Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Pure, unadulterated speculation... Siklos (hydroxyurea)

Hydroxyurea is an antimetabolite that is effective and FDA-approved for treatment of many conditions, including acute myeloid leukemia (cytoreduction), chronic myeloid leukemia, essential thrombocythemia (high-risk), head and neck cancer, hypereosinophilic syndrome (refractory), meningioma, polycythemia vera (high-risk), and sickle cell disease. It is sometimes used off-label for psoriasis. Brand name Droxia is supplied as 200mg, 300mg, and 400mg capsules. Brand name Hydrea is supplied as 500mg capsules. Most prescriptions are for the only generic form, which is a 500mg capsule. All forms, especially generic, have long been prescribed for sickle cell disease (SCD), although neither Droxia or Hydrea ever had SCD listed as an indication on the FDA-approved drug label. In 2017, Siklos (dissolving hydroxyurea tablet) was approved for pediatric SCD, and later it was also approved for adult SCD. Siklos was originally approved with pediatric exclusivity that ends 12/21/24, per the Orange Book. A supply of generic hydroxyurea 500mg capsule (2 per day) would cost ~$20/month, while brand name Siklos retails at $1900/month. All forms of hydroxyurea have two black box warnings on the label for bone marrow suppression and secondary malignancy, and there are a plethora of other potential, serious complications. Nasty stuff, always must be handled with impermeable gloves.

There seems to be at least one major advantage of the tablet over the capsule:

Administration: Adult
Oral: Administer at the same time each day.

Capsules (Droxia, Hydrea): Swallow whole; the manufacturer does not recommend opening, breaking, or chewing the capsules. For patients unable to swallow capsules, an oral solution may be prepared.

Tablets (Siklos): Administer with water. If unable to swallow tablets whole, may disperse immediately before use in a small amount of water in a teaspoon (add tablet to spoon, add water; tablet dissolves in ~1 minute; administer immediately); drink an additional glass of water after administering the dose. The 100 mg tablets are scored with 1 line to enable splitting into 2 parts and the 1,000 mg tablets are scored with 3 lines to enable splitting into 4 parts; wear gloves and use a damp paper towel surface to break scored tablets (properly dispose of used gloves and paper towel).

I don't have access to any IQVIA sales data, but one should take caution when considering the annual sales of brand name Siklos. First, Siklos is only FDA-approved for pediatric and adult SCD, not all the other stuff. Second, Siklos tablets costs literally 100X generic hydroxyurea capsules, with only minimal advantage. If cost-competitive, a generic tablet would immediately compete with all of the generic capsules for every hydroxyurea indication, not just SCD. I believe a generic dissolving tablet could potentially become the dominant form, but cost will always beat convenience at the pharmacy, so pricing will determine its acceptance and use. The first company to file an ANDA application for generic Siklos will receive six months of generic exclusivity for the tablet form.

And please don't forget, this is pure speculation based on scant clues, for entertainment purposes only. Enjoy.

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