October 15, 2017 (Vol. 37, No. 18)

Industry Watch: Approved Amgen-Allergan Biosimilar Fuels Competitive Pressures for Roche, Genentech

Amgen and Allergan have won the first U.S. approval for a cancer biosimilar following FDA authorization of Mvasi (bevacizumab-awwb), a near-copy of Roche subsidiary Genentech’s Avastin (bevacizumab). Mvasi has been approved for adults with specific forms of colorectal, lung, brain, kidney and cervical cancers.

Just when Mvasi will reach the market—and its cost—remain unknown.

Avastin retains U.S. patent exclusivity until 2019—patents that earlier this year were at the center of a legal wrangle between Amgen and Genentech. Amgen is not discussing Mvasi’s launch date or pricing, but is providing application and manufacturing information to Genentech, as required by the Biologics Price Competition and Innovation Act.

In February 2017, Genentech sued Amgen, contending that Amgen violated the Biologics Price Competition and Innovation Act, specifically, the information disclosure requirements related to patent disputes. A federal judge dismissed Genentech’s complaint “without prejudice,” allowing for refiling within 45 days. A unanimous High Court sided with biosimilars developers.

Genentech spokeswoman Meghan Cox told GEN the company won’t discuss its dispute with Amgen.

Mvasi adds to competitive pressures on Genentech and Roche. During the first half of 2017, Roche’s sales of Avastin dipped 1% to CHF 3.405 billion ($3.55 billion). Roche is relying on sales overseas, especially in China, saying its U.S. sales decline is “largely due to growing use of cancer immunotherapy medicines in lung cancer.”

Amgen, in contrast, has 10 biosimilar programs in the pipeline, including four oncology biosimilars that are being codeveloped with Allergan.

Mvasi is the seventh biosimilar approved by the FDA, which expressed hope in a press release that its action would lower prices for new cancer treatments. Several Avastin biosimilar candidates are in Phase III, including Biocad’s BCD-021, Biocon’s biosimilar to bevacizumab; Boehringer Ingelheim’s BI695502; IBC Generium/Affitech’s GNR-011 (Phase II/III); Kyowa Hakko Kirin’s FKB238; Pfizer’s PF-06439535; and Samsung Bioepis’ SB8.

“It usually takes more than one competitor to have a major impact on price, and that will even be more [true] for biosimilars, since they are complicated to make and will have higher prices to begin with,” Brad Loncar, CEO of Loncar Investments, told GEN.

Discovery & Development: Gates Foundation Invests up to $40M in Immunocore to Develop TCR-Based Therapies

The Bill & Melinda Gates Foundation is investing up to $40 million in Immunocore to support development of the company’s soluble TCR (T-cell receptor)-based therapeutics, ImmTAV® (immune mobilizing monoclonal TCRs against virus) and ImmTAB® (immune mobilizing monoclonal TCRs against bacteria). ImmTAV and ImmTAB may prove to be effective against tuberculosis, human immunodeficiency virus (HIV), and other infectious diseases that pose global health challenges.

Namir Hassan, Ph.D., vice president of the infectious disease unit at Immunocore, commented, “We believe the immune system harbors the capacity to resolve problematic infectious diseases, and our TCR-based therapies are well placed to mobilize this process.” He adds that the company is focused on providing affordable medicines globally, including in the developing world.

The investment in Immunocore is being made as part of the Gates Foundation’s program-related investments (PRI) strategy, which aims to stimulate private sector–driven innovation and attract external capital to global health and development initiatives. The collaboration with the Gates Foundation also represents part of a larger Immunocore initiative to exploit the TCR-based therapeutics platform in non-oncology areas, including infectious diseases and autoimmune disorders. Preclinical data published last year demonstrated the potential for ImmTAV molecules to redirect the immune system to kill HIV-infected cells from patients treated using antiretrovial therapy.

U.K.-based Immunocore claims its platform of TCR-based soluble, synthetic bifunctional drugs can address both intracellular and extracellular targets. Lead ImmTAC® programs for cancer therapy are designed to trigger the patient’s own immune system to attack and kill cancer cells.

The firm’s most advanced ImmTAC candidate, MICgp100, targets the melanoma-associated antigen gp100, and is being evaluated in several studies, both as a monotherapy and as a component in combination therapies. Partners in the combination trials include AstraZeneca and Eli Lilly. Another partner, Glaxo-SmithKline, recently announced that it had selected a third target as part of a cancer discovery collaboration, a program that aims to develop ImmTAC molecules against targets that can’t be addressed using antibody-based technologies. 

Genomics & Proteomics: A Partnership for Improved Understanding of Genetic Results

Cost-effective sequencing can now provide insight into disease prevention and intervention. Though the tools for sequencing are readily available, resources for interpreting results and helping patients understand the information have been less accessible. However, a new partnership between Fabric Genomics and Genome Medical is looking to provide expert medical interpretation and counseling to physicians and patients on genomic data. Genome Medical will use Fabric Genomics’ clinical interpretation platform, Fabric Enterprise, for ongoing examination of its patients’ genomic data.

