The U.S. Supreme Court ruled on Monday in Federal Trade Commission v. Actavis Inc., et al. that pay-for-delay settlements between branded and generic drug manufacturers are not immune from antitrust litigation. The decision overturns a ruling by the U.S. Court of Appeals for the Eleventh Circuit that a pay-for-delay deal between the pharmaceuticals business of Solvay S.A. (Euronext:SOLB) and generic drug manufacturers, including Actavis Inc. (NYSE:ACT; formerly Watson Pharmaceuticals Inc.), was "immune from antitrust attack."
The appeals court had affirmed a district court's dismissal of the suit by the Federal Trade Commission against Solvay, which had paid generic manufacturers to abandon patent challenges and refrain from marketing a generic version of testosterone replacement therapy AndroGel. The U.S. District Court for the Northern District of Georgia dismissed the case because "the FTC had not alleged that the challenged agreements excluded competition to a greater extent than would the patent."
In a 5-3 decision, the Supreme Court held the "FTC should have been given the opportunity to prove its antitrust claim," as the anticompetitive consequences of pay-for-delay deals will "at least sometimes prove unjustified." The Supreme Court, which remanded the case back to the district court, did reject FTC's argument that pay-for-delay deals should be considered "presumptively unlawful," which would have put the burden of proof on the branded company to show the deals are not anticompetitive and unlawful.
AbbVie Inc. (NYSE:ABBV), which acquired the pharmaceuticals business of Solvay in 2010, recorded AndroGel sales of $1.2 billion in 2012.
Johnson & Johnson (NYSE:JNJ) will acquire cancer company Aragon Pharmaceuticals Inc. (San Diego, Calif.) for $650 million in cash up front, plus up to $350 million in milestones. J&J will gain Aragon's androgen receptor antagonist program, which includes ARN-509, a second-generation androgen receptor antagonist in Phase II testing to treat castration-resistant prostate cancer (CRPC). Prior to the deal, Aragon will spin out into Seragon Pharmaceuticals all of its assets outside of the androgen receptor antagonist program. The newco -- which will be financed by existing Aragon investors and will retain Aragon's management team -- will focus on Aragon's selective estrogen receptor degrader (SERD) platform, including ARN-810, an oral SERD in Phase I testing for estrogen receptor-positive metastatic breast cancer.
J&J said ARN-509 will complement Zytiga abiraterone acetate, which the pharma markets in the U.S. and EU in combination with prednisone to treat metastatic CRPC. The deal, which has been approved by the boards of both companies, is slated to close next quarter. BofA Merrill Lynch advised Aragon.
Medivation Inc. (NASDAQ:MDVN) fell $3.45 to $47.41 on Monday on news of the deal. The company and partner Astellas Pharma Inc. (Tokyo:4503) market prostate cancer drug Xtandi enzalutamide, an oral androgen receptor antagonist. Medivation is appealing a December ruling by a California state court that Aragon owns ARN-509, which Medivation has said is based on technology similar to Xtandi (see BioCentury Extra, Dec. 26, 2012).
MedImmune LLC partnered with NGM Biopharmaceuticals Inc. (South San Francisco, Calif.) to develop and commercialize peptide and antibody therapeutics to treat Type II diabetes and obesity based on a set of undisclosed secreted peptide hormones identified with NGM's enteroendocrine cell (EEC) program. The companies will characterize and prioritize the peptide hormones and will jointly develop candidates, to which MedImmune has an exclusive option to license worldwide rights. MedImmune, the biologics unit of AstraZeneca plc (LSE:AZN; NYSE:AZN), will be responsible for further preclinical and clinical development and commercialization of licensed candidates. NGM will receive an undisclosed upfront payment and research funding. The company also is eligible for undisclosed milestones, plus royalties.
Amicus Therapeutics Inc. (NASDAQ:FOLD) fell $0.65 (20%) to $2.54 on Monday after announcing that FDA said 12-month data from a Phase III trial of Amigal migalastat to treat Fabry's disease would not support approval of an NDA. The news came at a meeting Amicus had with the agency to discuss six-month data from the Phase III FACETS (Study 011) trial of Amigal. In February, Amicus had said the 12-month data, which are expected in 4Q13, would "add to the entirety of the data that FDA has indicated would support a potential U.S. conditional approval." Amicus reported six-month data from FACETS in December showing that Amigal missed the primary endpoint (see BioCentury Extra, Feb. 15).
