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BioCentury Extra
As published Wednesday, May 06, 2015 7:30 PM PST

  • Alexion to acquire Synageva for $8.4B

    Synageva BioPharma Corp. (NASDAQ:GEVA) soared $107.52 (112%) to $203.39 on news that Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) will acquire the company for $115 in cash and 0.6581 Alexion shares per Synageva share, or about $8.4 billion total based on Alexion's Tuesday close. The offer is more than twice Synageva's market cap of $3.8 billion at market close Tuesday, before the deal was announced.

    The deal gives Alexion Kanuma seblipase alfa, a recombinant human lysosomal acid lipase (LAL) enzyme replacement therapy (ERT) under Priority Review by FDA and accelerated assessment by EMA to treat LAL deficiency. Its PDUFA date is Sept. 8. Alexion expects a decision in the EU next half.

    Alexion will also gain Synageva's SBC-103, a recombinant human N-acetylglucosaminidase alpha (NAGLU) in a Phase I/II trial for mucopolysaccharidosis IIIB (MPS IIIB, Sanfilippo B syndrome). Preliminary data from the trial are expected next half. Alexion will also acquire 12 preclinical programs from Synageva.

    Alexion CEO David Hallal said on a conference LAL deficiency is substantially under-diagnosed and that the company expects annual Kanuma revenues to eventually exceed $1 billion.

    Synageva was known as AviGenics Inc. before it was repurposed in 2008 into a Phase I rare disease play with senior managers from Alexion; Genzyme Corp., now a unit of Sanofi (Euronext:SAN; NYSE:SNY); and Roche (SIX:ROG; OTCQX:RHHBY). Synageva completed a reverse merger in 2011 with Trimeris Inc. Synageva has raised more than $1 billion in follow-ons since 2012.

    Alexion expects the acquisition to be accretive to non-GAAP EPS in 2018. The deal has been approved unanimously by both companies' boards and is slated to close mid-year.

    Synageva Chairman Felix Baker will join Alexion's board. Hedge fund Baker Brothers Advisors is Synageva's largest shareholder; as of April 10, the firm and its affiliates held 11.8 million of Synageva's 39.8 million outstanding shares.

    Lazard and JPMorgan is advising Alexion, and Wachtell, Lipton, Rosen & Katz is its counsel. Goldman Sachs is advising Synageva, and Sullivan & Cromwell and Ropes & Gray are its counsel.

    Alexion shed $13.55 (8%) to $155 on Tuesday, losing about $2.7 billion in market cap.

  • CAFC delays launch of Zarxio

    The U.S. Court of Appeals for the Federal Circuit (CAFC) granted a motion from Amgen Inc. (NASDAQ:AMGN) for a preliminary injunction against the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) that will delay the launch of Zarxio filgrastim-sndz, a biosimilar of Amgen's Neupogen filgrastim, until the court resolves Amgen's appeal.

    Amgen argued that it would suffer irreparable harm from price erosion upon Zarxio's launch. The CAFC did not provide a reason for its decision.

    In March, the U.S. District Court for the Northern District of California denied a basket of Amgen claims and motions and ruled in favor of Sandoz's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) (see BioCentury Extra, March 25).

    Amgen appealed the decisions to the CAFC, which is scheduled to hear oral arguments beginning June 3.

    Zarxio is the first approved biosimilar product in the U.S. Amgen was off $0.49 to $158.95 on Wednesday.

  • Gilead acquires EpiTherapeutics

    Gilead Sciences Inc. (NASDAQ:GILD) acquired epigenetics company EpiTherapeutics ApS (Copenhagen, Denmark) for $65 million in cash, subject to undisclosed adjustments.

    EpiTherapeutics is developing preclinical small molecule inhibitors of histone demethylases to treat cancer. Gilead declined to discuss its plans for EpiTherapeutics' candidates.

    Gilead President and COO John Milligan said last week during the company's 1Q15 earnings call that the company was interested in acquisitions, most likely of companies with later-stage candidates. The company also expressed an interest in epigenetic approaches to treating HBV.

    EpiTherapeutics' investors include Novo Seeds; Seed Capital; Lundbeckfond Emerge; MS Ventures; and Astellas Venture. The company closed its series A round in April 2014 with EUR 15.7 million ($21.2 million).

    Gilead shed $0.72 to $102.27 on Wednesday.

  • Juno meets its Fate in enhanced T cell therapy deal

    Fate Therapeutics Inc. (NASDAQ:FATE) jumped $2.28 (46%) to $7.24 on Wednesday after partnering with oncology company Juno Therapeutics Inc. (NASDAQ:JUNO). Fate will screen its library of small molecules to seek modulators that can enhance the activity of Juno's chimeric antigen receptor (CAR) and T cell receptor (TCR) therapies.

    Fate President and CEO Christian Weyer told BioCentury that the company is looking to improve the potency, persistence, proliferation and homing of Juno's T cell therapies. He said Fate's molecules work by up-regulating or down-regulating proteins on the surface of cells; he would not disclose which cell surface proteins the company intends to regulate, but said Fate previously demonstrated that one of its small molecules can dramatically up-regulate CXC chemokine receptor 4 (CXCR4; NPY3R), a protein involved in cell homing, on hematopoietic stem cells.

