bUrRpPPP!
5 년 전
California dermatology biotech Dermira will take on exclusive worldwide rights to IL-13 monoclonal antibody lebrikizumab from Roche, although the Big Pharma holds on to its rights for the med in certain indications.
The complex deal could be worth more than $1 billion in biobucks: Drilling down into the numbers, Dermira will make a first payment of $80 million to Roche, with future payments worth $55 million coming next year.
But that’s not all, as Dermira will also need to cough up extra payments if the med hits certain milestones, made up of $40 million when Dermira’s first phase 3 clinical study is started, and up to $210 million when it hits regulatory and first commercial sale milestones “in certain territories."
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And then there’s the big number: $1.025 billion, based on the “achievement of certain thresholds for net sales of lebrikizumab,” in indications other than interstitial lung disease, which Roche will be hanging on to.
And should it gain approval, Dermira will also be making royalty payments “representing percentages of net sales that range from the high single-digits to the high teens.”
This comes after a mixed bag of data for the med, as last February, Roche suffered a setback when it posted one win and one loss for identical phase 3 studies for lebrikizumab in asthma patients.
The side-by-side studies were designed to give Roche a solid foundation of data for the approval and marketing of the anti-inflammatory drug for a clearly defined patient population.
But while Lavolta I hit its primary endpoint on significantly cutting the rate of asthma exacerbations among patients selected on two key biomarkers for airway inflammation, levels of serum periostin or blood eosinophils, Lavolta II missed the exact same measure of efficacy.
Ironically, Dermira, which got off a $125 million IPO in 2014 and now has a market cap north of $1 billion, has seen a similar situation with its experimental sweat drug DRM04, which last summer passed one Phase 3 test, but narrowly missed its target on a second late-stage trial, although analysts believed this would still be good enough to gain an FDA approval.
bUrRpPPP!
5 년 전
Derm design phase 2 study is a joke...patients were required to use TCS twice daily ...OBJECTIVE:
We investigated the efficacy and safety of lebrikizumab, an IL-13 monoclonal antibody, as an add-on to topical corticosteroid (TCS) treatment
https://www.ncbi.nlm.nih.gov/pubmed/29353026
METHODS:
A randomized, placebo-controlled, double-blind, phase 2 study. Adults with moderate-to-severe AD were required to use TCS twice daily and then randomized (1:1:1:1) to lebrikizumab 125 mg single dose, lebrikizumab 250 mg single dose, lebrikizumab 125 mg every 4 weeks for 12 weeks, or placebo every 4 weeks for 12 weeks, after a 2-week TCS run-in. The primary endpoint was percentage of patients achieving Eczema Area and Severity Index (EASI)-50 at week 12.
RESULTS:
In total, 209 patients received the study drug. At week 12, significantly more patients achieved EASI-50 with lebrikizumab 125 mg every 4 weeks (82.4%; P = .026) than placebo every 4 weeks (62.3%); [/]patients receiving a single dose of lebrikizumab showed no statistically significant improvements in EASI-50 compared with placebo. Adverse events were similar between groups (66.7% all lebrikizumab vs 66.0% placebo) and mostly mild or moderate.
LIMITATIONS:
Protocol-mandated twice daily TCS treatment limits our understanding of the efficacy of lebrikizumab as a monotherapy. The short study duration did not enable long-term efficacy or safety evaluations.
CONCLUSION:
When combined with TCS, lebrikizumab 125 mg taken every 4 weeks led to a significant improvement and was well tolerated in patients with moderate-to-severe AD.
bUrRpPPP!
5 년 전
Analyst Irina Koffler also lowered her price target for the Menlo Park, California-based company to $14 from $17 a share. She said in a note to investors that she expects the Spanish pharmaceutical company Almirall to exercise its European rights to lebrikizumab, a treatment of moderate-to-severe atopic dermatitis.
Koffler said she attributes a 40% share selloff of the company's stock since April to financing uncertainty and the "lackluster" performance of the prescription anticholinergi Qbrexza.
"We believe Dermira could be strategically attractive to dermatology-focused companies," Koffler wrote. "We believe there could be significant cost synergies associated with cutting Qbrexza SG&A (Selling, General and Administrative Expenses)."
Koffler said that "the chief risk to our thesis is that Almirall walks away from EU rights."
"If Almirall abandons the deal, it may discourage other strategic interest in lebrikizumab as well," she wrote. "In this case, it's possible that Dermira would need to develop lebrikizumab on its own and pursue multiple financing rounds in the future against a limited catalyst calendar over the next three years while we await lebrikizumab approval and launch. Based on the pending Dermavant IPO focused on a Phase III psoriasis biologic, we believe the category is still attractive to investors and strategics and we view this scenario as unlikely."
crudeoil24
6 년 전
Dermira's Qbrexza For Treatment Of Excessive Underarm Sweating Gets FDA Approval -- MarketWatch
7:10 am ET June 29, 2018 (MarketWatch)
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Dermira Inc. (DERM) said Friday its Qbrexza cloth for topical treatment of primary axillary hyperhidrosis, or excessive underarm sweating, was approved by the Food and Drug Administration. Qbrexza is indicated for adult and pediatric patients nine years of age and older. The biopharmaceutical company said the cause of primary axillary hyperhidrosis is unknown, but affects nearly 10 million people in the U.S. The company expects Qbrexza to be available nationwide in pharmacies beginning in October 2018. The stock is currently halted for news until 7:30 a.m. ET. It has tumbled 68% year to date through Thursday, while the iShares Nasdaq Biotechnology ETF (IBB) has gained 1.1% and the S&P 500 has edged up 1.6%.
-Tomi Kilgore
For more from MarketWatch: http://www.marketwatch.com/newsviewer
(END) Dow Jones Newswires
June 29, 2018 07:10 ET (11:10 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.