Amicus said it now plans to meet with FDA in 2H14 to discuss a potential U.S. approval pathway for Amigal. The company also expects to report top-line data from the Phase III ATTRACT (Study 012) trial evaluating Amigal vs. enzyme replacement therapy (ERT) for Fabry's in 2H14.
Amicus is partnered with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Amigal, a small molecule that enhances alpha galactosidase A activity, under an amended 2010 deal. At March 31, Amicus had $84.8 million in cash, which it said was sufficient to fund the company until 2H14.
Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said thyroid cancer drug Caprelsa vandetanib from AstraZeneca plc (LSE:AZN; NYSE:AZN) provides "no additional benefit" over best supportive care, the comparator requested by Germany's Federal Joint Committee (G-BA). IQWiG said in a reassessment that AstraZeneca did not account for a difference in treatment duration between Caprelsa and the comparator, leading to "uncertainty" in the adverse event data. As a result, IQWiG said it "cannot be ruled out" that negative effects of Caprelsa outweigh its benefits to treat aggressive, symptomatic medullary thyroid cancer (MTC) that is unresectable and locally advanced or metastatic -- the drug's approved indication. According to IQWiG's assessment, the European Commission approved Caprelsa for a limited population to establish a positive benefit/risk profile.
AstraZeneca has until July 8 to respond to the assessment; a final assessment from G-BA is expected in early September.
Last September, G-BA issued an unfavorable benefit assessment for Caprelsa because AstraZeneca provided data from a broader patient population than the one for which the EGFR and VEGF receptor kinase inhibitor is approved. AstraZeneca took advantage of temporary changes to G-BA's assessment process allowing companies to immediately resubmit dossiers for drugs that were given a "no additional benefit" rating because data were deemed incomplete (see BioCentury Extra, Sept. 6, 2012).
Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Lyxumia lixisenatide from Sanofi (Euronext:SAN; NYSE:SNY) has "no additional benefit" over comparators requested by Germany's Federal Joint Committee (G-BA). Sanofi did not submit data directly comparing the glucagon-like peptide-1 receptor (GLP-1R) agonist to comparators. The institute said data submitted by the company indirectly comparing Lyxumia with two of the requested comparators -- in combination with metformin vs. sulfonylurea plus metformin, and in combination with basal insulin vs. human insulin -- were not "suitable."
Sanofi did not submit data indirectly comparing Lyxumia in combination with sulfonylurea vs. sulfonylurea plus metformin, another comparator requested by G-BA. Additionally, IQWiG rejected data submitted by Sanofi indirectly comparing Lyxumia plus metformin and sulfonylurea vs. basal insulin plus metformin and sulfonylurea because G-BA had requested Sanofi compare Lyxumia plus metformin and sulfonylurea vs. metformin and human insulin.
Sanofi has until July 8 to respond to the assessment; a final assessment from G-BA is expected in early September. The pharma has global commercialization rights to Lyxumia, which is under FDA review with an undisclosed PDUFA date, from Zealand Pharma A/S (CSE:ZEAL) under a 2003 deal. Zealand was up DKK1.50 to DKK68.50 on Monday.
A bid from Royalty Pharma (New York, N.Y.) to acquire Elan Corp. plc (NYSE:ELN) lapsed after Elan shareholders approved the biotech's proposal to repurchase $200 million in shares. Royalty was seeking to acquire Elan for $13 per share in cash plus a contingent value right (CVR) worth up to $2.50, which would have valued Elan at up to $7.9 billion. The bid was contingent on Elan shareholders rejecting all four transactions including the share buyback that Elan has proposed since Royalty's offer was unveiled in February.
Royalty had been seeking to make its offer contingent on Elan shareholders rejecting only two of the proposals: the acquisition of rare disease company AOP Orphan Pharmaceuticals AG (Vienna, Austria); and Elan's proposal to pay Theravance Inc. (NASDAQ:THRX) $1 billion for a 21% interest in royalties Theravance is eligible to receive from partner GlaxoSmithKline plc (NSE:GSK; NYSE:GSK) for four respiratory programs. The Irish Takeover Panel denied Royalty's request, but Royalty said the Irish High Court is scheduled to hear proceedings on Wednesday for a judicial review of the takeover panel's decision.
On Friday, Elan said it was proceeding with a formal sale process. The company was off $0.17 to $13.49 on Monday (see BioCentury Extra, June 14).
