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Genentech gets FDA approval for Rituxan SC

June 22, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved RITUXAN HYCELA (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL).

This new treatment includes the same monoclonal antibody as intravenous Rituxan (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin.

“With today’s approval of RITUXAN HYCELA, people with three of the most common blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that reduces the administration time can be important.”

Genentech has begun operating a second cell-culture plant at its massive Vacaville manufacturing complex, following approval in April from the European Medicines Agency to produce an under-the-skin treatment for certain blood cancers.

The new plant is part of a nearly $300 million, half-million-square-foot expansion that is set to almost double production of the Solano County site.

Genentech already produces the intravenous formulation of Rituxan, called Rituxan IV, at its first Vacaville cell-culture plant, called CCP1. The second facility, CCP2, was built in 2007 and shuttered in 2010 due to market demand and other issues.

To be used in the U.S., new Rituxan SC formulation required new clinical trials and a new FDA review. The new formulation includes the same monoclonal antibody as intravenous Rituxan and also hyaluronidase — a molecule that helps to deliver medicine under the skin. Rituxan IV has been the standard of care for treating B-cell non-Hodgkins lymphoma.

Genentech specializes in manufacturing biologics, a class of antibody medicines produced inside living cells designed to attach themselves to specific foreign substances in response to bacteria, viruses, fungus, animal dander or cancer cells, so the immune system can destroy them. Its Vacaville location is the largest producer of biologic materials for the parent company, the Swiss-based Roche Group. By 2018, Genentech and Roche will represent 25 percent of the worldwide biologics manufacturing capacity.

Tony Pankau, vice president and general manager at Vacaville, joined the company last November, following a 28-year career at Amgen. He said that once the Rituxan SC formulation is approved by the Food and Drug Administration for U.S. patients — anticipated by mid-year — Genentech can submit an application to the FDA for licensure of the CCP2 facility.

Rituxan SC is designed to reduce staff time and chair time for patients during the infusion process and when administering this drug. The company said studies have also shown that Rituxan IV and Rituxan SC have comparable efficacy and safety.

In addition to Rituxan IV, CCP1 produces three drug therapies for certain types of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla. It also manufactures Xolair for chronic idopathic uticaria — a type of chronic hives — and allergic symptoms, as well as Ocrevus for multiple sclerosis.

Genentech continues exploring and developing drugs for treating conditions such as Parkinson’s disease and Alzheimer’s disease. The company recently announced positive results based on two studies of its investigational hemophilia medicine emicizumab (shown in lower case until approved and given a brand name).

“Genentech expects more emicizumab results later this year and looks forward to submitting those findings to health authorities for approval consideration,” Pankau said. “Looking ahead, the company is also collaborating with German-based BioNTech to develop, manufacture and commercialize novel mRNA-based, individually tailored and personalized messenger RNA cancer vaccines.”

With more than 100 types of cancer variations identified, and with human immune systems unable to detect and effectively fight these cancers in most cases, new therapies are needed to apply targeted treatment.

CCP2 has potential to almost double the output of the Vacaville location. Five medicine batches of specific proteins are produced weekly at CCP1, enough to provide doses for 160,000 patients a week.

The annual output of CCP1 is 2,500 kilograms of various products, whereas the future output of CCP2 is expected to reach 4,000 kilograms. This output is in the form of vials of medications designed for infusion, injection and additional processing, not in capsule or tablet form.

Genentech gets FDA approval for Rituxan SC

June 22, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved RITUXAN HYCELA (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL).

This new treatment includes the same monoclonal antibody as intravenous Rituxan (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin.

“With today’s approval of RITUXAN HYCELA, people with three of the most common blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that reduces the administration time can be important.”

Though built 10 years ago, CCP2 was not operational for several years.

“Strategic decisions made about the timelines for starting up CCP2 were connected to an overarching strategy based on demand forecasts and production efficiencies across the entire Genentech/Roche global network,” Pankau said. “The exciting news is that as production demand has increased for our pipeline of more than 70 investigational medicines, CCP2 will now be able to provide us with much needed additional capacity.”

The second Vacaville cell culture plant on this 100-acre site was part of a $285 million expansion project that includes space for manufacturing, maintenance, laboratories, offices and warehousing. The entire 956,000 square foot facility employs over 1,000 workers, with some employees trained and certified to work in both plants. Of this total, CCP2 occupies 450,000 square feet of space, with 165,000 square feet devoted to labs and cell culture production made in accordance with the most stringent FDA protocols and procedures.

Plant operations are conducted around the clock under the direction of four process manufacturing and support groups headed by Jennifer Martinez, Elizabeth Kelly, Robert Davis, Richard Clements and Aaron Hunley.

Jose Nuno is a member of Genentech’s Utility Operations group that keeps the 10-building integrated campus running.

“Our campus receives 12,000 volts of electricity from PG&E supplemented by over 29,000 solar panels,” Nuno said. “This massive array produces 8.9 megawatts of power providing 24 percent of the site’s total electrical needs — equivalent to powering more than 22,000 homes or removing 23,000 cars from the roads for a year — over the course of the system’s lifespan. Genentech’s goal is to have 20 percent of all energy used coming from sustainable resources by 2020.”

The Solano County site also has six backup diesel generators producing 2 megawatts of power each, enough to power half of Vacaville for 12 hours.

Production of biologics requires ultrapure steam and refrigerated water. About 500,000 gallons of potable city water is processed each day. It initially contains 500 microsiemens per centimeter. Also the name of a German company founded by the discoverer, siemens is a unit of measurement of electrical conductivity of particles commonly found in water.

Genentech’s water is next run through water-softeners that remove calcium and magnesium then through a reverse osmosis process to remove all but 10 microsiemens of particulate matter. The final goal of having less than 2 microsiemens is achieved through a vapor-compression “still” that vaporizes water and condenses it.

All these critical utility operations are monitored from a control center where multiple screens display the status of every system in green (good), yellow (pay attention to this) or red (must fix as soon as possible) color codes.

“Our staff maintains and calibrates equipment throughout the facility, manages all lab equipment, develops and delivers technical training to staff, while also managing the metrology lab and the maintenance shop responsible for equipment rebuilds and fabrications of new components,” said Craig Doerfert, who leads the maintenance and operations group. “These onsite services save Genentech time, money and downtime – while often eliminating the need for factory representative outcalls for assistance.”

For earthquake protection, the facility has steel lateral cross-bracing throughout and large metal balls under the structure that would allow the buildings to move without collapsing in up to a 7-point Richter scale event.

Pankau said Genentech is partnering with the best and brightest research scientists in the industry to realize the potential of personalized health care and bring new medicines to patents faster, while finding ways to ensure patient access to these treatments.

“Those who work here consider it a privilege to make medicines that change people’s lives,” Pankau said. “Everyone has a singular mission with a heart-felt commitment to provide treatment therapies in a safe and efficient process that addresses serious or life threatening medical conditions. It takes a lot of dedicated people to do this — and they are making a monumental difference as we continue to look for more meds to add to our portfolio.”