    Juno will pay Fate $5 million up front and purchase 1 million Fate shares at $8. Fate is also eligible for $50 million in milestones per program, based on target selection and clinical, regulatory and commercial events, plus low single-digit royalties.

    Juno will fund development and commercialization for the four-year term of the partnership, after which Juno has an option to extend the deal by two years.

    Juno's three most advanced programs -- JCAR017, JCAR015 and JCAR014 -- use autologous T cells expressing CARs specific to CD19 to treat hematologic malignancies.

    Juno gained $0.73 to $44.01 on Wednesday.

  • GSK opts to retain ViiV stake

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said in its 1Q15 earnings announcement that it will retain its holding in ViiV Healthcare, its HIV-focused joint venture with Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd. (Tokyo:4507).

    GSK CEO Andrew Witty said last fall the company was considering selling a minority stake via an IPO, likely no sooner than 2016, that would allow GSK to retain a majority stake in ViiV. GSK owns 78.3% of ViiV, while Pfizer has 11.7% and Shionogi 10% (see BioCentury Extra, Oct. 22, 2014).

    ViiV sales in 1Q15 were L446 million ($675.2 million), up 42% from 1Q14. The JV has rights to Tivicay dolutegravir and Triumeq dolutegravir/abacavir/lamivudine, which had sales of L112 million ($169.6 million) and L81 million ($122.6 million) in 1Q15.

    GSK said it based its decision in part on "clear scope to develop multiple dolutegravir-based regimens" to treat HIV.

  • Management tracks

    H. Lundbeck A/S (CSE:LUN) named Kare Schultz president and CEO, effective May 20. Schultz was president and COO at Novo Nordisk A/S (CSE:NVO; NYSE:NVO). He replaces Ulf Wiinberg, who resigned in November 2014.

    Endocrine play Versartis Inc. (NASDAQ:VSAR) named Jay Shepard president and CEO. Shepard, a former executive partner at Sofinnova Ventures, joined Versartis as executive chairman in 2014. Former CEO Jeffrey Cleland will remain as senior scientific advisor.

    Neurology company Neuralstem Inc. (NYSE-M:CUR) named Jonathan Lloyd Jones CFO. Lloyd Jones was CFO at Columbia Laboratories Inc., now known as Juniper Pharmaceuticals (NASDAQ:JNP).

    Erba Diagnostics Inc. (NYSE-M:ERB) named Ernesina Scala CFO, effective May 1, and Chandra Krishnan SVP of global sales, marketing and business development, effective April 20. Scala was senior director of finance and CFO at Tyco International Ltd. (NYSE:TYC). Krishnan was head of marketing and corporate strategy at the Qiagen GmbH subsidiary of Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN).

  • Ardelyx falls on CKD trial miss

    Ardelyx Inc. (NASDAQ:ARDX) lost $2.61 (24%) to $8.30 on Wednesday after its tenapanor (AZD1722) missed the primary endpoint in a Phase IIa trial to treat chronic kidney disease (CKD) stage 3 in patients with Type II diabetes.

    In the 154-patient trial, tenapanor did not significantly reduce urinary albumin/creatine ratio vs. placebo from baseline to week 12 (16% vs. 11%) . Ardelyx did not provide a p-value.

    Ardelyx reported an increased incidence of diarrhea in the trial, but otherwise said the compound was well-toleated.

    AstraZeneca plc (LSE:AZN; NYSE:AZN) has exclusive, worldwide rights to tenapanor under an October 2012 deal covering Ardelyx's NHE3 inhibitor programs. AZ has until June 29 to decide whether to continue development of the small molecule inhibitor of non-absorbed solute carrier family 9 sodium hydrogen exchanger member 3 (SLC9A3; NHE3).

    The partners are developing tenapanor in three indications: CKD, hyperphosphatemia and constipation predominant irritable bowel syndrome (IBS-C).

    AZ spokesperson Blake Swagler told BioCentury the pharma is "exploring the data" and will work with Ardelyx to decide the next steps. Ardelyx would receive a $10 million milestone if AZ decides to continue development in IBS-C and a separate $20 million milestone for any other indication or multiple indications.

    On Feb. 2, Ardelyx said tenapanor met the primary endpoint in a Phase IIb trial to treat hyperphosphatemia, but the trial showed a higher than expected rate of diarrhea. At the time, Ardelyx CFO Mark Kaufmann said AZ would not decide whether to start a Phase III trial in hyperphosphatemia until it was able to review the results of the Phase IIa CKD trial (see BioCentury Extra, Feb. 2).

    Last October, tenapanor met the primary endpoint of increasing complete spontaneous bowel movement (CSBM) responder rate in a Phase IIb trial to treat IBS-C. In the event that AZ does not continue development in IBS-C, Ardelyx said it would start a Phase III trial in 4Q15 in the indication (see BioCentury Extra, Oct. 1, 2014).

