(HHS) challenging CMS’s decision about a year ago to rescind Medicare
Part D coverage of Auryxia (ferric citrate) for the treatment of iron
deficiency anemia in adult patients with chronic kidney disease not on
dialysis.
The company also seeks a reversal of a related
decision by CMS requiring prior authorization for Auryxia when used to
control serum phosphorus levels in adult patients with CKD on dialysis.
The FDA first approved the product in September
2014 for the hyperphosphatemia indication followed by the IDA indication
in November 2017.
https://seekingalpha.com/news/3505969-akebia-sues-feds-dropped-auryxia-coverageReata looks to outsmart Abbvie again
Fresh
from buying omaveloxolone and bardoxolone rights back from Abbvie,
Reata sees the first part of the puzzle fall into place.
Note to Abbvie management: the next time a biotech partner offers you
$330m out of the blue to buy back rights to some minor shared assets,
consider that it might be on to something.
Yesterday’s unexpectedly positive readout for Reata’s omaveloxolone in Moxie, a Friedreich’s ataxia study, came just four days after the biotech had struck a deal to reacquire the project from Abbvie. While it might seem inconceivable that the junior partner did not have at least some inkling that the study was about to read out positively, Reata today denied that this was the case.
“Neither Abbvie nor us had access to the results” before last week’s deal was done, Reata’s chief executive, Warren Huff, told analysts on a call today. The question yet to be answered is whether $330m was money well spent; however smart the buyback might have been omaveloxolone alone might not justify it.
Stifel analysts reckon the global market for Friedreich’s ataxia, a notoriously hard indication to crack, is worth over $3bn, but sellside consensus collected by EvaluatePharma sees omaveloxolone revenue forecasts translating to only $27m of NPV.
The much bigger test of the buyback is bardoxolone, Reata’s lead, for which a phase III study in Alport syndrome, reading out by the end of 2019, is a crucial binary outcome. Reata this morning traded up 45%.
Surprise
This likely reflects the surprising nature of omaveloxolone’s Friedreich’s win in Moxie. The study’s first part had been a bust, but Reata seized on an activity signal in a secondary endpoint.
That endpoint was the modified Friedreich’s ataxia rating scale (mFARS), and Reata redesigned Moxie to increase its chances of success: mFARS replaced peak work during maximal exercise as the primary endpoint, the treatment period was increased from 12 to 48 weeks, and only the 80% of the subjects without pes cavus entered into the primary analysis.
Pes cavus is a foot deformity that occurs in some Friedreich’s patients, and was blamed for the failure in Moxie’s first part. Part two hit on mFARS in the 82 subjects without pes cavus and – perhaps surprisingly – in the 103 all-comers too.
Two obvious questions are whether omaveloxolone’s potential label could be limited to subjects without pes cavus, and whether mFARS is an approvable metric. On an analyst call today Reata stated that the FDA had indicated in writing that mFARS was an “approval primary endpoint” in Friedreich’s, but that the breadth of any approval would be up to the agency.
Omaveloxolone’s safety profile will also raise questions, especially its effect on elevating the liver enzymes alanine transaminase and aspartate transaminase. Reata argues that increases in aminotransferases are a pharmacological effect of omaveloxolone, and that the elevations in Moxie were not associated with liver injury.
Abbvie had licensed bardoxolone and omaveloxolone for a remarkable
$850m up front, but in 2012 the former bombed in chronic kidney disease
after a heart failure signal. Reata then seemed to outfox its partner by
repositioning bardoxolone for rare forms of kidney disease, thanks
partly to money Abbvie had irreversibly pledged.
The big pharma group held data and rights to opt back in, but likely saw $330m as a way to recoup from Reata some of its sunk cost, given that the rare diseases where the two assets now held promise were of little interest to it. Whether Abbvie might have decided differently had it seen the Moxie data will remain a mystery.
https://www.evaluate.com/vantage/articles/news/trial-results/reata-looks-outsmart-abbvie-again
Yesterday’s unexpectedly positive readout for Reata’s omaveloxolone in Moxie, a Friedreich’s ataxia study, came just four days after the biotech had struck a deal to reacquire the project from Abbvie. While it might seem inconceivable that the junior partner did not have at least some inkling that the study was about to read out positively, Reata today denied that this was the case.
“Neither Abbvie nor us had access to the results” before last week’s deal was done, Reata’s chief executive, Warren Huff, told analysts on a call today. The question yet to be answered is whether $330m was money well spent; however smart the buyback might have been omaveloxolone alone might not justify it.
Stifel analysts reckon the global market for Friedreich’s ataxia, a notoriously hard indication to crack, is worth over $3bn, but sellside consensus collected by EvaluatePharma sees omaveloxolone revenue forecasts translating to only $27m of NPV.
The much bigger test of the buyback is bardoxolone, Reata’s lead, for which a phase III study in Alport syndrome, reading out by the end of 2019, is a crucial binary outcome. Reata this morning traded up 45%.
