Upcoming events – Migraine data for Amgen while Neurocrine looks to Tourette’s

Upcoming events – Migraine data for Amgen while Neurocrine looks to Tourette’s

Source EP Vantage
Company AmgenNeurocrine Biosciences 
Tags Analysis, Central Nervous System, Phase II, Phase III, Monoclonal Antibody, Free Content, Event - Open
Date September 09, 2016


Welcome to your weekly digest of approaching regulatory and clinical readouts. Phase III data are expected in the fourth quarter for Amgen ’s CGRP -targeting antibody erenumab  in episodic migraine, and with a marginally positive result already accomplished in the chronic form of the disease,  Amgen  needs to move fast to stay ahead of the competition.

And Neurocrine is expecting readouts from phase II trials of valbenazine  in Tourette’s syndrome. While this would add another string to  valbenazine ’s bow the main focus remains on its use in tardive  dyskinesia , where the big forecasts lie, and which could determine whether a partner will hop aboard.

Migraine

Amgen ’s erenumab , also known as AMG 334 , is in two phase III episodic migraine trials called Strive and Arise in 955 and 577 patients, respectively . Patients have four to 15 migraine days per month and fewer than 15 headache days per month.

Strive is testing once-monthly 70mg and 140mg subcutaneous erenumab  doses versus placebo. The Arise trial is again placebo controlled, but tests one dose of  erenumab  followed by an open-label phase. The primary outcome for both trials is change in mean monthly migraine days. Secondary measures include the proportion of subjects with at least 50% reduction from baseline in monthly migraine days.

Phase II results in the chronic form showed a small benefit, with the project cutting the number of monthly migraine days to about 11.4, just 2.4 days better than placebo. A high placebo response is not unusual in migraine trials, and Amgen  and its ex-US partner  Novartis  said the results were statistically significant, but at the time did not reveal the level of significance.

Although cross-study comparisons cannot really be relied on, a similar benefit has been reported from competitors AlderTeva  and Lilly  (Marginal migraine benefit puts Amgen and Novartis in pole position, 9 June, 2016).

Further data will be presented at the European Headache and Migraine Trust International Congress in Glasgow, UK, on September 15-18. The company has previously said it would file all the available chronic and episodic data in one package.

2022 worldwide sales of erenumab  are forecast to reach $475m, according to sellside consensus from  EvaluatePharma. With analysts pegging Teva ’s CGRP  inhibitor to be the big seller by 2022  Amgen  needs to play on its first-mover advantage.

CGRP  inhibitors in phase III development 
Project  Company  Approval expected  2022e sales ($m) 
TEV-48125   Teva   2018  1,069 
ALD403   Alder  Biopharmaceuticals   2018  993 
Galcanezumab   Eli Lilly   2017  484 
Erenumab /AMG  334  Amgen /Novartis  2017  475 

Tourette’s

Neurocrine’s valbenazine tosylate , previously called NBI-98854 , is now branded Ingrezza. Two phase II placebo-controlled trials, T-Forward and T-Force Green, are under way respectively  in adults and children with Tourette’s syndrome.

The studies are recruiting up to 90 subjects each, and data are expected before the end of the year. Two doses, given once daily for six weeks in the paediatric trial or eight weeks in the adult study, are being tested versus placebo. The primary endpoint is the severity of tic symptoms assessed by a global scale.

An open-label study for those completing the two trials has also been launched. Ingrezza is a VMAT2  inhibitor also in phase III for  tardive  dyskinesia , its more valuable indication. It is solely owned by Neurocrine, and has some hefty forecasts attached to it with 2022 sales expected to reach $1.3bn, according to EvaluatePharmaconsensus.

74% of 2022 forecasts are assigned to its dyskinesia  indication, which was recently filed with the FDA. With a breakthrough therapy designation attached approval could come as early as the second quarter of next year, and potential buyers will be watching with interest.

Project  Study  Trial ID 
Erenumab   Strive
Arise 
NCT02456740
NCT02483585 
Ingrezza  Adult trial
Paediatric
Open-label 
NCT02581865
NCT02679079
NCT02879578 

 

Drug prices quietly rise as politicians pounce

Drug prices quietly rise as politicians pounce

Source EP Vantage
Company Valeant Pharmaceuticals International, Alembic Pharmaceuticals, Almirall, Apotex, Aspen Pharmacare, Aytu BioScience, Boehringer Ingelheim, Kaléo, Mylan, Romark Laboratories, Salix Pharmaceuticals, Taro Pharmaceutical Industries, TOLMAR 
Tags Analysis, Company Strategy, Patent, Fines & Regulatory Issues, Free Content, Data Story
Date October 27, 2016


After a year of anti-pharma rhetoric from US politicians, it might be assumed that the sector would want to lie low on price increases at least until after the presidential election. The evidence shows that such an assumption would be misplaced.

