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BioCentury Extra
As published Friday, January 23, 2015 6:16 PM PST

  • FDA approves NPS's Natpara with boxed warning

    FDA approved Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The recombinant human parathyroid hormone 1-84 (PTH) is the first parathyroid hormone approved for the indication.

    NPS said it plans to launch Natpara in 2Q15. The drug, known in Europe as Natpar, is under EMA review. It has Orphan drug designation in both the U.S. and EU.

    Natpara's label carries a boxed warning noting a risk of osteosarcoma. The drug's use is restricted to patients who cannot be adequately controlled on calcium and vitamin D, and its availability will be restricted under a REMS.

    Last September, FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 8-5 to recommend approval of Natpara (see BioCentury Extra, Sept. 12, 2014).

    Shire plc (LSE:SHP; NASDAQ:SHPG) said last week it will acquire NPS for $46 per share, or $5.2 billion in cash (see BioCentury Extra, Jan. 12).

    The news came after market close on Friday. NPS was flat at $45.64 during the day, while Shire gained $2.27 to $216.03.

  • Array acquires BRAF inhibitor from Novartis

    Array BioPharma Inc. (NASDAQ:ARRY) surged $2.06 (41%) to $7.11 after gaining worldwide rights to encorafenib (LGX818) from Novartis AG (NYSE:NVS; SIX:NOVN). Array said it will make a "de minimis" upfront payment to Novartis, but the deal does not include milestones or royalties.

    Last month, Novartis returned to Array rights to oral small molecule selective MEK1 and MEK2 inhibitor binimetinib in the aftermath of Novartis' asset-swapping deal with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (BioCentury Extra, Dec. 3, 2014).

    Novartis will continue to conduct and fund the Phase III COLUMBUS trial of encorafenib plus binimetinib to treat BRAF-mutant melanoma through the completion of last patient first visit, but no later than June 30, 2016.

    Encorafenib, an oral BRAF inhibitor, is also in clinical testing as monotherapy and in combination with other agents to treat BRAF+ metastatic colorectal cancer and BRAF+ solid tumors. Novartis will conduct and fund all other ongoing encorafenib trials through no later than Dec. 31, 2015. After the encorafenib trials are transferred to Array, Novartis will reimburse Array for out-of-pocket costs and half of the FTE costs to complete each study.

    Novartis will continue to supply Array with encorafenib for clinical and commercial needs for up to 30 months after closing and give Array access to its pipeline compounds for combination studies with encorafenib.

    Array said it intends to find an "experienced partner" for global development and European commercialization of both encorafenib and binimetinib. If Array is unable to find a partner within a specified, undisclosed time period, a trustee may sell the company's European rights to the compounds.

    The deal is contingent on the closing this half of Novartis' pharma asset swap with GSK, in which Novartis gained 11 marketed cancer drugs and a Phase II candidate for ovarian cancer (see BioCentury, April 28, 2014).

  • Medicines Co. scores CHMP hat trick

    EMA's CHMP recommended marketing authorization of three candidates from The Medicines Co. (NASDAQ:MDCO): Kengrexal cangrelor to reduce thrombotic cardiovascular events, Orbactiv oritavancin to treat acute bacterial skin and skin structure infections (ABSSSIs), and Raplixa as a supportive treatment to improve hemostasis where standard surgical techniques are insufficient.

    Medicines Co. said CHMP based its approval of Kengrexal, a reversible purinergic receptor P2Y G protein-coupled 12 (P2RY12; P2Y12) antagonist, on results from the 11,145-patient Phase III CHAMPION PHOENIX trial, in which Kengrexal followed by Plavix clopidogrel met the primary composite endpoint of reducing all-cause mortality, MI, ischemia-driven revascularization and stent thrombosis at 48 hours vs. clopidogrel alone in patients undergoing percutaneous coronary intervention (PCI).

