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BioCentury Extra
As published Friday, June 26, 2015 5:42 PM PST


  • Seres posts big gain after upsized IPO

    Seres Therapeutics Inc. (NASDAQ:MCRB) gained $33.40 (186%) to $51.40 after raising $133.7 million through the sale of 7.4 million shares at $18 in a bumped-up IPO underwritten by Goldman Sachs; BofA Merrill Lynch; Leerink; and Canaccord.

    The IPO price valued the microbiome company at $681 million. Seres ended the day with a market cap of $1.9 billion.

    Seres said earlier this month it hoped to sell 6.3 million shares at $15-$17. At the midpoint, Seres would have raised $100 million and been valued at $586.5 million.

    In mid-2016, Seres expects data from a Phase II study of lead candidate SER-109 to treat recurrent Clostridium difficile infections. The oral mixture of microbiome organisms has breakthrough designation from FDA.

    Seres emerged from the Flagship VentureLabs incubator in 2013. Affiliates of Flagship Ventures held a 55% stake in Seres before the IPO, and a 44% stake after it.

  • CHMP backs therapies from Alexion, Novartis, Santhera

    EMA's CHMP issued several recommendations on Friday, backing approval of MAAs for candidates from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Novartis AG (NYSE:NVS; SIX:NOVN) and Santhera Pharmaceuticals Holding AG (SIX:SANN).

    CHMP recommended approval of Alexion's Strensiq asfotase alfa to treat bone manifestations of pediatric-onset hypophosphatasia. EMA is reviewing the compound under accelerated assessment. The fusion protein incorporating the catalytic domain of human tissue non-specific alkaline phosphatase (TNSALP; ALPL) and a bone-targeting peptide is under Priority Review by FDA. CHMP recommended Strensiq's approval under EMA's exceptional circumstances clause; CHMP required that Alexion collect further efficacy and safety data.

    The committee also backed approval of Alexion's Kanuma sebelipase alfa to treat lysosomal acid lipase (LAL) deficiency. EMA is reviewing the recombinant human LAL enzyme replacement therapy (ERT) under accelerated assessment; it is under Priority Review by FDA. Both Strensiq and Kanuma have Orphan Drug designation in the U.S. and EU, as well as Fast Track and breakthrough therapy designations in the U.S. Alexion gained rights to Kanuma via its acquisition of Synageva BioPharma Corp., which closed earlier this week.

    CHMP recommended approval of Novartis' Farydak panobinostat in combination with Velcade bortezomib and dexamethasone to treat adults with relapsed and/or refractory multiple myeloma (MM) who have received at least two prior regimens including bortezomib. FDA approved the oral pan-deacetylase (DAC) inhibitor earlier this year. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Johnson & Johnson (NYSE:JNJ) market Velcade.

    The committee backed approval of Santhera's Raxone idebenone to treat visual impairment in adolescent and adult patients with Leber's hereditary optic neuropathy (LHON). Santhera withdrew an MAA for Raxone in 2013 after CHMP said the benefits of the compound did not outweigh the risks. The short-chain benzoquinone has Orphan Drug designation in the U.S. and EU for LHON. CHMP recommended Raxone's approval under its exceptional circumstances clause; Santhera said it would gather additional long-term efficacy and safety data.

  • EMA to review drisapersen, Galafold, Alprolix

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said EMA accepted for review an MAA for drisapersen to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. In April, BioMarin completed submission of a rolling NDA to FDA for the antisense oligoribonucleotide that induces exon 51 skipping on the dystrophin gene. Drisapersen 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 (see BioCentury Extra, April 27). BioMarin slipped $0.52 to $134.84 on Friday.

    Amicus Therapeutics Inc. (NASDAQ:FOLD) said EMA accepted for review its MAA for Galafold migalastat to treat Fabry's disease in patients with amenable genetic mutations. Last month, EMA's CHMP granted accelerated assessment to Galafold. Next half, Amicus plans to submit an NDA to FDA and seek accelerated approval for the small molecule that enhances alpha galactosidase A activity. Amicus rose $0.39 to $14.05 on Friday.

