In the first lawsuit filed by an originator company over a biosimilars application, Amgen Inc. (NASDAQ:AMGN) alleged that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) has unlawfully refused to follow the patent resolution protocol laid out by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The suit, filed in the U.S. District Court for the Northern District of California, concerns Sandoz's application to market a biosimilar version of Amgen's Neupogen filgrastim G-CSF, a recombinant methionyl human granulocyte colony-stimulating factor.
Under BPCIA, Sandoz was required to provide Amgen with its BLA and manufacturing information for the biosimilar within 20 days of FDA's decision to accept the application for review. According to Amgen, Sandoz failed to disclose this information, thus depriving Amgen of the opportunity to assess potential patent infringement claims and potentially seek an injunction to prevent Sandoz from commercializing its biosimilar candidate.
Amgen is seeking restitution for unfair competition and an injunction to prevent Sandoz from commercializing the biosimilar filgrastim until Amgen is "restored to the position it would have been [in] had Defendents met their obligations under the BPCIA."
Amgen is also seeking an injunction to prevent Sandoz from advancing through FDA's approval process until the company has obtained permission from Amgen to use the filgrastim license.
Additionally, Amgen is seeking a judgement of patent infringement for U.S. patent No. 6,162,427. The suit also demands a jury trial.
In a recent interview on BioCentury This Week television, Geoffrey Eich of Amgen and Mark McCamish of Sandoz discussed their perspectives on the emerging U.S. market for biosimilars (see BioCentury This Week television, Oct. 12).
Amgen gained $2.70 to $161.58 Thursday. Novartis was up $0.64 to $91.95.
FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-1 to recommend approval of Savaysa edoxaban from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), but opinions differed on how the anticoagulant should be labeled.
In Daiichi's Phase III ENGAGE AF-TIMI 48 trial, Savaysa showed a favorable balance of risk and benefit only in a patient subgroup with mild renal impairment at the higher of two dose levels (60 mg). Patients with normal kidney function did better on warfarin.
The agency's analysis suggested the higher dose was not high enough to achieve an effective drug exposure in the body due to a renal clearance pathway for the drug. FDA speculated that higher doses might achieve similar benefits in patients with normal kidney function as those seen in patients with impaired kidney function.
The voting question for the committee was whether to recommend approval, and, if so, choose whether to approve a 60 mg dose for patients with normal or mildly impaired kidney function, approve a dose higher than 60 mg for patients with normal kidney function, or approve the drug only for patients with mild and moderate kidney impairment.
Committee members voting for approval were mixed on the three options.
Bristol-Myers Squibb Co. (NYSE:BMY) and OliPass Corp. (Suwon, South Korea) partnered to develop therapeutics against multiple targets using OliPass' peptide nucleic acid (PNA) technology platform.
OliPass will receive an undisclosed upfront payment and is eligible for development milestones and royalties. BMS will also provide research funding.
BMS declined to disclose information regarding specific compounds and targets, but said the partnership with OliPass will include a range of targets "consistent with our R&D strategy" including its interest in genetically defined diseases.
OliPass said its PNA-based compounds have shown antisense therapeutic activity in vivo at small doses.
Bristol-Myers Squibb Co. (NYSE:BMY) added $4.82 (9%) to $58.98 Thursday when it reported a 15% objective response rate (ORR) and estimated a 41% one-year survival rate in the Phase II CheckMate -063 trial evaluating Opdivo nivolumab as a third-line treatment for squamous cell non-small cell lung cancer (NSCLC). The -063 study is the basis for a rolling BLA submission to FDA that the pharma expects to complete by year end.
The single-arm study evaluated biweekly Opdivo monotherapy in 117 patients with NSCLC who had progressed after at least two prior systemic therapies. An independent review committee observed the 15% ORR at a minimum follow-up of 11 months, the study's primary endpoint. BMS compared the 41% one-year survival rate to a historically expected rate of 5.5-18%. Median overall survival (OS) for Opdivo patients was 8.2 months.
BMS expects to present CheckMate -063 data at the Chicago Multidisciplinary Symposium on Thoracic Oncology on Oct. 31.
