Welcome to your weekly digest of approaching regulatory and clinical read outs.
The May CHMP meeting is taking place next week and the European decision on subcutaneous Herceptin is expected at either this meeting or the next. The new formulation of the drug proved comparable to intravenous Herceptin in phase III and could offer improved dosing convenience to patients.
Elsewhere, the PDUFA for Depomed’s Sefelsa is expected on May 31, but given the negative advisory committee vote two months ago the prospects of approval are low. The Californian company will have to look to its pipeline for revenue, but with its lead product Gralise reporting lower than expected Q1 sales, as well as the risk of generics, this may be an uphill battle.
Committee for Medicinal Products for Human Use meeting May 27-30:
Roche/Halozyme Therapeutics: Herceptin SC
Subcutaneous (SC) Herceptin is said to offer a more convenient route of administration for patients as it is less invasive and much quicker – 5 minutes versus 30-90 minutes for intravenous (IV) Herceptin. It also has a cost saving potential by reducing the time a patient needs to stay in hospital.
At the European Breast Cancer Congress in March last year Roche reported positive phase III results from the HannaH trial testing SC Herceptin, which uses Halozyme’s Enhanze delivery platform, versus IV Herceptin. 596 patients with operable or locally advanced early breast cancer were given Herceptin before and after surgical intervention, with treatment duration of one year.
The trial resulted in blood concentrations of the drug at 69.0µg/mL and 51.8µg/mL with SC and IV formulations, respectively. Complete response rates were 45.4% and 40.7% for SC and IV, respectively. The safety profile for SC Herceptin was similar to that of its IV cousin.
Two further studies are ongoing: one, called PrefHer, evaluating patient preference for SC versus IV administration, and another, SafeHer, investigating the safety of assisted and self-administered SC Herceptin that uses a single-use injection device.
According to Jefferies analysts, commercial launch of Herceptin SC in the EU will be likely by the end of the year. Intravenous Herceptin sold $6.3bn worldwide last year, with a similar sales forecast in 2018 according to EvaluatePharma. With the introduction of Herceptin biosimilars possible in 2014, uptake of SC over IV could help Roche maintain market share.
US approval of Sefelsa, the treatment for vasomotor symptoms due to menopause – hot flashes – is looking highly unlikely. At the advisory committee in March the panel voted 2-12 against approval citing the lack of significant benefit compared with placebo and the short duration of effect. There were also concerns regarding the effect on cognitive function, dizziness and disorientation. Upon the news Depomed’s shares dropped nearly 10%, wiping $36m off its market cap.
The drug formerly known as Serada, and generically as gabapentin, has had a chequered past, with two previous trial failures behind it (Depomed blames placebo effect for plunge from glory, October 13, 2009). In October 2011 Depomed's shares fell 21% when the drug was also unsuccessful in meeting one of its four primary objectives in a phase III trial called Breeze 3, failing to significantly reduce the frequency of hot flashes at 12 weeks. It also fell short on both secondary measures of frequency and severity at 24 weeks, the full treatment duration of the study (Depomed flashes to new low after Serada setback, October 14, 2011).
Analysts are not showing faith, and have removed Serada from their financial models, with most now concentrating on the Californian company's other gabapentin-based drug Gralise, which is on the market for post-herpetic neuralgia. This key growth driver is forecast to reach 2018 sales of $168m according to EvaluatePharma.
However, in Q1 the company reported lower than expected Gralise revenues of $6.1m, compared with Roth Capital Partners' target of $7m – though the analysts note prescriptions are moving in the right direction and the recent price increase points to an improving situation.
Despite Gralise's patent protection to 2024, according to EvaluatePharma, there is active litigation against three ANDA filers, with Zacks Investment Research naming Actavis as the first to file. The Markman hearing, part of the generic approval process, is scheduled for June, and Depomed needs to stem the threat from generics.
American Society of Clinical Oncology annual meeting May 31 – June 4:
This year’s Asco meeting is taking place in Chicago, Illinois. Featured prominently will be the anti-PD-1/PD-L1 antibodies from Bristol-Myers Squibb, Roche and Merck (Asco preview: Bristol’s PD-1 combo seizes the early limelight, May 16, 2013). Gilead will report on its P13K inhibitor idelalisib (GS 1101) and Boehringer on nintedanib (Vargatef) (Asco preview – Boehringer turns failure into a debatable win, May 20, 2013).
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All information is sourced to analyst notes and the EvaluatePharma Calendar of Events tool.
Please note EP Vantage will be closed on May 27 for the bank holiday.