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BioCentury Extra
As published Monday, September 29, 2014 7:30 PM PST

  • CVR boosts Ambit in Daiichi Sankyo deal

    Daiichi Sankyo Co. Ltd. (Tokyo:4568) will acquire Ambit Biosciences Corp. (NASDAQ:AMBI) for up to $410 million. The deal includes $315 million in upfront cash, or $15 per share, plus $95 million in commercial milestones in the form of a contingent value right (CVR) worth up to $4.50 per share.

    Ambit closed up $7.14 (87%) to $15.34 on Monday's news.

    The biotech's lead candidate is quizartinib (AC220), an oral small molecule FMS-like tyrosine kinase 3 (FLT3; CD135) inhibitor. It is in Phase III trials to treat relapsed or refractory acute myelogenous leukemia (AML) in patients with FLT3 mutations, with the study expected to be completed in 2016-17. Quizartinib has Orphan Drug designation for the indication from FDA and European Commission.

    The upfront is an 83% premium to Ambit's closing price of $8.20 last Friday, but still below the stock's 52-week high of $21.44 in October 2013. Ambit fell sharply last December after FDA turned down the company's request to submit quizartinib under accelerated approval using a novel surrogate endpoint, complete remission with incomplete hematologic recovery (CRi), and dipped below $5 in July.

    Ambit raised $65 million in an IPO in May 2013 through the sale of 8.1 million shares at $8 per share.

    Centerview Partners and Leerink Partners LLC were Ambit's financial advisors, and Cooley LLP was its counsel. Simpson Thacher & Bartlett LLP was Daiichi Sankyo's counsel. The transaction is expected to close by year end.

  • AMAG gains on M&A deal to add Makena

    AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) jumped $6.54 (28%) to $29.72 Monday on news it agreed to acquire the maternal health business of Lumara Health Inc. (Chesterfield, Mo.) -- once known as KV Pharmaceutical Co. -- for $675 million in cash and stock, plus $350 million in potential sales milestones. AMAG will gain ownership of Lumara's Makena hydroxyprogesterone caproate injection to prevent preterm birth.

    AMAG will pay $600 million in cash and issue 3.2 million new shares, worth about $74.4 million based on Friday's closing price of $23.18. It has arranged for $340 million in debt from Jefferies Finance LLC to finance the transaction.

    The deal includes up to $300 million in milestone payments based on Makena annual sales thresholds of up to $500 million, plus a $50 million milestone if Makena sales exceed $200 million every year from 2015 to 2019. AMAG said product sales were more than $130 million in the 12 months ended Aug. 31.

    Makena is a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P). KV generated controversy when it gained FDA approval and Orphan Drug status for its formulation in 2011, and priced Makena well above versions created by compounding pharmacies. The company filed for Chapter 11 bankruptcy protection in 2012, saying FDA had not enforced Makena's market exclusivity. It emerged from Chapter 11 in September 2013 (see BioCentury Extra, Sept. 16, 2013).

    AMAG's lead marketed product is Feraheme ferumoxytol, which recorded $39.6 million in sales in 1H14. The product is approved in the U.S. to treat iron deficiency anemia in patients with chronic kidney disease (CKD).

    Separately, Perrigo Co. plc (NYSE:PRGO; Tel Aviv:PRGO) acquired Lumara's over-the-counter women's healthcare business for $82 million, giving it rights to Clindesse clindamycin phosphate and Gynazole-1 butoconazole nitrate vaginal creams and Evamist estradiol transdermal spray.

    The AMAG transaction is expected to close by year end.

  • EMA validates Opdivo MAA

    Bristol-Myers Squibb Co. (NYSE:BMY) said EMA validated an MAA for Opdivo nivolumab to treat non-small cell lung cancer (NSCLC). The pharma said the application is the "first completed regulatory submission" for a PD-1 inhibitor in that tumor type.

    Opdivo, a human IgG4 mAb against programmed cell death 1 (PDCD1; PD-1; CD279), already is under EMA review to treat advanced melanoma. By year end, BMS intends to complete an ongoing submission of a rolling BLA to FDA for Opvido as a third-line treatment for squamous cell NSCLC.

    BMS also said patients treated with Opdivo showed an overall response rate of 32% compared to 11% in patients treated with investigator's choice chemotherapy in a Phase III trial to treat advanced melanoma patients previously treated with BMS's Yervoy ipilimumab. BMS presented the interim data at the European Society for Medical Oncology (ESMO) Congress in Madrid.

    BMS was up $0.61 to $51.71 on Monday.

  • Alimera gains on Iluvien approval

    Alimera Sciences Inc. (NASDAQ:ALIM) added $0.41 to $5.33 on Monday after FDA approved Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema in patients who have been previously treated with corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).

    Alimera plans to launch Iluvien in the U.S. in 1Q15.

  • Genentech unveils OS benefit for Perjeta combo

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) presented Phase III data showing that Perjeta pertuzumab in combination with Herceptin trastuzumab and docetaxel chemotherapy increased the overall survival (OS) of patients with previously untreated HER2-positive metastatic breast cancer (MBC) by 15.7 months compared to Herceptin plus chemotherapy.

    The combination of Perjeta plus Herceptin and chemotherapy had already met the primary endpoint of progression-free survival (PFS) compared to Herceptin plus chemotherapy, and has been approved in the U.S. and EU in these patients.

