Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) entered a five-year deal under which the partners will jointly develop and commercialize immuno-oncology candidates including PD-1 inhibitor REGN2810 and a pipeline of preclinical monoclonal and bi-specific antibodies. Regeneron began a Phase I study of REGN2810 in 1Q15.
While REGN2810 lags behind other clinical and marketed PD-1 and PD-L1 inhibitors, Regeneron President and CEO Leonard Schleifer said in January that having checkpoint inhibitors and antibody candidates "under one roof" would allow the company to have more control over the price of combination therapies.
The partners will jointly develop a preclinical pipeline which includes a PD-L1 inhibitor, antibodies targeting lymphocyte-activation gene 3 (LAG3; CD223) and glucocorticoid-induced tumor necrosis factor receptor (TNFR)-related protein (GITR; TNFRSF18), and bi-specific antibodies to treat hematologic and solid cancers. The companies expect to begin clinical testing next year of the candidates as monotherapies and in combinations. The deal does not include chimeric antigen receptor (CAR) therapies.
Regeneron will receive $640 million up front and is eligible for a $375 million sales milestone. Sanofi will contribute $750 million and Regeneron $250 million to fund discovery and early development of immuno-oncology antibodies. Each company will commit $325 million to develop REGN2810.
Regeneron will lead development from discovery through proof of concept trials. Sanofi can then opt in for further development, after which the companies will each lead development of candidates on an alternating basis, including serving as the U.S. commercial lead, and will share worldwide profits equally. Regeneron will lead development of REGN2810.
Under a 2009 antibody deal, Sanofi is to commit $160 million to Regeneron annually through 2017. Under the new deal, $75 million of that funding will be re-allocated to the immuno-oncology deal for the next three years.
Regeneron gained $12.42 to $552.45 on Tuesday.
Gilead Sciences Inc. (NASDAQ:GILD) reported $4.9 billion in HCV sales in 2Q15, up 41% from $3.5 billion in 2Q14. Sales of Harvoni ledipasvir/sofosbuvir were $3.6 billion in 2Q15, while sales of Sovaldi sofosbuvir declined to $1.3 billion in 2Q15 from $3.5 billion in 2Q14.
Gilead raised its 2015 full year net product sales guidance to $29-$30 billion from its April guidance of $28-$29 billion.
EVP of Commercial Operations Paul Carter said the number of new HCV patients starting treatment will "continue to be influenced by restrictions applied by payers" and noted that "going forward, we believe more payers will lower restrictions allowing patients with lower fibrosis scores to access treatment."
On July 1, Gilead narrowed the eligibility criteria for its patient access program for HCV treatments in part to "help increase access among those payers who continue to restrict access" (see BioCentury Extra, July 17).
The company reported 2Q15 non-GAAP diluted EPS of $3.15, up 33% from $2.36 in 2Q14 and beating the Street's estimate of $2.71. Total revenues for the quarter were $8.2 billion, up 26% from $6.5 billion in 2Q14. Analysts had estimated $7.6 billion in revenues.
The earnings were released after market close. Gilead gained $2.53 to $113.07 on the day.
Merck & Co. Inc. (NYSE:MRK) will acquire cancer immunotherapy play cCAM Biotherapeutics Ltd. (Misgav, Israel) in a deal worth up to $605 million.
The acquisition gives Merck lead candidate CM-24, a humanized IgG4 mAb targeting carcinoembryonic antigen (CEA)-related cell adhesion molecule 1 (CEACAM1; CD66a) that is in Phase I testing to treat advanced or recurrent solid tumors. cCAM will receive $95 million up front and up to $510 million in milestones.
cCAM's CEO and VP of R&D Tehila Ben-Moshe previously told BioCentury CM-24 has the potential to complement PD-1 inhibitors. Merck's PD-1 inhibitor Keytruda pembrolizumab is approved in the U.S. to treat advanced melanoma patients who previously received Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY) and in the EU for first line and previously treated patients with unresectable or metastatic melanoma (see BioCentury Innovations, Jan. 29).
