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Three companies from three continents announced IPO plans Friday -- Prosensa B.V. (Leiden, the Netherlands), ReproCell Inc. (Yokohama, Japan) and Evoke Pharma Inc. (San Diego, Calif.). By BioCentury's tally, this brings the queue to 18, of which 11 were filed since the beginning of April (see below).
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Prosensa B.V. (Leiden, the Netherlands) filed to raise up to $60 million in an IPO on NASDAQ underwritten by JPMorgan; Citigroup; Leerink; Wedbush; and KBC Securities. Last month, partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) reported that continuous dosing with once-weekly subcutaneous drisapersen (PRO051, GSK2402968) met the primary in a Phase IIb trial to treat Duchenne muscular dystrophy (DMD), while intermittent dosing missed the endpoint (see BioCentury, April 15, 2013).
The antisense oligoribonucleotide that induces exon 51 skipping on the dystrophin gene is in Phase III testing for DMD, with data is expected in 4Q13. GSK has exclusive, worldwide rights to develop and commercialize drisapersen from Prosensa under a 2009 deal.
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Stem cell company ReproCell Inc. (Yokohama, Japan) filed to sell 642,000 shares in an IPO on the JASDAQ Growth Market of the Osaka Securities Exchange. The offer is underwritten by SMBC Nikko Securities and seven other firms. The shares have been approved for listing and are expected to start trading June 26. The company markets induced pluripotent stem cells (iPSC)-derived cardiomyocytes and neurons for drug discovery. It also markets media and reagents for embryonic stem cells and iPSCs.
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Gastrointestinal disease company Evoke Pharma Inc. (San Diego, Calif.) filed to raise up to $23.9 million in an IPO on NASDAQ underwritten by Aegis Capital. Next half, the company plans to start a Phase III trial of EVK-001, an intranasal formulation of metoclopramide, to treat female patients with symptoms associated with acute and recurrent diabetic gastroparesis. Top-line data are expected in late 2014 or early 2015.
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Shares of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) jumped C$10.18 (13%) to C$87.02 in Toronto and $9.80 (13%) to $84.47 in New York on Friday after the Wall Street Journal reported the company is in talks to acquire ophthalmic company Bausch + Lomb Inc. (Rochester, N.Y.) from private equity group Warburg Pincus for $9 billion. Valeant and Bausch + Lomb declined to comment; Warburg Pincus could not be reached. In March, Bausch + Lomb filed to raise up to $100 million in an IPO. Bausch + Lomb markets ophthalmic pharmaceuticals, contact lenses and lens care products, as well as ophthalmic surgical devices and instruments. At March 31, Valeant had $413.7 million in cash (see BioCentury Extra, March 22).
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Astellas Pharma Inc. (Tokyo:4503) and Medivation Inc. (NASDAQ:MDVN) said the pharma submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for enzalutamide to treat prostate cancer. FDA approved the oral androgen receptor antagonist as Xtandi last August for metastatic castration-resistant prostate cancer (CRPC) in men whose disease has progressed on or after docetaxel therapy. In April, EMA's CHMP recommended approval of an MAA for Xtandi in the FDA-approved indication. The companies partnered to develop and commercialize Xtandi in 2009 (see BioCentury Extra, April 26).
Medivation was off $0.95 to $48.86 on Friday.
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Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) disclosed in an SEC filing late Thursday that partner Astellas Pharma Inc. (Tokyo:4503) said it no longer plans to submit an MAA to EMA for tivozanib (AV-951, ASP4130) to treat advanced renal cell carcinoma (RCC). According to Aveo, Astellas does not intend to fund future trials in RCC. Aveo said it is also evaluating the path forward for the indication. Tivozanib is in Phase II testing for breast and colorectal cancer. Astellas could not be reached for comment. Aveo was up $0.01 to $2.71 on Friday.
In May, FDA's Oncologic Drugs Advisory Committee voted 13-1 that the benefit-risk profile of tivozanib does not support approval to treat RCC. An NDA for tivozanib is under review, with a July 28 PDUFA date. The companies partnered in 2011 to develop and commercialize tivozanib. Aveo has exclusive ex-Asian rights to the inhibitor of VEGF receptors 1, 2 and 3 from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) (see BioCentury Extra, May 2).
