Genentech Expands Xofluza® Access and Affordability for Upcoming Flu Season With Direct-to-Patient Launch

Genentech's new program will provide access to Xofluza through select pharmacies with a $50 cash pay option, 70 percent lower than the list price –

– Direct-to-patient program focuses on same day delivery in select U.S. markets and improves affordability for patients who are underinsured, uninsured or self-pay –

– This program addresses the significant public health impact that flu continues to have on society; the overall flu burden during the 2024-25 season was the most severe in seven years –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the company's first Direct-to-Patient (DTP) program. This program, which supports President Trump's goal to make medicines more affordable for American patients, applies to Xofluza ® (baloxavir marboxil), a single-dose oral antiviral medication used to treat the flu in patients ages five and up as well as those who have been exposed to the flu. This initiative will help reduce costs for people who don't have insurance, have limited coverage, or whose health plans don't cover Xofluza.

Genentech is collaborating with three pharmacies to offer the medication with a prescription: Alto Pharmacy Powered by Fuze Health, Amazon Pharmacy, and Mark Cuban Cost Plus Drug Company, PBC. Specific details include:

  • A new $50 cash pay option – 70 percent lower than the list price – is available to eligible patients via Alto Pharmacy and Cost Plus Drugs.
  • Same-day home delivery is available in select markets through Alto Pharmacy Powered by Fuze Health and Amazon Pharmacy.
  • For those who need it, home delivery via mail is also available nationwide through all three pharmacies for those who wish to use Xofluza as a prophylaxis treatment.

"This new approach will allow for convenient, same-day delivery of our vital flu treatment in select U.S. markets," said Ashley Magargee, chief executive officer of Genentech. "Expanding our distribution for Xofluza will allow us to reach more patients where they are increasingly interested in seeking their medicines."

Influenza remains a significant public health burden, and last year, the U.S. saw a return to a highly severe flu season impacting all age groups–children, adults and the elderly. According to the U.S. Centers for Disease Control and Prevention (CDC), the overall burden of influenza for the 2024-25 season was the most severe since the 2017-18 season with an estimated 47-82 million illnesses, 21-37 million medical visits, 610,000-1,300,000 hospitalizations and 27,000-130,000 deaths. Antivirals such as Xofluza are a vital line of defense to treat and help prevent serious illness from the flu.

Genentech has other programs available to make our medicines more affordable, including the Xofluza coupon, which has been enhanced this season. Eligible patients will pay as little as $35 for their Xofluza prescription with up to $70 off at most pharmacies, including Alto Pharmacy Powered by Fuze Health and Amazon Pharmacy, which will automatically apply the manufacturer-sponsored coupon directly to eligible orders.

Additional details will be available at https://www.xofluza.com .

About Xofluza ® (baloxavir marboxil)

Xofluza is a first-in-class, single-dose oral medicine with an innovative mechanism of action designed to block viral replication by inhibiting the cap-dependent endonuclease protein, potentially reducing the duration of infectiousness and disease. Xofluza's mechanism of action has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

Xofluza is approved in more than 80 countries for the treatment of uncomplicated influenza types A and B. In the U.S., Xofluza is approved for the treatment of influenza in people five years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications, and to prevent influenza in people five years of age and older following contact with a person who has influenza (post-exposure prophylaxis). Xofluza represents the first innovation in mechanism of action for an influenza antiviral approved in almost 20 years for treatment in children five and older, adolescents, and adults.

Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd.

Xofluza U.S. Indication

XOFLUZA is a prescription medicine used to:

  • treat the flu (influenza) in people 5 years of age and older who have flu symptoms for no more than 48 hours and who are:
    • otherwise healthy or
    • at high risk of developing problems from the flu
  • prevent the flu in people 5 years of age and older following contact with a person who has the flu (post-exposure prophylaxis).

XOFLUZA does not treat or prevent illness that is caused by infections other than the influenza virus.

XOFLUZA does not prevent bacterial infections that may happen with the flu.

It is not known if XOFLUZA is safe and effective for the treatment and prevention of the flu in children less than 5 years of age. XOFLUZA is not for use in children less than 5 years of age.

Important Safety Information

Who should not take XOFLUZA?

  • Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA

What should I tell my healthcare provider before using XOFLUZA?

  • Tell your healthcare provider about all of your medical conditions , including if you are:
    • Pregnant or plan to become pregnant. It is not known if XOFLUZA can harm your unborn baby.
    • Breastfeeding or plan to breastfeed. It is not known if XOFLUZA passes into your breast milk.
  • Talk to your healthcare provider before you receive a live flu vaccine after taking XOFLUZA.
  • Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements.

What are the possible side effects of XOFLUZA?

Serious side effects may include

  • Allergic reaction. Get emergency medical help right away if you develop any of the following signs or symptoms of an allergic reaction:
    • trouble breathing
    • skin rash, hives or blisters
    • swelling of your face, throat or mouth
    • dizziness or lightheadedness

The most common side effects of XOFLUZA for treatment of the flu in adults and adolescents (12 years of age and older) were diarrhea, bronchitis, nausea, sinusitis, and headache.

The most common side effects of XOFLUZA for treatment of the flu in children (5 years of age to less than 12 years of age) were diarrhea and vomiting.

These are not all the possible side effects of XOFLUZA. Call your healthcare provider for medical advice about side effects.

XOFLUZA is not effective in treating or preventing infections other than influenza. Other kinds of infections can have symptoms like those of the flu or occur along with flu and may need different kinds of treatment. Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with XOFLUZA or if your flu symptoms do not start to get better.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see full Prescribing Information , including Patient Product Information, or visit https://www.xofluza.com .

About Genentech in Influenza

Influenza is a serious infectious disease and represents a significant burden to public health. Genentech has a long history of developing innovative medicines that have transformed the field of infectious diseases. Genentech, a member of the Roche Group, is committed to addressing the unmet need in this area through Roche's agreement with Shionogi & Co., Ltd. to develop and commercialize Xofluza ® (baloxavir marboxil) in the U.S. market.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com .

Media Contact: Rachelle Benson Yabrov (650) 467-6800
Media Contact: Madaline Donnelly (202) 570-5824
Advocacy Contact: Del Conyers (571) 684-1616
Investor Contacts: Loren Kalm (650) 225-3217
Bruno Eschli +41 61 687 5284

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