Takeda Continues To Shed Pipeline Assets In Roivant Deal
This article was originally published in PharmAsia News
Executive Summary
Takeda has set up a new company with Roivant to expedite the development of relugolix, an oral GnRH antagonist, for indications including prostate cancer and endometriosis.
In a move that marks a continued shedding of selected non-core assets, Takeda Pharmaceutical Co. Ltd. has set up with partner Roivant Sciences Ltd. a new company to develop a late clinical stage molecule that has shown potential in both oncology and women's health indications.
Myovant Sciences has been established based on the granting to it of an exclusive worldwide license - excluding commercial rights in Japan and certain Asian countries - to the Japanese firm's relugolix (TAK-385). The founding partners claim the once-daily oral gonadotropin-releasing hormone (GnRH) receptor antagonist has best-in-class potential, given promising Phase II results and convenience benefits over existing injected therapies in the GnRH sector. [See Deal]
Industry endocrinology veteran Dr. Lynn Seely has been tapped to head the new venture, bringing more than two decades of drug development experience with her.
While no ownership split or financial terms were disclosed by either side, Myovant will progress relugolix through ex-Asia global Phase III development for endometriosis, uterine fibroids and hormone-sensitive prostate cancer (HSPC).
The drug has already been evaluated in around 1,300 patients across these various indications in Phase II, showing clinical benefit, and Takeda has begun enrolment in two Japanese Phase III trials for uterine fibroids, which it will continue to progress.
The new partnership is designed to allow the development of what is a promising but non-core asset, while tapping into relevant expertise and development capabilities and Takeda's commercial presence in Asia, Takeda's chief medical and scientific officer Dr. Andrew Plump said in a statement.
Also transferred to Myovant as part of the deal are exclusive worldwide rights to another Takeda pipeline asset, TAK-602 (RVT-602), for female infertility.
Promising Data
GnRH inhibition reduces levels of the sex hormones estrogen in women and testosterone in men, in turn cutting circulating quantities of luteinizing hormone and follicle-stimulating hormone. In men with HSPC, this also leads to reduced prostate-specific antigen (PSA), a key marker of the disease.
Myovant notes that the other benefits of oral GnRH antagonist administration include prevention of transient increases (flares) in gonadotropins secretion, and rapid onset and offset of endocrine effects.
A 216-patient study for uterine fibroids - benign growths affecting 10-15% of reproductive age women - demonstrated significant reduction in menorrhagia (severe menstrual bleeding). A trial in 487 patients with endometriosis - characterized by growth of uterine lining cells outside the uterus - also showed a significant lowering of menstrual and non-menstrual pelvic pain.
In HSPC, for which relugolix is a possible first-in-class oral GnRH therapy, two Phase II studies in a total of 225 men showed suppression of serum testosterone to castrate levels, along with decreased PSA counts, the firms said.
As for RVT-602, as an oligopeptide kisspeptin receptor agonist it activates the hypothalamus KISS1 (GPR54) receptor to stimulate the endogenous release of GnRH and related downstream hormones including leuteinizing hormone. In infertility treatment, the molecule has the potential to be an alternative to human chorionic gonadotropin or GnRH agonists as a trigger for egg maturation during in vitro fertilization procedures.
Expertise, Strategy
New Myovant president and CEO Seely was chief medical officer for 10 years to 2015 at Medivation Inc., the US-based prostate cancer specialist currently the target of a $9.3bn acquisition offer from Sanofi. She is currently a director at Blueprint Medicines Corp.
Seely led the development of Medivation's prostate cancer drug Xtandi (enzalutamide) and helped build the clinical organization at the firm, along with regulatory, manufacturing and other functions.
Given Myovant's early stage of development, it looks highly likely that subsequent licensing deals with a commercial partner will be pursued for relugolix outside Takeda's territories.
For its part, privately held Roivant, based in Hamilton, Bermuda, has a strategy to acquire projects or companies with assets in its main areas of therapeutic focus, which include neurology, hepatology, oncology, pulmonary and rare diseases.
The firm says it looks for "unique, late-stage drug candidates with accelerated regulatory pipelines or potential that may be under-appreciated," and the new Myovant venture therefore seems a good fit for this modus operandi.
Another Japanese firm, Eisai Co. Ltd., recently reached a deal to divest its transdermal phosphodiesterase 4 (PDE4) inhibitor E6005 to Roivant, in a move to completely exit the dermatology area (Also see "Eisai Exits Dermatology Through Roivant Deal" - Scrip, 24 Nov, 2015.).
Roivant is already developing through its New York-listed Axovant Sciences Ltd. subsidiary a candidate for dementia, RVT-101, an oral 5HT6 receptor antagonist now moving into Phase III for Alzheimer's disease in combination with donepezil (Eisai's now genericized Aricept).
Roivant's main investors are QVT Financial and Dexcel Pharma, and it also has a "significant investment" in hepatitis B venture Arbutus Biopharma Corp. (formerly Tekmira Pharm).
Takeda has taken a series of small and major steps over the past few years to concentrate in-house effort on its main therapeutic areas of oncology, gastroenterology and CNS, notably including a Japanese alliance for a portfolio of mature products (Also see "Takeda Lays Out Teva JV Impact, Confirms Blopress Transfer" - Scrip, 28 Dec, 2015.).
In March, Takeda licensed TAK-233, a non-core pipeline urology molecule, to Outpost Medicine, a US-based start-up co-founded by its former top R&D executive (Also see "Takeda Moves Incontinence Candidate To New Venture" - Scrip, 16 Mar, 2016.).