The human IgG4 mAb against programmed cell death 1 (PDCD1; PD-1; CD279) has Fast Track designation to treat NSCLC, melanoma and renal cell carcinoma (RRC). Opdivo has a March 30, 2015, PDUFA date for previously treated advanced melanoma, for which it has breakthrough designation. EMA validated an MAA for Opdivo in the indication in September.
BMS has worldwide rights from Ono Pharmaceutical Co. Ltd. (Tokyo:4528), excluding Japan, Korea and Taiwan, where Ono retains rights. Japan approved Opdivo for unresectable melanoma in July.
Bind Therapeutics gained $1.11 (14%) to $8.94 after publication of an abstract containing preliminary data from a Phase II trial of BIND-014 to treat non-small cell lung cancer (NSCLC). The compound had a 63% disease control rate among 8 stage III/IV NSCLC patients who tested positive for the K-Ras (KRAS) mutation, including 25% with a partial response and 38% with stable disease after at least 12 weeks.
The abstract was published in advance of BIND's Nov. 19 poster presentation at the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI), and American Association for Cancer Research (AACR) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.
BIND-014 is a polymeric nanoparticle containing docetaxel that concentrates in the neovasculature surrounding tumors and targets prostate-specific membrane antigen (PSMA; FOLH1; GCPII). Patients with the KRAS mutation are generally unresponsive to solvent-based docetaxel, the abstract said.
The study enrolled 40 NSCLC patients with characterized genomic status including the epidermal growth factor (EGFR) mutation, anaplastic lymphoma kinase (ALK) rearrangement, and KRAS mutation who had failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease. Among 33 evaluable patients in all three categories, 15% had a PR and 36% had stable disease after at least 12 weeks.
Neutropenia, anemia and neuropathy, commonly seen in solvent-based D (sbD) tumors, were also reduced with BIND-014 treatment.
In May, Bind said an interim Phase II analysis of 6 patients with KRAS mutation positive stage III/IV NSCLC showed BIND-014 led to two confirmed PRs and two cases of SD ≥12 weeks.
Incyte Corp. (NASDAQ:INCY) jumped $6.31 (11%) to $64.18 on Thursday after its 3Q14 earnings beat Street expectations, including a 63% increase in Jakafi ruxolitinib sales compared to 3Q13.
Jakafi, sold outside the U.S. as Jakavi, brought in $97.8 million in 3Q14 compared to $60.2 million in the prior year period. Incyte raised 2014 Jakafi revenue guidance to $350-$360 million, up from $330-$340 million, excluding royalties on ex-U.S. sales via partner Novartis AG (NYSE:NVS; SIX:NOVN).
Overall quarterly revenue was $198.1 million and diluted EPS was $0.33, beating Street estimates of $150 million and flat, respectively. The quarter included $85 million in milestones from Novartis related to European reimbursement and Japanese approval.
The oral Janus kinase-1 (JAK-1) and JAK-2 inhibitor is approved to treat myelofibrosis (MF) in the U.S. and Japan and to treat splenomegaly or symptoms related by MF in the EU.
An sNDA for Jakafi to treat polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea is under Priority Review, with a Dec. 5 PDUFA date.
In other pipeline milestones, Incyte expects top-line data from the first Phase III trial of baricitinib (LY3009104) to treat rheumatoid arthritis (RA) in late 2014 or early 2015. Eli Lilly and Co. (NYSE:LLY) has exclusive, worldwide rights to develop and commercialize baricitinib for RA under a 2009 deal.
Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) fell $14.70 (14%) to $91.11 on Thursday as investors digested comments on the company's earnings call related to a previously announced September warning letter from FDA about off-label marketing of pain drug Exparel. The bupivacaine liposome extended-release injectable suspension is approved for postoperative pain management.
Barclays analyst Douglas Tsao asked whether FDA's letter had caused "any impact in terms of accounts."
Chairman, President and CEO David Stack said that "pharmacy-driven misrepresentations" such as that the drug now has a black box warning or was pulled from the market have "caused some market disruptions." He did not elaborate.