    Biogen Inc. (NASDAQ:BIIB) and Swedish Orphan Biovitrum AB (SSE:SOBI) said EMA accepted for review an MAA for Alprolix to treat hemophilia B. Swedish Orphan has a pending option to assume final development and commercialization of Alprolix in the EU, Russia and certain countries in the Middle East and North Africa. The recombinant fusion protein consisting of human coagulation Factor IX attached to the Fc domain of human IgG1 is approved in the U.S., Australia, Canada and Japan. Biogen dipped $2.56 to $408.73 on Friday, while Swedish Orphan gained EUR 2.90 to EUR 111.20.

  • Actelion, Max Planck launch vaccine play Vaxxilon

    Actelion Ltd. (SIX:ATLN) and the Max Planck Society launched Vaxxilon AG (Reinach, Switzerland), a newco focused on developing synthetic carbohydrate vaccines.

    Vaxxilon licensed exclusive rights to multiple preclinical vaccine candidates against undisclosed targets from the Max Planck Society and plans to have its first candidate in the clinic within three years. Actelion will invest EUR 30 million ($34 million) into Vaxxilon over the next three to four years.

    Actelion executive Tom Monroe will lead Vaxxilon. David Stout will be the startup's chairman. Stout, an Actelion director, was president of pharmaceutical operations at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

  • Management tracks

    CNS company KemPharm Inc. (NASDAQ:KMPH) promoted LaDuane Clifton to CFO from VP of finance and corporate controller. He replaces Gordon Johnson, who became CBO.

    Food allergy company DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) named Hugh Sampson CSO, effective Nov. 1. Sampson is a professor of pediatrics and director of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai (New York, N.Y.).

    Drug delivery play Flamel Technologies S.A. (NASDAQ:FLML) named Sandy Hatten SVP of quality and regulatory affairs. Hatten was SVP of quality at Mallinckrodt plc (NYSE:MNK).

  • Alder raises $200M in follow-on

    Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) raised $200 million through the sale of 4.5 million shares at $44.50 in a follow-on underwritten by Credit Suisse; Leerink; Wells Fargo; and Bernstein. Alder proposed the offering after market close on Wednesday, when its share price was $49.82.

    The follow-on is Alder's second of 2015. It raised $203.6 million in January.

    The company said it had received input from FDA on a development plan that would support a BLA submission of IV ALD403. In 2H15, the company plans to begin a Phase III trial of the mAb targeting calcitonin gene-related peptide (CGRP) to treat high frequency migraine, and intends to start a second Phase III study next year to treat chronic migraine. Both studies will evaluate change in migraine days among patients receiving ALD403 vs. placebo

    Alder shed $0.05 to $45.64 on Friday.

  • Highland raises $25M in venture round

    Highland Therapeutics Inc. (Toronto, Ontario) raised $25 million in a venture round led by Eastern Capital. Highland CFO Nelson Isabel declined to disclose whether other investors participated.

    Highland develops modified-release formulations of approved drugs that are intended for nighttime dosing with onset prior to awakening. Isabel said Highland plans to begin a pivotal trial "in the next month or so" of HLD-200, a modified-release formulation of the generic methylphenidate, to treat ADHD. By year end, the company plans to start a Phase IIb trial of HLD-100, a reformulated amphetamine, to treat ADHD.

    Citibank also provided a $25 million credit facility to the company.

  • Financial tracks

    Jefferies hired Brian Abrahams as a managing director in biotechnology equity research. Abrahams was a managing director and senior biotechnology analyst at Wells Fargo.

  • Industry voices opposition to Innovation Act

    The Biotechnology Industry Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Venture Capital Association (NVCA) were among several trade organizations that issued a joint statement opposing the Innovation Act (H.R. 9).

    The proposed legislation, which the U.S. House Judiciary Committee passed earlier this month, includes a provision that would prevent parties such as hedge funds from using the inter partes review (IPR) system to manipulate financial markets (see BioCentury Extra, June 11).

    The trade groups' statement said the Innovation Act "fails to adequately address abusive practices against legitimate patent owners." According to the groups, the bill could be considered by the full House as early as the week of July 6.

    Earlier this month, the U.S. Senate Judiciary Committee endorsed companion legislation, the Patent Act (S. 1137), though the bill's sponsors said they intend to modify IPR provisions to address the life sciences industry's concerns prior to a vote by the full Senate (see BioCentury Extra, June 4).

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