Mizuho analyst Irina Koffler raised her price target for Mylan (MYL) to $32 after the company received its “hard-fought” FDA approval for generic Advair, a $1.5B inhaler product in the U.S. The analyst, however, reiterates a Neutral rating on the shares. She remains cautious on Mylan’s longer-term growth outlook and strategy.
Thursday, January 31, 2019
Alexion, Caelum Biosciences announce collaboration to develop CAEL-101
Alexion Pharmaceuticals and Caelum Biosciences announced a collaboration to develop CAEL-101 for light chain amyloidosis. CAEL-101 is a first-in-class amyloid fibril targeted therapy designed to improve organ function by reducing or eliminating amyloid deposits in patients with AL amyloidosis. AL amyloidosis is a rare systemic disorder that causes misfolded immunoglobulin light chain protein to build up in and around tissues, resulting in progressive and widespread organ damage, most commonly to the heart and kidneys. Under the terms of the agreement, Alexion will acquire a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 2 data for pre-negotiated economics. Alexion will make payments to Caelum totaling up to $60M, including the purchase price for the equity and milestone-dependent development funding payments. The collaboration also provides for potential additional payments of up to $500M, including the upfront and regulatory and commercial milestone payments, in the event Alexion exercises the acquisition option. The collaboration will leverage Alexion’s expertise in rare disease antibody development and commercial franchise in hematology. Alexion and Caelum will collaborate on the design of the ongoing development program for CAEL-101. Caelum will be responsible for conducting the development program through the end of Phase 2 and for manufacturing CAEL-101.
MeiraGTx partnering with Janssen to develop, market retinal disease therapy
MeiraGTx (MGTX) has entered into a broad strategic collaboration with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize gene therapies for the treatment of inherited retinal diseases. The two companies will collaborate in the clinical development of MeiraGTx’s IRD pipeline, including product candidates for achromatopsia, or ACHM, caused by mutations in either CNGB3 or CNGA3 and X-linked retinitis pigmentosa. In addition, MeiraGTx and Janssen are entering into a research collaboration covering MeiraGTx’s pipeline of pre-clinical programs for IRDs and also entering into a research collaboration to further develop AAV manufacturing technology. MeiraGTx will receive $100M in cash as an upfront payment and is eligible to receive additional payments for achieving development and sales milestones related to its CNGB3, CNGA3 and XLRP programs of up to $340M, and untiered royalties of 20% of annual net sales for the CNGB3, CNGA3 and XLRP programs. Janssen has agreed to fund all clinical development and commercialization costs for these programs. MeiraGTx and Janssen are also entering into a research collaboration to develop a pipeline of IRD gene therapy candidates; a significant portion of the costs of the research collaboration will be paid by Janssen. Janssen has the right to opt-in to programs coming out of this research collaboration at the time of clearance of an IND application by the FDA. MeiraGTx will receive an opt-in payment, development milestones and a high teens untiered royalty on annual net sales of commercialized products coming out of this collaboration. The transaction is expected to close in Q1.
Mesoblast initiated at H.C. Wainwright
Mesoblast assumed with a Buy at H.C. Wainwright. H.C. Wainwright analyst Swayampakula Ramakanth assumed coverage of Mesoblast with a Buy rating and $6.50 price target. The company’s proprietary platform has been validated by two commercial cellular therapy products, TEMCELL and Alofisel, which were approved in Japan in 2015 for the treatment of acute Graft Versus Host Disease, and in Europe in 2018 for the treatment of perianal fistula, Ramakanth tells investors in a research note. Further, he calls Mesoblast’s product pipeline “mature” with seven product candidates targeting ten indications.
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