An analysis of drug prices shows that while pharma companies have been more reluctant to use monopoly power to push through huge increases in 2016, in more competitive markets the rises have been every bit the equal of 2015’s (see tables below). And despite its drubbing last year and promises to change its ways, Valeant is still a notable presence on this year’s list (After Turing, the industry’s biggest price gougers, September 23, 2015).

This finding means that the reintroduction of Auvi-Q  announced yesterday may not yield any additional relief for the severely allergic patients who need an  emergency  epinephrine  injector. Indeed,  Kaléo  has little incentive to come in much below the $300 per pack list price pledged for the  authorised Epipen generic announced in August by  Mylan , the biggest drug-pricing villain of 2016 (EpiPen’s new lease of life a Mylan windfall, March 2, 2016). 

Modest brands

These lists are taken from EvaluatePharma’s US pricing analysis, based on the federal government’s National Average Drug Acquisition Cost weekly survey of pharmacy level prescription drug costs. They are ranked on the biggest percentage change between the second quarters of 2015 and 2016.

It does not incorporate additional rebates over the NADAC price, nor include drugs administered in hospitals. However, it provides a snapshot of drugmakers’ pricing strategy over a recent 12-month period.

No generic availability 
Product  Company  FDA approval   Price increase* 
Cuprimine   Valeant   1970  +330% 
Leukeran   Aspen Pharmacare   1957  +95% 
Alinia   Romark Laboratories   2002  +87% 
Primsol   Aytu BioScience   2000  +69% 
Altabax   Almirall   2007  +58% 
*Pharmacy acquisition cost, Q2 2016 vs Q2 2015.  

A big change from the last time EP Vantage did this analysis is the magnitude of the biggest increase among the products with no generic competitors – just a 330% jump for chelating agent  Cuprimine  compared to 2015’s huge 928% for beta blocker Dutuprol. And instead of six with triple-digit increases, as in 2015,  Cuprimine  was the only one in 2016.

This suggests that the bad publicity and political pressure has yielded some moderation, at least in this space of older or off-patent branded drugs that have yet to see competition.

Cuprimine  is sold by Valeant, the speciality pharma embattled over its pricing and distribution practices. As he sought to reassure investors and the public about its strategy earlier this year, former chief executive J. Michael  Pearson  said “any future price increases will be more modest and in line with industry practices and managed-care contracts.”

 Generics available 
Product  Company  FDA approval   Price increase* 
Locoid   Valeant   1987  +786% 
Benzamycin   Valeant   1984  +679% 
Zegerid   Salix   2006  +620% 
Librax   Valeant   1961**  +478% 
Metrogel-Vaginal   Valeant   1992  +351% 
*Pharmacy acquisition cost, Q2 2016 vs Q2 2015. 
**Year launched 

That statement is belied by this analysis, which finds that six Valeant products appear in these analyses of the biggest price increases.

Competing to raise prices

One of those six, the skin cream cream Locoid , saw the single biggest increase. A product with a generic equivalent, Locoid  saw its price rise a staggering 786%. That was matched by an exactly identical percentage increase for  Taro ’s hydrocortisone butyrate , ie generic Locoid . A similar pattern was seen with Valeant’s Benzamycin  and  Tolmar ’s generic equivalent, erythromycin  and  benzoyl peroxide .

Generics 
Product  Company  FDA approval   Price increase 
Hydrocortisone Butyrate   Taro   2004  +786% 
Ofloxacin   Valeant 
Apotex  
2008
2007 
+747% 
Leflunomide   Emcure 
Apotex 
Alembic 
2005
2005
2011 
+706% 
Erythromycin  and  Benzoyl Peroxide   Tolmar   2004  +679% 
Naproxen   Boehringer Ingelheim   1994  +565% 
*Pharmacy acquisition cost, Q2 2016 vs Q2 2015.  

Counterintuitively, it was this more competitive area of branded products with generic equivalents where Valeant and its comrades were most successful in pushing through price increases. Cuprimine ’s 330% jump was exceeded by the top five price increases in both the category of branded drugs with generic competition and the category of generic drugs.

With this many triple-digit increases, it is no wonder that pharma has become such a lightning rod for criticism and that both major US presidential candidates agree on some policies to bring drug prices under control. Among major industry leaders, Allergan ’s Brent Saunders appears to be responsive to this criticism and has vowed to keep price increases to less than 10% a year.

Yet despite Mr Pearson ’s pledge, Valeant can still be seen pushing the public’s tolerance for fast-rising drug costs. If his successor, Joseph Papa, is intent on following words with deeds, at this time next year Valeant’s name will not be listed in this analysis.