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BioCentury Extra
As published Wednesday, September 17, 2014 6:14 PM PST

  • Tokai raises $92.7M in upsized IPO

    Tokai Pharmaceuticals Inc. (NASDAQ:TKAI) was up $8.76 (58%) to $23.76 on its first day of trading Wednesday after raising $97.2 million through the sale of 6.5 million shares at $15 in an IPO. The IPO price valued the company at $327.6 million. BMO Capital Markets Corp; Stifel; William Blair; and Janney Montgomery Scott are underwriters.

    Earlier this month, Tokai said it planned to sell 5.4 million shares at $13-$15. At $14, the offering would have raised $75.6 million.

    Next half, Tokai plans to start Phase III testing of galeterone (TOK-001) to treat castration-resistant prostate cancer (CRPC). The compound is a selective androgen receptor modulator (SARM) and cytochrome P450 17 alpha-hydroxylase/C17, 20 lyase (CYP17) inhibitor.

  • Gilead's simtuzumab misses in pancreatic cancer

    Gilead Sciences Inc. (NASDAQ:GILD) said simtuzumab (GS-6624) missed the primary endpoint of progression-free survival (PFS) in a Phase II trial to treat patients with advanced pancreatic cancer.

    Patients received intravenous simtuzumab plus Gemzar gemcitabine from Eli Lilly and Co. (NYSE:LLY) or placebo plus Gemzar. Median PFS was 3.5 months for the low-dose simtuzumab group, 3.7 months for the high-dose group and 3.7 months for placebo.

    Gilead gained simtuzumab, a humanized mAb against lysyl oxidase-like 2 (LOXL2), through its 2011 acquisition of Arresto BioSciences Inc. (Palo Alto, Calif.) for $225 million.

    By year end, Gilead expects data from Phase II studies of the first-in-class mAb in colorectal cancer and myelofibrosis. Data from a Phase II trial in non-alcoholic steatohepatitis (NASH) are expected in mid-2015.

    LOXL2 cross-links collagen and creates a scaffold for fibroblasts to grow. Inhibiting the enzyme prevents infiltration and activation of fibroblasts, thereby inhibiting stroma formation around tumors. Although stroma surrounding pancreatic cancers is thought to hinder drug delivery, academic researchers recently reported that in some cases the stroma may actually be a protective response against the disease (see SciBX: Science-Business eXchange, June 12).

    Gilead closed down $0.92 to $103.84 on Wednesday.

  • Flexion falls on FX006 trial hold

    Flexion Therapeutics Inc. (NASDAQ:FLXN) fell $4.38 (23%) to $15.00 in early after-hours trading on Wednesday on post-market news that FDA placed a clinical hold on an ongoing Phase IIb trial of FX006 to treat osteoarthritis (OA) knee pain.

    Flexion said the hold is due to an infection in one patient's knee joint after an injection of FX006.

    Earlier this month, Flexion announced plans to start Phase III testing of FX006 by year end with an NDA submission to FDA expected in 1H16.

  • CVS reports on Sovaldi discontinuation rates

    Discontinuation rates for HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) were nearly four times higher in a real-world setting than in clinical trials, according to an analysis of 1,965 patients from pharmacy benefits manager CVS Caremark Corp. (NYSE:CVS).

    CVS reported an overall discontinuation rate of 8.1% for Sovaldi, up from 2% observed in clinical trials of Sovaldi plus peginterferon and ribavirin and 3.6% for Sovaldi plus Olysio simeprevir from Medivir AB (SSE:MVIR B) and Johnson & Johnson (NYSE:JNJ).

    Across all regimens, CVS said treatment-naïve patients were significantly more likely to discontinue therapy than treatment-experienced patients (8.7% vs. 5.3%, p<0.05).

    CVS has previously questioned Sovaldi's cost, $84,000 for a 12-week course of therapy (see BioCentury Extra, July 21). CVS also said it observed a downward trend in the number of new Sovaldi prescriptions from May to August, contrasting the rapid uptake after its December launch. The PBM attributed the trend to the expected release of Gilead's fixed-dose combination of Sovaldi and ledipasvir, which would require eight weeks of therapy.

    The combination is under Priority Review in the U.S., with an Oct. 10 PDUFA date. Gilead was off $0.94 to $103.82 on Wednesday.

  • Sutro, Merck KGaA in ADC deal

    Sutro Biopharma Inc. (South San Francisco, Calif.) and the EMD Serono division of Merck KGaA (Xetra:MRK) partnered to use Sutro's Xpress CF and Xpress CF+ cell-free protein synthesis technologies to discover and develop antibody-drug conjugates (ADCs) against undisclosed cancer targets.

    Sutro will receive an undisclosed upfront payment and research funding. The biotech also is eligible for up to $298 million in R&D and regulatory milestones, plus royalties.

    Sutro will be responsible for delivering ADCs for Phase I trials. EMD Serono will have exclusive, worldwide rights to resulting products and will be responsible for clinical development and commercialization.

    In June, EMD Serono partnered with Mersana Therapeutics Inc. (Cambridge, Mass.) to discover and co-develop ADCs (see BioCentury Extra, June 24).