“By combining our expertise in genome interpretation with Genome Medical’s team of physicians and genetic counselors, we can offer patients and physicians a clinical solution by combining genomic knowledge with patient care to improve their health,” explained Martin Reese, Ph.D., CEO at Fabric Genomics.

Through this partnership, Genome Medical’s expert team of physicians and genetic counselors will be able to turn to Fabric Enterprise to augment the information provided to individuals and clinicians. Genome Medical’s workflow will now provide an end-to-end offering by helping patients and physicians decide whether they need a test, how to order the right test, how to interpret test results, understand ways to covert the results into actionable medical decisions, and reinterpret DNA over the course of treatment, if applicable.

“Year after year, our knowledge about how genetics affects health and our ability to apply this knowledge to improve patient health grows dramatically,” stated Steven Bleyl, M.D., Ph.D., CMO at Genome Medical. “We believe genomic medicine is a lifelong journey. To that end, it will be increasingly important that our clinicians have the right tools to view, query, interpret and reinterpret our patients’ genetic information over time. We have partnered with Fabric Genomics to meet that crucial need.”

Bioprocessing: Catalent to Acquire Cook Pharmica for $950M

Catalent said it agreed to acquire Cook Pharmica for $950 million in a deal that would continue the consolidation of contract development and manufacturing organizations (CDMOs)—to which biopharmas have increasingly outsourced operations—and bolster the buyer’s biologics capabilities.

The acquisition would join Cook Pharmica’s drug substance and drug product manufacturing and related services with Catalent’s development, delivery, and supply operations—creating a combined company that, the buyer says, would strengthen its position in biologics development and analytical services, manufacturing, and finished product supply.

The deal further advances global consolidation of the CDMO market, which has seen the closing of two multibillion-dollar transactions this year. One was Thermo Fisher Scientific’s approximately $7.2-billion acquisition of Parexel, which was announced May 15, 2017 and completed August 29, 2017. The other was Lonza’s $5.5-billion cash purchase of Capsugel, a drug capsule and delivery systems firm, from its private equity owner KKR, announced in December 2016 and completed July 6, 2017.

Also among 2017 CDMO deals, affiliates of The Carlyle Group and GTCR on August 31 completed their acquisition of Albany Molecular Research (AMRI) for about $922 million cash, while JSR Life Sciences agreed in June 2017 to acquire mammalian cell-line development specialist Selexis and integrate it with KBI Biopharma, a company which Japan-based JSR acquired in 2015.

Catalent says the Bloomington facility’s biomanufacturing capacity and expertise in sterile formulation and fill/finish across liquid and lyophilized vials, prefilled syringes, and cartridges “perfectly augments” its current expertise in cell-line engineering, bioconjugate development, analytical services, biomanufacturing, prefilled syringe technologies, and blow/fill/seal technologies.

“The complementary biologics development, biomanufacturing, and fill/finish capabilities of Catalent and Cook Pharmica will provide biopharmaceutical firms with a single, integrated partner supporting a wide range of clinical and commercial needs,” Catalent chair and CEO John Chiminski said in a statement.

“We are very excited to join forces with the talented Cook Pharmica team in Bloomington, IN, and plan to invest aggressively there, in our rapidly expanding Madison, WI, facility, and in the rest of the Catalent Biologics network to build a true global leader in the biologics market, which will help us to improve the lives of patients around the world,” Chiminski added.

Molecular Diagnostics: Individumed, Helomics Launch Cancer Biomarker Collaboration

Indivumed and Helomics said they will analyze human cancer biospecimens and annotated clinical data from consenting patients worldwide, in a collaboration designed to enable basic and translational research through the development of biomarkers.

The collaboration will combine Indivumed’s global cancer database, biobank, and research laboratory with Helomics’ advanced clinical laboratory diagnostic tests, proprietary D-CHIP™ (Dynamic Clinical Health Insight Platform) bioinformatics platform launched in April 2017, and custom project services for customers.

Helomics is an integrated clinical contract research organization based in Pittsburgh, PA, where the company maintains its CLIA-certified clinical and research laboratories. The company’s Helomics Biomarker Panel consists of tests designed for any solid tumor type—though the tumor types most frequently tested through the panel, according to Helomics, are gynecologic cancers, lung cancer, breast cancer, colon cancer, and pancreatic cancer.

Indivumed is an ISO-certified global oncology research company based in Hamburg, Germany. The company’s cancer database, which covers 22 different cancer types, combines clinical information from more than 320 validated clinical data points for each patient—including long-term outcome information with raw biological data (including protein, phosphoprotein, and DNA/RNA expression).

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