    Spokesperson Robert Laverty said Medicines Co. responded in December to a complete response letter it received from FDA in August for cangrelor (see BioCentury Extra, May 1, 2014).

    CHMP based its recommendation of Orbactiv oritavancin, a semi-synthetic lipoglycopeptide antibiotic, on results from the Phase III SOLO I and SOLO II trials, in which a single 1,200 mg IV dose of Orbactiv demonstrated non-inferiority to 7-to-10 days of twice-daily vancomycin in patients with ABSSSIs.

    FDA approved Orbactiv in August to treat ABSSSIs caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). It has Qualified Infectious Disease Product (QIDP) status (see BioCentury Extra, Aug. 6, 2014).

    CHMP based its recommendation of Raplixa, a dry powder topical fibrin sealant composed of fibrinogen and thrombin, on the Phase III FINISH-3 trial, which compared Raplixa plus gelatin sponge vs. gelatin sponge alone as a hemostat in four surgical indications including spinal surgery, hepatic resection, vascular surgery and soft tissue dissection.

    A BLA for Raplixa is under FDA review. The PDUFA date was Jan. 31, but Laverty said the agency recently notified the company it is extending the date by up to three months.

    Laverty said Medicines Co. plans to partner all three compounds in Europe.

    The Medicines Co. closed up $0.90 to $28.40 on Friday.

  • CHMP recommends Sivextro for ABSSSI

    EMA's CHMP recommended marketing authorization of oral and IV Sivextro tedizolid from Merck & Co. Inc. (NYSE:MRK) to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. CHMP said the authorization would include a pharmacovigilance plan. Merck obtained rights to Sivextro earlier this week when it completed its acquisition of Cubist Pharmaceuticals Inc. (see BioCentury, Dec. 15, 2014).

    FDA approved the second-generation oxazolidinone that inhibits bacterial protein biosynthesis last June to treat ABSSSI caused by susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) (see BioCentury Extra, June 20, 2014).

    Cubist gained Sivextro through its 2013 acquisition of Trius Therapeutics Inc.

  • FDA approves Novartis' meningitis B vaccine

    FDA approved Bexsero from Novartis AG (NYSE:NVS; SIX:NOVN) to prevent invasive meningococcal disease caused by serogroup B in individuals aged 10-25. The multicomponent meningococcal serogroup B vaccine had breakthrough therapy designation in the U.S. and had already been approved under a treatment IND in the U.S. as part of vaccination programs at two universities.

    Bexsero is slated to launch this quarter. Spokesperson Elizabeth Power said Novartis will announce a price in about two weeks.

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) is buying Novartis' vaccines business, including Bexsero, while Novartis is acquiring GSK's portfolio of marketed cancer products in an asset swap. The deals are slated to close in 1H15 (see BioCentury, April 28, 2014).

    In October, FDA approved Trumenba from Pfizer Inc. (NYSE:PFE) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25. Trumenba, which also had breakthrough therapy designation, is a bivalent meningococcal B vaccine targeting LP2086 (factor Hbinding protein) (see BioCentury Extra, Oct. 29, 2014).

  • Funding roundup: Auspex, Radius, Zafgen, Otonomy, Verastem, Vitae

    Auspex Pharmaceuticals Inc. (NASDAQ:ASPX), Radius Health Inc. (NASDAQ:RDUS), Zafgen Inc. (NASDAQ:ZFGN), Otonomy Inc. (NASDAQ:OTIC), Verastem Inc. (NASDAQ:VSTM) and Vitae Pharmaceuticals Inc. (NASDAQ:VTAE) have raised more than $600 million in follow-on offerings since market close on Thursday. The flurry puts an exclamation point on what was already one of biotech's strongest money-raising weeks in history.

