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BioCentury Extra
As published Monday, June 29, 2015 7:16 PM PST

  • Celgene, Juno in 10-year pact

    Juno Therapeutics Inc. (NASDAQ:JUNO) gained $17.20 (37%) to $63.50 in after-hours trading after announcing a 10-year deal with Celgene Corp. (NASDAQ:CELG) to develop immunotherapies for cancer and autoimmune diseases, with an initial focus on chimeric antigen receptor (CAR) T cell and T cell receptor (TCR) therapies. Juno will receive $150.2 million in upfront cash plus $849.8 million through the sale to Celgene of 9.1 million newly issued Juno shares at $93, which is a 100% premium over Juno's Monday close.

    Celgene will receive options to develop and commercialize Juno's cancer and cell therapy autoimmune candidates outside North America, including its CAR T programs against CD19 and CD22. Juno's three most advanced programs -- JCAR015, JCAR017 and JCAR014 -- use autologous T cells expressing CARs specific to CD19 to treat hematologic malignancies. The company said last month it expects to begin a Phase II study in mid-2015 of JCAR015 to treat acute myelogenous leukemia (ALL), and a Phase I/II trial of JCAR017 this year to treat non-Hodgkin's lymphoma (NHL). The National Cancer Institute is conducting a Phase I study of Juno's JCAR018, a CAR T therapy targeting CD22, to treat ALL or NHL.

    For any program on which Celgene exercises its option, Juno will be eligible for royalties. Excluded from the deal are Juno's programs targeting tumor necrosis factor (TNF) receptor superfamily member 17 (TNFRSF17; BCMA; CD269). Celgene and bluebird bio Inc. (NASDAQ:BLUE) agreed earlier this month to narrow their CAR T cell therapy deal to focus exclusively on BCMA (see BioCentury Extra, June 3).

    Celgene also will receive an option to co-promote two other Juno programs outside China, and may select another program subject to additional conditions.

    Juno will receive options to co-develop and co-promote undisclosed Celgene programs targeting T cells. If Juno exercises an option, Celgene and Juno would share profits and losses 70-30.

    Celgene now owns 10% of Juno, and is eligible to acquire a maximum of 30% of Juno over the course of the deal.

    The deal gives Celgene the right to nominate a Juno director. Celgene expects to nominate Thomas Daniel, president of Celgene research and early development.

    Both companies' boards approved the deal, which is expected to close next quarter.

    On a conference call, Celgene executives declined to disclose the size of the option fees, but CFO Peter Kellogg said they will be based on a sliding scale related to a program's stage of development.

  • Intercept submits OCA NDA

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said it submitted an NDA to FDA for accelerated approval of OCA obeticholic acid to treat primary biliary cirrhosis (PBC). The company also said EMA accepted for review an MAA for OCA to treat PBC.

    The oral farnesoid X receptor (FXR; NR1H4) agonist has Orphan Drug designation from FDA and EMA, as well as Fast Track designation from FDA, in the indication.

    Intercept said last month it expects to begin a Phase III study next quarter of OCA to treat non-alcoholic steatohepatitis (NASH) (see BioCentury Extra, May 19).

    Intercept dipped $15.31 to $240.39 on Monday. It announced the news after market close.

  • BioMarin, Sarepta DMD submissions move forward

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) and Sarepta Therapeutics Inc. (NASDAQ:SRPT) each provided regulatory updates for their Duchenne muscular dystrophy programs on Monday. BioMarin said FDA accepted and granted Priority Review to an NDA for drisapersen to treat DMD amenable to exon 51 skipping. The PDUFA date is Dec. 27. BioMarin said FDA plans to hold an advisory committee meeting to discuss the NDA, but has not set a date.

    On Friday, BioMarin said EMA accepted for review an MAA for drisapersen. The antisense oligoribonucleotide that induces exon 51 skipping on the dystrophin gene has Fast Track and breakthrough therapy designations from FDA and Orphan Drug designation in the U.S. and EU. BioMarin gained the product through its acquisition of Prosensa Holding N.V. last quarter. The company lost $2.53 to $132.31 on Monday.

    Sarepta said it completed submission of a rolling NDA to FDA for eteplirsen (AVI-4685) to treat DMD. The company requested Priority Review for the phosphorodiamidate morpholino oligomer (PMO) targeting exon 51. Eteplirsen has Orphan Drug designation in the U.S. and EU and Fast Track designation in the U.S. to treat DMD.

    Separately, Sarepta announced a senior secured loan facility allowing it to borrow up to $40 million from Midcap Financial; the company has drawn down $20 million. Sarepta shed $3.08 (10%) to $28.18 on Monday.