  • Sun licenses Merck's tildrakizumab

    Merck & Co. Inc. (NYSE:MRK) granted Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) exclusive, worldwide rights to tildrakizumab (MK-3222). The anti-IL-23 antibody is in two Phase III trials to treat chronic plaque psoriasis, with data expected in June 2015.

    Merck will receive $80 million up front and is eligible for undisclosed regulatory and sales milestones as well as tiered royalties. Sun will fund Merck's ongoing clinical and regulatory development of tildrakizumab, and will assume full responsibility for further development and potential commercialization.

    The acquisition is part of Sun's plan to build a dermatology pipeline.

  • Sanofi, MyoKardia in cardiomyopathy deal

    Sanofi (Euronext:SAN; NYSE:SNY) and MyoKardia Inc. (San Francisco, Calif.) partnered to develop targeted therapeutics for hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM).

    MyoKardia will develop two HCM programs through early human efficacy studies, after which the companies will share development costs equally. Sanofi received ex-U.S rights to commercialize the HCM products, and MyoKardia retains commercialization rights in the U.S.

    Sanofi will fund development of the DCM program and has worldwide development and commercialization rights to DCM therapies.

    MyoKardia received $45 million up front, and is eligible for an additional $155 in equity investments, milestones and R&D services through 2018.

  • Auxilium jumps on Endo bid

    Auxilium jumped $9.66 (45%) to $31.18 on Wednesday after Endo International plc (NASDAQ:ENDP; TSX:ENL) made an unsolicited bid to acquire the specialty pharma postmarket on Tuesday (see BioCentury Extra, Sept. 16).

    Auxilium said it is reviewing Endo's bid but is not backing out of its ongoing merger with ophthalmic play QLT Inc. (TSX:QLT; NASDAQ:QLTI). Auxilium's board adopted a one-year stockholder rights plan.

    If Auxilium accepts Endo's offer, it would have to pay QLT a $28.4 million breakup fee.

    Endo closed up $3.08 to $68.25, while QLT was off US$0.81 (13%) to US$5.39 on Wednesday.

  • NICE draft recommends Olysio for some HCV patients

    The U.K.'s NICE issued draft guidance recommending Olysio simeprevir from Medivir AB (SSE:MVIR B) and Johnson & Johnson (NYSE:JNJ) in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infection.

    The committee did not recommend using Olysio to treat chronic HVC genotype 4 infection, and requested that the drug's owners demonstrate whether its effectiveness in genotype 1 patients can be generalized to include genotype 4.

    NICE did not recommend Olysio in combination with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat either genotype 1 or 4 infections. Comments are due Oct. 6.

    The European Commission approved Olysio, an HCV NS3/4A protease inhibitor, in May to treat HCV genotypes 1 and 4 infection in combination with peginterferon, ribavirin and/or Sovaldi. J&J and Medivir plan to launch Olysio in the EU by year end. An sNDA to expand Olysio's label to include a Sovaldi combination for HCV genotype 1 is under FDA Priority Review with a Nov. 6 PDUFA date. The pharma markets simeprevir in the U.S., Canada, Japan and Russia to treat chronic HCV genotype 1 infection in combination with interferon and ribavirin in patients with compensated liver disease.

  • NICE backs Tafinlar

    The U.K.'s NICE issued a final appraisal determination (FAD) recommending Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat adults with unresectable or metastatic melanoma with a BRAF V600 mutation, its approved indication.

    Tafinlar, which is recommended at 150 mg twice daily and comes in 28-capsule packages, has a list price of L1,400 ($2,275) for a 75 mg capsule package and L933.33 ($1,517) for a 50 mg capsule package. The pharma has agreed to provide the oral BRAF protein kinase inhibitor at an undisclosed discount under a patient access scheme, upon which NICE's recommendation is contingent.

    Novartis AG (NYSE:NVS; SIX:NOVN) is acquiring GSK's portfolio of 11 marketed cancer drugs, including Tafinlar, in a deal slated to close in 1H15 (see BioCentury, April 28).

  • NICE still mulling changes

    The U.K.'s NICE said it is undecided on how to amend its medicine and technology appraisal methods. Moreover, NICE said any changes to its appraisal methods will not sufficiently address concerns about how the NHS accesses new treatments.

    To help address such concerns, NICE proposed creating an innovation office within NICE that would work with development-stage companies. NICE also said there needs to be agreement among NICE, NHS and the Department of Health concerning NHS's "willingness to pay for new treatments."

    Finally, NICE said there should be more risk sharing between companies and NHS that could use NHS England's Commissioning through Evaluation (CtE) initiative as a model. CtE provides funding in certain circumstances for treatments or services not routinely funded by the NHS.

    In March, NICE sought input on proposed changes that would more explicitly take into account the burden of illness and the wider impact of diseases on society (see BioCentury, April 4).

    On Wednesday, the organization released the agenda and papers from relevant discussions at its board meeting (see BioCentury Extra, March 26).

  • FDA awards C-Path $2.1M

    FDA awarded the first $2.1 million of a potential $10.5 million five-year grant to the not-for-profit Critical Path Institute (Tucson, Ariz.). C-Path creates public-private partnerships to speed up drug development and approval.

    The new funding will support three consortia, which are aimed at detecting new biomarkers, examining drug toxicity and modeling the course of neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease, C-Path COO Steve Broadbent told BioCentury.

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