    Auspex raised $169.5 million through the sale of 3 million shares at $56.50. Existing shareholders sold another 1 million shares in the offering. JPMorgan; Stifel; BMO Capital Markets; Baird; and William Blair were underwriters. Auspex proposed the offering after market close on Wednesday when its shares were valued at $62.83. The company gained $1.56 to $58.46 on Friday. Auspex nearly doubled in value on Dec. 17, 2014, after its SD-809 met the primary endpoint in a Phase III trial to treat chorea associated with Huntington's disease (see BioCentury Extra, Dec. 16, 2014).

    Radius raised $147 million through the sale of 4 million shares at $36.75. Underwriters were Goldman Sachs; BofA Merrill Lynch; and Cowen. The company proposed its offering after market close on Tuesday when its shares were $39.37. Radius gained $1.14 to $38.65 on Friday. Last month, its abaloparatide-SC met the primary endpoint of a Phase III study to reduce fractures in postmenopausal osteoporosis (see BioCentury Extra, Dec. 22, 2014).

    Zafgen raised $138 million by selling 3.9 million shares at $35. Leerink; Cowen; Canaccord Genuity; and JMP Securities were underwriters. The company proposed its offering after market on Tuesday when its shares closed at $35.79. Zafgen gained $1.90 to $38.97 on Friday. Earlier this month, its beloranib met the primary endpoint of weight reduction in a Phase II trial to treat adults with hypothalamic injury associated obesity (HIAO) (see BioCentury Extra, Jan. 7).

    Otonomy raised $74.6 million through the sale of 2.6 million shares at $29.25. Underwriters were JPMorgan; Piper Jaffray; Cowen; and Sanford C. Bernstein. Otonomy proposed the offering on Jan. 8, when its stock was valued at $35.66. Its shares rose $3.59 (12%) to $32.93 on Friday. Otonomy raised $100 million in a bumped-up IPO last August (see BioCentury Extra, Aug. 13, 2014).

    Verastem raised $47.1 million through the sale of 7.3 million shares at $6.50. Jefferies; Leerink; Guggenheim; and Oppenheimer were underwriters. Verastem proposed the offering post-market on Tuesday when its shares finished at $8.99. The company gained $0.58 to $7.58 on Friday. Its lead program, defactinib (VS-6063), is in Phase II studies to treat mesothelioma and non-small cell lung cancer (NSCLC).

    Vitae raised $35.7 million through the sale of 3 million shares at $11.90. Stifel; BMO Capital Markets; Piper Jaffray; JMP Securities; and Wedbush PacGrow Life Sciences were underwriters. Vitae proposed the offering before market open on Jan. 8, when its share price was $18.39. The company climbed $2.95 (25%) to $14.94 on Friday. Last September, Vitae raised $55 million in its IPO (see BioCentury Extra, Sept. 24, 2014).

    In total, biotechs raised about $2.6 billion in follow-ons this week.

  • Gene therapy newco Genenta raises EUR 6.2M toward series A

    Gene therapy newco Genenta Science s.r.l. (Milan, Italy) raised EUR 6.2 million ($7.2 million) in a series A round from undisclosed private investors including individuals, entrepreneurs, managers and family offices. Chairman and CEO Pierluigi Paracchi told BioCentury the company expects to close the round at EUR 10 million ($11.6 million) within a month.

    Paracchi said the company's key IP is an miRNA-based method of regulating interferon-alpha expression that was developed at San Raffaele Hospital in the lab of Luigi Naldini, the chairman of Genenta's scientific advisory board. Genenta uses lentiviral vectors to transfer the IFN-alpha gene into autologous hematopoietic stem cells (HSCs). The gene is then selectively turned on only in tumor-infiltrating monocytes and macrophages.

    Paracchi said Genenta expects to start its first clinical trial to treat multiple myeloma at the end of 2016 or beginning of 2017.

    Genenta also named Roger Abravanel and Gabriella Camboni to its board. Abravanel, a former McKinsey & Co. director, is a director at Teva Pharmaceutical Industries Ltd. (NYSE:TEVA). Camboni founded Ethical Oncology Science S.p.A., which was acquired by Clovis Oncology Inc. (NASDAQ:CLVS) in 2013.