  • Adaptive Biotechnologies raises $195M series F

    Adaptive Biotechnologies Corp. (Seattle, Wash.) raised $195 million in a series F round, the third largest disclosed venture round for a biotech this year. Matrix Capital Management led Adaptive's round; other new investors Senator Investment Group, Tiger Management, Rock Springs Capital and an undisclosed investor participated, as did existing investors Viking Global, Casdin Capital and Alexandria Real Estate Equities.

    Adaptive uses high throughput sequencing and bioinformatics technologies to profile T and B cell receptors. In addition to using the F round proceeds to develop clinical and research-only diagnostics, the company also plans to use apply its immunosequencing technology for target discovery.

    "The first step in therapeutics is moving into adoptive T cell therapy as a discovery partner," President and CEO Chad Robins told BioCentury. "It remains to be seen whether we'll take some programs in-house down the road."

    The largest biotech venture financing of 2015 remains the $450 million round by Moderna Therapeutics Inc. (Cambridge, Mass.) in January. Last week, Intarcia Therapeutics Inc. (Boston, Mass.) raised $225 million in a royalty deal that gives its investors the option to convert their royalty stakes into equity (see BioCentury, May 4).

  • IPO roundup: Adaptimmune, CoLucid, OpGen, HTG

    Cancer immunotherapy company Adaptimmune Therapeutics plc (NASDAQ:ADAP), migraine treatment developer CoLucid Pharmaceuticals Inc. (NASDAQ:CLCD), diagnostics company OpGen Inc. (NASDAQ:OPGN), and HTG Molecular Diagnostics Inc. (NASDAQ:HTMG) all lost ground in their first days of trading after going public this week.

    Adaptimmune lost $1 to $16 in its first day of trading Wednesday after raising $191.3 million through the sale of 11.3 million ADSs at $17 in an upsized IPO underwritten by BofA Merrill Lynch; Cowen; Leerink; and Guggenheim Securities. The IPO price valued Adaptimmune at $1.2 billion. Adaptimmune said last month it hoped to sell 9.4 million ADSs at $15-$17. At 9.4 million ADSs and a midpoint of $16, it would have raised $150 million and been valued at $1.1 billion. The company is conducting Phase I/II studies of its lead candidate, an enhanced T cell receptor (TCR) therapy targeting cancer/testis antigen 1B (CTAG1B; NY-ESO-1), to treat solid tumors and hematologic malignancies.

    CoLucid tumbled $2 (20%) to $8 in its first day of trading Wednesday after it raised $55 million through the sale of 5.5 million shares at $10 in an IPO underwritten by Piper Jaffray; Stifel; William Blair; and Ladenburg Thalmann. The offering price valued CoLucid at $151.4 million. Last month, CoLucid said it hoped to sell 5.4 million shares at $13-$15. At $14, it would have raised $75 million and been valued at $210 million. The company expects data in 3Q16 from the Phase III SAMURAI trial of lasmiditan (COL-144), its oral selective agonist of serotonin (5-HT1F) receptor, to treat acute migraine.

    OpGen lost $0.20 to $4.65 on Wednesday after shedding $1.15 (19%) in its first day of trading Tuesday. The company raised $17.1 million through the sale of 2.9 million units at $6 in an IPO underwritten by Maxim Group and National Securities. Each unit comprises a share and a five-year warrant to purchase another share at $6.60. The offering price valued OpGen at $64.3 million. Last month, it had hoped to sell 3.8 million shares at $8-$10; at $9, it would have raised $34.2 million and been valued at $104.6 million. OpGen markets tests for multi-drug resistant bacterial infections.

    HTG lost $0.23 to $13.77 in its first day of trading Wednesday. The company raised $50 million through the sale of 3.6 million shares at $14 in an IPO underwritten by Leerink; Canaccord; and JMP Securities. The deal price valued HTG at $94.5 million. HTG markets the HTG Edge platform to automate molecular profiling of genes and gene activity.

  • FDA reviewers propose routes to Ebola vaccine approval

    FDA's Vaccines and Related Biological Products advisory committee will meet on May 12 to discuss the types of efficacy data that can be used to support the approval of Ebola vaccines. In briefing documents released ahead of Tuesday's meeting, FDA reviewers said the direct evaluation of Ebola vaccines using clinical endpoint studies may not be feasible due to a significant decline in Ebola infection rates.

    Reviewers said approval can be based on human trials using a surrogate endpoint, such as immune response, that is "reasonably likely" to predict clinical benefit.

    Alternatively, reviewers said Ebola vaccine approval can be based on animal studies if safety has been established in human studies and results of the animal studies show the vaccine is "reasonably likely" to lead to a clinical benefit in humans. If animal studies are used to support approval, the reviewers said post-marketing studies must be conducted to verify clinical benefit when they are feasible and ethical.

  • Market Entry Strategy and Planning with Campbell Alliance

    Find a commercialization partner, or go it alone? This decision involves not only strategic questions regarding a company's identity and core competencies, but also multiple value drivers that are easy to overlook. This article examines how a value-based approach can help companies position themselves to ensure their business plans contribute to a product's success and an improved return on investment. Download your copy now!

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