The stock hit came as the company reported 3Q14 revenues roughly in line with consensus estimates and EPS ahead of the Street. Net sales of Exparel were $50.2 million compared to $20 million in 3Q13 and sequentially up 12% from $44.9 million in 2Q14.
Cortendo AB (Gothenburg, Sweden) said it will raise SEK 81.5 million ($11.3 million) in a private placement. The company will also drop plans to list on the Oslo Axess exchange and consider a U.S. listing instead.
The company plans to sell 19.3 million shares at SEK 4.22 to HealthCap; Third Swedish National Pension Fund; Storebrand; and Arctic Fund Management. The financing is subject to shareholder approval at a Dec. 1 meeting. A majority of Cortendo's shareholders already plan to approve the financing and elect a board member nominated by HealthCap.
Cortendo said it will not complete its Oslo Axess listing and will de-list from Norway's NOTC, where it is traded over-the-counter. Instead, it will evaluate a U.S. financing and listing strategy to fund development of lead candidate NormoCort (COR-003).
In August, Cortendo began a Phase III trial of NormoCort to treat Cushing's syndrome. The 2S,4R-enantiomer of ketoconazole, an inhibitor of cytochrome P450 family 11 subfamily B polypeptide 1 (CYP11B1), CYP17A1 and CYP21A2, has Orphan Drug designation in the U.S. and EU.
Rhythm Pharmaceuticals Inc. (Boston, Mass.) withdrew its proposed IPO on NASDAQ. Last week, the company received $40 million up front in a deal giving Actavis plc (NYSE:ACT) an option to acquire a Rhythm subsidiary that is developing relamorelin (RM-131).
In August, Rhythm filed to raise up to $86.3 million in an IPO underwritten by Citigroup; Cowen; Canaccord Genuity; Oppenheimer; and Cantor Fitzgerald.
Actavis obtained an option to acquire the Rhythm Health Inc. subsidiary and worldwide rights to relamorelin for an undisclosed amount after Rhythm completes a Phase IIb study of the ghrelin agonist to treat diabetic gastroparesis. Rhythm expects to begin that trial by early 2015.
Rhythm already has completed two Phase II trials of relamorelin to treat diabetic gastroparesis and chronic constipation. The compound has Fast Track designation from FDA in diabetic gastroparesis.
Rhythm's other subsidiary, Rhythm Metabolic Inc., is developing the small peptide melanocortin 4 receptor (MC4R) agonist RM-493 to treat obesity. In August, Rhythm reported that RM-493 improved resting energy expenditure measured in a room calorimeter in a Phase Ib trial. The company licensed both relamorelin and RM-493 from Ipsen Group (Euronext:IPN; Pink:IPSEY).
FibroGen Inc. (San Francisco, Calif.) set terms for its IPO on NASDAQ and plans to sell 7.1 million shares at $16-$19. At $17.50, the company would raise $124.3 million and be valued at $974.3 million. Goldman Sachs; Citigroup; Leerink Partners; RBC Capital Markets; Stifel, Nicolaus; and William Blair are underwriters.
Partner AstraZeneca plc (LSE:AZN; NYSE:AZN) plans to purchase $20 million of FibroGen stock in a concurrent private placement at the IPO price.
Earlier this month, FibroGen filed to raise up to $125 million in the IPO.
The company's lead compound is roxadustat (FG-4592, ASP1517), a small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH; EGLN) that is in Phase III testing to treat anemia in chronic kidney disease (CKD). Astellas Pharma Inc. (Tokyo:4503) has rights to roxadustat from FibroGen in Japan, Europe, the Commonwealth of Independent States (CIS), the Middle East and South Africa. FibroGen and AstraZeneca partnered to develop and commercialize roxadustat worldwide, excluding the countries in which Astellas already has rights.
FibroGen also is developing FG-3019, a human mAb against connective tissue growth factor (CTFG) that is in Phase II testing to treat idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis.
EMA already allows extrapolation of evidence of biosimilarity from one indication to others. A headline in the Oct. 29 BioCentury Extra misstated the agency's existing practice.
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