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Bayer AG (Xetra:BAYN) said the European Commission approved a label expansion for 2.5 mg twice-daily Xarelto rivaroxaban to include the prevention of atherothrombotic events in combination with standard antiplatelet therapy after acute coronary syndrome (ACS) in adults with elevated cardiac biomarkers. In March, FDA issued a second complete response letter for an sNDA from the Janssen Research & Development LLC unit of U.S. partner Johnson & Johnson (NYSE:JNJ) seeking to expand Xarelto's label to include the reduction of the risk of cardiovascular events in ACS patients.
The direct Factor Xa inhibitor is approved in Europe to treat pulmonary embolism (PE) and deep vein thrombosis (DVT), to prevent venous thromboembolism (VTE) in patients undergoing hip or knee replacement surgery and to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and recurrent DVT and PE following an acute DVT.
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Five German medical societies criticized the early benefit assessment process under drug pricing law AMNOG, saying that conclusions by the Institute for Quality and Efficiency in Healthcare (IQWiG) "not infrequently" deviate from current treatment standards. The groups also said comparator therapies selected by Germany's Federal Joint Committee (G-BA) are often "unfitting" and contrary to current medical knowledge. In a statement, G-BA Chairman Josef Hecken said the arguments were "in no way convincing."
The position paper was jointly issued by the German Diabetes Society (DDG); the German Society for Internal Medicine (DGIM); the German Society for Cardiology (DKG); the German Cancer Society (DKG); and the German Society for Digestive and Metabolic Diseases (DGVS). The paper was issued in response to a request for comments on draft revisions to IQWiG's methods document, which describes its legal and scientific procedures. The comment period closed Wednesday. IQWIG has not said when the methods paper will be finalized (see BioCentury Extra, April 24).
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Consortia led by the Critical Path Institute and Europe's Innovative Medicines Initiative (IMI) partnered to develop new biomarkers to predict, diagnose and monitor drug-induced injury to the liver, kidney and vascular system. The Predictive Safety Testing Consortium (PSTC) led by C-Path and the Safer and Faster Evidence-based Translation (SAFE-T) consortium led by IMI said the partnership will submit coordinated data for review by regulatory agencies in the U.S., EU and Japan. The consortia were previously collaborating informally. In May 2011, C-Path and IMI signed a memorandum of understanding to share information and develop research and testing methods (see BioCentury Extra, June 14, 2011).
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Rep. Morgan Griffith (R-Va.) introduced a bill that would create a provisional approval process for drugs granted Fast Track designation by FDA. The Patient Choice Act of 2013 (H.R. 2090) would allow companies to request provisional approval for Fast Track compounds by submitting only safety data showing the risk of death or morbidity from the disease outweighed the risk of death from the treatment. According to Kelly Lungren McCollum, chief of staff for Rep. Griffith, companies would be required to continue to work towards regular or accelerated approval by FDA and the provisional approval would be withdrawn if a drug is reviewed but not approved by FDA.
Lungren McCollum told BioCentury the legislation does not impose limitations on off-label prescribing, though FDA could impose such limitations as part of a REMS. Patients receiving provisionally approved drugs would be required to provide informed consent.
The bill also allows a company to request provisional approval for drugs approved for more than four years in the EU or one of several "listed countries," including Japan. The bill was referred to the U.S. House Committee on Energy and Commerce.
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Speaking at the Johnson & Johnson (NYSE:JNJ) annual R&D analyst day, Joaquin Duato, worldwide chairman, pharmaceuticals, said the company expects biosimilars to compete like lower-cost branded drugs and that a biosimilar of Remicade infliximab sells at a 5% discount in Korea. The May 23 edition of BioCentury Extra misattributed the comments.
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BioCentury Extra will not publish on Monday, May 27, in observance of the Memorial Day holiday in the U.S. Postings of BioCentury Extra will resume on Tuesday, May 28.
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