Gilead Sciences Inc. (NASDAQ:GILD) slipped $3.53 to $85.02 in early after-hours trading after it reported HCV revenues that missed Street estimates and lowered its 2016 guidance, largely to reflect slowing sales and deeper discounts for HCV drug Harvoni ledipasvir/sofosbuvir. The company now expects $29.5-$30.5 billion in 2016 net sales, down from $30-$31 billion.
Total 2Q16 product sales were $7.7 billion, down from $8.1 billion in 2Q15. U.S. sales of Harvoni fell to $1.5 billion from $2.8 billion in 2Q15, while EU sales dropped to $512 million from $623 million, missing consensus estimates in both territories. Sales of Epclusa sofosbuvir/velpatasvir, approved in the U.S. last month as a pan-genotypic HCV treatment, were $64 million. For all HCV products, sales sank to $4 billion from $4.9 billion in 2Q15.
Sales of HIV products rose to $3.1 billion from $2.7 billion in 2Q15, partially offsetting the decline in HCV. Truvada emtricitabine/tenofovir sales rose to $942 million from $849 million in 1Q15. Sales of HIV treatment Genvoya were $302 million in 2Q16, beating the consensus estimate. FDA approved Genvoya in November 2015.
Total Japan revenue dropped 43% sequentially, reflecting the impact of the country's mandatory price reductions for Harvoni and Sovaldi sofosbuvir (see BioCentury Extra, March 9).
Overall revenues were $7.78 billion, down from $8.24 billion in 2Q15 and just shy of the $7.79 billion consensus.
On a conference call Monday, COO Kevin Young said Gilead expects new patient starts to decline gradually until "an equilibrium will eventually be hit" in the HCV market. He said a decrease in patient starts and increased rebates for payers both contributed to reduced HCV revenue in 2Q16, offsetting greater patient access as some payers eliminated fibrosis score qualifications for coverage of HCV treatments.
President and CEO John Milligan reiterated that the company will consider business development options in oncology.
The company reported non-GAAP diluted EPS of $3.08, down from $3.15 in 2Q15 but beating the $3.02 consensus.
Gilead released its earnings after market hours. It gained $2 to $88.55 on Monday.
Ocular Therapeutix Inc. (NASDAQ:OCUL) said it received a complete response letter from FDA for Dextenza (OTX-DP) to treat ocular pain following ophthalmic surgery. Ocular said the agency cited "deficiencies in manufacturing process and controls," but no safety or efficacy concerns.
The company said it is working with FDA to resolve the CRL. Dextenza is a hydrogel-based punctum plug that delivers sustained- and tapered-release dexamethasone over one month.
Ocular fell $0.75 (15%) to $4.42 on Monday.
Weeks after hiring patent attorney Mika Reiner Mayer as a partner, Cooley expanded its life sciences patent practice by adding Mayer's former team of 11 lawyers and patent agents from Morrison & Foerster. The hires include Walter Wu, a former physician-attorney at Morrison, who becomes a Cooley partner. Mayer, who co-founded Morrison's venture IP group, joined Cooley last month.
Tobira Therapeutics Inc. (NASDAQ:TBRA) plummeted $6.75 (60%) to $4.50 on Monday after it said cenicriviroc (formerly TBR-652) missed the primary endpoint of the Phase IIb CENTAUR study to treat non-alcoholic steatohepatitis (NASH). The compound failed to produce a two-point reduction in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) with no worsening of fibrosis stage at one year vs. placebo.
Cenicriviroc did meet a secondary endpoint, leading to a significantly higher proportion of patients whose fibrosis improved by at least one stage without worsening of steatohepatitis vs. placebo (20% vs. 10%, p=0.02). Fibrosis stage was assessed using the NASH Clinical Research Network (CRN) scoring system, according to ClinicalTrials.gov.
On a conference call Monday, CEO Laurent Fischer said Tobira plans to meet with regulators this year to discuss using one-stage fibrosis improvement without worsening of steatohepatitis as the primary outcome of a Phase III study. It hopes to start a pivotal trial as soon as possible next year, Fischer said.
The compound missed one secondary endpoint in CENTAUR, complete resolution of steatohepatitis. Fischer said FDA has told the company that CENTAUR's primary endpoint is not considered registrational.
Tobira said cenicriviroc's safety profile was comparable to placebo. It plans to present detailed CENTAUR data at an upcoming medical conference.
Tobira is also evaluating cenicriviroc in the Phase II PERSEUS study to treat primary sclerosing cholangitis. The compound is a dual CC chemokine receptor 5 (CCR5; CD195) and CCR2 (CD192) antagonist. Tobira has exclusive worldwide rights to cenicriviroc from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
Two other compounds are in Phase III to treat NASH: Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) and elafibranor (GFT505) from Genfit S.A. (Euronext:GNFT). Ocaliva is an oral farnesoid X receptor (FXR; NR1H4) agonist. Elafibranor is a dual PPAR alpha and delta agonist.
In the placebo-controlled Phase III REGENERATE study of Ocaliva, the co-primary endpoints are the proportion of patients with at least one stage of improvement of liver fibrosis with no worsening of NASH, and the proportion of patients who achieve NASH resolution with no worsening of liver fibrosis. The primary endpoint of the Phase III RESOLVE-IT study of elafibranor is NASH resolution without worsening of fibrosis.