Surprise
This likely reflects the surprising nature of omaveloxolone’s Friedreich’s win in Moxie. The study’s first part had been a bust, but Reata seized on an activity signal in a secondary endpoint.
That endpoint was the modified Friedreich’s ataxia rating scale (mFARS), and Reata redesigned Moxie to increase its chances of success: mFARS replaced peak work during maximal exercise as the primary endpoint, the treatment period was increased from 12 to 48 weeks, and only the 80% of the subjects without pes cavus entered into the primary analysis.
Pes cavus is a foot deformity that occurs in some Friedreich’s patients, and was blamed for the failure in Moxie’s first part. Part two hit on mFARS in the 82 subjects without pes cavus and – perhaps surprisingly – in the 103 all-comers too.
Two obvious questions are whether omaveloxolone’s potential label could be limited to subjects without pes cavus, and whether mFARS is an approvable metric. On an analyst call today Reata stated that the FDA had indicated in writing that mFARS was an “approval primary endpoint” in Friedreich’s, but that the breadth of any approval would be up to the agency.
Omaveloxolone’s safety profile will also raise questions, especially its effect on elevating the liver enzymes alanine transaminase and aspartate transaminase. Reata argues that increases in aminotransferases are a pharmacological effect of omaveloxolone, and that the elevations in Moxie were not associated with liver injury.
| Summary of Reata’s Moxie trial (NCT02255435) | ||
|---|---|---|
| Omaveloxolone 150mg/day | Placebo | |
| Subjects without pes cavus (n) | 40 | 42 |
| PRIMARY: 48wk mFARS* | 2.40-point net improvement (p=0.014) | |
| SECONDARY: PGIC** improvement | No benefit (p=0.125) | |
| SECONDARY: change in peak workload during exercise | No meaningful improvement | |
| All-comers (n) | 51 | 52 |
| SECONDARY: 48wk mFARS* | 1.93-point net improvement (p=0.034) | |
| SECONDARY: PGIC** improvement | Favoured omaveloxolone (p=0.028) | |
| Safety analysis (n) | 51 | 52 |
| ALT increases | 19 (37%) | 1 (2%) |
| AST increases | 11 (22%) | 1 (2%) |
| Discontinuation due to AE | 4 (8%) | 2 (4%) |
| *Friedreich’s ataxia scale, vs baseline; higher is worse; **patient global impression of change. | ||
The big pharma group held data and rights to opt back in, but likely saw $330m as a way to recoup from Reata some of its sunk cost, given that the rare diseases where the two assets now held promise were of little interest to it. Whether Abbvie might have decided differently had it seen the Moxie data will remain a mystery.
https://www.evaluate.com/vantage/articles/news/trial-results/reata-looks-outsmart-abbvie-again
Progyny Inc. Sets IPO at 10 Million Shares; Sees Pricing at $14-$16
Progyny Inc., a benefits-management company backed by private-equity
firm TPG Inc., on Tuesday said it expects to sell 6.7 million shares at
$14 to $16 apiece in its initial public offering.
At the $15 midpoint of that range, the New York company focused on fertility and family-building benefits said it expects net proceeds of about $91 million.
Certain shareholders, including Germany’s Merck KGaA (MRK.XE), are selling another 3.3 million shares in the IPO, for a total offering of 10 million shares, Progyny said.
Progyny will have about 82.2 million shares outstanding after the IPO, according to a filing with the Securities and Exchange Commission, for a market capitalization of roughly $1.23 billion at the $15-a-share midpoint.
TPG, which isn’t selling any shares, will own about 25% of Progyny after the offering.
https://www.marketscreener.com/MERCK-KGAA-436395/news/Merck-Progyny-Inc-Sets-IPO-at-10-Million-Shares-Sees-Pricing-at-14-16-Each-29378916/
At the $15 midpoint of that range, the New York company focused on fertility and family-building benefits said it expects net proceeds of about $91 million.
Certain shareholders, including Germany’s Merck KGaA (MRK.XE), are selling another 3.3 million shares in the IPO, for a total offering of 10 million shares, Progyny said.
Progyny will have about 82.2 million shares outstanding after the IPO, according to a filing with the Securities and Exchange Commission, for a market capitalization of roughly $1.23 billion at the $15-a-share midpoint.
TPG, which isn’t selling any shares, will own about 25% of Progyny after the offering.
https://www.marketscreener.com/MERCK-KGAA-436395/news/Merck-Progyny-Inc-Sets-IPO-at-10-Million-Shares-Sees-Pricing-at-14-16-Each-29378916/
Insurers Rise With UnitedHealth Earnings Beat
Shares of managed-care companies rose after UnitedHealth Group posted better-than-expected third-quarter results and raised its profit guidance.