Also on Monday, FDA accepted and granted Priority Review to an NDA for Merck's grazoprevir/elbasvir (MK-5172/MK-8742) to treat HCV genotypes 1, 4 or 6. The PDUFA date is Jan. 28, 2016. Grazoprevir is an HCV NS3/4A protease inhibitor and elbasvir is an HCV NS5A protein inhibitor.
Boehringer Ingelheim GmbH (Ingelheim, Germany) obtained exclusive, worldwide rights, excluding certain Asian territories, to lung cancer treatment HM61713 from Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940).
Boehringer will receive rights to the EGFR mutant selective inhibitor outside South Korea, China and Hong Kong. HM61713 is in a Phase II trial to treat non-small cell lung cancer in patients with T790M mutations who are resistant to other therapies targeting EGFR. The partners, which did not respond to inquiries, expect a Phase III trial to begin next year.
Hanmi will receive $50 million up front and is eligible for $680 in milestones, plus double-digit tiered royalties.
Boehringer markets Gilotrif/Giotrif afatinib and Vargatef nintedanib to treat NSCLC. Gilotrif is a dual inhibitor of EGFR1 and HER2, and Vargetef is a small molecule inhibitor of multiple pro-angiogenic kinases, including VEGF, platelet derived growth factor receptor (PDGFR) and fibroblast growth factor (FGF) receptor (FGFR).
Genomics play BGI (Shenzhen, China) announced the resignation of CEO Jun Wang. He will continue to serve as a director while he leads a new division focusing on artificial intelligence.
Diagnostics company Laboratory Corp. of America Holdings (NYSE:LH) said Deborah Keller will succeed Joseph Herring as CEO of Covance Inc. Herring is retiring. LabCorp acquired Covance in February; Keller was EVP of Covance and group president of R&D laboratories.
Osteoporosis and cancer company Radius Health Inc. (NASDAQ:RDUS) named Lorraine Fitzpatrick CMO. Fitzpatrick was medicine development leader for Xgeva denosumab at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Oncology company Forma Therapeutics Inc. named John Hohneker EVP and head of R&D. Hohneker was SVP and global head of development in immunology and dermatology at Novartis AG (NYSE:NVS; SIX:NOVN).
Gilead Sciences Inc. (NASDAQ:GILD) promoted William Lee to EVP of research and Brett Pletcher to EVP, general counsel and corporate secretary; both will join the senior leadership committee. Lee was SVP of research, and Pletcher was SVP and general counsel.
Immunomedics Inc. (NASDAQ:IMMU) sank $1.16 (31%) to $2.55 after partner UCB Group (Euronext:UCB) said epratuzumab missed its primary endpoints in the identical Phase III EMBODY 1 and EMBODY 2 trials to treat systemic lupus erythematosus (SLE).
UCB said there was no statistically significant difference between patients treated with epratuzumab plus standard therapy vs. placebo plus standard therapy. The primary endpoint was percentage of patients meeting treatment response criteria at week 48 as measured by the BILAG-based combined lupus assessment (BICLA). UCB spokesperson Andrea Christopher declined to comment on next steps for the program.
UCB has rights to epratuzumab for autoimmune indications, while Immunomedics retains rights in cancer indications. The humanized mAb targeting CD22 is in a Phase III trial in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and in Phase II studies in adults with ALL and non-Hodgkin's lymphoma (NHL).
UCB shed EUR 2.50 to EUR 67 on Tuesday.
Loxo Oncology Inc. (NASDAQ:LOXO) gained $4.33 (26%) to $20.91 after Cancer Discovery published a brief describing a response in the first patient in a Phase I trial of LOXO-101 in patients with advanced solid tumors.
