The biotech sector was in focus last week with regular pipeline updates and collaboration/licensing deals. While biotech bigwig Amgen’s (AMGN – Free Report) drugs won both FDA and EC approvals, Axovant (AXON – Free Report) soared on a licensing deal Oxford BioMedica. Meanwhile, Regeneron (REGN – Free Report) collaborated with Zoetis to discover new veterinary treatments.
Recap of Important Stories:
Amgen Gets FDA Nod to Addition of Data to Kyprolis: Amgen announced that the FDA has approved its supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the phase III trial, ASPIRE, to myeloma drug, Kyprolis. The data added to the label showed that Kyprolis, Revlimid and dexamethasone (KRd) significantly reduced the risk of death by 21% and extended overall survival by 7.9 months versus Revlimid and dexamethasone alone (Rd) in patients with relapsed or refractory multiple myeloma. In addition, the European Commission (EC) approved a label expansion for Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. This is the third indication for which Prolia has received EC approval.
Regeneron Collaborates With Zoetis: Regeneron announced a five-year collaboration agreement with Zoetis whereby the latter will use its monoclonal antibody therapeutics in animals and discover new veterinary treatments. Per the terms, Regeneron has granted Zoetis a license for its proprietary VelocImmune antibody technology, which the latter will use to develop monoclonal antibodies modified for species-specific use in companion and livestock animals. In exchange, Regeneron will receive a license fee, approval and sales milestone payments and royalties on any potential veterinary treatments.
Axovant Sciences Soar on Gene Therapy Deal: Shares of Axovant Sciences gained after the company announced that it has licensed the exclusive worldwide rights to develop and commercialize AXO-LentiPD from Oxford BioMedicafor Parkinsons’ disease. AXO-LentiPD, formerly OXB-102, is an experimental gene therapy being developed for Parkinson’s disease, which delivers three genes encoding a critical set of enzymes required for dopamine synthesis in the brain. Axovant plans to initiate a phase I/II dose escalation study on AXO-LentiPD in patients with advanced Parkinson’s disease, by the end of 2018.
Per the terms of the agreement, Axovant will make an initial payment of $30 million in cash to obtain rights to AXO-Lenti-PD, as well as its predecessor product, ProSavin. Out of this $30 million, $5 million is applied as a credit against the process development work and clinical supply that Oxford BioMedica will provide to Axovant. In addition, Oxford BioMedica will also be entitled to receive additional development, regulatory and commercial milestone payments, potentially in excess of $812 million and tiered royalties on net sales of AXO-Lenti-PD, if approved. Meanwhile, Axovant will receive $25 million equity financing from Roivant Sciences to support clinical development of AXO-Lenti-PD and additional business development. The company also got a new chief technology officer, Fraser Wright. (Read more: Axovant Gains on Licensing Deal with Oxford BioMedica)
Axovant currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Biogen Acquires Asset for Thrombosis: Biogen (BIIB – Free Report) entered into an exclusive option agreement with TMS Co., Ltd. to acquire TMS-007 and backup compounds for an upfront payment of $4 million. The agreement also includes an additional $18 million payment if Biogen exercises its option, with up to $335 million in potential development and commercialization milestones as well as tiered royalties. TMS-007, a plasminogen activator, enables to restore blood flow following acute stroke, with an extended treatment window versus the current standard of care. The candidate is currently being evaluated in a double-blind, placebo-controlled phase II study in Japan for the safety and efficacy of a single IV administration of TMS-007 in approximately 60-90 patients with AIS up to 12 hours after stroke onset. The first patient was dosed in February 2018. The acquisition is in line with Biogen’s efforts to broaden its neurology portfolio.
Alexion Teams With Complement Pharma: Alexion Pharmaceuticals, Inc. (ALXN – Free Report) announced a partnership with Complement Pharma to co-develop the preclinical C6 complement inhibitor, CP010, for neurodegenerative disorders. CP010 is a humanized monoclonal antibody in preclinical stages that binds to C6 in circulation to inhibit its function throughout the body by preventing MAC formation in both the periphery and the central nervous system. Alexion and Complement Pharma will collaborate on the development program for CP010. Complement Pharma will be responsible for conducting preclinical and phase I studies as well as manufacturing CP010. In exchange, Alexion will provide Complement Pharma with up to €14 million in milestone-dependent payments through phase Ib development. Alexion is looking to develop its pipeline and reduce dependence on key drug Soliris for pipeline development. (Read more: Alexion-Complement Pharma Tie Up to Treat Neuro Disorders)
The NASDAQ Biotechnology Index gained 1.59% over the last five trading sessions. Among the major biotech stocks, Vertex gained 3.62%. Over the past six months, Celgene has lost 28.9%, while Vertex has gained 7.15%. (See the last biotech stock roundup here: Biotech Stock Roundup: Regeneron, Celgene, Amgen Impress at ASCO)
What’s Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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