Deal-Making

Novartis waves goodbye to biosimilars with Sandoz split

Novartis will spin-off its generics division Sandoz, which includes a portfolio of eight biosimilar products. In 2018, Novartis granted its generic and biosimilar medicine division Sandoz more autonomy while claiming to be “completely committed” to the business. Since then, analysts and investors have been hedging their bets as to when the inevitable spin-off would therefore occur. Following a strategic review last year, the Swiss firm has now cemented a separation plan to be completed by the second half of 2023.…

Cytiva and Caring Cross to develop CAR-T for HIV

Cytiva’s support will enable Caring Cross to develop and distribute its CAR-T cell therapy for HIV to low-to-middle-income countries, says firm. Caring Cross’ first therapeutic candidate is an anti-HIV duoCAR-T cell therapy, which the organization claims is designed to supress HIV replication and remove HIV-expressing cells in individuals with HIV. Additionally, it is developing a stem cell gene therapy for sickle cell disease and beta-thalassemia. “Approximately 38 million people worldwide are living with HIV. Current treatment options are limited to…

Bavarian Nordic inks fill/finish deal with GRAM for monkeypox vaccine

Bavarian Nordic has entered into an agreement with Grand River Aseptic Manufacturing (GRAM) for fill and finish of the firm’s smallpox/monkeypox vaccine, Jynneos. In September 2019, the US Food and Drug Administration (FDA) gave Bavarian Nordic the go ahead to manufacture and distribute the liquid-frozen suspension of its vaccine Jynneos (known as Imvanex in Europe) for smallpox and monkeypox in adults aged 18 years and over. Now, with the firm receiving an additional order for 2.5 million doses of the vaccine…

Vendor identity: Catalent could enter the CDMO elite with Repligen buy

Thermo Fisher branched out from bioprocess vendor to CDMO via M&A so could Catalent do the reverse through a speculative bid to buy Repligen? Earlier this month, rumors emerged that Repligen rejected an unsolicited bid from contract development and manufacturing organization (CDMO) Catalent. According to the StreetInsider, Repligen viewed the offer as being too low, citing a source with knowledge of the matter. Neither Catalent nor Repligen have commented on any rumored bid. But would a merger with Repligen make…

Gilead buys back China rights to ADC Trodelvy for $455m

Shanghai Everest Medicines has returned the rights for Trodelvy (sacituzumab govitecan) to Immunomedics, a subsidiary of Gilead Sciences, in an agreement worth up to $455 million. In 2009, Everest acquired rights to the Trop-2 antibody-drug conjugate (ADC) candidate in an $835 million deal ($65 million upfront). Two months ago, Everest was approved to launch Trodelvy in China as a third-line therapy for metastatic triple-negative breast cancer (TNBC). Everest will receive $280 million in upfront payments and up to $175 million in future milestones. The…

Merck enters $221m ‘circular’ RNA partnership with Orna

Merck & Co. has collaborated with Orna Therapeutics to develop and commercialize vaccines and therapeutics targeting oncology and infectious diseases. Merck (known as MSD outside of the US and Canada) will make an upfront payment of $150 million to circular RNA (oRNA) therapy firm Orna to discover, drive, and commercialize different programs. This payment will be expensed by Merck in the third quarter of this year. Orna has the potential to receive up to $3.5 billion in sales, development and…

Mayo Clinic and Resilience enter biomanufacturing pact

Biomanufacturing services firm National Resilience will collaborate with Mayo’s Center for Regenerative Medicine in Minnesota. The collaboration will see Resilience and Mayo create process development labs, analytical development labs, and quality control labs at Mayo’s Center for Regenerative Medicine in Rochester, Minnesota, to jointly develop and progress cell therapies and other advanced modalities into the clinic. The partnership also hopes to attract third-party biotech companies interested in sponsoring clinical trials for new therapeutics, as well as collaborating on their process…

Tonix looks to live virus vaccines to prevent the spread of monkeypox

Tonix Pharmaceuticals claims that using a smallpox vaccine model could stop the spread of monkeypox. The technology is being applied to vaccines against COVID-19, smallpox, and monkeypox. According to Seth Lederman, CEO of Tonix, the firm has “recreated a vaccine that we think is similar to what Edward Jenner used” in 1798. While Lederman told us the undisclosed cell line is “pretty standard” in its technique, TNX-801 is a live virus vaccine based on synthesized horsepox (sHPXV) that it claims…

Sanofi inks cancer antibody deal and invests $305m in Innovent

Suzhou Innovent Biologics will develop two Sanofi cancer candidates in China  with Sanofi investing $305 million in Innovent at a 20% premium to current prices. The drug candidates are (1) tusamitamab ravtansine, an anti-CEACAM5 antibody-drug conjugate in Phase III trials, and (2) non-alpha IL-2 in Phase II trials (combined with Innovent’s PD-1, sintilimab). Innovent will be responsible for China clinical development of both Sanofi candidates, but will commercialize only tusamitamab ravtansine. Sanofi will be eligible for $81 million in milestones…

Sartorius lays out $500m to buy recombinant albumin firm Albumedix

Sartorius Stedim Biotech will add a portfolio of recombinant albumin-based products used in drug manufacture and a 72,000 square-foot production facility through the acquisition of Albumedix. During its second quarter financial call last month, bioprocess vendor Sartorius spoke about its desire to acquire complementary technologies and innovation through a war chest of around €10 billion ($10.2 billion) firepower at its disposal. Less than three weeks on, and the firm has pulled the trigger, agreeing to buy Albumedix for approximately ÂŁ415…