The brief described one female patient with a tropomyosin receptor kinase fusion cancer, specifically advanced soft tissue sarcoma metastatic to the lungs, who had received multiple prior treatments. Loxo said the patient had a partial response after one month and "almost complete tumor disappearance" after four months of treatment with the neurotrophic tyrosine kinase receptor 1 (TrkA; NTRK1) inhibitor. Loxo said the patient's shortness of breath was resolved and quality of life improved.
VP of Corporate Strategy and Development Jacob Naarden told BioCentury Loxo is continuing to enroll patients in the dose-escalation study, which had 15 patients as of March 31. Naarden said Loxo expects full data by June 2016. The company has rights to LOXO-101 from a 2013 deal with Array BioPharma Inc. (NASDAQ:ARRY) (see BioCentury Extra, July 10, 2013).
University of Colorado Cancer Center, the Knight Cancer Institute at Oregon Health & Science University, and Foundation Medicine Inc. (NASDAQ:FMI) also participated in the study.
NantKwest Inc. (NASDAQ:NK) gained $9.64 (39%) to $34.94 in its first day of trading Tuesday after raising $207.2 million in a bumped up IPO of 8.3 million shares at $25 that valued the company at $2 billion, based on 78.9 million shares outstanding. NantKwest raised an additional $17 million through the sale of 680,000 shares to Celgene Corp. (NASDAQ:CELG) in a concurrent private placement.
Earlier this month, NantKwest (formerly Conkwest Inc.) said it planned to sell 7 million shares at $20-$23; the company filed in June to raise up to $172.5 million. NantKwest also raised $71 million last month in venture rounds (see BioCentury Extra, June 25).
BofA Merrill Lynch; Citigroup; Jefferies; Piper Jaffray; and MLV were underwriters.
NantKwest is developing a pipeline of cancer immunotherapies using activated natural killer (NK) cells.
Deerfield Management closed a $550 million healthcare venture capital fund, which it said it will invest in early stage science and therapeutics to treat genetic diseases, cancer and Orphan diseases. The firm said the fund also will invest in "technologies that can transform how therapeutics are developed and improve the way healthcare is delivered to patients."
James Flynn, the managing partner of Deerfield Management, told BioCentury the firm plans to invest the Deerfield Healthcare Innovations Fund in at least 30 companies, with investment sizes ranging from less than $1 million to as much as $50 million if necessary. He said the firm's 2014-vintage crossover fund, Deerfield Private Design III, may co-invest in start-ups alongside the new fund (see BioCentury, April 14, 2014).
LPs in the new fund include New York-Presbyterian Hospital; Memorial Sloan Kettering Cancer Center; Seattle Children's Hospital; the Robert Wood Johnson Foundation; Princeton University; and Northwestern University.
Flynn said the VC fund has already invested in TriNetX Inc. (Cambridge, Mass.), an IT company that connects clinical researchers with patients based on electronic medical records.
Reps. Scott Peters (D-Calif.) and Ryan Costello (R-Pa.) led a bipartisan group of 80 Representatives who submitted a letter to U.S. House leadership supporting a carveout to the Innovation Act (H.R. 9) that would exempt drug patents from inter partes review.
The bill, which the House Judiciary Committee passed earlier this month, includes a provision that would prevent parties such as hedge funds from using the IPR system to manipulate financial markets (see BioCentury Extra, June 11).
The letter's authors argued an exemption from IPRs is necessary to preserve a balance between the needs for innovation and for incentivizing generic and biosimilar competition that were put in place by the Drug Price Competition and Patent Term Restoration Act (commonly known as Hatch-Waxman) and the Biologics Price Competition and Innovation Act (BPCIA). They said the IPR exemption is "crucial to maintaining the substantial R&D investments needed to develop new treatments and cures."
Consumer groups and generic drug companies are lobbying against exempting drugs from IPR challenges, arguing that the exception would limit competition and increase prices. The biopharma industry has strongly supported an exemption. A House vote on the bill originally scheduled for this month has been delayed until September (see BioCentury Extra, July 16).
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