Intercept gained $0.30 to $158.50 on Monday. Genfit was off EUR 0.32 to EUR 24.59.
Celgene Corp. (NASDAQ:CELG) said it does not plan to seek approval of Revlimid lenalidomide as a maintenance therapy for diffuse large B cell lymphoma patients who respond to first-line therapy of Rituxan rituximab plus CHOP chemotherapy. On Monday, the company said an interim analysis of overall survival data in the Phase III REMARC study showed Revlimid did not lead to an OS benefit vs. placebo in the indication.
Celgene said Revlimid met the primary endpoint of improving progression-free survival vs. placebo in REMARC, which enrolled 650 responders to induction therapy.
Revlimid, a thalidomide analog, is approved to treat multiple myeloma, myelodysplastic syndrome (MDS) and mantle cell lymphoma (MCL).
Next year, Celgene expects data from the Phase III RELEVANCE study of Revlimid plus rituximab in previously untreated follicular lymphoma, and from the Phase III AUGMENT study of the same combo in relapsed/refractory follicular and marginal zone lymphoma.
Celgene rose $0.41 to $107.93 on Monday. The company announced the news after market close, and slipped $3.23 to $104.70 in early after-hours trading.
AbbVie Inc. (NYSE:ABBV) and Bristol-Myers Squibb Co. (NYSE:BMY) plan to start a Phase I/II study this year of antibody-drug conjugate (ADC) Rova-T rovalpituzumab in combination with Opdivo nivolumab, and in combination with Opdivo plus Yervoy ipilimumab, to treat relapsed extensive-stage small cell lung cancer (SCLC).
Last month, CSO and EVP of R&D Michael Severino told investors that AbbVie intended to develop Rova-T in combination with PD-1 inhibitors and other immunotherapies, including approved checkpoint inhibitors (see BioCentury, June 13).
Rova-T is an ADC targeting delta-like protein 3 (DLL3), which is expressed on the surface of SCLC tumors in about 80% of patients, but absent on normal tissue. AbbVie obtained Rova-T via its acquisition of StemCentrx Inc. for $5.8 billion up front and up to $4 billion in milestones.
Opdivo is a human IgG4 mAb against PD-1. Yervoy is a human mAb against cytotoxic T-lymphocyte associated protein 4 (CTLA4; CD152).
Tricida Inc. (South San Francisco, Calif.) raised $55 million in a series C round led by new investor Longitude Capital. New investor Vivo Capital also participated, as did existing investors OrbiMed, Sibling Capital Ventures and Limulus Venture Partners.
This year, Tricida expects to complete and report data from a Phase I/II study of lead compound TRC101 in patients with chronic kidney disease (CKD) and metabolic acidosis. The non-absorbed compound is designed to treat electrolyte imbalances in CKD patients. The company declined to disclose TRC101's mechanism.
Longitude's David Hirsch joined Tricida's board.
Jilin Zixin Pharmaceutical Co. Ltd. (Shanghai:002118) will take a 67% stake in sequencing company Nabsys Inc. (Providence, R.I.) via a $42 million investment, according to a regulatory filing.
Nabsys develops semiconductor-based tools for genome mapping. In March, the company said it had completed a financial restructuring and re-hired founding CEO Barrett Bready.
The filing said Nabsys will receive $6 million initially, but did not disclose conditions for the company to receive the balance. Nabsys did not respond to inquiries.
Vtesse Inc. (Gaithersburg, Md.) raised $17 million from insiders in an extension of its series A round, bringing the total to $42 million. Last year, Vtesse was spun out of Orphan drug accelerator Cydan Development Inc. (Cambridge, Mass.) with $25 million.
All of the company's existing investors participated, including Alexandria Venture Investments, Bay City Capital, Lundbeckfond Ventures, New Enterprise Associates (NEA) and Pfizer Venture Investments.
Vtesse's VTS-270 is in a Phase IIb/III study to treat ultra-Orphan lysosomal storage disorder Niemann-Pick disease type C1 (NPC1). The compound has breakthrough therapy designation from FDA, and Orphan drug Designation in the U.S. and EU, for the indication.
VTS-270 is a 2-hydroxypropyl-b-cyclodextrin targeting cholesterol and sphingolipid storage. Vtesse has exclusive, worldwide rights from NIH to develop the compound for lysosomal storage disorders (see BioCentury, May 4, 2015).
Just Biotherapeutics Inc. (Seattle, Wash.) raised $14 million in a series A2 round. The Bill & Melinda Gates Foundation invested $8 million of the new money. Existing investors Merck & Co. Inc. (NYSE:MRK), Lilly Asia Ventures and Arch Venture Partners each contributed $2 million.
Just says its technology is designed to lower the costs of designing molecules and manufacturing biologics. It plans to use the funds to build its integrated lab infrastructure and a pilot plant, and to add GMP capabilities. The company is seeking to apply its technology in both developing and developed markets.
Last September, Just raised $15 million in its series A round (see BioCentury Extra, Sept. 18, 2015).
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