  • Amgen files IPRs against Humira patents

    Amgen Inc. (NASDAQ:AMGN) filed two inter partes review (IPR) petitions with the U.S. Patent and Trademark Office challenging patents from AbbVie Inc. (NYSE:ABBV) covering a formulation of Humira adalimumab. Amgen alleged that claims in U.S. Patents Nos. 8,916,157 and 8,916,158 are unpatentable on the grounds of obviousness, since the prior art taught a person of skill how to create the Humira formulation. Both patents were issued last year.

    Amgen has said it hopes to launch ABP 501, a biosimilar of Humira, in 2017. In February, ABP 501 met the primary endpoint of equivalence to Humira in a Phase III trial to treat moderate to severe rheumatoid arthritis (RA). Amgen said it plans to use trials of ABP 501 in RA and plaque psoriasis to support approval in Humira's other indications, including Crohn's disease, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and polyarticular juvenile idiopathic arthritis (see BioCentury Extra, Feb. 3).

    Humira sales were $3.1 billion in 1Q15, accounting for 62% of AbbVie's total net sales in that period. Patents covering the human mAb against tumor necrosis factor (TNF) alpha will begin to expire in December 2016.

  • Novartis acquires pain play Spinifex

    Novartis AG (NYSE:NVS; SIX:NOVN) will acquire chronic pain treatment developer Spinifex Pharmaceuticals Pty. Ltd. (Preston, Australia) for $200 million up front. Spinifex shareholders are eligible for undisclosed milestones. The companies expect the deal to close next half.

    Spinifex's lead candidate is EMA401, an angiotensin II type 2 (AT2) receptor (ATGR2) antagonist. Last year, EMA401 met the primary endpoint of reducing pain vs. placebo in a Phase II trial to treat postherpetic neuralgia (PHN). Spinifex said Novartis plans to begin Phase IIb studies to treat patients with PHN or painful diabetic neuropathy (PDN), and "pursue a broad peripheral neuropathic pain (PNP) label."

    Novartis spokesperson Eric Althoff told BioCentury the candidate would complement Novartis' existing neurology pipeline and its presence in chemotherapy, with potential for approval to treat chemotherapy-induced peripheral neuropathy (CIPN).

  • AMAG acquires Cord Blood Registry

    AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) will acquire stem cell company Cord Blood Registry (San Bruno, Calif.) for $700 million in cash. CBR stores more than 600,000 preserved umbilical cord blood and tissue stem cell units.

    AMAG said the deal will bolster its maternal health offerings. The company markets Makena hydroxyprogesterone caproate injection to reduce the risk of preterm birth in women who are pregnant with one baby and have spontaneously delivered one preterm baby in the past. AMAG obtained Makena when it acquired Lumara Health Inc. last fall (see BioCentury Extra, Sept. 29, 2014).

    Private equity firm GTCR acquired CBR in 2012. The company had $126 million in pro forma revenue in 2014; AMAG expects CBR to generate similar or slightly larger pro forma revenue in 2015.

    The deal is slated to close next quarter. AMAG said it has secured $800 million in debt funding from Jefferies and Barclays to fund the acquisition. Deutsche Bank and Jefferies advised AMAG, and Goodwin Procter was its counsel. Kirkland & Ellis served as counsel to GTCR and CBR.

    AMAG lost $3.22 to $67.14 on Monday.

  • Immunocore, Lilly partner for melanoma combos

    Immunocore Ltd. (Abingdon, U.K.) partnered with Eli Lilly and Co. (NYSE:LLY) to study combination regimens including Immunocore's IMCgp100 and Lilly's galunisertib (LY2157299) and merestinib (LY2801653) to treat melanoma.

    The companies will conduct a Phase Ib/II trial of IMCgp100 plus galunisertib to treat metastatic cutaneous melanoma, and a Phase Ib/II trial of IMCgp100 plus merestinib to treat metastatic uveal melanoma. Both trials are expected to begin in 2016. Immunocore and Lilly declined to disclose financial terms of the deal.

    IMCgp100 is a monoclonal T cell receptor anti-CD3 scFv fusion protein that activates T cells against silver homolog (SILV; PMEL17; GP100). Galunisertib is a transforming growth factor (TGF) beta receptor 1 (TGFBR1; ALK5) inhibitor and merestinib is a c-Met receptor tyrosine kinase (c-MET; MET; HGFR; c-Met proto-oncogene) inhibitor.

    Last year, Immunocore partnered with Lilly to use Immunocore's ImmTAC technology to discover and develop ImmTACs against three undisclosed oncology targets. ImmTACs are bispecific molecules consisting of a soluble monoclonal T cell receptor (mTCR) fused to an anti-CD3 antibody fragment that recruits T cells to the tumor (see BioCentury Extra, July 16, 2014).

    In April, Immunocore also partnered with the MedImmune unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) to conduct a Phase Ib/II trial combining IMCgp100 with MEDI4736 and/or tremelimumab to treat metastatic melanoma. MEDI4736 is a human IgG1 mAb targeting PD-L1 and tremelimumab is a human mAb against CTLA-4 (CD152).

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