Index Ventures launched XO1 Ltd. (Cambridge, U.K.) with $11 million in a series A round to develop ichorcumab, a preclinical synthetic mAb against the exosite 1 region of thrombin licensed from the University of Cambridge. The virtual newco plans to start clinical testing of the anticoagulant in volunteers within two years. Index's David Grainger is interim CEO and the firm's Kevin Johnson joined XO1's board. Andy Walsh from Cambridge Enterprise, the university's commercialization arm, also joined XO1's board.
The investment came from Index's EUR 150 million ($197.2 million) Index Life VI, the firm's first fund solely dedicated to life sciences (see BioCentury, March 26, 2012).
Cancer company Onconova Therapeutics Inc. (Newton, Pa.) filed to raise up to $75 million in an IPO underwritten by Citigroup; Leerink; Piper Jaffray; and Janney Montgomery Scott. Onconova's rigosertib is in the Phase III ONTIME trial to treat high-risk myelodysplastic syndromes (MDS). Top-line overall survival (OS) data from the trial, for which Onconova has an SPA, are expected in 4Q13 or 1Q14. The oral dual inhibitor of phosphoinositide 3-kinase (PI3K) and polo-like kinase 1 (PLK1; STPK13) also is in the Phase III ONTRACT trial to treat metastatic pancreatic cancer and in Phase II testing to treat lower-risk MDS and head and neck cancers. Baxter International Inc. (NYSE:BAX) has exclusive European commercialization rights to rigosertib, and SymBio Pharmaceuticals Ltd. (JASDAQ:4582) has rights to develop and commercialize the compound in Japan and Korea.
Repros Therapeutics Inc. (NASDAQ:RPRX) and Exact Sciences Corp. (NASDAQ:EXAS) both announced plans late Monday to raise money in follow-ons. Repros proposed to sell up to 3 million shares in a follow-on underwritten by BofA Merrill Lynch; Lazard; Ladenburg; and Ascendiant Capital Markets. If sold at Repros' close of $17.93 on Monday, the company would raise $53.8 million. Repros' Androxal enclomiphene, a trans-isomer of clomiphene citrate, is in Phase III testing to treat secondary hypogonadism, with an NDA submission slated for mid-2014.
Separately, Exact Sciences proposed a follow-on underwritten by Jefferies and Baird. Last week, Exact Sciences said it submitted the final module of a PMA to FDA for Cologuard as a colorectal cancer screening test. Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene (see BioCentury Extra, June 10).
Repros was off $0.81 on Monday. Exact Sciences was up $0.25 to $12.59 on the day.
Gastrointestinal company RaQualia Pharma Inc. (JASDAQ:4579) said it hopes to raise at least Y3.3 billion ($34.7 million) through the exercise of 2,500 stock acquisition rights by Merrill Lynch Japan Securities. Each right entitles Merrill to purchase 1,000 shares at 90% of the previous day's closing price, with an initial exercise price of Y1,310, RaQualia's closing price on Friday, before the deal was announced. The minimum exercise price is Y917. RaQualia was up Y201 (15%) to Y1,511 on Monday.
Last year, RaQualia said it was restructuring to focus on four compounds in development for gastrointestinal diseases, including RQ-00000010, a serotonin 5-HT4 partial agonist in Phase I testing, and RQ-00000004, a H+/K ATPase pump in Phase II testing to treat gastroesophageal reflux disease (GERD) (see BioCentury Extra, Nov. 13, 2012).
India is in the process of developing a health technology assessment board and the country's Department of Health Research signed a memorandum of understanding (MOU) with the U.K.'s NICE to help with the process. NICE will provide advice and support on clinical practice guidelines and quality standards, and how to apply and implement health technology assessments. The parties are setting up a joint steering committee.
Gilead Sciences Inc. (NASDAQ:GILD) reported interim data showing twice-daily oral idelalisib led to an overall response rate (ORR), the primary endpoint, of 53.6% in the Phase II Study 101-09 to treat refractory indolent non-Hodgkin's lymphoma (NHL). In 125 patients in the single-arm, open-label trial, there were five complete responses, 60 partial responses and two minor responses, plus 46 cases of stable disease. The median progression-free survival (PFS) was 11.4 months, and 89% of patients experienced "some shrinkage" in lymph node size. Data are slated to be presented on Thursday at the Malignant Lymphoma meeting in Lugano.
Idelalisib is in Phase III testing in combination with various approved therapies for previously treated indolent NHL and for previously treated chronic lymphocytic leukemia (CLL). Gilead gained idelalisib, a small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta, through its 2011 acquisition of Calistoga Pharmaceuticals Inc. Gilead was off $1.20 to $51.03 on Monday.