Global Markets

Biotech money: Global funding down despite spate of IPOs

A decline in venture capital (VC) funding has been offset by a flood of IPOs with growth coming from non-US biotechs, according to a Jefferies analyst. For April and May 2019, biotech funding has declined 6.5% year-on-year to $9.3 billion (€8.3 billion) according to Jefferies analyst David Windley. This, he said in a note, is due to a 46% drop in VC funding as the private market continues to be less kind to biotech over the past few periods. “Both…

Catalent to invest up to $10m into ex-BMS fill/finish site

Catalent will retain all 700 staff and invest up to $10 million into a site in Italy it is acquiring from Bristol-Myers Squibb. The deal, announced this week, will see the contract development and manufacturing organization expand its biologics network outside of the US through the addition of a sterile product manufacturing and packaging facility in Anagni, Italy. Financial details regarding Catalent’s first biologics manufacturing facility in Europe have not been divulged, but a spokesperson told this publication the CDMO…

The scale-X factor: Univercells wins $14m grant to make low-cost measles vaccines

Univercells aims to make affordable measles and rubella vaccines using its NevoLine biomanufacturing platform incorporating the scale-X fixed-bed bioreactor. In a consortium with Batavia Biosciences and Natrix Separations, Belgium-based Univercells has been able to develop a manufacturing platform that has slashed the cost of production of inactivated polio vaccine (sIPV). Now, through a $14.3 million (€12.8 million) from the Bill & Melinda Gates Foundation, the firm is looking to adapt the platform to produce low-cost measles and rubella (M&R) vaccines…

Amgen: ‘We’ve shaved 3 years off development but can do better’

Amgen says it hopes to rapidly develop new medicines from a collaboration with Intermountain Health as its EVP of R&D discusses changing timelines. Wholly-owned Amgen subsidiary deCODE genetics will have access to the genomes of 500,000 Utah-based participants from a study carried out by not-for-profit healthcare provider Intermountain Healthcare. Amgen hopes to use this data to uncover new insights into specific diseases and develop new medicines that reach the right disease targets. Speaking at the Goldman Sachs 40th Annual Global…

America has 20 approved biosimilars but you’ll never believe how many have launched!

With the FDA approving Amgen And Allergan’s version of Roche’s Herceptin (trastuzumab) America’s biosimilar tally has reached 20… But only seven have reached the market. Clickbait headline aside, this week marks another major milestone in the US biosimilar market: the approval of its twentieth biosimilar Kanjinti (trastuzumab-anns), a version of Roche’s cancer monoclonal antibody Herceptin developed by Amgen and Allergan. The approval is the third in Amgen’s portfolio and the second of four biosimilars from an Amgen and Allergan collaboration…

Hitachi supplying gene therapy Zynteglo for bluebird in EU

bluebird bio will use Hitachi Chemical subsidiary apceth Biopharma to commercially manufacture its recently EU approved gene therapy Zynteglo. Earlier this month, the European Medicines Agency (EMA) approved orphan drug Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – previously known as LentiGlobin – as a one-off treatment for beta-thalassaemia. Zynteglo uses a lentiviral viral vector to add functional copies of a modified β-globin gene into a patient’s own stem cells, addressing the underlying genetic cause of patients for whom a…

Ionis pledges to up its RNA game in SMA and elsewhere

Self-proclaimed pioneer of RNA-targeted medicine Ionis Pharmaceuticals says it is looking to develop an “even better medicine” to Spinraza to treat spinal muscular atrophy (SMA). At its annual meeting of stockholders earlier this month, Ionis Pharmaceuticals spoke about the success of its flagship molecule, Spinraza (nusinersen), an oligonucleotide approved by the US Food and Drug Administration (FDA) in December 2016 for the treatment of SMA. “Spinraza is the standard-of-care for all forms of the disease SMA. It is a medicine…

Vaccines the ‘backwaters of the pharma industry’ due to low price expectation

Historic low prices and the fact they are administered to healthy people means vaccine development plays second fiddle to biologics, according to a panel of experts. At the BPI West event in Santa Clara, California earlier this year, Rahul Singhyi, COO of Takeda vaccines, told delegates that vaccines used to be viewed as “the backwaters of the pharma industry.” Fast forward several months to the BPI Europe event in Vienna, Austria, and Bioprocess Insider asked four more experts within the…

Making rare disease successes more common

Complex pathologies and small patient populations make rare disease R&D difficult according to Alexion, which says recent FDA guidelines are welcome. At large biopharma firms, rare disease drug R&D projects are becoming common. Their high revenue potential combined with IP advantages afforded to such products makes them an attractive focus for developers. For example, orphan drug designation entitles firms to reduced fees, tax breaks for trials and extended market exclusivity. Investors also welcome such designation. According to one study, developers…