Shionogi Partnering

Partnering

At Shionogi, innovation starts in our labs. Shionogi colleagues are also part of a creative matrix connecting our in-house scientific knowledge with the expertise of strategic partners at leading academic centers, pharmaceutical companies and biotechs. Business development and alliance management are core competencies for Shionogi.

Tailoring Strategic Partnerships

We often consider forming strategic alliances as we believe that partnerships can further our goal of delivering life-saving therapies to patients. We have a history of creatively designed collaborations that are tailored to the particular circumstances of the drugs involved. These alliances take several forms—research collaborations with institutions featuring overlapping interests and strong technology, early-stage licensing of Shionogi-discovered programs that do not fit our strategy or require scientific expertise we do not possess, development partnerships and commercial partnerships.

We also recognize that no company has a monopoly on innovation. In addition to drug candidates originating from our research labs, we continuously search for development programs at universities and other companies whose compounds have strong therapeutic potential and might be better developed and commercialized by Shionogi Inc. In all cases, our partnering efforts are driven by our determination to bring safe and innovative therapies to patients with serious unmet medical needs as quickly as possible.

Our Partners

Duchesnay

Moderate to severe dyspareunia is a symptom of vulvar and vaginal atrophy related to menopause. OSPHENA® (ospemifene), an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, acts like an estrogen on vaginal tissues to make them thicker and less fragile, to help improve the condition of these tissues and help relieve pain associated with intercourse.

Duchesnay is a company solely focused on women’s health therapeutics, and it became Shionogi’s exclusive licensee for OSPHENA in the U.S. and Canada in March 2017. Duchesnay exclusively promotes OSPHENA in the U.S. and will be solely responsible for all development, regulatory and commercial activities in Canada. For an interim defined period, Shionogi will supply the product to Duchesnay as well as perform certain other functions such as distribution in the U.S., clinical trial management, regulatory services and providing market access support.

Roche

Epidemic and pandemic influenza is a major public health concern, and novel influenza drugs that will offer significant improvement over current therapy are urgently needed. Worldwide, annual influenza epidemics are estimated to result in 3 to 5 million cases of severe illness and 250,000 to 500,000 deaths.1

Shionogi’s baloxavir marboxil (S-033188) has a mechanism of action, cap-dependent endonuclease inhibition, and is being studied to treat influenza using a single one-time oral dosing regimen. Development and commercialization of S-033188 are in collaboration with F. Hoffmann-La Roche Ltd.

Shionogi entered a commercialization agreement in which Roche, which has previous successful experience developing and commercializing treatments for influenza, is co-developing S-033188 and may commercialize it worldwide (excluding Japan and Taiwan). Shionogi maintains certain co-promotion rights in the U.S. and will receive royalties from Roche on S-033188 sales if it is successful in gaining regulatory approvals.

ViiV

There is no cure for HIV, but effective treatment can control the virus so that people with HIV can live healthy and productive lives. ViiV Healthcare Ltd., a company exclusively dedicated to HIV, and Shionogi have partnered to advance treatment and care for people living with HIV through development of integrase inhibitors discovered by Shionogi. Today ViiV commercializes three products that contain dolutegravir and is developing cabotegravir, an ultra-long-acting integrase inhibitor.

The relationship, which includes GSK and Pfizer, aligns with the shared goal of advancing the integrase inhibitor portfolio while streamlining the development process in order to ensure that people living with HIV have access to treatments more quickly. For Shionogi, the relationship offers the value of a royalty stream augmented by dividends through its equity share of ViiV while releasing financial, operational and R&D resources to support its other pipeline products in global development.