    Median OS, a secondary endpoint, became available after a median follow-up of 50 months. Overall survival with Perjeta was 56.5 months compared to 40.8 months without it. Genentech presented the data at the European Society for Medical Oncology (ESMO) Congress in Madrid.

    Perjeta is a mAb HER dimerization inhibitor that prevents HER2 from binding to other HER receptors (HER1/EGF, HER3, and HER4). Herceptin is a humanized mAb against HER2. The triple combination with chemo also received accelerated approval from FDA in October 2013 for neoadjuvant breast cancer.

  • PARP ovarian data boosts Clovis

    Clovis Oncology Inc. (NASDAQ:CLVS) gained $5.59 (13%) to $48.08 on Monday after presenting results from two trials evaluating rucaparib (CO-338) for platinum-sensitive ovarian cancer at the European Society of Medical Oncology (ESMO) Congress in Madrid.

    The oral inhibitor of poly(ADP-ribose) polymerase-1 (PARP-1) and PARP-2 achieved disease control rates of 93% in 20 patients with germline breast cancer early onset (BRCA) mutations in the Phase II portion of a Phase I/II trial evaluating 600 mg given twice daily.

    Clovis also announced preliminary results from its Phase II ARIEL2 trial, which showed that combining tumor BRCA1/2 mutation status with genomic loss of heterozygosity (LOH) analysis may help predict which ovarian cancer patients are likely to respond to rucaparib. The study assay segments patients into three potentially rucaparib-sensitive populations: BRCA mutant with high genomic LOH, BRCA mutant with low genomic LOH, and BRCA wild-type with high genomic LOH. Initial efficacy data from ARIEL2 will be presented in November.

    Clovis has exclusive, worldwide rights to develop and commercialize rucaparib under a 2011 deal with Pfizer Inc. (NYSE:PFE).

  • Seattle Genetics: More Adcetris data at ASH

    Seattle Genetics Inc. (NASDAQ:SGEN) was off $2.98 to $38.30 on Monday after reporting Adcetris brentuximab vedotin met the primary endpoint of improving progression-free survival (PFS) vs. placebo (HR=0.57, p=0.001) in the Phase III AETHERA trial to treat patients with Hodgkin's lymphoma (HL) who are at risk of progression following an autologous stem cell transplant (ASCT). The company said the data equate to a 75% gain in PFS for the treated arm.

    No statistically significant difference was seen between the two treatment arms in an interim analysis of overall survival (OS). On a conference call, Seattle Genetics deferred several analyst questions about the OS results, noting that median OS has not been reached and the next readout would be expected in 2016. The company said the next AETHERA presentation, at the American Society of Hematology (ASH) meeting in December, would provide details on the PFS data and safety results.

    In response to a question from Lisa Zhang of Goldman Sachs, the company noted the placebo arm was "roughly" in line with historical data showing about 50% of patients progress at about 12 months.

    Seattle Genetics plans to meet with FDA by year end to discuss submission of an sBLA in 1H15. The antibody-drug conjugate (ADC) comprising an anti-CD30 mAb and monomethyl auristatin E (MMAE) is approved in 45 countries including the U.S. to treat relapsed HL and systemic anaplastic large cell lymphoma. Seattle Genetics has exclusive rights to commercialize Adcetris in the U.S. and Canada. Partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) has commercialization rights elsewhere.

  • Tonix plummets on Phase IIb miss

    Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) fell $7.01 (50%) to $6.95 on Monday after its TNX-102 SL missed the primary endpoint in a Phase IIb trial to treat fibromyalgia.

    In the 205-patient BESTFIT study, 2.8 mg of the sublingual formulation of cyclobenzaprine given before bed failed to reduce average daily pain scores from baseline to 12 weeks compared to placebo.

    In a conference call, Tonix CEO Seth Lederman said the company plans to pursue a Phase III trial based on improvements in several secondary endpoints, and will meet with FDA to discuss an appropriate primary endpoint for the trial.

    The company also plans to launch a Phase II trial in 4Q14 of TNX-102 SL to treat sleep disturbances in patients with post-traumatic stress disorder (PTSD).

  • Catalyst's Firdapse meets in LEMS Phase III

    Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX) said its oral potassium channel blocker Firdapse amifampridine met the co-primary endpoints in a Phase III trial to treat Lambert-Eaton myasthenic syndrome (LEMS). In the 38-patient study, Firdapse improved scores vs. placebo on the change in subject global impression and quantitative myasthenia gravis scales (p=0.0028 and p=0.0452, respectively).

    Firdapse has breakthrough designation in the U.S., where Catalyst plans to submit a rolling NDA to FDA in early 2015. Catalyst obtained North American rights to Firdapse from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) in 2012.

    The news was announced after market close on Monday. Catalyst was up a penny to $2.99 on the day. BioMarin was up $0.64 to $73.

  • NeuroSigma sets IPO range

    NeuroSigma Inc. (Los Angeles, Calif.) amended its IPO on NASDAQ and now plans to sell 3.6 million shares at $13-$15. At $14, NeuroSigma would raise $50 million and be valued at $176.9 million. The company filed last month to raise up to $50 million. Jefferies; BTIG; and Craig-Hallum Capital Group are underwriters.

    NeuroSigma markets its Monarch external trigeminal nerve stimulation (eTNS) system in the EU, Canada and Australia for drug-resistant epilepsy and in the EU and Canada for major depressive disorder (MDD). Monarch comprises external electrodes placed on the forehead and a pulse generator. The company also is developing a second-generation system.

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