  • Cancer play Syndax pulls IPO

    Syndax Pharmaceuticals Inc. (Waltham, Mass.) withdrew its IPO on NASDAQ. The company did not give a reason in a regulatory filing, and declined comment to BioCentury. Planned underwriters were Deutsche Bank; Jefferies; JMP Securities; and Wedbush PacGrow.

    Syndax said in June it planned to sell 4.3 million shares at $13-$15. At $14, it would have raised $60.2 million and been valued at $170.5 million. The company amended its IPO in November, removing the proposed number of shares and price range.

    NIH's National Cancer Institute is sponsoring a Phase III trial of Syndax's lead candidate, entinostat (SNDX-275), to treat advanced breast cancer. The trial, which began in March 2014, has an SPA from FDA. Syndax has exclusive, worldwide rights to the oral histone deacetylase (HDAC) inhibitor from Bayer AG (Xetra:BAYN).

    Syndax's investors include Domain Associates; MPM Capital; Forward Ventures; Avalon Ventures; Pappas Ventures; and Rusnano.

  • Egalet's rise continues after abuse-deterrence data

    Egalet Corp. (NASDAQ:EGLT) rose $2.43 (40%) to $8.54 on Friday, a day after reporting that 60 mg Egalet-001 had significantly lower abuse potential compared to a marketed morphine tablet. Egalet posted two-day gains of $3.61 (73%).

    The company said Thursday that "drug liking" scores for a manipulated version of its abuse-deterrent, extended-release, oral formulation of morphine were significantly lower than those for manipulated 60 mg MS Contin morphine sulfate controlled-release oral tablets from Purdue Pharma L.P. (Stamford, Conn.). The trial found no statistical difference in drug liking between intact and manipulated Egalet-001. Egalet plans to submit an NDA for its compound in mid-2016 (see BioCentury Extra, Jan. 22).

  • Venture tracks

    Frazier Healthcare promoted Ben Magnano to general partner from senior associate. He is a member of Frazier's growth buyout team, which invests in healthcare services, pharmaceutical services, healthcare IT, products, supplies and specialty distribution.

  • EMA recommends suspending drugs tested by Indian CRO

    EMA recommended that marketing authorizations be suspended for hundreds of medicines whose approvals were based primarily on clinical studies conducted at GVK Biosciences Pte. Ltd. (Hyderabad, India), a CRO. EMA sent its recommendation to the European Commission for review in advance of a legally binding decision.

    EMA based its recommendation on CHMP's review of over 1,000 "pharmaceutical forms and strengths of medicines" studied at the Indian site. CHMP began the review last September after inspectors from the French National Agency for Medicines and Health Products Safety (ANSM) alleged that 10 GVK employees falsified electrocardiograms in nine clinical trials of generic drugs from 2008-13 (see BioCentury Extra, Dec. 5, 2014).

    EMA said CHMP found sufficient evidence from sources outside of GVK to allow over 300 of the reviewed medicines to remain on the market. EMA recommends the rest be suspended unless they are deemed to be "of critical importance for patients" due to a lack of alternative therapies. EMA said its member states are to decide which drugs are critical; companies will have 12 months to submit additional data.

    EMA noted there is no evidence of harm or lack of effectiveness for any of the drugs studied at GVK and said patients should continue to take their prescribed drugs.

  • FDA panel to review compounding revisions

    FDA's Pharmacy Compounding Advisory Committee (PCAC) will meet on Feb. 23-24 to discuss proposed revisions to the agency's lists of bulk substances that may or may not be compounded under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

    PCAC will discuss comments received on FDA's notice of proposed rulemaking that seeks to add 25 drug products to the list that cannot be compounded based on new data indicating they are unsafe or ineffective.

    The committee will also discuss six bulk substances that have been nominated for inclusion on the list that can be compounded and will consider proposed criteria for further developing the list.

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