Anthem shares rose 6.9%, and those of Cigna rose 6%. Humana posted a 5% gain, while Centene shares rose 4.3%.
UnitedHealth posted sales of $60.35 billion for the third quarter, up 6.71% from the comparable quarter a year ago and beating the $59.76 billion analysts polled by FactSet had expected.
The Minnesota-based company’s earnings rose to $3.67 a share, up 13% from the comparable period last year. Analysts were expecting $3.55 a share.
The company said it expects profit for the full year to be between $14.15 a share and $14.25 a share, compared with its previous forecast of $13.95 a share to $14.15 a share.
https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/Insurers-Rise-With-UnitedHealth-Earnings-Beat-29379010/
Anthem shares rose 6.9%, and those of Cigna rose 6%. Humana posted a 5% gain, while Centene shares rose 4.3%.
UnitedHealth posted sales of $60.35 billion for the third quarter, up 6.71% from the comparable quarter a year ago and beating the $59.76 billion analysts polled by FactSet had expected.
The Minnesota-based company’s earnings rose to $3.67 a share, up 13% from the comparable period last year. Analysts were expecting $3.55 a share.
The company said it expects profit for the full year to be between $14.15 a share and $14.25 a share, compared with its previous forecast of $13.95 a share to $14.15 a share.
https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/Insurers-Rise-With-UnitedHealth-Earnings-Beat-29379010/
UnitedHealth Raises Profit Targets on Higher Sales
UnitedHealth Group Inc. boosted its profit guidance for the year as
revenue growth from its network of health services, premiums and
health-care plan membership fueled the company’s third-quarter
performance.
The company projects its 2019 per-share earnings to be between $14.15 and $14.25, compared with its previous forecast of $13.95 to $14.15. UnitedHealth said it expects adjusted per-share earnings to come in between $14.90 and $15 a share, compared with earlier projections of $14.70 a share to $14.90 a share.
The parent of the nation’s largest health insurer posted sales of $60.35 billion for the third quarter, up 6.71% from the comparable quarter a year ago and beating the $59.76 billion analysts polled by FactSet had expected.
Sales for the Optum health-services business grew 13.39% to $28.8 billion compared with the year-ago period. Sales for the UnitedHealthcare health-benefits platform grew 4.79% to $48.1 billion during the quarter as commercial and Medicare Advantage membership grew, UnitedHealth said.
Overall, earnings rose to $3.67 a share, up 13.3% from the comparable period last year. Analysts were expecting $3.55 a share.
UnitedHealth reported an adjusted profit of $3.88 a share, topping analysts’ estimates of $3.75 a share.
https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/UnitedHealth-Raises-Profit-Targets-on-Higher-Sales-29376653/?countview=0
The company projects its 2019 per-share earnings to be between $14.15 and $14.25, compared with its previous forecast of $13.95 to $14.15. UnitedHealth said it expects adjusted per-share earnings to come in between $14.90 and $15 a share, compared with earlier projections of $14.70 a share to $14.90 a share.
The parent of the nation’s largest health insurer posted sales of $60.35 billion for the third quarter, up 6.71% from the comparable quarter a year ago and beating the $59.76 billion analysts polled by FactSet had expected.
Sales for the Optum health-services business grew 13.39% to $28.8 billion compared with the year-ago period. Sales for the UnitedHealthcare health-benefits platform grew 4.79% to $48.1 billion during the quarter as commercial and Medicare Advantage membership grew, UnitedHealth said.
Overall, earnings rose to $3.67 a share, up 13.3% from the comparable period last year. Analysts were expecting $3.55 a share.
UnitedHealth reported an adjusted profit of $3.88 a share, topping analysts’ estimates of $3.75 a share.
https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/UnitedHealth-Raises-Profit-Targets-on-Higher-Sales-29376653/?countview=0
Abeona up 25% on positive long-term data on RDEB cell therapy
Abeona Therapeutics (ABEO +25.3%) is up on modestly higher volume on the heels of long-term results
from a Phase 1/2a clinical trial evaluating autologous gene-corrected
cell therapy EB-101 in patients with a rare inherited skin blistering
disorder called recessive dystrophic epidermolysis bullosa (RDEB).
Three years after treatment with EB-101, the
majority of patients experienced sustained wound healing, with 80%
(n=16/20) achieving at least 50% healing and 70% (n=14/20) achieving at
least 75% healing, superior to the 17% of untreated patients who
experienced at least 50% healing at year 2 (year 3 results not
provided).
50% or greater wound healing was associated with
no pain (n=0/16) or itch (n=0/16) three years after treatment compared
to 53% (n=20/38) and 61% (n=23/38), respectively, at baseline.
No new safety signals were observed and no replication competent virus was present at any time point.
A Phase 3 trial, VIITAL, is next up.
https://seekingalpha.com/news/3505838-abeona-25-percent-positive-long-term-data-rdeb-cell-therapy
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