Biopharmaceutical News Week 34
Valeant acquires Sprout (Canada) for $1 billion just two days after Sprout won US FDA approval for Addyi (flibanserin) as the world’s first female low libido treatment. According to the terms of the deal Valeant will acquire Sprout in an all-cash deal, around $500 million as an upfront payment, an additional $500 million in the first quarter of next year and milestones on future profits.
Roche acquires privately held gene-sequencing company Kapa Biosystems for an undisclosed amount. Kapa’s protein engineering technology allows for the generation and screening of large numbers of enzyme variants.
Novartis enters into an exclusive worldwide license agreement with AVEO Oncology (USA) for the development of AVE-380, a humanized antibody targeting growth differentiation factor 15 (GDF15) as well as related antibodies. GDF15 is a pro-inflammatory cytokine whose elevated levels are associated with cachexia in cachetic cancer patients. Under the terms of the deal AVEO will receive an upfront payment of $15 million and up to $311 million in contingent product related milestones.
…and acquires all rights for GlaxoSmithKline experimental drug ofatumumab for the treatment of multiple sclerosis for more than $1 billion. Under the terms of the agreement, GSK will receive an upfront payment of $300 million, $200 million contingent on the initiation of Phase III trials and up to $534 million in potential milestone fees.
Novo Nordisk buys access to Genmab’s bispecific antibody technology for two undisclosed non-cancer related therapeutic programmes. Under the terms of the agreement, Novo Nordisk will pay an upfront payment of $2 million and potential milestone fees of about $250 million for each exclusive license or about $200 million for every non-exclusive license, plus sales royalties.
Janssen Biotech buys an exclusive license for immunotherapy ADC-1013 from Alligator’s Bioscience (Sweden). Financial terms were not disclosed.
….and stops its seven year alliance with Hutchinson MediPharma (China) to develop the inflammation/immunology investigational drug HMPL-507. The Hong Kong based company will carry-on independently the further development of the drug.
AbbVie buys United’s Paediatric Priority Review Voucher (PPRV) for $350 million. AbbVie has thus far remained silent about which drug it has in mind for the voucher which will allow a significant cutting of the target review time.
Approval of drugs, vaccines, diagnostics and devices
US FDA approves Sprout’s Addyi or flibanserin, the first drug intended to treat low female libido, also known as hypoactive sexual desire disorder (HSDD) The drug was approved with a black-box warning and a risk management programme. Addyi, which was originally discovered by Boehringer Ingelheim, is a serotonin 1A and 2A receptor antagonist, but the mechanism by which the drug improves sexual desire is not known.
The European Commission approves Novartis’s Odomzo for the treatment of locally advanced basal cell carcinoma (BCC). BCC accounts for more than 80% of non-melanoma skin cancers and consists of abnormal, uncontrolled growths or lesions that arise in the skin's basal cells, which line the deepest layer of the epidermis. Odomzo or sonidegib is an oral, selective smoothened inhibitor that regulates the hedgehog signalling pathway, known to play a critical role in stem cell maintenance and tissue repair as well as in advanced BCC. The drug had been approved by US FDA a few weeks ago.
US FDA approves GE Healthcare low-dose computer tomography (CT) lung cancer screening device. GE Healthcare is the first company to have its low-dose CT solution to screen patients at high-risk of developing lung cancer cleared by the agency
US FDA expands Seattle Genetics Adcetris or brentuximab vedotin for use immediately after autologous hematopoietic stem cell transplant in Hodgkin lymphoma patients.
Drugs at clinical stage
ASLAN Pharmaceuticals (Singapore and Taiwan) has received US FDA orphan designation for ASLAN001 (varlitinib), a pan-HER inhibitor as a treatment for cholangiocarcinoma, a rare form of bile duct cancer.
Medical Devices and Diagnosis News
Harvard University Wyss Institute for Biologically Inspired Engineering launches an updated version of its blood-cleansing device that treats sepsis by mimicking human spleen.
Norway launches Oslo Cancer Cluster Innovation Park, a $120 million cancer hub which houses hospitals, Big Pharma and an incubator for the next generation of Norwegian oncology startups.
- 3rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
- BioPharm America 2015 on September 15-17 in Boston (USA)
- Innovation Days on October 5-6 in Paris (France)
- BIO Japan on October 13-16 in Yokohama (Japan)
- BIO Latin America on October 14-16 in Rio de Janeiro (Brazil).
- 15th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
- BIO Europe 2015 on November 2-4 in Munich (Germany)
- Biofit 2015 on December 1-2 in Strasbourg (France)
Author: Jean-Claude Muller, Special Advisor at I&IR, firstname.lastname@example.org
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